Academic journal article Health Law Review

Children and Research Participation: Who Makes What Decisions

Academic journal article Health Law Review

Children and Research Participation: Who Makes What Decisions

Article excerpt

Introduction

The three federal research funding agencies in Canada--the Canadian Institutes for Health Research, the Natural Sciences and Engineering Research Council, and the Social Sciences and Humanities Research Council--recently created the Panel on Research Ethics (announced November 9,2001). The mandate of this inter-agency panel is, in part, to ensure that the Tri-Council Policy Statement (TCPS) on research involving humans remains a "living" document; that is, this panel is charged with updating and revising the TCPS. In this paper, I call attention to the TCPS sections that apply to research involving children (i.e., individuals below the legal age of majority). In particular, I argue that the use of assent and dissent for children's role in decision-making about research participation is inadequate. This inadequacy stems from a failure to fully recognize and appreciate the developing decision-making skills of children. Accordingly, I offer an alternative approach to involving children in decision-making about r esearch participation. This approach is based on the decisional capacities of children and links these developing capacities to different levels of involvement in decision-making about participation in research.

While the relevant TCPS sections for children and research participation include Articles 2.5-2.7 and 5.3, I am most interested in the claims made about assent and dissent in Article 2.7:

Where free and informed consent has been obtained from an authorized third party, and in those circumstances where the legally incompetent individual understands the nature and consequences of the research, the researcher shall seek to ascertain the wishes of the individual concerning participation. The potential subject's dissent will preclude his or her participation.

[Explanation] Many individuals who are not legally competent are still able to express their wishes in a meaningful way, even if such expression may not fulfil the requirements for free and informed consent. Prospective subjects may thus be capable of verbally or physically assenting to, or dissenting from, participation in research. Those who may be capable of assent or dissent include: (a) those whose competence is in the process of development, such as children whose capacity for judgement and self-direction is maturing... (1)

The TCPS limits the role of children in decision-making about research participation to being able to assent, verbally or physically, and dissent. Neither assent nor dissent is defined; no other, or expanded, role for children in decision-making is considered. The concern for the vulnerability of children and the need to protect them is commendable. And yet, if children are to be treated with respect and dignity, as the TCPS also states, it seems plausible to argue that an improved recognition of the developing decisional capacities of children requires a more nuanced approach to their role(s) in decision-making about research participation. This is the focus of the discussion below.

Setting the Stage

Research involving children poses a number of difficulties, the most perplexing of which concerns the role that children should play in decision-making about their research participation. In the neonatal period, and during early infancy, this is a non-issue since these children clearly cannot be involved in any decision-making, let alone decision-making regarding research participation. Beyond this early developmental stage, however, the issue is considerably more complex.

Decision-making is a skill set that is mastered over time. It includes (but is not limited to) the ability to sift through emotions, to decipher ambiguous information, to interpret facial expressions, to decode tones of voice, to weigh options, and to make value judgments. From a very early age, even before children have any significant verbal skills, they are invited by their parents and others to practice the most basic of these requisite skills, as when they are encouraged to choose between two breakfast cereals. …

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