9. Subject Considerations

9.1 Clinical trial subject recruitment: Are digital advertisements (including social media streams such as TikTok) allowed and, if so, what regulations govern them?

Yes, subject to certain conditions.

Participant-driven approaches must implement proper processes to support privacy during recruitment activities.   Furthermore, there may be a necessity of screening eligibility of potential participants after self-selection (e.g., when social media is used for recruitment purposes). REB approval requirements must be met in each instance.

9.2 Vulnerable Subjects

In accordance with Chapter 11 of the Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans, in all Canadian clinical trials, research participants selected from vulnerable populations must be provided additional protections to safeguard their health and welfare during the informed consent process. 

Vulnerable populations are characterized as those who may be unduly influenced by the expectation, whether justified or not, of benefits associated with participation, or of a retaliatory response from not participating. Examples are members of a group with a hierarchical structure, such as medical, pharmacy, dental, and nursing students, subordinate hospital and laboratory personnel, employees of the pharmaceutical industry, members of the armed forces, and persons kept in detention. Other vulnerable subjects include patients with incurable diseases, persons in nursing homes, unemployed or impoverished persons, patients in emergency situations, ethnic minority groups, homeless persons, nomads, refugees, minors, and those incapable of giving consent, elderly, children, mentally ill, prisoners, etc.). 

The responsibility of the REB is to protect the right, safety, and well-being of all human subjects. REBs are required to pay special attention to protecting participants who are from vulnerable populations.

9.3 Pediatrics (including whether consent from a single parent is sufficient vs. requiring both parents to sign)

When the research participant is a child, the informed consent form (ICF) must be signed by the child’s legal representative(s) and/or guardian(s). All pediatric participants, however, should be informed to the extent compatible with the child’s understanding, and if capable, the pediatric participant should sign and personally date the ICF.

In Canada, minors are persons under the age of 18 or 19, depending on the province or territory in which they reside. As the Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans does not specify an age of consent for children, the Research Ethics Board: Overview of the Health Canada and Public Health Agency of Canada REB holds that the decision on whether to seek consent from children is based on whether they have the capacity to understand the research and the risks and benefits of their participation. 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. For children who are not sufficiently mature to provide consent but are able to understand the nature of study participation, researchers must obtain the child’s assent in addition to the consent of an authorized third party. The decision of a child not to assent must be respected regardless of whether third-party consent was obtained.

Information on "minor child" and "youth" as per provincial definition is provided on the Government of Canada's official site “Provincial definitions of a minor”.

The following criteria is used to determine 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

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.

The Government of Canada has issued Advice to Healthcare Professionals on parental or guardian consent requirements when parents of a minor child are divorcing or getting divorced, as a consequence of provisions contained in the federal Divorce Act.

The term “decision-making responsibility” of a parent or guardian includes decisions about a child’s healthcare. If both parents have decision-making responsibilities for a child, they are both required to consent to healthcare decisions and treatment regarding their child, unless they have agreed, or a court has ordered, otherwise. A Healthcare Professional is required to establish who legally has decision-making responsibility in relation to a minor child. A copy of any parenting order or agreement may be included in the child’s medical file. 

9.4 Financial Disclosures

The Canadian regulations do not indicate the requirement for investigators/sub-investigators to sign a Financial Disclosure form. However, when the clinical trial is part of a US IND, the FDA requirements will apply.

9.5 ICF translations – Are Certificates Required?

The national law is silent on whether a translation certification is required. However, under normal practice, Certificate of Translations (CoTs) are not required to be submitted. However, relevant CoTs should be filed within the Trial Master File.

9.6 Subject Compensation: Is there a need for a local sponsor to be listed on the insurance certificate, the insurance certificate to cover the duration of the study and specific minimum amounts of coverage to be specified, both for individual events occurring and in aggregate?

The Food and Drug Regulations do not require the sponsor to provide insurance coverage to investigators, institutions, or trial participants. However, the Canadian GCP provides guidelines for sponsors on the provision of insurance.

Please refer to Section 2.18 of this guidebook for a discussion of insurance requirements.