Children and research participation: who makes what decisions.

• Author: Simpson, Christy
• Position: Canada

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. With time and practice, a range of decision-making skills is mastered, and there is a move from simple and safe decisions to complex and value-laden decisions. Typically, different (and more or less) skills are required for different types of decisions and these skills are often practiced on an as needed basis, proceeding by trial and error. The mastery of these skills will depend on the child's physical, emotional, and developmental status, unique personality, life experience, social and moral ma turity, and cognitive capacities. The point, as regards the issue of children's decision-making concerning research participation, is that different skills are required for different kinds of research, and some children will have mastered some of these skills prior to reaching the legal age of majority.

This fact behooves those of us who support research involving children (including parents, researchers, and Research Ethics Board (REB) members) to carefully consider how best to protect children's interests, while at the same time respecting and nurturing their developing decision-making capacities. As explained above, current practice is to request assent from, and respect the dissent of, children. This common practice is unsatisfactory, however, since it fails to meaningfully acknowledge and respect the changing nature of children's abilities to participate in discussions about research, and to make independent decisions about their participation in research. Indeed, the use of assent and dissent as meaningful moral categories frequently promotes the goal of protecting children's interests (e.g., protecting them from research harm), at the expense of recognizing and nurturing their decision-making abilities.

In this paper, I suggest that there are four, possibly five, categories of child research participants, and that in each category there are unique consultation and decision-making roles for children, their parents, researchers and REB members. (2) Of particular interest is the expanding role for children in decision-making about research participation, and how this shifts what is ethically required of others. But first, it is appropriate to review the preconditions for respectful research involving children.

Children and Research Participation

Children should not be excluded from research of potential medical benefit for themselves, or of potential medical benefit for children as a group, simply because they are children. To exclude them from research participation solely on this basis would be to unfairly deny them the potential benefits of medical research including the potential to ameliorate, alleviate, or prevent physical or psychological problems. The obligation to protect children from unnecessary research harm must be balanced with the recognition that children, individually and as a group, can benefit from research participation. Indeed, along with others, I believe that research involving children is ethically acceptable, (3) provided a number of ethical preconditions are met. Most important among these are the requirements that the research must have scientific merit, must be done with legally competent adults first (where appropriate and feasible), there must be a proportionate harm-benefit ratio (as contrasted with a minimal risk threshold),(4) and finally there must be appropriate involvement of children in the decision-making process and a morally valid authorization or consent to research participatio n.

Scientific Merit

Scientific merit includes both scientific validity and scientific value. A study is scientifically valid provided it is designed to yield reliable information, according to accepted principles of research practice, concerning the hypothesis being tested. For example, the results of a study whose sample size is too small, or skewed, or poorly controlled, cannot be generalized toward confirmation or disconfirmation of the hypothesis, and the study is therefore invalid. A second and distinct understanding of the requirement of scientific merit focuses upon "value" rather than (mere) "validity." A study may be well-designed relative to its hypothesis, and therefore scientifically valid, but may nonetheless be of no value because the hypothesis itself is trivial or otherwise uninteresting. (5) In my view, a necessary condition of ethically acceptable research involving children is that the research be scientifically valid and of scientific value.

The Descending Order of Permissibility

Years ago, Hans Jonas argued persuasively that the most vulnerable among us should be the last to participate in research and be exposed to research risks. (6) Consistent with this view, whenever appropriate and feasible, research involving legally competent adults should precede equivalent research involving either legally competent or incompetent children. This will not be possible, however, for the study of...