sample of consent form for research participants

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IRB Consent Form Templates

A collection of informed consent, assent, and debriefing templates that can be used for your human participant research study.

General Consent Form Templates

Social and Behavioral Research Projects (last updated 03/16/2023)

Biomedical Research Projects (last updated 07/18/2022)

Consent Form Templates for Specific Biomedical Procedures

MRI and fMRI

Blood Collection by Finger Stick

Blood Collection by Venipuncture

Oral Consent Template

Guidance for Protocols Involving Oral Consent

Debriefing Template

Guidance and Template for Debriefing Participants

Studies Involving Children (Assent/Permission Forms)

Parent-Guardian Permission for Studies Involving Children

Sample Parental Notification Form

Sample Child Assent Form

Performance Release for Minors

Performance Releases

Performance Release for Adults

Sample consent and permission forms

General consent form to participate in research (DOC)

Two stage project consent form (DOC)

Parent permission form for research with child (DOC)

Child assent form (DOC)

Multiple consent form including audio-recording and quotations (DOC)

Photo and video consent form (DOC)

Video-recording consent form (DOC)

Re-contact agreement form (DOC)

Post-debriefing consent form (DOC)

UCL Research Ethics

• Advice on writing an information sheet and consent form

Writing a Participant Information Sheet and Consent Form

Recruitment documents help people make informed choices about whether to participate in a research study. Find out how to write a Participant Information Sheet, example forms and further guidance.

Writing a Participant Information Sheet

Participant Information Sheets must be designed to assist participants to make informed choices. Potential recruits must be given sufficient information to allow them to decide whether or not they want to take part. The process of obtaining consent and the accompanying documentation must be approved by a research ethics committee and, where only verbal consent to research is contemplated include consideration of an appropriate process for witnessing the consent.

Researchers must take the steps necessary to ensure that all participants in the research understand the process in which they are to be engaged, including why their participation is necessary, how it will be used, and how and to whom it will be reported so that the prospective participant can make an informed decision about whether they really do want to take part.

It is highly recommended that the information provided is presented on headed paper and is accurate, clear and simple so that someone with a reading age of 8 would understand the contents (use short words, sentences and paragraphs). The information should be specific to the proposed research and appropriate for the social and cultural context in which is it being given. It is important to avoid technical terms, jargon and abbreviations, bias, coercion or any inappropriate inducements.

What should the Participant Information Sheet include:

• A friendly invitation to participate.
• A brief and simple explanation of the purposes of the research and a statement explaining how the participant was chosen and how many other participants will be involved in the study.
• A statement that participation is voluntary; refusal to participate will involve no penalty or loss of benefits to which the participant is otherwise entitled; and the participant may discontinue participation at any time without penalty or loss of benefits.
• A thorough explanation of the expected duration of participation in the research and the procedures to be followed.
• A description of any reasonably foreseeable risks or discomforts and any benefits to the participant. For research involving more than minimal risk, an explanation as to whether any compensation or any medical treatments are available if injury occurs and, if so, what they consist of, or where further information may be obtained.
• A statement describing the extent, if any, to which confidentiality of records identifying the participant will be maintained.
• It is considered good practice for researchers to debrief participants at the conclusion of the research and to provide them with copies of any reports or other publications arising from their participation.
• If appropriate, a statement indicating that the data might be used for additional or subsequent research.
• An explanation of who to contact for answers to pertinent questions about the research and the rights of the participant and who to contact in the event of a research-related injury to the participant.
• If applicable, a statement declaring that each researcher who may have access to children (aged under 18) or vulnerable adults has undergone a satisfactory criminal records check.
• Remember to thank your participant for considering taking part in the study and include a statement indicating that the research study has been approved by the UCL Research Ethics Committee.

Language and layout

It is highly recommended that the information provided is presented on headed paper and is accurate, clear, and simple. The information should be specific to the proposed research and appropriate for the social and cultural context in which is it being given. It is important to avoid technical terms, jargon, and abbreviations, bias, coercion, or any inappropriate inducements.

The following points should be considered when writing an information sheet:

• Use clear, non-technical language. We recommend that you refer to the  Plain English Campaign
• Use appropriate language for the target audience. For example, consider the different ways needed to communicate with primary school children as opposed to their teachers, or people with expertise in the area of study as opposed to people with no such knowledge
• Divide the text into paragraphs for ease of reading
• Consider using sub-headings for clarity, such as questions and answers
• Make sure the font and font size are legible.

Ask someone else to review your information sheet before it is circulated.

• Template Participant Information Sheet  (Word)
• Template Consent Form  (Word)
• Guidance on obtaining consent from research participants online (for online and in-person study designs)

Authors: Dr Pippa Lally, Behavioural Science and Health, and Jack Hindley, Information Services Division, UCL

• Recording & Obtaining Consent

UCL Research Ethics Committee Guidance Note 2: Extract from Nuffield Council on Bioethics website

Page last updated: April 2023

Sample Consent Forms

Consent form templates.

These consent form templates have been posted for your reference.  When completing and IRB submission in IRBIS, please fill in the application and use the consent form builder specific to your project.  For more information, please find instructions here .

Summary of Changes to the Regulations for Informed Consent:  Revised Common Rule Changes to Informed Consent and Waiver Requirements

Summary of Changes to Consent Documents:

• Informed Consent Documents – Version 2.0 Summary of Changes
• Informed Consent Documents – Version 2.1 Summary of Changes
• Informed Consent Documents – 10/26/2020 Summary of Changes
• Informed Consent Documents – 4/10/2023 Summary of Changes

Concise Summary examples can be found here .

Guidance on the use of plain language in consent forms:

• Clinical Research Glossary
• Webinar: The Promise of Plain Language: Launching a Glossary to Support Participant Understanding of Clinical Research – Recording & Slides

There are a few additional forms that are not provided online and may be accessed below.  As needed, these should be completed and uploaded to your IRB application.

Foreign Language Consent Forms

COVID-19 Related Forms:

• Spanish-IRB-COVID Information Sheet
• Spanish COVID Consent Letter v2
• Spanish COVID Informational Sheet Translation Certificate

Informed Consent Short Form (for a single subject who may be illiterate, or otherwise unable to read the consent form — used when full consent form has to be read or translated for subject).

• Informed Consent Short Form Guidance
• Simplified Chinese

HIPAA Templates

• Sample HIPAA Authorization Template
• Sample HIPAA Authorization Template in Spanish ( Certification )

Understanding Informed Consent Forms

The informed consent form puts you in control of your health decisions and protects your rights.

Before you join a cancer research study, you’ll receive an informed consent form to review, ask questions about, and sign. The form covers a description of the study’s purpose, procedures and safety measures researchers will follow, and what is expected of study participants. 

The form is part of the informed consent process. This process protects your rights. It also gives you control over your choice to take part in research.

Federal law requires that researchers give the informed consent form to potential participants. You will have a chance to ask questions about information you read in the form. Once you understand the study, you can choose if you want to sign the consent form and take part.

Getting comfortable with informed consent forms

Understanding a consent form is an important part of the informed consent process. All informed consent forms are different. But most forms will have the same kinds of information about the study divided into sections.  

Overview of study This section tells you: 

• what question researchers are hoping to answer with the study 
• the main potential risks and benefits of taking part in the study 
• your responsibilities as a participant  



The overview also describes the choices you have if you do not take part in the study. And it explains the reasons you might leave the study early. This section also lets you know that taking part is voluntary and you may leave the study at any time.

Study design This section describes:

• each study group
• what each group will be asked to do, including tests and procedures you will have and drugs you will take
• how many people will be in each group
• how long the study will last

Risks and benefits This section describes:

• all known potential risks and benefits of taking part in the study 
• the most common side effects
• how the study will help doctors learn about your disease

Cost This section explains the costs of taking part in a study. Insurance and the study sponsor should cover some expenses. But you might have others, such as the cost of travel to the trial site. Learn more about who pays for clinical trials .

Safety and Clinical Trials

Explore the many safety measures in place to help keep you safe during a trial or study.

Your rights This section covers your rights:

• if you are injured because of the study or neglect 
• to privacy when it comes to sharing your medical information 
• to leave the study at any time

How to get more information on the study This section provides ways to:

• learn more about the study
• learn more about your rights as a participant
• reach the study team

Signature As with most legal documents, informed consent forms require a signature. But it’s important to remember that you are not signing away your rights or binding yourself to the study. You may still leave the study at any time. If a participant is under 18 years of age, read about the children’s assent process . 

Sample informed consent form

Read a sample consent form to become familiar with the content and sections. Note: this form is for informational purposes only and does not represent a real study. Your form may have other sections, and may present the information in a different way.

Tips for reading informed consent forms

Amy Rose oversees the day-to-day operations of clinical research, including the informed consent process for potential research participants. She is the associate director in Clinical Research Services at University of Pittsburgh Medical Center Hillman Cancer Center.

If you are thinking about taking part in a clinical trial, Amy suggests that you: 

• Bring a friend or relative to the appointment when your study team discusses the study and informed consent form. 
• Take the form home . Read it in a comfortable place, take notes, and jot down questions for your doctor or study team. “You can highlight things and write down questions right on the consent form,” Amy said.  
• Ask a close friend or spouse to read the form so you can discuss it with them. Have them take notes too, and compare your understanding. Reviewing it with your primary care provider can also be helpful, Amy said. 
• Don’t be afraid to ask questions . Amy said she and other medical professionals don’t always realize when they aren’t explaining things clearly. They may be in a rush or too steeped in the language of medicine. 
• You can decide not to take part before or after you sign the form. “We always tell people their participation is completely voluntary,” Amy said. “You do not have to continue just because you sign this consent today.” 

The informed consent process does not end when you sign a form and decide to take part. Your doctor and study team will keep you updated about the study so you can continue to make informed decisions. 

Have questions about informed consent?

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Home » Informed Consent in Research – Types, Templates and Examples

Informed Consent in Research – Types, Templates and Examples

Table of Contents

Informed Consent in Research

Informed consent is a process of communication between a researcher and a potential participant in which the researcher provides adequate information about the study, its risks and benefits, and the participant voluntarily agrees to participate. It is a cornerstone of ethical research involving human subjects and is intended to protect the rights and welfare of participants.

Types of Informed Consent in Research

There are different types of informed consent in research , which may vary depending on the nature of the study, the type of participants, and the context. Some of the common types of informed consent in research include:

Written Consent

This is the most common type of informed consent, where participants are provided with a written document that explains the study and its requirements. The document typically includes information about the purpose of the study, procedures involved, risks and benefits, confidentiality, and participant rights. Participants are asked to sign the document as an indication of their willingness to participate.

Oral Consent

In some cases, oral consent may be used when a written document is not practical or feasible. Oral consent involves explaining the study and its requirements to participants verbally and obtaining their consent. This method may be used for studies with illiterate or visually impaired participants or when conducting research remotely.

Implied Consent

Implied consent is used in studies where participants’ actions are taken as an indication of their willingness to participate. For example, a participant may be considered to have given implied consent if they show up for a scheduled appointment for the study.

Opt-out Consent

This method is used when participants are given the opportunity to decline participation in a study. Participants are provided with information about the study and are given the option to opt-out if they do not wish to participate. This method is commonly used in population-based studies or surveys.

Assent is used in studies involving minors or participants who are unable to provide informed consent due to cognitive impairment or disability. Assent involves obtaining the agreement of the participant to participate in the study, along with the consent of a legally authorized representative.

Informed Consent Format in Research

Here’s a basic format for informed consent that can be customized for specific research studies:

• Introduction : Begin by introducing yourself and the purpose of the study. Clearly state that participation is voluntary and that participants can withdraw at any time without penalty.
• Study Overview : Provide a brief overview of the study, including its purpose, methods, and expected outcomes.
• Procedures : Describe the procedures involved in the study in clear, concise language. Include information about the types of data that will be collected, how they will be collected, and how long the study will take.
• Risks and Benefits : Outline the potential risks and benefits of participating in the study. Be honest and upfront about any discomfort, inconvenience, or potential harm that may be involved, as well as any potential benefits.
• Confidentiality and Privacy : Explain how participant data will be collected, stored, and used, and what measures will be taken to ensure confidentiality and privacy.
• Voluntary Participation: Emphasize that participation is voluntary and that participants can withdraw at any time without penalty. Explain how to withdraw from the study and who to contact if participants have questions or concerns.
• Compensation and Incentives: If applicable, explain any compensation or incentives that will be offered to participants for their participation.
• Contact Information: Provide contact information for the researcher or a representative from the research team who can answer questions and address concerns.
• Signature : Ask participants to sign and date the consent form to indicate their voluntary agreement to participate in the study.

Informed Consent Templates in Research

Here is an example of an informed consent template that can be used in research studies:

Introduction

You are being invited to participate in a research study. Before you decide whether or not to participate, it is important for you to understand why the research is being done, what your participation will involve, and what risks and benefits may be associated with your participation.

Purpose of the Study

The purpose of this study is [insert purpose of study].

If you agree to participate, you will be asked to [insert procedures involved in the study].

Risks and Benefits

There are several potential risks and benefits associated with participation in this study. Some of the risks include [insert potential risks of participation]. Some of the benefits include [insert potential benefits of participation].

Confidentiality

Your participation in this study will be kept confidential to the extent allowed by law. All data collected during the study will be stored in a secure location and only accessed by authorized personnel. Your name and other identifying information will not be included in any reports or publications resulting from this study.

Voluntary Participation

Your participation in this study is completely voluntary. You have the right to withdraw from the study at any time without penalty. If you choose not to participate or if you withdraw from the study, there will be no negative consequences.

Contact Information

If you have any questions or concerns about the study, you can contact the investigator(s) at [insert contact information]. If you have questions about your rights as a research participant, you may contact [insert name of institutional review board and contact information].

Statement of Consent

By signing below, you acknowledge that you have read and understood the information provided in this consent form and that you freely and voluntarily consent to participate in this study.

Participant Signature: _____________________________________ Date: _____________

Investigator Signature: ____________________________________ Date: _____________

Examples of Informed Consent in Research

Here’s an example of informed consent in research:

Title : The Effects of Yoga on Stress and anxiety levels in college students

Introduction :

We are conducting a research study to investigate the effects of yoga on stress and anxiety levels in college students. We are inviting you to participate in this study.

If you agree to participate, you will be asked to attend four yoga classes per week for six weeks. Before and after the six-week period, you will be asked to complete surveys about your stress and anxiety levels. Additionally, we will measure your heart rate variability at the beginning and end of the six-week period.

Risks and Benefits:

There are no known risks associated with participating in this study. However, the benefits of practicing yoga may include decreased stress and anxiety levels, increased flexibility and strength, and improved overall well-being.

Confidentiality:

All information collected during this study will be kept strictly confidential. Your name will not be used in any reports or publications resulting from this study.

Voluntary Participation:

Participation in this study is completely voluntary. You are free to withdraw from the study at any time without penalty.

Contact Information:

If you have any questions or concerns about this study, you may contact the principal investigator at (phone number/email address).

By signing this form, I acknowledge that I have read and understood the above information and agree to participate in this study.

Participant Signature: ___________________________

Date: ___________________________

Researcher Signature: ___________________________

Importance of Informed Consent in Research

Here are some reasons why informed consent is important in research:

• Protection of participants’ rights : Informed consent ensures that participants understand the nature and purpose of the research, the risks and benefits of participating, and their rights as participants. It empowers them to make an informed decision about whether to participate or not.
• Ethical responsibility : Researchers have an ethical responsibility to respect the autonomy of participants and to protect them from harm. Informed consent is a crucial way to uphold these principles.
• Legality : Informed consent is a legal requirement in most countries. It is necessary to protect researchers from legal liability and to ensure that research is conducted in accordance with ethical standards.
• Trust : Informed consent helps build trust between researchers and participants. When participants understand the research process and their role in it, they are more likely to trust the researchers and the study.
• Quality of research : Informed consent ensures that participants are fully informed about the research and its purpose, which can lead to more accurate and reliable data. This, in turn, can improve the quality of research outcomes.

Purpose of Informed Consent in Research

Informed consent is a critical component of research ethics, and it serves several important purposes, including:

• Respect for autonomy: Informed consent respects an individual’s right to make decisions about their own health and well-being. It recognizes that individuals have the right to choose whether or not to participate in research, based on their own values, beliefs, and preferences.
• Protection of participants : Informed consent helps protect research participants from potential harm or risks that may arise from their involvement in a study. By providing participants with information about the study, its risks and benefits, and their rights, they are able to make an informed decision about whether to participate.
• Transparency: Informed consent promotes transparency in the research process. It ensures that participants are fully informed about the research, including its purpose, methods, and potential outcomes, which helps to build trust between researchers and participants.
• Legal and ethical requirements: Informed consent is a legal and ethical requirement in most research studies. It ensures that researchers obtain voluntary and informed agreement from participants to participate in the study, which helps to protect the rights and welfare of research participants.

Advantages of Informed Consent in Research

The advantages of informed consent in research are numerous, and some of the most significant benefits include:

• Protecting participants’ autonomy: Informed consent allows participants to exercise their right to self-determination and make decisions about whether to participate in a study or not. It also ensures that participants are fully informed about the risks, benefits, and implications of participating in the study.
• Promoting transparency and trust: Informed consent helps build trust between researchers and participants by providing clear and accurate information about the study’s purpose, procedures, and potential outcomes. This transparency promotes open communication and a positive research experience for all parties involved.
• Reducing the risk of harm: Informed consent ensures that participants are fully aware of any potential risks or side effects associated with the study. This knowledge enables them to make informed decisions about their participation and reduces the likelihood of harm or negative consequences.
• Ensuring ethical standards are met : Informed consent is a fundamental ethical requirement for conducting research involving human participants. By obtaining informed consent, researchers demonstrate their commitment to upholding ethical principles and standards in their research practices.
• Facilitating future research : Informed consent enables researchers to collect high-quality data that can be used for future research purposes. It also allows participants to make an informed decision about whether they are willing to participate in future studies.

About the author

Muhammad Hassan

Researcher, Academic Writer, Web developer

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Informed Consent and Consent Forms for Research Participants

Informed consent is a communication process by which researchers reach agreement with people about whether they wish to participate in research. Confusing informed consent with a signed consent form may violate the ethical intent of informed consent, which is to communicate clearly and respectfully, to foster trust, comprehension, and good decision making, and to ensure that participation is voluntary.

Consent forms are often written in “legalese” and are long, complex, and often inappropriate to the culture or language of the potential subject, insulting, and virtually impossible for most people to comprehend. They convey to some the impression that signing such a formal-looking document commits them to participation. Among subjects who willingly sign documents, most sign the consent form without reading it.

How has this come to pass? Early concern with ethics of human research was about biomedical research and focused on the necessity of obtaining informed consent. Over the decades, the elements of informed consent have grown in number, as has the idea that informed consent is a form that is to be signed by the subject. According to the Federal Regulation of Human Research 46.117(a):

Except as provided in paragraph (c) of this section, informed consent shall be documented by the use of a written consent form approved by the IRB and signed by the subject or the subject’s legally authorized representative. A copy shall be given to the person signing the form.

However, many researchers and the Institutional Review Boards that govern their research fail to recognize that 46.117(c) provides for a waiver of signed consent forms:

(c) An IRB may waive the requirement for the investigator to obtain a signed consent form for some or all subjects if it finds either: (1) That the only record linking the subject and the research would be the consent document and the principal risk would be potential harm resulting from a breach of confidentiality. Each subject will be asked whether the subject wants documentation linking the subject with the research, and the subject’s wishes will govern, or (2) That the research presents no more than minimal risk of harm to subjects and involves no procedures for which written consent is normally required outside of the research context.

The reason for obtaining a signed consent form has always been much more to protect the researcher and the institution than to serve the interests of the research subject. In case the subject claims later that consent was inadequate or omitted, the researcher can counter by showing the form. Recently, the Office of Human Research Protection has imposed highly publicized and costly sanctions against a few research institutions. Understandably, IRBs and research administrators consider it in their self-interest to make highly conservative decisions. Since IRBs must take steps to justify waiving documentation of informed consent by deeming the research to be minimal risk, many consider it safer not to do so, fearing that such an action might leave them open to questions by the OHRP. Thus, the reason for obtaining a signed consent form is typically to protect the institution, not the subject. Researchers, science, institutions, subjects, and IRBs would all be better off if they made intelligent interpretations of the requirements of the Common Rule.

The Social and Behavioral Sciences Working Group has made various recommendations based on the Common Rule, designed to guide social and behavioral researchers and IRBs out of such conundrums. The authors, both members of the Working Group, developed recommendations concerning informed consent, some of which are summarized here:

1. Informed consent should take the form of an open, easily understood communication process. Typically, this means a friendly verbal exchange between researcher and subject, with a written summary of the information for the subject to keep, as appropriate. (The copy for the subject to keep would be inappropriate if the written record of the subject’s participation could be damaging to the subject, as when the research is about domestic violence, or illegal behavior). Both the verbal and written discussion should be brief, and simply phrased at such a level that all of the subjects can understand it.

2. Subjects must receive enough easily understood, accurate information to judge whether the risk or inconvenience involved is at a level they can accept. The responsibility rests with the investigator to describe any risks accurately and understandably. There are many kinds of minor or everyday risks or inconveniences that most persons would gladly undertake if it were their choice to do so, but which they would not wish to have imposed upon them unilaterally. However, some may make a rational decision that the experience would be too stressful, risky, or unpleasant for some idiosyncratic reason that applies to them and not to other subjects.

3. Especially when the research procedure is long and complex, the researcher must make it quite clear that the subject is free to ask questions at any time. Informed consent, as a conversation (not a form), needs to be available throughout the research, as subjects do not necessarily develop questions or concerns about their participation until they are well into the research experience. For example, a discussion of confidentiality may not capture subjects’ attention or comprehension until they are asked some quite personal questions in the ensuing research experience.

4. When subjects can readily refuse to participate by hanging up the phone or tossing out a mailed survey, the informed consent can be extremely brief (a sentence or two). Courtesy and professionalism require that the identity of the researcher and research institution be mentioned, along with the nature and purpose of the research. However, if there are no risks, benefits, or confidentiality issues involved, these topics and the right to refuse to participate need not be mentioned, as such details would be gratuitous and might decrease participation by implying greater risk that actually exists. If the researcher has any connection with the institution at which the subjects receive health care or other essential services, it is necessary to mention the right of the research subject to refuse or withdraw without prejudice. Such rights may be honored implicitly by making it clear that you are asking their permission to involve them as research subjects.

5. Verbal informed consent need not be detailed and written consent is not appropriate when the research is not concerned with sensitive personal information and when subjects are peers or superiors of the researcher.

6. The cultural norms and life-styles of subjects should be considered when deciding how to approach informed consent. For example, research on homeless injection drug users should probably be preceded by a several week-long process of “hanging out” and talking with them. The resulting informal communication will raise issues they wish to discuss with the researcher. The conditions under which the research is conducted can then be negotiated orally between the researcher and the community members, as appropriate. Written documents and signed forms would expose subjects to risk of arrest and serve no redeeming purpose.

7. A wide range of media are appropriate for administering informed consent. Video tapes, brochures, group discussions, web sites, community newsletters, and the “grape vine” can be more appropriate ways of communicating with potential subjects than the potentially confusing formal consent forms that often are used.

8. When written or signed consent places subjects at risk, it must be waived. There are times when the written record is the only evidence that the subject has participated in a study in which there is acknowledgement or appearance of situations that would place the subject at risk.

9. When it is important to have some record of the informed consent but when written or signed consent would place the subject at risk or be difficult for the subject to read, one useful procedure is to have a trusted colleague witness the verbal consent.

10. Community consultation, or meeting with community leaders of the potential subjects, is a useful way to plan research that is likely to raise sensitive questions among those to be studied and members of their community. This is not a substitute for individual informed consent, but often clears the way for potential subjects to be ready to decide whether to participate.

11. In certain circumstances, persons are not in a position to decide whether to consent until immediately after their participation, e.g., in brief sidewalk interviews, which persons are likely to welcome.

12. Some research cannot validly be conducted if all details are disclosed at the outset. The alternatives to outright deception of subjects are to a) obtain permission to provide only a description of what the subject will experience, with an agreement that the full details of the study will be disclosed afterward; b) obtain permission to engage in concealment or deception with the understanding that pilot research has shown that peers of the subject do not find such concealment or deception objectionable and that a full explanation will follow their participation, c) explain that the subject might be enrolled in one of several possible conditions and to gain permission to disclose in which of these the subject was actually enrolled after his or her participation is completed.

Author’s Note: The Social and Behavioral Sciences Working Group (formerly a part of the National Human Research Protections Advisory Council but now an independent body) chaired by Felice Levine helped to develop these ideas.

Reference Melton, G., Levine, R. J., Koocher, G., Rosethal, R., & Thompson, W. (1988). Community Consultation in Socially Sensitive Research: Lessons from Clinical Trials on Treatments for AIDS. American Psychologist , 43, 573-581.

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About the Authors

Joan Sieber is professor of psychology at California State University, Hayward. She received her bachelor's, master's, and doctorate from the University of Delaware. Robert J. Levine is professor of medicine and co-chair of the interdisciplinary bioethics project at Yale University. He is also the founding editor of IRB: A Review of Human Subjects Research.

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Sample Informed Consent Form (HERB)

  Informed Consent Form

The Department of Psychology at Wagner College supports the practice of protection of human participants in research.  The following will provide you with information about the experiment that will help you in deciding whether or not you wish to participate.  If you agree to participate, please be aware that you are free to withdraw at any point throughout the duration of the experiment without any penalty [Note: the penalty statement is only appropriate for students] .

In this study we will ask you to __________________ * .  If you have any [ insert reason why they should not participate if applicable ], please inform the experimenter and the study will end now.  All information you provide will remain confidential and will not be associated with your name.  If for any reason during this study you do not feel comfortable, you may leave the laboratory and receive credit for the time you participated and your information will be discarded.  Your participation in this study will require approximately _____ minutes.  When this study is complete you will be provided with the results of the experiment if you request them, and you will be free to ask any questions.  If you have any further questions concerning this study please feel free to contact us through phone or email: RESEARCHER NAME at NAME@wagner.edu (718-) or SUPERVISOR NAME at NAME@wagner.edu (718-).  Please indicate with your signature on the space below that you understand your rights and agree to participate in the experiment.

Your participation is solicited, yet strictly voluntary.  All information will be kept confidential and your name will not be associated with any research findings.    ______________________________                                    _______________________________             Signature of Participant                                                 NAME, Investigator

  ______________________________                     Print Name ------------------------------------- PLEASE NOTE: If your participants cannot legally give consent (those under 18, for example), the form must be addressed to the parent or guardian.

*If you are asking the participant to read something, view something, reveal personal information, eat something, taste/smell something, you must inform them.  You must warn participants if it is possible something you ask them to read or view may be offensive or explicit.  Please describe how long (approximately) the procedure will take.   Potential participants must be able to make an informed consent to participate! **If your consent form is more than one page long, be sure to number the pages in the manner shown below with a space for the participant to initial each page (so they it can be confirmed that they read each page). example: "page 1 of 4 _____" for the first page of a four-page form.

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• v.14(2); 2018 Jun

How to obtain informed consent for research

1 University of Messina, “G. Martino” Hospital, Messina, Italy

Amelia Licari

2 University of Pavia, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy

Current biomedical research on human subjects requires clinical trial, which is defined as “any research study that prospectively assigns human participants or groups of humans to one or more health-related interventions [ i.e. drugs, cells or other biological products, surgical procedures, devices] to evaluate the effects on health outcomes” [1]. In our modern ethical conception, all research conducted on humans must be pre-emptively accepted by the subjects themselves through the procedure known as informed consent, which is a process by which “a subject voluntarily confirms his or her willingness to participate in a particular trial, after having been informed of all aspects of the trial that are relevant to the subject’s decision to participate”, as stated in the International Council for Harmonisation Good Clinical Practice guidelines [2]. Informed consent is documented by means of a written, signed and dated informed consent form. This form is required in the following cases: 1) when the research involves patients, children, incompetent/incapacitated persons, healthy volunteers, immigrants or others ( e.g. prisoners); 2) when the research uses/collects human genetic material, biological samples or personal data [3].

Short abstract

The process of obtaining informed consent for clinical trials is tightly regulated; complications arise in circumstances when consent may be waived, or when needed from vulnerable populations http://ow.ly/rEMe30j5MVq

Current biomedical research on human subjects requires clinical trial, which is defined as “any research study that prospectively assigns human participants or groups of humans to one or more health-related interventions [ i.e. drugs, cells or other biological products, surgical procedures, devices] to evaluate the effects on health outcomes” [ 1 ]. In our modern ethical conception, all research conducted on humans must be pre-emptively accepted by the subjects themselves through the procedure known as informed consent, which is a process by which “a subject voluntarily confirms his or her willingness to participate in a particular trial, after having been informed of all aspects of the trial that are relevant to the subject’s decision to participate”, as stated in the International Council for Harmonisation Good Clinical Practice guidelines [ 2 ]. Informed consent is documented by means of a written, signed and dated informed consent form. This form is required in the following cases: 1) when the research involves patients, children, incompetent/incapacitated persons, healthy volunteers, immigrants or others ( e.g. prisoners); 2) when the research uses/collects human genetic material, biological samples or personal data [ 3 ].

The informed consent form must be written in language easily understood by the subjects, it must minimise the possibility of coercion or undue influence, and the subject must be given sufficient time to consider participation. However, informed consent is not merely a form that is signed, but is a process in which the subject has an understanding of the research and its risks, and it is tightly described in ethical codes and regulations for human subject research [ 2 ].

Educational aims

• To provide a comprehensive overview of issues in obtaining informed consent in clinical research.
• To describe the process of obtaining informed consent in clinical trials.
• To highlight the circumstances under which informed consent can be waived.
• To review the setting of obtaining informed consent from “vulnerable populations”.

The informed consent process

The voluntary expression of the consent by a competent subject and the adequate information disclosure about the research are critical and essential elements of the informed consent process [ 4 ]. Competent subjects able to comprehend the research-related information should personally decide and provide the consent on research participation. Conditions posing practical challenges in obtaining informed consent from the real subject may include situations of medical emergency or obtaining consent from “vulnerable” subjects and/or children [ 5 ].

Research-related information must be presented to enable people to voluntarily decide whether or not to participate as a research subject. For an ethically valid consent, information provided to a research subject should include, but not be limited to: information about the health condition for which the research is proposed; details of the nature and purpose of the research; the expected duration of the subject’s participation; a detailed description of study treatment or intervention and of any experimental procedures (including, in the case of randomised clinical trials (RCTs), also blinding and randomisation); a statement that participation in research is voluntary; probable risks and benefits associated with research participation; details of the nature of the illness and possible outcome if the condition is left untreated; availability, risks and benefits of alternative treatments; information about procedures adopted for ensuring data protection/confidentiality/privacy, including duration of storage of personal data; details about the handling of any incidental findings of the research; description of any planned genetic tests; details of insurance coverage in case of injury; reference contacts for any further answers to pertinent questions about the research and the subject’s rights and in case of any research-related injury to the subject; and any other information that seems necessary for an informed decision to be taken by the subject. Of particular importance, a statement offering the subject the opportunity to withdraw at any time from the research without consequences must be provided during the information disclosure [ 2 ]. Specific information should be provided in case of research projects involving children, incapacitated adults not able to give informed consent, illiterate populations, etc. (as will be described later in this article).

The information about the research should be given by a physician or by other individuals ( i.e.  researchers) with appropriate scientific training and qualifications [ 6 ]. Furthermore, the location where the informed consent is being discussed, and the subject’s physical, emotional and psychological capability, must be taken into consideration when taking consent from a human subject.

Informed consent: when is it not necessary?

After institutional review board (IRB) or independent ethics committee approval is achieved, obtaining informed consent from each human subject prior to his/her participation in clinical trial is mandatory [ 5 ]. However, when specific circumstances occur, the informed consent can be waived, and “research without consent” is possible, which allows enrolment of patients without their consent, under strict regulation [ 7 ]. In order that research without consent is considered justifiable, the following three conditions have to be met: 1) it is impracticable to obtain consent, 2) the research does not infringe the principle of self-determination, and 3) the research provides significant clinical relevance [ 8 ].

The first condition, of “impracticability”, occurs when obtaining informed consent is burdened by high impact in terms of time and economic resources or could compromise the study’s validity [ 8 ]. The second condition means that, although physicians are requested to ensure that the patient has understood the aim of the research and the risks and/or benefits associated with study participation, the researchers are also advised to respect the patient’s decision-making capacity, not interfering with his/her decisions and acting always in the patient’s best interest [ 9 ]. The third condition leads to justification of waiving consent when the clinical relevance and public health importance are potentially high [ 8 ].

The formal literature identifies different types of RCTs and classifies them into three macro-areas: 1) RCTs based on infeasibility of informed consent; 2) RCTs that omit informed consent only for control groups; and 3) RCTs that omit informed consent entirely.

RCTs based on infeasibility of informed consent

Emergency clinical studies, involving critically ill subjects, represent an exception to the requirement of informed consent. The investigated life-saving therapy and the medical intervention may be required immediately, not permitting the researchers to wait and respect all procedures of obtaining informed consent. Within this context, the researchers will be able to proceed with patient recruitment, also without the subject’s consent to treatment, when, prior to the study, the IRB has ascertained the presence of mandatory conditions ( table 1 ) [ 10 ].

Table 1

Conditions to be met in emergency clinical study

Cluster randomised studies include cluster-cluster and individual-cluster research [ 11 ]. In cluster-cluster designs ( e.g. studies on infectious disease prevention), the intervention involves the entire target community, so that single subjects cannot refuse it [ 12 ]. Conversely, in individual-cluster designs ( e.g. studies on primary care), although the intervention involves all the selected community, the right to refuse treatment is allowed. Under this circumstance, the omission of informed consent is justified only when the treatment refusal undermines the validity of the research study and/or procedures [ 13 ].

RCTs that omit informed consent only for control groups

In Zelen’s single-consent model ( e.g. RCTs in infectious or oncological diseases), randomisation occurs prior to any consent, and informed consent is sought only from individuals assigned to experimental treatment [ 14 ]. In the control group, the physicians do not make substantial changes in routine patient care, so informed consent is not required for patient enrolment [ 8 ].

In order to improve study recruitment, Zelen developed the double-consent design. Specifically, informed consent is requested for subjects to be involved in the study but not for the randomisation, preventing psychological distress [ 14 ].

In follow-up studies, the nested consent model ( e.g. for single cohort studies) or cohort multiple RCTs model ( e.g. for multiple cohort studies) is applied. In these variants, patients give their consent for prospective follow-up; however, they remain blinded to any randomised experimental interventions [ 15 ].

In trials using the model of “consent to postponed information”, the informed consent process is carried out after the study is completed [ 16 ].

All these RCT types aim to avoid unnecessary stress in patients who will not receive the new promising experimental treatment. Moreover, these clinical study designs do not affect the standard therapeutic approach or infringe the rights of the patients in the control group; therefore, the clinical trial can proceed without obtaining informed consent [ 8 ].

RCTs that omit informed consent entirely

Based on the fact that patients are assigned to standard care interventions, no informed consent is sought either in low-risk pragmatic RCTs [ 17 ] or in prompted optional randomisation trials [ 18 , 19 ]. However, in a low-risk pragmatic RCT, patients do not have the possibility to choose one of the two standard treatments, whereas in a prompted optional randomisation trial, both the researchers and the enrolled patients can choose one type of treatment over another, despite the randomisation results [ 6 ].

Special needs: vulnerable patients

A “vulnerable population” is defined as a disadvantaged community subgroup unable to make informed choices, protect themselves from inherent or intended risks, or keep their own interests safeguarded [ 20 ]. In the health domain, “vulnerable populations” refers to physical vulnerability ( e.g. pregnant women, fetuses, children, orphans, students, employees, prisoners, the military, and those who are chronically or terminally ill), psychological vulnerability (cognitively and intellectually impaired individuals) and social vulnerability (those who are homeless, from ethnic minorities, are immigrants or refugees) [ 20 ].

Due to a compromised free will and inability to make conscious decisions, several ethical dilemmas (related to communications, privacy and treatment) often arise when research involves these populations. Guaranteeing protection of rights, safety, data privacy and confidentiality of vulnerable subjects are prerogatives of good clinical practice, and law dispositions are regulated and strictly monitored by the applicable authorities [ 21 ].

Physical vulnerability

For a long time, pregnant women were excluded from clinical research because of their “vulnerability”. Although pregnant women are able to make informed and conscious choices, they have been considered “vulnerable” due to the potential risks to the fetus, who is also considered as a “patient” [ 22 ]. More recently, with the consideration of pregnant women as “scientifically complex” rather than “vulnerable” subjects, it has been permitted to involve this category in research trials [ 23 ]. The “scientific complexity” reflects both ethical and physiological complexity. The ethical aspects are secondary to the need to find a balance between interests of the fetus and the mother. The physiological aspects are strictly related to the pregnancy status [ 24 ].

Research studies involving pregnant women and fetuses have to satisfy specific federal regulations ( table 2 ). The following appropriate precautions should be taken in research studies involving pregnant women: no pregnant woman may be involved as a subject in a human clinical research project unless the purpose of the research is to meet the health needs of the mother and the fetus will be placed at risk only to the minimum extent necessary to meet such needs, or the risk to the fetus is minimal [ 25 ].

Table 2

Conditions to be met in research studies involving pregnant women and fetuses

Researchers can enrol pregnant women only when the mother and/or the father are legally competent. In fact, the consent to participate in research may be either self-directed (only the mother’s consent is required) or made with the guidance of the woman’s partner. However, the father’s consent need not be obtained when: 1) the research activity is directed to the health needs of the mother; 2) the father’s identity is doubtful; 3) the father is absent; or 4) a pregnancy from rape has occurred [ 26 ]. The consent signature requirements from the mother and father are summarised in table 3 . Once the informed consent is obtained, the pregnant women will be included into any phase of the study unless the research project will be compromised or the patient’s health (mother and/or fetus) will be in danger.

Table 3

Consent signature requirements for pregnant women and children

# : consent requirements are the same whether the risk is “no more than minimal” or “more than minimal”.

Medical students and employees, who take part in numerous aspects of patient care in primary, secondary and tertiary care settings, are often invited to participate in human studies as volunteers. Frequently, the requesting researcher is their supervisor or instructor, who may push them to participate in the study, which can negatively influence their decision and also violate the consent legitimacy. Therefore, in order to protect these subjects against “coercion” or “undue influence”, when an investigator wishes to recruit medical students or employees, they must first obtain IRB approval for inclusion in the study of these vulnerable subgroups [ 27 ].

Prisoners, defined as any individual involuntarily confined or detained in a penal institution, are considered as “vulnerable” because they may be coerced into study participation, and also, due to both cognitive and psychiatric disorders, they can show an impaired ability to provide voluntary informed consent [ 28 ]. To protect this population, the Office for Human Research Protections has stipulated federal regulations according to which the only studies that may involve prisoners are those with independent and valid reasons for involving them ( table 4 ) [ 25 ].

Table 4

Studies that may involve prisoners

Due to the context of war in which they work, as well as the critical care setting in which they are treated, military subjects often receive medical care and/or participate in biomedical research under an “implied consent” condition. Moreover, the superior–subordinate relationship contributes to favour coercion or undue influence, making this population vulnerable [ 29 ]. To curb this phenomenon and to ensure that participation is truly voluntary, the US Dept of Defense agencies have adopted requirements similar to those that govern medical research that applies to the civilian population. Accordingly, the medical research recruitment session happens in the absence of superiors, and the informed consent is obtained prior to participating in a medical research study. The presence of an ombudsman guarantees and verifies that the participation is voluntary and that the information provided during recruitment is complete, accurate and clear. A payment as an incentive is acceptable but it must not be used to legitimise a coercive interference. Additional protection is provided to students at service academies, especially those aged <18 years. However, when emergency research is conducted or the research study advances the development of a medical product needed by the armed forces, informed consent will not be required [ 29 ].

Psychological vulnerability

Mental disability may compromise the self-determination and decision-making capacities [ 30 ]. Researchers interested in enrolling individuals with cognitive disorders are invited to apply different strategies to promote a better understanding of information-gathering processes. Simplifying the questions and content, adopting supportive technologies, using a more simple language, and spending more time for the information process have been suggested as useful and valid measures. When all these strategies prove to be insufficient, the investigators are required to obtain consent from a legally authorised representative [ 30 ].

Social vulnerability

Similarly to other vulnerable populations, research involving the homeless, ethnic minorities, immigrants and refugees is regulated by laws and specific procedures. Cultural and language differences, “undocumented” migrant status, and the precarious legal positions of these subjects raise several ethical issues, such as whether the participation is truly voluntary, or there are unrealistic expectations, or any benefits for their “status”.

Obtaining informed consent in these groups is extremely complex. A friendly procedure has been identified as the best way to adequately involve these vulnerable groups. A health centre or community building could represent an accessible location. The reimbursement of travel expenses for applicants can be a valid solution to obtain a representative sample for the clinical research. Clear and simple language, emphasising confidentiality, with the help of professional interpreters, can tempt migrants to sign the consent form. Lastly, the possibility of receiving something back in return for their contribution may enable successful enrolment of migrants in research [ 31 ].

Special needs: children

Because of their young age as well as their limited emotional and intellectual abilities, children are considered to be legally incompetent to give valid informed consent; thus, to enrol a child in a research study, the permission by at least one parent or legal representative is mandatory ( table 3 ). For subjects aged <18 years, biological or adoptive parents or legal guardians (persons having both legal capacity and responsibility) can give consent on behalf of their child, exercising free power of choice without any form of coercion. While married mothers and fathers both have parental responsibility, unmarried parents can exert parental responsibility only if they are named individually on the child’s birth certificate. Also, divorced parents maintain parental responsibility, but it is necessary to know to whom the child’s custody has been assigned [ 32 ]. However, on this matter, the European laws and regulations are not harmonised and several discrepancies are present in each country [ 33 ].

Despite potential benefits for the research subjects, the failure of parents to give consent (or their refusal to give consent) is not a rare circumstance [ 34 ]. It can be the case that researchers are dealing with underage parents, so that, although underage parents are responsible for representing their children, as minors themselves they are not considered to be sufficiently mature; therefore, they will be not able to give valid consent. Literacy and socioeconomic levels have been identified as the most common reasons for parental non-response [ 34 ]. Clarity and adequate explanation of research information materials should be part of effective planning to overcome language and social barriers.

In clinical studies in which the adopted methodology constitutes “less than minimal risks” for children, passive parental consent represents a possible way to more easily obtain informed parental consent [ 34 ]. Furthermore, parents can be informed with regard to a possible study involving their children, and, at the time of data collection, only the child’s assent is required. In fact, although the child’s decision-making capacity and understanding of the research project in which he/she will be involved may be limited, the Medical Research Council have shown that, when study details are provided and communicated in a clear and adequate manner, the child can be able to reach a decision and participate consciously in the research [ 35 ]. “Assent” is the term coined to express the child’s willingness to participate in clinical trials despite their young age. The “assent” should include and respect the following key points: 1) helping the child to acquire disease awareness; 2) explaining the potential impact of the experimental treatment; 3) evaluating the child’s ability to understand and adapt to new situations or challenges; and 4) positively influencing the patient’s willingness to participate in clinical trials [ 36 ]. Although the “assent” is not mandatory for research offering a direct benefit for the child, it arises from the need to respect paediatric research subjects [ 37 ]. The evaluation of the capacity to provide the “assent” is based on developmental stage, intellectual abilities and life or disease experience. Usually, the cut-off age of 7 years is used for the beginning of logical thought processes and rational decision making [ 38 ]. However, “assent” for children aged <7 years can be also required once the ability to read and write has been verified [ 32 ]. Figures 1 and ​ and2 2 summarise the parental and assent permission requirements, respectively.

Flow chart of parental permission requirements.

Flow chart of child assent requirements.

When conducting clinical research, the obtaining of informed consent is required. Informed consent is a procedure through which a competent subject, after having received and understood all the research-related information, can voluntarily provide his or her willingness to participate in a clinical trial. However, when it is impracticable to obtain consent, and the research does not infringe the principle of self-determination and also provides significant clinical relevance, the researcher is legally authorised to proceed without informed consent. Furthermore, in order to preserve the self-determination and decision-making rights, specific law dispositions are applied when vulnerable populations are enrolled in clinical trials.

Self-evaluation questions

• a) Diagnosis
• b) Risks and benefits of treatment
• c) Alternatives to treatment
• d) Family’s wishes
• a) When a minor is considered as emancipated
• b) When a patient is found to be incompetent
• c) When immediate treatment is necessary to prevent death or permanent impairment
• d) When the subject is aged >18 years
• a) Minor is married or divorced
• b) Minor on active duty in the US armed forces
• c) Minor is considered self-sufficient by a court
• d) Minor having a son

Suggested answers

• All research conducted on humans must be pre-emptively accepted by the subjects themselves through the procedure known as informed consent.
• Voluntary expression of consent and adequate information disclosure about the research are critical and essential elements of the informed consent process.
• When specific circumstances occur, informed consent can be waived: if it is impracticable to obtain consent, if the research does not infringe the principle of self-determination, and if the research provides significant clinical relevance.
• Participation of vulnerable patients in clinical trials is regulated by specific law dispositions.

Conflict of interest: None declared.

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• The RELIEF feasibility trial: topical lidocaine patches in older adults with rib fractures
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• Madeleine Clout 1 ,
• Nicholas Turner 1 ,
• Clare Clement 2 ,
• Philip Braude 3 ,
• http://orcid.org/0000-0001-6131-0916 Jonathan Benger 4 ,
• James Gagg 5 ,
• Emma Gendall 6 ,
• Simon Holloway 7 ,
• Jenny Ingram 8 ,
• Rebecca Kandiyali 9 ,
• Amanda Lewis 1 ,
• Nick A Maskell 10 ,
• David Shipway 11 ,
• http://orcid.org/0000-0002-6143-0421 Jason E Smith 12 ,
• Jodi Taylor 13 ,
• Alia Darweish Medniuk 14 ,
• http://orcid.org/0000-0002-2064-4618 Edward Carlton 15 , 16
• 1 Population Health Sciences , University of Bristol , Bristol , UK
• 2 University of the West of England , Bristol , UK
• 3 CLARITY (Collaborative Ageing Research) , North Bristol NHS Trust , Westbury on Trym , UK
• 4 Faculty of Health and Life Sciences , University of the West of England , Bristol , UK
• 5 Department of Emergency Medicine , Somerset NHS Foundation Trust , Taunton , UK
• 6 Research and Innovation , Southmead Hospital , Bristol , UK
• 7 Pharmacy Clinical Trials and Research , Southmead Hospital , Bristol , UK
• 8 Bristol Medical School , University of Bristol , Bristol , UK
• 9 Warwick Clinical Trials Unit , Warwick Medical School , Coventry , UK
• 10 Academic Respiratory Unit , University of Bristol , Bristol , UK
• 11 Department of Medicine for Older People, Southmead Hospital , North Bristol NHS Trust , Bristol , UK
• 12 Emergency Department , University Hospitals Plymouth NHS Trust , Plymouth , UK
• 13 Bristol Trials Centre, Population Health Sciences , University of Bristol , Bristol , UK
• 14 Department of Anaesthesia and Pain Medicine , Southmead Hospital , Bristol , UK
• 15 Emergency Department , Southmead Hospital , Bristol , UK
• 16 Department of Emergency Medicine, Translational Health Sciences , University of Bristol , Bristol , UK
• Correspondence to Dr Edward Carlton, Emergency Department, Medicine Translational Health Sciences, Southmead Hospital, Bristol, BS10 5NB, UK; eddcarlton{at}gmail.com

Background Lidocaine patches, applied over rib fractures, may reduce pulmonary complications in older patients. Known barriers to recruiting older patients in emergency settings necessitate a feasibility trial. We aimed to establish whether a definitive randomised controlled trial (RCT) evaluating lidocaine patches in older patients with rib fracture(s) was feasible.

Methods This was a multicentre, parallel-group, open-label, feasibility RCT in seven hospitals in England and Scotland. Patients aged ≥65 years, presenting to ED with traumatic rib fracture(s) requiring hospital admission were randomised to receive up to 3×700 mg lidocaine patches (Ralvo), first applied in ED and then once daily for 72 hours in addition to standard care, or standard care alone. Feasibility outcomes were recruitment, retention and adherence. Clinical end points (pulmonary complications, pain and frailty-specific outcomes) and patient questionnaires were collected to determine feasibility of data collection and inform health economic scoping. Interviews and focus groups with trial participants and clinicians/research staff explored the understanding and acceptability of trial processes.

Results Between October 23, 2021 and October 7, 2022, 206 patients were eligible, of whom 100 (median age 83 years; IQR 74–88) were randomised; 48 to lidocaine patches and 52 to standard care. Pulmonary complications at 30 days were determined in 86% of participants and 83% of expected 30-day questionnaires were returned. Pulmonary complications occurred in 48% of the lidocaine group and 59% in standard care. Pain and some frailty-specific outcomes were not feasible to collect. Staff reported challenges in patient compliance, unfamiliarity with research measures and overwhelming the patients with research procedures.

Conclusion Recruitment of older patients with rib fracture(s) in an emergency setting for the evaluation of lidocaine patches is feasible. Refinement of data collection, with a focus on the collection of pain, frailty-specific outcomes and intervention delivery are needed before progression to a definitive trial.

Trial registration number ISRCTN14813929 .

• feasibility studies
• frail elderly

Data availability statement

Data are available on reasonable request. Further information and patient-facing materials (including model consent forms) are available at https://relief.blogs.bristol.ac.uk/ . Data available on request.

This is an open access article distributed in accordance with the Creative Commons Attribution 4.0 Unported (CC BY 4.0) license, which permits others to copy, redistribute, remix, transform and build upon this work for any purpose, provided the original work is properly cited, a link to the licence is given, and indication of whether changes were made. See:  https://creativecommons.org/licenses/by/4.0/ .

https://doi.org/10.1136/emermed-2024-213905

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WHAT IS ALREADY KNOWN ON THIS TOPIC

Studies have evaluated the use of lidocaine patches in patients with rib fractures showing reductions in opioid use, improvements in pain scores and reductions in length of hospital stay.

Importantly, none has focused on older patients, who stand to gain the most benefit from improved analgesic regimens to reduce adverse pulmonary complications.

WHAT THIS STUDY ADDS

In this feasibility trial, prespecified progression criteria around recruitment, follow-up and adherence were met, demonstrating it is feasible to conduct randomised controlled trials in older patients, who are in pain, in an emergency setting.

There were challenges in data collection for pain and frailty-specific measures, together with treatment crossover, that require consideration in definitive trial design.

HOW THIS STUDY MIGHT AFFECT RESEARCH, PRACTICE OR POLICY

Researchers can adapt study processes to be inclusive of older patients in the emergency setting.

There are challenges in terms of data collection around pain and frailty-specific outcome measures which future research should consider.

Introduction

Rib fractures represent the most common non-spinal fracture in older people. 1 Age ≥65 years remains a predictor of morbidity and mortality in patients with rib fractures. 2 Pain can compromise normal respiratory function, with over 15% of older patients experiencing complications including pneumonia and death. 3

The mainstay for treatment of rib fracture pain remains strong opioid analgesia. However, as a result of poor physiological reserve, older patients are more vulnerable than younger people to the side effects of strong opioid medication such as nausea, constipation, sedation, delirium and respiratory depression. 4 Invasive approaches, such as thoracic epidural anaesthesia, have been used to reduce the likelihood of these side effects, but require specialist anaesthetic support, monitoring in a high-dependency environment and are only used in around 20% of admitted patients. 5 6

Lidocaine patches applied over rib fractures have been suggested as a non-invasive method of local anaesthetic delivery to improve respiratory function, reduce opioid consumption and consequently reduce pulmonary complications. 7 Studies have evaluated the use of lidocaine patches in patients with rib fractures showing reductions in opioid use, 8 improvements in pain scores 9 10 and reductions in length of hospital stay. 11 However, these studies are limited by retrospective design and low patient numbers with consequent bias and low precision. Importantly, none has focused on older patients, who are more susceptible to the development of pulmonary complications, 2 or tested lidocaine patches as an intervention in the ED where opioid analgesia is the mainstay of treatment.

Older people have often been excluded from research, relating to multiple long-term health conditions, social and cultural barriers and potentially impaired capacity to provide informed consent. 12 In addition, recruitment of older patients who are in pain in an emergency setting may pose further challenges around information provision and collection of clinical and patient-reported outcomes.

The aim of this trial was to establish whether a definitive randomised controlled trial (RCT) to evaluate the benefit of lidocaine patches, first applied in the ED, for older people requiring admission to hospital with rib fracture(s) is feasible.

Detailed methods, including detailed consent procedures, are described in full elsewhere. 13

Design, setting and participants

The Randomised Evaluation of topical Lidocaine patches in Elderly patients admitted to hospital with rib Fractures (RELIEF) study was a multicentre, parallel-group, open-label, individually randomised, feasibility RCT, conducted in seven NHS hospitals: five major trauma centres (Southmead Hospital; Royal Infirmary of Edinburgh; Derriford Hospital, Plymouth; Queen Elizabeth University Hospital, Glasgow; St George’s Hospital, London) and two trauma units (Musgrove Park Hospital, Taunton; Royal Devon and Exeter Hospital). The trial included a health economic scoping analysis and an integrated qualitative study. Patients were eligible for recruitment if they were aged ≥65 years, presented at any time after injury with traumatic rib fracture(s) (including multiple fractures, flail chest and traumatic haemothorax/pneumothorax even if this required intercostal chest drainage), confirmed radiologically (by CXR or CT conducted as part of routine care) and required hospital admission for ongoing care. Exclusion criteria are detailed in figure 1 .

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Exclusion criteria.

Randomisation and blinding

Participants were randomised in the ED by trained research or clinical staff, using an online randomisation system, with the randomisation sequence generated by Sealed Envelope (London, UK). Participants were allocated to the intervention or standard care in a 1:1 ratio. Randomisation was stratified by trial site and gender and blocked within strata. Allocations were blinded only to those performing central review of data for the assessment of outcomes.

Intervention

Participants randomised to the intervention received up to 3×700 mg lidocaine patches (Ralvo) at a time applied over the most painful area of rib injury. Patches were first applied in the ED, then once daily for 12 hours in accordance with the manufacturer’s (Grünenthal, Aachen, Germany) instructions. Treatment continued for up to 72 hours or until discharge from hospital. The intervention was additive to standard care (below). If participants subsequently underwent regional anaesthesia, patches were removed and no further patches were applied but data collection continued according to group allocation.

Standard care

All participants received standard local analgesic treatment for patients with rib fractures; this was not controlled for trial purposes. Data were collected on paracetamol, weak opioid, strong opioid and other non-opioid analgesia prescriptions in ED and for the 72-hour intervention period in both arms of the trial. 14

Patient and public involvement

Patient and public involvement was ensured at all stages of trial design, and continued throughout the trial’s lifetime via a patient advisory group and patient representation on the trial steering committees.

Clinical outcomes and measurement

Outcomes were measured at baseline, 72 hours (during or on completion of intervention) and 30-day postrandomisation. A full schedule of clinical data, questionnaires and end points is included in the published protocol. 13 Clinical end points were collected only to understand the feasibility of data collection and not to conduct hypothesis testing. Key clinical data and their measurement are briefly summarised as follows (further details on scales used are provided in the online supplemental material ):

Supplemental material

Demographics, injury details, relevant medical history and Clinical Frailty Scale (CFS) 15 : collected by researcher from clinical notes.

Retrospective pre-injury and baseline post-injury health EQ-5D-5L 16 : completed with participant/relative/carer.

Timed Up and Go test. 17

72 hours postrandomisation (intervention period) collected until discharge if sooner

Patient-reported pain scores: 4-hourly pain assessment using a Visual Analogue Scale (VAS) (scaled from 0 to 100). Recorded in a booklet provided to the patient.

Frailty-specific outcomes: Abbey Pain Scale, 18 4-AT delirium assessment tool, 19 constipation (Bristol Stool Chart), Timed Up and Go test. 17 Obtained by researchers.

Analgesia; ED and inpatient (72 hours) analgesic prescriptions, advanced analgesic provision (patient controlled analgesia (PCA), epidural, nerve block). Obtained by researchers from medical records.

30 days (+10 days) postrandomisation

Pulmonary complications: a priori proposed primary outcome for a definitive trial. Collected after review of medical records and adjudicated by site lead clinician.

Delirium: binary measure of any inpatient episode of delirium recorded in clinical notes.

Resource use: including admitted hospital length of stay, intensive care unit length of stay, unplanned readmission, discharge destination (notes review).

Questionnaires: booklets containing EQ-5D-5L and ICECAP-O 16 20 were sent by post to participants. Participants were permitted to complete these with the assistance of carers, although formal proxy versions of questionnaires were not provided.

Sample size

As this was a feasibility trial, it was not appropriate to calculate a sample size to detect a specified treatment effect size. In line with published ‘rules-of-thumb’, we determined that a total sample size of 100 would be sufficient to provide estimates of feasibility measures (recruitment, retention, data completion and adherence). 21 Recruitment was originally planned to take place over 18 months across three sites. However, trial set-up was delayed due to the COVID-19 pandemic. To achieve target recruitment within the funding period, the recruitment period was shortened to 12 months across seven sites.

Statistical methods

Feasibility measures were analysed and reported following the Consolidated Standards of Reporting Trials guidance extension for feasibility studies to include descriptive and summary statistics both overall and by treatment arm. 22

Descriptive statistics for participant characteristics and clinical outcome data were reported as means or medians with measures of dispersion for continuous outcomes and frequencies and percentages for categorical outcomes.

A priori thresholds for recruitment, follow-up and adherence were established to inform the feasibility of progression (table 2).

Integrated qualitative study

Telephone interviews were undertaken with trial participants around 1 month (and up to 90 days) postrandomisation. Interviews and focus groups were conducted with clinicians/research staff closely involved in the trial set-up, recruitment and follow-up. These explored trial participation experiences including understanding and acceptability of processes, pain control including perceived benefits of lidocaine patches and views on trial outcomes (topic guides are included in the online supplemental material ). Interviews and focus groups were audio-recorded, transcribed and analysed using thematic analysis. 23 Qualitative findings were integrated with other elements using a ‘following a thread’ approach. 24 This involved analysing each dataset and then using insights from the qualitative themes to contextualise and explain quantitative outcomes with data presented together.

Health economic scoping

An evaluation of the feasibility of identifying and measuring health economics outcome data was completed, with the focus on establishing the most appropriate outcome measures for inclusion in a future economic evaluation alongside the definitive trial. The EQ-5D-5L (health-related quality of life) patient-reported questionnaire 16 was completed at baseline, to capture retrospective pre-injury state and baseline post-injury state, and 30 days postrandomisation. In addition to the standard EQ-5D questionnaire, which typically elicits post-injury health status, we additionally assessed pre-injury status by making an approved change to the wording. The ICECAP-O (measure of capability in older people) 20 was also collected at 30 days. Information on key resources, including length of stay, intensive care use and medication prescribing, was also collected.

Between 23 October 2021 and 7 October 2022, 447 patients were assessed for eligibility, of which 206 were eligible; of these, 29 declined and 77 were not approached. Therefore, 100 patients were randomised; 48 participants were allocated to lidocaine patches and 52 to standard care ( figure 2 ). Six participants died prior to the 30-day follow-up timepoint and three participants withdrew from questionnaire completion, but had clinical data retained for analysis. Baseline characteristics were well balanced between groups ( table 1 ).

Screening, recruitment, allocation and follow-up (Consolidated Standards of Reporting Trials diagram).

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Baseline demographics and injury characteristics

Participants were predominantly women (47%), of white British ethnicity (92%), with a median age of 83 years (IQR 74–88). Participants were predominantly admitted from their own homes (92%), were independent (75%) but were living with very mild frailty (median CFS 4; IQR 3–5). The most common mechanism of injury was a fall from <2 m (81%). On average, participants sustained four rib fractures (SD 2.0)and they were at high risk of developing pulmonary complications at baseline (median STUMBL score 21 (IQR 16–33)), equating to a 70% risk. 3

Feasibility outcomes

Table 2 details the prespecified progression criteria around recruitment, follow-up and adherence together with observed results.

Prespecified progression criteria and observed results

Recruitment and consent

An average of 14 participants were recruited per site (range 3–37) in 12 months. Participants were predominately recruited from major trauma centres (n=87).

Agreement to participate was largely obtained from patients (70%): personal consultees (in England) or legal representatives (in Scotland) were approached in 27% of cases, and professional consultees were used in 3% of cases.

In the qualitative research, clinical and research staff closely involved in delivering the trial reported challenges in recruiting within the ED setting. These challenges included general ED pressures, reliance on referrals from wider clinical teams not directly engaged in the research, resource-intensive monitoring of ED attendances for potentially eligible patients, the necessity to rapidly attend ED (when not based in the department) to approach patients and lack of out-of-hours research staff (although some engaged clinicians were able to recruit out of hours). However, they were able to recruit well by raising awareness of the trial and fostering good collaborative relationships with the wider ED clinical team members, who were able to actively participate in patient identification. Insights from older patients were limited due to challenges with interview engagement (of 26 participants approached for interviews, 7 took part, 5 declined, 14 did not respond). However, older patients interviewed welcomed being approached and were willing to participate in the trial because they wanted to help, but were sometimes unsure of trial details. Staff needed to consider older patients’ vulnerability, and carefully manage consent processes to avoid overwhelming them, while ensuring their full understanding of involvement and the option not to participate.

Follow-up and data completeness

The proposed primary outcome of adverse pulmonary complications at 30 days was completed for 86% of participants (data missing in 14%, due to transfer to remote facilities or discharge home and no further records were available). For the 30-day patient-completed questionnaires, in total 71 were returned (fully or partially completed), 15 were unreturned despite repeated contact and 14 had reasons recorded for non-return (7 deaths, 4 remained unwell/confused, 3 withdrawals). This equates to an overall return rate of 71% but rising to 83% when return was anticipated. Qualitative findings regarding questionnaire completion highlighted the unblinded nature of the intervention, with standard care participants not feeling part of the trial, potentially impacting their understanding of completing questionnaires in future research.

Pain and frailty-specific outcomes (important secondary outcomes but not included in prespecified progression criteria) were not feasible to collect as completeness was <65%. Table 3 summarises data completeness on these measures and qualitative exploration of factors influencing data collection.

Pain and frailty-specific outcomes that were not feasible to collect and qualitative exploration of factors influencing data collection

In the intervention arm, 44/48 (92%) participants had at least one lidocaine patch applied in ED at a median time of 393.5 min after arrival. In the standard care arm, 17/52 (33%) participants also had a lidocaine patch applied in ED and were therefore classed as non-adherent. However, overall adherence was 79% meeting the prespecified green criteria for feasibility (>75%). Themes identified in the qualitative research with clinical/research staff addressing variation in care included standard care (some hospitals use patches as standard care, others do not), patch application (eg, where best to place patches in the presence of multiple fractures), provision of nerve blockade (the ongoing use of lidocaine patches when nerve blocks are subsequently used), equipoise (mixed views on the benefits of patches) and patch acceptability (perceived benefits of patches to patients) (see online supplemental material for details).

Clinical outcomes

72-hour outcomes

Data on ED and inpatient (72 hours) analgesic prescriptions, together with advanced analgesic provision (PCA, epidural, nerve blocks) were collected in >75% of participants ( table 4 ) Analgesic prescriptions within ED and as an inpatient were similar between arms. Overall, 33/97 (34%) participants had advanced analgesia with 21/97 (22%) receiving some form of nerve blockade and 12/97 (13%) receiving PCA within the 72-hour intervention period.

30-day outcomes

Overall, 46/86 (53%) participants with complete data met the outcome of composite pulmonary complications within 30 days; 20 (48%) in the lidocaine patch arm and 26 (59%) in the standard care arm. The median length of hospital stay was 9.1 days (IQR 5.2–15.4) and over 30% of participants did not return to their baseline level of function on discharge (requiring increased package of care, residential, nursing or rehabilitation). Descriptive data on all 30-day outcomes is included in table 4 .

We achieved our objectives in terms of piloting instruments of data collection: administration of EQ-5D-5L and ICECAP-O measures and case report forms to record length of stay, use of analgesia and discharge destination ( table 4 ).

As anticipated EQ-VAS at baseline (measuring overall health status with 100 being best imaginable health) were reported as higher pre-injury (median 80 (60–90)) compared with post-injury (median 50 (25–70)). At 30 days, EQ-5D-5L completeness was 44% and ICECAP-O was 65%. In terms of the trajectory of health status, as anticipated the baseline EQ-5D-5L post-injury tariff had the lowest median (0.44 (0.25–0.63)) while at 30 days these data indicated participants had only partially recovered in terms of health status (0.59 (0.27–0.74)) ( table 4 ). The overall median ICECAP-O tariff at 30 days was 0.77, which is slightly below a published population norm of 0.81. 25

This trial suggests it is feasible to recruit older patients with rib fracture(s) in an emergency setting. Consent processes modified for older patients were effective and acceptable to patients and carers. However, pain and frailty-specific outcomes were not feasible to collect. While these were not anticipated primary outcomes for a future trial, they are clearly important secondary outcomes in this population. Our qualitative work highlighted areas for improvement in this regard. These include bespoke training for researchers when unfamiliar with measures (Abbey Pain Scale, 4-AT delirium assessment tool), embedding measures such as 4-AT delirium assessment tool into clinical practice and increased recognition of the potential to overwhelm older injured patients through research procedures when designing trials. It should be noted that the World Hip Trauma Evaluation platform study appears to have overcome many of these barriers to data collection in a similar population. 26

Data collection for the suggested primary outcome of a definitive trial (adverse pulmonary complications) was feasible, and the high rates of this outcome within the population confirm that it remains a target outcome for early analgesic interventions in older patients with rib fracture(s).

Paper-based, mailed out, patient-completed questionnaires were returned at high rates, suggesting that this remains an acceptable option for older participants in research. This aligns with consensus recommendations that alternatives should be offered to digital data collection to avoid digital exclusion in older patients. 12 However, for those patients with cognitive impairment, consideration of formal proxy versions of questionnaires should be considered where available.

While adherence to the intervention was high and overall adherence was deemed feasible, significant crossover in the standard care arm was seen. This finding suggests clinicians may lack equipoise in sites where lidocaine patches are already in use; this was confirmed in our healthcare professional focus groups. However, these focus groups also highlighted discrepancies in prescribing/availability and a recognition of the potential harm of overuse of lidocaine patches (at the expense of other analgesic modalities). In order to overcome these challenges in equipoise, avoid crossover and fully understand the clinical effectiveness of topical lidocaine, a definitive trial would need to test active patches against placebo patches rather than standard care.

In this trial, older patients admitted to hospital with radiologically confirmed rib fracture(s) were living with very mild frailty (median CFS 4) and were predominantly injured after a fall from standing (<2 m), a finding consistent with previous reports. 27 Despite having isolated rib fracture(s), many participants had prolonged hospital stays (median 9 days) and >30% did not return to baseline functional status on discharge. STUMBL scores recorded at baseline suggested a population at high risk of developing adverse pulmonary complications and this finding was confirmed in 30-day outcome collection. Development of delirium appeared lower than reported in other cohorts, 6 but may reflect a lack of robust data collection. Notable findings that may provide targets for service improvements include prolonged times between injury and hospital arrival (20 hours) and low rates of prehospital analgesia administration. In addition, in-hospital (72 hours) analgesic prescriptions appear to rely heavily on strong opioid analgesia, with more advanced analgesic modalities being used in only around one-fifth of this vulnerable patient group.

Rib fracture(s) were diagnosed by CT in over 90% of cases. This may reflect a more liberal use of CT in older patients with suspected trauma following influential reports such as Trauma Audit Research Network Major Trauma in Older People 28 and the majority of sites being major trauma centres. However, this finding may also reflect selection bias towards more severely injured patients, given that our inclusion criteria required radiological confirmation of rib fracture(s) and prior studies have demonstrated a poor sensitivity of X-ray diagnosis, with only 40% accuracy in older patients. 29 Amending the inclusion criteria to include patients with clinically suspected (rather than radiologically confirmed) rib fractures may mitigate against this selection bias and also allow the inclusion of those patients who are less severely injured and potentially more frail.

Our health economic scoping revealed key findings to be considered in future research involving older adults in emergency settings. Modification of the standard EQ-5D to obtain retrospective pre-injury health status may be beneficial in assessing specific impacts of injury in economic modelling. However, since response rates to the ICECAP-O were higher than for the EQ-5D at 30 days, which may reflect a patient preference for completing a measure specifically designed for use in older people, it is possible that this is a more appropriate measure for use in a definitive trial.

Conclusions

This trial has demonstrated that recruitment of older patients with rib fracture(s) in an emergency setting for the evaluation of early analgesic interventions (in the form of lidocaine patches) is feasible. Refinement of data collection, with a focus on collecting pain and frailty-specific outcomes, as well as intervention delivery, is needed before progressing to a definitive trial.

Ethics statements

Patient consent for publication.

Not applicable.

Ethics approval

The protocol (V.4.0 4 March 2022) and other related participant-facing documents were approved by the UK Health Research Authority and UK Research Ethics Committees (REC): 21/SC/0019 (South Central—Oxford C REC; IRAS reference 285096) and 21/SS/0043 (Scotland A REC; IRAS reference 299793). Participants gave informed consent to participate in the study before taking part.

Acknowledgments

Sponsor: North Bristol NHS Trust (R&I reference: 4284). Trial management: this trial was designed and delivered in collaboration with the Bristol Trials Centre, a UKCRC registered clinical trials unit, which is in receipt of National Institute for Health Research CTU support funding. The trial management group included all authors and particular thanks are given to Gareth Williams who led patient and public contributions on the trial management group. Trial Steering Committee: the RELIEF trial team would like to thank all members of the independent members of the committee who gave up their time to provide oversight of this work: Fiona Lecky (Clinical Professor in Emergency Medicine and TSC Chair), Rachel Bradley (Consultant in General, Geriatric and Orthogeriatric Medicine), Sean Ewings (Associate Professor of Medical Statistics, Southampton Clinical Trials Unit, University of Southampton), Gordon Halford (Patient and Public Involvement Contributor). Participating sites: the RELIEF trial team would like to thank all staff involved at the seven participating sites (Southmead Hospital, North Bristol NHS Trust, Principal Investigator (PI): Edward Carlton, Associate PI: Fraser Birse; Royal Infirmary of Edinburgh, NHS Lothian, PI: Rachel O’Brien; Derriford Hospital, University Hospitals Plymouth NHS Trust, co-PIs: Jason Smith and Robert James, Associate PI: Rory Heath; Queen Elizabeth University Hospital, NHS Greater Glasgow and Clyde, co-PIs: Fraser Denny and David Lowe, Associate PI: Nathalie Graham; St George's Hospital London, St George's University Hospitals NHS Foundation Trust, PI: Melanie Lynn; Musgrove Park Hospital, Somerset NHS Foundation Trust, PI: James Gagg; Royal Devon and Exeter Hospital, Royal Devon University Healthcare NHS Foundation Trust, PI: Andy Appelboam).

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Supplementary materials

Supplementary data.

This web only file has been produced by the BMJ Publishing Group from an electronic file supplied by the author(s) and has not been edited for content.

• Data supplement 1

Handling editor Kirsty Challen

X @DrPhilipBraude, @eddcarlton

Presented at Results were presented in part at the Royal College of Emergency Medicine Annual Scientific Conference on 26 September 2023 and Age Anaesthesia Annual Scientific Meeting on 12 May 2023.

Contributors MC and NT have had full access to all data in the study and take full responsibility for the integrity of the data and accuracy of data analysis. Study concept and design: EC, NT, CC, PB, JB, JG, JI, RK, NAM, DS, JS, ADM. Analysis and interpretation of data: all authors. Drafting of manuscript: EC, CC, MC, RK, NT. Critical revision of manuscript for important intellectual content: all authors. Statistical analysis: NT. Obtained funding: EC, NT, CC, PB, JB, JG, JI, RK, NAM, DS, JS, ADM. EC is the guarantor of the study.

Funding This study is funded by the NIHR [Advanced Fellowship (NIHR300068)]. The views expressed are those of the author(s) and not necessarily those of the NIHR or the Department of Health and Social Care

Disclaimer The funder was not involved in the design, execution, analysis and interpretation of data or writing up of the trial.

Competing interests None declared.

Patient and public involvement Patients and/or the public were involved in the design, or conduct, or reporting, or dissemination plans of this research. Refer to the 'Methods' section for further details.

Provenance and peer review Not commissioned; externally peer reviewed.

Supplemental material This content has been supplied by the author(s). It has not been vetted by BMJ Publishing Group Limited (BMJ) and may not have been peer-reviewed. Any opinions or recommendations discussed are solely those of the author(s) and are not endorsed by BMJ. BMJ disclaims all liability and responsibility arising from any reliance placed on the content. Where the content includes any translated material, BMJ does not warrant the accuracy and reliability of the translations (including but not limited to local regulations, clinical guidelines, terminology, drug names and drug dosages), and is not responsible for any error and/or omissions arising from translation and adaptation or otherwise.

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