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  • 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

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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.


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.


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.


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

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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  

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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.


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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.

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Yanni Wu, Chunlan Zhou, Mingyu Hu & Weilian Cong

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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.

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Correspondence to Chunlan Zhou .

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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.

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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

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  • Venkataramana Kandi, Sabitha Vadakedath. Ethical Considerations in Clinical Research: A Comprehensive Review. American Journal of Public Health Research . Vol. 10, No. 2, 2022, pp 42-52. https://pubs.sciepub.com/ajphr/10/2/2 ">Normal Style
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Ethical Considerations in Clinical Research: A Comprehensive Review

Clinical studies involve research that is carried out in human beings and has direct implications on the health of people who participate in it as study subjects. Moreover, clinical trials are performed on healthy and diseased human subjects, wherein the safety and efficacy of a novel drug/device are tested. Therefore, the study design and the subject recruitment assumes increased significance. In this review we attempt to comprehensively discuss the importance of ethics in clinical research and specific ethical considerations concerning the evaluation of medical products, epidemiological studies, human genetics, and genomic research, transplantation studies, reproductive procedures/interventions, research among geriatric and pediatric populations and research involving the development of vaccines and diagnostic devices.

1. Introduction

The term clinical research does not necessarily mean research that is conducted concerning a new drug/clinical entity. It refers to all the types of research that include the recruitment of human participants. Clinical research covers all the areas but is not limited to treatment and diagnosis. Areas concerning public health, like the prevention of diseases with vaccines, epidemiological research, and the research that analyses the patient records, research on stored biological specimens also falls under the preview of clinical research. The clinical research, under its umbrella, ensures that the research is carried out following the principles and the guidelines formulated both by the local, national, and international bodies like the Institutional Ethics Committee (IEC), and the International Council for Harmonization (ICH). Because clinical research is carried out in human beings, ethical considerations like the protection of the rights, safety, well-being, autonomy, right to compensation of the study participants assume increased significance 1 . It has been reported that the IEC, during its review process seriously considers three issues about the conduction of clinical trial research, which include science, ethics, and data quality. Such a review would ensure that research has been initiated to improve the current knowledge and ensure benefits to the people and doesn’t cause unnecessary harm to the study participants 2 .

To conduct clinical research involving an investigational new product/drug, the sponsors/ investigators must justify the research and determine the objectives. The study must take into consideration all the ethical guidelines laid out by both the local and the international regulatory agencies. The sponsor and the investigators must take responsibility for the rights of the participants. Also, they must ensure that device principles to recruit the participants, the exclusion criteria, and the terms of voluntary participation and withdrawal of the subjects any time during the study, obtaining well-informed consent. The investigational new drug (IND) must be carefully handled and stored by the principles laid down by the investigational brochure. The IND must be adequately evaluated for its similarity to an already available drug, the relevant pre-clinical data that supports the aims and objectives of the study. A well-structured protocol paves way for successful clinical research. The essential elements of a protocol include the title, date, identification number, any amendments which are again numbered, name, address, contact numbers of the sponsors, and the monitor or a clinical research organizer (CRO).

The protocol must also contain the name, title, and contact numbers of the medical experts designated by the sponsor, the investigators who conduct the study, the names address, and the contact numbers of the centers of the study. The protocol should have information regarding the potential foreseeable risks and the benefits to studying participants. It must contain information about the type of the study design that includes if the study is randomized, comparative, blinded/open, placebo-controlled, parallel groups, cross-over technique, double-blind, single-blind, randomization, and placebo-controlled. Before the initiation of the drug, the trial protocol must have passed the review of the IEC. The IEC must review, the recruitment procedures followed concerning special/vulnerable group subjects like the people belonging to the economically weak communities.

The responsibility of the sponsors to ensure the quality controls, quality assurance, and publication and reporting policies assume increased significance. The protocol must mention that the data generated from the study will be presented for monitoring, audits, review by the independent ethics committee, and other regulatory inspections. The IEC must ensure that each protocol must be submitted along with a copy of a case report form (CRF), and a well-drafted informed consent form. The protocol must mention in detail the financial agreements (if any) between the sponsor-researcher, sponsor-manufacturer, and any other relationship. It also should mention the compensation and the accident/injury monitoring/handling policy. The clinical research sponsors and the investigators must ensure that the study is conducted following the ethical (Declaration of Helsinki/ Ethical Guidelines for Biomedical Research on Human Subjects by ICMR) and safety considerations of the participants. The sponsor must make a legal agreement/contract both with the investigator and the institution. The sponsor should provide the protocol, the standard operating procedures (SOP), and the investigational brochure for review and evaluation before the start of the study. It is the responsibility of the sponsor to ensure that the study is conducted as per good clinical practice (GCP) guidelines.

Clinical research is carried out not only by the pharmaceutical industries, which is usually on a large scale but also is done by the clinicians, academicians at various institutions that include the medical college, hospitals, and small-time research centers. Research by a pharmaceutical company involves huge financial commitments, whereas research carried out by the academician/clinician as a part of his/her teaching/physicians’ role usually involves less/no financial obligations. The industry people may follow several regulations, which may not be the case by the academician/clinician. Therefore, such research and its investigators are required to understand the various aspects of clinical research including the principles, and guidelines of conducting the research. They must satisfy the regulations recommended by the CDSCO, Drugs and Cosmetics Act (1940) and Drugs and Cosmetics Rules (1945), ethical guidelines of the Indian Council of Medical Research (2006), and the Indian Good Clinical Practice Guideline (2001) 19 .

In the current review, we comprehensively discuss the general ethical considerations involved in clinical research and specific ethical issues concerning the reviews of study/protocol, evaluation of medical products, epidemiological studies, human genetics, and genomic research, transplantation studies, reproductive procedures/interventions, research among geriatric and pediatric populations and research involving vaccines and diagnostic devices.

2. General Ethical Issues and Review Procedures in Clinical Research

It is essential to understand the general ethical issues and the review process involved before conducting the clinical research. Since clinical research requires the participation of humans in the form of study subjects, individuals are recruited based on certain criteria and principles designated by the regulatory bodies in the form of informed consent. Among the basic principles which should be considered before enrolling the study participants, the respect for autonomy (participant must be allowed to decide by himself both participate and to stop participating if he/she wishes), beneficence (participant must get the benefit and should never be harmed), non-maleficence (participants must be made completely aware of the study process), and justice (participants must be given the best deal irrespective of the study results). The study participants should be made aware of all the information regarding the duration, procedures followed, investigations to be conducted, potential risks including the foreseeable and those which may be unknown, benefits of the study both to the participants and to the society/community, compensation details, risk management procedures including the treatments available, confidentiality issues, loses (no loss of benefits if the participant withdraws) and benefits concerning commercialization.

The informed consent and its contents are thoroughly evaluated by the respective institutional review boards (IRB’s)/IEC/research ethics board (REB) before the approval of the clinical research protocol. The basic responsibilities of the review boards are to ensure the participant’s rights, dignity, and well-being. The clinical research is conducted in a single center, or it may be a multi-center study. Also, the participants may belong to different communities and have varied cultural and societal backgrounds. Therefore, the information regarding the research to be conducted must be provided to the participants in a manner that is suitable for them to completely understand. It is important to acquire a signed informed consent wherever possible (verbal consent recorded in a video in some cases) and if a participant is uneducated, a thumb impression may be taken.

Waiver of informed consent may be considered in cases where the participants may be taking part in a Human immunodeficiency virus (HIV) study and are HIV positive, where it is difficult to keep the confidentiality. Also, informed consent may be waived off during an emergency, where the patients are treated with a novel drug considering the risks to benefit ratio. The participants must be given the liberty to ask any relevant questions regarding the clinical research process and the investigators must take fresh informed consent during any deviations from the study process. Depending on the nature of a study, the review boards must screen and categorize the protocols submitted for approval into three categories. The review boards, considering the type of the study and the associated risks to the participant’s group the protocols are categorized into a) exempted from review, b) expedited review, and c) full review. The ideal composition of an institutional review board and the study categorization based on risk to the participants is shown in Table 1 and Table 2 respectively.

Table 1. Composition of an ideal institutional review board

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Table 2. The categorization of review of protocols based on the type of study

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3. Ethical Considerations for Clinical Evaluation of Medical Products

This concept elaborates on the principles and guidelines of clinical evaluation of drugs that include the different phases of a clinical trial, the specific principles of drug trials, surgical procedures, device trials, vaccine trials, trials involving herbal medicine, and methods of monitoring and reporting adverse drug reactions. It has been noted that the complexities associated with human clinical research have increased over time. The most basic principles involved in the conduction of human clinical research are autonomy, non-maleficence, beneficence, and justice. A clinical trial (randomized, single/double-blinded), according to the revised schedule “Y” of the drugs and cosmetic act (DCA) 2005 is defined as the systematic study of a new medical product (drug/device/surgical procedure/diagnostic test/vaccine/herbal medicine), to assess its clinical and pharmacological (pharmacokinetics and pharmacodynamics) effects, safety (adverse reactions/events), and efficacy.

According to the DCA-1945, a drug to be tested is called a new chemical entity (NCE), which may be an approved drug being tested for a different indication, at a different dosage, and in a different route of administration. It may also include the study of two individually approved drugs in combination (interaction studies), called fixed drug combinations (FDC). The medical product trials involve several sensitive issues that include the use of a placebo (a dummy), and a sham surgery, which by any means do not satisfy the basic principles of clinical research involving humans as suggested by the Helsinki declaration. Drug trials which include the medical products not approved by the regulatory authorities come under the preview of the law of the land.

The guidelines and the general principles while designing, conducting, recording, and reporting clinical research may be suggested by the local regulatory authorities like the Indian Good Clinical Practices (GCP) of India, which follow the regulatory guidelines recommended by the international authorities like the World Health Organization (WHO) and International Committee on Harmonization (ICH). A clinical trial is conducted to study an NCE, comparison of two approved drugs, and the efficacy and the effects of combination drugs. A clinical trial involves four phases that include phases I, II, III, and IV. Also, the clinical research involves special studies called bioavailability/bioequivalence studies (testing new drug dosage forms and the drugs approved in other countries for systemic absorption) and the dissolution studies (testing the solid dosage forms of drugs, their dosage, and bioavailability in different formulations). The phases of clinical trials, their roles, and the nature of studies are elaborated in Table 3 .

Table 3. Different phases of clinical trial studies

scholarly articles on ethical considerations in research

Table 4. classification of the medical devices into four classes based on their risk levels

scholarly articles on ethical considerations in research

The ICMR had revised the regulations about the ethical considerations in research involving human participants. This guideline, which was released in 2017, was the 4th amendment to the research guidelines involving human subjects in India 3 . This release had revised the principles regarding the issues about the general ethical issues, ethics review procedures, research in a vulnerable population, principles concerning clinical trials of drugs, interventions, public health research, social, behavioral sciences research, research during emergencies, disasters/calamities, and storage of biological materials, bio-banking, and data handling. In the united states of America (USA), the food and drugs administration’s (FDA) Food, Drug, and Cosmetic Act frames the investigational device exemptional (IDE) rules which govern the safety, efficacy, and performance of a medical device 4 . In India, the regulatory guidelines with regards to medical devices do not fall under the drugs and cosmetics act (DCA) which deals with drugs. The M-III schedule under the new central drug standards control organization (CDSO) guidelines classify the medical devices into four classes (A, B, C, and D) based on their risk levels to patients as shown in Table 4 5 .

4. Ethical Considerations for Epidemiological Studies

Clinical research involves studies that are undertaken to identify public health problems. Such research which is undertaken at the community level including a large group of the population comes under the category of cross-sectional, case-control, cohort, and observational studies. In countries like India and other developing countries, epidemiological studies on both communicable (infectious diseases) and non-communicable (heart, liver, and lung diseases) diseases assume increased significance. Such epidemiological studies, which include both the healthy as well as diseased people help in identifying the causes/risk factors and developing mechanisms to prevent them in the future. Epidemiological research may be carried out in the form of research, a health program, or a surveillance activity.

Ethical concerns in epidemiological studies are multifaceted and complex majorly because of the length of the duration of the study, the number, and the versatility of the participants who belong to the different socio-economic milieu. Epidemiological studies are different types of clinical research, and they assume significance because of their association with a huge financial commitment. Therefore, extreme care is required to address all the concerns including the practical aspects, the technical areas, and the ethical concerns before initiating the study. Different types of epidemiological studies and their applications are elaborated in Table 5 .

Table 5. Different types of epidemiological studies and their applications

scholarly articles on ethical considerations in research

The epidemiological research follows the guidelines recommended by the council of an international organization on medical sciences (CIOMS) and the WHO. The ethical guidelines majorly satisfy the safety concerns of the study population and make sure that no harm is done to the participants, maximize benefits to both the individuals and the community involved, maintenance of scientific objectivity, and integrity of the study results. In cohort and experimental studies, the group with the potential risk factors is observed and intervention is blinded with placebo respectively, which poses a serious ethical concern. This may pose risk to a certain group of study participants which needs to be ethically justified. Involving the participants, their community leaders, village heads, and the panchayat leaders may be crucial in protecting the participant's rights against financial inducements, privacy, and confidentiality issues.

The epidemiological studies majorly include the public health programs and research activities are undertaken by the governments. Such research usually involves a large group of population and involves huge finances. Therefore, addressing the ethical issues before the initiation of the epidemiological studies could be instrumental in the success of the programs/research activities 6 . Epidemiological studies like health systems research (HSR) are a unique type of clinical research since it doesn’t involve the trial of drugs. A previous study highlights the significance of eight ethical issues that may determine the study in terms of the protection of the human rights of the study participants. These issues include the nature of the intervention, types of research subjects, units of intervention and observation, informed consent, controls and comparisons, risk assessment, the inclusion of vulnerable groups, and benefits of research 7 . The principles concerning the ethics concerning the conduction and analysis of epidemiological research were initially proposed by the Council for International Organizations of Medical Sciences (CIOMS) in the year 1991. Although the same ethical guidelines were suggested for the epidemiological studies, later it was realized that such research is different from normal research, and it needs some special considerations. Given the implications of the epidemiological research both on the individuals as well as the community, certain principles were suggested that included minimizing risk on the patients and benefiting both the participants and the community. It emphasizes maintaining public trust in research results and adopting high scientific standards and incorporating representatives from the community into the team. Also, it elaborates principles of adhering to the community commitments, to ensure that the benefits are extended to the community, besides keeping respect for cultural diversities 8 .

5. Ethical Considerations for Human Genetics and Genomic Research

The clinical research involving the human genome is associated with the risks and benefits, confidentiality issues, parental, newborn, children, and anonymous testing for genetic disorders. After the completion of human genome sequencing for the first time in the year 2000, scientists acquired an improved understanding of the cause of many diseases. This has paved the way for the development of regulations that govern researchers/scientists who carry out genetic mapping and genetic diagnoses. With increased knowledge of human genetics, scientists have been trying to cure and prevent genetic diseases using gene therapy (somatic cell gene therapy, germline therapy). This had prompted ethical concerns throughout the world, and the regulatory authorities make sure that such a therapeutic approach should not be misused and must be available to all mankind irrespective of their financial status.

Several gene banks and cell-line repositories have started to function by collecting the human genome/DNA/tissue/ cord blood for future use. The collections can be of two types: the unidentified samples, and the identified samples/collections. The samples may also be collected exclusively for research and are labeled as anonymous samples, unlinked samples, and coded samples. The genetic research also follows the same ethical guidelines as do the other types of clinical research, where protecting the participant’s rights is given increased priority. Also, genetic research is concerned not only with the individuals but also with the family and the community/society. Therefore, additional care is taken to address ethical concerns to avoid physical, psychological harm, and damage to familial relationships.

Clinical research concerning genetics appears to be quite tricky as it may lead to several unforeseen consequences that may reflect on individuals, families, and society. Genetic counseling of the participants/families requires that they share a lot of the personal information with the investigators rising potential ethical concerns like undue inducements (financial). Confidentiality appears to be at stake during and after the genetic counseling and potential diagnosis. Therefore, it is important to de-link the research results and consider revealing the results of informed consent in cases where the results are beneficial both to the individuals and the community.

Genetic research requires certain special considerations while obtaining informed consent from the participants of the study. Because of the potential implications associated with the diagnosis of genetic diseases, informed consent is obtained in-group from all the representatives of the community which may be led by a group/community head/leader/representative. The informed consent should contain necessary relevant information of the research process, must carry information about the potential risks, and must give the time and choice of either participating/not/withdrawing from the study. After the discovery of the double-helical structure of the deoxyribonucleic acid (DNA), and the human genome project, the research concerning human genetics started evolving. The genomic research deals with the identification of the genes coding for various proteins, and enzymes, knowing the mutations that may cause drug resistance, and cancers, and finding out the genetic basis of disease/infection susceptibility among different people. Because of the financial consideration and the possibility of personalized medicine taking a toll on the ethical aspects in genetics research that can be protected by well-informed consent, and a thorough ethics review 9 . The emergence of newer microbial infections had thrown several public health challenges both to the governments and the healthcare workers. In recent research, a newer technology named Gene drive technology was proposed as a potentially beneficial and cost-effective strategy for controlling the transmission of deadly and debilitating microbial infections in people worldwide. The gene drive technology facilitates the inheritance of the gene of interest, thereby increasing its prevalence in the community 10 .

6. Ethical Considerations for Transplantation Research

Transplantation is a process where an organ from one individual (donor) is grafted into a different individual (recipient). Transplantations are a complex surgical procedure that poses a potential ethical concern. The subject of transplantation is emerging in the twenty-first century, and although we stand in its infancy, the subject is ever-growing. There are different types of transplantation procedures that include live donor transplants, cadaver transplants (cadaver donor), the xeno-transplantation (donors are animals other than humans, usually homo-sapiens, chimpanzees), and the transplantation carried out for cosmetic purposes. Cadaveric transplantation poses an ethical concern because here the donor is dead.

The donor’s death must be scientifically proven to perform a transplantation procedure. According to the ‘Transplantation of Human Organs Act, 1994’ with ‘Transplantation of Human Organs Rules, 1995, death may be an irreversible loss of the function of the brainstem and loss of brain-stem reflexes (no pupil constriction to light), although the heart may still be beating for a certain time. During live donor transplantation, it must be noted that only the organs capable of regenerating (bone marrow, liver, skin), or a paired organ (kidneys) needs to be chosen for transplantation. Although an organ transplantation procedure is undertaken to save a human life, protecting the rights of the donors assumes increased significance. The donor’s life should not be placed at risk due to organ donation. Therefore, transplantations should only be attempted after carefully considering the potential benefits against the foreseeable risks both to the donors and the recipients and the donor’s health must be given high priority.

Voluntary informed consent of the donor must be obtained after informing in detail about the potential risks to him/her after the transplantation. Since getting/finding a voluntary donor is very difficult and the transplantation is a costly affair, scientists may be forced to create/clone human beings, which is against the ethical principles laid down by the international regulatory bodies. Recently, increased awareness has spread among the literate people regarding the importance of organ donation after death. There are now special drives for encouraging people to donate their organs after death, and such a will can be communicated to family members or the hospitals as a “living will” (consent to donate their organs after death while still alive with a witness of two or more people/family members).

Such transplantation procedures are undertaken solely for saving the lives of people and should never be associated with any financial benefits. Cases of embryonic stem cell transplantations from the aborted fetus, dead fetus, and neonates are all governed by the local and international ethics (IEC) guidelines and the regulatory bodies like the Institutional Committee for Stem Cell Research and Therapy (IC-SCRT), and the National Apex Committee for Stem Cell Research and Therapy (NAC-SCRT). Rather than research, transplantation is a surgical procedure, which is undertaken to protect the life of a human being. It involves the grafting of a human organ from a donor. Such a process is very critical both in terms of medical and ethical reasons. Transplantations can be of various types like live donor transplantation (related/unrelated), cadaveric transplantation (organ transplantation from a dead person), fetal organ transplantation (embryonic stem cells), neural transplantations, bone marrow transplants, xeno-transplantation (animal tissue/organs) 11 . The informed consent in such procedures may be influenced by the financial benefits. Besides, during cadaveric transplants, the person’s consent is not available. Defining death, especially the term ‘brain dead’ is not completely understood in society and could be misused 11

Because of a big gap between the demand and supply of organs for transplantation, there is an increased significance of the ethical concerns related to organ transplantation procedures. The major ethical issues concerning transplantations stem from the description of death (brain dead), informed consent of a live donor, financial obligations related to the transplantation procedures, ethical concerns of donor registries, the international organ trade, issues with the allocation of the organs, and waitlist 12 .

7. Ethical Considerations for Assisted Reproductive Technologies

There are several concerns related to the legitimacy of the children born through assisted reproductive technology (ART). The process of the in-vitro fertilization technology (IVF), the surrogate motherhood, and the procedures for the preservation, utilization, and disposal of unused embryos is very critical. During the process of ART, the sperm or the ovum is acquired from the sperm/ovum banks. The child born in such a way legally belongs to the parents and in no war will be related to the sperm/ovum donors. Also, it is the laboratory’s responsibility to make sure that confidentiality is maintained. If sperm and the ovum are collected from the parents (married couple) themselves, there will be no need for medico-legal considerations. When the IVF is combined with the embryo transfer (IVF-ET), and in cases where the sperm/ovum is donated, and the embryo is implanted in a different womb (surrogate), there will be different parental origins, which in turn increases the ethical, and medico-legal concerns. The IVF, ART, and surrogacy pose increased ethical concerns. Surrogacy may be wrongly utilized by the financially sound parties by influencing the surrogate mother using financial inducements. In surrogacy, the women, her husband need to give their consent to carry the embryo until the child’s delivery and would hand over the child to the genetic parents.

If a problem arises about the child’s future, DNA fingerprinting technology may be used to confirm the parenthood, where surrogate mother/parents don’t match with the child’s genetic make-up. All the records containing the complete details of the source of the sperm/ovum, the parents who agreed for surrogacy must be maintained, which would form the documents for verification in the future. The IVF and the ART may be performed and monitored by qualified personnel and a decision of surrogacy must be taken only after thorough genetic counseling, screening, and medical reasons justifying the inability to carry the embryo. Surrogacy is a complete legal contract, where the mother is appropriately compensated both during the pregnancy and the delivery. The preservation periods of the embryos are specified both locally (Indian council for medical research (ICMR) and internationally (WHO). In the United Kingdom, the embryos may be stored in a frozen state for 10 years and the semen may be frozen for five years. In general terms, it is not approved to use an embryo after 14 days of formation.

Although assisted reproductive technology (ART) is instrumental in solving fertility issues, it had thrown several challenges in terms of ethical, legal, and social concerns. The most significant factor is the issue of financial implications, where the ART may be more accessible to people with increased financial strengths. Ethical concerns are also expected concerning the embryonic genetic screening and diagnosis, donor gametes (sperms, oocytes), embryo donation, surrogacy, and gestational carriers, and most significantly, the potential harm that the ART itself may pose to the individuals 13 . The Indian scenario is quite intriguing, where on one side, there is an increase in the ART capabilities, and on the other side, there is a lack of standardization of the procedures. Furthermore, in India, the reporting mechanism regarding the conduction of ART is not adequate. It was recommended that there should be an ART registry in place for guidance on the standardization of the protocols and to improve 14 .

8. Ethical Considerations and Guidelines for Clinical Research among Geriatric Population

Because clinical research is critical for the advancement of medicine and improvement of public health, and it involves human participants, many ethical issues may be associated with such type of research. The ICH prescribes harmonized tripartite guidelines for the conduction of clinical research among various groups/types of populations. In this concept, we understand the ICH harmonized tripartite guidelines concerning geriatric people (age greater than 65 years). Geriatric age group people are sensitive to medical interventions due to extreme age, co-morbid conditions, and drug interactions. Age-related diseases like Alzheimer’s and heart diseases are common among the geriatric group and clinical research in this area benefits such people. Since old age may compromise the functions of the organs like the liver, kidneys, the clinical research trials involving newer drugs/new combinations of the older approved drugs/formulations may pose potential risks to the participant’s health. While initiating clinical research among the geriatric population, it is important to recruit subjects with ages greater than 75 years, and those who have co-morbidities. Also, it is important to include younger age group subjects and compare the activities of the newer drug among the geriatric population.

It is recommended that the geriatric age subjects must be included in phase II and phase III stages of clinical research. Also, a productive result/meaningful comparison is expected when more than or at least 100 geriatric age participants are recruited. The basic knowledge that a researcher acquires by including both the older and younger age groups is that it facilitates the understanding of the role of the proper functioning of organs like the liver and the kidneys, which are required for drug metabolism, absorption, and excretion (pharmacokinetics). It is recommended that the pharmacokinetic studies are preferably performed in the healthy geriatric population or diseased people. To improve the knowledge of the pharmacokinetics of the drugs, the researchers must include both the young and the geriatric population with hepatic and renal diseases. To study the pharmacodynamics (therapeutic response to different doses of drugs, side effects at varied drug concentrations), the geriatric age people are recruited except in cases while testing sedative, hypnotic, and anti-psychotic/psycho-active drug candidates. People with an age of more than 65 years may be categorized as the geriatric age group. This age group is considered the fast-growing age group around the world. The geriatric age group forms a significant portion of the patients who present to the hospital for healthcare needs. Most clinical trials fail to recruit people in the geriatric age group, although this age group forms a significant chunk among the people who consume medications for various causes that may include cardiovascular diseases, arthritis, Parkinson’s disease, Alzheimer’s disease, and cancer.

The developed nations and the regulatory authorities in such countries have already initiated mechanisms to include the geriatric ager group in the clinical trials unless there is a valid reason to exclude them. The scenario is not very good in developing nations including India, where the CDSCO is yet to liberalize the age limit that is in place for various drug-related clinical research trials 15 . It was in 2010, that the ICH E7 Guideline, which deals with the clinical research concerning the geriatric age group was revised. This revision had relevant information that considers the rapidly growing geriatric age group population. Regulatory recommendations from the ICH formulated the guideline and recommend the inclusion of geriatric age people in various clinical research trials 16 .

9. Ethical Considerations and Guidelines among Pediatric Population

The clinical research trials are critical among various age groups, and the pediatric age is among the most sensitive. Because of the sensitivities associated with the clinical research in the pediatric age group, there are only fewer drugs approved for pediatric use. Therefore, there is an increased necessity for the development of pediatric medical products throughout the world. The ICH guidelines for clinical research in the pediatric age group facilitate the safe, efficient, and ethical study of medicinal products. The ICH guidelines concerning various clinical research concerns in the pediatric population are presented in Table 6 .

Table 6. List of ICH documents with relevant information impacting on pediatric studies

scholarly articles on ethical considerations in research

  • Tables index View option Full Size Previous Table

Among the general principles recommended by the ICH concerning the pediatric population, “the medicines prescribed for pediatric use must be appropriately evaluated before use” appears to be the most significant. It is recommended that in any clinical research trial, a pediatric group should be included which is important to obtain the knowledge of the effects of drugs and may facilitate the use of a drug in such populations in the future. The clinical research on the pediatric population must be done responsibly, and according to the local and international guidelines. The companies, regulatory authorities, health professionals, and society should take responsibility for clinical research in the pediatric population.

Clinical research for the drug development process in the pediatric population should consider the nature/seriousness of the clinical condition to be treated, its prevalence, effectiveness, and adverse effects of the currently available drugs for the same condition, development of pediatric-specific endpoints, and the pediatric age range to be included for testing. Another important consideration while conducting clinical research trial includes the development of pediatric formulations which provides dose accuracy and increase drug compliance. Different types of drug formulations are developed for pediatric use that includes liquids, suspensions, chewable tablets, injectable formulations. The oral formulations must be developed in flavors and colors, which may be more acceptable for pediatric use.

Clinical research involving the pediatric population poses a unique scenario that is encountered with the adult population. Research including the children pose issues with informed consent and is considered very crucial. Due to this factor, several clinical research studies fail to adequately represent the age group and therefore, the safety, efficacy of drugs that are used are not completely clear. The Standards for Research (StaR) in Child Health, promulgated by the USA and the European Union in the year 2009, had proposed aims to improve the design, conduct, and reporting of clinical research trials in the pediatric age population 17 . A recent report had observed that one out of five clinical research trials among the pediatric population fails because of the faulty study design, lack of experiment planning, and inadequate participant enrolment. This study had highlighted the significance of planning clinical research concerning the modes of administration of the drugs, dosage studies, monitoring, and safety studies, apart from the ethics of recruitment and informed consent 18 .

10. Ethical Considerations and Guidelines for Vaccines and Diagnostic Devices

There are various phases of clinical trials that include the phases of the vaccine trial, clinical trials involving the surgical procedure, and diagnostic methods, and the clinical trials involving the herbal source medical products. The clinical research with regards to the vaccine trials is like the clinical research drug trials with some mild differences. During phase I of a drug trial, the IND is given to healthy people (30) for understanding its tolerability and safety. Similarly, in a vaccine trial, the vaccine is given to low-risk people to study the immunogenicity, safety, and other biological consequences/effects. The study also examines the safety and effectiveness of the routes of administration of the vaccine. In phase II trial of a drug trial around 100 healthy subjects are recruited, whereas, in a vaccine trial, one can choose to include healthy/low-risk people to administer the vaccine (prophylactic) or choose high-risk/diseased people for vaccine administration (therapeutic). This phase majorly examines the effectiveness of the vaccine in a trial. Under phase III of a vaccine trial, the vaccine is administered to thousands of people, usually, high-risk groups, and examine its efficacy in terms of immunogenicity and its ability to prevent disease transmission.

Although a vaccine trial is very important from the public health perspective, the sponsor and the investigators of the study must ensure that the clinical research is carried out following the principles, and guidelines laid down by the Drug Controller General of India (DCGI), Department of Biotechnology (DBT) and the Ministry of Environment and Genetic Engineering Approval Committee (GEAC). The sponsor and the investigators must be cautious during the vaccine trial involving a live/live attenuated vaccine. Because such vaccines may pose potential risks of infections to the volunteers/participants/study subjects, they should be adequately informed about the consequences, and informed consent is duly obtained from all the participants. Concerning the clinical research involving surgical procedures/devices, diagnostic devices/bio-equipment, which is an emerging field of research in India, the policies on regulation of such research are still a novice. Only the needle and syringe manufacture has been till now governed by the DCA, 1940 act. The medical devices include both the critical (catheters, implants like the pacemakers, stents, etc.) and non-critical (thermometer, blood pressure apparatus, etc.) devices, and all these are considered inert and are not considered therapeutic. Only recently the Indian Medical Devices Regulatory Authority (IMDRA) has been constituted as a regulatory authority with regards to the manufacture of medical/surgical devices. The IMRDA regulations are constituted by the Society of Biomedical Technology (SBMT) under the Defence Research Development Organization (DRDO).

Stringent ethics consideration must be given regarding the exposure of the study participants to radio-active chemicals, X-rays, and other herbal medicinal products. The radiation exposures must be performed following the regulatory authority (like the Bhabha Atomic Research Centre, Mumbai (BARC). The regulatory requirements for the conduction of clinical research in the development of vaccines, and diagnostic devices, as recommended by the WHO include Good Manufacturing Practice (GMP) for drugs/medical products, biologicals, regulation, and licensing of biological products in countries with newly developing regulatory authorities, and guidelines for national authorities on quality assurance for biological products 20 . Violation of human rights concerning the informed consent and the conduction of clinical trial in human papillomavirus (HPV) vaccine trial which included 24,000 schoolgirls surfaced in India in 2009. This case highlights the lack of human rights protection of the study participants 21 .

The international covenant on economic, social, and cultural rights (ICESCR) defines that the right to health includes the right to control their health, the right to be free from interference, torture, and irresponsible medical treatment/experimentation. It also stresses the need for considering the benefits to risks before initiation of a trial and ensuring regular participant health monitoring both during and after the clinical research trial.

11. Current Perspectives

Because the research involving the human subjects was being carried out for several decades, and that the responsibility of the safety and well-being of the participating patient was completely in the hands of the physician/clinician (taking the Hippocratic oath) treating the patient, not much was looked into the ethical considerations beyond this aspect (medical ethics). But, as time passed by, and after considering the incidents like the Nazi’s mishandling the soldiers at the Nuremberg during the second world war, the need for separate ethics, research ethics, and the relevant guidelines have emerged 22 . Since the clinical research with randomize-controlled trial (RCT) experimentation results in improved results, and data accuracy, such type of clinical research is regarded as the best. There are several types of randomization techniques like the simple randomization, block randomization (creating blocks of the participants and randomizing each block to improve the study balance and results), restricted randomization (unbalanced randomization, where the patients are recruited only after considering their interest in the study and rule out dropouts), stratified (to minimize the imbalances concerning the prognostic factors, that may include the sex, site of the study, etc. and thus minimize the imbalances), and adaptive randomization (consider a change in the allocation of the drug after having known its therapeutic effects and minimize the imbalance) 23 . The medical graduates, during their dissertation study, take up the projects that involve human participants. Therefore, they need to understand the significance of the principles of clinical research involving human subjects and the value of a well-designed informed consent, and the in-depth process of obtaining it from all the study participants. A recent study had noted that although the medical post-graduates have enough knowledge on the aspects of informed consent, there is a need for regular continuing medical education (CME) programs, and workshops to update them 24 . The CDSCO of India launched the materiovigilance program (MvPI) at the Indian Pharmacopeia Commission (IPC), Ghaziabad in the year 2015 with the principal aims to oversee the medical device-associated adverse events (MDAE), sensitize the healthcare workers regarding the adverse event reporting, generate reliable safety, efficacy, and performance data, and report the information to the regulatory authorities which take the decisions on the approval and marketing of the products 25 .

A new strategy to improve the social value of global health research, where research is conducted in multicentre at different countries was proposed in low-income countries. This promulgates benefit-sharing as a key strategy to address the moral issues relevant to the individuals, the communities, and the respective countries 26 .

In the epidemiological research concerning the surveillance of infectious diseases like the Influenza virus, it is important to address the relevant ethical concerns. Epidemiological research studies the distribution and determinants of the diseases. Epidemiological studies are also undertaken to understand the disease mechanisms, diagnosis and prognostic efficacy, efficacy of new therapeutic interventions, and most significantly, to understand the association between the exposures and outcome 27 . The concept of clinical research was previously confined predominantly to the developed countries, majorly because of financial constraints. But, in recent times, the developing nations have been actively involved in clinical research owing to the advantages to the availability of the varied population, and the health benefits to the people and the community as a whole 28 . The ethical considerations become even more significant during the research on psychiatric patients. Informed consent in such type of research becomes critical and should be carefully obtained from the participating patients after evaluating the clinical, ethical, and legal aspects. As per the Mental Healthcare Act (MHCA) 2017, and the ICMR’s the National Ethical Guidelines for Biomedical and Health Research involving Human Participant for research protocols, and informed consent indicating the patients/participants autonomy to participate in the study that includes admission, treatment, planning, and research interventions, and other procedures are essential 29 .

Apart from the regular clinical research, there may be occasions where an unapproved drug (safety and efficacy are not known) needs to be administered to the study participants (compassionate use). The compassionate use of the drugs (after phase III clinical trials) is a situation that arises when the patients are suffering from potentially life-threatening diseases, and the regular therapeutic options are not effective enough to treat. It has been noted that in any such situations the approval of the ethics committee remains the mainstay before the study is initiated. A well-designed informed consent delineating the necessary information about the compassionate drug, its potential foreseeable and un-foreseeable adverse effects, and other information concerning the modes of administration, compensation terms, and benefits may be instrumental in safeguarding the patients’ rights and protect him/her from abuse 30 . The informed consent may be waived off under some special circumstances, and it may be difficult/tricky to obtain informed consent from the vulnerable population like the pregnant women, the fetuses, children, orphans, employees, army personnel/soldiers, psychologically imbalanced and terminally ill people 31 . During the ART therapeutics, it has been noted that there is a chance for the excess embryos which were collected from one donor to be wrongly utilized. Such supernumerary embryos are either cryopreserved or utilized to treat a different couple for infertility. In the Indian couples, it was observed that they preferred to donate the excess embryos rather than their disposition 32 . A recent research report had evaluated the documents related to the pharmacokinetics, safety. and efficacy of the drugs regarding the geriatric population when a drug is under evaluation for approval at the Food and Drug Administration (FDA). This study has noted that the data relevant to the use of drugs in the geriatric age group was insufficient and needs improvement 33 .

12. Conclusion

The involvement of human participants in the clinical research is associated with increased risk and health implications among study participants. Therefore, clinical studies are screened and thoroughly monitored by the local, national, and international regulatory agencies. The institutional ethics committees ensure that the studies are appropriately designed, and participants are recruited voluntarily and after informed consent. The pediatric population, and the geriatric age group, along with other vulnerable groups like the pregnant women, and their representation in clinical trials is not adequately addressed over a period. With the availability of increased scientific technologies, and improved infrastructure, vaccine, and device development clinical studies have become feasible. However, such clinical trials should be cautiously undertaken after carefully evaluating the ethical considerations as discussed comprehensively in this article.

Published with license by Science and Education Publishing, Copyright © 2022 Venkataramana Kandi and Sabitha Vadakedath

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    Definition. Ethics is a set of standards, a code, or value system, worked out from human reason and experience, by which free human actions are determined as ultimately right or wrong, good, or evil. If acting agrees with these standards, it is ethical, otherwise unethical. Scientific research refers to a persistent exercise towards producing ...

  7. 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 ...

  8. (PDF) Ethical Considerations in Research

    of power and authority are all 'ethical considerations inherent in and raised. by ESL research' (p. . 1) . Koulouriotis further reiterates the point that a great. proportion of research in ESL ...

  9. 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 ...

  10. Ethics in Research: A Comparative Study of Benefits and Limitations

    Abstract. Ethics, as an integral component of human decision-making, undeniably shape the landscape of scientific research. This article delves deeply into the nuanced realm of ethical ...

  11. Ethical Considerations in Research

    In the conduct of research, several key principles and actions must be observed and preserved. These include freedom from harm, right to self-determination, right to privacy, and right to anonymity and confidentiality (See Figure 2). Freedom from physical or mental harm or discomfort should be of utmost concern to the researcher.

  12. (PDF) Exploring Ethical Considerations in Research: Guidelines and

    The article aims to identify the ethical guidelines which have been f ollowed. recently in the conduction of research and also the issues faced with them, and the unethical practices reported ...

  13. Ethical Considerations in Research

    Ethical considerations related to conducting research also involve standards for the storage and analysis of research data so cases like the Schön scandal can be reviewed expeditiously. Generally speaking, all research data, including primary materials and raw data, such as survey questionnaires, measurements, recordings, and computer results, must be stored in secure and durable storage ...

  14. 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 ...

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

    To discuss the ethical considerations involving research patients with advanced cancer: ... recognizing this action as similar to the peer review of scholarly productions. The members of RECs should have more knowledge on qualitative research to be able to evaluate the damages and also the benefits of this type of research.

  16. (PDF) Ethical Considerations in Qualitative Study

    The protectio n of human subjects through the. application of appropriat e ethical princi ples is. important in any research study (1). In a. qualitative study, et hical considerations have a ...

  17. Ethical Considerations in Clinical Research: A Comprehensive Review

    The ICMR had revised the regulations about the ethical considerations in research involving human participants. This guideline, which was released in 2017, was the 4th amendment to the research guidelines involving human subjects in India 3.This release had revised the principles regarding the issues about the general ethical issues, ethics review procedures, research in a vulnerable ...

  18. Full article: How has applying a national player development programme

    Ethical considerations. The research strictly followed the ethical guidelines of The National Committee for Research Ethics in the Social Sciences and the Humanities [NESH] (2019). Before data collection, the Norwegian Centre for Research Data (Sikt) Footnote 4 approved the study's legal basis for data processing Footnote 5.

  19. The Ethics of Research, Writing, and Publication

    Nothing is more exciting than seeing your name in print as the author of a well-written article in a respected, peer-reviewed, scholarly journal. A published article is the ultimate goal of a research project, an evidence-based design project, a case study, or an opinion or theory article that reviews and analyzes previous literature and makes ...

  20. (PDF) Ethical Considerations in Research

    Kathleen Haynes. W eek 10, Discussion-Initial Post. Ethical Considerations in Research. Research is an important component of expanding knowledge and understanding the. world, and the people that ...