Have a language expert improve your writing

Run a free plagiarism check in 10 minutes, generate accurate citations for free.

  • Knowledge Base

Methodology

  • Ethical Considerations in Research | Types & Examples

Ethical Considerations in Research | Types & Examples

Published on October 18, 2021 by Pritha Bhandari . Revised on June 22, 2023.

Ethical considerations in research are a set of principles that guide your research designs and practices. Scientists and researchers must always adhere to a certain code of conduct when collecting data from people.

The goals of human research often include understanding real-life phenomena, studying effective treatments, investigating behaviors, and improving lives in other ways. What you decide to research and how you conduct that research involve key ethical considerations.

These considerations work to

  • protect the rights of research participants
  • enhance research validity
  • maintain scientific or academic integrity

Table of contents

Why do research ethics matter, getting ethical approval for your study, types of ethical issues, voluntary participation, informed consent, confidentiality, potential for harm, results communication, examples of ethical failures, other interesting articles, frequently asked questions about research ethics.

Research ethics matter for scientific integrity, human rights and dignity, and collaboration between science and society. These principles make sure that participation in studies is voluntary, informed, and safe for research subjects.

You’ll balance pursuing important research objectives with using ethical research methods and procedures. It’s always necessary to prevent permanent or excessive harm to participants, whether inadvertent or not.

Defying research ethics will also lower the credibility of your research because it’s hard for others to trust your data if your methods are morally questionable.

Even if a research idea is valuable to society, it doesn’t justify violating the human rights or dignity of your study participants.

Prevent plagiarism. Run a free check.

Before you start any study involving data collection with people, you’ll submit your research proposal to an institutional review board (IRB) .

An IRB is a committee that checks whether your research aims and research design are ethically acceptable and follow your institution’s code of conduct. They check that your research materials and procedures are up to code.

If successful, you’ll receive IRB approval, and you can begin collecting data according to the approved procedures. If you want to make any changes to your procedures or materials, you’ll need to submit a modification application to the IRB for approval.

If unsuccessful, you may be asked to re-submit with modifications or your research proposal may receive a rejection. To get IRB approval, it’s important to explicitly note how you’ll tackle each of the ethical issues that may arise in your study.

There are several ethical issues you should always pay attention to in your research design, and these issues can overlap with each other.

You’ll usually outline ways you’ll deal with each issue in your research proposal if you plan to collect data from participants.

Voluntary participation means that all research subjects are free to choose to participate without any pressure or coercion.

All participants are able to withdraw from, or leave, the study at any point without feeling an obligation to continue. Your participants don’t need to provide a reason for leaving the study.

It’s important to make it clear to participants that there are no negative consequences or repercussions to their refusal to participate. After all, they’re taking the time to help you in the research process , so you should respect their decisions without trying to change their minds.

Voluntary participation is an ethical principle protected by international law and many scientific codes of conduct.

Take special care to ensure there’s no pressure on participants when you’re working with vulnerable groups of people who may find it hard to stop the study even when they want to.

Here's why students love Scribbr's proofreading services

Discover proofreading & editing

Informed consent refers to a situation in which all potential participants receive and understand all the information they need to decide whether they want to participate. This includes information about the study’s benefits, risks, funding, and institutional approval.

You make sure to provide all potential participants with all the relevant information about

  • what the study is about
  • the risks and benefits of taking part
  • how long the study will take
  • your supervisor’s contact information and the institution’s approval number

Usually, you’ll provide participants with a text for them to read and ask them if they have any questions. If they agree to participate, they can sign or initial the consent form. Note that this may not be sufficient for informed consent when you work with particularly vulnerable groups of people.

If you’re collecting data from people with low literacy, make sure to verbally explain the consent form to them before they agree to participate.

For participants with very limited English proficiency, you should always translate the study materials or work with an interpreter so they have all the information in their first language.

In research with children, you’ll often need informed permission for their participation from their parents or guardians. Although children cannot give informed consent, it’s best to also ask for their assent (agreement) to participate, depending on their age and maturity level.

Anonymity means that you don’t know who the participants are and you can’t link any individual participant to their data.

You can only guarantee anonymity by not collecting any personally identifying information—for example, names, phone numbers, email addresses, IP addresses, physical characteristics, photos, and videos.

In many cases, it may be impossible to truly anonymize data collection . For example, data collected in person or by phone cannot be considered fully anonymous because some personal identifiers (demographic information or phone numbers) are impossible to hide.

You’ll also need to collect some identifying information if you give your participants the option to withdraw their data at a later stage.

Data pseudonymization is an alternative method where you replace identifying information about participants with pseudonymous, or fake, identifiers. The data can still be linked to participants but it’s harder to do so because you separate personal information from the study data.

Confidentiality means that you know who the participants are, but you remove all identifying information from your report.

All participants have a right to privacy, so you should protect their personal data for as long as you store or use it. Even when you can’t collect data anonymously, you should secure confidentiality whenever you can.

Some research designs aren’t conducive to confidentiality, but it’s important to make all attempts and inform participants of the risks involved.

As a researcher, you have to consider all possible sources of harm to participants. Harm can come in many different forms.

  • Psychological harm: Sensitive questions or tasks may trigger negative emotions such as shame or anxiety.
  • Social harm: Participation can involve social risks, public embarrassment, or stigma.
  • Physical harm: Pain or injury can result from the study procedures.
  • Legal harm: Reporting sensitive data could lead to legal risks or a breach of privacy.

It’s best to consider every possible source of harm in your study as well as concrete ways to mitigate them. Involve your supervisor to discuss steps for harm reduction.

Make sure to disclose all possible risks of harm to participants before the study to get informed consent. If there is a risk of harm, prepare to provide participants with resources or counseling or medical services if needed.

Some of these questions may bring up negative emotions, so you inform participants about the sensitive nature of the survey and assure them that their responses will be confidential.

The way you communicate your research results can sometimes involve ethical issues. Good science communication is honest, reliable, and credible. It’s best to make your results as transparent as possible.

Take steps to actively avoid plagiarism and research misconduct wherever possible.

Plagiarism means submitting others’ works as your own. Although it can be unintentional, copying someone else’s work without proper credit amounts to stealing. It’s an ethical problem in research communication because you may benefit by harming other researchers.

Self-plagiarism is when you republish or re-submit parts of your own papers or reports without properly citing your original work.

This is problematic because you may benefit from presenting your ideas as new and original even though they’ve already been published elsewhere in the past. You may also be infringing on your previous publisher’s copyright, violating an ethical code, or wasting time and resources by doing so.

In extreme cases of self-plagiarism, entire datasets or papers are sometimes duplicated. These are major ethical violations because they can skew research findings if taken as original data.

You notice that two published studies have similar characteristics even though they are from different years. Their sample sizes, locations, treatments, and results are highly similar, and the studies share one author in common.

Research misconduct

Research misconduct means making up or falsifying data, manipulating data analyses, or misrepresenting results in research reports. It’s a form of academic fraud.

These actions are committed intentionally and can have serious consequences; research misconduct is not a simple mistake or a point of disagreement about data analyses.

Research misconduct is a serious ethical issue because it can undermine academic integrity and institutional credibility. It leads to a waste of funding and resources that could have been used for alternative research.

Later investigations revealed that they fabricated and manipulated their data to show a nonexistent link between vaccines and autism. Wakefield also neglected to disclose important conflicts of interest, and his medical license was taken away.

This fraudulent work sparked vaccine hesitancy among parents and caregivers. The rate of MMR vaccinations in children fell sharply, and measles outbreaks became more common due to a lack of herd immunity.

Research scandals with ethical failures are littered throughout history, but some took place not that long ago.

Some scientists in positions of power have historically mistreated or even abused research participants to investigate research problems at any cost. These participants were prisoners, under their care, or otherwise trusted them to treat them with dignity.

To demonstrate the importance of research ethics, we’ll briefly review two research studies that violated human rights in modern history.

These experiments were inhumane and resulted in trauma, permanent disabilities, or death in many cases.

After some Nazi doctors were put on trial for their crimes, the Nuremberg Code of research ethics for human experimentation was developed in 1947 to establish a new standard for human experimentation in medical research.

In reality, the actual goal was to study the effects of the disease when left untreated, and the researchers never informed participants about their diagnoses or the research aims.

Although participants experienced severe health problems, including blindness and other complications, the researchers only pretended to provide medical care.

When treatment became possible in 1943, 11 years after the study began, none of the participants were offered it, despite their health conditions and high risk of death.

Ethical failures like these resulted in severe harm to participants, wasted resources, and lower trust in science and scientists. This is why all research institutions have strict ethical guidelines for performing research.

If you want to know more about statistics , methodology , or research bias , make sure to check out some of our other articles with explanations and examples.

  • Normal distribution
  • Measures of central tendency
  • Chi square tests
  • Confidence interval
  • Quartiles & Quantiles
  • Cluster sampling
  • Stratified sampling
  • Thematic analysis
  • Cohort study
  • Peer review
  • Ethnography

Research bias

  • Implicit bias
  • Cognitive bias
  • Conformity bias
  • Hawthorne effect
  • Availability heuristic
  • Attrition bias
  • Social desirability bias

Ethical considerations in research are a set of principles that guide your research designs and practices. These principles include voluntary participation, informed consent, anonymity, confidentiality, potential for harm, and results communication.

Scientists and researchers must always adhere to a certain code of conduct when collecting data from others .

These considerations protect the rights of research participants, enhance research validity , and maintain scientific integrity.

Research ethics matter for scientific integrity, human rights and dignity, and collaboration between science and society. These principles make sure that participation in studies is voluntary, informed, and safe.

Anonymity means you don’t know who the participants are, while confidentiality means you know who they are but remove identifying information from your research report. Both are important ethical considerations .

You can only guarantee anonymity by not collecting any personally identifying information—for example, names, phone numbers, email addresses, IP addresses, physical characteristics, photos, or videos.

You can keep data confidential by using aggregate information in your research report, so that you only refer to groups of participants rather than individuals.

These actions are committed intentionally and can have serious consequences; research misconduct is not a simple mistake or a point of disagreement but a serious ethical failure.

Cite this Scribbr article

If you want to cite this source, you can copy and paste the citation or click the “Cite this Scribbr article” button to automatically add the citation to our free Citation Generator.

Bhandari, P. (2023, June 22). Ethical Considerations in Research | Types & Examples. Scribbr. Retrieved January 3, 2024, from https://www.scribbr.com/methodology/research-ethics/

Is this article helpful?

Pritha Bhandari

Pritha Bhandari

Other students also liked, data collection | definition, methods & examples, what is self-plagiarism | definition & how to avoid it, how to avoid plagiarism | tips on citing sources, what is your plagiarism score.

U.S. flag

An official website of the United States government

The .gov means it’s official. Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

The site is secure. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

  • Publications
  • Account settings
  • Advanced Search
  • Journal List
  • v.21(2); 2020 Feb 5

Real‐time ethics engagement in biomedical research

Jeremy sugarman.

1 Johns Hopkins, Baltimore MD, USA

Annelien L Bredenoord

2 University Medical Center Utrecht, Utrecht the Netherlands

Biomedical research often raises ethical questions that are usually addressed ad hoc or in retrospective. Real‐time ethical engagement as part of research may be better suited to identify ethical issues.

An external file that holds a picture, illustration, etc.
Object name is EMBR-21-e49919-g001.jpg

Biomedical research inevitably involves ethical issues. Some raise broad public concerns, particularly when researchers obviously violate established ethical norms. For example, He Jiankui's work using CRISPR/Cas9 to genetically modify human embryos to prevent HIV transmission, which resulted in the birth of the world's first two gene‐edited babies, generated widespread condemnation of this use of human germline modifications. Ethical issues also arise in the earlier phases of basic research, such as the public release of the HeLa cell genome by the European Molecular Biological Laboratory that created controversy over privacy concerns. At other times, ethical issues are more subtle and may not be recognized as such or raise public concern. For instance, there are important ethical considerations related to using banked biospecimens in translational research. Similarly, creating neurological chimeric mouse models involves moral considerations related to the potential humanization of these models 1 , and embryo models from human stem cells are entangled in debates about the moral status of the embryo 2 .

Nonetheless, efforts should be taken to identify and manage ethical issues as early as possible in order to provide ethical guidance throughout the entire research process, and mitigate negative effects, harms and wrongs (K.R. Jongsma & A.L. Bredenoord, under review). In this paper, we describe how ethics expertise can contribute to biomedical research through real‐time engagement and some of the challenges associated with such efforts. To do so, we offer our experiences with two particular examples: organoid technology and umbilical cord blood (UCB) banking and transplantation.

… efforts should be taken to identify and manage ethical issues as early as possible in order to provide ethical guidance throughout the entire research process…

Is there an ethicist in the laboratory?

What exactly constitutes (bio)ethics expertise is far from a settled issue even though the issues have been broadly discussed in clinical settings 3 . Nonetheless, some distinctive elements can be identified, such as skills in reasoning about morally relevant concepts and arguments, and an understanding of relevant literature and precedents. Regardless, ethics expertise can contribute to research policies and practices in several ways. First, ethicists can help to identify and raise awareness about whether ethical challenges are involved in particular research efforts. Second, they can alert scientists to relevant guidelines or scholarship. Third, they can provide normative judgments and deliberate about appropriate courses of action or the development of novel treatments and technologies. Fourth, they can help anticipate societal impact. Fifth, they can employ methods from the social sciences to conduct empirical bioethics research with, for example, end users (patients, professionals, data subjects), to inform an anticipatory and constructively guiding approach to research practices (K.R. Jongsma & A.L. Bredenoord, under review).

Just as in clinical settings, ethics engagement can take different forms. Ad hoc consultation—the “beeper ethicist”—is a familiar way of involving ethicists in clinical practice, such as whether to discontinue life‐sustaining interventions. Ad hoc consultations are also employed for ethical questions in basic and translational research. This approach may be incredibly valuable and sufficient for some research, but a single consultation may miss the potential for more added value of what ethicists can contribute.

At the other side of the spectrum is having an ethicist or ethics team work alongside 4 or embedded with the research team. This can vary from “desk experiments” where ethicists work with teams of basic and translational researchers, to robust, real‐time engagement that involves normative research and obtaining empirical data to help inform deliberations and decision‐making (K.R. Jongsma & A.L. Bredenoord, under review). To ground this discussion in real examples, we describe our experience with real‐time ethics engagement that has employed both conceptual–normative and empirical aspects to address organoid technology and UCB banking and transplantation.

Organoid technology

Organoids are three‐dimensional self‐organized tissue cultures derived from stem cells. Organoids can be studied as models for organ growth and development, to test medications, or for transplantation. For example, gut organoids are used in the context of precision medicine for cystic fibrosis (CF), brain organoids can be used to study the biological aspects of psychiatric conditions, liver organoids are being developed for transplantation, and gastruloids that resemble early‐stage embryos provide insights into early embryonic development 5 .

Of particular relevance are concerns about conflicts of interest if ethicists merely provide window dressing for what others might consider to be unethical research.

At an early stage, pioneers in organoid research recognized that while organoids have enormous scientific and clinical potential, there were some associated ethical issues, so they approached the University Medical Center Utrecht ethics team for advice 5 . A small interdisciplinary team subsequently analyzed the ethics and research implications of organoid technology throughout the research cycle, from fundamental preclinical research to translational and clinical applications, as well as the societal impacts 5 . The team also looked at the ethics of organoid biobanking. Internal funding made it possible to have a small team of ethicists embedded in both the Hubrecht Institute where the organoids were developed and the Wilhelmina Children's Hospital whose patients participated in organoid‐related research.

Organoid technology is particularly promising for CF, as it offers a strikingly accurate personalized model of the disease. Intestinal organoids, derived from rectal biopsy material, permit the prediction of individual drug response 6 , but the value and concerns regarding this emerging technology were initially unclear. The team therefore decided to explore patients’ perspectives on organoid technology in a qualitative study. Specifically, the team conducted 23 interviews with 26 respondents: 14 adult patients and 12 parents of young patients with CF 6 . In addition, the team conducted three focus groups with patients or parents of patients with metabolic disorders, to discuss the ethical challenges of a first in human liver organoid transplantation trial. These empirical studies provided invaluable input about what patients and tissue donors perceive as the key ethical dimensions of organoid technology.

Cystic fibrosis patients and their parents, for example, expressed an ambiguous relationship to organoids as both closely and distantly related to themselves. These and other findings inspired further reflection on the moral status of organoids and other key ethical themes such as commercial use, consent, and governance. Particularly, the notion of organoids as hybrids that relate to persons and their bodies and to technologies and markets in ambiguous ways helped to prompt rethinking about the (commercial) use and exchange of organoids in an ethically sound way 7 .

The ethical challenges of organoid research are not limited to national borders, as legislation regarding the derivation, use, and storage of stem cells and the launch of clinical trials can be different on national, European Union (EU), and international levels. At the moment, the Utrecht ethics group is involved in an EU H2020 project aimed at building a European Organoid Biobank for patients with rare CF mutations ( http://www.hitcf.org ), where the ethics team co‐produces the governance and ethics of this biobank.

Umbilical cord blood banking and transplantation

Umbilical cord blood banking is now commonplace, and UCB transplantation is a standard treatment option for a variety of diseases and conditions. However, as these practices were first being explored, an array of ethical challenges were encountered. Relatively soon after the first successful UCB transplantation was performed and the first UCB banks were being constructed, one of the scientific leaders sought ethics expertise, which initially resulted in a collaborative conceptual scoping paper, outlining some of the main ethical issues 8 .

As described in more detail elsewhere 9 , a series of ethics activities followed. First, in order to include the perspectives of additional stakeholders, a working group was assembled to deliberate the relevant issues and to offer guidance. Second, given that the informational needs and perspectives of pregnant women regarding the possible collection of UCB were unclear, a series of focus groups was conducted that proved invaluable in designing and implementing a recruitment and informed consent process for a public UCB bank. Third, in order to assess the effectiveness of these processes, a quantitative survey of those who donated UCB was performed. Fourth, qualitative analyses of marketing messages of different cord blood banks were carried out to inform deliberations about their ethical appropriateness. Subsequently, ad hoc consultations have been used to address emerging issues in UCB transplantation, for example, as it is being explored for non‐malignant conditions.

Potential barriers

Despite the benefits, robust ethics engagement can face a series of potential barriers. For example, scientists must be open to ethics engagement and inquiry, and that requires collaboration, openness, time, and resources. It may also include the need for funding, which may not be trivial; however, in our experience, it accounts for only a small fraction of the funding for most scientific endeavors. When there are insufficient funds available to support ethics engagement, it can be possible to seek institutional or external support. Yet, the process of obtaining funding may take considerable time, slowing down the analyses of the ethical issues as research is proceeding.

There are options for engaging ethics expertise into basic and translational research in ways that can be grounded in the realities of scientific research.

Of course, ethics engagement can itself be associated with ethics concerns. Of particular relevance are concerns about conflicts of interest if ethicists merely provide window dressing for what others might consider to be unethical research. As with conflicts of interests associated with research in general, the nature of support and contributions should be transparent in describing the work and any resulting guidance, including publications and presentations. Depending on the nature of the initiative, it can be prudent to somehow involve those who are otherwise external to the project or an institution in developing or reviewing recommendations and publications. Additional ethics concerns arise when conducting empirical bioethics research, which can usually be addressed through existing oversight mechanism, such as review (or review exemption) by research ethics committees.

Further reading

Boers SL, Van Delden JJM, Clevers H, Bredenoord AL (2016) Organoid biobanking: identifying the ethics. EMBO Reports 17(7):938–41

This paper reviews whether and to what extent organoids give new twists to the ethical challenges in stem cell research and related fields, particularly the ethical challenges related to the donation, storage, and use of organoids.

Boers SN, Bredenoord AL (2018) Consent for governance in the ethical use of organoids. Nature Cell Biology 20:642–645

The authors propose consent for governance as a promising paradigm for the derivation, storage, and use of complex human tissue products, among which organoids. Consent for governance entails an initial consent procedure that provides donors with information on governance and shifts the ethical emphasis from initial consent to ongoing governance obligations, which include protection of donor privacy, participant engagement, benefit sharing, and ethical oversight.

Bruce CR, Peña A, Kusin BB, Allen NG, Smith ML, Majumder MA (2014) An embedded model for ethics consultation: characteristics, outcomes, and challenges. AJOB Empirical Bioethics 5:3, 8–18, https://doi.org/10.1080/23294515.2014.889775

In this paper, the authors describe a model of clinical ethics consultation, which they term “embedded ethics” and involves embedding clinical ethics consultants within clinical specialties and subspecialties based on institutional needs and areas of clinical ethicists’ expertise.

Huch M, Gehart H, van Boxtel R, Hamer K, Blokzijl F, Verstegen MM, Ellis E, van Wenum E, Fuchs SA, de Ligt J, van de Wetering M, Sasaki N, Boers SJ, Kemperman H, de Jonge J, IJzermans JN, Nieuwenhuis EE, Hoekstra R, Strom S, Vries RR, van der Laan LJ, Cuppen E, Clevers H (2015) Long‐term culture of genome‐stable bipotent stem cells from adult human liver. Cell 160(1–2):299–312

This report describes that single mouse Lgr5 + liver stem cells can be expanded as epithelial organoids in vitro and can be differentiated into functional hepatocytes in vitro and in vivo. The authors also delineate conditions allowing long‐term expansion of adult bile duct‐derived bipotent progenitor cells from human liver.

Porter KM, Danis M, Taylor HA, Cho, MK, Wilfond BS, on behalf of the Clinical Research Ethics Consultation Collaborative Repository Group (2018) The emergence of clinical research ethics consultation: insights from a national collaborative. The American Journal of Bioethics 18:1, 39–45, https://doi.org/10.1080/15265161.2017.1401156

The report describes a national research ethics consultation (REC) service as a forum in which to discuss challenging or novel ethical issues not fully addressed by regulations. This is a reaction to the increasing complexity of human subjects research and its oversight.

Travis J. Privacy flap forces withdrawal of DNA data on cancer cell line. Science 2013 March 26. Available at: https://www.sciencemag.org/news/2013/03/privacy-flap-forces-withdrawal-dna-data-cancer-cell-line

This paper describes the controversy after the European Molecular Biology Laboratory (EMBL) announced that a research team had deciphered much of the genetic sequence of the widely used HeLa cell line and had made the information available publicly. EMBL has withdrawn those data and apologized for potentially violating the privacy of Henrietta Lacks, the woman who was the original source of the cells, and that of her descendants.

Concluding comments

There are options for engaging ethics expertise into basic and translational research in ways that can be grounded in the realities of scientific research. While we have provided some examples based on our experience, more rich descriptions of both good and bad experiences with ethics engagement are needed to help inform the refinement of these approaches. Such information should be useful in establishing best practices for ethics engagement to improve the process of science. This seems far superior to retrospective ethics critiques once work is published. More importantly, engaging ethics expertise should enhance the possibility of conducting ethically sound research.

Conflict of interest

Jeremy Sugarman is a member of Merck KGaA's Bioethics Advisory Panel and Stem Cell Research Oversight Committee; is a member of IQVIA's Ethics Advisory Panel; and has been a consultant to Portola Pharmaceuticals, Inc. Annelien Bredenoord is a member of IQVIA's Ethics Advisory Panel.

EMBO Reports (2020) 21 : e49919 [ PMC free article ] [ PubMed ] [ Google Scholar ]

Thank you for visiting nature.com. You are using a browser version with limited support for CSS. To obtain the best experience, we recommend you use a more up to date browser (or turn off compatibility mode in Internet Explorer). In the meantime, to ensure continued support, we are displaying the site without styles and JavaScript.

  • View all journals
  • My Account Login
  • Explore content
  • About the journal
  • Publish with us
  • Sign up for alerts
  • Open access
  • Published: 22 April 2023

Ethical considerations for researchers developing and testing minimal-risk devices

  • Anna Wexler   ORCID: orcid.org/0000-0002-6723-9038 1 &
  • Emily Largent 1  

Nature Communications volume  14 , Article number:  2325 ( 2023 ) Cite this article

4255 Accesses

12 Altmetric

Metrics details

  • Engineering
  • Institutions
  • Materials for devices

This comment provides an overview of ethical considerations for researchers developing and testing minimal-risk devices that interact or interface with people, such as electronic wearables and biomedical sensors. We outline the process of independent review, emphasizing that research can undergo different levels of review depending on its design and risk level. Using scenarios drawn from our own experience, we outline salient ethical considerations for research with such minimal-risk devices.

An increasing number of tools and devices that directly interact or interface with people for electronic wearable and bioengineering applications are being developed, tested, and marketed to consumers 1 . For example, wearable devices, which may record everything from skin temperature to electrical brainwave signals, enable wearers to monitor a wide range of information generated by their bodies. Part of the device development process includes prototyping and testing, as researchers must establish the reliability and validity of their wearable by having people use it. Many engineers and materials scientists may, however, not be aware that they should obtain approval from an independent review committee prior to testing their device with people. This independent oversight requirement does not merely apply to clinical trials testing novel drugs or devices in patient populations; it can also extend to researchers and engineers developing seemingly “harmless” sensors or conducting “quick” validation tests on themselves or members of their lab group.

In the process known as “independent review,” researchers submit a detailed study plan or “protocol” to a group of experts not affiliated with the research who are able to assess the protocol and ensure its compliance with ethical standards and relevant research regulations. Independent review can be a legal requirement (e.g., for government-funded research or research submitted to drug or device regulators) or an institutional one (e.g., if the research is conducted under the auspices of a university or academic medical center). Other gatekeepers may also require independent review. For example, before publication, many academic journals require authors to affirm their studies were conducted with adequate participant protections, and platforms such as Apple’s app store require evidence of independent ethics review before distributing software that collects data for research purposes 2 . Notably, compliance with such requirements cannot be achieved retrospectively; thus, researchers must address independent review prospectively or risk myriad consequences.

In this article, we provide an overview of research ethics considerations for researchers developing and testing wearable health devices with human subjects. We first review the importance of independent review. Next, we outline the process of independent review, emphasizing that research can undergo different levels of review depending on its design and risk level. Finally, using scenarios drawn from our real-word experience, we outline salient ethical considerations for research with wearables and describe the steps researchers can take to ensure compliance with ethics requirements.

Why is independent review important?

Though a researcher may simply be seeking to better understand the performance or function of their wearable device, if they are doing so by interacting with and collecting information from living individuals, they are conducting “human subjects research” (see Table  1 for definition). Multiple national and international consensus documents have set forth ethical guidelines for research conducted with human subjects 3 . There are notable commonalities across these research ethics guidelines, which have been distilled by prominent research ethicists into seven requirements for ethical research 3 . These requirements apply to human subjects research, including but not limited to research with wearable health devices. The research must be (1) socially valuable and (2) scientifically rigorous, as well as offer (3) a favorable risk–benefit ratio. Subjects must (4) be selected fairly and (5) give informed consent for their participation. Researchers must (6) demonstrate respect for potential and enrolled subjects. Finally, the research must (7) undergo independent review. As we discuss below, independent review helps to assure compliance with relevant ethical and regulatory requirements and to address additional issues as they arise.

Researchers have certain reasonable interests—such as the desire to publish, develop and market a new wearable health device, or obtain grant funding—that may not be aligned with subjects’ interests. Even well-intentioned researchers may be unable to reflect impartially on their own research. Review by individuals unaffiliated with the research provides an opportunity for impartial assessment to minimize the effects of any conflicts of interest and ensure appropriate safeguards are in place to protect and promote subjects’ wellbeing 3 .

For this reason, numerous stakeholders might require independent review. For instance, in the United States, independent review is required for clinical investigations of interventions—such as drugs, biologics, and devices—under the jurisdiction of the U.S. Food and Drug Administration, as well as for human subjects research funded by many federal agencies. Institutions engaged in federally-funded human subjects research, such as universities and academic medical centers, must comply with federal research regulations, and many elect to extend independent review requirements to all human subjects research conducted under their auspices, regardless of funding source. Similar regulations and guidelines exist across the globe 3 , 4 .

Before prototyping and testing their wearable devices, researchers should acquaint themselves with any relevant independent review requirements. This involves becoming familiar with both legal and local institutional requirements. Furthermore, even absent a legal or institutional requirement, independent review may be necessary to satisfy other stakeholders, including private funders, academic journals, or app platforms. Thus, researchers should also consider their funding source as well as how they might want to disseminate their findings or market their wearable health devices and address any oversight requirements entailed by those choices.

Who conducts independent review, and how does it proceed?

Independent review is undertaken by committees officially constituted to oversee human subjects research 5 . In the United States, these are known as institutional review boards (IRBs); elsewhere they may be known as research ethics committees or independent ethics committees 4 , 5 , 6 . Hereafter, we will use “committee” or “independent review committee” to refer to these bodies. Committee members typically have a range of expertise so that they can provide robust review. Some committees are operated by academic or other institutions, others are operated by governments or funders 7 , and still others are independent (i.e., not affiliated with an institution) and review research for a fee 8 .

While each independent review committee has different requirements, reflecting both their own policies and relevant regulations, a researcher who is conducting human subjects research typically must prepare and submit a detailed protocol that outlines the study objectives, methods, data management and analysis procedures, and plans to address ethical issues that may arise. This protocol is then reviewed by the committee, which can approve it, require modifications to it, or reject it. If a researcher has questions—for instance, regarding the need for independent review or how to prepare a protocol—many committees have websites that provide submission guidelines and resources, as well as contact information for the committee.

Protocols may undergo different levels of review depending on specific aspects of the study’s design and risk profile. For example, in the United States, there are three main designations: exempt research , expedited review , and full committee review (see Fig.  1 ). Research that involves “minimal risk” (see Table  1 ) to subjects and includes only behavioral research—such as surveys or passive observation—may be deemed exempt from federal regulations and need not undergo IRB review, though the IRB may still need to assess the protocol to confirm its exempt status. Research that involves minimal risk but does not meet the requirements for an exemption may qualify for expedited review . For example, data collected through noninvasive means, such as wearable devices and sensors, or via recordings (e.g., audio, textual, or visual) will typically qualify for expedited review. When review is expedited, the protocol may be reviewed by one or more experienced IRB members without the need to convene the full committee, which may result in faster review. All research that is deemed to involve higher levels of risk requires full committee review . Importantly, researchers themselves do not determine the appropriate level of review; this assessment is made by the committee after the protocol’s submission.

figure 1

A researcher developing a new device should carefully consider whether the research must undergo independent review prior to commencing research. If independent review is necessary, the researcher must prepare a protocol and submit it to an independent review committee that will determine the appropriate level of review (i.e., exempt, expedited, or full committee review). The committee will review the protocol, and either approve it, require modifications, or reject it. Research should only begin once the protocol is approved.

Independent review committees are generally subject to legislation at the national level, with a goal of better serving local needs and addressing cultural preferences 6 . This can result in substantial variability in review procedures between and within countries and underscores the importance of familiarizing oneself with relevant laws 6 , 7 , 9 . While the details do vary, in a broad sense, most committees will look to see that the seven requirements of ethical research, described above, are satisfied.

What do independent review committees look for in a research protocol involving human subjects?

While it is not possible to cover all ethical considerations relevant to device research, here we use two scenarios of researchers developing wearable health devices to illustrate salient ethical features that researchers should consider. Note that the ethical issues highlighted here are not unique to wearable device research and must also be addressed for other kinds of research with human subjects.

Scenario 1: A university professor is developing a wet adhesive on-skin sensor that assesses both cardiac rhythms and hydration levels. The professor plans to validate the device on students enrolled in a course she teaches. She would like to collect additional data from students’ smartphones, such as location and activity data, to see if she can detect meaningful correlations between physical activity, heart rate, and hydration levels .

Fair subject selection : The proposed sample—students enrolled in the professor’s course—is a “convenience sample,” chosen for being close at hand rather than for the advancement of scientific goals. This raises questions about fair subject selection—that is, whether the subjects are chosen for scientific purposes rather than factors unrelated to the purposes of the study, like vulnerability or privilege. Indeed, this sample may differ from the general population in some way, introducing bias. Thus, in developing study methodology, researchers should ensure that their sample is fairly chosen and justified by the science.

Risk–benefit ratio : Although the research described in the above scenario would likely meet the definition of minimal risk, this will be a fact-specific determination, as wet adhesives involve chemicals that can irritate the skin or cause allergic reactions. The committee will consider physical risks as well as psychological, social, and economic risks. The professor in the scenario, like all researchers, should enumerate risks and burdens to subjects, identify and implement steps to minimize them, and—once they are minimized—weigh whether the potential benefits of the study (i.e., either direct benefits to participants or socially beneficial knowledge) outweigh the risks to subjects.

Data protection and privacy : Breaches of privacy and confidentiality pose risks to participants. In this scenario, the location data the professor proposes to collect may intrude on her students’ privacy and, if breached, reveal sensitive information like home addresses. When creating a study plan, researchers should consider the least-intrusive means of achieving their research aims and propose clear methods of data protection like encrypting data or stripping it of identifiers.

Informed consent : Prior to participating in a study, prospective participants must understand the purpose of the study as well as attendant risks and benefits so they can make an informed decision about participation. This is usually achieved through an “informed consent” process in which the researcher shares key information about a study with a prospective subject, often orally and in writing. Independent review committees often make templates or standard language available to researchers to ensure the disclosure of all necessary information, some of which may be dictated by research regulations.

It is important that consent is not only informed but voluntary, and independent review committees are charged with assuring that consent is obtained under circumstances that minimize the possibility of coercion or undue influence. (Coercion occurs when there is a threat to make an individual worse off or to deny them of something to which they are entitled, and undue influence occurs when something of extreme value is offered to individuals, leading them to make an unreasonable decision) 10 . In the above scenario, committee members may be reasonably concerned that the professor’s students will feel compelled to participate given the power imbalance in their student–teacher relationship. For example, students might worry that they will be graded more harshly if they do not enroll. When developing a study protocol, researchers should take care to consider and address potential threats to voluntariness.

Incidental findings : Previously unknown medical conditions may be unintentionally discovered in the course of research; such a discovery is known as an “incidental finding” 11 . In this scenario, it is possible that the professor might detect a heart arrythmia in one of her students that would require medical attention. Researchers should anticipate that incidental findings may arise in their studies and prospectively develop plans for managing them; this might include informing individuals of such findings or referring them to an appropriate clinician.

Scenario 2: An engineering Ph.D. student is developing a t-shirt with an integrated electrothermal heater that can be worn during cold-weather sports activities to improve athletic performance. He has comprehensively tested mechanical robustness and uniform temperatures in the lab and would like to commence testing the t-shirt on people. To avoid having to find volunteers, he plans to test on the shirt on himself and submit the results for publication in an academic journal .

Self-experimentation : Independent review may seem unnecessary when the researcher and human subject are one and the same because we think autonomous individuals can permissibly choose to impose risks and burdens on themselves, but many academic institutions have policies requiring researchers to obtain approval prior to experimenting on themselves 12 . Further, given that the Ph.D. student plans to submit his research for publication, he will likely need evidence of independent ethics review even if the source of his data is self-experimentation. This scenario illustrates the importance of being familiar with local requirements and considering downstream uses of the data to ensure compliance with independent review obligations.

Scientific rigor : Independent review committees will often assess whether the proposed research methods are valid and feasible and will answer the research question. In this scenario, the committee will likely worry that having only one research participant means that there will not be sufficient power for data analysis. Because research involves exposing subjects to risks, researchers should design their studies to have clear scientific objectives and utilize accepted methods.

Additional ethical considerations

Several additional ethical issues fall outside independent review committees’ typical purview review but are worth mentioning. First, many wearable devices that utilize biomedical sensors—such as pulse oximeters and heart rate monitors—have been shown to be less accurate for individuals with darker skin tones 13 . Researchers should take care not to test their prototypes on homogenous groups of individuals, which may introduce bias and limit generalizability.

Second, while there is a tendency to assume that more data is always beneficial, this is not necessarily the case. Consider wearable electroencephalogram (EEG) devices, which are intended to enable better at-home seizure detection and monitoring for individuals with epilepsy. While these devices are being developed with the intention of improving patients’ lives, there might be unintended negative consequences. For example, EEG devices may capture data regarding subclinical seizures (i.e., only detectable via EEG) that could limit individuals’ driving privileges 14 .

Finally, while researchers tend to assume that their wearable devices will be used in the manner intended, others may utilize devices in unexpected ways. In the realm of noninvasive brain stimulation, for instance, early prototypes of simple brain stimulation devices led to the rise of a do-it-yourself community wherein members of the public turned to investigator-published literature to inform their practices 15 , despite warnings that safety was not yet well established. Thus, even during development, researchers should be aware of how their devices and research findings may be used in unintended ways.

As researchers develop novel wearable health devices and begin testing them with people, it is crucial that they understand and comply with relevant research ethics requirements and regulations. This includes satisfying independent review requirements imposed by their institution, funder, government, or other stakeholders prior to commencing research, as ethics approval cannot be obtained retroactively. For researchers conducting research outside of institutions that have standing review committees, there are independent committees that will review protocols for a fee. Researchers can reach out to the committee reviewing their protocols to ask questions (e.g., about the level of review) and to obtain helpful resources, such as directions for protocol preparation or informed consent form templates. Furthermore, maintaining an awareness of additional ethical considerations—such as the possibility of bias, downstream implications, and unintended uses—can help researchers develop wearable health devices in a responsible manner.

Tu, J. & Gao, W. Ethical considerations of wearable technologies in human research. Adv. Healthc. Mater. 10 , 2100127 (2021).

Article   CAS   Google Scholar  

Meyer, M. N. There oughta be a law: when does(n’t) the U.S. Common Rule apply? J. Law Med. Ethics 28 , 60–73 (2020).

Article   Google Scholar  

Emanuel, E. J., Wendler, D. & Grady, C. What makes clinical research ethical? JAMA 283 , 2701–2711 (2000).

Article   CAS   PubMed   Google Scholar  

Liu, X. et al. Performance of IRBs in China: a survey on IRB employees and researchers’ experiences and perceptions. BMC Med Ethics 23 , 89 (2022).

Article   PubMed   PubMed Central   Google Scholar  

Grady, C. Institutional review boards purpose and challenges. Chest 148 , 1148–1155 (2015).

Timmers, M. et al. How do 66 European institutional review boards approve one protocol for an international prospective observational study on traumatic brain injury? Experiences from the CENTER-TBI study. BMC Med. Ethics 21 , 36 (2020).

Ding, J., Yin, Y., Fang, K., Zhang, W. & Luo, S. A narrative review on the development of the ethical review mode of multicenter clinical trials in China. Ann. Transl. Med. 10 , 1–10 (2022).

Lynch, H. F. & Rosenfeld, S. Institutional review board quality, private equity, and promoting ethical human subjects research. Ann. Intern. Med. 173 , 558–562 (2020).

Article   PubMed   Google Scholar  

Bartlett, E. E. International analysis of institutional review boards registered with the U.S. Office for Human Research Protections. J. Empir. Res. Hum. Res. 3 , 49–56 (2008).

Largent, E. A. & Lynch, H. F. Paying research participants: regulatory uncertainty, conceptual confusion, and a path forward. Yale J. Health Pol. Law Ethics 17 , 61–141 (2017).

Google Scholar  

Wolf, S. M. et al. Managing incidental findings in human subjects research: analysis and recommendations. J. Law Med. Ethics 36 , 219–248 (2008).

Meyer, M. Whose business is it if you want to induce a bee to sting your penis? Bill of Health. https://blog.petrieflom.law.harvard.edu/2014/04/04/whose-business-is-it-if-you-want-to-induce-a-bee-to-sting-your-penis/ (2014).

Zinzuwadia, A. & Singh, J. P. Wearable devices—addressing bias and inequity. Lancet Digit. Health 4 , e856–e857 (2022).

Antwi, P. et al. Driving status of patients with generalized spike–wave on EEG but no clinical seizures. Epilepsy Behav. 92 , 5–13 (2019).

Wexler, A. The practices of do-it-yourself brain stimulation: implications for ethical considerations and regulatory proposals. J. Med. Ethics 42 , 211–215 (2016).

Common Rule. 45 C.F.R. § 46.102. https://www.hhs.gov/ohrp/regulations-and-policy/regulations/45-cfr-46/revised-common-rule-regulatory-text/index.html (2018).

Download references

Acknowledgements

E.L. and A.W. acknowledge funding from the NIH National Institute on Aging (NIA) under award number P30-AG-073105. E.L. is supported by the Greenwall foundation and the NIA under awards K01AG064123 and R01AG077111. A.W. is supported by the NIH Office of the Director under Award Number DP5OD026420.

Author information

Authors and affiliations.

Department of Medical Ethics & Health Policy, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA

Anna Wexler & Emily Largent

You can also search for this author in PubMed   Google Scholar

Contributions

AW and EL jointly contributed to the conception, writing, and editing of this manuscript.

Corresponding author

Correspondence to Anna Wexler .

Ethics declarations

Competing interests.

The authors declare no competing interests.

Peer review

Peer review information.

Nature Communications thanks William Navaraj and the other, anonymous, reviewer(s) for their contribution to the peer review of this work.

Additional information

Publisher’s note Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Rights and permissions

Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The images or other third party material in this article are included in the article’s Creative Commons license, unless indicated otherwise in a credit line to the material. If material is not included in the article’s Creative Commons license and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this license, visit http://creativecommons.org/licenses/by/4.0/ .

Reprints and permissions

About this article

Cite this article.

Wexler, A., Largent, E. Ethical considerations for researchers developing and testing minimal-risk devices. Nat Commun 14 , 2325 (2023). https://doi.org/10.1038/s41467-023-38068-6

Download citation

Received : 09 January 2023

Accepted : 13 April 2023

Published : 22 April 2023

DOI : https://doi.org/10.1038/s41467-023-38068-6

Share this article

Anyone you share the following link with will be able to read this content:

Sorry, a shareable link is not currently available for this article.

Provided by the Springer Nature SharedIt content-sharing initiative

Quick links

  • Explore articles by subject
  • Guide to authors
  • Editorial policies

Sign up for the Nature Briefing newsletter — what matters in science, free to your inbox daily.

scholarly articles on ethical considerations in research

  • Original article
  • Open access
  • Published: 13 July 2021

Assisting you to advance with ethics in research: an introduction to ethical governance and application procedures

  • Shivadas Sivasubramaniam 1 ,
  • Dita Henek Dlabolová 2 ,
  • Veronika Kralikova 3 &
  • Zeenath Reza Khan 3  

International Journal for Educational Integrity volume  17 , Article number:  14 ( 2021 ) Cite this article

13k Accesses

11 Citations

4 Altmetric

Metrics details

Ethics and ethical behaviour are the fundamental pillars of a civilised society. The focus on ethical behaviour is indispensable in certain fields such as medicine, finance, or law. In fact, ethics gets precedence with anything that would include, affect, transform, or influence upon individuals, communities or any living creatures. Many institutions within Europe have set up their own committees to focus on or approve activities that have ethical impact. In contrast, lesser-developed countries (worldwide) are trying to set up these committees to govern their academia and research. As the first European consortium established to assist academic integrity, European Network for Academic Integrity (ENAI), we felt the importance of guiding those institutions and communities that are trying to conduct research with ethical principles. We have established an ethical advisory working group within ENAI with the aim to promote ethics within curriculum, research and institutional policies. We are constantly researching available data on this subject and committed to help the academia to convey and conduct ethical behaviour. Upon preliminary review and discussion, the group found a disparity in understanding, practice and teaching approaches to ethical applications of research projects among peers. Therefore, this short paper preliminarily aims to critically review the available information on ethics, the history behind establishing ethical principles and its international guidelines to govern research.

The paper is based on the workshop conducted in the 5th International conference Plagiarism across Europe and Beyond, in Mykolas Romeris University, Lithuania in 2019. During the workshop, we have detailed a) basic needs of an ethical committee within an institution; b) a typical ethical approval process (with examples from three different universities); and c) the ways to obtain informed consent with some examples. These are summarised in this paper with some example comparisons of ethical approval processes from different universities. We believe this paper will provide guidelines on preparing and training both researchers and research students in appropriately upholding ethical practices through ethical approval processes.

Introduction

Ethics and ethical behaviour (often linked to “responsible practice”) are the fundamental pillars of a civilised society. Ethical behaviour with integrity is important to maintain academic and research activities. It affects everything we do, and gets precedence with anything that would include/affect, transform, or impact upon individuals, communities or any living creatures. In other words, ethics would help us improve our living standards (LaFollette, 2007 ). The focus on ethical behaviour is indispensable in certain fields such as medicine, finance, or law, but is also gaining recognition in all disciplines engaged in research. Therefore, institutions are expected to develop ethical guidelines in research to maintain quality, initiate/own integrity and above all be transparent to be successful by limiting any allegation of misconduct (Flite and Harman, 2013 ). This is especially true for higher education organisations that promote research and scholarly activities. Many European institutions have developed their own regulations for ethics by incorporating international codes (Getz, 1990 ). The lesser developed countries are trying to set up these committees to govern their academia and research. World Health Organization has stated that adhering to “ ethical principles … [is central and important]... in order to protect the dignity, rights and welfare of research participants ” (WHO, 2021 ). Ethical guidelines taught to students can help develop ethical researchers and members of society who uphold values of ethical principles in practice.

As the first European-wide consortium established to assist academic integrity (European Network for Academic Integrity – ENAI), we felt the importance of guiding those institutions and communities that are trying to teach, research, and include ethical principles by providing overarching understanding of ethical guidelines that may influence policy. Therefore, we set up an advisory working group within ENAI in 2018 to support matters related to ethics, ethical committees and assisting on ethics related teaching activities.

Upon preliminary review and discussion, the group found a disparity in understanding, practice and teaching approaches to ethical applications among peers. This became the premise for this research paper. We first carried out a literature survey to review and summarise existing ethical governance (with historical perspectives) and procedures that are already in place to guide researchers in different discipline areas. By doing so, we attempted to consolidate, document and provide important steps in a typical ethical application process with example procedures from different universities. Finally, we attempted to provide insights and findings from practical workshops carried out at the 5th International Conference Plagiarism across Europe and Beyond, in Mykolas Romeris University, Lithuania in 2019, focussing on:

• highlighting the basic needs of an ethical committee within an institution,

• discussing and sharing examples of a typical ethical approval process,

• providing guidelines on the ways to teach research ethics with some examples.

We believe this paper provides guidelines on preparing and training both researchers and research students in appropriately upholding ethical practices through ethical approval processes.

Background literature survey

Responsible research practice (RRP) is scrutinised by the aspects of ethical principles and professional standards (WHO’s Code of Conduct for responsible Research, 2017). The Singapore statement on research integrity (The Singapore Statement on Research integrity, 2010) has provided an internationally acceptable guidance for RRP. The statement is based on maintaining honesty, accountability, professional courtesy in all aspects of research and maintaining fairness during collaborations. In other words, it does not simply focus on the procedural part of the research, instead covers wider aspects of “integrity” beyond the operational aspects (Israel and Drenth, 2016 ).

Institutions should focus on providing ethical guidance based on principles and values reflecting upon all aspects/stages of research (from the funding application/project development stage upto or beyond project closing stage). Figure  1 summarizes the different aspects/stages of a typical research and highlights the needs of RRP in compliance with ethical governance at each stage with examples (the figure is based on Resnik, 2020 ; Žukauskas et al., 2018 ; Anderson, 2011 ; Fouka and Mantzorou, 2011 ).

figure 1

Summary of the enabling ethical governance at different stages of research. Note that it is imperative for researchers to proactively consider the ethical implications before, during and after the actual research process. The summary shows that RRP should be in line with ethical considerations even long before the ethical approval stage

Individual responsibilities to enhance RRP

As explained in Fig.  1 , a successfully governed research should consider ethics at the planning stages prior to research. Many international guidance are compatible in enforcing/recommending 14 different “responsibilities” that were first highlighted in the Singapore Statement (2010) for researchers to follow and achieve competency in RRP. In order to understand the purpose and the expectation of these ethical guidelines, we have carried out an initial literature survey on expected individual responsibilities. These are summarised in Table  1 .

By following these directives, researchers can carry out accountable research by maximising ethical self-governance whilst minimising misconducts. In our own experiences of working with many researchers, their focus usually revolves around ethical “clearance” rather than behaviour. In other words, they perceive this as a paper exercise rather than trying to “own” ethical behaviour in everything they do. Although the ethical principles and responsibilities are explicitly highlighted in the majority of international guidelines [such as UK’s Research Governance Policy (NICE, 2018 ), Australian Government’s National Statement on Ethical Conduct in Human Research (Difn website a - National Statement on Ethical Conduct in Human Research (NSECHR), 2018 ), the Singapore Statement (2010) etc.]; and the importance of holistic approach has been argued in ethical decision making, many researchers and/or institutions only focus on ethics linked to the procedural aspects.

Studies in the past have also highlighted inconsistencies in institutional guidelines pointing to the fact that these inconsistencies may hinder the predicted research progress (Desmond & Dierickx 2021 ; Alba et al., 2020 ; Dellaportas et al., 2014 ; Speight 2016 ). It may also be possible that these were and still are linked to the institutional perceptions/expectations or the pre-empting contextual conditions that are imposed by individual countries. In fact, it is interesting to note many research organisations and HE institutions establish their own policies based on these directives.

Research governance - origins, expectations and practices

Ethical governance in clinical medicine helps us by providing a structure for analysis and decision-making. By providing workable definitions of benefits and risks as well as the guidance for evaluating/balancing benefits over risks, it supports the researchers to protect the participants and the general population.

According to the definition given by National Institute of Clinical care Excellence, UK (NICE 2018 ), “ research governance can be defined as the broad range of regulations, principles and standards of good practice that ensure high quality research ”. As stated above, our literature-based research survey showed that most of the ethical definitions are basically evolved from the medical field and other disciplines have utilised these principles to develop their own ethical guidance. Interestingly, historical data show that the medical research has been “self-governed” or in other words implicated by the moral behaviour of individual researchers (Fox 2017 ; Shaw et al., 2005 ; Getz, 1990 ). For example, early human vaccination trials conducted in 1700s used the immediate family members as test subjects (Fox, 2017 ). Here the moral justification might have been the fact that the subjects who would have been at risk were either the scientists themselves or their immediate families but those who would reap the benefits from the vaccination were the general public/wider communities. However, according to the current ethical principles, this assumption is entirely not acceptable.

Historically, ambiguous decision-making and resultant incidences of research misconduct have led to the need for ethical research governance in as early as the 1940’s. For instance, the importance of an international governance was realised only after the World War II, when people were astonished to note the unethical research practices carried out by Nazi scientists. As a result of this, in 1947 the Nuremberg code was published. The code mainly focussed on the following:

Informed consent and further insisted the research involving humans should be based on prior animal work,

The anticipated benefits should outweigh the risk,

Research should be carried out only by qualified scientists must conduct research,

Avoiding physical and mental suffering and.

Avoiding human research that would result in which death or disability.

(Weindling, 2001 ).

Unfortunately, it was reported that many researchers in the USA and elsewhere considered the Nuremberg code as a document condemning the Nazi atrocities, rather than a code for ethical governance and therefore ignored these directives (Ghooi, 2011 ). It was only in 1964 that the World Medical Association published the Helsinki Declaration, which set the stage for ethical governance and the implementation of the Institutional Review Board (IRB) process (Shamoo and Irving, 1993 ). This declaration was based on Nuremberg code. In addition, the declaration also paved the way for enforcing research being conducted in accordance with these guidelines.

Incidentally, the focus on research/ethical governance gained its momentum in 1974. As a result of this, a report on ethical principles and guidelines for the protection of human subjects of research was published in 1979 (The Belmont Report, 1979 ). This report paved the way to the current forms of ethical governance in biomedical and behavioural research by providing guidance.

Since 1994, the WHO itself has been providing several guidance to health care policy-makers, researchers and other stakeholders detailing the key concepts in medical ethics. These are specific to applying ethical principles in global public health.

Likewise, World Organization for Animal Health (WOAH), and International Convention for the Protection of Animals (ICPA) provide guidance on animal welfare in research. Due to this continuous guidance, together with accepted practices, there are internationally established ethical guidelines to carry out medical research. Our literature survey further identified freely available guidance from independent organisations such as COPE (Committee of Publication Ethics) and ALLEA (All European Academics) which provide support for maintaining research ethics in other fields such as education, sociology, psychology etc. In reality, ethical governance is practiced differently in different countries. In the UK, there is a clinical excellence research governance, which oversees all NHS related medical research (Mulholland and Bell, 2005 ). Although, the governance in other disciplines is not entirely centralised, many research funding councils and organisations [such as UKRI (UK-Research and Innovation; BBSC (Biotechnology and Biological Sciences Research Council; MRC (Medical Research Council); EPSRC (Economic and Social Research Council)] provide ethical governance and expect institutional adherence and monitoring. They expect local institutional (i.e. university/institutional) research governance for day-to-day monitoring of the research conducted within the organisation and report back to these funding bodies, monthly or annually (Department of Health, 2005). Likewise, there are nationally coordinated/regulated ethics governing bodies such as the US Office for Human Research Protections (US-OHRP), National Institute of Health (NIH) and the Canadian Institutes for Health Research (CIHR) in the USA and Canada respectively (Mulholland and Bell, 2005 ). The OHRP in the USA formally reviews all research activities involving human subjects. On the other hand, in Canada, CIHR works with the Natural Sciences and Engineering Research Council (NSERC), and the Social Sciences and Humanities Research Council (SSHRC). They together have produced a Tri-Council Policy Statement (TCPS) (Stephenson et al., 2020 ) as ethical governance. All Canadian institutions are expected to adhere to this policy for conducting research. As for Australia, the research is governed by the Australian code for the responsible conduct of research (2008). It identifies the responsibilities of institutions and researchers in all areas of research. The code has been jointly developed by the National Health and Medical Research Council (NHMRC), the Australian Research Council (ARC) and Universities Australia (UA). This information is summarized in Table  2 .

Basic structure of an institutional ethical advisory committee (EAC)

The WHO published an article defining the basic concepts of an ethical advisory committee in 2009 (WHO, 2009 - see above). According to this, many countries have established research governance and monitor the ethical practice in research via national and/or regional review committees. The main aims of research ethics committees include reviewing the study proposals, trying to understand the justifications for human/animal use, weighing the merits and demerits of the usage (linking to risks vs. potential benefits) and ensuring the local, ethical guidelines are followed Difn website b - Enago academy Importance of Ethics Committees in Scholarly Research, 2020 ; Guide for Research Ethics - Council of Europe, 2014 ). Once the research has started, the committee needs to carry out periodic surveillance to ensure the institutional ethical norms are followed during and beyond the study. They may also be involved in setting up and/or reviewing the institutional policies.

For these aspects, IRB (or institutional ethical advisory committee - IEAC) is essential for local governance to enhance best practices. The advantage of an IRB/EEAC is that they understand the institutional conditions and can closely monitor the ongoing research, including any changes in research directions. On the other hand, the IRB may be overly supportive to accept applications, influenced by the local agenda for achieving research excellence, disregarding ethical issues (Kotecha et al., 2011 ; Kayser-Jones, 2003 ) or, they may be influenced by the financial interests in attracting external funding. In this respect, regional and national ethics committees are advantageous to ensure ethical practice. Due to their impartiality, they would provide greater consistency and legitimacy to the research (WHO, 2009 ). However, the ethical approval process of regional and national ethics committees would be time consuming, as they do not have the local knowledge.

As for membership in the IRBs, most of the guidelines [WHO, NICE, Council of Europe, (2012), European Commission - Facilitating Research Excellence in FP7 ( 2013 ) and OHRP] insist on having a variety of representations including experts in different fields of research, and non-experts with the understanding of local, national/international conflicts of interest. The former would be able to understand/clarify the procedural elements of the research in different fields; whilst the latter would help to make neutral and impartial decisions. These non-experts are usually not affiliated to the institution and consist of individuals representing the broader community (particularly those related to social, legal or cultural considerations). IRBs consisting of these varieties of representation would not only be in a position to understand the study procedures and their potential direct or indirect consequences for participants, but also be able to identify any community, cultural or religious implications of the study.

Understanding the subtle differences between ethics and morals

Interestingly, many ethical guidelines are based on society’s moral “beliefs” in such a way that the words “ethics”‘and “morals” are reciprocally used to define each other. However, there are several subtle differences between them and we have attempted to compare and contrast them herein. In the past, many authors have interchangeably used the words “morals”‘and “ethics”‘(Warwick, 2003 ; Kant, 2018 ; Hazard, GC (Jr)., 1994 , Larry, 1982 ). However, ethics is linked to rules governed by an external source such as codes of conduct in workplaces (Kuyare et al., 2014 ). In contrast, morals refer to an individual’s own principles regarding right and wrong. Quinn ( 2011 ) defines morality as “ rules of conduct describing what people ought and ought not to do in various situations … ” while ethics is “... the philosophical study of morality, a rational examination into people’s moral beliefs and behaviours ”. For instance, in a case of parents demanding that schools overturn a ban on use of corporal punishment of children by schools and teachers (Children’s Rights Alliance for England, 2005 ), the parents believed that teachers should assume the role of parent in schools and use corporal or physical punishment for children who misbehaved. This stemmed from their beliefs and what they felt were motivated by “beliefs of individuals or groups”. For example, recent media highlights about some parents opposing LGBT (Lesbian, Gay, Bisexual, and Transgender) education to their children (BBC News, 2019 ). One parent argued, “Teaching young children about LGBT at a very early stage is ‘morally’ wrong”. She argued “let them learn by themselves as they grow”. This behaviour is linked to and governed by the morals of an ethnic community. Thus, morals are linked to the “beliefs of individuals or group”. However, when it comes to the LGBT rights these are based on ethical principles of that society and governed by law of the land. However, the rights of children to be protected from “inhuman and degrading” treatment is based on the ethical principles of the society and governed by law of the land. Individuals, especially those who are working in medical or judicial professions have to follow an ethical code laid down by their profession, regardless of their own feelings, time or preferences. For instance, a lawyer is expected to follow the professional ethics and represent a defendant, despite the fact that his morals indicate the defendant is guilty.

In fact, we as a group could not find many scholarly articles clearly comparing or contrasting ethics with morals. However, a table presented by Surbhi ( 2015 ) (Difn website c ) tries to differentiate these two terms (see Table  3 ).

Although Table 3 gives some insight on the differences between these two terms, in practice many use these terms as loosely as possible mainly because of their ambiguity. As a group focussed on the application of these principles, we would recommend to use the term “ethics” and avoid “morals” in research and academia.

Based on the literature survey carried out, we were able to identify the following gaps:

there is some disparity in existing literature on the importance of ethical guidelines in research

there is a lack of consensus on what code of conduct should be followed, where it should be derived from and how it should be implemented

The mission of ENAI’s ethical advisory working group

The Ethical Advisory Working Group of ENAI was established in 2018 to promote ethical code of conduct/practice amongst higher educational organisations within Europe and beyond (European Network for Academic Integrity, 2018 ). We aim to provide unbiased advice and consultancy on embedding ethical principles within all types of academic, research and public engagement activities. Our main objective is to promote ethical principles and share good practice in this field. This advisory group aims to standardise ethical norms and to offer strategic support to activities including (but not exclusive to):

● rendering advice and assistance to develop institutional ethical committees and their regulations in member institutions,

● sharing good practice in research and academic ethics,

● acting as a critical guide to institutional review processes, assisting them to maintain/achieve ethical standards,

● collaborating with similar bodies in establishing collegiate partnerships to enhance awareness and practice in this field,

● providing support within and outside ENAI to develop materials to enhance teaching activities in this field,

● organising training for students and early-career researchers about ethical behaviours in form of lectures, seminars, debates and webinars,

● enhancing research and dissemination of the findings in matters and topics related to ethics.

The following sections focus on our suggestions based on collective experiences, review of literature provided in earlier sections and workshop feedback collected:

a) basic needs of an ethical committee within an institution;

b) a typical ethical approval process (with examples from three different universities); and

c) the ways to obtain informed consent with some examples. This would give advice on preparing and training both researchers and research students in appropriately upholding ethical practices through ethical approval processes.

Setting up an institutional ethical committee (ECs)

Institutional Ethical Committees (ECs) are essential to govern every aspect of the activities undertaken by that institute. With regards to higher educational organisations, this is vital to establish ethical behaviour for students and staff to impart research, education and scholarly activities (or everything) they do. These committees should be knowledgeable about international laws relating to different fields of studies (such as science, medicine, business, finance, law, and social sciences). The advantages and disadvantages of institutional, subject specific or common (statutory) ECs are summarised in Fig.  2 . Some institutions have developed individual ECs linked to specific fields (or subject areas) whilst others have one institutional committee that overlooks the entire ethical behaviour and approval process. There is no clear preference between the two as both have their own advantages and disadvantages (see Fig. 2 ). Subject specific ECs are attractive to medical, law and business provisions, as it is perceived the members within respective committees would be able to understand the subject and therefore comprehend the need of the proposed research/activity (Kadam, 2012 ; Schnyder et al., 2018 ). However, others argue, due to this “ specificity ”, the committee would fail to forecast the wider implications of that application. On the other hand, university-wide ECs would look into the wider implications. Yet they find it difficult to understand the purpose and the specific applications of that research. Not everyone understands dynamics of all types of research methodologies, data collection, etc., and therefore there might be a chance of a proposal being rejected merely because the EC could not understand the research applications (Getz, 1990 ).

figure 2

Summary of advantages and disadvantages of three different forms of ethical committees

[N/B for Fig. 2 : Examples of different types of ethical application procedures and forms used were discussed with the workshop attendees to enhance their understanding of the differences. GDPR = General Data Protection Regulation].

Although we recommend a designated EC with relevant professional, academic and ethical expertise to deal with particular types of applications, the membership (of any EC) should include some non-experts who would represent the wider community (see above). Having some non-experts in EC would not only help the researchers to consider explaining their research in layperson’s terms (by thinking outside the box) but also would ensure efficiency without compromising participants/animal safety. They may even help to address the common ethical issues outside research culture. Some UK universities usually offer this membership to a clergy, councillor or a parliamentarian who does not have any links to the institutions. Most importantly, it is vital for any EC members to undertake further training in addition to previous experience in the relevant field of research ethics.

Another issue that raises concerns is multi-centre research, involving several institutions, where institutionalised ethical approvals are needed from each partner. In some cases, such as clinical research within the UK, a common statutory EC called National Health Services (NHS) Research Ethics Committee (NREC) is in place to cover research ethics involving all partner institutions (NHS, 2018 ). The process of obtaining approval from this type of EC takes time, therefore advanced planning is needed.

Ethics approval forms and process

During the workshop, we discussed some anonymised application forms obtained from open-access sources for qualitative and quantitative research as examples. Considering research ethics, for the purpose of understanding, we arbitrarily divided this in two categories; research based on (a) quantitative and (b) qualitative methodologies. As their name suggests their research approach is extremely different from each other. The discussion elicited how ECs devise different types of ethical application form/questions. As for qualitative research, these are often conducted as “face-to-face” interviews, which would have implications on volunteer anonymity.

Furthermore, discussions posited when the interviews are replaced by on-line surveys, they have to be administered through registered university staff to maintain confidentiality. This becomes difficult when the research is a multi-centre study. These types of issues are also common in medical research regarding participants’ anonymity, confidentially, and above all their right to withdraw consent to be involved in research.

Storing and protecting data collected in the process of the study is also a point of consideration when applying for approval.

Finally, the ethical processes of invasive (involving human/animals) and non-invasive research (questionnaire based) may slightly differ from one another. Following research areas are considered as investigations that need ethical approval:

research that involves human participants (see below)

use of the ‘products’ of human participants (see below)

work that potentially impacts on humans (see below)

research that involves animals

In addition, it is important to provide a disclaimer even if an ethical approval is deemed unnecessary. Following word cloud (Fig.  3 ) shows the important variables that need to be considered at the brainstorming stage before an ethical application. It is worth noting the importance of proactive planning predicting the “unexpected” during different phases of a research project (such as planning, execution, publication, and future directions). Some applications (such as working with vulnerable individuals or children) will require safety protection clearance (such as DBS - Disclosure and Barring Service, commonly obtained from the local police). Please see section on Research involving Humans - Informed consents for further discussions.

figure 3

Examples of important variables that need to be considered for an ethical approval

It is also imperative to report or re-apply for ethical approval for any minor or major post-approval changes to original proposals made. In case of methodological changes, evidence of risk assessments for changes and/or COSHH (Control of Substances Hazardous to Health Regulations) should also be given. Likewise, any new collaborative partners or removal of researchers should also be notified to the IEAC.

Other findings include:

in case of complete changes in the project, the research must be stopped and new approval should be seeked,

in case of noticing any adverse effects to project participants (human or non-human), these should also be notified to the committee for appropriate clearance to continue the work, and

the completion of the project must also be notified with the indication whether the researchers may restart the project at a later stage.

Research involving humans - informed consents

While discussing research involving humans and based on literature review, findings highlight the human subjects/volunteers must willingly participate in research after being adequately informed about the project. Therefore, research involving humans and animals takes precedence in obtaining ethical clearance and its strict adherence, one of which is providing a participant information sheet/leaflet. This sheet should contain a full explanation about the research that is being carried out and be given out in lay-person’s terms in writing (Manti and Licari 2018 ; Hardicre 2014 ). Measures should also be in place to explain and clarify any doubts from the participants. In addition, there should be a clear statement on how the participants’ anonymity is protected. We provide below some example questions below to help the researchers to write this participant information sheet:

What is the purpose of the study?

Why have they been chosen?

What will happen if they take part?

What do they have to do?

What happens when the research stops?

What if something goes wrong?

What will happen to the results of the research study?

Will taking part be kept confidential?

How to handle “vulnerable” participants?

How to mitigate risks to participants?

Many institutional ethics committees expect the researchers to produce a FAQ (frequently asked questions) in addition to the information about research. Most importantly, the researchers also need to provide an informed consent form, which should be signed by each human participant. The five elements identified that are needed to be considered for an informed consent statement are summarized in Fig.  4 below (slightly modified from the Federal Policy for the Protection of Human Subjects ( 2018 ) - Diffn website c ).

figure 4

Five basic elements to consider for an informed consent [figure adapted from Diffn website c ]

The informed consent form should always contain a clause for the participant to withdraw their consent at any time. Should this happen all the data from that participant should be eliminated from the study without affecting their anonymity.

Typical research ethics approval process

In this section, we provide an example flow chart explaining how researchers may choose the appropriate application and process, as highlighted in Fig.  5 . However, it is imperative to note here that these are examples only and some institutions may have one unified application with separate sections to demarcate qualitative and quantitative research criteria.

figure 5

Typical ethical approval processes for quantitative and qualitative research. [N/B for Fig. 5 - This simplified flow chart shows that fundamental process for invasive and non-invasive EC application is same, the routes and the requirements for additional information are slightly different]

Once the ethical application is submitted, the EC should ensure a clear approval procedure with distinctly defined timeline. An example flow chart showing the procedure for an ethical approval was obtained from University of Leicester as open-access. This is presented in Fig.  6 . Further examples of the ethical approval process and governance were discussed in the workshop.

figure 6

An example ethical approval procedures conducted within University of Leicester (Figure obtained from the University of Leicester research pages - Difn website d - open access)

Strategies for ethics educations for students

Student education on the importance of ethics and ethical behaviour in research and scholarly activities is extremely essential. Literature posits in the area of medical research that many universities are incorporating ethics in post-graduate degrees but when it comes to undergraduate degrees, there is less appetite to deliver modules or even lectures focussing on research ethics (Seymour et al., 2004 ; Willison and O’Regan, 2007 ). This may be due to the fact that undergraduate degree structure does not really focus on research (DePasse et al., 2016 ). However, as Orr ( 2018 ) suggested, institutions should focus more on educating all students about ethics/ethical behaviour and their importance in research, than enforcing punitive measures for unethical behaviour. Therefore, as an advisory committee, and based on our preliminary literature survey and workshop results, we strongly recommend incorporating ethical education within undergraduate curriculum. Looking at those institutions which focus on ethical education for both under-and postgraduate courses, their approaches are either (a) a lecture-based delivery, (b) case study based approach or (c) a combined delivery starting with a lecture on basic principles of ethics followed by generating a debate based discussion using interesting case studies. The combined method seems much more effective than the other two as per our findings as explained next.

As many academics who have been involved in teaching ethics and/or research ethics agree, the underlying principles of ethics is often perceived as a boring subject. Therefore, lecture-based delivery may not be suitable. On the other hand, a debate based approach, though attractive and instantly generates student interest, cannot be effective without students understanding the underlying basic principles. In addition, when selecting case studies, it would be advisable to choose cases addressing all different types of ethical dilemmas. As an advisory group within ENAI, we are in the process of collating supporting materials to help to develop institutional policies, creating advisory documents to help in obtaining ethical approvals, and teaching materials to enhance debate-based lesson plans that can be used by the member and other institutions.

Concluding remarks

In summary, our literature survey and workshop findings highlight that researchers should accept that ethics underpins everything we do, especially in research. Although ethical approval is tedious, it is an imperative process in which proactive thinking is essential to identify ethical issues that might affect the project. Our findings further lead us to state that the ethical approval process differs from institution to institution and we strongly recommend the researchers to follow the institutional guidelines and their underlying ethical principles. The ENAI workshop in Vilnius highlighted the importance of ethical governance by establishing ECs, discussed different types of ECs and procedures with some examples and highlighted the importance of student education to impart ethical culture within research communities, an area that needs further study as future scope.

Declarations

The manuscript was entirely written by the corresponding author with contributions from co-authors who have also taken part in the delivery of the workshop. Authors confirm that the data supporting the findings of this study are available within the article. We can also confirm that there are no potential competing interests with other organisations.

Availability of data and materials

Authors confirm that the data supporting the findings of this study are available within the article.

Abbreviations

ALL European academics

Australian research council

Biotechnology and biological sciences research council

Canadian institutes for health research

Committee of publication ethics

Ethical committee

European network of academic integrity

Economic and social research council

International convention for the protection of animals

institutional ethical advisory committee

Institutional review board

Immaculata university of Pennsylvania

Lesbian, gay, bisexual, and transgender

Medical research council)

National health services

National health services nih national institute of health (NIH)

National institute of clinical care excellence

National health and medical research council

Natural sciences and engineering research council

National research ethics committee

National statement on ethical conduct in human research

Responsible research practice

Social sciences and humanities research council

Tri-council policy statement

World Organization for animal health

Universities Australia

UK-research and innovation

US office for human research protections

Alba S, Lenglet A, Verdonck K, Roth J, Patil R, Mendoza W, Juvekar S, Rumisha SF (2020) Bridging research integrity and global health epidemiology (BRIDGE) guidelines: explanation and elaboration. BMJ Glob Health 5(10):e003237. https://doi.org/10.1136/bmjgh-2020-003237

Article   Google Scholar  

Anderson MS (2011) Research misconduct and misbehaviour. In: Bertram Gallant T (ed) Creating the ethical academy: a systems approach to understanding misconduct and empowering change in higher education. Routledge, pp 83–96

BBC News. (2019). Birmingham school LGBT LESSONS PROTEST investigated. March 8, 2019. Retrieved February 14, 2021, available online. URL: https://www.bbc.com/news/uk-england-birmingham-47498446

Children’s Rights Alliance for England. (2005). R (Williamson and others) v Secretary of State for Education and Employment. Session 2004–05. [2005] UKHL 15. Available Online. URL: http://www.crae.org.uk/media/33624/R-Williamson-and-others-v-Secretary-of-State-for-Education-and-Employment.pdf

Council of Europe. (2014). Texts of the Council of Europe on bioethical matters. Available Online. https://www.coe.int/t/dg3/healthbioethic/Texts_and_documents/INF_2014_5_vol_II_textes_%20CoE_%20bio%C3%A9thique_E%20(2).pdf

Dellaportas S, Kanapathippillai S, Khan, A and Leung, P. (2014). Ethics education in the Australian accounting curriculum: a longitudinal study examining barriers and enablers. 362–382. Available Online. URL: https://doi.org/10.1080/09639284.2014.930694 , 23, 4, 362, 382

DePasse JM, Palumbo MA, Eberson CP, Daniels AH (2016) Academic characteristics of orthopaedic surgery residency applicants from 2007 to 2014. JBJS 98(9):788–795. https://doi.org/10.2106/JBJS.15.00222

Desmond H, Dierickx K (2021) Research integrity codes of conduct in Europe: understanding the divergences. https://doi.org/10.1111/bioe.12851

Difn website a - National Statement on Ethical Conduct in Human Research (NSECHR). (2018). Available Online. URL: https://www.nhmrc.gov.au/about-us/publications/australian-code-responsible-conduct-research-2018

Difn website b - Enago academy Importance of Ethics Committees in Scholarly Research (2020, October 26). Available online. URL: https://www.enago.com/academy/importance-of-ethics-committees-in-scholarly-research/

Difn website c - Ethics vs Morals - Difference and Comparison. Retrieved July 14, 2020. Available online. URL: https://www.diffen.com/difference/Ethics_vs_Morals

Difn website d - University of Leicester. (2015). Staff ethics approval flowchart. May 1, 2015. Retrieved July 14, 2020. Available Online. URL: https://www2.le.ac.uk/institution/ethics/images/ethics-approval-flowchart/view

European Commission - Facilitating Research Excellence in FP7 (2013) https://ec.europa.eu/research/participants/data/ref/fp7/89888/ethics-for-researchers_en.pdf

European Network for Academic Integrity. (2018). Ethical advisory group. Retrieved February 14, 2021. Available online. URL: http://www.academicintegrity.eu/wp/wg-ethical/

Federal Policy for the Protection of Human Subjects. (2018). Retrieved February 14, 2021. Available Online. URL: https://www.federalregister.gov/documents/2017/01/19/2017-01058/federal-policy-for-the-protection-of-human-subjects#p-855

Flite, CA and Harman, LB. (2013). Code of ethics: principles for ethical leadership Perspect Health Inf Mana; 10(winter): 1d. PMID: 23346028

Fouka G, Mantzorou M (2011) What are the major ethical issues in conducting research? Is there a conflict between the research ethics and the nature of nursing. Health Sci J 5(1) Available Online. URL: https://www.hsj.gr/medicine/what-are-the-major-ethical-issues-in-conducting-research-is-there-a-conflict-between-the-research-ethics-and-the-nature-of-nursing.php?aid=3485

Fox G (2017) History and ethical principles. The University of Miami and the Collaborative Institutional Training Initiative (CITI) Program URL  https://silo.tips/download/chapter-1-history-and-ethical-principles # (Available Online)

Getz KA (1990) International codes of conduct: An analysis of ethical reasoning. J Bus Ethics 9(7):567–577

Ghooi RB (2011) The nuremberg code–a critique. Perspect Clin Res 2(2):72–76. https://doi.org/10.4103/2229-3485.80371

Hardicre, J. (2014) Valid informed consent in research: an introduction Br J Nurs 23(11). https://doi.org/10.12968/bjon.2014.23.11.564 , 567

Hazard, GC (Jr). (1994). Law, morals, and ethics. Yale law school legal scholarship repository. Faculty Scholarship Series. Yale University. Available Online. URL: https://digitalcommons.law.yale.edu/cgi/viewcontent.cgi?referer=https://www.google.com/&httpsredir=1&article=3322&context=fss_papers

Israel, M., & Drenth, P. (2016). Research integrity: perspectives from Australia and Netherlands. In T. Bretag (Ed.), Handbook of academic integrity (pp. 789–808). Springer, Singapore. https://doi.org/10.1007/978-981-287-098-8_64

Kadam R (2012) Proactive role for ethics committees. Indian J Med Ethics 9(3):216. https://doi.org/10.20529/IJME.2012.072

Kant I (2018) The metaphysics of morals. Cambridge University Press, UK https://doi.org/10.1017/9781316091388

Kayser-Jones J (2003) Continuing to conduct research in nursing homes despite controversial findings: reflections by a research scientist. Qual Health Res 13(1):114–128. https://doi.org/10.1177/1049732302239414

Kotecha JA, Manca D, Lambert-Lanning A, Keshavjee K, Drummond N, Godwin M, Greiver M, Putnam W, Lussier M-T, Birtwhistle R (2011) Ethics and privacy issues of a practice-based surveillance system: need for a national-level institutional research ethics board and consent standards. Can Fam physician 57(10):1165–1173.  https://europepmc.org/article/pmc/pmc3192088

Kuyare, MS., Taur, SR., Thatte, U. (2014). Establishing institutional ethics committees: challenges and solutions–a review of the literature. Indian J Med Ethics. https://doi.org/10.20529/IJME.2014.047

LaFollette, H. (2007). Ethics in practice (3rd edition). Blackwell

Larry RC (1982) The teaching of ethics and moral values in teaching. J High Educ 53(3):296–306. https://doi.org/10.1080/00221546.1982.11780455

Manti S, Licari A (2018) How to obtain informed consent for research. Breathe (Sheff) 14(2):145–152. https://doi.org/10.1183/20734735.001918

Mulholland MW, Bell J (2005) Research Governance and Research Funding in the USA: What the academic surgeon needs to know. J R Soc Med 98(11):496–502. https://doi.org/10.1258/jrsm.98.11.496

National Institute of Health (NIH) Ethics in Clinical Research. n.d. Available Online. URL: https://clinicalcenter.nih.gov/recruit/ethics.html

NHS (2018) Flagged Research Ethics Committees. Retrieved February 14, 2021. Available online. URL: https://www.hra.nhs.uk/about-us/committees-and-services/res-and-recs/flagged-research-ethics-committees/

NICE (2018) Research governance policy. Retrieved February 14, 2021. Available online. URL: https://www.nice.org.uk/Media/Default/About/what-we-do/science-policy-and-research/research-governance-policy.pdf

Orr, J. (2018). Developing a campus academic integrity education seminar. J Acad Ethics 16(3), 195–209. https://doi.org/10.1007/s10805-018-9304-7

Quinn, M. (2011). Introduction to Ethics. Ethics for an Information Age. 4th Ed. Ch 2. 53–108. Pearson. UK

Resnik. (2020). What is ethics in Research & why is it Important? Available Online. URL: https://www.niehs.nih.gov/research/resources/bioethics/whatis/index.cfm

Schnyder S, Starring H, Fury M, Mora A, Leonardi C, Dasa V (2018) The formation of a medical student research committee and its impact on involvement in departmental research. Med Educ Online 23(1):1. https://doi.org/10.1080/10872981.2018.1424449

Seymour E, Hunter AB, Laursen SL, DeAntoni T (2004) Establishing the benefits of research experiences for undergraduates in the sciences: first findings from a three-year study. Sci Educ 88(4):493–534. https://doi.org/10.1002/sce.10131

Shamoo AE, Irving DN (1993) Accountability in research using persons with mental illness. Account Res 3(1):1–17. https://doi.org/10.1080/08989629308573826

Shaw, S., Boynton, PM., and Greenhalgh, T. (2005). Research governance: where did it come from, what does it mean? Research governance framework for health and social care, 2nd ed. London: Department of Health. https://doi.org/10.1258/jrsm.98.11.496 , 98, 11, 496, 502

Book   Google Scholar  

Speight, JG. (2016) Ethics in the university |DOI: https://doi.org/10.1002/9781119346449 scrivener publishing LLC

Stephenson GK, Jones GA, Fick E, Begin-Caouette O, Taiyeb A, Metcalfe A (2020) What’s the protocol? Canadian university research ethics boards and variations in implementing tri-Council policy. Can J Higher Educ 50(1)1): 68–81

Surbhi, S. (2015). Difference between morals and ethics [weblog]. March 25, 2015. Retrieved February 14, 2021. Available Online. URL: http://keydifferences.com/difference-between-morals-and-ethics.html

The Belmont Report (1979). Ethical Principles and Guidelines for the Protection of Human Subjects of Research. The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. Retrieved February 14, 2021. Available online. URL: https://www.hhs.gov/ohrp/sites/default/files/the-belmont-report-508c_FINAL.pdf

The Singapore Statement on Research Integrity. (2020). Nicholas Steneck and Tony Mayer, Co-chairs, 2nd World Conference on Research Integrity; Melissa Anderson, Chair, Organizing Committee, 3rd World Conference on Research Integrity. Retrieved February 14, 2021. Available online. URL: https://wcrif.org/documents/327-singapore-statement-a4size/file

Warwick K (2003) Cyborg morals, cyborg values, cyborg ethics. Ethics Inf Technol 5(3):131–137. https://doi.org/10.1023/B:ETIN.0000006870.65865.cf

Weindling P (2001) The origins of informed consent: the international scientific commission on medical war crimes, and the Nuremberg code. Bull Hist Med 75(1):37–71. https://doi.org/10.1353/bhm.2001.0049

WHO. (2009). Research ethics committees Basic concepts for capacity-building. Retrieved February 14, 2021. Available online. URL: https://www.who.int/ethics/Ethics_basic_concepts_ENG.pdf

WHO. (2021). Chronological list of publications. Retrieved February 14, 2021. Available online. URL: https://www.who.int/ethics/publications/year/en/

Willison, J. and O’Regan, K. (2007). Commonly known, commonly not known, totally unknown: a framework for students becoming researchers. High Educ Res Dev 26(4). 393–409. https://doi.org/10.1080/07294360701658609

Žukauskas P, Vveinhardt J, and Andriukaitienė R. (2018). Research Ethics In book: Management Culture and Corporate Social Responsibility Eds Jolita Vveinhardt IntechOpenEditors DOI: https://doi.org/10.5772/intechopen.70629 , 2018

Download references

Acknowledgements

Authors wish to thank the organising committee of the 5th international conference named plagiarism across Europe and beyond, in Vilnius, Lithuania for accepting this paper to be presented in the conference.

Not applicable as this is an independent study, which is not funded by any internal or external bodies.

Author information

Authors and affiliations.

School of Human Sciences, University of Derby, DE22 1, Derby, GB, UK

Shivadas Sivasubramaniam

Department of Informatics, Mendel University in Brno, Zemědělská, 1665, Brno, Czechia

Dita Henek Dlabolová

Centre for Academic Integrity in the UAE, Faculty of Engineering & Information Sciences, University of Wollongong in Dubai, Dubai, UAE

Veronika Kralikova & Zeenath Reza Khan

You can also search for this author in PubMed   Google Scholar

Contributions

The manuscript was entirely written by the corresponding author with contributions from co-authors who have equally contributed to presentation of this paper in the 5th international conference named plagiarism across Europe and beyond, in Vilnius, Lithuania. Authors have equally contributed for the information collection, which were then summarised as narrative explanations by the Corresponding author and Dr. Zeenath Reza Khan. Then checked and verified by Dr. Dlabolova and Ms. Králíková. The author(s) read and approved the final manuscript.

Corresponding author

Correspondence to Shivadas Sivasubramaniam .

Ethics declarations

Competing interests.

We can also confirm that there are no potential competing interest with other organisations.

Additional information

Publisher’s note.

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Rights and permissions

Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/ . The Creative Commons Public Domain Dedication waiver ( http://creativecommons.org/publicdomain/zero/1.0/ ) applies to the data made available in this article, unless otherwise stated in a credit line to the data.

Reprints and permissions

About this article

Cite this article.

Sivasubramaniam, S., Dlabolová, D.H., Kralikova, V. et al. Assisting you to advance with ethics in research: an introduction to ethical governance and application procedures. Int J Educ Integr 17 , 14 (2021). https://doi.org/10.1007/s40979-021-00078-6

Download citation

Received : 17 July 2020

Accepted : 25 April 2021

Published : 13 July 2021

DOI : https://doi.org/10.1007/s40979-021-00078-6

Share this article

Anyone you share the following link with will be able to read this content:

Sorry, a shareable link is not currently available for this article.

Provided by the Springer Nature SharedIt content-sharing initiative

  • Higher education
  • Ethical codes
  • Ethics committee
  • Post-secondary education
  • Institutional policies
  • Research ethics

International Journal for Educational Integrity

ISSN: 1833-2595

  • Submission enquiries: Access here and click Contact Us
  • General enquiries: [email protected]

scholarly articles on ethical considerations in research

  • Research article
  • Open access
  • Published: 05 December 2019

Reporting of ethical approval and informed consent in clinical research published in leading nursing journals: a retrospective observational study

  • Yanni Wu 1   na1 ,
  • Michelle Howarth 2   na1 ,
  • Chunlan Zhou   ORCID: orcid.org/0000-0001-8537-2679 1 ,
  • Mingyu Hu 1 &
  • Weilian Cong 1  

BMC Medical Ethics volume  20 , Article number:  94 ( 2019 ) Cite this article

35k Accesses

13 Citations

8 Altmetric

Metrics details

Ethical considerations play a prominent role in the protection of human subjects in clinical research. To date the disclosure of ethical protection in clinical research published in the international nursing journals has not been explored. Our research objective was to investigate the reporting of ethical approval and informed consent in clinical research published in leading international nursing journals.

This is a retrospective observational study. All clinical research published in the five leading international nursing journals from the SCI Journal Citation Reports between 2015 and 2017 were retrieved to evaluate for evidence of ethical review.

A total of 2041 citations have been identified from the contents of all the five leading nursing journals that were published between 2015 and 2017. Out of these, 1284 clinical studies have been included and text relating to ethical review has been extracted. From these, most of prospective clinical studies (87.5%) discussed informed consent. Only half of those (52.9%) reported that written informed consent had been obtained; few (3.6%) reported oral consent, and few (6.8%) used other methods such as online consent or completion and return of data collection (such as surveys) to denote assent. Notably, 36.2% of those did not describe the method used to obtain informed consent and merely described that “ consent was obtained from participants or participants agreed to join in the research ”. Furthermore, whilst most of clinical studies (93.7%) mentioned ethical approval; 92.5% of those stated the name of ethical committee and interestingly, only 37.1% of those mentioned the ethical approval reference. The rates of reporting ethical approval were different between different study type, country, and whether financial support was received (all P  < 0.05).

The reporting of ethics in leading international nursing journals demonstrates progress, but improvement of the transparency and the standard of ethical reporting in nursing clinical research is required.

Peer Review reports

Given the importance of protecting human subjects in clinical research, there is now greater scrutiny of researchers to ensure that ethical principles have been met during the process [ 1 , 2 ]. The World Medical Association issued the Declaration of Helsinki in 1964 and established the international ethical regulations for medical studies involving human subjects with subsequent updates [ 3 ]. The Declaration of Helsinki highlighted two aspects of ethical considerations: that all of the participants have the right to be informed about the study, by giving informed consent, and that an ethics committee approval should have got to ensure the appropriateness of design before initiating a research [ 4 ]. Furthermore, journals and publishers, have a responsibility to act as “gate-keepers”, and are obliged to scrutinize whether ethical approval of human research has been obtained priori to submission of papers [ 5 ]. This responsibility mirrors the requirement of the Declaration of Helsinki that “ Researchers, authors, sponsors, editors and publishers all have ethical obligations……Reports of research not in accordance with the principles of this Declaration should not be accepted for publication ” [ 4 ]. This duty of journals and publishers is supported by the International Committee of Medical Journal Editors (ICMJE) [ 6 ] and adopted by journal editors and publishers. Following this, the Nuremberg Code [ 7 ], the World Association of Medical Editors (WAME) [ 8 ], and the Committee of Publication Ethics (COPE) [ 9 ] established ethical principles to protect human right in medical research. For example, COPE stipulated that journals should provide guidance to support the reporting of ethical approval and informed consent when publishing human research.

However, the reporting of ethical considerations still less than ideal in human research though it is acknowledged that some progress has made in recent years. For example, Yank and Rennie [ 1 ] investigated the ethical protections of clinical trials published in top five medical journals including The Lancet, JAMA, BMJ, The New England Journal of Medicine, and Annals of Internal Medicine and found that 31 and 26% articles published before 1997 did not report ethical approval and informed consent, respectively. Furthermore, 18% of publications in these five journals after 1997 did not report ethical approval and informed consent. More recently, similar findings were identified by a range of authors, suggesting that this is a common challenge faced by journals [ 10 , 11 , 12 , 13 , 14 , 15 , 16 , 17 ]. For example, Schroter, Plowman [ 10 ] reviewed five general medical journals and reported that 47 and 31% of human research did not describe whether informed consent and ethical approval have obtained. More recently, the increasing concern on human rights protection has influenced this and ethical transgressions have improved. This was illustrated by Bridoux, Schwarz [ 18 ], who reported that 92.2% of surgical trials described informed consent and 87.7% stated ethical approval. However, publications that are not in accordance with the principles of ethical reporting remains common [ 19 , 20 , 21 , 22 ]. For example, Murphy, Nolan [ 20 ] identified that 42.9 and 49.9% of clinical research published in three leading European Otolaryngology periodicals did not report informed consent and ethical approval, respectively.

Nursing research has progressed rapidly during the last three decades and supported the development of efficient and high-quality care. This is observed in a number of nursing academic journals, increased volume of nursing research, and professors in nursing [ 23 , 24 , 25 ]. The growth in nursing research presents a range of challenges, not least because of the vulnerable groups that nursing research includes and the capability and capacity of nurses to conduct ethically sound research. Worryingly, it is acknowledged that many nurses receive inadequate education, often compounded with lack of ethical awareness and knowledge when conducting clinical research [ 26 , 27 , 28 , 29 ]. This was reflected in findings reported by Negarandeh and Gobady [ 30 ] who identified that 70.8% of nurses and midwives lack of education on ethical issues. These challenges within nursing research has raised concerns and the International Council of Nurses Code of Ethics for Nurses [ 31 ] has founded to regulate research ethics in the nursing profession. Therefore, it is essential to identify the extent to which ethical review is reported in nursing publications to both regulate and monitor ethics in nursing research involving human subjects.

Currently, the majority of ethics investigation have focused on reports in medical journals. In order to identify the extent to which ethical approval on human research is reported in nursing journals, we conducted a study to explore the ethical considerations among 12 Chinese top nursing journals. Our findings identified that only 51.8 and 25.9% of clinical trials reported informed consent and ethical approval, respectively [ 32 ]. The purposes of this study were to assess the rates of reporting of ethical considerations in five leading international nursing journals following the work of Yank and Rennie [ 1 ].

Study design and inclusion criteria

This is a retrospective observational study adhered to STROBE guidelines. All publications that reported clinical research in five high ranked nursing journals, according to the 2017 SCI Journal Citation Reports’ impact factor between 2015 and 2017 were retrieved to evaluate for evidence of ethical review. These journals, with a high impact factor, were International Journal of Nursing Studies (3.755), European Journal of Cardiovascular Nursing (2.763), Journal of Family Nursing (2.537), Nurse Education Today (2.533), and Birth-issues in Perinatal Care (2.518). Publications were included if the following criteria were met: (1) Clinical research articles: as described by previous studies [ 10 , 11 , 13 , 20 ], the sample frame selected included all original research articles involving human participants or human tissue. (2) Full-text articles. Supplement published studies, protocols, laboratory and animal studies, reviews, letters, editorials, discussion papers, erratum/corrigendum, commentaries, and news were excluded.

Data extraction

Data were extracted between August 2017 and July 2018. The contents and full-text PDFs of the five top nursing journals between 2015 and 2017 were extracted and downloaded from the Wiley Online Library or the ScienceDirect through the university subscription. Two authors (W.C and M.H1) independently reviewed the articles published in the five nursing journals in keeping with the standardized eligibility criteria to ensure the accuracy and credibility of the process. All of the articles were identified and reviewed based on the contents of each issue of journal. The full text of each included article was carefully read and the results were recorded in a standardized data extraction form. Disagreements were resolved by consensus or the third person (Y.W). Following this, articles that did not report ethical review were checked again by the third person (Y.W).

The primary outcome of our study was to ascertain the rates of reporting informed consent and ethical approval. We included papers with any of the following types descriptions (with examples). (1) Informed consent – a. written informed consent obtained (“ the written informed consent was obtained from participants or the legally authorized representative ”), b. oral informed consent obtained (“ the oral/verbal consent was obtained from participants ”), c. other consent type (has been categorized as “ the participants’ consent was indicated by the completion and returning of the questionnaire ”, “ consent was obtained through providing information and finishing consent section or a consent form within the online portal ”, and “ the informed consent was indicated by participants take part in evaluations ”), d. the consent type not reported (only described that “ consent was obtained from participants or participants agreed to join in the research ”, but did not indicate the way to get the consent), and e. consent was waived or not required (“ informed consent was exempted or not required due to the policy or the law of the government or the type of the research ”). The dates on informed consent in the study were collected on prospective studies only [ 20 ]. (2) Ethical approval – we checked to determine if the study reported that it was approved by the ethics committee in the hospital or other institutions before undertaking the research. We also examined whether the name of the ethical committee and ethical approval reference number was reported.

The secondary outcomes of our study included the rates of reporting other details related to ethical approval and informed consent including ethical statement. For example, whether the author declared that the research conformed to the Declaration of Helsinki, and if the research participants had been told that they have the right to withdraw from the study at any time without reprisal. There was excellent agreement on the two primary outcome measures between two authors (W.C and M.H1) (reporting of informed consent and ethical approval) ( k  > 0.95 for all).

We collated additional information that included the study type, funding sources, and nationality of publishing institution to enable subgroup analysis. Firstly, the type of research was categorized as either prospective or retrospective based on prior studies [ 11 , 13 , 15 ]. Following this, the prospective studies were divided into randomized controlled trial (RCT), nonrandomized trial, observational study (including audit, surveys, quality assurance activities, prospective cohort study, and qualitative study), single-arm, specimen, and mixed methods study. The retrospective studies were divided into specimen, chart review, and database analysis. Secondly, data were gathered on whether research received financial support following the work of Yank and Reinnie [ 1 ], regardless of the type of funding. Finally, given the different clinical ethical dilemmas in different countries [ 33 ], we identified the nationality of publishing institution of each study, defined as the country of the research conducted institution.

Data analysis

Data was analyzed using SPSS 20.0 software (IBM, USA). The rates of informed consent and ethical approval between year, study types, funding sources, and different countries were compared by use of Chi-square tests or Fisher’s exact tests (where cell size was less than 5). All P values were two-sided, and a value of P <  0.05 was indicated significant.

Study selection

A total of 2041 citations were identified from the contents of all the five leading nursing journals published between 2015 and 2017. From these, 757 were screened out using the data extraction process. These were: 335 reviews, one laboratory investigation, one research protocol, and 420 other types (letters, editorials, discussion papers, erratum/corrigendum, commentaries, and news). In total, 1284 clinical papers were included to extract the data of ethical review (see Fig.  1 ).

figure 1

PRISMA Flow Diagram

  • Informed consent

Of the 1284 clinical studies, 99 were retrospective studies and 1185 were prospective studies. Of the 1185 prospective studies, 1037 (87.5%) mentioned informed consent. However, only 549 (52.9%) of those reported that written informed consent had been obtained, and only 37 (3.6%) of these had reported oral consent. Interestingly, 70 (6.8%) of studies had used other ways to indicate participants’ consent, such as ‘assent’ through the completion and return of the questionnaire in surveys, or finishing online consent section, or implied by participants attend research evaluations. Notably, a small number 375 (36.2%) described that “ consent was obtained from participants or participants agreed to join in the research ” but did not elaborate on the methods used to gain consent. Furthermore, six (0.5%) studies stated that the informed consent from participants were waived or not required due to the policy or the law of the government or the type of the research (Table  1 ). In addition, the rates of reporting informed consent between different publication years and evidence of research funding demonstrated no statistical significance (all P  > 0.05) but variances were observed between different country ( P  < 0.001) (Table  2 ).

  • Ethical approval

Our results indicate that 1203 (93.7%) of 1284 clinical studies reported ethical approval in the main text of the paper. Of the 1203 studies, 1144 (95.1%) reported that ethics committee approval was obtained before the study was undertaken and 59 (4.9%) of studies stated that the ethical approval for the study was not required or waived under the local or national laws. Notably, of the 1144 studies that reported ethical approval had been obtained, a larger number, 1058 (92.5%) of studies stated the name of ethical committee, however, only 424 (37.1%) of studies included the ethical approval reference number. A small number, 181 (14.1%) of studies stated that ethical considerations of the research conformed to the Declaration of Helsinki (Table 1 ). Furthermore, no statistically significant differences were found between 2015 and 2017 in relation to the rates of reporting ethical approval ( P  > 0.05). Notably, the rates of reporting ethical approval were different between different study type, country, and whether mentioning financial support (all P  < 0.05). The rates of reporting ethical approval in prospective studies was much higher than retrospective studies (94.6% vs 82.8%). Moreover, the reporting of ethical approval in the studies that had financial support, was much higher than those who did not receive funding (95.2% vs 91.9%) (Table 2 ).

Our findings revealed a relative progression in the reporting of ethics as compared with prior studies such as Yank and Rennie [ 1 ], Schroter, Plowman [ 10 ], Pitak-Arnnop, Sader [ 14 ], and Fitzgerald [ 19 ]. For example, we identified that 87.5% of prospective clinical studies reported informed consent and 93.7% of clinical studies stated that ethical approval had been obtained. This is similar to Bridoux, Schwarz [ 18 ] findings that reported 87.7 and 92.2% of surgical trials stated ethical approval and informed consent, respectively. However, the reporting rates of ethics were much higher than most of other studies. For example, informed consent and ethical approval were reported in 53 and 69% in five general medical journals, 68.5 and 71% in six leading anesthesia journals, 36 and 39.3% in four major orthodontic journals, 57.1 and 50.1% in three leading European Otolaryngology journals, as well as 16 and 54% in three paediatric surgical journals, respectively [ 10 , 11 , 19 , 20 , 22 ]. Furthermore, the reporting of ethical considerations in the five leading international journals was more frequent than the twelve top Chinese nursing journals we previously investigated in 2017. These earlier findings highlighted that only 51.8 and 25.9% of clinical trials stated informed consent and ethical approval, respectively [ 32 ]. This more recent increase may have been influenced though the rapid development of medical technology which has enriched the content of nursing clinical research. However, it is acknowledged that China’s higher nursing education developed slowly because of civil wars and external invasion until 1949 and still need more efforts to improve the knowledge and awareness of ethics among nursing researcher [ 34 ].

Importantly, our findings indicated that the reporting of ethical approval in leading international nursing journals is less than ideal and work is needed to develop a standardized approach. Whilst our research illustrates a welcome progression, equally, the reporting of ethical approval is now recognized by leading journals as an essential pre-publication requirement. However, the detail of what is reported needs to be developed to enable readers and editors to understand that the reporting of consent was more than just ‘consent’ and that it was truly informed, thus reflecting the autonomous rights of the research participants. Merely stating fact that ‘informed consent’ was obtained, does not necessarily mean that consent was actually informed [ 1 ]. Signing a consent form or explicitly negotiated verbal consent presents two traditional methods in which participants’ informed consent is obtained [ 3 ]. With the rapid development of network techniques, using electronic methods to obtain informed consent is now considered to be a convenient as compared to other ways especially in some online questionnaire survey research. Furthermore, based on the 375 studies that did not describe the way to get the consent, determining whether the ethical considerations reported were implemented as challenging. Moreover, the reason for exemption should be declared by the authors which should include a rationale for absence of informed consent and/or ethical approval. For example, lack of informed consent maybe as a result of fully anonymised samples or legal reasons [ 15 ]. In our study, only 59 (4.9%) of studies stated that the ethical approval for the study was not required or waived under the local or national laws. Of the studies that have been identified as not reporting ethical considerations, we are unable to report whether the ethical protections of these studies were deemed unnecessary or if the researcher did not consider it. Therefore, the reporting of ethical protection of clinical research in leading nursing journals needs to be transparent and standardized.

Furthermore, our study identified progression in the reporting of ethical approval, however, only 37.1% of studies mentioned the ethical approval reference number. Although the ethical principles of the Declaration of Helsinki and the ICMJE do not stipulate that authors report the name of ethics committee and the approval number in the text, it has been recommended by many researchers [ 1 , 20 , 35 ]. Similar reporting expectations are included in the author instructions in numerous medical journals such as the BMJ , the European Journal of Cardiovascular Nursing , and the Journal of Family Nursing . This conflict in reporting of ethical committees and references numbers could be explained by the following two reasons. Firstly, the inclusion of the ethics committee details and reference helps to regulate ethical statement and to make sure that the ethical approval is authentic. Secondly, there is strong evidence to show the different effectiveness and practice between different local committees, stating the name of ethics committee could also help readers or others make decisions on the ethical protections of the study [ 36 , 37 ]. In addition, our study, only five clinical studies stated the organizational approval to conduct the research including the approval from the dean’s office, the school management, and the head of the department. Though this may be due to the organization policy, this approach does not comply with the principles of the Declaration of Helsinki which states that the research should be approved by an independent ethics committee. Therefore, the statement of the ethics committee approval in clinical studies still need to be standardized and improved.

It was surprising that there was no difference between publication year on ethical considerations in leading international nursing journals, which is contrary to the results on twelve Chinese nursing journals demonstrated a sharp improvement previously identified between 2013 and 2016 [ 32 ]. This may have been influenced by recent higher education institution, the ethics committee, and the nursing journals efforts in China in recent years.

Furthermore, our research demonstrated that the rates of reporting ethical approval in prospective studies was much higher than retrospective studies (94.6% vs 82.8%). Specifically, RCTs showed a relatively high reporting rates whereas the study type of database and single-arm need more attention to improve the reporting of ethical considerations. This is supported by Block [ 13 ] who found that the RCTs showed a high proportion in reporting of ethical approval. Most of researchers obtained ethics committee approval for RCTs and were not realized that approval still required for studies that do not enroll human participants such as retrospective studies on chart or database review [ 15 ]. Moreover, although we only retrieved the rates of reporting informed consent in prospective studies in line with prior studies [ 13 , 20 ], we are aware that neither retrospective studies published in the five leading international nursing journals stated the informed consent. The Declaration of Helsinki states that if informed consent for medical research using existing human data or material is impracticable to obtain, the research could be done after approval of an ethics committee. Furthermore, some researchers also stated that the informed consent is not required to the retrospective studies because this kind of study meet the criteria that “ the research involves no more than minimal risk to the subjects ” [ 13 ].

In summary, nursing journals assume an extremely important social, moral and ethical responsibility to improve and regulate the reporting of ethical considerations in clinical research. The reporting of ethics in the five leading international nursing journals showed some progress, but effort is still required to standardize the transparency and detail of ethical reporting.

Availability of data and materials

The datasets used and/or analyzed during the current study are available from the corresponding author on reasonable request.

Abbreviations

The Committee of Publication Ethics

The International Committee of Medical Journal Editors

Randomized controlled trials

The World Association of Medical Editors

Yank V, Rennie D. Reporting of informed consent and ethics committee approval in clinical trials. Jama. 2002;287(21):2835–8.

Article   Google Scholar  

Fernandez Lynch H, Joffe S, Feldman EA. Informed consent and the role of the treating physician. N Engl J Med. 2018;378(25):2433–8.

Nathanson V. Revising the declaration of Helsinki. BMJ. 2013;346:f2837.

World Medical Association. Declaration of Helsinki. Ethical principles for medical research involving human subjects. Jama. 2013;310(20):2191–4.

Angelski C, Fernandez CV, Weijer C, Gao J. The publication of ethically uncertain research: attitudes and practices of journal editors. BMC Med Ethics. 2012;13(1):4.

International Committee of Medical Journal Editors. Uniform requirements for manuscripts submitted to biomedical journals. Updated October 2001. Rom J Gastroenterol. 2003;12(1):74–83.

Google Scholar  

Merz JF. The Nuremberg code and informed consent for research. Jama. 2018;319(1):85–6.

The World Association of Medical Editors. Publication ethics policies for medical journals 2011 [cited 2019 April 2]. Available from: http://www.wame.org .

The Committee on Publication Ethics. A code of conduct for editors of biomedical journals 2011 [cited 2019 April 2]. Available from: http://publicationethics.org/files/Code%20of%20conduct%20for%20journal% 20editors_0.pdf.

Schroter S, Plowman R, Hutchings A, Gonzalez A. Reporting ethics committee approval and patient consent by study design in five general medical journals. J Med Ethics. 2006;32(12):718–23.

Myles PS, Tan N. Reporting of ethical approval and informed consent in clinical research published in leading anesthesia journals. Anesthesiologists. 2003;99(5):1209–13.

Henley LD, Frank DM. Reporting ethical protections in physical therapy research. Phys Ther. 2006;86(4):499–509.

Block MI, Khitin LM, Sade RM. Ethical process in human research published in thoracic surgery journals. Ann Thorac Surg. 2006;82(1):6–12.

Pitak-Arnnop P, Sader R, Herve C, Dhanuthai K, Bertrand JC, Hemprich A. Reporting of ethical protection in recent oral and maxillofacial surgery research involving human subjects. Int J Oral Maxillofac Surg. 2009;38(7):707–12.

Bauchner H, Sharfstein J. Failure to report ethical approval in child health research: review of published papers. BMJ. 2001;323(7308):318–9.

Bavdekar SB, Gogtay NJ, Wagh S. Reporting ethical processes in two Indian journals. Indian J Med Sci. 2008;62(4):134–40.

Sumathipala A, Siribaddana S, Hewege S, Lekamwattage M, Athukorale M, Siriwardhana C, et al. Ethics review committee approval and informed consent: an analysis of biomedical publications originating from Sri Lanka. BMC Med Ethics. 2008;9(1):3.

Bridoux V, Schwarz L, Moutel G, Michot F, Herve C, Tuech JJ. Reporting of ethical requirements in phase III surgical trials. J Med Ethics. 2014;40(10):687–90.

Fitzgerald R. The reporting of ethical approval and informed consent for clinical trials in four major orthodontic journals: University of Liverpool; 2012.

Murphy S, Nolan C, O'Rourke C, Fenton JE. The reporting of research ethics committee approval and informed consent in otolaryngology journals. Clinical Otolaryngol. 2015;40(1):36–40.

Lawrence DJ. Human subject research: reporting ethics approval and informed consent in 3 chiropractic journals. J Manip Physiol Ther. 2011;34(9):627–33.

Dingemann J, Dingemann C, Ure B. Failure to report ethical approval and informed consent in paediatric surgical publications. Eur J Pediatr Surg. 2011;21(4):215–9.

Thompson DR. Fostering a research culture in nursing. Nurs Inq. 2003;10(3):143–4.

Polit DF, Beck CT. Nursing research: principles and methods: Lippincott Williams & Wilkins; 2004.

Clark AM, Thompson DR. What is real success in nursing research? 2018.

Book   Google Scholar  

Mohajjel-Aghdam A, Hassankhani H, Zamanzadeh V, Khameneh S, Moghaddam S. Knowledge and performance about nursing ethic codes from Nurses' and Patients' perspective in Tabriz teaching hospitals, Iran. J Caring Sci. 2013;2(3):219–27.

Fernandez CV. Publication of ethically suspect research: should it occur? Int J Qual Health Care. 2005;17(5):377–8.

Freda MC, Kearney MH. Ethical issues faced by nursing editors. West J Nurs Res. 2005;27(4):487–99.

Huang X, O’Connor M, Ke L-S, Lee S. Ethical and methodological issues in qualitative health research involving children: a systematic review. Nurs Ethics. 2016;23(3):339–56.

Negarandeh R, Gobady S. A survey of knowledge and attitude of Zanjan Hospitals' nurses and midwives towards ethical issues. J Zanjan Univ Med Sci Health Serv. 2001;9(36):55–9.

International Council of Nursing. The ICN code of ethics for nurses. Nurs Ethics. 2001;8(4):375–9.

Wu Y, Howarth M, Zhou C, Ji X, Ou J, Li X. Reporting of ethical considerations in clinical trials in Chinese nursing journals. Nurs Ethics. 2019;26(4):973–83.

Miljeteig I, Defaye F, Desalegn D, Danis M. Clinical ethics dilemmas in a low-income setting-a national survey among physicians in Ethiopia. BMC Med Ethics. 2019;20(1):1–13.

Wong FK, Zhao Y. Nursing education in China: past, present and future. J Nurs Manag. 2012;20(1):38–44.

Astaneh B, Khani P. The Frequency of Reporting Ethical Issues in Human Subject Articles Published in Iranian Medical Journals: 2009–2013. Sci Eng Ethics. 2019;25(1):159–70.

Middle C, Johnson A, Petty T, Sims L, Macfarlane A. Ethics approval for a national postal survey: recent experience. Bmj. 1995;311(7006):659–60.

Stair TO, Reed CR, Radeos MS, Koski G, Camargo CA. Variation in institutional review board responses to a standard protocol for a multicenter clinical trial. Acad Emerg Med Off J Soc Acad Emerg Med. 2001;8(6):636–41.

Download references

Acknowledgements

Not applicable.

The project was funded by the China Editology Society of Science Periodicals (CESSP) of China Association for Science and Technology (No. castqk2017-qnkt-01). The funder had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.

Author information

Yanni Wu and Michelle Howarth contributed equally to this work.

Authors and Affiliations

Nanfang Hospital, Southern Medical University, Guangzhou, Guangdong, People’s Republic of China

Yanni Wu, Chunlan Zhou, Mingyu Hu & Weilian Cong

The School of Health & Society, University of Salford, Greater Manchester, UK

Michelle Howarth

You can also search for this author in PubMed   Google Scholar

Contributions

YW, MH2, and CZ were responsible for protocol design of the research. YW, WC and MH1 extracted and analyzed the data from the five leading nursing journals. YW wrote the first draft of the manuscript and MH2 helped with the revisions of the article. All authors read and approved the final manuscript.

Corresponding author

Correspondence to Chunlan Zhou .

Ethics declarations

Ethics approval and consent to participate.

The study is exempt from review by the Ethics Committee of Nanfang Hospital based on the basis that this type of study is non-human subject research, and waived the need for informed consent.

Consent for publication

Competing interests.

The authors declare that they have no competing interests.

Additional information

Publisher’s note.

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Rights and permissions

Open Access This article is distributed under the terms of the Creative Commons Attribution 4.0 International License ( http://creativecommons.org/licenses/by/4.0/ ), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver ( http://creativecommons.org/publicdomain/zero/1.0/ ) applies to the data made available in this article, unless otherwise stated.

Reprints and permissions

About this article

Cite this article.

Wu, Y., Howarth, M., Zhou, C. et al. Reporting of ethical approval and informed consent in clinical research published in leading nursing journals: a retrospective observational study. BMC Med Ethics 20 , 94 (2019). https://doi.org/10.1186/s12910-019-0431-5

Download citation

Received : 27 November 2018

Accepted : 27 November 2019

Published : 05 December 2019

DOI : https://doi.org/10.1186/s12910-019-0431-5

Share this article

Anyone you share the following link with will be able to read this content:

Sorry, a shareable link is not currently available for this article.

Provided by the Springer Nature SharedIt content-sharing initiative

  • Clinical research
  • Nursing journal
  • Research ethics

BMC Medical Ethics

ISSN: 1472-6939

scholarly articles on ethical considerations in research

scholarly articles on ethical considerations in research

Top 5 Academic Publishing Trends That Will Dominate in 2024

January 2, 2024

scholarly articles on ethical considerations in research

1. AI-powered Research and Review: Paradigm Shift or Pandora’s Box?

Trend: AI is rapidly transforming research workflows, from hypothesis generation to data analysis and manuscript drafting. Tools like generative AI and large language models are poised to revolutionize peer review, potentially speeding up the process while raising concerns about bias and ethical considerations.

Impact: Academic publishers can leverage AI to streamline submission and review processes, personalize content recommendations for readers, and offer innovative research tools. However, they must address concerns about transparency, human oversight, and potential biases in AI-driven decisions.

2. Open Access Evolves: Beyond the Gold Standard

Trend: While open access (OA) is gaining traction, diverse models like diamond and platinum OA are emerging. These models offer alternative funding mechanisms and potentially greater author control over content, challenging the traditional “gold OA” model.

Impact: Publishers need to adapt to the evolving OA landscape by offering flexible publishing models, exploring sustainable funding mechanisms, and collaborating with institutions and libraries to ensure wider access to research.

3. Micropublication and Snackable Research: Attention Spans in the Digital Age

Trend: Attention spans are shrinking, and researchers are increasingly seeking concise, bite-sized formats for consuming and sharing research. Micropublications, short-form articles, and video summaries are gaining popularity as alternatives to traditional lengthy papers.

Impact: Publishers can cater to this trend by developing platforms for micropublications, partnering with video platforms for research summaries, and offering modular content formats that can be easily shared and digested.

4. Data-Driven Decision Making: Metrics Beyond the Citation Count

Trend: Researchers and publishers are moving beyond traditional metrics like citations to consider alternative indicators of research impact, such as altmetrics, social media engagement, and real-world applications. This shift necessitates robust data collection and analysis to inform decision-making.

Impact: Publishers can leverage data analytics to provide authors with insights into their research’s reach and impact, optimize marketing and dissemination strategies, and identify emerging research trends.

5. Collaborative Publishing: Breaking Down Silos and Embracing Openness

Trend: Cross-disciplinary research and collaboration are becoming increasingly important, and publishers can facilitate this by fostering open access platforms, encouraging co-authorship across disciplines, and supporting collaborative research initiatives.

Impact: Embracing collaboration can lead to more impactful research, wider dissemination of knowledge, and the breaking down of traditional academic silos. Publishers can play a key role in facilitating this shift.

About Rakhesh Ravi

This website uses cookies to provide you with the best experience on our website, better understand the use of our website and services, and to optimize promotional activity. By using our website, you agree to the use of cookies as in our Privacy Policy . Accept and Close

scholarly articles on ethical considerations in research

Have a language expert improve your writing

Run a free plagiarism check in 10 minutes, generate accurate citations for free.

  • Knowledge Base

Methodology

  • Ethical Considerations in Research | Types & Examples

Ethical Considerations in Research | Types & Examples

Published on October 18, 2021 by Pritha Bhandari . Revised on June 22, 2023.

Ethical considerations in research are a set of principles that guide your research designs and practices. Scientists and researchers must always adhere to a certain code of conduct when collecting data from people.

The goals of human research often include understanding real-life phenomena, studying effective treatments, investigating behaviors, and improving lives in other ways. What you decide to research and how you conduct that research involve key ethical considerations.

These considerations work to

  • protect the rights of research participants
  • enhance research validity
  • maintain scientific or academic integrity

Table of contents

Why do research ethics matter, getting ethical approval for your study, types of ethical issues, voluntary participation, informed consent, confidentiality, potential for harm, results communication, examples of ethical failures, other interesting articles, frequently asked questions about research ethics.

Research ethics matter for scientific integrity, human rights and dignity, and collaboration between science and society. These principles make sure that participation in studies is voluntary, informed, and safe for research subjects.

You’ll balance pursuing important research objectives with using ethical research methods and procedures. It’s always necessary to prevent permanent or excessive harm to participants, whether inadvertent or not.

Defying research ethics will also lower the credibility of your research because it’s hard for others to trust your data if your methods are morally questionable.

Even if a research idea is valuable to society, it doesn’t justify violating the human rights or dignity of your study participants.

Here's why students love Scribbr's proofreading services

Discover proofreading & editing

Before you start any study involving data collection with people, you’ll submit your research proposal to an institutional review board (IRB) .

An IRB is a committee that checks whether your research aims and research design are ethically acceptable and follow your institution’s code of conduct. They check that your research materials and procedures are up to code.

If successful, you’ll receive IRB approval, and you can begin collecting data according to the approved procedures. If you want to make any changes to your procedures or materials, you’ll need to submit a modification application to the IRB for approval.

If unsuccessful, you may be asked to re-submit with modifications or your research proposal may receive a rejection. To get IRB approval, it’s important to explicitly note how you’ll tackle each of the ethical issues that may arise in your study.

There are several ethical issues you should always pay attention to in your research design, and these issues can overlap with each other.

You’ll usually outline ways you’ll deal with each issue in your research proposal if you plan to collect data from participants.

Voluntary participation means that all research subjects are free to choose to participate without any pressure or coercion.

All participants are able to withdraw from, or leave, the study at any point without feeling an obligation to continue. Your participants don’t need to provide a reason for leaving the study.

It’s important to make it clear to participants that there are no negative consequences or repercussions to their refusal to participate. After all, they’re taking the time to help you in the research process , so you should respect their decisions without trying to change their minds.

Voluntary participation is an ethical principle protected by international law and many scientific codes of conduct.

Take special care to ensure there’s no pressure on participants when you’re working with vulnerable groups of people who may find it hard to stop the study even when they want to.

Informed consent refers to a situation in which all potential participants receive and understand all the information they need to decide whether they want to participate. This includes information about the study’s benefits, risks, funding, and institutional approval.

You make sure to provide all potential participants with all the relevant information about

  • what the study is about
  • the risks and benefits of taking part
  • how long the study will take
  • your supervisor’s contact information and the institution’s approval number

Usually, you’ll provide participants with a text for them to read and ask them if they have any questions. If they agree to participate, they can sign or initial the consent form. Note that this may not be sufficient for informed consent when you work with particularly vulnerable groups of people.

If you’re collecting data from people with low literacy, make sure to verbally explain the consent form to them before they agree to participate.

For participants with very limited English proficiency, you should always translate the study materials or work with an interpreter so they have all the information in their first language.

In research with children, you’ll often need informed permission for their participation from their parents or guardians. Although children cannot give informed consent, it’s best to also ask for their assent (agreement) to participate, depending on their age and maturity level.

Anonymity means that you don’t know who the participants are and you can’t link any individual participant to their data.

You can only guarantee anonymity by not collecting any personally identifying information—for example, names, phone numbers, email addresses, IP addresses, physical characteristics, photos, and videos.

In many cases, it may be impossible to truly anonymize data collection . For example, data collected in person or by phone cannot be considered fully anonymous because some personal identifiers (demographic information or phone numbers) are impossible to hide.

You’ll also need to collect some identifying information if you give your participants the option to withdraw their data at a later stage.

Data pseudonymization is an alternative method where you replace identifying information about participants with pseudonymous, or fake, identifiers. The data can still be linked to participants but it’s harder to do so because you separate personal information from the study data.

Confidentiality means that you know who the participants are, but you remove all identifying information from your report.

All participants have a right to privacy, so you should protect their personal data for as long as you store or use it. Even when you can’t collect data anonymously, you should secure confidentiality whenever you can.

Some research designs aren’t conducive to confidentiality, but it’s important to make all attempts and inform participants of the risks involved.

As a researcher, you have to consider all possible sources of harm to participants. Harm can come in many different forms.

  • Psychological harm: Sensitive questions or tasks may trigger negative emotions such as shame or anxiety.
  • Social harm: Participation can involve social risks, public embarrassment, or stigma.
  • Physical harm: Pain or injury can result from the study procedures.
  • Legal harm: Reporting sensitive data could lead to legal risks or a breach of privacy.

It’s best to consider every possible source of harm in your study as well as concrete ways to mitigate them. Involve your supervisor to discuss steps for harm reduction.

Make sure to disclose all possible risks of harm to participants before the study to get informed consent. If there is a risk of harm, prepare to provide participants with resources or counseling or medical services if needed.

Some of these questions may bring up negative emotions, so you inform participants about the sensitive nature of the survey and assure them that their responses will be confidential.

The way you communicate your research results can sometimes involve ethical issues. Good science communication is honest, reliable, and credible. It’s best to make your results as transparent as possible.

Take steps to actively avoid plagiarism and research misconduct wherever possible.

Plagiarism means submitting others’ works as your own. Although it can be unintentional, copying someone else’s work without proper credit amounts to stealing. It’s an ethical problem in research communication because you may benefit by harming other researchers.

Self-plagiarism is when you republish or re-submit parts of your own papers or reports without properly citing your original work.

This is problematic because you may benefit from presenting your ideas as new and original even though they’ve already been published elsewhere in the past. You may also be infringing on your previous publisher’s copyright, violating an ethical code, or wasting time and resources by doing so.

In extreme cases of self-plagiarism, entire datasets or papers are sometimes duplicated. These are major ethical violations because they can skew research findings if taken as original data.

You notice that two published studies have similar characteristics even though they are from different years. Their sample sizes, locations, treatments, and results are highly similar, and the studies share one author in common.

Research misconduct

Research misconduct means making up or falsifying data, manipulating data analyses, or misrepresenting results in research reports. It’s a form of academic fraud.

These actions are committed intentionally and can have serious consequences; research misconduct is not a simple mistake or a point of disagreement about data analyses.

Research misconduct is a serious ethical issue because it can undermine academic integrity and institutional credibility. It leads to a waste of funding and resources that could have been used for alternative research.

Later investigations revealed that they fabricated and manipulated their data to show a nonexistent link between vaccines and autism. Wakefield also neglected to disclose important conflicts of interest, and his medical license was taken away.

This fraudulent work sparked vaccine hesitancy among parents and caregivers. The rate of MMR vaccinations in children fell sharply, and measles outbreaks became more common due to a lack of herd immunity.

Research scandals with ethical failures are littered throughout history, but some took place not that long ago.

Some scientists in positions of power have historically mistreated or even abused research participants to investigate research problems at any cost. These participants were prisoners, under their care, or otherwise trusted them to treat them with dignity.

To demonstrate the importance of research ethics, we’ll briefly review two research studies that violated human rights in modern history.

These experiments were inhumane and resulted in trauma, permanent disabilities, or death in many cases.

After some Nazi doctors were put on trial for their crimes, the Nuremberg Code of research ethics for human experimentation was developed in 1947 to establish a new standard for human experimentation in medical research.

In reality, the actual goal was to study the effects of the disease when left untreated, and the researchers never informed participants about their diagnoses or the research aims.

Although participants experienced severe health problems, including blindness and other complications, the researchers only pretended to provide medical care.

When treatment became possible in 1943, 11 years after the study began, none of the participants were offered it, despite their health conditions and high risk of death.

Ethical failures like these resulted in severe harm to participants, wasted resources, and lower trust in science and scientists. This is why all research institutions have strict ethical guidelines for performing research.

If you want to know more about statistics , methodology , or research bias , make sure to check out some of our other articles with explanations and examples.

  • Normal distribution
  • Measures of central tendency
  • Chi square tests
  • Confidence interval
  • Quartiles & Quantiles
  • Cluster sampling
  • Stratified sampling
  • Thematic analysis
  • Cohort study
  • Peer review
  • Ethnography

Research bias

  • Implicit bias
  • Cognitive bias
  • Conformity bias
  • Hawthorne effect
  • Availability heuristic
  • Attrition bias
  • Social desirability bias

Ethical considerations in research are a set of principles that guide your research designs and practices. These principles include voluntary participation, informed consent, anonymity, confidentiality, potential for harm, and results communication.

Scientists and researchers must always adhere to a certain code of conduct when collecting data from others .

These considerations protect the rights of research participants, enhance research validity , and maintain scientific integrity.

Research ethics matter for scientific integrity, human rights and dignity, and collaboration between science and society. These principles make sure that participation in studies is voluntary, informed, and safe.

Anonymity means you don’t know who the participants are, while confidentiality means you know who they are but remove identifying information from your research report. Both are important ethical considerations .

You can only guarantee anonymity by not collecting any personally identifying information—for example, names, phone numbers, email addresses, IP addresses, physical characteristics, photos, or videos.

You can keep data confidential by using aggregate information in your research report, so that you only refer to groups of participants rather than individuals.

These actions are committed intentionally and can have serious consequences; research misconduct is not a simple mistake or a point of disagreement but a serious ethical failure.

Cite this Scribbr article

If you want to cite this source, you can copy and paste the citation or click the “Cite this Scribbr article” button to automatically add the citation to our free Citation Generator.

Bhandari, P. (2023, June 22). Ethical Considerations in Research | Types & Examples. Scribbr. Retrieved January 4, 2024, from https://qa.scribbr.com/methodology/research-ethics/

Is this article helpful?

Pritha Bhandari

Pritha Bhandari

Other students also liked, data collection | definition, methods & examples, what is self-plagiarism | definition & how to avoid it, how to avoid plagiarism | tips on citing sources, what is your plagiarism score.

Ethical Issues in Research: Perceptions of Researchers, Research Ethics Board Members and Research Ethics Experts

  • Published: 12 August 2022
  • Volume 21 , pages 269–292, ( 2023 )
  • Marie-Josée Drolet   ORCID: orcid.org/0000-0001-8384-4193 1 ,
  • Eugénie Rose-Derouin 2 ,
  • Julie-Claude Leblanc 2 ,
  • Mélanie Ruest 2 &
  • Bryn Williams-Jones 3  

18k Accesses

5 Citations

5 Altmetric

Explore all metrics

In the context of academic research, a diversity of ethical issues, conditioned by the different roles of members within these institutions, arise. Previous studies on this topic addressed mainly the perceptions of researchers. However, to our knowledge, no studies have explored the transversal ethical issues from a wider spectrum, including other members of academic institutions as the research ethics board (REB) members, and the research ethics experts. The present study used a descriptive phenomenological approach to document the ethical issues experienced by a heterogeneous group of Canadian researchers, REB members, and research ethics experts. Data collection involved socio-demographic questionnaires and individual semi-structured interviews. Following the triangulation of different perspectives (researchers, REB members and ethics experts), emerging ethical issues were synthesized in ten units of meaning: (1) research integrity, (2) conflicts of interest, (3) respect for research participants, (4) lack of supervision and power imbalances, (5) individualism and performance, (6) inadequate ethical guidance, (7) social injustices, (8) distributive injustices, (9) epistemic injustices, and (10) ethical distress. This study highlighted several problematic elements that can support the identification of future solutions to resolve transversal ethical issues in research that affect the heterogeneous members of the academic community.

Similar content being viewed by others

scholarly articles on ethical considerations in research

Approaching Research in a Prepared, Mindful and Ethical Manner

scholarly articles on ethical considerations in research

Conceptualising Ethical Issues in the Conduct of Research: Results from a Critical and Systematic Literature Review

Élie Beauchemin, Louis Pierre Côté, … Bryn Williams-Jones

scholarly articles on ethical considerations in research

Stakeholders’ Experiences of Research Integrity Support in Universities: A Qualitative Study in Three European Countries

Natalie Evans, Ivan Buljan, … the EnTIRE consortium

Avoid common mistakes on your manuscript.

Introduction

Research includes a set of activities in which researchers use various structured methods to contribute to the development of knowledge, whether this knowledge is theoretical, fundamental, or applied (Drolet & Ruest, accepted ). University research is carried out in a highly competitive environment that is characterized by ever-increasing demands (i.e., on time, productivity), insufficient access to research funds, and within a market economy that values productivity and speed often to the detriment of quality or rigour – this research context creates a perfect recipe for breaches in research ethics, like research misbehaviour or misconduct (i.e., conduct that is ethically questionable or unacceptable because it contravenes the accepted norms of responsible conduct of research or compromises the respect of core ethical values that are widely held by the research community) (Drolet & Girard, 2020 ; Sieber, 2004 ). Problematic ethics and integrity issues – e.g., conflicts of interest, falsification of data, non-respect of participants’ rights, and plagiarism, to name but a few – have the potential to both undermine the credibility of research and lead to negative consequences for many stakeholders, including researchers, research assistants and personnel, research participants, academic institutions, and society as a whole (Drolet & Girard, 2020 ). It is thus evident that the academic community should be able to identify these different ethical issues in order to evaluate the nature of the risks that they pose (and for whom), and then work towards their prevention or management (i.e., education, enhanced policies and procedures, risk mitigation strategies).

In this article, we define an “ethical issue” as any situation that may compromise, in whole or in part, the respect of at least one moral value (Swisher et al., 2005 ) that is considered socially legitimate and should thus be respected. In general, ethical issues occur at three key moments or stages of the research process: (1) research design (i.e., conception, project planning), (2) research conduct (i.e., data collection, data analysis) and (3) knowledge translation or communication (e.g., publications of results, conferences, press releases) (Drolet & Ruest, accepted ). According to Sieber ( 2004 ), ethical issues in research can be classified into five categories, related to: (a) communication with participants and the community, (b) acquisition and use of research data, (c) external influence on research, (d) risks and benefits of the research, and (e) selection and use of research theories and methods. Many of these issues are related to breaches of research ethics norms, misbehaviour or research misconduct. Bruhn et al., ( 2002 ) developed a typology of misbehaviour and misconduct in academia that can be used to judge the seriousness of different cases. This typology takes into consideration two axes of reflection: (a) the origin of the situation (i.e., is it the researcher’s own fault or due to the organizational context?), and (b) the scope and severity (i.e., is this the first instance or a recurrent behaviour? What is the nature of the situation? What are the consequences, for whom, for how many people, and for which organizations?).

A previous detailed review of the international literature on ethical issues in research revealed several interesting findings (Beauchemin et al., 2021 ). Indeed, the current literature is dominated by descriptive ethics, i.e., the sharing by researchers from various disciplines of the ethical issues they have personally experienced. While such anecdotal documentation is relevant, it is insufficient because it does not provide a global view of the situation. Among the reviewed literature, empirical studies were in the minority (Table  1 ) – only about one fifth of the sample (n = 19) presented empirical research findings on ethical issues in research. The first of these studies was conducted almost 50 years ago (Hunt et al., 1984 ), with the remainder conducted in the 1990s. Eight studies were conducted in the United States (n = 8), five in Canada (n = 5), three in England (n = 3), two in Sweden (n = 2) and one in Ghana (n = 1).

Further, the majority of studies in our sample (n = 12) collected the perceptions of a homogeneous group of participants, usually researchers (n = 14) and sometimes health professionals (n = 6). A minority of studies (n = 7) triangulated the perceptions of diverse research stakeholders (i.e., researchers and research participants, or students). To our knowledge, only one study has examined perceptions of ethical issues in research by research ethics board members (REB; Institutional Review Boards [IRB] in the USA), and none to date have documented the perceptions of research ethics experts. Finally, nine studies (n = 9) adopted a qualitative design, seven studies (n = 7) a quantitative design, and three (n = 3) a mixed-methods design.

More studies using empirical research methods are needed to better identify broader trends, to enrich discussions on the values that should govern responsible conduct of research in the academic community, and to evaluate the means by which these values can be supported in practice (Bahn, 2012 ; Beauchemin et al., 2021 ; Bruhn et al., 2002 ; Henderson et al., 2013 ; Resnik & Elliot, 2016; Sieber 2004 ). To this end, we conducted an empirical qualitative study to document the perceptions and experiences of a heterogeneous group of Canadian researchers, REB members, and research ethics experts, to answer the following broad question: What are the ethical issues in research?

Research Methods

Research design.

A qualitative research approach involving individual semi-structured interviews was used to systematically document ethical issues (De Poy & Gitlin, 2010 ; Hammell et al., 2000 ). Specifically, a descriptive phenomenological approach inspired by the philosophy of Husserl was used (Husserl, 1970 , 1999 ), as it is recommended for documenting the perceptions of ethical issues raised by various practices (Hunt & Carnavale, 2011 ).

Ethical considerations

The principal investigator obtained ethics approval for this project from the Research Ethics Board of the Université du Québec à Trois-Rivières (UQTR). All members of the research team signed a confidentiality agreement, and research participants signed the consent form after reading an information letter explaining the nature of the research project.

Sampling and recruitment

As indicated above, three types of participants were sought: (1) researchers from different academic disciplines conducting research (i.e., theoretical, fundamental or empirical) in Canadian universities; (2) REB members working in Canadian organizations responsible for the ethical review, oversight or regulation of research; and (3) research ethics experts, i.e., academics or ethicists who teach research ethics, conduct research in research ethics, or are scholars who have acquired a specialization in research ethics. To be included in the study, participants had to work in Canada, speak and understand English or French, and be willing to participate in the study. Following Thomas and Polio’s (2002) recommendation to recruit between six and twelve participants (for a homogeneous sample) to ensure data saturation, for our heterogeneous sample, we aimed to recruit approximately twelve participants in order to obtain data saturation. Having used this method several times in related projects in professional ethics, data saturation is usually achieved with 10 to 15 participants (Drolet & Goulet, 2018 ; Drolet & Girard, 2020 ; Drolet et al., 2020 ). From experience, larger samples only serve to increase the degree of data saturation, especially in heterogeneous samples (Drolet et al., 2017 , 2019 ; Drolet & Maclure, 2016 ).

Purposive sampling facilitated the identification of participants relevant to documenting the phenomenon in question (Fortin, 2010 ). To ensure a rich and most complete representation of perceptions, we sought participants with varied and complementary characteristics with regards to the social roles they occupy in research practice (Drolet & Girard, 2020 ). A triangulation of sources was used for the recruitment (Bogdan & Biklen, 2006 ). The websites of Canadian universities and Canadian health institution REBs, as well as those of major Canadian granting agencies (i.e., the Canadian Institutes of Health Research, the Natural Sciences and Engineering Research Council of Canada, and the Social Sciences and Humanities Research Council of Canada, Fonds de recherche du Quebec), were searched to identify individuals who might be interested in participating in the study. Further, people known by the research team for their knowledge and sensitivity to ethical issues in research were asked to participate. Research participants were also asked to suggest other individuals who met the study criteria.

Data Collection

Two tools were used for data collecton: (a) a socio-demographic questionnaire, and (b) a semi-structured individual interview guide. English and French versions of these two documents were used and made available, depending on participant preferences. In addition, although the interview guide contained the same questions, they were adapted to participants’ specific roles (i.e., researcher, REB member, research ethics expert). When contacted by email by the research assistant, participants were asked to confirm under which role they wished to participate (because some participants might have multiple, overlapping responsibilities) and they were sent the appropriate interview guide.

The interview guides each had two parts: an introduction and a section on ethical issues. The introduction consisted of general questions to put the participant at ease (i.e., “Tell me what a typical day at work is like for you”). The section on ethical issues was designed to capture the participant’s perceptions through questions such as: “Tell me three stories you have experienced at work that involve an ethical issue?” and “Do you feel that your organization is doing enough to address, manage, and resolve ethical issues in your work?”. Although some interviews were conducted in person, the majority were conducted by videoconference to promote accessibility and because of the COVID-19 pandemic. Interviews were digitally recorded so that the verbatim could be transcribed in full, and varied between 40 and 120 min in duration, with an average of 90 min. Research assistants conducted the interviews and transcribed the verbatim.

Data Analysis

The socio-demographic questionnaires were subjected to simple descriptive statistical analyses (i.e., means and totals), and the semi-structured interviews were subjected to qualitative analysis. The steps proposed by Giorgi ( 1997 ) for a Husserlian phenomenological reduction of the data were used. After collecting, recording, and transcribing the interviews, all verbatim were analyzed by at least two analysts: a research assistant (2nd author of this article) and the principal investigator (1st author) or a postdoctoral fellow (3rd author). The repeated reading of the verbatim allowed the first analyst to write a synopsis, i.e., an initial extraction of units of meaning. The second analyst then read the synopses, which were commented and improved if necessary. Agreement between analysts allowed the final drafting of the interview synopses, which were then analyzed by three analysts to generate and organize the units of meaning that emerged from the qualitative data.

Participants

Sixteen individuals (n = 16) participated in the study, of whom nine (9) identified as female and seven (7) as male (Table  2 ). Participants ranged in age from 22 to 72 years, with a mean age of 47.5 years. Participants had between one (1) and 26 years of experience in the research setting, with an average of 14.3 years of experience. Participants held a variety of roles, including: REB members (n = 11), researchers (n = 10), research ethics experts (n = 4), and research assistant (n = 1). As mentioned previously, seven (7) participants held more than one role, i.e., REB member, research ethics expert, and researcher. The majority (87.5%) of participants were working in Quebec, with the remaining working in other Canadian provinces. Although all participants considered themselves to be francophone, one quarter (n = 4) identified themselves as belonging to a cultural minority group.

With respect to their academic background, most participants (n = 9) had a PhD, three (3) had a post-doctorate, two (2) had a master’s degree, and two (2) had a bachelor’s degree. Participants came from a variety of disciplines: nine (9) had a specialty in the humanities or social sciences, four (4) in the health sciences and three (3) in the natural sciences. In terms of their knowledge of ethics, five (5) participants reported having taken one university course entirely dedicated to ethics, four (4) reported having taken several university courses entirely dedicated to ethics, three (3) had a university degree dedicated to ethics, while two (2) only had a few hours or days of training in ethics and two (2) reported having no knowledge of ethics.

  • Ethical issues

As Fig.  1 illustrates, ten units of meaning emerge from the data analysis, namely: (1) research integrity, (2) conflicts of interest, (3) respect for research participants, (4) lack of supervision and power imbalances, (5) individualism and performance, (6) inadequate ethical guidance, (7) social injustices, (8) distributive injustices, (9) epistemic injustices, and (10) ethical distress. To illustrate the results, excerpts from verbatim interviews are presented in the following sub-sections. Most of the excerpts have been translated into English as the majority of interviews were conducted with French-speaking participants.

figure 1

Ethical issues in research according to the participants

Research Integrity

The research environment is highly competitive and performance-based. Several participants, in particular researchers and research ethics experts, felt that this environment can lead both researchers and research teams to engage in unethical behaviour that reflects a lack of research integrity. For example, as some participants indicated, competition for grants and scientific publications is sometimes so intense that researchers falsify research results or plagiarize from colleagues to achieve their goals.

Some people will lie or exaggerate their research findings in order to get funding. Then, you see it afterwards, you realize: “ah well, it didn’t work, but they exaggerated what they found and what they did” (participant 14). Another problem in research is the identification of authors when there is a publication. Very often, there are authors who don’t even know what the publication is about and that their name is on it. (…) The time that it surprised me the most was just a few months ago when I saw someone I knew who applied for a teaching position. He got it I was super happy for him. Then I looked at his publications and … there was one that caught my attention much more than the others, because I was in it and I didn’t know what that publication was. I was the second author of a publication that I had never read (participant 14). I saw a colleague who had plagiarized another colleague. [When the colleague] found out about it, he complained. So, plagiarism is a serious [ethical breach]. I would also say that there is a certain amount of competition in the university faculties, especially for grants (…). There are people who want to win at all costs or get as much as possible. They are not necessarily going to consider their colleagues. They don’t have much of a collegial spirit (participant 10).

These examples of research misbehaviour or misconduct are sometimes due to or associated with situations of conflicts of interest, which may be poorly managed by certain researchers or research teams, as noted by many participants.

Conflict of interest

The actors and institutions involved in research have diverse interests, like all humans and institutions. As noted in Chap. 7 of the Canadian Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans (TCPS2, 2018),

“researchers and research students hold trust relationships, either directly or indirectly, with participants, research sponsors, institutions, their professional bodies and society. These trust relationships can be put at risk by conflicts of interest that may compromise independence, objectivity or ethical duties of loyalty. Although the potential for such conflicts has always existed, pressures on researchers (i.e., to delay or withhold dissemination of research outcomes or to use inappropriate recruitment strategies) heighten concerns that conflicts of interest may affect ethical behaviour” (p. 92).

The sources of these conflicts are varied and can include interpersonal conflicts, financial partnerships, third-party pressures, academic or economic interests, a researcher holding multiple roles within an institution, or any other incentive that may compromise a researcher’s independence, integrity, and neutrality (TCPS2, 2018). While it is not possible to eliminate all conflicts of interest, it is important to manage them properly and to avoid temptations to behave unethically.

Ethical temptations correspond to situations in which people are tempted to prioritize their own interests to the detriment of the ethical goods that should, in their own context, govern their actions (Swisher et al., 2005 ). In the case of researchers, this refers to situations that undermine independence, integrity, neutrality, or even the set of principles that govern research ethics (TCPS2, 2018) or the responsible conduct of research. According to study participants, these types of ethical issues frequently occur in research. Many participants, especially researchers and REB members, reported that conflicts of interest can arise when members of an organization make decisions to obtain large financial rewards or to increase their academic profile, often at the expense of the interests of members of their research team, research participants, or even the populations affected by their research.

A company that puts money into making its drug work wants its drug to work. So, homeopathy is a good example, because there are not really any consequences of homeopathy, there are not very many side effects, because there are no effects at all. So, it’s not dangerous, but it’s not a good treatment either. But some people will want to make it work. And that’s a big issue when you’re sitting at a table and there are eight researchers, and there are two or three who are like that, and then there are four others who are neutral, and I say to myself, this is not science. I think that this is a very big ethical issue (participant 14). There are also times in some research where there will be more links with pharmaceutical companies. Obviously, there are then large amounts of money that will be very interesting for the health-care institutions because they still receive money for clinical trials. They’re still getting some compensation because its time consuming for the people involved and all that. The pharmaceutical companies have money, so they will compensate, and that is sometimes interesting for the institutions, and since we are a bit caught up in this, in the sense that we have no choice but to accept it. (…) It may not be the best research in the world, there may be a lot of side effects due to the drugs, but it’s good to accept it, we’re going to be part of the clinical trial (participant 3). It is integrity, what we believe should be done or said. Often by the pressure of the environment, integrity is in tension with the pressures of the environment, so it takes resistance, it takes courage in research. (…) There were all the debates there about the problems of research that was funded and then the companies kept control over what was written. That was really troubling for a lot of researchers (participant 5).

Further, these situations sometimes have negative consequences for research participants as reported by some participants.

Respect for research participants

Many research projects, whether they are psychosocial or biomedical in nature, involve human participants. Relationships between the members of research teams and their research participants raise ethical issues that can be complex. Research projects must always be designed to respect the rights and interests of research participants, and not just those of researchers. However, participants in our study – i.e., REB members, researchers, and research ethics experts – noted that some research teams seem to put their own interests ahead of those of research participants. They also emphasized the importance of ensuring the respect, well-being, and safety of research participants. The ethical issues related to this unit of meaning are: respect for free, informed and ongoing consent of research participants; respect for and the well-being of participants; data protection and confidentiality; over-solicitation of participants; ownership of the data collected on participants; the sometimes high cost of scientific innovations and their accessibility; balance between the social benefits of research and the risks to participants (particularly in terms of safety); balance between collective well-being (development of knowledge) and the individual rights of participants; exploitation of participants; paternalism when working with populations in vulnerable situations; and the social acceptability of certain types of research. The following excerpts present some of these issues.

Where it disturbs me ethically is in the medical field – because it’s more in the medical field that we’re going to see this – when consent forms are presented to patients to solicit them as participants, and then [these forms] have an average of 40 pages. That annoys me. When they say that it has to be easy to understand and all that, adapted to the language, and then the hyper-technical language plus there are 40 pages to read, I don’t understand how you’re going to get informed consent after reading 40 pages. (…) For me, it doesn’t work. I read them to evaluate them and I have a certain level of education and experience in ethics, and there are times when I don’t understand anything (participant 2). There is a lot of pressure from researchers who want to recruit research participants (…). The idea that when you enter a health care institution, you become a potential research participant, when you say “yes to a research, you check yes to all research”, then everyone can ask you. I think that researchers really have this fantasy of saying to themselves: “as soon as people walk through the door of our institution, they become potential participants with whom we can communicate and get them involved in all projects”. There’s a kind of idea that, yes, it can be done, but it has to be somewhat supervised to avoid over-solicitation (…). Researchers are very interested in facilitating recruitment and making it more fluid, but perhaps to the detriment of confidentiality, privacy, and respect; sometimes that’s what it is, to think about what type of data you’re going to have in your bank of potential participants? Is it just name and phone number or are you getting into more sensitive information? (participant 9).

In addition, one participant reported that their university does not provide the resources required to respect the confidentiality of research participants.

The issue is as follows: researchers, of course, commit to protecting data with passwords and all that, but we realize that in practice, it is more difficult. It is not always as protected as one might think, because professor-researchers will run out of space. Will the universities make rooms available to researchers, places where they can store these things, especially when they have paper documentation, and is there indeed a guarantee of confidentiality? Some researchers have told me: “Listen; there are even filing cabinets in the corridors”. So, that certainly poses a concrete challenge. How do we go about challenging the administrative authorities? Tell them it’s all very well to have an ethics committee, but you have to help us, you also have to make sure that the necessary infrastructures are in place so that what we are proposing is really put into practice (participant 4).

If the relationships with research participants are likely to raise ethical issues, so too are the relationships with students, notably research assistants. On this topic, several participants discussed the lack of supervision or recognition offered to research assistants by researchers as well as the power imbalances between members of the research team.

Lack of Supervision and Power Imbalances

Many research teams are composed not only of researchers, but also of students who work as research assistants. The relationship between research assistants and other members of research teams can sometimes be problematic and raise ethical issues, particularly because of the inevitable power asymmetries. In the context of this study, several participants – including a research assistant, REB members, and researchers – discussed the lack of supervision or recognition of the work carried out by students, psychological pressure, and the more or less well-founded promises that are sometimes made to students. Participants also mentioned the exploitation of students by certain research teams, which manifest when students are inadequately paid, i.e., not reflective of the number of hours actually worked, not a fair wage, or even a wage at all.

[As a research assistant], it was more of a feeling of distress that I felt then because I didn’t know what to do. (…) I was supposed to get coaching or be supported, but I didn’t get anything in the end. It was like, “fix it by yourself”. (…) All research assistants were supposed to be supervised, but in practice they were not (participant 1). Very often, we have a master’s or doctoral student that we put on a subject and we consider that the project will be well done, while the student is learning. So, it happens that the student will do a lot of work and then we realize that the work is poorly done, and it is not necessarily the student’s fault. He wasn’t necessarily well supervised. There are directors who have 25 students, and they just don’t supervise them (participant 14). I think it’s really the power relationship. I thought to myself, how I saw my doctorate, the beginning of my research career, I really wanted to be in that laboratory, but they are the ones who are going to accept me or not, so what do I do to be accepted? I finally accept their conditions [which was to work for free]. If these are the conditions that are required to enter this lab, I want to go there. So, what do I do, well I accepted. It doesn’t make sense, but I tell myself that I’m still privileged, because I don’t have so many financial worries, one more reason to work for free, even though it doesn’t make sense (participant 1). In research, we have research assistants. (…). The fact of using people… so that’s it, you have to take into account where they are, respect them, but at the same time they have to show that they are there for the research. In English, we say “carry” or take care of people. With research assistants, this is often a problem that I have observed: for grant machines, the person is the last to be found there. Researchers, who will take, use student data, without giving them the recognition for it (participant 5). The problem at our university is that they reserve funding for Canadian students. The doctoral clientele in my field is mostly foreign students. So, our students are poorly funded. I saw one student end up in the shelter, in a situation of poverty. It ended very badly for him because he lacked financial resources. Once you get into that dynamic, it’s very hard to get out. I was made aware of it because the director at the time had taken him under her wing and wanted to try to find a way to get him out of it. So, most of my students didn’t get funded (participant 16). There I wrote “manipulation”, but it’s kind of all promises all the time. I, for example, was promised a lot of advancement, like when I got into the lab as a graduate student, it was said that I had an interest in [this particular area of research]. I think there are a lot of graduate students who must have gone through that, but it is like, “Well, your CV has to be really good, if you want to do a lot of things and big things. If you do this, if you do this research contract, the next year you could be the coordinator of this part of the lab and supervise this person, get more contracts, be paid more. Let’s say: you’ll be invited to go to this conference, this big event”. They were always dangling something, but you have to do that first to get there. But now, when you’ve done that, you have to do this business. It’s like a bit of manipulation, I think. That was very hard to know who is telling the truth and who is not (participant 1).

These ethical issues have significant negative consequences for students. Indeed, they sometimes find themselves at the mercy of researchers, for whom they work, struggling to be recognized and included as authors of an article, for example, or to receive the salary that they are due. For their part, researchers also sometimes find themselves trapped in research structures that can negatively affect their well-being. As many participants reported, researchers work in organizations that set very high productivity standards and in highly competitive contexts, all within a general culture characterized by individualism.

Individualism and performance

Participants, especially researchers, discussed the culture of individualism and performance that characterizes the academic environment. In glorifying excellence, some universities value performance and productivity, often at the expense of psychological well-being and work-life balance (i.e., work overload and burnout). Participants noted that there are ethical silences in their organizations on this issue, and that the culture of individualism and performance is not challenged for fear of retribution or simply to survive, i.e., to perform as expected. Participants felt that this culture can have a significant negative impact on the quality of the research conducted, as research teams try to maximize the quantity of their work (instead of quality) in a highly competitive context, which is then exacerbated by a lack of resources and support, and where everything must be done too quickly.

The work-life balance with the professional ethics related to work in a context where you have too much and you have to do a lot, it is difficult to balance all that and there is a lot of pressure to perform. If you don’t produce enough, that’s it; after that, you can’t get any more funds, so that puts pressure on you to do more and more and more (participant 3). There is a culture, I don’t know where it comes from, and that is extremely bureaucratic. If you dare to raise something, you’re going to have many, many problems. They’re going to make you understand it. So, I don’t talk. It is better: your life will be easier. I think there are times when you have to talk (…) because there are going to be irreparable consequences. (…) I’m not talking about a climate of terror, because that’s exaggerated, it’s not true, people are not afraid. But people close their office door and say nothing because it’s going to make their work impossible and they’re not going to lose their job, they’re not going to lose money, but researchers need time to be focused, so they close their office door and say nothing (participant 16).

Researchers must produce more and more, and they feel little support in terms of how to do such production, ethically, and how much exactly they are expected to produce. As this participant reports, the expectation is an unspoken rule: more is always better.

It’s sometimes the lack of a clear line on what the expectations are as a researcher, like, “ah, we don’t have any specific expectations, but produce, produce, produce, produce.” So, in that context, it’s hard to be able to put the line precisely: “have I done enough for my work?” (participant 3).

Inadequate ethical Guidance

While the productivity expectation is not clear, some participants – including researchers, research ethics experts, and REB members – also felt that the ethical expectations of some REBs were unclear. The issue of the inadequate ethical guidance of research includes the administrative mechanisms to ensure that research projects respect the principles of research ethics. According to those participants, the forms required for both researchers and REB members are increasingly long and numerous, and one participant noted that the standards to be met are sometimes outdated and disconnected from the reality of the field. Multicentre ethics review (by several REBs) was also critiqued by a participant as an inefficient method that encumbers the processes for reviewing research projects. Bureaucratization imposes an ever-increasing number of forms and ethics guidelines that actually hinder researchers’ ethical reflection on the issues at stake, leading the ethics review process to be perceived as purely bureaucratic in nature.

The ethical dimension and the ethical review of projects have become increasingly bureaucratized. (…) When I first started working (…) it was less bureaucratic, less strict then. I would say [there are now] tons of forms to fill out. Of course, we can’t do without it, it’s one of the ways of marking out ethics and ensuring that there are ethical considerations in research, but I wonder if it hasn’t become too bureaucratized, so that it’s become a kind of technical reflex to fill out these forms, and I don’t know if people really do ethical reflection as such anymore (participant 10). The fundamental structural issue, I would say, is the mismatch between the normative requirements and the real risks posed by the research, i.e., we have many, many requirements to meet; we have very long forms to fill out but the research projects we evaluate often pose few risks (participant 8). People [in vulnerable situations] were previously unable to participate because of overly strict research ethics rules that were to protect them, but in the end [these rules] did not protect them. There was a perverse effect, because in the end there was very little research done with these people and that’s why we have very few results, very little evidence [to support practices with these populations] so it didn’t improve the quality of services. (…) We all understand that we have to be careful with that, but when the research is not too risky, we say to ourselves that it would be good because for once a researcher who is interested in that population, because it is not a very popular population, it would be interesting to have results, but often we are blocked by the norms, and then we can’t accept [the project] (participant 2).

Moreover, as one participant noted, accessing ethics training can be a challenge.

There is no course on research ethics. […] Then, I find that it’s boring because you go through university and you come to do your research and you know how to do quantitative and qualitative research, but all the research ethics, where do you get this? I don’t really know (participant 13).

Yet, such training could provide relevant tools to resolve, to some extent, the ethical issues that commonly arise in research. That said, and as noted by many participants, many ethical issues in research are related to social injustices over which research actors have little influence.

Social Injustices

For many participants, notably researchers, the issues that concern social injustices are those related to power asymmetries, stigma, or issues of equity, diversity, and inclusion, i.e., social injustices related to people’s identities (Blais & Drolet, 2022 ). Participants reported experiencing or witnessing discrimination from peers, administration, or lab managers. Such oppression is sometimes cross-sectional and related to a person’s age, cultural background, gender or social status.

I have my African colleague who was quite successful when he arrived but had a backlash from colleagues in the department. I think it’s unconscious, nobody is overtly racist. But I have a young person right now who is the same, who has the same success, who got exactly the same early career award and I don’t see the same backlash. He’s just as happy with what he’s doing. It’s normal, they’re young and they have a lot of success starting out. So, I think there is discrimination. Is it because he is African? Is it because he is black? I think it’s on a subconscious level (participant 16).

Social injustices were experienced or reported by many participants, and included issues related to difficulties in obtaining grants or disseminating research results in one’s native language (i.e., even when there is official bilingualism) or being considered credible and fundable in research when one researcher is a woman.

If you do international research, there are things you can’t talk about (…). It is really a barrier to research to not be able to (…) address this question [i.e. the question of inequalities between men and women]. Women’s inequality is going to be addressed [but not within the country where the research takes place as if this inequality exists elsewhere but not here]. There are a lot of women working on inequality issues, doing work and it’s funny because I was talking to a young woman who works at Cairo University and she said to me: “Listen, I saw what you had written, you’re right. I’m willing to work on this but guarantee me a position at your university with a ticket to go”. So yes, there are still many barriers [for women in research] (participant 16).

Because of the varied contextual characteristics that intervene in their occurrence, these social injustices are also related to distributive injustices, as discussed by many participants.

Distributive Injustices

Although there are several views of distributive justice, a classical definition such as that of Aristotle ( 2012 ), describes distributive justice as consisting in distributing honours, wealth, and other social resources or benefits among the members of a community in proportion to their alleged merit. Justice, then, is about determining an equitable distribution of common goods. Contemporary theories of distributive justice are numerous and varied. Indeed, many authors (e.g., Fraser 2011 ; Mills, 2017 ; Sen, 2011 ; Young, 2011 ) have, since Rawls ( 1971 ), proposed different visions of how social burdens and benefits should be shared within a community to ensure equal respect, fairness, and distribution. In our study, what emerges from participants’ narratives is a definite concern for this type of justice. Women researchers, francophone researchers, early career researchers or researchers belonging to racialized groups all discussed inequities in the distribution of research grants and awards, and the extra work they need to do to somehow prove their worth. These inequities are related to how granting agencies determine which projects will be funded.

These situations make me work 2–3 times harder to prove myself and to show people in power that I have a place as a woman in research (participant 12). Number one: it’s conservative thinking. The older ones control what comes in. So, the younger people have to adapt or they don’t get funded (participant 14).

Whether it is discrimination against stigmatized or marginalized populations or interest in certain hot topics, granting agencies judge research projects according to criteria that are sometimes questionable, according to those participants. Faced with difficulties in obtaining funding for their projects, several strategies – some of which are unethical – are used by researchers in order to cope with these situations.

Sometimes there are subjects that everyone goes to, such as nanotechnology (…), artificial intelligence or (…) the therapeutic use of cannabis, which are very fashionable, and this is sometimes to the detriment of other research that is just as relevant, but which is (…), less sexy, less in the spirit of the time. (…) Sometimes this can lead to inequities in the funding of certain research sectors (participant 9). When we use our funds, we get them given to us, we pretty much say what we think we’re going to do with them, but things change… So, when these things change, sometimes it’s an ethical decision, but by force of circumstances I’m obliged to change the project a little bit (…). Is it ethical to make these changes or should I just let the money go because I couldn’t use it the way I said I would? (participant 3).

Moreover, these distributional injustices are not only linked to social injustices, but also epistemic injustices. Indeed, the way in which research honours and grants are distributed within the academic community depends on the epistemic authority of the researchers, which seems to vary notably according to their language of use, their age or their gender, but also to the research design used (inductive versus deductive), their decision to use (or not use) animals in research, or to conduct activist research.

Epistemic injustices

The philosopher Fricker ( 2007 ) conceptualized the notions of epistemic justice and injustice. Epistemic injustice refers to a form of social inequality that manifests itself in the access, recognition, and production of knowledge as well as the various forms of ignorance that arise (Godrie & Dos Santos, 2017 ). Addressing epistemic injustice necessitates acknowledging the iniquitous wrongs suffered by certain groups of socially stigmatized individuals who have been excluded from knowledge, thus limiting their abilities to interpret, understand, or be heard and account for their experiences. In this study, epistemic injustices were experienced or reported by some participants, notably those related to difficulties in obtaining grants or disseminating research results in one’s native language (i.e., even when there is official bilingualism) or being considered credible and fundable in research when a researcher is a woman or an early career researcher.

I have never sent a grant application to the federal government in English. I have always done it in French, even though I know that when you receive the review, you can see that reviewers didn’t understand anything because they are English-speaking. I didn’t want to get in the boat. It’s not my job to translate, because let’s be honest, I’m not as good in English as I am in French. So, I do them in my first language, which is the language I’m most used to. Then, technically at the administrative level, they are supposed to be able to do it, but they are not good in French. (…) Then, it’s a very big Canadian ethical issue, because basically there are technically two official languages, but Canada is not a bilingual country, it’s a country with two languages, either one or the other. (…) So I was not funded (participant 14).

Researchers who use inductive (or qualitative) methods observed that their projects are sometimes less well reviewed or understood, while research that adopts a hypothetical-deductive (or quantitative) or mixed methods design is better perceived, considered more credible and therefore more easily funded. Of course, regardless of whether a research project adopts an inductive, deductive or mixed-methods scientific design, or whether it deals with qualitative or quantitative data, it must respect a set of scientific criteria. A research project should achieve its objectives by using proven methods that, in the case of inductive research, are credible, reliable, and transferable or, in the case of deductive research, generalizable, objective, representative, and valid (Drolet & Ruest, accepted ). Participants discussing these issues noted that researchers who adopt a qualitative design or those who question the relevance of animal experimentation or are not militant have sometimes been unfairly devalued in their epistemic authority.

There is a mini war between quantitative versus qualitative methods, which I think is silly because science is a method. If you apply the method well, it doesn’t matter what the field is, it’s done well and it’s perfect ” (participant 14). There is also the issue of the place of animals in our lives, because for me, ethics is human ethics, but also animal ethics. Then, there is a great evolution in society on the role of the animal… with the new law that came out in Quebec on the fact that animals are sensitive beings. Then, with the rise of the vegan movement, [we must ask ourselves]: “Do animals still have a place in research?” That’s a big question and it also means that there are practices that need to evolve, but sometimes there’s a disconnection between what’s expected by research ethics boards versus what’s expected in the field (participant 15). In research today, we have more and more research that is militant from an ideological point of view. And so, we have researchers, because they defend values that seem important to them, we’ll talk for example about the fight for equality and social justice. They have pressure to defend a form of moral truth and have the impression that everyone thinks like them or should do so, because they are defending a moral truth. This is something that we see more and more, namely the lack of distance between ideology and science (participant 8).

The combination or intersectionality of these inequities, which seems to be characterized by a lack of ethical support and guidance, is experienced in the highly competitive and individualistic context of research; it provides therefore the perfect recipe for researchers to experience ethical distress.

Ethical distress

The concept of “ethical distress” refers to situations in which people know what they should do to act ethically, but encounter barriers, generally of an organizational or systemic nature, limiting their power to act according to their moral or ethical values (Drolet & Ruest, 2021 ; Jameton, 1984 ; Swisher et al., 2005 ). People then run the risk of finding themselves in a situation where they do not act as their ethical conscience dictates, which in the long term has the potential for exhaustion and distress. The examples reported by participants in this study point to the fact that researchers in particular may be experiencing significant ethical distress. This distress takes place in a context of extreme competition, constant injunctions to perform, and where administrative demands are increasingly numerous and complex to complete, while paradoxically, they lack the time to accomplish all their tasks and responsibilities. Added to these demands are a lack of resources (human, ethical, and financial), a lack of support and recognition, and interpersonal conflicts.

We are in an environment, an elite one, you are part of it, you know what it is: “publish or perish” is the motto. Grants, there is a high level of performance required, to do a lot, to publish, to supervise students, to supervise them well, so yes, it is clear that we are in an environment that is conducive to distress. (…). Overwork, definitely, can lead to distress and eventually to exhaustion. When you know that you should take the time to read the projects before sharing them, but you don’t have the time to do that because you have eight that came in the same day, and then you have others waiting… Then someone rings a bell and says: “ah but there, the protocol is a bit incomplete”. Oh yes, look at that, you’re right. You make up for it, but at the same time it’s a bit because we’re in a hurry, we don’t necessarily have the resources or are able to take the time to do things well from the start, we have to make up for it later. So yes, it can cause distress (participant 9). My organization wanted me to apply in English, and I said no, and everyone in the administration wanted me to apply in English, and I always said no. Some people said: “Listen, I give you the choice”, then some people said: “Listen, I agree with you, but if you’re not [submitting] in English, you won’t be funded”. Then the fact that I am young too, because very often they will look at the CV, they will not look at the project: “ah, his CV is not impressive, we will not finance him”. This is complete nonsense. The person is capable of doing the project, the project is fabulous: we fund the project. So, that happened, organizational barriers: that happened a lot. I was not eligible for Quebec research funds (…). I had big organizational barriers unfortunately (participant 14). At the time of my promotion, some colleagues were not happy with the type of research I was conducting. I learned – you learn this over time when you become friends with people after you enter the university – that someone was against me. He had another candidate in mind, and he was angry about the selection. I was under pressure for the first three years until my contract was renewed. I almost quit at one point, but another colleague told me, “No, stay, nothing will happen”. Nothing happened, but these issues kept me awake at night (participant 16).

This difficult context for many researchers affects not only the conduct of their own research, but also their participation in research. We faced this problem in our study, despite the use of multiple recruitment methods, including more than 200 emails – of which 191 were individual solicitations – sent to potential participants by the two research assistants. REB members and organizations overseeing or supporting research (n = 17) were also approached to see if some of their employees would consider participating. While it was relatively easy to recruit REB members and research ethics experts, our team received a high number of non-responses to emails (n = 175) and some refusals (n = 5), especially by researchers. The reasons given by those who replied were threefold: (a) fear of being easily identified should they take part in the research, (b) being overloaded and lacking time, and (c) the intrusive aspect of certain questions (i.e., “Have you experienced a burnout episode? If so, have you been followed up medically or psychologically?”). In light of these difficulties and concerns, some questions in the socio-demographic questionnaire were removed or modified. Talking about burnout in research remains a taboo for many researchers, which paradoxically can only contribute to the unresolved problem of unhealthy research environments.

Returning to the research question and objective

The question that prompted this research was: What are the ethical issues in research? The purpose of the study was to describe these issues from the perspective of researchers (from different disciplines), research ethics board (REB) members, and research ethics experts. The previous section provided a detailed portrait of the ethical issues experienced by different research stakeholders: these issues are numerous, diverse and were recounted by a range of stakeholders.

The results of the study are generally consistent with the literature. For example, as in our study, the literature discusses the lack of research integrity on the part of some researchers (Al-Hidabi et al., 2018 ; Swazey et al., 1993 ), the numerous conflicts of interest experienced in research (Williams-Jones et al., 2013 ), the issues of recruiting and obtaining the free and informed consent of research participants (Provencher et al., 2014 ; Keogh & Daly, 2009 ), the sometimes difficult relations between researchers and REBs (Drolet & Girard, 2020 ), the epistemological issues experienced in research (Drolet & Ruest, accepted; Sieber 2004 ), as well as the harmful academic context in which researchers evolve, insofar as this is linked to a culture of performance, an overload of work in a context of accountability (Berg & Seeber, 2016 ; FQPPU; 2019 ) that is conducive to ethical distress and even burnout.

If the results of the study are generally in line with those of previous publications on the subject, our findings also bring new elements to the discussion while complementing those already documented. In particular, our results highlight the role of systemic injustices – be they social, distributive or epistemic – within the environments in which research is carried out, at least in Canada. To summarize, the results of our study point to the fact that the relationships between researchers and research participants are likely still to raise worrying ethical issues, despite widely accepted research ethics norms and institutionalized review processes. Further, the context in which research is carried out is not only conducive to breaches of ethical norms and instances of misbehaviour or misconduct, but also likely to be significantly detrimental to the health and well-being of researchers, as well as research assistants. Another element that our research also highlighted is the instrumentalization and even exploitation of students and research assistants, which is another important and worrying social injustice given the inevitable power imbalances between students and researchers.

Moreover, in a context in which ethical issues are often discussed from a micro perspective, our study helps shed light on both the micro- and macro-level ethical dimensions of research (Bronfenbrenner, 1979 ; Glaser 1994 ). However, given that ethical issues in research are not only diverse, but also and above all complex, a broader perspective that encompasses the interplay between the micro and macro dimensions can enable a better understanding of these issues and thereby support the identification of the multiple factors that may be at their origin. Triangulating the perspectives of researchers with those of REB members and research ethics experts enabled us to bring these elements to light, and thus to step back from and critique the way that research is currently conducted. To this end, attention to socio-political elements such as the performance culture in academia or how research funds are distributed, and according to what explicit and implicit criteria, can contribute to identifying the sources of the ethical issues described above.

Contemporary culture characterized by the social acceleration

The German sociologist and philosopher Rosa (2010) argues that late modernity – that is, the period between the 1980s and today – is characterized by a phenomenon of social acceleration that causes various forms of alienation in our relationship to time, space, actions, things, others and ourselves. Rosa distinguishes three types of acceleration: technical acceleration , the acceleration of social changes and the acceleration of the rhythm of life . According to Rosa, social acceleration is the main problem of late modernity, in that the invisible social norm of doing more and faster to supposedly save time operates unchallenged at all levels of individual and collective life, as well as organizational and social life. Although we all, researchers and non-researchers alike, perceive this unspoken pressure to be ever more productive, the process of social acceleration as a new invisible social norm is our blind spot, a kind of tyrant over which we have little control. This conceptualization of the contemporary culture can help us to understand the context in which research is conducted (like other professional practices). To this end, Berg & Seeber ( 2016 ) invite faculty researchers to slow down in order to better reflect and, in the process, take care of their health and their relationships with their colleagues and students. Many women professors encourage their fellow researchers, especially young women researchers, to learn to “say No” in order to protect their mental and physical health and to remain in their academic careers (Allaire & Descheneux, 2022 ). These authors also remind us of the relevance of Kahneman’s ( 2012 ) work which demonstrates that it takes time to think analytically, thoroughly, and logically. Conversely, thinking quickly exposes humans to cognitive and implicit biases that then lead to errors in thinking (e.g., in the analysis of one’s own research data or in the evaluation of grant applications or student curriculum vitae). The phenomenon of social acceleration, which pushes the researcher to think faster and faster, is likely to lead to unethical bad science that can potentially harm humankind. In sum, Rosa’s invitation to contemporary critical theorists to seriously consider the problem of social acceleration is particularly insightful to better understand the ethical issues of research. It provides a lens through which to view the toxic context in which research is conducted today, and one that was shared by the participants in our study.

Clark & Sousa ( 2022 ) note, it is important that other criteria than the volume of researchers’ contributions be valued in research, notably quality. Ultimately, it is the value of the knowledge produced and its influence on the concrete lives of humans and other living beings that matters, not the quantity of publications. An interesting articulation of this view in research governance is seen in a change in practice by Australia’s national health research funder: they now restrict researchers to listing on their curriculum vitae only the top ten publications from the past ten years (rather than all of their publications), in order to evaluate the quality of contributions rather than their quantity. To create environments conducive to the development of quality research, it is important to challenge the phenomenon of social acceleration, which insidiously imposes a quantitative normativity that is both alienating and detrimental to the quality and ethical conduct of research. Based on our experience, we observe that the social norm of acceleration actively disfavours the conduct of empirical research on ethics in research. The fact is that researchers are so busy that it is almost impossible for them to find time to participate in such studies. Further, operating in highly competitive environments, while trying to respect the values and ethical principles of research, creates ethical paradoxes for members of the research community. According to Malherbe ( 1999 ), an ethical paradox is a situation where an individual is confronted by contradictory injunctions (i.e., do more, faster, and better). And eventually, ethical paradoxes lead individuals to situations of distress and burnout, or even to ethical failures (i.e., misbehaviour or misconduct) in the face of the impossibility of responding to contradictory injunctions.

Strengths and Limitations of the study

The triangulation of perceptions and experiences of different actors involved in research is a strength of our study. While there are many studies on the experiences of researchers, rarely are members of REBs and experts in research ethics given the space to discuss their views of what are ethical issues. Giving each of these stakeholders a voice and comparing their different points of view helped shed a different and complementary light on the ethical issues that occur in research. That said, it would have been helpful to also give more space to issues experienced by students or research assistants, as the relationships between researchers and research assistants are at times very worrying, as noted by a participant, and much work still needs to be done to eliminate the exploitative situations that seem to prevail in certain research settings. In addition, no Indigenous or gender diverse researchers participated in the study. Given the ethical issues and systemic injustices that many people from these groups face in Canada (Drolet & Goulet, 2018 ; Nicole & Drolet, in press ), research that gives voice to these researchers would be relevant and contribute to knowledge development, and hopefully also to change in research culture.

Further, although most of the ethical issues discussed in this article may be transferable to the realities experienced by researchers in other countries, the epistemic injustice reported by Francophone researchers who persist in doing research in French in Canada – which is an officially bilingual country but in practice is predominantly English – is likely specific to the Canadian reality. In addition, and as mentioned above, recruitment proved exceedingly difficult, particularly amongst researchers. Despite this difficulty, we obtained data saturation for all but two themes – i.e., exploitation of students and ethical issues of research that uses animals. It follows that further empirical research is needed to improve our understanding of these specific issues, as they may diverge to some extent from those documented here and will likely vary across countries and academic research contexts.

Conclusions

This study, which gave voice to researchers, REB members, and ethics experts, reveals that the ethical issues in research are related to several problematic elements as power imbalances and authority relations. Researchers and research assistants are subject to external pressures that give rise to integrity issues, among others ethical issues. Moreover, the current context of social acceleration influences the definition of the performance indicators valued in academic institutions and has led their members to face several ethical issues, including social, distributive, and epistemic injustices, at different steps of the research process. In this study, ten categories of ethical issues were identified, described and illustrated: (1) research integrity, (2) conflicts of interest, (3) respect for research participants, (4) lack of supervision and power imbalances, (5) individualism and performance, (6) inadequate ethical guidance, (7) social injustices, (8) distributive injustices, (9) epistemic injustices, and (10) ethical distress. The triangulation of the perspectives of different members (i.e., researchers from different disciplines, REB members, research ethics experts, and one research assistant) involved in the research process made it possible to lift the veil on some of these ethical issues. Further, it enabled the identification of additional ethical issues, especially systemic injustices experienced in research. To our knowledge, this is the first time that these injustices (social, distributive, and epistemic injustices) have been clearly identified.

Finally, this study brought to the fore several problematic elements that are important to address if the research community is to develop and implement the solutions needed to resolve the diverse and transversal ethical issues that arise in research institutions. A good starting point is the rejection of the corollary norms of “publish or perish” and “do more, faster, and better” and their replacement with “publish quality instead of quantity”, which necessarily entails “do less, slower, and better”. It is also important to pay more attention to the systemic injustices within which researchers work, because these have the potential to significantly harm the academic careers of many researchers, including women researchers, early career researchers, and those belonging to racialized groups as well as the health, well-being, and respect of students and research participants.

Al-Hidabi, Abdulmalek, M. D., & The, P. L. (2018). Multiple Publications: The Main Reason for the Retraction of Papers in Computer Science. In K. Arai, S. Kapoor, & R. Bhatia (eds), Future of Information and Communication Conference (FICC): Advances in Information and Communication, Advances in Intelligent Systems and Computing (AISC), Springer, vol. 886, pp. 511–526

Allaire, S., & Deschenaux, F. (2022). Récits de professeurs d’université à mi-carrière. Si c’était à refaire… . Presses de l’Université du Québec

Aristotle (2012). Aristotle’s Nicomachean Ethics . Chicago: The University of Chicago Press

Google Scholar  

Bahn, S. (2012). Keeping Academic Field Researchers Safe: Ethical Safeguards. Journal of Academic Ethics , 10 , 83–91. https://doi.org/10.1007/s10805-012-9159-2

Article   Google Scholar  

Balk, D. E. (1995). Bereavement Research Using Control Groups: Ethical Obligations and Questions. Death Studies , 19 , 123–138

Beauchemin, É., Côté, L. P., Drolet, M. J., & Williams-Jones, B. (2021). Conceptualizing Ethical Issues in the Conduct of Research: Results from a Critical and Systematic Literature Review. Journal of Academic Ethics , Early Online. https://doi.org/10.1007/s10805-021-09411-7

Berg, M., & Seeber, B. K. (2016). The Slow Professor . University of Toronto Press

Birchley, G., Huxtable, R., Murtagh, M., Meulen, R. T., Flach, P., & Gooberman-Hill, R. (2017). Smart homes, private homes? An empirical study of technology researchers’ perceptions of ethical issues in developing smart-home health technologies. BMC Medical Ethics , 18 (23), 1–13. https://doi.org/10.1186/s12910-017-0183-z

Blais, J., & Drolet, M. J. (2022). Les injustices sociales vécues en camp de réfugiés: les comprendre pour mieux intervenir auprès de personnes ayant séjourné dans un camp de réfugiés. Recueil annuel belge d’ergothérapie , 14, 37–48

Bogdan, R. C., & Biklen, S. K. (2006). Qualitative research in education: An introduction to theory and methods . Allyn & Bacon

Bouffard, C. (2000). Le développement des pratiques de la génétique médicale et la construction des normes bioéthiques. Anthropologie et Sociétés , 24 (2), 73–90. https://doi.org/10.7202/015650ar

Bronfenbrenner, U. (1979). The Ecology of Human development. Experiments by nature and design . Harvard University Press

Bruhn, J. G., Zajac, G., Al-Kazemi, A. A., & Prescott, L. D. (2002). Moral positions and academic conduct: Parameters of tolerance for ethics failure. Journal of Higher Education , 73 (4), 461–493. https://doi.org/10.1353/jhe.2002.0033

Clark, A., & Sousa (2022). It’s time to end Canada’s obsession with research quantity. University Affairs/Affaires universitaires , February 14th. https://www.universityaffairs.ca/career-advice/effective-successfull-happy-academic/its-time-to-end-canadas-obsession-with-research-quantity/?utm_source=University+Affairs+e-newsletter&utm_campaign=276a847f 70-EMAIL_CAMPAIGN_2022_02_16&utm_medium=email&utm_term=0_314bc2ee29-276a847f70-425259989

Colnerud, G. (2015). Ethical dilemmas in research in relation to ethical review: An empirical study. Research Ethics , 10 (4), 238–253. DOI: https://doi.org/10.1177/1747016114552339

Davison, J. (2004). Dilemmas in Research: Issues of Vulnerability and Disempowerment for the Social Workers/Researcher. Journal of Social Work Practice , 18 (3), 379–393. https://doi.org/10.1080/0265053042000314447

DePoy, E., & Gitlin, L. N. (2010). Introduction to Research . St. Louis: Elsevier Mosby

Drolet, M. J., & Goulet, M. (2018). Travailler avec des patients autochtones du Canada ? Perceptions d’ergothérapeutes du Québec des enjeux éthiques de cette pratique. Recueil annuel belge francophone d’ergothérapie , 10 , 25–56

Drolet, M. J., & Girard, K. (2020). Les enjeux éthiques de la recherche en ergothérapie: un portrait préoccupant. Revue canadienne de bioéthique , 3 (3), 21–40. https://doi.org/10.7202/1073779ar

Drolet, M. J., Girard, K., & Gaudet, R. (2020). Les enjeux éthiques de l’enseignement en ergothérapie: des injustices au sein des départements universitaires. Revue canadienne de bioéthique , 3 (1), 22–36. https://www.erudit.org/fr/revues/bioethics/2020-v3-n1-bioethics05237/1068761ar/

Drolet, M. J., & Maclure, J. (2016). Les enjeux éthiques de la pratique de l’ergothérapie: perceptions d’ergothérapeutes. Revue Approches inductives , 3 (2), 166–196

Drolet, M. J., Pinard, C., & Gaudet, R. (2017). Les enjeux éthiques de la pratique privée: des ergothérapeutes du Québec lancent un cri d’alarme. Ethica – Revue interdisciplinaire de recherche en éthique , 21 (2), 173–209

Drolet, M. J., & Ruest, M. (2021). De l’éthique à l’ergothérapie: un cadre théorique et une méthode pour soutenir la pratique professionnelle . Québec: Presses de l’Université du Québec

Book   Google Scholar  

Drolet, M. J., & Ruest, M. (accepted). Quels sont les enjeux éthiques soulevés par la recherche scientifique? In M. Lalancette & J. Luckerhoff (dir). Initiation au travail intellectuel et à la recherche . Québec: Presses de l’Université du Québec, 18 p

Drolet, M. J., Sauvageau, A., Baril, N., & Gaudet, R. (2019). Les enjeux éthiques de la formation clinique en ergothérapie. Revue Approches inductives , 6 (1), 148–179. https://www.erudit.org/fr/revues/approchesind/2019-v6-n1-approchesind04618/1060048ar/

Fédération québécoise des professeures et des professeurs d’université (FQPPU). (2019). Enquête nationale sur la surcharge administrative du corps professoral universitaire québécois. Principaux résultats et pistes d’action . Montréal: FQPPU

Fortin, M. H. (2010). Fondements et étapes du processus de recherche. Méthodes quantitatives et qualitatives . Montréal, QC: Chenelière éducation

Fraser, D. M. (1997). Ethical dilemmas and practical problems for the practitioner researcher. Educational Action Research , 5 (1), 161–171

Fraser, N. (2011). Qu’est-ce que la justice sociale? Reconnaissance et redistribution . La Découverte

Fricker, M. (2007). Epistemic Injustice: Power and the Ethics of Knowing . Oxford University Press

Giorgi, A. (1997). De la méthode phénoménologique utilisée comme mode de recherche qualitative en sciences humaines: théories, pratique et évaluation. In J. Poupart, L. H. Groulx, J. P. Deslauriers, et al. (Eds.), La recherche qualitative: enjeux épistémologiques et méthodologiques (pp. 341–364). Boucherville, QC: Gaëtan Morin

Giorgini, V., Mecca, J. T., Gibson, C., Medeiros, K., Mumford, M. D., Connelly, S., & Devenport, L. D. (2016). Researcher Perceptions of Ethical Guidelines and Codes of Conduct. Accountability in Research , 22 (3), 123–138. https://doi.org/10.1080/08989621.2014.955607

Glaser, J. W. (1994). Three realms of ethics: Individual, institutional, societal. Theoretical model and case studies . Kansas Cuty, Sheed & Ward

Godrie, B., & Dos Santos, M. (2017). Présentation: inégalités sociales, production des savoirs et de l’ignorance. Sociologie et sociétés , 49 (1), 7. https://doi.org/10.7202/1042804ar

Hammell, K. W., Carpenter, C., & Dyck, I. (2000). Using Qualitative Research: A Practical Introduction for Occupational and Physical Therapists . Edinburgh: Churchill Livingstone

Henderson, M., Johnson, N. F., & Auld, G. (2013). Silences of ethical practice: dilemmas for researchers using social media. Educational Research and Evaluation , 19 (6), 546–560. https://doi.org/10.1080/13803611.2013.805656

Husserl, E. (1970). The crisis of European sciences and transcendental phenomenology . Evanston, IL: Northwestern University Press

Husserl, E. (1999). The train of thoughts in the lectures. In E. C. Polifroni, & M. Welch (Eds.), Perspectives on Philosophy of Science in Nursing . Philadelphia, PA: Lippincott. 247 – 62. 43

Hunt, S. D., Chonko, L. B., & Wilcox, J. B. (1984). Ethical problems of marketing researchers. Journal of Marketing Research , 21 , 309–324

Hunt, M. R., & Carnevale, F. A. (2011). Moral experience: A framework for bioethics research. Journal of Medical Ethics , 37 (11), 658–662. https://doi.org/10.1136/jme.2010.039008

Jameton, A. (1984). Nursing practice: The ethical issues . Englewood Cliffs, Prentice-Hall

Jarvis, K. (2017). Dilemmas in International Research and the Value of Practical Wisdom. Developing World Bioethics , 17 (1), 50–58. DOI: https://doi.org/10.1111/dewb.12121

Kahneman, D. (2012). Système 1, système 2: les deux vitesses de la pensée . Paris: Flammarion

Keogh, B., & Daly, L. (2009). The ethics of conducting research with mental health service users. British Journal of Nursing , 18 (5), 277–281. https://doi.org/10.12968/bjon.2009.18.5.40539

Lierville, A. L., Grou, C., & Pelletier, J. F. (2015). Enjeux éthiques potentiels liés aux partenariats patients en psychiatrie: État de situation à l’Institut universitaire en santé mentale de Montréal. Santé mentale au Québec , 40 (1), 119–134

Lynöe, N., Sandlund, M., & Jacobsson, L. (1999). Research ethics committees: A comparative study of assessment of ethical dilemmas. Scandinavian Journal of Public Health , 27 (2), 152–159

Malherbe, J. F. (1999). Compromis, dilemmes et paradoxes en éthique clinique . Anjou: Éditions Fides

McGinn, R. (2013). Discernment and denial: Nanotechnology researchers’ recognition of ethical responsibilities related to their work. NanoEthics , 7 , 93–105. https://doi.org/10.1007/s11569-013-0174-6

Mills, C. W. (2017). Black Rights / White rongs. The Critique of Racial Liberalism . Oxford University Press

Miyazaki, A. D., & Taylor, K. A. (2008). Researcher interaction biases and business ethics research: Respondent reactions to researcher characteristics. Journal of Business Ethics , 81 (4), 779–795. DOI https://doi.org/10.1007/s10551-007-9547-5

Mondain, N., & Bologo, E. (2009). L’intentionnalité du chercheur dans ses pratiques de production des connaissances: les enjeux soulevés par la construction des données en démographie et santé en Afrique. Cahiers de recherche sociologique , 48 , 175–204. https://doi.org/10.7202/039772ar

Nicole, M., & Drolet, M. J. (in press). Fitting transphobia and cisgenderism in occupational therapy, Occupational Therapy Now

Pope, K. S., & Vetter, V. A. (1992). Ethical dilemmas encountered by members of the American Psychological Association: A national survey. The American Psychologist , 47 (3), 397–411

Provencher, V., Mortenson, W. B., Tanguay-Garneau, L., Bélanger, K., & Dagenais, M. (2014). Challenges and strategies pertaining to recruitment and retention of frail elderly in research studies: A systematic review. Archives of Gerontology and Geriatrics , 59 (1), 18–24. https://doi.org/10.1016/j.archger.2014.03.006

Rawls, J. (1971). A Theory of Justice . Harvard University Press

Resnik, D. B., & Elliott, K. C. (2016). The Ethical Challenges of Socially Responsible Science. Accountability in Research , 23 (1), 31–46. https://doi.org/10.1080/08989621.2014.1002608

Rosa, H. (2010). Accélération et aliénation. Vers une théorie critique de la modernité tardive . Paris, Découverte

Sen, A. K. (2011). The Idea of Justice . The Belknap Press of Harvard University Press

Sen, A. K. (1995). Inegality Reexaminated . Oxford University Press

Sieber, J. E. (2004). Empirical Research on Research Ethics. Ethics & Behavior , 14 (4), 397–412. https://doi.org/10.1207/s15327019eb1404_9

Sigmon, S. T. (1995). Ethical practices and beliefs of psychopathology researchers. Ethics & Behavior , 5 (4), 295–309

Swazey, J. P., Anderson, M. S., & Lewis, K. S. (1993). Ethical Problems in Academic Research. American Scientist , 81 (6), 542–553

Swisher, L. L., Arsalanian, L. E., & Davis, C. M. (2005). The realm-individual-process-situation (RIPS) model of ethical decision-making. HPA Resource , 5 (3), 3–8. https://www-s3-live.kent.edu/s3fs-root/s3fs-public/file/RIPS_DecisionMaking_0.pdf

Tri-Council Policy Statement (TCPS2) (2018). Ethical Conduct for Research Involving Humans . Government of Canada, Secretariat on Responsible Conduct of Research. https://ethics.gc.ca/eng/documents/tcps2-2018-en-interactive-final.pdf

Thomas, S. P., & Pollio, H. R. (2002). Listening to Patients: A Phenomenological Approach to Nursing Research and Practice . New York: Springer Publishing Company

Wiegand, D. L., & Funk, M. (2012). Consequences of clinical situations that cause critical care nurses to experience moral distress. Nursing Ethics , 19 (4), 479–487. DOI https://doi.org/10.1177/0969733011429342

Williams-Jones, B., Potvin, M. J., Mathieu, G., & Smith, E. (2013). Barriers to research on research ethics review and conflicts of interest. IRB: Ethics & Human Research , 35 (5), 14–20

Young, I. M. (2011). Justice and the Politics of difference . Princeton University Press

Download references

Acknowledgements

The team warmly thanks the participants who took part in the research and who made this study possible. Marie-Josée Drolet thanks the five research assistants who participated in the data collection and analysis: Julie-Claude Leblanc, Élie Beauchemin, Pénéloppe Bernier, Louis-Pierre Côté, and Eugénie Rose-Derouin, all students at the Université du Québec à Trois-Rivières (UQTR), two of whom were active in the writing of this article. MJ Drolet and Bryn Williams-Jones also acknowledge the financial contribution of the Social Sciences and Humanities Research Council of Canada (SSHRC), which supported this research through a grant. We would also like to thank the reviewers of this article who helped us improve it, especially by clarifying and refining our ideas.

Author information

Authors and affiliations.

Department of Occupational Therapy (OT), Université du Québec à Trois-Rivières (UQTR), Trois-Rivières (Québec), Canada

Marie-Josée Drolet

Bachelor OT program, Université du Québec à Trois-Rivières (UQTR), Trois-Rivières (Québec), Canada

Eugénie Rose-Derouin, Julie-Claude Leblanc & Mélanie Ruest

Department of Social and Preventive Medicine, School of Public Health, Université de Montréal, Montréal (Québec), Canada

Bryn Williams-Jones

You can also search for this author in PubMed   Google Scholar

Corresponding author

Correspondence to Marie-Josée Drolet .

Ethics declarations

Competing interests and funding.

As noted in the Acknowledgements, this research was supported financially by the Social Sciences and Humanities Research Council of Canada (SSHRC).

Additional information

Publisher’s note.

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Rights and permissions

Reprints and permissions

About this article

Cite this article.

Drolet, MJ., Rose-Derouin, E., Leblanc, JC. et al. Ethical Issues in Research: Perceptions of Researchers, Research Ethics Board Members and Research Ethics Experts. J Acad Ethics 21 , 269–292 (2023). https://doi.org/10.1007/s10805-022-09455-3

Download citation

Received : 24 March 2022

Revised : 13 July 2022

Accepted : 13 July 2022

Published : 12 August 2022

Issue Date : June 2023

DOI : https://doi.org/10.1007/s10805-022-09455-3

Share this article

Anyone you share the following link with will be able to read this content:

Sorry, a shareable link is not currently available for this article.

Provided by the Springer Nature SharedIt content-sharing initiative

  • Researchers
  • Research Ethics Board Members
  • Research Ethics experts
  • Find a journal
  • Publish with us
  • Track your research

IMAGES

  1. Ethical Considerations in Qualitative Research

    scholarly articles on ethical considerations in research

  2. Ethical Considerations During Research 1

    scholarly articles on ethical considerations in research

  3. Ethical considerations in research involving older people

    scholarly articles on ethical considerations in research

  4. (PDF) Ethical Considerations in Research

    scholarly articles on ethical considerations in research

  5. SOLUTION: Ethical Considerations In Research

    scholarly articles on ethical considerations in research

  6. (PDF) Sample ethical considerations in social research.

    scholarly articles on ethical considerations in research

VIDEO

  1. ethical AI yolo object detection ambulance detection show AI helps him 1

  2. محاضرة Ethical Considerations in Conducting Research ❙ طرق البحث العلمي ❙ الفرقة الرابعة ❙ 2024

  3. Research Ethics

  4. HURRY AND APPLY!!! THESE AGENCIES ARE RECRUITING FOR THE NHS// AGENCIES RECRUITING FOR THE NHS IN UK

  5. ⚖️Ethical Principles in Research🩺

  6. Ethical considerations in clinical research

COMMENTS

  1. Download .nbib

    According to Sieber ( 2004 ), ethical issues in research can be classified into five categories, related to: (a) communication with participants and the community, (b) acquisition and use of research data, (c) external influence on research, (d) risks and benefits of the research, and (e) selection and use of research theories and methods.

  2. Principles of Clinical Ethics and Their Application to Practice

    The 4 main ethical principles, that is beneficence, nonmaleficence, autonomy, and justice, are defined and explained. Informed consent, truth-telling, and confidentiality spring from the principle of autonomy, and each of them is discussed.

  3. Ethical Dilemmas in Qualitative Research: A Critical Literature Review

    From an ethical viewpoint, conducting research with vulnerable populations requires protection for them because data collection methods, such as in-depth interviews with sensible themes, can delve into interpersonally and politically charged matters, which can create potentially conflicting situations ( Peter, 2015 ).

  4. Ethical Considerations for Qualitative Research Methods During the

    In this paper, we discuss core ethical and methodological considerations in the design and implementation of qualitative research in the COVID-19 era, and in pivoting to virtual methods—online interviews and focus groups; internet-based archival research and netnography, including social media; participatory video methods, including photo elicit...

  5. Principles of research ethics: A research primer for low- and middle

    This paper describes the basic principles of Western research ethics - respect for persons, beneficence, and justice - and how the principles may be contextualized in different settings, by researchers of various backgrounds with different funding streams. Examples of lapses in ethical practice of research are used to highlight best practices.

  6. Research Ethics

    Research Ethics - StatPearls - NCBI Bookshelf Multiple examples of past unethical research studies conducted in the past throughout the world have cast a significant historical shadow on research involving human subjects.

  7. Research Ethics: Sage Journals

    Research Ethics is aimed at all readers and authors interested in ethical issues in the conduct of research, the regulation of research, the procedures and process of ethical review as well as broader ethical issues related to research … | View full journal description This journal is a member of the Committee on Publication Ethics (COPE).

  8. Ethical Considerations in Research

    Ethical considerations in research are a set of principles that guide your research designs and practices. Scientists and researchers must always adhere to a certain code of conduct when collecting data from people.

  9. Understanding Ethical Issues of Research Participation from the

    The objective of this analysis was to examine ethical issues in research with children and adolescents from their perspective as participants, including: assent, parental consent, risk perception, impact of research participation, and incentives. Methods

  10. Legal and ethical issues in research

    In this article, we will briefly review the legal and ethical issues pertaining to recruitment of human subjects, basic principles of informed consent and precautions to be taken during data and clinical research publications.

  11. Ethical, Practical, and Methodological Considerations for Unobtrusive

    As Internet research grows in popularity, attention to the ethics of studying online content is crucial to ensuring ethical diligence and appropriateness. Over recent years, ethical guidelines and ...

  12. (PDF) Ethical Considerations in Research

    Ethical reflections extend to respecting cultural norms, values, and sensitivities while sharing data, conducting research, and determining ownership and utilization of intellectual property...

  13. Full article: Principles for ethical research involving humans: ethical

    Morality, ethics and ethical practice. Ethics, or moral philosophy, is a branch of philosophy that seeks to address questions of morality. Morality refers to beliefs or standards about concepts like good and bad, right and wrong (Jennings Citation 2003).When used as the basis for guiding individual and collective behaviour, ethics takes on a normative function, helping individuals consider how ...

  14. Real‐time ethics engagement in biomedical research

    Biomedical research often raises ethical questions that are usually addressed ad hoc or in retrospective. Real‐time ethical engagement as part of research may be better suited to identify ethical issues. Subject Categories: S&S: Economics & Business, S&S: History & Philosophy of Science Biomedical research inevitably involves ethical issues.

  15. The Ethics of Research, Writing, and Publication

    The reporting of the findings in peer-reviewed, scholarly journals requires as much ethical conduct as does the actual research design, data collection, and analysis. All aspects of research and the publication of research findings require ethical conduct from the research investigators, authors, editors, peer reviewers, and publishers.

  16. Ethical considerations for researchers developing and testing ...

    12 Altmetric Metrics This comment provides an overview of ethical considerations for researchers developing and testing minimal-risk devices that interact or interface with people, such as...

  17. Assisting you to advance with ethics in research: an introduction to

    Ethics and ethical behaviour are the fundamental pillars of a civilised society. The focus on ethical behaviour is indispensable in certain fields such as medicine, finance, or law. In fact, ethics gets precedence with anything that would include, affect, transform, or influence upon individuals, communities or any living creatures. Many institutions within Europe have set up their own ...

  18. (PDF) Ethical Considerations in Qualitative Study

    Ethical Considerations in Qualitative Study Authors: Siti Roshaidai Arifin International Islamic University Malaysia The protection of human subjects through the application of appropriate...

  19. Reporting of ethical approval and informed consent in clinical research

    Ethical considerations play a prominent role in the protection of human subjects in clinical research. To date the disclosure of ethical protection in clinical research published in the international nursing journals has not been explored. Our research objective was to investigate the reporting of ethical approval and informed consent in clinical research published in leading international ...

  20. Ethical Considerations in Research

    Abstract. For beginning researchers undertaking their first major research project, can often be a time of mixed emotions. Initial meetings with supervisors or research collaborators involve addressing questions around the nature and scope of the research question, the methodological tools that will be used to collect data and the ease with ...

  21. Ethics in educational research: Review boards, ethical issues and

    Academic researchers and professional associations have argued current ethical procedures in the form of ethics review committees are often lacking in knowledge and expertise of particular ethical contexts, including education ( Sikes and Piper, 2010 ).

  22. Ethical Considerations in Psychology Research

    There have been cases of academic researchers building online research websites such as personality "tests" that have then been adapted to gather massive amounts of profile data and, with the use of artificial intelligence, to personalize the targeting of political messaging to individuals. ... Oates, J. (2020). Ethical Considerations in ...

  23. Building trust in vulnerable and under-resourced communities: Ethical

    Download Citation | On Jan 1, 2024, Tung-Sung Tseng and others published Building trust in vulnerable and under-resourced communities: Ethical considerations in research | Find, read and cite all ...

  24. Top 5 Academic Publishing Trends That Will Dominate in 2024

    Impact: Publishers can leverage data analytics to provide authors with insights into their research's reach and impact, optimize marketing and dissemination strategies, and identify emerging research trends. 5. Collaborative Publishing: Breaking Down Silos and Embracing Openness. Trend: Cross-disciplinary research and collaboration are ...

  25. [QA] Ethical Considerations in Research

    Revised on June 22, 2023. Ethical considerations in research are a set of principles that guide your research designs and practices. Scientists and researchers must always adhere to a certain code of conduct when collecting data from people. The goals of human research often include understanding real-life phenomena, studying effective ...

  26. Ethical Issues in Research: Perceptions of Researchers, Research Ethics

    Following the triangulation of different perspectives (researchers, REB members and ethics experts), emerging ethical issues were synthesized in ten units of meaning: (1) research integrity, (2) conflicts of interest, (3) respect for research participants, (4) lack of supervision and power imbalances, (5) individualism and performance, (6) inade...