Assent to research

Assent to research is a method of expression significant for recognizing autonomy, and represents agreement to become a research subject. “Informed consent is morally valid when disclosure and comprehension of Information is discussed in the presences of voluntariness and the competence to consent” (The Nuremburg Code). A morally valid choice therefore includes the concept of “assent”, when a prospective subject lacks capacity to provide legally effective consent. Seeking assent provides the means for a person to communicate a negative preference on participating in a study..

MUHC health research conducted in populations not legally capable to provide consent is subject to Article 21 of the Civil Code of Quebec; a special provision intended to increase protections for “vulnerable” people invited to participate in research. In Quebec, only REBs designated by the Quebec Minister of Health may approve research involving children and incapacitated adults. All MUHC REBs maintain “ministerial designation” for this type of review.

Individuals with some ability to understand the proposed study may be able to express their wishes in a meaningful way by verbally or physically assenting to, or dissenting from research participation. TCPS2 identifies persons who may be capable of assent or dissent as:

• those whose capacity is in the process of development, such as children whose capacity for judgment and self-direction is maturing;
• those who once were capable of making an autonomous decision regarding consent but whose capacity is diminishing or fluctuating; and
• those whose capacity remains only partially developed, such as those living with permanent cognitive impairment.

Adequate provisions must be made for seeking the assent of children and legally incapacitated adults when the REB determines potential subjects would be capable of providing assent. The REB takes into account the age, maturity, and psychological state of the study population, and the decision may apply to all potential study subjects, or only to one individual. When the REB decides that assent is required they also determine how assent will be documented.

Normally, assent is a necessary condition for research participation to proceed and expression of dissent or other signs suggesting the person does not wish to participate must be respected. The assent of the subject is not a necessary condition when REB determines that:

• the capacity of some or all of the study population is so limited that they cannot reasonably be consulted, or
• the experimental intervention holds out a prospect of direct benefit to the health or well being of the subject and is available only in the context of the research.

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