IRBIS does NOT generate these documents with application-specific information.
Concise Summary examples can be found here .
Guidance on the use of plain language in consent forms:
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.
COVID-19 Related Forms:
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).
UCL Research Ethics
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.
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.
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:
Ask someone else to review your information sheet before it is circulated.
Page last updated: June 2024
Home » Informed Consent in Research – Types, Templates and Examples
Table of Contents
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.
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:
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.
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 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.
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.
Here’s a basic format for informed consent that can be customized for specific research studies:
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: _____________
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: ___________________________
Here are some reasons why informed consent is important in research:
Informed consent is a critical component of research ethics, and it serves several important purposes, including:
The advantages of informed consent in research are numerous, and some of the most significant benefits include:
Researcher, Academic Writer, Web developer
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Updated June 23, 2023
A research informed consent form is used for the purpose of freeing students/faculty of any liability while performing a research study with human participants. Not only does the consent form liberate the researchers of accountability, it briefs the participants of how the research will be conducted, presented and reported. The participants must be fully aware of any risks or potential discomfort that may arise during the study. It should also be made known that participation is voluntary and that the participants can withdraw from the study. A step-by-step guide to filling out a general research informed consent form can be found below.
Instructions – Use to fill in the blank template.
Step 1 – Download in PDF , Microsoft Word (.docx) , or Open Document Text (.odt) .
Step 2 – The title of the research study being conducted must be included at the top of the consent form.
Step 3 – Enter the following information related to the primary researcher in the fields provided:
Step 4 – The purpose of the study, the procedures, the risks, and the benefits should be listed under each appropriate corresponding category with the participant’s initials included at the bottom of the page.
Step 5 – Any compensation that is to be provided to the participant(s) should be included under the “Compensation” section on page 2.
Step 6 – A telephone number and email address should be supplied under the “Contact Information” section in case the participant does not want to contact the primary researcher directly. The participant must initial the bottom of the second page.
Step 7 – Signatures must be produced by the participant and the researcher, with the date on which the form was signed next to each signature.
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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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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Feeling unsure or overwhelmed as an early-career psychology student? Second-year graduate student Mariel Barnett shares advice to quell uncertainties.
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Consent Form for Participation in a Research Study
To administrate a Consent Form to each participant is mandatory for any research involving human subjects. Please find below (or download here ) a template of consent form.
ESSEC Business School
Title of Study
DESCRIPTION: You are invited to participate in a research study on ( describe project in non-technical language; include types of questions that will be asked, if applicable; explain purpose of the research). You will be asked to (describe procedures ; mention video/audio taping, if applicable, and what will become of tapes after use, e.g., shown at scientific meetings; describe the final disposition of the tapes).
TIME INVOLVEMENT: Your participation will take approximately (insert duration ).
PROTECTION OF CONFIDENTIALITY: The information that you give in the study will be handled confidentially. Your information will be assigned a code number. The list connecting your name to this code will be kept in a locked file. When the study is completed and the data have been analyzed, this list will be destroyed. Your name will not be used in any report.
The information that you give in the study will be handled confidentially. Your data will be anonymous which means that your name will not be collected or linked to the data.
PAYMENTS: You will receive (describe reimbursement; where there is none, state as such) as payment for your participation.
PARTICIPANT’S RIGHTS: If you have read this form and have decided to participate in this project, please understand your participation is voluntary and you have the right to withdraw your consent or discontinue participation at any time . In this case, you will not earn any money (or credits). You have the right to refuse to answer particular questions. The results of this research study may be presented at scientific or professional meetings or published in scientific journals.
If you have read this form and have decided to participate in this project, please understand your participation is voluntary and you have the right to withdraw your consent or discontinue participation at any time without penalty or loss of benefits to which you are otherwise entitled . You have the right to refuse to answer particular questions. The results of this research study may be presented at scientific or professional meetings or published in scientific journals.
DEBRIEFING: A debriefing will be done at the end of the study.
CONTACT INFORMATION:
If you have any questions, concerns or complaints about this research, its procedures, risks and benefits, contact the Researcher, (name and email of Researcher).
I agree to participate in the research study described above.
Signature: ________________________________________ Date: _____________
IMAGES
VIDEO
COMMENTS
se this template if your research is NOT. derally-sponsore. A. D participants are adults.Avoid Common Problems with Consent Forms. Read these tips!1. ustomize this template to reflect the specifics of your study and participan. population.Text in [brackets] represents study-specific information that must be added.A ba.
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)
If you like, a summary of the results of the study will be sent to you. If you have any other concerns about your rights as a research participant that have not been answered by the investigators, you may contact the Smith College Institutional Review Board at [email protected] or (413) 585-3562.
this section, and all sections of the consent form, use simple, plain English. This section is required.) Procedures to be followed: (Here describe the research procedures to be followed, including duration of the subject's participation. Experimental procedures must be identified. This section is required.) Risks to study participants:
This template is a guide to help researchers design study information sheets and consent forms. It has been designed with reference to HRA Participant Information Sheet Preparation Guidance. Sample text is italicised. Alter or delete as required as you produce the draft. Standard required text is underlined.
Sample Informed Consent Form- ©NCPI. The following is a sample consent form for a research project. It is a research project on faculty life on campus, carried out by the principle investigator (PI) of this project from the fake-named Century University. The interviewer (the investigator) should have the interviewee read this form carefully ...
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)
2023-04-10. Assent Form Ages 7-14. 2023-06-27. Consent Addendum for Unencrypted Communication. 2020-10-26. Information or Fact Sheet. 2023-04-10. The following documents are samples. IRBIS does NOT generate these documents with application-specific information.
The consent form must include their name, title(s), phone number and/or email. Question about participant's rights or research-related injury should be directed to the Institutional Review Board (IRB): Crown Family School of Social Work, Policy, and Practice University of Chicago 969 East 60th Street Chicago, Illinois 60637 Telephone: 773-834 ...
Page%2%of%4% Participant's initials: _____ 5. xperimental procedures involved in the study if any: 6. escription of the discomforts inconveniences andor riss that ...
Version. Consent Addendum This is a consent addendum to allow already enrolled participants to agree to additional study procedures not disclosed in the initial consent form. This form supplements the consent and HIPAA authorization the subject already provided for a research study. Consent Addendum. 3-11-2020.
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.
The forms should be provided to participants in addition to the main study consent form. The language in these forms can also be adapted and added to consent forms for studies in which COVID-19 screening and testing procedures are being done for study purposes, i.e., the results of the screening and/or testing will be used as study data. To do ...
Receipt of informed consent- By completing and submitting the survey, I acknowledge having received the information regarding consent, and that I may call the investigators involved in the study, or supervising professor, Dr. XXXX, in order to discuss confidentially any questions about participation in the study.
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 ...
Participation in research involves some loss of privacy. We will do our best to make sure that information about you is kept confidential, but we cannot guarantee total confidentiality. Your personal information may be viewed by individuals involved in this research and may be seen by people including those collaborating, funding, and ...
How to Write. Step 1 - Download in PDF, Microsoft Word (.docx), or Open Document Text (.odt). Step 2 - The title of the research study being conducted must be included at the top of the consent form. Step 3 - Enter the following information related to the primary researcher in the fields provided: Step 4 - The purpose of the study, the ...
the research process. The researcher should retain one copy of the consent form signed by both themse. ves and the participant. The participant should also be given a copy of the consent form as a record of wha. they have signed up to.Even if a person has signed a consent form consent should still be re-established at the poin.
Sample Consent Form [Title of Study] Consent Form You are invited to participate in a research study of [insert general statement about study]. You were selected as a possible participant because [explain how subject was identified]. We ask that you read this form and ask any questions you may have before agreeing to be in the study.
Informed consents should include theBelow is an example of an. ev. ew Board Hofstra University Office of. Research and Sponsored Programs 516-463-50541. Introduction and Purpose of the StudyInclude a brief overview. of the study on a level of understanding for the person who will be signing the form. Remember.
An example of an online informed consent form is posted at the end of this document. Telephone: Typically, these components will be written as the beginning of the "script" and verbal consent will be requested before beginning the telephone survey. A copy of the script must be provided to the IRB. Paper Survey: Typically, these components ...
Your specific consent form should include information pertinent to your specific research project, and may need to be considerably different from this sample. The highlighted sections are to be filled in by you.) My name is (name of person doing project), and I am a (student/professor, etc.) at Union College. I am inviting you to participate in ...
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 ...
ESSEC Business School. Consent Form for Participation in a Research Study . Title of Study. DESCRIPTION: You are invited to participate in a research study on (describe project in non-technical language; include types of questions that will be asked, if applicable; explain purpose of the research). You will be asked to (describe procedures; mention video/audio taping, if applicable, and what ...
I have carefully read and fully understood the points and statements of this form. All my questions were answered to my satisfaction, and I voluntarily agree to participate in this study. I obtained a copy of this consent form co-signed by the interviewer. 27. ANNEX II: SAMPLE CONSENT FOR PARTICIPATION IN RESEARCH INTERVIEW.