Research Ethics Board: Reference materials

The REB Secretariat has prepared a variety of reference materials that provide additional information and more detailed ethics guidance for researchers. For any questions related to these materials, please contact the REB Secretariat at hc.reb-cer.sc@canada.ca or 613-941-5199.

On this page:

Consent form template

This template is provided as a guide for researchers. Researchers are welcome to change or omit any headings and sample text as appropriate to the study.

The consent form should include the letterhead or logo of the principal investigator’s organization(s) in the header of the consent form. After receiving ethics approval, add the approval date and the consent form version number in the footer. The first approved version is v1. If subsequent amendments to the consent form are requested and approved, the approval date and version number (e.g. v2) must be updated.

1. Project title
  • Indicate the title of project. The title must match that provided in Section 1.1 of the Application for Initial Review of Research Involving Humans.
2. Study investigators
  • Include the name, affiliation and contact information of the named investigators listed in Section 1 of the Application for Initial Review of Research Involving Humans.
3. Funding source
  • Indicate the funder or study sponsor.
4. Invitation to participate
  • Include an invitation to participate. The consent form must invite, not ask, the participant to participate in the study. Ensure there is no language that may inadvertently coerce the participant.
  • Assure participants that researchers will inform them of any new findings so they can reassess whether they want to continue to participate in the study.
  • Sample text:
  • You are being invited to participate in a research study. Choosing whether or not to participate is entirely your choice. If you decide not to participate, there will be no negative impacts [on the care you will receive, on your relationship with the researcher, etc.]. The information provided in this form tells you about what is involved in the research, what you will be asked to do, and any potential risks or benefits. Please read this form carefully, take all the time you need, and ask any questions you may have.
  • Consent is an ongoing process. During the research study, we will tell you about any significant finding that could affect your willingness to continue to participate in this study.
5. Purpose of the research study
  • Explain the overall purpose of the research study, in plain language.
  • Describe what the study will assess and what the researcher hopes to achieve.
  • Include a description of the basic study design.
  • Do not use any jargon or technical terms that the prospective participant may not understand.
6. What you will be asked to do
  • Explain, using plain language, what the participant will be asked to do (e.g., complete a survey, participate in focus groups, provide a blood sample).
  • Provide a brief description of the research procedures, using enough detail for the participant to clearly understand what will be expected of them.
  • Include the location of the study, the expected duration of the participant’s involvement, and an explanation of the responsibilities of the participant.
  • Sample text:
  • If you decide to participate in this research, you will be asked to attend [number of visits] at [researcher lab] located at [location]. The visit will take approximately [hours/minutes] during which you will be asked to [describe procedure].
7. Who can take part in the research study?
  • Explain any characteristics the participant must have to be eligible to participate in the study.
  • Any conditions (e.g., being above or below a certain age) that exclude a participant from participation must be stated.
  • Mention the recruitment target/number of participants involved.
8. Possible risks and benefits

Risks

  • Explain, in plain language, all reasonably foreseeable risks, discomforts or inconveniences that may occur as a result of participation in the research.
  • Explain what steps the researcher will take to minimize these risks.
  • Make it clear that if participants feel uncomfortable, they may withdraw at any time.
  • There should always be a statement indicating that risk is involved, even if it is minimal. Sample text for minimal risk studies:
  • The risks associated with the study are minimal. The harms or discomforts are no greater than what an average person would expect to experience in everyday life.
  • Indicate that participants are not waiving their legal rights in the event that they are harmed. Sample text:
  • By agreeing to participate in this research, you are not giving up or waiving any legal rights in the event that you are harmed during the research.

Benefits

  • Explain, in plain language, any potential benefits, both to the participant and in general, that may arise from research participation.
  • If there are no expected direct benefits to the participant, this should be stated. Sample text:
  • There is no guarantee that you will benefit directly from participating in this study. However, your participation will advance knowledge about … which may benefit …
9. Compensation/reimbursement
  • Describe any compensation, incentives or reimbursements to be paid or given to participants. Explain how participant withdrawal will affect the offered compensation (e.g., prorated remuneration).
  • If no compensation will be provided, this should be stated.
10. Privacy and confidentiality
  • Explain what information will be collected about participants and for what purpose.
  • Specify the type of information that will be collected (e.g., will it be coded or de-identified?) and how it will be stored.
  • State who will have access to the collected information.
  • Describe the efforts that will be made to prevent the risk of participant re-identification.
  • For projects led by Health Canada or PHAC researchers, include the following privacy notice:
  • The personal information collected in this research project is handled in accordance with the Privacy Act. We only collect the information we need to carry out the research as authorized under section 4 of the Department of Health Act. In addition to protecting your personal information, the Privacy Act gives you the right to request access to, and correction of, your personal information. For more information about these rights, or about our privacy practices, please contact the Health Canada and the Public Health Agency of Canada’s Privacy Management Division at 613-954-9165 or hc.privacy-vie.privee.sc@canada.ca. You also have the right to file a complaint with the Privacy Commissioner of Canada if you think your personal information has been handled improperly.

Limits to confidentiality

  • Explain any limits on confidentiality.
  • If focus groups will be held, participants should understand that there is no guarantee that other participants will maintain full confidentiality. Sample text:
  • Please be aware that there are limits to confidentiality in a focus group setting. All members of the focus group will be asked to respect the privacy of other members and to keep what is said confidential. However, there is no guarantee that they will do so. Please keep this in mind when deciding what you feel comfortable sharing.
  • Include information regarding any legal obligation to breach confidentiality (e.g., duty to report suspected child abuse, harm to self or others). Sample text:
  • No personal information will be shared with anyone outside of the core research team, unless required by law. Instances where researchers are required, by law, to breach confidentiality include the following: child abuse or neglect that is ongoing and unknown to police, cases of imminent risk of physical harm to oneself or another, cases of sexual abuse, sexual assault, or sexual harassment by a health professional.

Data or sample retention

  • Explain the plans for the data or samples after collection and analysis are complete (e.g., how long it will be retained, when and how it will be destroyed, the security of identified data or samples).
  • If the researcher will submit data to a repository or samples to a biobank, this must be indicated. State the type of information (e.g., directly identifying, de-identified, anonymized) that will be stored.
  • If future use of the data or samples beyond the current study is anticipated, this should be explained. Explain whether future use is part of the study or if participants can opt out (see suggested text on the Signature Page). Clarify whenever possible whether future research will be similar to the current study, and whether the research might include genetic studies.
11. Reporting of results
  • State how, if at all, participants will be informed of the results of the research and whether participants will receive individual results or group results.
  • Provide information regarding the dissemination of research results and the measures that will be taken to maintain confidentiality.
  • Explain whether participants will be identified directly or indirectly. Sample text:
  • We will only report group results; therefore, you will not be identified in any way in our reports.
  • If direct quotes from participants will be used in the analysis, include a statement to this effect. Indicate that any quotes will be anonymized and will not be attributed to a specific individual. Consider giving participants the option to opt out of the use of their direct quotes (see suggested text on the Signature Page).
12. Withdrawing from the study
  • Assure the participant that their participation is completely voluntary, that they are under no obligation to participate and are free to withdraw at any time without consequence.
  • Make it clear that their decision to withdraw will not influence their relationship with the researcher in any way.
  • Explain what will happen to their samples or data if they choose to withdraw.
  • If applicable, clearly state the point in the study at which removal of samples or data becomes difficult or impossible.
13. Conflicts of interest
  • Clearly describe any perceived, real or potential conflicts of interest on the part of the researchers, institutions or sponsors, including the possibility of financial gain from commercialization of the research findings.
14. Questions and contact information
  • Suggested text:
  • If you have any questions about the study, please contact:
  • [Insert name, phone number and email address of the member of the study team who will be available to answer questions or address any problems that may arise.]
  • If you have any questions about your rights as a research participant, you may contact:
  • Health Canada-PHAC Research Ethics Board Secretariat
    70 Colombine Driveway, Room 941C, PL: 0909C
    Brooke Claxton Building, Tunney’s Pasture
    Ottawa, ON K1A 0K9
    Telephone: 613-941-5199
    Facsimile: 613-941-9093
    Email: hc.reb-cer.sc@canada.ca
  • This research study was reviewed and approved by the Health Canada and Public Health Agency of Canada Research Ethics Board.
Signature page
  • Sample text:
  • Project title: Insert title of project
  • Lead researcher: Name and contact information
  • Statement of consent
  • By signing this form, I agree that:
    • The study has been explained to me
    • All my questions have been answered
    • Possible harm and discomforts and possible benefits (if any) of this study have been explained to me
    • I have been told that my personal information will be kept confidential
  • In addition, I understand that:
    • I have the right not to participate and the right to stop at any time
    • I may refuse to participate without consequence
    • I have a choice of not answering specific questions
    • I am free now, and in the future, to ask any questions about the study
    • No information that would identify me will be released or printed without asking me first
    • I will receive a signed copy of this consent form
  • If participants will be provided the choice to opt in or out of certain research elements, consent for those should be sought separately from overall study participation. Clearly indicate that participants can still participate in the study if they do not consent to the optional elements. Sample text (note that these are common examples and not an exhaustive list):
  • You can still participate in the research if you select no:
    • I agree that I may be quoted directly and anonymously: Yes/No
    • I consent to being contacted in the future for participation in research studies: Yes/No
    • I agree to have my samples or data retained for future research: Yes/No
    • I agree that my interview may be audio/video recorded: Yes/No
  • Name:
    Signature:
    Date:
  • If a summary of results is being offered to participants, this option can be provided on the consent form. Sample text:
  • Please provide an email address below if you would like to be sent a summary of the study results.
  • Email address:
  • The consent form should also be signed by the person obtaining consent. Sample text:
  • Signature of the person obtaining consent
  • By signing this form, I attest that:
    • I have explained the study to the prospective participant
    • I answered all of their questions
    • I provided a copy of this consent form to the participant
    • The participant seemed to understand the consent form and agreed to participate
  • Name:
    Signature:
    Date:

Assent form template

This template is provided as a guide for researchers when developing assent forms for children and youth. Researchers are welcome to change or omit any headings and sample text as appropriate to the study. Researchers are encouraged to adapt the template according to the target age group. For example, when seeking assent from young children, it may be beneficial to omit sections or combine sections for simplicity.

The assent form should include the letterhead or logo of the principal investigator’s organization(s) in the header of the assent form. After receiving ethics approval, add the approval date and the assent form version number in the footer. The first approved version is v1. If subsequent amendments to the assent form are requested and approved, the approval date and version number (e.g. v2) must be updated.

1. Project title
  • Include a short version of the main study title or paraphrase the study title so that it is easy to understand.
2. Who are we?
  • Include the name of the named investigators listed in Section 1 of the Application for Initial Review of Research Involving Humans and their institution(s).
  • There is no need to include the study sponsor or funder.
3. Invitation
  • Include an invitation to participate. The assent form must invite, not ask, the participant to participate in the study. Ensure there is no language that may inadvertently coerce the participant.
  • Sample text:
  • Your parents have allowed me to talk to you about a research study. A research study is a way to learn more about something. We would like to invite you to be a part of this study. This paper will explain the study to you, and then you can decide if you want to join. Nobody will make you be part of the study and nobody will be mad if you chose not to join. If you decide to be a part of the study, but change your mind later, you can stop.
4. Why are we doing this study?
  • Briefly explain what the study is about and why it is being done, in plain language.
  • Explain what you hope to find out.
  • Do not use any jargon or technical terms.
5. What will happen in this study?
  • Explain, using plain language, what the participant will be asked to do (e.g., complete a survey, participate in focus groups, provide a blood sample).
  • Provide a brief description of the research procedures, using enough detail for the participant to clearly understand what will be expected of them.
  • Include the location of the study, the expected duration of the participant’s involvement, and an explanation of the responsibilities of the participant.
  • Sample text:
  • If you decide to join this study, you will be asked to come to [number of visits] at [researcher lab]. The visit will take between [insert time range of xx to yy minutes]. At the visit, there are some things we will ask you to do. First, [insert details]. Second, you will be asked to [insert details]. Third, you will be asked to [insert details]. Last, I will ask you to [insert details]. All you have to do is try your best.
6. Can anything bad happen to you?
  • Explain, in plain language, any possible side effects or discomforts that the participant might experience.
  • Make it clear that if participants feel uncomfortable, they can stop at any time.
  • Explain what the participant should do if they are not feeling well during the study.
  • There should always be a statement indicating that risk is involved, even if it is minimal. Sample text for minimal risk studies:
  • We do not think that being in this study will hurt you or make you feel bad. The researchers are doing everything they can to make sure that you feel comfortable. But if you do not feel good about anything you can stop at any time.
7. Will this study help you?
  • Explain, in plain language, any potential benefits that may arise from research participation.
  • If there are no expected direct benefits to the participant, this should be stated. Sample text:
  • Sometimes good things happen to people who are in a research study. These good things are called benefits. We do not know if you will be helped in any way by being in the study. But by participating you are helping us learn more about something important which will hopefully help other children like you. This is a benefit.
8. Who will know that you are in this study?
  • Explain that any information collecting about participants will be kept private.
  • State that only those involved in the study and their parents will know that they took part.
  • Sample text:
  • Your name will not be attached to anything you do during this study. This means that nobody will know which answers were yours or what you did. Only the people involved in the study will see your answers. Your parents will not see your answers.

Limits to confidentiality

  • Explain any limits on confidentiality.
  • If focus groups will be held, participants should understand that there is no guarantee that other participants will maintain full confidentiality. Sample text:
  • Since there are other children in this study who will hear your answers, we can’t promise that they will keep what you say private. This means that you should only say what you are comfortable with other people hearing.
  • If relevant, include information regarding any legal obligation to breach confidentiality (e.g., duty to report suspected child abuse, harm to self or others). Sample text:
  • The only time that we will ever share your information is if we have to for your safety. If your answers tell us that you or someone else is being hurt, we will need to share this information to protect you.
9. Do you have to be in this study?
  • Assure the participant that their participation is completely voluntary, that they are under no obligation to participate and are free to withdraw at any time without consequence.
  • Explain that participants are encouraged to take time to decide and discuss with their parents.
  • Make it clear that their decision to withdraw will not influence their relationship with the researcher in any way.
  • Sample text:
  • You do not have to take part in this study if you don’t want to. It is your choice. You don’t have to decide right away and you can talk with your parents about it. If you decide to join now but change your mind later, that’s okay too. Nobody will be upset with you if you decide you don’t want to participate or if you change your mind. All you have to do is tell us you don’t want to be in the study.
10. What will happen after the study?
  • Sample text:
  • After the study, we will write about what we learned. We will not include your name so nobody will know that you were in the study.
11. Do you have any questions?
  • Sample text:
  • You can ask questions at any time. There are no bad questions. You can ask questions now or later. Here are our phone numbers:
  • [Insert name and phone number of the member of the study team who will be available to answer questions or address any problems that may arise.]
Signature page
  • The child should indicate their consent by writing their name on the form. Two versions of the assent agreement are provided below. Option 1 should be used for younger children, and option 2 for older children. The text can be adapted as appropriate to the study.
  • Sample text – option 1:
  • Assent to participate:
    Before you decide if you want to take part in this study, make sure you understand what you need to do and that all of your questions have been answered.
  • Do you agree to take part in this study? Yes/No
  • If yes, write your name on the line below:
  • Child’s first and last name, printed:
    Date:
  • Sample text – option 2:
  • Assent: When I put my name on this form, it means that:
    • You explained the study to me and my parent/guardian.
    • If I had any questions, you answered them.
    • I was told about what will happen during the study, and what I will need to do.
    • I understand that I do not have to be in the study if I do not want to, and I can stop at any time without problems.
    • I can ask all the questions I want to, about the study, at any time.
    • My name and other stuff about me will be kept private.
    • No one will know that it is me who answered the questions.
    • If the study team wants to use my name and other information about me, you will ask me and my parent/guardian(s) first, before using it.
    • I will receive a copy of this form.
  • If you want to be in the study, write your name on the line below:
  • Child’s first and last name, printed:
    Date:
  • The assent form should also be signed by the person obtaining assent. Sample text:
  • Signature of the person obtaining assent
  • By signing this form, I attest that:
    • I have explained the study to the prospective participant
    • I answered all of their questions
    • I provided a copy of this assent form to the participant
    • The participant seemed to understand the assent form and agreed to participate
  • Name:
    Signature:
    Date

Sample consent forms

These forms were created using the REB Secretariat’s consent form template as a guide. Two sample consent forms are provided here: one for a quantitative research study and the other for a qualitative research study. Note that the studies described in these forms are fictitious and are used for illustrative purposes only.

Sample assent form

This form was created using the REB Secretariat’s assent form template as a guide. Note that the study described in this form is fictitious and is used for illustrative purposes only.

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