The Office of Research Integrity and Compliance (ORIC) provides the templates below to help researchers prepare consent documents for IRB review. Each template shows the required wording, the guidance for each section, and the places where you will add details about your study. Download the Word version to build your own document.
Which Template Do I Need?
Informed Consent Agreement
For adult participants when you will collect a signed record of consent. Use this for most studies.
Signature: Required from the participant
Informed Consent Cover Letter
For adult participants when no signature is collected, usually with anonymous surveys.
Signature: Not required
Parent/Guardian Permission
For participants under 18. A parent or legal guardian gives permission before the child takes part.
Signature: Required from parent/guardian
Assent or Assent Script
For children, alongside parent/guardian permission. Written assent for ages 7 and older; a verbal script for children who cannot yet read.
Signature: Requested when possible
Studies with minors need two documents
If your participants are children, plan to submit both the Parent/Guardian Permission form and an Assent form or script. The parent’s permission does not replace the child’s own agreement.
Before You Start
Avoid the most common cause of IRB delays
An incomplete or unclear consent document is one of the most common reasons IRB approval is delayed. Following these templates closely will help your submission move through review smoothly.
- Write in the second person (“you will be asked to…”).
- Use 12-point font and aim for a sixth to eighth grade reading level.
- Keep the required wording exactly as written. It does not need to be bold in your final document.
- Remove all guidance text before you submit. Your final document should contain only the language participants will read.
- Students: do not list your personal phone number or email address. Use your research advisor’s UCA contact information instead.
- Data storage: research data must be stored at UCA for at least three years after the study is completed.
Informed Consent Agreement
Use this template when adult participants will sign to show their voluntary agreement to take part.
Download Word Template (.docx)
University of Central Arkansas
Informed Consent Agreement
[Your Research Study Title]
If including the exact title might bias the results, use a general title instead.
Required wording
You are being asked to participate in a research study. Before you give your consent to volunteer, it is important you read the following information and ask as many questions as necessary to be sure you understand what you will be asked to do.
Investigators
Provide the names and degrees of all investigators involved in the research study. Indicate the department and institution with which each investigator is affiliated. If you are a student, include the name and phone number of your research advisor. Also provide the UCA address and phone number.
If you are a student, please do not list your personal phone number or email address.
Purpose of the Research
This research study is designed to . . . [state what the study is designed to assess or study].
The data from this research will be used to . . . [explain how data will be used].
If you are a student, indicate how the results will contribute to your course of study.
Procedures
If you volunteer to participate in this study, you will be asked to . . . [describe what the subject will do step-by-step, using lay language].
If the description is complicated, use bullets or number the steps. If controls are used, also explain what will be expected of the controls.
Your participation will take approximately . . . [amount of time required; if more than one session, frequency, etc.].
If any procedures are experimental, identify them here. If audio or video recordings will be made, state this and how they will be used.
Potential Risks or Discomforts
DO NOT state that there are no risks or discomforts. You may say there are no foreseeable risks associated with the study. Describe any reasonably foreseeable risks, discomforts, inconveniences, or costs associated with this research that the subjects may encounter. These could be physical, psychological, emotional, social, or economic. Inform the subject of any provisions for managing these and of the subject’s right to stop participating, either temporarily or permanently.
Potential Benefits of the Research
Describe any benefits the subjects can expect as a result of participating in the study. If there are no benefits to the subjects, state this. Describe any potential benefits to science/society that may result from this research.
Identifiable Private Information or Identifiable Biospecimens
Include one of the two statements below, based on your research plans.
Option A
Use if future research use is possible.
Identifiers might be removed. After such removal, the de-identified information or biospecimens could be used and/or distributed to another investigator for future research without additional informed consent from the subject or the legally authorized representative.
Option B
Use if there will be no future research use.
Subjects’ information or biospecimens collected as part of this research will not be used or distributed for future research studies, even if identifiers are removed.
Confidentiality and Data Storage
Describe the precautions taken to preserve the confidentiality/privacy of subjects. If confidentiality will NOT be maintained, state this and explain if names, images, or recordings will be used and how and when they will be used.
Include the procedures for using and storing data [e.g., in Dr. X’s office] and who will have access to the data [e.g., the investigator and advisor]. Data must be stored at UCA for at least 3 years after completion of the study.
If video or audio recordings will be used, describe exactly how the recordings will be used, who will have access, how long the recordings will be stored, and when they will be destroyed.
Participation and Withdrawal
Required wording
Your participation in this research study is voluntary. You may refuse to participate without penalty. If you decide to participate, you are free to stop at any time without penalty by just stopping and/or telling the investigator.
If subjects can withdraw after data collection has taken place, say something like:
To withdraw from the study after data collection has been completed, contact . . . [tell who to contact and how].
If the data is anonymous, say something like:
You may not withdraw from the study after data collection has been completed since your name is not linked to the data.
Questions about the Research
Required wording
If you have any questions about the research, please ask them now. If you have questions later, you may contact . . . [name(s), UCA phone].
If you are a student, please do not list your personal phone number or email address.
Required wording
This research project has been reviewed and approved by the Institutional Review Board for the Protection of Human Subjects at the University of Central Arkansas. If you believe there is any infringement upon your rights as a research subject, you may contact the Research Compliance Coordinator at (501) 450-3451.
Subject’s Agreement
Required wording
I have read the information provided above. My signature below indicates my voluntary agreement to participate in this research study. Please return one copy of this consent form and keep one copy for your records.
If audio/video recording and/or names will be used, add a statement about also agreeing to be recorded and/or named.
Signature of Research Subject
Date
Signature of Investigator (optional)
Date
Additional elements: include only when appropriate
Incentives to Participate
An incentive or inducement is something like money or a gift certificate. Candy or stickers are considered token gifts. If an incentive is offered, describe what is being offered and what is required to obtain it. Incentives and token gifts are given even if the subject does not complete participation.
Reasons for Exclusion from this Study
State in basic lay language the reasons a subject should be excluded from participating (e.g., being a smoker, pregnant, under the age of 18, a medical condition). Include only those reasons that could not be pre-determined by the investigator.
In Case of Injury
Include this section if your study involves MORE than minimal physical risk.
Required wording
It is unlikely that participation in this project will result in harm to participants. If an injury to a participant does occur, he or she may be seen by Student Health Services or a local or regional medical facility. All expenses associated with care will be the responsibility of the subject and his/her insurance.
If the research is not conducted at UCA or the subject is not a UCA student or employee, leave out the option of using Student Health Services.
Informed Consent Cover Letter
Use this template when no signature is collected from participants, usually with anonymous surveys. Participants agree by completing the survey or interview.
Download Word Template (.docx)
University of Central Arkansas
Informed Consent Cover Letter
[Your Research Study Title]
If including the exact title might bias the results, use a general title instead. You may write this as a letter, but make sure to include the information listed below.
Required wording
You are being asked to participate in a research study. Before you give your consent to volunteer, it is important that you read the following information to be sure you understand what you will be asked to do.
Investigators
Provide the names and degrees of all investigators involved in the research study. Indicate the department and institution with which each investigator is affiliated. If you are a student, include the name and phone number of your research advisor. Also provide the UCA address and phone number. If you are a student, please do not list your personal phone number or email address.
Purpose of the Research
This research study is designed to . . . [state what the study is designed to assess or study].
The data from this research will be used to . . . [explain how data will be used].
If you are a student, indicate how the results will contribute to your course of study.
Procedures
If you volunteer to participate in this study, you will be asked to . . . [describe what the subject will do, using lay language].
If the description is complicated, use bullets or a list.
Your participation will take approximately . . . [amount of time in minutes or hours].
Potential Risks or Discomforts
DO NOT state that there are no risks or discomforts. You may say there are no foreseeable risks associated with the study. Describe any reasonably foreseeable risks, discomforts, inconveniences, or costs associated with this research that the subjects may encounter. These could be physical, psychological, emotional, social, or economic.
Potential Benefits of the Research
Describe any benefits the subjects can expect as a result of participating in the study. If there are no benefits to the subjects, state this. Describe any potential benefits to science/society that may result from this research.
Identifiable Private Information or Identifiable Biospecimens
Include one of the two statements below, based on your research plans.
Option A
Use if future research use is possible.
Identifiers might be removed. After such removal, the de-identified information or biospecimens could be used and/or distributed to another investigator for future research without additional informed consent from the subject or the legally authorized representative.
Option B
Use if there will be no future research use.
Subjects’ information or biospecimens collected as part of this research will not be used or distributed for future research studies, even if identifiers are removed.
Confidentiality and Data Storage
Describe the precautions taken to preserve the confidentiality/privacy of subjects. If confidentiality will NOT or CANNOT be maintained, state this and explain.
Include the procedures for using and storing data [e.g., in Dr. X’s office] and who will have access to the data [e.g., the investigator and advisor]. Data must be stored at UCA for at least 3 years after completion of the study.
Participation and Withdrawal
Required wording
Your participation in this research study is voluntary. You may refuse to participate or stop participation at any time without penalty. To stop . . . [tell how, e.g., simply stop answering the questions, turn in an incomplete survey, tell the investigator].
Questions about the Research
Required wording
If you have any questions about the research, you may contact . . . [name, UCA phone, email, mailing address, whatever is appropriate to your study].
If you are a student, please do not list your personal phone number or email address.
Required wording
This research project has been reviewed and approved by the Institutional Review Board for the Protection of Human Subjects at the University of Central Arkansas.
Required wording
I have read the information provided above. I understand that . . . [by returning a completed questionnaire/survey, by agreeing to be interviewed, etc.], I am agreeing to participate in this research study.
Required wording
KEEP THIS INFORMED CONSENT COVER LETTER FOR YOUR RECORDS.
Investigator signature and date are optional, but a nice touch.
Parent/Guardian Permission
Use this template when participants are under 18. Pair it with the Assent template so the child is also asked to agree.
Download Word Template (.docx)
University of Central Arkansas
Parent or Legal Guardian Permission for Child to Participate in a Research Study
[Research Study Title]
Required wording
You are being asked to give permission for your child to participate in a research study. Before you give permission for your child to participate, it is important you read the following information and ask as many questions as necessary to be sure you understand what your child is being asked to do.
Investigators
Provide the names and degrees of all investigators involved in the research study. Indicate the department and institution with which each investigator is affiliated. If you are a student, include the name and phone number of your research advisor. Also provide the UCA address and phone number.
If you are a student, please do not list your personal phone number or email address.
Purpose of the Research
This research study is designed to . . . [state what the study is designed to assess or study].
The data from this research will be used to . . . [explain how data will be used].
If you are a student, indicate how the results will contribute to your course of study.
Procedures
If you allow your child to participate in this study, he/she will be asked to . . . [describe what the subject will do step-by-step, using lay language].
If the description is complicated, use bullets or number the steps. If controls are used, also explain what will be expected of the controls.
Your child’s participation will take approximately . . . [amount of time required; if more than one session, frequency, etc.].
If the time required is lengthy, mention that a break (or two) is a possibility.
Your child will be asked to assent to participate in this research. He/she can refuse to participate without penalty or can stop participation at any time just by telling the investigator he/she wants to stop.
If a token gift (e.g., candy, pencil, stickers) will be given to the child for participation, mention it here. If any procedures are experimental, identify them here. If audio or video recordings will be made, state this and how they will be used.
Potential Risks or Discomforts
DO NOT state that there are no risks or discomforts. You may say there are no foreseeable risks associated with the study. Describe any reasonably foreseeable risks, discomforts, inconveniences, or costs associated with this research that the subjects may encounter. These could be physical, psychological, emotional, social, or economic. Inform the parents/guardians of any provisions for managing these and of the subject’s right to stop participating, either temporarily or permanently.
Potential Benefits of the Research
Describe any benefits the subjects (or the parents/guardians) can expect as a result of participating in the study. If there are no benefits to the subjects, state this. Describe any potential benefits to science/society that may result from this research.
Identifiable Private Information or Identifiable Biospecimens
Include one of the two statements below, based on your research plans.
Option A
Use if future research use is possible.
Identifiers might be removed. After such removal, the de-identified information or biospecimens could be used and/or distributed to another investigator for future research without additional informed consent from the subject or the legally authorized representative.
Option B
Use if there will be no future research use.
Subjects’ information or biospecimens collected as part of this research will not be used or distributed for future research studies, even if identifiers are removed.
Confidentiality and Data Storage
Describe the precautions taken to preserve the confidentiality/privacy of subjects. If confidentiality will NOT be maintained, state this and explain if names, images, or recordings will be used and how and when they will be used.
Include the procedures for using and storing data [e.g., in Dr. X’s office] and who will have access to the data [e.g., the investigator and advisor]. Data must be stored at UCA for at least 3 years after completion of the study.
If video or audio recordings will be used, describe exactly how the recordings will be used, who will have access, how long the recordings will be stored, and when they will be destroyed.
Participation and Withdrawal
Required wording
Participation in this research study is voluntary. You may refuse to allow your child to participate without penalty to you or your child. If you decide to allow your child to participate, you are free to stop his/her participation without penalty by just stopping and/or telling the investigator. Also, your child may stop participating by telling the investigator he/she wants to stop.
If subjects can withdraw after data collection has taken place, say something like:
To withdraw from the study after data collection has been completed, contact . . . [tell who to contact and how].
If the data is anonymous, say something like:
You may not withdraw from the study after data collection has been completed since your name is not linked to the data.
Questions about the Research
Required wording
If you have any questions about the research, please ask them now. If you have questions later, you may contact . . . [name(s), UCA phone].
If you are a student, please do not list your personal phone number or email address.
Required wording
This research project has been reviewed and approved by the Institutional Review Board for the Protection of Human Subjects at the University of Central Arkansas. If you believe there is any infringement upon your rights as a research subject, you may contact the Research Compliance Coordinator at (501) 450-3451.
Parent or Legal Guardian Permission
Required wording
I have read the information provided above. I agree to let my child participate in this research study. I also understand my child’s assent to participate in this study will be sought. Please return one copy of this consent form and keep one copy for your records.
If audio/video recording and/or names will be used, add a statement about also agreeing to be recorded and/or named.
Name of Child (please print)
Signature of Parent/Legal Guardian
Date
Signature of Investigator
Date
Additional elements: include only when appropriate
Incentives to Participate
An incentive or inducement is something like money or a gift certificate. Candy or stickers are considered token gifts. If an incentive is offered, describe what is being offered and what is required to obtain it. Incentives and token gifts are given even if the subject does not complete participation.
Reasons for Exclusion from this Study
State in basic lay language the reasons a subject should be excluded from participating (e.g., being a smoker, pregnant, under the age of 18, a medical condition). Include only those reasons that could not be pre-determined by the investigator.
In Case of Injury
Include this section if your study involves MORE than minimal physical risk.
Required wording
It is unlikely participation in this project will result in harm to participants. If an injury to a participant does occur, he or she may be seen by a local or regional medical facility. All expenses associated with care will be the responsibility of the participant’s parents/legal guardian and his/her insurance.
Assent or Assent Script
Use this template to ask children for their own agreement to participate, after a parent or guardian has given permission.
Download Word Template (.docx)
Written assent (ages 7 and older)
If children seven years and older will be included in the study, an assent agreement (requiring signature, if possible) is necessary.
Use age-appropriate language: the younger the child, the less information given. A typical teenager could receive an assent (or an informed consent cover letter) using the same language as an adult.
Images and a larger font size are appropriate for younger children. If possible, keep the assent agreement to one page or less.
Verbal assent script (usually ages 6 and under)
If the child is not able to read, present age-appropriate research information verbally to obtain verbal assent. For a very young child, simply ask something like, “Are you ready to [activity], like your mommy/daddy/teacher told you we would be doing today?”
Regain verbal assent periodically throughout the activity, since young children can stay focused for shorter periods. Simply ask, “Would you like to continue or would you like to stop?”
Silence is not assent
When using verbal assent, failure to object should not be taken as assent. Be sure to receive a positive response, such as a “yes” or an affirmative nod. If the child does not want to participate or resists, you must accept that as a refusal. The parent, guardian, or teacher may not pressure the child into participating.
University of Central Arkansas
Informed Assent Agreement
[Insert Research Study Title Here]
All guidance in this template appears in gray italics. Do not include it in your final document.
Some researchers [or students, investigators, or people] at UCA are doing a project about [topic]. This is called a research study.
The purpose of this research study is [simple explanation of the goal of the research/what you are trying to find out].
You are asked to be in this research study because [simple explanation of why the child is invited to participate/has been chosen as a participant].
The researchers in charge of this study are [name investigators].
This study will take place at [state where research will take place] and will last [state how long the child’s participation will take].
During this study, this is what will happen: [simple explanation of procedures; a list often works well].
Depending on the length of time for data collection, you might mention that the child should tell you if he/she needs to use the restroom or just needs a break.
Mention any risks, discomforts, and potential benefits of the study, appropriate for the age level.
If confidential questionnaires are involved, add a section such as:
Only the investigator(s) doing this study will know your answers. Your parents (and teachers, if the study is conducted at the child’s school) will not know.
If it seems appropriate, use one of the following. All incentives must be age appropriate and approved by the IRB.
You will not be given anything for being in this research study. OR You will be given [incentive] for being in this research study.
Required wording
Your (mom/dad/parents/guardians) have said it is okay for you to be in this research study. You do not have to be in this study if you do not want to. If you want to stop, you can tell us by saying, “I would like to stop.”
Please mark one of the choices below:
☐ NO, I do not want to be in this study.
☐ YES, I want to be in this study.
Name or Signature of Subject (as appropriate; not used with anonymous surveys)
Date
Signature of Person Obtaining Assent (optional)
Date
Required wording
KEEP A COPY OF THIS ASSENT FORM FOR YOURSELF.
Submitting your consent documents
Upload your completed consent, permission, and assent documents with your study submission in Cayuse Human Ethics. Before uploading, check that all guidance text and brackets have been removed and that every required statement is included.