Waiving of Informed Consent
Minimal Risk Projects
In some cases, waiving the requirement to obtain informed consent will be considered for projects that are clearly below minimal risk when it can be demonstrated that the requirement to obtain consent would constitute an unreasonable barrier to the conduct of the research. Researchers asking for a waiver of consent must justify in their Harmony Health Research Application:
a) Why such a waiver is necessary for the conduct of the research.
b) That the research presents no risks to the participants.
c) That the participants will not be identifiable from the data collected.
d) That the requirement to obtain consent would constitute an unreasonable barrier.
e) The research does not involve a therapeutic intervention.
Waiver of Consent in Emergency Health Situations
TCPS 2 Article 3.8 states, “Subject to all applicable legal and regulatory requirements, research involving medical emergencies shall be conducted only if it addresses the emergency needs of the individuals involved, and then only in accordance with criteria established in advance of such research by the REB. The REB may allow research that involves medical emergencies to be carried out without the consent of participants, or of their authorized third party if all of the following apply:
a) A serious threat to the prospective participant requires immediate intervention.
b) Either no standard efficacious care exists, or the research offers a realistic possibility of direct benefit to the participant in comparison with standard care.
c) Either the risk is not greater than that involved in standard efficacious care, or it is clearly justified by the prospect for direct benefits to the participant.
d) The prospective participant is unconscious or lacks capacity to understand the risks, methods and purposes of the research project.
e) Third party authorization cannot be secured in sufficient time, despite diligent and documented efforts to do so.
f) No relevant prior directive by the participant is known to exist.
When a previously incapacitated participant regains decision-making capacity, or when an authorized third party is found, consent shall be sought for continuation in the project, and for subsequent examinations or tests related to the research project.”
When informed consent of the participant or the LAR is not feasible, the researcher should consult a patient representative/advocate, if available, to assess the circumstances prior to enrollment.
The Principal Investigator must provide justification for this waiver of consent in the initial Harmony application. If a waiver of consent occurs outside the approved research proposal, it must be reported in Harmony using the Major Protocol Deviation Form within 3 business days.
Waiving of Parental/Guardian Consent
A waiver of parental/guardian consent may be considered for older adolescents with sufficient decision-making capacity, for research projects clearly below minimal risk.
In very limited circumstances, a waiver will be considered for above minimal risk projects when participation in the research may be beneficial to the participant, and third-party knowledge of the subject matter may place the adolescent at risk (e.g., projects involving investigations of adolescent beliefs and behaviors regarding sexuality or use of recreational drugs; research addressing domestic violence or child abuse). For projects of this nature, the researcher must be certain that the adolescent understands the nature and consequences of the research. The researcher should still encourage the adolescent to discuss the research with a parent/guardian or a child advocate (i.e., teacher, guidance counselor, or a person who knows the child well) and ensure adequate resources for counseling are available.
Researchers asking for a waiver of parental/guardian consent must justify in the Harmony Health Research Application:
a) Why such a waiver is necessary for the conduct of the research.
b) That the research presents no risks to the participants or that adequate resources are in place to address the potential risks.
c) That adequate steps have been taken to inform the parents of the research when appropriate.
d) That each participant has the capacity to consent, meaning they are cognitively mature enough to understand the consent procedure and the potential risks involved.