9. Subject Considerations

9.1 Clinical trial subject recruitment: are digital advertisements (including social media streams such as TikTok) allowed? 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 for screening the 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.

https://www.ctontario.ca/act-advancing-clinical-trials/ontario-resource-guide-for-decentralized-clinical-trials/erecruitment/

9.2 Vulnerable Subjects

In accordance with 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, etc.). 

The responsibility of the REBs 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.

https://ethics.gc.ca/eng/tcps2-eptc2_2022_chapter11-chapitre11.html

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 following official site: https://www.canada.ca/en/immigration-refugees-citizenship/corporate/publications-manuals/operational-bulletins-manuals/refugee-protection/canada/processing-provincial-definitions-minor.html

The following criteria are 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 the 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.

https://www.canada.ca/en/immigration-refugees-citizenship/corporate/publications-manuals/operational-bulletins-manuals/refugee-protection/canada/processing-provincial-definitions-minor.html

The Government of Canada has issued the 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.

https://www.justice.gc.ca/eng/fl-df/medical-sante.html

9.4 Financial Disclosures

Canadian regulations do not require compensation for trial participation. However, the informed consent form (ICF) should contain a statement with a description of the anticipated prorated payment to the participant(s) that is reasonably expected for participation in the trial. Any compensation or incentive to participants must not be so excessive that it may unfairly influence participants, or cause them to overlook important facts and risks. REB guidance states that the ICF should describe any compensation, incentives, or reimbursements to be paid or given to participants and how participant withdrawal will affect the offered compensation (e.g., prorated remuneration). If no compensation will be provided, this should be stated.

https://ethics.gc.ca/eng/tcps2-eptc2_2022_chapter3-chapitre3.html

9.5 ICF translations – are certificates required?

No.

Consent forms should be provided in the language that participants are most comfortable with. An ICF is to be presented in plain language that the participant is able to understand. ICFs should be translated where it is relevant to particular communities. If there is a language barrier, the QI should select an intermediary who has the necessary language skills to ensure effective communication. The level of language used should be appropriate to the age and comprehension/reading level of the participant population.

Item 5.10 Good Clinical Practices, C.05.010 (h) requires every sponsor to ensure that written informed consent is obtained from each participant. Interpretation notes specify that the “ICF must be made available for each subject in either official language or other as appropriate” and further states that “Health Canada expects that sponsors can demonstrate that the subject has read and understood the entire informed consent document(s). This could be through initialing each page of the ICF, or a statement included at the end stating that the subject has read and understood all the pages.

The ICF should be paginated to ensure that the complete document is presented to the subject.”

https://www.canada.ca/en/health-canada/services/drugs-health-products/compliance-enforcement/good-clinical-practices/guidance-documents/guidance-drugs-clinical-trials-human-subjects-gui-0100/document.html#a510

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 2.20 for a discussion of insurance requirements.