informed consent form sample for research

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 )

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Informed Consent Guidelines & Templates

U-m hrpp informed consent information.

See the HRPP Operations Manual, Part 3, Section III, 6 e .

The human subjects in your project must participate willingly , having been adequately informed about the research.  

• If the human subjects are part of a vulnerable population (e.g., prisoners, cognitively impaired individuals, or children), special protections are required.
• If the human subjects are children , in most cases you must first obtain the permission of parents in addition to the consent of the children.

Contact the IRB Office for more information .

See the Waiver Guidelines  for information about, and policies regarding, waivers for informed consent or informed consent documentation. 

See the updated  Basic Informed Consent Elements document  for a list of 2018 Common Rule basic and additional elements. 

Informed Consent Process

Informed consent is the process of telling potential research participants about the key elements of a research study and what their participation will involve.  The informed consent process is one of the central components of the ethical conduct of research with human subjects.  The consent process typically includes providing a written consent document containing the required information (i.e., elements of informed consent) and the presentation of that information to prospective participants.  

In most cases, investigators are expected to obtain a signature from the participant on a written informed consent document (i.e., to document the consent to participate) unless the IRB has waived the consent requirement or documentation (signature) requirement .

• Projects which collect biospecimens for genetic analysis must obtain documented (signed) informed consent.
• It is an ethical best practice to include an informed consent process for most exempt research .   IRB-HSBS reviews, as applicable, the IRB application for exempt research, but not the informed consent document itself.  A suggested consent template for exempt research can be found below under the References and Resources section.  A companion protocol template for exempt research may be found in the feature box, Related Information (top right).

Informed consent documents

An  informed consent document  is typically used to provide subjects with the information they need to make a decision to volunteer for a research study.  Federal regulations ( 45 CFR 46.116 ) provide the framework for the type of information (i.e., the "elements") that must be included as part of the consent process.  New with the revised 2018 Common Rule is the requirement that the consent document begin with a "concise and focused" presentation of key information  that will help potential participants understand why they might or might not want to be a part of a research study.  

Key Information Elements

The image below displays the  five elements identified in the preamble to the revised Final Rule  as suggested key information.  

Note: Element number 5 (alternative procedures) applies primarily to clinical research.

General Information & Tips for Preparing a Consent Document

Reading level.

Informed consent documents should be written in plain language at a level appropriate to the subject population, generally at an 8th grade reading level .  A best practice is to have a colleague or friend read  the  informed consent document for comprehension before submission with the IRB application.  Always:

For guidance on using plain language, examples, and more, visit: http://www.plainlanguage.gov/

• Tailor the document to the subject population.
• Avoid technical jargon or overly complex terms.
• Use  straightforward  language that is understandable.

Writing tips

The informed consent document should succinctly describe the research as it has been presented in the IRB application.

• Use the second (you) or third person (he/she) to present the study details.  Avoid use of the first person (I).  
• Include a statement of agreement at the conclusion of the informed consent document. 
• The consent doucment must be consistent with what is described in the IRB application.

Document Formating for Uploading into eResearch

• Remove "track changes" or inserted comments from the consent documentation prior to uploading the document into the IRB application (Section 10-1) for review.
• Use a consistent, clearly identified file naming convention for multiple consent/assent documents.

Informed Consent Templates

IRB-HSBS strongly recommends that investigators use one of the informed consent templates developed to include the required consent elements (per  45 CFR 46.116 ), as well as other required regulatory and institutional language.  The templates listed below include the new consent elements outlined in the 2018 Common Rule.

References and Resources

PDF.  Lists the basic and additional elements required for inclusion or to be included, as appropriate to the research, in the informed consent documentation, along with the citiation number [e.g., _0116(b)(1)] within the revised Common Rule.  New elements associated with the 2018 Common Rule are indicated in bold text.

Strongly recommended for studies that involve the collection of biospecimens and/or genetic or genomic analysis, particularly  federally sponsored clinical trials that are required to post a consent document on a public website.  Last updated:  04/10/2024.

Informed Consent documents are not reviewed by the IRB for Exempt projects.  However, researchers are ethically bound to conduct a consent process with subjects.  This template is suggested for use with Exempt projects. Last updated 4/17/24

(Word) Blank template with 2018 revised Common Rule key information and other required informed consent elements represented as section headers; includes instructions and recommended language.  It is strongly advised that you modify this template to draft a project-specific informed consent document for your study for IRB review and approval.  Last updated: 04/10/2024

(Word) General outline to create and post a flyer seeking participation in a human subjects study.  Includes instructions.

(Word) Two sample letters for site approval cooperation between U-M and other institutions, organizations, etc.  Letters of cooperation must be on U-M letterhead and signed by an appropriate official.  These letters are uploaded into the Performance Site section of the eResearch IRB application.

For use by U-M Dearborn faculty, staff, and students conducting non-exempt human subjects research using subject pools. Last updated 4/10/24

For use by U-M Dearborn faculty, staff, and students conducting exempt human subjects research using subject pools

Researchers who will conduct data collection that is subject to the General Data Protection Regulation (GDPR) must use this template in tandem with a general consent for participation template/document.

• Child assent ages 3-6
• Child assent 7-11
• Parent permission
• Brief protocol for exempt research including data management and security questionnaire
• Child assent 12-14
• Introductory psychology subject pool general consent template
• Introductory psychology subject pool exempt consent template

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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 Templates

Use These Templates to Properly Inform Prospective Participants on Scope of Research

Informed consent is a cornerstone principal of ethical human subjects research. Researchers must ensure prospective participants receive information about the study, sufficiently detailed to facilitate a truly informed choice, in a manner that facilitates voluntary consideration of whether to participate. This ethical obligation exists for all research—exempt and non-exempt.

Federal regulations outline informed consent requirements for non-exempt research, including a list of information participants must receive (i.e.,  elements of informed consent ).  Using one of the templates below helps ensure that your consent form includes these elements.  The templates are only a guide.  Templates can and should be adapted to fit the study plans and needs of prospective participants. However,  all  of the consent elements must be included in your consent form unless your study is eligible for exempt review.

Consent forms must be carefully drafted to facilitate comprehension.   Detailed guidance  and  a checklist  are available to aid researchers.

An IRB-approval stamp will be applied to approved consent forms.  Please leave a 1 ½ inch margin at the top of the document to accommodate the stamp.  Avoid including unnecessary headings (e.g., Attachment or Appendix) on the consent form.  Researchers are strongly advised to copy/print the stamped consent form for use during the study—doing so assures the current IRB-approved version is used and assures participants that the study has been reviewed by the IRB.

I nformed Consent Form Template –Q & A Format  (UPDATED: 1.24.22)

Informed Consent Form Template –Standard Format  (UPDATED: 1.24.22)

Parental Informed Consent Form Template –Q & A Format  (UPDATED: 1.24.22)

Parental Informed Consent Form Template –Standard Format  (UPDATED: 1.24.22)

Informed Consent Addendum Template –use for re-consenting or to inform participants of new information  (UPDATED: 3.22.22)

For additional guidance about informed consent, see the following:

Consent Process  – guidance on developing a meaningful informed consent process

Assent Process  – guidance on obtaining assent from children

Elements of Informed Consent  – a detailed description of required consent elements and consent form considerations

Waivers or Alterations of Consent  – guidance on when consent requirements can be altered or waived

Retention of Signed Consent Forms  – guidance on retention of consent forms

Informed Consent for Exempt Research

Use of a formal informed consent form containing all the elements of consent is not required for research under exempt review.  However, researchers are ethically obligated to obtain the voluntary agreement of prospective participants before including them in research.  For more information and examples of consent forms appropriate for exempt research see  Informed Consent for Exempt Studies .

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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

Guidance and Sample Language for Consent and Assent Documents

Below are the regulatory elements of informed consent, with corresponding guidance and sample language. These samples are not intended to be comprehensive and should be modified to enhance comprehension as appropriate for the target population of research participants.

This information is also available in Word document format .

General Guidance for Writing Consent Documents

• Informed consent is a process, not just a document. Information must be presented that will enable potential participants to voluntarily decide whether to enroll in the study. Informed consent is a fundamental mechanism to ensure respect for persons through provision of thoughtful consent for a voluntary act. The procedures used in obtaining informed consent should be designed to educate potential study participants in terms that they can understand. Therefore, consent documents must be written in plain language with as few technical terms as possible.
• Shorter documents result in greater comprehension of the content. Therefore, consent documents should be limited to required elements and presented in a way that highlights key information. Non-essential information should be omitted or captured in a supplemental document.
• The consent document should be written at a level comprehensible to the population eligible to enroll in the study. According to the US Department of Education and the National Institute of Literacy, 50% of adults in US cannot read a book at the 8th grade level (Organization for Economic Cooperation and Development, 2016). If your study targets the “average” adult in the US, the ideal consent form would be written below an 8th grade reading level, with a readability score of more than 50 (the higher the score, the easier your document is to read). Use Flesch-Kincaid to test the readability level of your document. See Microsoft Office Support for more information. According to Microsoft, this paragraph is written a 14th grade level.
• Use of illustrations, diagrams, color, and supplemental materials are encouraged when their use may enhance comprehension.
• Write directly to the reader, as though you are explaining the facts in person. Consent language should be written in the second person (“you” or “your child”), not in the first person (“I”).
• Minimize passive voice to the extent possible. Example of passive voice: “A summary of results will be sent to all study participants.” Example of active voice: “We will send you a summary of the results.”

Additional guidance is available from the Office of Human Research Protection (PDF) .

Basic Elements of Informed Consent §__.116(b)

Consent element: purpose, duration, and procedures.

From the regulations: A statement that the study involves research, an explanation of the purposes of the research and the expected duration of the subject’s participation, a description of the procedures to be followed, and identification of any procedures that are experimental.

Guidance: Clearly and briefly state the purpose of the research.

Sample language: This study is about {briefly describe the purpose of the study} .

Sample language for studies involving deception: For scientific reasons, this consent form does not include all of the information about the research question being tested. The researchers will give you more information when your participation in the study is over.

Guidance: Insert the expected length of time it will take for study visits or scheduled procedures, as well as the total expected length of participation (for example, the interview will take about one hour; you will be asked to visit the lab three times and each visit will take about two hours). Avoid references to specific dates in case your study does not begin or end on schedule.

Sample language: Your participation in this study will last about {insert the expected length of time it will take a participant to complete the study} .

Procedures or Activities

Guidance: Make clear that the activity involves research and describe the overall experience that will be encountered. If the study activities are complex, lengthy, or repetitious, it may increase comprehension to provide simple charts or calendars and supplemental documents that include the detailed descriptions.

Sample language:

• You should not be in this study if {include primary exclusion criteria in simple terms}.
• We are asking you if you want to be in this study because {insert brief description of study population}.
• If you take part in this study, we will ask you to {include overview of study activities in simple terms}.

Recordings and photographs

Guidance: Indicate whether audio or video recordings or will be made or whether photographs will be taken. Clearly state whether recording is required or optional. If required, explain that they should not enroll if they do not wish to be recorded.

Future contact

Sample Language: We may contact you in the future for another similar study. You may ask us to stop contacting you at any time.

Sample Language: We may give you a placebo. A placebo has no active ingredients.

Randomization

Sample Language: This study involves a process called randomization. Randomization means that you are put into one of the groups by chance. It is like flipping a coin {modify if more than two groups (like drawing names from a hat)}. The group that you will be in will not be chosen by you or the researchers. You will have a {insert chance – equal, one in three, etc.} chance of being placed in any group.

Blood draws

Sample Language: We will draw about {insert teaspoons/tablespoons or other lay measurement} of blood by putting a needle into a vein in your arm. This is the standard method used to obtain blood for tests. {If more than one draw will occur, insert the following sentence} We will take a total of {insert teaspoons/tablespoons or other lay measurement} of blood over the course of this study.

Studies involving radiation exposure

Guidance: Describe the equipment that will be used, how much radiation participants will receive for each set of scans performed and for the cumulative dose from the study using mrems and a lay comparison.

Consent Element: Risks

From the regulations: A description of any reasonably foreseeable risks or discomforts to the subject.

Guidance: All reasonably foreseeable risks, discomforts, inconveniences, and harms that are associated with the research activity should be described. Investigators should be forthcoming about risks and not understate reasonably foreseeable risks.

Do not include evaluative statements about the risks, such as, “Risks are minimal.” If the actual probability of risk is known, this information can be included if it could further enable a participant to assess their personal risk. For example, “In previous studies, about 10% of the participants felt dizzy after the [intervention].”

If collecting individually identifiable information (such as names or birthdates), a potential for breach of confidentiality exists.

Depending on the type of study, some risks may be better described as things that could make the participant “uncomfortable” – such as fatigue or embarrassment.

Sample language: Some things that could happen to you if you are in this study are {include reasonably foreseeable risks in simple terms}.

Sample Language: The risks of having blood drawn from your arm include some pain when the needle goes in and a small risk of bruising and/or infection at that site. Some people get lightheaded, nauseous, or faint. You are less likely to have these problems if you drink at least two glasses of water and have a snack before the blood draw {modify for fasting draws} . The American Red Cross recommends that you do not donate more than 1 pint (32 tablespoons) of blood within a 2-month period. Tell the study team if you have recently had your blood drawn for any reason.

Guidance: Insert explanation of any study activities that may involve risks to the participant or to an embryo or fetus if the participant is or may become pregnant.

Sample language: This study involves activities that are not safe for pregnant women. So, if you can become pregnant, we will do a pregnancy test before {describe the testing or intervention method} . – AND/OR – There may be a risk of harm to an unborn child. You must use an effective form of pregnancy prevention while you are enrolled in this study. We will discuss the risk with you in more detail. Notify the study team immediately if you think or know that you have become pregnant during the course of this study.

Pregnancy and studies involving radiation exposure

Sample Language: You may not participate in {the aspect of the study causing the radiation exposure/bone scan} if you are pregnant or suspect you may be pregnant. If you can become pregnant, {the aspect of the study causing the radiation exposure/bone scan} must be performed within the first few days of the beginning of your last period to reduce the risk of performing the scan on a developing embryo. Notify the study team immediately if you think or know that you have become pregnant.

VO2max Testing

Sample Language: The risks of being in this study include:

• Acute exercise may present a risk of sudden death
• Overall risk of cardiac events is about 6 events per 10,000 tests
• Serious injury
• Physical discomfort from the test and equipment
• Muscle aches, cramps, joint pain
• Muscle strain and/or joint injury
• Delayed muscle soreness
• Abnormal blood pressure/heart rate
• Shortness of breath
• Lightheadedness, fainting

Conflict of Interest

Sample language: A conflict of interest occurs when a researcher or the University has a financial or other interest that could affect the research. In some situations, the results of a study might lead to a financial gain or other benefit for the researcher(s) and/or the University.

{Insert one of the statements below, followed by a brief description of the potential conflict}

If you have questions or concerns about this, please contact the Human Research Protection Program office at (541) 737-8008.

• One or more of the researchers working on this study has a conflict of interest.
• Oregon State University has a conflict of interest.
• One or more of the researchers working on this study and Oregon State University have conflicts of interest.

Consent Element: Benefits

From the regulations: A description of any benefits to the subject or to others that may reasonably be expected from the research.

Guidance: Any benefits to participants or others that may reasonably be expected from the research should be described. Investigators should be frank about benefits and not overestimate or magnify the possibility of benefit to the participants. If there is no reasonable expectation of benefit, the participant should be told this. Payment to participants should not be listed or described as a benefit of being in the research.

Sample language when direct benefit to participants is anticipated: Some good things that might happen to you if you are in this study are {include any direct benefits} . We are not sure that these things will happen.

Sample language when no direct benefit to participants is anticipated: This study is not designed to benefit you directly.

Consent Element: Alternative Procedures

From the regulations: A disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the subject.

Guidance: If participants can have the same experience or receive the same resources without being in the study, this should be clearly stated.

Sample language: You could {insert information about the alternative} instead of being in this study.

Consent Element: Confidentiality

From the regulations: A statement describing the extent, if any, to which confidentiality of records identifying the subject will be maintained.

Guidance: Participants may be indirectly identifiable if, for example, direct quotes are used, the organization the person is affiliated with is named, there are sufficient data points to re-identify the individual, or the people who are invited to participate are part of a small or well-defined group.

Describe who (researcher team, employer, funder, people outside of OSU) might have access to identifiers, not how access to identifiers will be prevented (encryption, locked cabinets, etc.).

If audio or video recordings will be made, explain who will have access, if they will be used for educational purposes, and when they will be destroyed.

If FDA-regulated, the FDA should specifically be listed as a regulatory agency that may access or inspect records (for example, “The FDA, other regulatory agencies and Oregon State University employees…”).

If the study is funded, include sponsor as an entity that may see the information.

As applicable, see additional section on collecting identifiable private information or identifiable biospecimens.

Sample language options:

• Your participation in this study is anonymous.
• We plan to make the results of this study public but we will not include your name or other information that identifies you.
• Other people may learn that you participated in this study but the information you provide will be kept confidential to the extent permitted by law. Research records will be stored securely. Regulatory agencies and Oregon State University employees may access or inspect records pertaining to this research as part of routine oversight or university business. Some of these records could contain information that personally identifies you.

Sharing data/samples

Guidance: If data or samples will be shared with individuals or organizations external to OSU (for example, collaborators, site of research, etc.), provide general information about what will be shared, with whom, and whether it will be individually identifiable. Note that names of individual recipients of shared data or samples are not necessary.

Sample language: We will share your responses with researchers at other universities, but we will not include your name.

Breach of Confidentiality

Sample Language: There is a chance that we could accidentally disclose information that identifies you.

Internet and/or email

Sample Language: The security and confidentiality of information collected from you online cannot be guaranteed.

Focus Groups

Sample Language: We will ask members of the focus group to maintain the confidentiality of comments made during the discussion. However, there is still a risk that comments you make during the discussion may be shared outside of the group.

Certificate of Confidentiality

Guidance: When a researcher obtains a Certificate of Confidentiality, the participants must be told about protections afforded by the Certificate and any exceptions to those protections. For example, the circumstances in which the investigators plan to disclose, voluntarily, identifying information about research participants (for example, child abuse, harm to self or others, etc.). This information should be included in the consent form. The researchers should eliminate provisions in the consent form that may be inconsistent with the Certificate protections (such as references to disclosures required by law, since the Certificate enables researchers to resist disclosures that would otherwise be compelled by law). Researchers may not represent the Certificate as an endorsement of the research project by the DHHS.

If the study is NIH-funded or you have or plan to obtain a Certificate of Confidentiality from the NIH, include the relevant language below in the consent document:

Sample language: Most people outside of the study team will not see research information that includes your name. This includes people who try to get your information using a court order. We could give out this information if you gave us permission. We will give out this information if we need to report child abuse or neglect, or if we think you are planning to hurt yourself or others.

Studies that may reveal violence, abuse, neglect, or self-inflicted injury

Sample Language: Under Oregon law, we are required to report to the appropriate authorities any information concerning child abuse or neglect. We may also report threats of harm to self or to others.

Genetic Research

Guidance: Additional information that may be provided includes whether or not participants have the option of knowing the results of their genetic analysis, whether incidental findings will be shared with participants, whether or not genetic counseling would be available and who would pay for such counseling.

Note: GINA requires IRB review of genetic research on biological specimens even if the project is limited to research on samples without individual identifiers (anonymous or coded specimens). See the Fact Sheet for Researchers and Institutional Review Boards (PDF) for more information.

Sample language: A Federal law, called the Genetic Information Nondiscrimination Act (GINA), makes it illegal for health insurance companies, group health plans, and most employers to discriminate against you based on your genetic information. This law will protect you in the following ways:

• Health insurance companies and group health plans may not request your genetic information that we get from this research or when making decisions regarding your eligibility or premiums.
• Employers with 15 or more employees may not use your genetic information that we get from this research when making a decision to hire, promote, or fire you or when setting the terms of your employment.

This law does not protect you against genetic discrimination by companies that sell life insurance, disability insurance, or long-term care insurance.

Recruiting from the Center for Healthy Aging Research (CHAR) LIFE Registry

Guidance: CHAR requires that researchers who recruit from the LIFE Registry provide them with a list of participants who were recruited from the Registry. If participants will be recruited from the Registry, please insert the following paragraph:

Sample Language: If we contacted you through the Center for Healthy Aging Research (CHAR) LIFE Registry, we will be providing CHAR with any updates to your contact information. We will also tell them whether you chose to participate in this research study.

ClinicalTrials.gov

Guidance: If the study is a clinical trial and will be posted to ClinicalTrials.gov, the sentence below must be included verbatim.

Required language: A description of this clinical trial will be available on http://www.ClinicalTrials.gov , as required by U.S. Law. This website will not include information that can identify you. At most, the website will include a summary of the results. You can search this website at any time.

Consent Element: Research-related injury

From the regulations: For research involving more than minimal risk, an explanation as to whether any compensation and an explanation as to whether any medical treatments are available if injury occurs and, if so, what they consist of, or where further information may be obtained.

Risks related to physical injury or mental/emotional harm

Guidance: If research-related injury (such as, physical, psychological, social, financial, or otherwise) is possible in research that is more than minimal risk, an explanation must be given as to whether any compensation and treatment will be provided to an injured participant. The compensation and treatment should be described, or the participant should be told where further information might be obtained. The regulations prohibit requiring participants to waive or appear to waive their legal rights.

Sample language for unfunded and federal funded studies: If you have been injured because you are in this study, {insert description of plan or process that may be followed} . Oregon State University has no program to pay for the treatment of research-related injuries.

Sample language for industry funded studies: If you have been injured because you are in this study, {insert description of plan or process that may be followed} . Costs related to the treatment of research-related injuries {insert the sponsor’s language for coverage of these injuries} .

Consent Element: Contact information

From the regulations: An explanation of whom to contact for answers to pertinent questions about the research and research subjects’ rights, and whom to contact in the event of a research-related injury to the subject.

• Contact information

Guidance: Sample language is provided but should be altered if there is no reasonable expectation that participants would be able to contact or communicate with the PI or IRB (for example, no access to telephone or internet; language barrier). When that is the case, local contact information for an individual or organization that can answer pertinent questions about the research and the participant’s rights should be provided.

Sample language: If you have any questions about this research project, please contact: {insert name(s) and contact information for the Principal Investigator}. If you have questions about your rights or welfare as a participant, please contact the OSU Human Research Protection Program office, at (541) 737-8008 or by email at [email protected] .

Consent Element: Voluntariness

From the regulations: A statement that participation is voluntary, refusal to participate will involve no penalty or loss of benefits to which the subject is otherwise entitled and the subject may discontinue participation at any time without penalty or loss of benefits to which the subject is otherwise entitled.

Guidance: The reference to benefits that participants may be concerned with are those that are connected to the study topic. See sample language for multiple scenarios below.

Sample language: Being in this study is voluntary. If you decide to be in the study, you are free to stop at any time without penalty. We may keep and use information that we collected about you while you were in the study unless you ask for that information to be destroyed.

Note: The language in the consent form or process should not promise that data will be destroyed at a participant’s request if that data is essential for assessing or tracking risks to the participant or others.

Required vs optional questions

Guidance: If the study involves interviews, surveys, or questionnaires, with optional questions, include a statement that the participant is free to skip any questions that they would prefer not to answer. If answering all questions is required, clearly state that while study participation is voluntary, all questions must be answered in order for their individual responses to be included in the study results.

Research during class time

Guidance: If study activities take place during class time, explain what participants will do during that time if they choose not to participate.

Students as participants

Sample Language: Your decision to take part or not take part in this study will not affect your grades, your relationship with your professors, or your standing in the University.

Employees as participants

Sample Language: Your decision to take part or not take part in this study will not affect your job.

When the researchers have a pre-existing relationship with potential participants

Sample Language: Your decision to take part or not take part in this study will not affect your relationship with the researcher.

Sample Language: Choosing to take part or choosing not to take part in this study will not impact the length of your sentence, your parole, or any other aspect of your incarceration.

Consent Element: Identifiable information or biospecimens

From the regulations: One of the following statements must be included for any research that involves the collection of identifiable private information or identifiable biospecimens:

• A statement that identifiers might be removed from the identifiable private information or identifiable biospecimens and that, after such removal, the information or biospecimens could be used for future research studies or distributed to another investigator for future research studies without additional informed consent from the subject or the legally authorized representative, if this might be a possibility; OR
• A statement that the subject’s information or biospecimens collected as part of the research, even if identifiers are removed, will not be used or distributed for future research studies.

Note 1: The language in option 1 is incompatible with the General Data Protection Regulation (GDPR) and cannot be used if data will be collected from people in the European Union or the broader European Economic Area (EEA).

Note 2: The language in option 1 should be included if data sharing is a requirement of the sponsor or of the journals to which you intend to submit a manuscript. Example:

From NSF Proposal & Award Policies & Procedures Guide (PAPPG) Chapter XI.D.4. : Investigators are expected to share with other researchers, at no more than incremental cost and within a reasonable time, the primary data, samples, physical collections and other supporting materials created or gathered in the course of work under NSF grants. Grantees are expected to encourage and facilitate such sharing.

From PLOS : PLOS journals require authors to make all data underlying the findings described in their manuscript fully available without restriction, with rare exception.

Note 3: The Office of the Registrar will not approve a consent process that asks OSU students to consent to future unspecified research. This language is also incompatible with the General Data Protection Regulation (GDPR) and cannot be used if data will be collected from people in the European Union or the broader European Economic Area (EEA).

Guidance: If you plan to store data or samples, explain how long they will be retained (for example, indefinitely, five years, destroyed when the study is completed), how they will be stored (that is, with or without identifiers), what they will be used for, whether they will be shared, and whether subject permission will be sought for future studies.

Sample language for biological samples: We may keep your blood sample forever. We do not know what studies we might do in the future. We would like your permission now to use or share your blood sample without having to ask you again in the future 1 . We will only use your blood sample in other studies about diabetes. We will remove your name and any other information that identifies you before we use it in a new study or share it with other researchers. There is still a chance that someone could figure out that the information is about you. 2

Sample language for data (1): We may keep information about you forever. We do not know what studies we might do in the future. We would like your permission now to use or share your personal information without having to ask you again in the future. We will only use your information in other studies about how people spend money. We will remove your name and any other information that identifies you before we use it in a new study or share it with other researchers. There is still a chance that someone could figure out that the information is about you.

Sample language for data (2): We may keep information about you forever. We do not know what studies we might do in the future. We would like your permission now to use your personal information without having to ask you again in the future. We will only use your information in other studies about how people spend money. We will remove your name and any other information that identifies you before we use it in a new study. We will not share your responses or other information about you with people outside of the study team. There is still a chance that someone could figure out that the information is about you.

Sample language for data (3): The information that you give us will only be used for this study 3 . We will not share information about you with others or use it in future studies without your consent. There is still a chance that someone could figure out that the information is about you 4 .

1. This language addresses the requirement at 45CFR46.116(b)(9) related to the collection of identifiable private information or specimens.

2. The latter half of this sentence addresses the 21st Century Cures Act definition of identifiable, sensitive information as any information through which an individual is identified; or for which there is at least a very small risk… that some combination of the information, a request for the information, and other available data sources could be used to deduce the identity of an individual.

3. This language addresses the requirement at 45CFR46.116(b)(9) related to the collection of identifiable private information or specimens.

4. The latter half of this sentence addresses the 21st Century Cures Act definition of identifiable, sensitive information as any information through which an individual is identified or for which there is at least a very small risk… that some combination of the information, a request for the information, and other available data sources could be used to deduce the identity of an individual.

Additional Elements of Informed Consent, as applicable §__.116(c)

Consent element: unforeseeable risks.

From the regulations: A statement that the particular treatment or procedure may involve risks to the subject (or to the embryo or fetus, if the subject is or may become pregnant) that are currently unforeseeable.

Sample Language: We may not know about all of the risks of being in this study.

Note: If this language is relevant for your study, it may make sense to follow this with information about how you will handle significant new findings (see additional consent element).

Consent Element: Termination of participation by PI

From the regulations: Anticipated circumstances under which the subject’s participation may be terminated by the investigator without regard to the subject's or the legally authorized representative’s consent.

Guidance: Describe any circumstances under which the researcher might end a participant's enrollment in the study (for example, participant does not come in for critical visits or does not follow instructions for study activities, etc.).

Consent Element: Costs

From the regulations: Any additional costs to the subject that may result from participation in the research.

Guidance: Insert any costs to the participants for which they will not be compensated or procedures that will be billed to their insurance (for example, lab tests, treatment at an outside facility, parking, lost, damaged, or unreturned study equipment, etc.).

Consent Element: Procedures for withdrawing

From the regulations: The consequences of a subject’s decision to withdraw from the research and procedures for orderly termination of participation by the subject

Consent Element: Significant new findings

From the regulations: A statement that significant new findings developed during the course of the research that may relate to the subject’s willingness to continue participation will be provided to the subject.

Guidance: A statement that if significant new findings develop during the course of the research, those findings will be provided to the participant if the information might impact their willingness to stay in the study.

Consent Element: Number of subjects

From the regulations: The approximate number of subjects involved in the study.

Note: This is not necessary for minimal risk studies.

Consent Element: Commercial profit

From the regulations: A statement that the subject’s biospecimens (even if identifiers are removed) may be used for commercial profit and whether the subject will or will not share in this commercial profit.

Consent Element: Research results

From the regulations: A statement regarding whether clinically relevant research results, including individual research results, will be disclosed to subjects, and if so, under what conditions.

Guidance: Explain whether and how study results will be shared with participants and whether shared results will be individual level or aggregated.

Consent Element: Whole genome sequencing

From the regulations: For research involving biospecimens, whether the research will (if known) or might include whole genome sequencing (i.e., sequencing of a human germline or somatic specimen with the intent to generate the genome or exome sequence of that specimen).

Additional Miscellaneous Information, as applicable

From the regulations: …the IRB shall determine that adequate provisions are made for soliciting the assent of the children, when in the judgment of the IRB the children are capable of providing assent. In determining whether children are capable of assenting, the IRB shall take into account the ages, maturity, and psychological state of the children involved.

Guidance: Assent is a person's agreement to participate in research. Mere failure to object is not assent.

A verbal assent process is generally more appropriate for children up to age seven. Written assent documents can be used for older children when appropriate. The guidance in this section provides a framework for obtaining assent from children, as well as from adults who lack the capacity to provide consent.

The investigator should respect the decision of a minor or cognitively impaired participant who chooses not to participate, even when the parent or legally authorized representative is willing to consent on their behalf.

Like consent, assent is a process, not just a document. Information must be presented in a way that enables people to choose whether to participate.

Write directly to the reader, as though you are explaining the facts in person. Assent language should be written in the second person (“you”), not in the first person (“I”). Minimize passive voice to the extent possible. Example of passive voice: “A summary of results will be sent to all study participants.” Example of active voice: “We will tell you and your parents what we learned from the study when it is over.”

Sample language for parental consent forms: The researcher talked to me and my child about the study. They asked us to talk to them about any questions that we have now. We know that we can call them in the future if more questions come up.

Guidance: Clearly describe the monetary compensation (total amount, average total amount, amount per visit, amount per hour, etc.). If compensation is pro-rated when a participant withdraws prior to completing the study, explain how it is pro-rated. If participants must complete the study activities in order to receive compensation, please state. Describe any non-monetary compensation (for example, extra credit, gift certificate), separately from monetary compensation and include the approximate value when appropriate.

Compensation offered in the form of checks and compensation greater than or equal to $600 paid within one calendar year, requires the collection of identifying information for the purposes of tax reporting. In these cases, the consent document must inform participants that they will be asked to provide their Social Security Number or Individual Tax Identification Number to receive payment. In the event that the target population is known not to possess such identification, a flat tax may be withheld from payments large enough to require reporting to the Internal Revenue Service (IRS). If this is the approach to be taken by the PI, the consent document should include a brief statement indicating that taxes will be withheld from the study payment and an estimate of the net amount participants should anticipate. Contact the HRPP office for more information.

Sample language: You will be paid $5 for being in this research study even if you skip questions that you do not want to answer.

Raffles and lotteries

Guidance: These incentives are permitted in some circumstances. Please see the policy on the HRPP website for additional information.

Sample Language: We will give everyone interested in this study an OSU coffee cup and a raffle ticket. We will enter all of the ticket numbers into a drawing for an iPad. The chance of winning is about 1 in 100. We cannot promise that you will win anything. We can enter you into the drawing even if you choose not to be in the study or if you choose not to finish the study activities.

Guidance: The IRB strongly discourages use of the "first person" statement in consent documents (using, "I have been fully informed about..."). Such statements ask participants to make statements that the participant is not in a position to verify (for example, the participant has no way to verify that the investigator has provided full and complete information).

European Union General Data Protection Regulation (GDPR)

Guidance: The effective date for the General Data Protection Regulation was May 25, 2018. The aim of the GDPR is to protect people in the European Union and the broader European Economic Area (EEA) from privacy and data breaches. The scope of the regulation is broad and can include data collected from residents of other countries when they are visiting EU or EEA countries.

A Compilation of Guidances on the GDPR can be found on the Office of Human Research Protections website.

Contact the OSU Data Protection Officer if you plan to collect data from research participants who reside or will be in EU or EEA countries at the time of data collection.

Consent Process

The GDPR requires that consent from the participant be freely given, specific, informed and an unambiguous indication of the participant's wishes. Consent must be made by a statement or by a clear affirmative action signifying agreement to the processing of their personal data [ Article 4, GDPR ]. Because explicit consent is required from participants before data about them can be collected for research, the IRB will not be permitted to waive the requirement for obtaining informed consent and cannot approve a plan that is limited to notification or “opt-out” if participants are located in the EEA.

Consent Elements

The majority of required consent elements outlined in the GDPR align with the elements required from research participants in the US. Three additional elements must be included in the consent document, as applicable:

Participants must be provided with contact information for the researcher and a Data Protection Officer. The contact information for the DPO at OSU is:

Tom Ordeman, Data Protection Officer [email protected] 541-737-9800 Oregon State University A008 Kerr Administration Building Corvallis, OR 97331-4501

When data will be transferred from participants or researcher sites in the EEA to the US, researchers must disclose to participants that US data privacy laws have not been deemed adequate by the European Commission.

Collaborators in the EEA will only be able to receive and analyze personal data sent from researchers in the US if the consent process included the GDPR-required elements.

• Transfer of data from the EEA to the US
• Transfer of data from the US to the EEA

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?

Connect with our cancer information specialists.

Phone: 1-800-4-CANCER   Chat: LiveHelp Email:   [email protected]

Available Monday–Friday 9:00 a.m. to 9:00 p.m. ET.

Editable documents containing required information.

Standard Informed Consent Template

New IRBMED studies should most often use the latest Standard Informed Consent template available on this webpage.

Specialty Consent Templates may be appropriate for low-risk studies with simpler study methodologies.

Downloadable Standard Informed Consent Template

The working version template containing blue and orange text boxes is updated with additional instructions and required language. IRBMED recommends using the working version template for creating the consent document. If using the outline version (without the blue-box instructions), always use the working version as a companion document for additional information and as-applicable required language.

Changes to the Standard Consent Template

April 2024: Extensive revisions, including a new section

Changes to note throughout the document

• All appearances of the term “subject” have been replaced with “participant.”
• Most orange boxes indicating ICH-GCP -specific instructions have been revised to pertain to all research as applicable.
• Office of Technology Transfer’s name change to Innovation Partnerships  has been incorporated.
• IRBMED has developed new approach to addressing participation in sub-studies, depending on whether the substudy/ies involve factors, such as procedures or risks, that differ significantly from those in the main study. 
• To better organize consent document information by clearly separating main study information from all information about data and biospecimen storage, future use, and sharing, this document contains a new section, which is numbered section 12. 
• The signature section (formerly section 12) is shifted down to a new section 13.

Changes to instructions and as-applicable template text (blue/orange boxes)

• The orange box has been changed to blue and references to ICH-GCP have been removed
• The text of a former orange ICH-GCP box has been incorporated into body text
• In section 1.1 (key information), sample descriptions of clinical trial phases have been rewritten.
• Also in section 1.1, new help text guides researchers in choosing which study risks represent key information and which needn’t be included in this section.
• In section 4.1, guidance on blinded studies has been narrowed to apply only to certain scenarios.
• Sub-studies that involve factors, such as procedures or risks, that are similar to those in the main study, or that involve only storage and/or use of samples and information gathered in the main study, appear in section 4.1 or the new section 12. These instances are expected to be the most common.
• Sub-studies that involve factors, such as procedures or risks, that differ significantly from those in the main study should now appear in an appendix added to very end of the template. These instances are expected to be relatively uncommon.
• In section 5.1 (risks), help text pertaining to efforts to mitigate study risk has been rewritten.
• Also in 5.1, risk language regarding COVID-19 vaccination has been inserted.
• Recommended language regarding study benefit (section 5.2) has been revised.
• In section 8.1, which addresses costs of study participation, help text regarding costs of treatment for study-related injury has been revised by the Calendar Analysis and Review Office (CRAO) to reflect changes in university policy. These policy changes affect investigator-initiated and federally sponsored research only.
• The blue box guiding researchers on explaining mitigation of confidentiality risk in section 9.1 has been augmented with new language about protecting electronic data, including data stored on cloud servers.
• Language in section 9.1 regarding Certificates of Confidentiality has been revised.
• Language in Section 9.1 regarding adult and child abuse has been revised to clarify who required reporters will include, for what Michigan law requires reporting, and a revision to the policies linked in the blue boxes.
• Help text on HIV testing has been both condensed and moved from what was formerly 11.2 (Which documents will I receive?) to section 4.1 (study procedures). The move was prompted by changes in Michigan law that no longer require researchers to provide subjects undergoing HIV testing with an informational pamphlet.

Changes to document body text

• In section 1.1 (key information), language regarding duration of study participation has been revised.
• Section 4.1 (procedures): This template instructs researchers to mark any procedures or risks included in the consent document but completed as part of standard clinical treatment with a “[not research]” tag. This is not required for all studies but can be used when research and standard clinical procedures overlap.
• Section 5.1: The passage beginning “Additionally, there may be a risk of loss of confidentiality or privacy” is new.
• Section 5.1 also now includes language pertaining to the risks associated with premedications.
• Section 7.2: The three-paragraph passage beginning “You are free to partially or completely end your participation in the study” is new.
• Language in section 7.2 regarding the risks of discontinuing study participation has undergone revision.
• Section 8.3 (“Who could benefit financially from information learned in the study?”) now contains prompt language researchers should use to disclose the source of funding for the University of Michigan study.
• Language about basic (non-HIPAA) privacy and confidentiality measures in section 9.1 have been added.
• Language to be added if adult or child abuse may be revealed during the study has been updated.
• 9.2: In the list of entities that may see subjects’ data, the bullet addressing use of research data by federal agencies and other entities for safety oversight purposes now closes with the phrase: “and for quality improvement purposes.”
• 9.2: In the list of entities that may see subjects’ data, the bullet about collecting subjects’ Social Security numbers has been revised by the Human Subjects Incentives Program (HSIP) to reflect their new expectations and policies . See also Research A-Z Payment to Research Participants , heading "Incentive," subheading "HSIP."
• The statement in section 9.2 about the expiration or termination of HIPAA Authorization has been revised. Representatives of the Compliance Office reviewed and approved these changes.
• Section 11: Language from a former orange box has been added indicating participants will receive a copy of the  signed and dated informed consent document.
• The template’s signature section, formerly section 12, is now numbered Section 13.
• Signature boxes pertaining to optional aspects, such as unspecified future use and participation in sub-studies, were altered to contain yes/no boxes, but with a note instructing researchers to collect subjects’ signatures only when they select the yes box.

New section: data and biospecimen storage, future use, and sharing

To better organize consent document information by clearly separating main study information from all information about data and biospecimen storage, future use, and sharing, this document contains a new section. The new section 12 shifts the signature section to a new section 13.

• 12.1: Explaining the concepts of storage, use, and sharing.
• 12.2: Detailed description of each possible type of storage, use, and sharing, each enclosed in its own blue help text box, as follows.
• 12.2-A: Storage, future use, and sharing of information permitted by the revised Common Rule and applicable to most research under IRBMED oversight The language (previously in Section 4.4) has been updated to include a selection for industry sponsored or investigator-initiated research; all research submitted to IRBMED must include one of these two statements. This segment alerts potential participants that any data that have been used, placed in the medical record, or, in the majority of cases, shared with others cannot be retrieved and destroyed even if consent to their storage and use is withdrawn. See also Research A-Z Retention of Research Data/Biospecimens , heading "C. Retention for Future Research."
• 12.2-B: Storage, use, and sharing of data per NIH policy—both the data management and sharing (DMS) policy and the genomic data sharing (GDS) policy Language relating to the new DMS policy is new whereas language relating to the GDS policy was previously found in Section 4.1.
• 12.2.C: Storage, future use, and sharing of subjects’ data and/or biospecimens as a necessary condition of participation in the main study This language includes the caution that data may not be retrievable or destructible under certain circumstances. It also clarifies that subjects who withdraw consent to storage, future use, and sharing will be withdrawn from the main study. This language was previously found in Section 4.1.
• 12.2-D: Genomic data sharing in non-NIH-sponsored research This covers scenarios in which researchers are not obliged by policy to share genomic data but choose to do so. This language was previously found in Section 4.1.
• 12.2-E: Optional storage, unspecified future use, and sharing of subjects’ data and/or biospecimens The guidance prompts researchers to caution subjects that if they withdraw their consent to this optional activity, the researchers will attempt but may be unable to retrieve and destroy data and specimens that have been shared with other researchers. It also states that data and materials that have already been used in research, or data that has been placed within the medical record, cannot be retrieved and destroyed. This language was previously found in Section 4.1.

When uploading your informed consent form in eResearch

• New Applications:  Please make sure to delete all instruction boxes, comments, and headers from the original working template. Also be sure to proofread the document for spelling, grammar, and formatting errors.
• Edit the most recent version of the CLEAN informed consent document found in 10-1.1. 

Turn on “Track Changes” feature in Word.

Save “Track Changes” version in .docx or .doc format.

Upload ONLY "Track Changes" document on the previous tracked-changes stack in 10-1.1 using the ellipsis (three dots) next to the version number column. 

• Use the standard naming conventions for stacks from the  Document Revision Guidance, Naming Convention, and Version Control  statement of practice. Also be sure to proofread the document for spelling, grammar, and formatting errors.
• For informed consent documents that are uploaded in eResearch but are no longer in use, please simply change the document file name by adding the phrase “X - Not in use” or "X - Out of Date" to the file name. Do not delete these documents from the eResearch application.

Contact us at  [email protected]  or 734-763-4768 / (Fax 734-763-1234) 2800 Plymouth Road, Building 520, Room 3214, Ann Arbor, MI 48109-2800

A list of IRBMED staff is available through our website .

Edited By: [email protected] Last Updated: August 21, 2024 94:00 PM

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Sample Consent Forms

These consent forms were used in various NIH-funded research projects and have been approved by the relevant local IRBs. These completed forms are meant to complement the sample language found in the other sections. They are not provided as guidance or templates promoted by NHGRI, but as references to inform investigators and IRBs considering these issues. Consent forms should be tailored to each individual study.

Additional Resources

• The Global Alliance for Genomics and Health maintains sample consent clauses relevant to genomics research projects that may be helpful when developing consent forms.  
• The NIH Office of Human Subjects Research Protections has created a useful list of consent templates for NIH Intramural Researchers . These include consent templates that have been updated to comply with the Revised Common Rule, as well as older forms that might be useful in crafting consent language.   Note: these templates are not specifically for genomics projects .

Related Content

Last updated: March 16, 2022

Medical Research: Forms & Consent Templates

Main navigation.

This section contains all of the forms and consent templates that apply to investigators from:     • School of Medicine (SoM)    • Veteran's Affairs (VA) Hospital 

*Please note that when creating a protocol for IRB submission, these investigators need to select the Medical eProtocol Application category.

If you have questions or are having trouble accessing these forms, please contact IRB Education ( email or call 650-724-7141).

The consent/assent form should be in a language that is understandable to someone without a medical or scientific background. Please use the Microsoft Readability Statistics tool as needed when writing your consent form.

See  consent template updates  for recent changes.

Other Forms:

eProtocol Forms:

Examples and Tools

Informed consent documents explain to potential participants the information that a reasonable person would want to have in order to make an informed decision about whether to participate. Using this standard, informed consent remains focused on what information a reasonable person would want to have to make an informed choice about participation; this includes:

• the nature of the research project,
• why they are candidates for the research,
• what risks, benefits, and alternatives are associated with the research, and
• what rights they have as research subjects.

The consent form is one part of the dialogue that investigators have with each subject.

Informed Consent Document Tips

It is recommended that forms for adult subjects be written at a 6 th -grade reading level or lower, information should be accurate, precise, in sufficient detail, and organized in a way that facilitates an understanding of why one might, or might not, want to participate.

Moreover, the informed consent should not merely be a list of isolated facts. Many consent forms are not as good as they could be in terms of aiding decision-making. The goal is to help people process the complicated information they’re being given and make it easier for them to make a more informed decision. Ways to facilitate understanding:

• sentences and paragraphs are short,
• terms and concepts are simple,
• technical information is explained in non-technical ways, and
• subjects are directly addressed as “you;” investigators are referred to as “we.”

The consent form should be easy to look at, with:

• a clear layout,
• white-space borders, and
• easy to read fonts.

Exempt Research Informed Consent Example

Non-Exempt Research Informed Consent Example

WTO / Legal / Consent / Free Informed Consent for Research Templates

Free Informed Consent for Research Templates

From schools and colleges to medical studies, groups can be given research projects to work on. Specific research studies will need consent if any human participants are involved. This is to protect the faculty of the school and the students running the test from liability should there be any incidents. Consent is recorded using a Research Informed Consent Form .

What is Informed Consent in Research?

When doing research using human beings, informed consent means going over the details of the research being done, any medications, risks potential , benefits, and they must be aware that they are volunteers that can withdraw from the study at any time they wish. The participant must give this consent before they enter any research facility.

Free Templates & Examples

What is a Research Informed Consent Form?

This is the document that participants of research will sign once all of the details of the study have been gone over and are clearly understood by the participants. It frees those researching liability and makes the participants aware of their responsibilities as well. Any risks must be fully documented on the form.

The standard consent process has two separate stages:

• Stage 1: In this stage, information is given, and the participant is given time to reflect upon that information. They are under no obligation to respond or agree to anything.
• Stage 2: This is the stage where consent is obtained. The terms of the research project are gone over individually, and the participant agrees to each of these terms before they can participate in the research. Once the Research Informed Consent Form has been signed, consent has been given.

All researchers must ensure that they comply with the General Data Protection Regulation both during the research and after. If the research you are doing will involve photos or filming , you need to gain consent for that as well.

This type of form is used to protect the people, and the organization is researching liability issues should something happen to a participant. Without it, if the participant should become injured or ill during the research, they can sue the organization and researchers because there is no proof that they were legally made aware of any risks.

Also, if a threat is not mentioned in the consent form, it can make the researchers liable. This is why it’s essential to be very thorough and disclose all of the facts and information regarding the research being done.

When Should a Research Informed Consent Form be Used?

Written consent forms should be used in situations where:

• The research project has several stages or is complex
• Initial access to participants requires that written information is provided.
• You need to have extra proof that the participants understood the consent terms, especially where consent is necessary for data copyrighting and future use.

What It Should Include?

Your form should have the title of the research study being done, along with the contact information of the leading researcher overseeing the project. Next, there should be detailed information on the study’s purpose, what procedures will be used, any risks to the participants, and any benefits. The participant should initial each of these sections once they have been gone over, and the participant understands the information.

You should have a compensation section if compensation were provided to the participant. You should also have alternative contact details should a participant not wish to contact the primary researcher directly. Lastly, signatures of both the participant and the researcher need to be on the form, along with the date the form is being signed.

Frequently Asked Questions

It is required when doing any type of clinical research. The informed consent procedure is where a competent participant is given all of the details needed to make an informed decision to participate. It needs to show that the participant voluntarily agreed to take part in the research knowing all of the risks and procedures involved.

In general, informed consent forms remain valid for a period for 30-day or the duration of the study.

Yes. Research is voluntary, and participants have the right to stop at any point during the study.

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