The responsibility to seek assent from a child to participate in medical research was published in the Canadian Medical Research Council “Guidelines on Research Involving Human Subjects” (1987) stating: "A minor child, incapable of giving legally and ethically acceptable consent, may give assent." In Quebec, conducting health research in children is governed by the Civil Code of Quebec, Article 21 that includes the assent requirement.
Almost all MUHC pediatric research is conducted at the Montreal Children’s Hospital (MCH) site where the child’s assent is central to the participation decision. With respect to cognitive norms and developmental maturity, a separate assent document written in language and a reading level understandable to children aged 7 to 12 years is routinely required. If a parent “consents” to enroll their child in research but the child refuses, the negative choice should take precedence. Mere failure to object should not be construed as agreement to participate. When study eligibility criteria include children younger than 7 years, the informed consent discussion should include the child, but only the written consent of the parent or legal guardian is necessary to enroll the child in the research.
The Pediatric (PED) REB at the MCH is an authoritative resource concerning the ethical conduct of all research with a pediatric component at the MUHC. If an REB reviews a study designed for an adult population that also permits enrollment of children, the REB Chair at the adult site consults the PED REB Chair to request adequate input for the ethical deliberation. When an adult research study designed to enroll children is approved at an MUHC adult site, the PED REB Chair is consulted to provide opinion on appropriate safety monitoring for the study.
Seeking consent and assent for pediatric research is challenging, and a family-centered approach to planning the informed consent discussion is recommended. When the discussion includes the child in the decision-making, ethical standards expected for MUHC pediatric research are met.
Usually, subject recruitment takes longer in pediatric clinical trials and ICH GCP E11suggests only investigators with pediatric research experience should conduct studies with invasive procedures in children. A pediatrician with broad clinical experience may not necessarily possess the specialized skill to lead the informed consent discussion involving children, and mentoring is encouraged.
Obtaining knowledge of the effects of medicinal products in children is an important goal of pediatric research, yet the rights of a child to withdraw from a study must be respected. In certain investigational treatment studies there may be circumstances whereby, in the opinion of the investigator or parents, withdrawal from the study would jeopardize the child’s health. In this situation, continued parental or legal guardian consent should be sufficient to allow ongoing research participation.
Written documentation of explicit consent should be obtained from research subjects enrolled in studies as minor children, once they turn 18 years old, if still participating in the study. This includes subjects whose identifiable data was collected and stored in research data repositories and tissue banks.