Research Ethics Board: Consent process

For research with humans to be considered ethical, it is essential that participants provide their free, informed and ongoing consent. Research can begin only after the participants have provided their initial consent, and individuals must have the possibility to withdraw their consent at any point during the research project. In this regard, consent is not a single event but rather an ongoing process, starting with the researcher's first contact with the individual and continuing until the study is complete or the participant withdraws.

Individuals of any age who lack the capacity to decide for themselves should still have the opportunity to participate in research that may benefit themselves or others. At the same time, their limited decision-making capacity should not be used to inappropriately include them in research. For these individuals, authorized third parties with the necessary legal authority may consent on their behalf, although researchers should also seek their assent if they are capable of expressing their wishes in a meaningful way.

The information below provides an overview of the key considerations regarding the consent process and several resources prepared by the REB Secretariat to assist researchers in drafting consent and assent forms. For more details, please refer to TCPS 2, Chapter 3 - The Consent Process.

On this page:

Key considerations

General principles

Consent shall be given voluntarily

Voluntary consent means that individuals have chosen to participate in research according to their own values, preferences and wishes, free of undue influence or coercion. For instance, individuals may experience undue influence when they are recruited by someone in a position of authority over them. Also of concern are excessively large incentives to participate, as they may cause participants to disregard the risks involved in the research such that their participation is no longer truly voluntary.

Participants should be free to withdraw from the research project at any time, for any or no reason, without suffering any consequences or disadvantages for doing so. For example, if any payments have been offered to participants, these should still be provided (in all or in part) even if the participant withdraws before completing the study. It is essential that compensation does not coerce participants to remain in the study despite their wish to withdraw.

Withdrawal of consent should also include the ability to withdraw any data or human biological materials that the participant has provided to the researchers. For various reasons, it may not be possible to withdraw a participant's samples or data from a particular repository or study. This may be the case, for instance, when the samples or data have been anonymized, or once the results of the study have been published. This should, however, be clearly stated in the consent process and explained to the REB.

Consent shall be informed

Researchers must give prospective participants all the information necessary for them to make an informed decision about participating in the research. Of note:

  • The information must be provided in plain language that the participants will easily understand. A reading level of grade 6 to 8 is generally recommended. The following resources may be helpful in preparing documents in plain language:
  • Consent forms should be provided in the language that participants are most comfortable with (whether English, French or another language).
  • The person obtaining consent may need to explain the consent form verbally, in addition to the participant reading the information provided, to ensure that the participant fully understands the information. If necessary, written documentation may be supplemented with audio and/or visual aids or accompanied by video presentations.
  • Participants must be given enough time to fully consider the information and have the opportunity to ask any questions before deciding whether they would like to participate.

Researchers are invited to consult the following resources for additional information and guidance in creating a consent form:

Consent shall be an ongoing process

Consent is a process that begins with the initial contact for recruitment and carries through to the end of the participants' involvement in the project. This means, for example, that if any changes are made to the research project or any new information comes to light that may affect the participants' willingness to remain involved, researchers are obligated to inform the participants in case they wish to reconsider the basis for their consent.

The process of consent also applies to children who lacked the decision-making and legal capacity to consent on their own behalf at the time of recruitment. If during the course of the study the children mature to the point where they are capable of providing their own consent, the researcher must seek their consent at that time.

Documenting consent

The most common method for documenting consent is to obtain written consent in a signed statement from the participant. However, there are circumstances in which written consent may not be feasible or desirable, for example due to logistical issues or because of the preferences of the participants. In addition, some individuals may perceive written consent as an attempt to legalize the consent process, thereby creating mistrust. It is also important to recognize that in some cultures written consent is not consistent with community traditions. In these cases, it may be more appropriate to use a handshake, a verbal agreement or oral consent.

If researchers plan to obtain non-written consent, they must explain their strategy to the REB. For additional guidance, see Article 10.2 of TCPS 2.

Capacity for children to provide consent

TCPS 2 does not specify an age of consent for children. Determining whether to seek consent from children is not based on their age. Rather, it depends on whether they have the capacity to understand the significance of the research and the implications of the risk and benefits to themselves. Thus, youth who have not reached the age of majority (either 18 or 19 depending on the province or territory) may still be old enough to provide their own consent.

If a child is not sufficiently mature to provide his or her own consent but is able to understand the nature of participation in the study, researchers must obtain the child's assent to participate (in addition to the consent of an authorized third party). If a child does not assent to participate, this wish must be respected regardless of whether third party consent was obtained.

Researchers should consider the following criteria when determining whether participants can provide their own consent, or whether an authorized third party should be involved:

  • The risk level associated with the research project
  • The legal requirements for age of consent in that jurisdiction
  • The characteristics of the research participant (e.g., maturity level)
  • In certain cases, the topic of the research itself

The following legal considerations should also be taken into account:

  • Emancipated minor doctrine: adolescents who live independently from parents or guardians, or who are parents themselves are generally considered capable of providing their own consent.
  • Mature minor doctrine: in 2009, the Supreme Court of Canada ruled that "If, after a careful analysis of the young person's ability to exercise mature and independent judgment, the court is persuaded that the necessary level of maturity exists, the young person's views ought to be respected."
  • Quebec civil code, Section 21: "Consent to research that could interfere with the integrity of a minor may be given by the person having parental authority or the tutor. A minor 14 years of age or over, however, may give consent alone if, in the opinion of the competent research ethics committee, the research involves only minimal risk and the circumstances justify it."

At a practical level, it is generally accepted that youth can consent to minimal risk studies at 16 years of age, and that assent should be sought from children beginning at approximately 7 years of age. However, it is ultimately up to the researcher to determine whether to obtain assent or consent from children, and to provide the rationale for this decision to the REB. Researchers should also consider that within a single research project, some minors may be capable of consenting while others may not.

Researchers are invited to consult the following resources for additional information and guidance in creating an assent form:

Consent for adults with diminished decision-making capacity

Adults with diminished decision-making capacity include:

  • individuals whose decision-making capacity remains only partially developed, such as those living with permanent cognitive impairment, and
  • individuals who once were capable of making an autonomous decision regarding consent but whose decision-making capacity is diminishing or fluctuating (e.g., due to cognitive impairment resulting from an injury or disease).

As is the case for any vulnerable population, care must be taken to ensure that adults with diminished decision-making capacity are not inappropriately included in research because of their situation, and neither should they be excluded from participating in research that may benefit them.

In general, many of the same principles for obtaining consent for children apply to adults with diminished decision-making capacity. For example, authorized third parties can provide consent for adults who lack the capacity to decide on their own behalf in accordance with the best interests of the persons concerned. In such cases, participants should still be involved to the greatest extent possible in the decision-making process, and their assent to participate must be obtained if they are capable of expressing their wishes in a meaningful way (whether verbally or physically). Importantly, when authorization for participation was granted by an authorized third party and a participant acquires or regains decision-making capacity during the course of the research, the researcher shall promptly seek the participant's consent as a condition of continuing participation.

Consent for future use of data or biological materials

The focus of consent is naturally on the immediate use of participants' data or biological materials for the study at hand. However, depending on the nature of the data or materials, they may also be useful for secondary future research studies. In such cases, researchers should consider describing this possibility in the consent form and obtaining permission from participants to retain their data or biological materials for future use. If consent for future use is not obtained initially then researchers may be required to re-consent individuals in the future, which can be onerous and often impractical if many years have passed since the initial consent was obtained.

Researchers should be as specific as possible when describing the potential future uses. For example, if researchers are proposing to collect human biological samples to measure certain environmental contaminants, a potential future use may be to measure other to-be-determined contaminants. If future uses include possible genetic or genomic studies, this must be stated. Note that the REB may not approve future uses that are too open-ended or too dissimilar from the initial use.

It is generally preferable to give participants the opportunity to opt out of future use. If this option is not provided, researchers should be prepared to explain their decision to the REB. When seeking consent, researchers may wish to give participants different options for how their samples or data can be used, in order to accommodate differences in comfort levels among participants.

In rare cases, it may be possible to use identifiable information for secondary use without the consent of the participants who provided that information (as described Article 5.5A of TCPS 2). However, the conditions are strict and the onus is on the researcher to demonstrate to the REB that all the conditions in Article 5.5A have been satisfied. While the possibility of an exception may exist, the REB generally expects that researchers will make every reasonable effort to seek the consent of participants. Thus, the best practice is for researchers to always obtain consent for future use at the time of initial recruitment if there is any possibility of secondary use of data or biological materials.

Consent for participation in clinical trials

Researchers conducting clinical trials should be aware that there are additional requirements for obtaining informed consent. For example, Article 3.2 of TCPS 2 specifies that consent forms for clinical trials must include information on stopping rules and when researchers may remove participants from trial. Researchers should refer to TCPS 2, Chapter 11, for additional information on the ethical conduct of clinical trial research. The International Conference on Harmonisation E6, in particular section 4.8, also includes specific guidelines for informed consent of trial subjects that must be followed for trials that require approval by Health Canada or other regulatory bodies.

Consent form template

This template is a guide to assist researchers applying to the Health Canada-PHAC REB. It should not be interpreted as a standard for other institutions. This template follows the guidance provided in TCPS 2 (Chapter 3: The Consent Process) which is the official human research ethics policy of the Canadian federal research granting agencies.

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 (for example, “The success of this study relies on your participation.”).
  • 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 continued access to any services or benefits, 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 that continues for as long as you are in the study. If something changes during the research study or there is any new information that could affect your willingness to continue to participate, we will tell you and ask whether you still consent to participate in the study. Remember that you are free to withdraw your consent at any time for any reason, even if nothing in the study has changed.
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.
  • Indicate whether any aspects of the research activities will be audio or video recorded.
  • 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, and the likelihood that participants could experience harm.
  • 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 likelihood of your being harmed as a result of participating in this study is extremely low. 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:
  • You may not receive any direct benefit 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 protections 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.
  • State whether the information will be used or shared for any other reason. If shared, include information on who it will be shared with. Specify whether the participant can opt out of sharing, and if so, explain the process (e.g., by indicating their choice on the signature page).
  • Describe the efforts that will be made to protect the information, including to maintain confidentiality and to prevent the risk of participant re-identification.

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.
  • Federal or provincial legislation and/or ethical codes of conduct may require the disclosure of information to authorities to protect the well-being of individuals, groups or communities. Include information regarding any legal obligation to breach confidentiality (e.g., laws requiring the reporting of children in need of protection or the presence of reportable communicable diseases). Sample text:
  • No personal information will be shared with anyone outside of the core research team [or indicate who else the information is shared with, as noted above], except in certain limited circumstances as outlined in the Privacy Notice. We are also required by law, under section 25 of the Ontario Health Protection and Promotion Act (HPPA), to inform the provincial public health authorities if our tests show that you have hepatitis C. Note that this is standard process for diseases like hepatitis C regardless of where and how you get tested in this province because it is considered a reportable disease.

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 publication and dissemination of research results, including whether research results will be made available in open access publications or open data repositories (e.g., Government of Canada open data portal), and the measures that will be taken to maintain confidentiality. Sample text:
  • A de-identified dataset, without any personal identifiers, may be posted on the Government of Canada open government portal, an online repository that makes data freely available to the public.
  • 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 not include direct identifiers, such as names or identifying numbers, 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.
  • Clearly state the point during or after the study at which removal of samples or data becomes impossible.
  • Explain how the participant can request removal of their information after their participation is complete, if applicable.
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
    Email: reb-cer@hc-sc.gc.ca
  • [Optional:] This research study was reviewed 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
  • Privacy notice: For projects led by Health Canada or PHAC researchers, consent forms must include a Privacy Notice in accordance with the Privacy Act. Researchers should contact the HC-PHAC Privacy Management Division for text to use when drafting the Privacy Notice.
  • 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 protected
  • 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 directly identify me will be released or printed without my consent
    • 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, but any quotes will not include information that could directly identify me: 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 a guide to assist researchers applying to the Health Canada-PHAC REB. It should not be interpreted as a standard for other institutions. This template follows the guidance provided in TCPS 2 (Chapter 3: The Consent Process) which is the official human research ethics policy of the Canadian federal research granting agencies.

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. They are meant to assist researchers applying to the Health Canada-PHAC REB and should not be interpreted as a standard for other institutions. The forms follow the guidance provided in TCPS 2 (Chapter 3: The Consent Process) which is the official human research ethics policy of the Canadian federal research granting agencies.

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. It is meant to assist researchers applying to the Health Canada-PHAC REB and should not be interpreted as a standard for other institutions. The form follows the guidance provided in TCPS 2 (Chapter 3: The Consent Process) which is the official human research ethics policy of the Canadian federal research granting agencies.

Note that the study described in this form is fictitious and is used for illustrative purposes only.

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