Research Ethics Board: Policies, guidelines and resources
The Health Canada-PHAC REB reviews applications in accordance with the considerations set out in the Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans (TCPS 2) as the minimum standard. TCPS 2 is the foundation for the REB’s operational and guidance documents (which include the Operational Policy Framework, evaluation criteria and requirements for informed consent). The REB also takes into account to relevant federal laws and regulations, such as the Privacy Act and clinical trial regulations, where applicable.
On this page
- TCPS 2 and related ethics resources
- REB evaluation criteria
- Informed consent process
- Clinical trial regulations
- REB Operational Policy Framework
TCPS 2 and related ethics resources
The Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans (TCPS 2) is a joint policy of Canada’s three federal research agencies – the Canadian Institutes of Health Research (CIHR), the Natural Sciences and Engineering Research Council of Canada (NSERC), and the Social Sciences and Humanities Research Council of Canada (SSHRC). Recognizing that TCPS is the prevailing Canadian standard for ethical research, Health Canada and PHAC have adopted TCPS to guide the ethical aspects of the design, review and conduct of research involving humans. Related links:
The Declaration of Helsinki is an official policy document of the World Medical Association, the global representative body for physicians, developed as a statement of ethical principles to provide guidance to physicians and other participants in medical research involving human subjects.
The Belmont Report was the work of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. It identifies three basic principles underlying the ethics of human research: respect for persons, beneficence and justice.
The Canadian Association of Research Ethics Boards (CAREB) is a grassroots national membership organization intended to represent the interests of all Canadian REBs and to reflect REB perspectives and concerns.
REB evaluation criteria
Research involving humans can be ethically justified only when:
- The research is scientifically sound;
- The potential benefit significantly outweighs the potential for harm;
- There is an adequate process for informed consent, and assent where applicable; and
- There is justice or fairness in selection of participants.
Thus, when assessing whether a proposal meets the ethical requirements for research involving humans, the REB focuses on the following five elements:
- Selection and recruitment
- Informed consent process
- Potential harms and benefits
- Privacy and confidentiality
Applicants should ensure that their research protocols provide sufficient detail so that the REB can appropriately assess the proposal against these criteria. The research protocol instructions on the REB website provide additional information relevant to each of these elements. Applicants are advised to follow these instructions closely when drafting their protocols.
Informed 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 informed consent. For more details, please refer to TCPS 2, Chapter 3 – The Consent Process. The following resources have been prepared by the REB Secretariat to assist researchers in drafting consent and assent forms:
Principles of informed consent
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.
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.
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.
Clinical trial regulations
Health Canada regulates the sale and importation of certain drugs, medical devices and natural health products that will be used in human clinical trials. This includes health products not authorized/licenced in Canada, as well as Canadian market authorized drugs and licensed medical devices and natural health products that are being investigated for potential use outside their approved indication. Health Canada requires that the drug sponsor (individual, corporate body, institution or organization) and medical device manufacturer/importer undertaking the clinical study obtain institutional Research Ethics Board approval prior to opening the clinical trial in Canada, in accordance with Division 5 of the Food and Drug Regulations, Part 4 of the Natural Health Product Regulations or Part 3 of the Medical Devices Regulations.
The Health Canada and Public Health Agency of Canada (PHAC) Research Ethics Board (REB) only reviews clinical trials being undertaken and conducted by investigators from Health Canada or PHAC. The REB does not provide advice to external researchers.
For further information regarding the regulatory requirements, investigators may contact:
- For pharmaceutical drugs: Office of Clinical Trials, Therapeutic Products Directorate. Email: firstname.lastname@example.org
- For biologics and radiopharmaceuticals: Office of Regulatory Affairs, Biologic and Radiopharmaceutical Drugs Directorate. Email: email@example.com
- For medical devices: Bureau of Investigational Testing Authorization, Special Access Program and Post-Market Surveillance, Medical Devices Directorate. Email: firstname.lastname@example.org
- For natural health products: Natural and Non-prescription Health Products Directorate. Email: email@example.com
For more information, please see:
- Clinical trials and drug safety
- Guidance Document For Clinical Trial Sponsors: Clinical Trial Applications
- Clinical Trials For Natural Health Products
- Applications for Medical Device Investigational Testing Authorizations Guidance Document
- Guidance document for Preparation of an Application for Investigational Testing - In Vitro Diagnostic Devices
- ICH Guidelines
- ICH Guidance E6(R2): Good Clinical Practice
REB Operational Policy Framework
The REB Operational Policy Framework provides information about the REB’s authorities, mandate and scope, committee structure and review process.
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