research consent letter sample

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IRB Consent Form Templates

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

General Consent Form Templates

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

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

Consent Form Templates for Specific Biomedical Procedures

MRI and fMRI

Blood Collection by Finger Stick

Blood Collection by Venipuncture

Oral Consent Template

Guidance for Protocols Involving Oral Consent

Debriefing Template

Guidance and Template for Debriefing Participants

Studies Involving Children (Assent/Permission Forms)

Parent-Guardian Permission for Studies Involving Children

Sample Parental Notification Form

Sample Child Assent Form

Performance Release for Minors

Performance Releases

Performance Release for Adults

Sample Consent 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 )

• Privacy Policy

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 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

IRB-Health Sciences and Behavioral Sciences (IRB-HSBS)

Phone: (734) 936-0933 Fax: (734) 936-1852 [email protected]

• Human Subjects Protections

Consent, Assent, and Screening Templates

Biomedical Research Consent Templates

Minimal Risk Research Consent Templates (Expedited or Exempt)

These templates are appropriate for social, behavioral, and educational ("SBER") research that does not include any biomedical procedures.

• Study Information Sheet (no signature)
• Consent Form (includes signature)
• Consent Form for Federally Funded Research
• Parent Permission Form (parents provide permission for child to participate)
• Parent Consent Form (parents complete research procedures themselves)
• Oral Consent Script Outline
• Sample Debriefing Script

Biomedical Research Informed Consent Templates

• Biomedical Research Consent Template
• Consent Template for Expanded Access Research
• Right to Try Consent Template
• Humanitarian Use Device Consent Template

Child and Adolescent Assent Templates

• Child Assent Template (Age 7-12)
• Adolescent Assent Template for Non-Treatment Studies (Age 13-17)

Addendum Consent Templates

• Addendum Consent Template for Non-Treatment Studies  (for new procedures, risks)
• Addendum Consent Template for Treatment Studies  (for new procedures, risks)

Screening Scripts

• Screening Script for non-Treatment Studies
• Screening Script for Treatment Studies

Consent Standards and Sample Language

• Social, Behavioral & Educational ("SBER") Consent form Standards and Template Language
• Biomedical Research Consent Form Standards and Sample Language

Comprehension Tools

• PRISM Readability Tool Kit
• Self-Certification of Surrogate Decision Makers for Potential Research Subject's Participation in UC Research  (For use  only  in studies the IRB has reviewed and explicitly approved for surrogate consent)
• Decision-Making Capacity Assessment Tool  (for potential subjects who may have cognitive impairments)

Other References

• Research Participant Bill of Rights/Experimental Subjects Bill of Rights  - available in 34 languages
• Conducting Risk-Benefit Assessments
• Obtaining and Documenting Informed Consent  (v. 07-28-11)
• Requesting Waivers and Exceptions to Informed Consent  (v. 07-28-11)
• Child Assent and Permission by Parents or Guardians  (v. 09-06-11)
• The Use of Legally Authorized Representatives or Surrogate Consent  (v. 06-21-10)
• Recruitment and Screening Methods and Materials  (v. 09-05-11)

We appreciate your suggestions for improving templates and/or adding sample language to the standards documents. Please email  OHRPPEQI@research.ucla.edu to provide your feedback.

Research Informed Consent Form

Thank you for downloading!

How would you rate your free form.

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.

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:

• Phone number
• Email address

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.

Information-consent letters and forms

An information-consent letter is used most often to inform a potential participant about a research study and to document a participant's agreement to take part in the study.

Sample information-consent letters and forms

Statements to include if:

• providing remuneration ;
• using a draw ;
• conducting research with children ;
• collecting data using online surveys/questionnaires (e.g., Qualtrics), Skype/MS Teams/Zoom platforms or other online data collection methods ; and/or
• anonymous survey . 

If providing remuneration include the following in the information letter:

• of cash or near-cash with value less than $300 include: "The amount received is taxable. It is your responsibility to report this amount for income tax purposes."
• value $300 or more include the following: "The amount received is taxable. You will be asked to sign a release of personal information form for purposes of remuneration and for issuing a tax slip."

If using a draw include the following in the information letter:

"In appreciation of the time you have given to this study, you can enter your name into a draw for 1 of X prizes. The prizes include [insert prizes and dollar value, for example "a movie pass or a $10 Tim Horton's gift card"]. Your odds of winning one of the prizes is 1 in X [or if the odds is unknown or difficult to determine the following can be stated: "Your odds of winning one of the prizes is based on the number of individuals who participate in the study. We expect that approximately X individuals will take part in the study."] Information collected to draw for the prizes will not be linked to the study data in any way, and this identifying information will be stored separately, then destroyed after the prizes have been provided. The amount received is taxable. It is your responsibility to report this amount for income tax purposes."

If conducting research with children where you may be obligated to disclose information that would need to be reported include the following in the information letter to the parents/guardians:

• "In cases where researchers believe that a child may need protection from harm, researchers must by law report this information to authorities."

  Updated: If using an online platform (e.g., MS Teams, Zoom) to collect data from surveys, interviews or focus groups, include the following language in the information letter.

If using a University of Waterloo supported platform (e.g., MS Teams, Zoom):

• “The interview will be conducted over an online platform, [name of platform]. [Name of platform] has implemented technical, administrative, and physical safeguards to protect the information provided via the Services from loss, misuse, and unauthorized access, disclosure, alteration, or destruction. However, no Internet transmission is ever fully secure or error free.” 

If using another platform (e.g., Google Forms, Survey Monkey) :

• “The interview will be conducted over [insert name of platform]. When information is transmitted over the internet privacy cannot be guaranteed. There is always a risk your responses may be intercepted by a third party (e.g., government agencies, hackers). University of Waterloo researchers will not collect or use internet protocol (IP) addresses or other information which could link your participation to your computer or electronic device without first informing you." 

Internet Survey Using  Qualtrics : (Note: this statement can be used because uWaterloo has a license for this software) 

• "You will be completing the study by an online survey operated by Qualtrics. Qualtrics has implemented technical, administrative, and physical safeguards to protect the information provided via the Services from loss, misuse, and unauthorized access, disclosure, alteration, or destruction. However, no Internet transmission is ever fully secure or error free. 

[If IP tracking is turned off]: “Please Note: We do not collect or use internet protocol (IP) addresses or other information which could link your participation to your computer or electronic device.” 

[If IP tracking is not turned off]: “Qualtrics temporarily collects your computer IP address to avoid duplicate responses in the dataset but will not collect information that could identify you personally.” 

Internet Survey ( Using something other than Qualtrics ) 

• “When information is transmitted or stored on the internet privacy cannot be guaranteed. There is always a risk your responses may be intercepted by a third party (e.g., government agencies, hackers). [Name of company] temporarily collects your [company/contributor] ID and computer IP address to avoid duplicate responses in the dataset but will not collect information that could identify you personally." 

For researchers who wish to offer an alternative to online participation or for participant groups with limited access to the internet please include:

• "If you prefer not to participate using this online method, please contact one of the researchers so you can participate using an alternative method such as a paper-based questionnaire or telephone call. The alternate method may decrease anonymity but confidentiality will be maintained."

If conducting an anonymous survey include something similar to the following in the information letter:

• "Because this is an anonymous survey the researchers have no way of identifying you or getting in touch with you should you choose to tell us something about yourself or your life experiences."

Waterloo finance policy on remuneration to research participants

Informed consent process and checklist for creating an information consent letter

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• Understanding Risk in Research
• Vulnerable Participants
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• Determining HSR or SBS

Consent Templates

The templates below were created to help you create the documents you will need to communicate to participants what they will do in the study. The documents you provide participants will range from recruitment materials to post-debrief consent forms, and you need to submit everything that you provide to a participant to our Board for review. For more information about the consent process see  Consent .

• General Consent Template : This form covers all of the basic elements that are required for a consent document. Even if you don't plan to use this exact document, refer to it to ensure that you have all of the appropriate elements in place in your consent procedure.
• Electronic Consent Template :  This form is modeled after the General Consent Template with some modifications that make it more appropriate for an online format. For more information about this template, see Electronic Consent . 
• Parent Consent : If you are including minors in your study, you will need to provide a consent form for parents and an age appropriate assent form for minors. This form is a guide for creating a parent informed consent document. This form can also be used as a guide for surrogate consent procedures.
• Minor Assent (for ages 13-17) : This template provides the basic elements required for older minors to provide assent and could also be used as a model for higher functioning individuals with diminished mental capacity.
• Minor Assent (for ages 7-12) : This template provides the basic elements required for younger minors to provide assent and could also be used as a model for higher functioning individuals with diminished mental capacity. For children younger than 7, assent forms are not required but include information in the consent section regarding what you will say to them about the study (where appropriate).
• Capacity to Consent Template : For some participant populations, it may be necessary to determine if a participant is able to provide consent; if not, a surrogate can be used (you will also need a surrogate consent form and participant assent form, similar to the parent/child consent/assent forms).
• GDPR Informed Consent Addendum : If you are collecting data from citizens of the European Union or the United Kingdom, you will need to provide additional information to your participants, per the GDPR. For more information, see the Research in an International Setting and/or Location and International Research Data Source .  
• Study Information Sheet : While many studies do not require researchers to collected signed consent forms, we generally require that participants receive a Study Information Sheet to provide them with information about the study. This information can be provided as a paper document at the beginning of a survey.
• Electronic Study Information Page : This template is similar to the Study Information Sheet with modification for an electronic delivery. For more information about this template, see Electronic Consent .  
• Parent Notification Template : Typically used for studies in an educational setting (particularly where the study is exempt but parent notification is still required), this template is a guide for creating a notification letter to send home to parents.
• Oral Consent Card : Typically used in anthropology studies where the participant may be uncomfortable with a form and/or unable to use it, the Oral Consent Card provides all of the elements required for consent in a bullet format so that the researcher can refer to each point as he or she is obtaining consent from the participant.
• Oral Consent Template : This form is also used in situations where the participant is uncomfortable with a form and/or unable to use it. It is more suited to non-anthropology research (though anthropologists are welcome to refer to it as well).
• Sample Debriefing Form : A debriefing form is a summary of the study given to a participant in a deception study and/or a study that includes students from a participant pool. The purpose is to educate participants about the study and to provide them with resources, particularly if the study is upsetting.
• Advertising Flyer Template : Recruitment materials are part of the consent process and it is important that participants are accurately informed about the study throughout the process. You are not required to use this flyer template (it is a model appropriate for a flyer posted around campus), but it is important that you follow the  guide provided in Recruitment .
• ResearchMatch Advertising Template : The NIH funds a free and secure recruitment tool called ResearchMatch that helps to connect researchers with volunteers that are interested in participating in studies. If you are interested in using ResearchMatch to help advertise for your study, complete this ResearchMatch Advertising Template and upload.
• Materials Release Form : The data you collect from your participants may be useful in other spheres, such as an educational tool and/or library archive. Using data in this manner is beyond the scope of the study and you should seek additional permission to use the participant's data in this way. This form allows a participant to declare how they would like their materials to be used by the researcher if the researcher wants to use the materials in situations beyond the study.
• Data Release Form : This form is similar to the Post-Debrief Consent Form; it is used when a participant has been recorded or photographed without their knowledge.
• Post-Debrief Consent Form : This form is used in a deception study after the deception is revealed to the participant. The participant is given an opportunity to decide if they still want to participate after the true purpose of the study is revealed.
• The title of protocol must match the title on all consent forms.   The title must be relevant, appropriate, and easy to understand. Include the project title on all pages of the consent form.
• List the page numbers on all pages of the consent form  in the standard format: Page 1.
• Delete all colored text from the final copy of your form.   The colored text is for explanation purposes only.
• Make sure that the form matches the descriptions in the protocol  and vice versa.
• Include all relevant information in the consent form  rather than referring to previous verbal explanations.  The consent form should provide a complete explanation of what the participant is agreeing to do in the study.
• Be aware of the needs of the participant.  Avoid using jargon and acronyms that the participant may not understand; make sure the reading comprehension level is appropriate.
• Do not use statements that make implicit demands on participants to participate , e.g., "You will enjoy and benefit from participating in this study."
• Prepare the consent forms in the standard format provided in the template,  with all headings addressed. Use the standard language provided on the template where appropriate.
• Please proofread the consent forms  for grammar and spelling errors.
• Do not use language that revokes a participant’s legal rights .  A consent form is not a legal document.
• Do not require the participants to sign consent to long statements written in first person , e.g., “I agree to participate in this research study.  I understand that the risks are minimal and that I will receive no benefits.  I know how to withdraw from this study.  I will receive $X in payment for participating.  I understand that if I withdraw from the study before my participation is complete, I will receive prorated payment according to the following schedule . . .  I agree not to hold the researchers liable for any injuries resulting from participation in this study. . .”   DO ask participants to sign consent to a simple agreement statement  at the end of the consent form:  “I agree to participate in the research study described above.”

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Templates (consent and recruitment)

Note: consent forms should be written in a way that facilitates participant comprehension. The general recommendation from the Office of Human Research Protections is that consent forms should read at an 8th grade level. Follow these instructions to check the readability of your consent form.

Clinicaltrials.gov " Plain Language checklist for Lay Brief Summaries ," a glossary of lay terms is available in the resources section.  

Consent Template  — (revised 12/20/19) a template that can be used for most studies. This template includes A/V information and a child assent template. 

• TIP! make sure your consent form and application consistently describe the study. Lack of congruency across documents is a frequent IRB comment. 

Online Study Consent Template  - (revised 4/10/20) a template to be used for online studies

Parental Consent Template  — a template to be used for parental consent 

Assent Template - (posted 10/21/22) - this template can be used for children under 12 years of age some adult populations that may have limited decision making capacity. 

Clinical Trial and Biomedical Study Consent Template  - (new 11/5/21) use this template for clinical trial and biomedical studies. 

Audio/Video Consent Form - RETIRED, relevant information has been merged with the "consent template." 

Class Project Consent Form  - this template is only to be used for class project applications - do not use this for requests submitted via Kuali. 

Letter of Support  — A sample letter of support for research from a school/institution/entity, to be used as a template by the investigator.

Recruitment Guidance and Template  — This includes information on participant recruitment (including the use of social media) and includes templates for letter, email, and flier recruitment. 

Debriefing Template  - for deception studies - a template to be used when creating a debriefing script.

Referral Template - This template provides counseling referral contact information for projects that involve sensitive or emotional content. This is not a referral procedure - investigators are responsible for developing their own procedures. 

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Action Research Tutorials-CCAR

Action research tutorials, tutorial 5: plan for action, consent letters.

When is a consent letter needed? Action research is conducted primarily on the researcher as it is about improving skills through taking action. When actions are a part of doing one's job and do not require anything that a person would not already be doing as a part of their job, then one could argue that informed consent is not required, but it is crucial all people involved are aware of the effort. This means that any immediate supervisor should be aware of the plans and those involved should also know what is being done and why. Often this can be accomplished informally with co-workers. For example one might say to co-workers, I am interested in the way that social networking might improve the way we deal with this specific problem. Are you interested in exploring this with me? In this way, you enlist co-action researchers in your investigations, not subjects. However, if you are dealing with a protected group, such as children, you need to be very careful that your procedures have been approved by your academic advisor, your work supervisor or any other body that either of these people might require. In this case, a consent or information letter to the parents is good practice. If the activity is part of your teaching and you expect all students to participate in all aspects of the activity, then an information notice rather than a consent letter might be sent to the parents. If school-age children are being asked to give feedback on your teaching or complete a voluntary survey, it is likely that you will follow research approval procedures including collecting parental consent. Pay attention to your situation and edit these letters as appropriate for your situation. For example, an educational activity may be something that will be expected of all children in the classroom and therefore is not voluntary. So you would delete the comment about this activity being voluntary.  

Templates for Action Research letters

1) Consent Letter Template for an Action Researcher in a Graduate Program 2) Consent Letter Template for an A ction Researcher in a School 3) Information Letter Template  

1) For a Graduate Student...

Dear Parent/Guardian: I am a graduate student in _[name of program and university]. I am working towards a [type of degree] degree in [type of degree]. As part of my work, I want to increase my skill and understanding of [topic of research]. Specifically, I want to understand more about [details of action research project]. My goal is to improve my skills in [anticipated outcomes of the project]. I expect that this will help your child/the student in my class to be able to.  I would like to invite your child to participate in this activity. I will [a detailed description of what you will be doing, where it will take place and who will be involved, and their role and relationship to the child]. This will involve keeping track of [detailed description of any data collected and what exactly will be done with it. Specify any risks that you see to the student, no matter how minor they might seem. For example, "students might be concerned to let other students see their writing" and then what you are going to do to minimize this risk. ] I will protect your child's identity and privacy by [paragraph of how you will protect the child's privacy specifically concerning analysis and sharing of data with others in discussions or reports] Participation in this activity is voluntary. Your child is free to refuse to be interviewed, surveyed, and observed. Your child may change his/her mind about participating in this activity at any time. Your child’s standing in [activity or class] will not be influenced by agreeing or refusing to participate in any portion of this project. If you have any questions about my plans, please contact me, [name] by e-mail [email] or by phone [number]. You are also welcome to contact my professor, [name] at [contact information] .  If you agree that your child can take part in my project, please return a signed copy of this form to me as soon as possible. You may keep the other copy for future reference. Thank you in advance for your cooperation, and I hope your child enjoys [name the activity]! I am very excited about the potential of [name of project] to improve [anticipated outcome for the child]. I give my permission for my child [name] to participate in the [name of project]. Date:_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ Parent/Guardian Signature:_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ Please print your name on this line:_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ Questions or concerns about your rights in this research project can be directed to [contact information] EXAMPLE of a Consent Letter using his Template  

Template for teachers engaged in Action Research on their own.

Dear Parent/Guardian of _: I am your child's [topic or grade level] teacher, and I want to increase my skill and understanding about [topic of action research]. Specifically, I want to understand more about [more details about the project]. My goal is to improve my ability to help your child (or the students in my class) to be able to. I would like to invite your child to participate in this activity. I will ....[detailed description of what you will be doing]. This will involve keeping track of [detailed description of any data collected and what exactly will be done with it. Specify any risks that you see to the student, no matter how minor they might seem. For example, "students might be concerned to let other students see their writing" and then what you are going to do to minimize this risk. ] I will protect your child's privacy by [paragraph of how you will protect the child's privacy specifically concerning analysis and sharing of data with others in discussions or reports] (if there are risks) The risks that I see to your child is the possibility of concern over [describe any risks you see to the student, for example, concern about sharing their ideas with others.] I will reduce this risk by [what will you do to minimize the risk, for example, work with the students to develop a respectful attitude for sharing work in progress).  Participation in this activity is voluntary. Your child is free to refuse to be interviewed, surveyed, and observed. Your child may change his/her mind about participating in this activity at any time. Your child’s standing in [describe action - technology club, running team or program] will not be influenced by agreeing or refusing to participate in any portion of this project. If you have any questions about my plans, please contact me, [name] by e-mail [email] or by phone [number]. You are also welcome to contact Principal [name] at [contact information] with any questions you might have.  If you agree that your child can take part in my project, please return a signed copy of this form to me as soon as possible. You may keep the other copy for future reference. Thank you in advance for your cooperation, and I hope your child enjoys [name the activity]! I am very excited about the potential of [anticipated outcome for the child and researcher]_ I give my permission for my child [name] to participate in the [name of project]. [name]_ _ _ _ _ _ to participate in the [name of project]. Date:_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ Parent/Guardian Signature:_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ Please print your name on this line:_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ Questions or concerns about your rights in this research project can be directed to [contact information] (If the impact is minimal and you see no risks, your school district might only require passive consent, in which case you might change the last paragraph to something more like: I expect that participation in this experience will benefit your child as well as help me improve my skills in [area you are working on]. If you would do not want to have your child participate, please contact me. [name and contact information] An Information Letter Template Dear Parent/student/Coworker/ This year I am working on developing my skills to ... I am pleased to be working with you/your child and hope you will help me in my quest to learn more about..... I look forward to learning with and from you and hope that you will be willing to share your feedback and be as honest as possible. I will learn more if you are willing to share what you notice or think about these new ideas. You can reach me at (contact information is not already known)

• Sample Forms

FREE 8+ Sample Research Consent Forms in PDF | MS Word

The research consent form is a smart way to legalize the participation of a candidate in the research work. If you are doing a research and would be interviewing somebody and asking lots of questions etc, the answers to which you would be the using in your studies, you must take the prior consent of the person. One must be willfully participating in a research. New researchers may have a cloudy concept of what exactly a well-formatted consent form with all clauses should look like. For a complete guide, the templates are made available online. You May also See  Survey Consent Forms

Research Consent Form Template

Sample consent form - 8+ examples in word, pdf, sample informed consent form - 9+ examples in pdf, word, sample interview consent form - 9+ free documents download in ..., medical research consent form.

Size: 516 KB

If you are interviewing somebody for a medical research, the purpose being medical or clinical studies, then you must make use of this format or template. This contains all important points which your participant should be aware of, and agree to. The party should read thoroughly and sign the consent form to be a part of your medical research.

Qualitative Research Consent Form

Size: 49 KB

The consent form format is for qualitative research. Any qualitative research campaign which involves interviewing parties, and nothing in their opinions or recording of their sounds or videos etc, should take consent of the parties through this form. This template contains a complete structured format.

Psychology Research Consent Form

Size: 66 KB

The psychology research consent has to be taken from them who would be participating in the research. This consent form will tell the participants that their statements are recorded or videoed for research work and that these would be used for drawing conclusions about psychological studies. The consent of the participants is very important so that you do not face any legal issue later.

Patient Research Consent Form

Simple Research Consent Form

Sample Research Consent Form

Size: 68 KB

Example Research Consent Form

Size: 24 KB

Printable Research Consent Form

Size: 128 KB

Basic Research Consent Form

Size: 257 KB

Why You Need the Research Consent Form

The simple reason why you need the consent form to be signed by the parties duly before you start interviewing or experimenting is, to avoid legal conflicts with any participant in future. If your participant challenges you anytime in the future that you wrongfully took their interview and had no right to publish or use their statements in any work or public releases, then you would be in trouble. To make it safe and legal from the beginning, you must make them sign the consent form after thoroughly reading and agreeing to what they read.

Importance of the Consent Form Template

The templates of research consent forms are quite important for use especially when you are a new researcher. A new researcher would obviously have lesser knowledge of consent form uses, formats etc. To help them out the templates plays a great role. It gives you a full structured form and the clauses in most cases are universally applicable for all researchers. Therefore you have to give in minimal effort for customizing. Only your research details and subject etc has to be entered at appropriate places to complete the form and use it. With the use of a well-structured consent form, you will be in a safe side forever as the researcher, and will not be questioned by authorities. You May also See  Medical Consent Forms

How to Use the Template

The simple use of the templates is by downloading them from an online template bank, and then customizing them as per the requirements of your research paper or topic. To do this you will have to surf through the various styles of research consent form templates. They are available in Word and PDF formats. It will take you a little time, and soon you will spot the one needed. Most downloads are free while some ask for a minimal charge. After you download, read thoroughly to keep on adding details of your paper wherever applicable. Finally, the form is personalized and ready for use. Get a print, and get going.

The use of research or informed consent form is mandatory in today’s research work and is smart and must use to avoid legal complication and challenges to your work. You can make it simple by downloading a template format online and use this to make a perfect consent form.

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