prompted with questions because I would never have thought of those issues, even as a 13-year-old… . When I was asked by the researcher did you consider this, what about these consequences, I began to change my idea of whether I would really want to participate in that study.
Sarah Lippincott, research participant, 2003
Although research is limited and findings are not entirely consistent, they support a gradual expansion of the involvement of children in discussions and decisions about research participation. For younger children, the emphasis should be on providing basic information about what will happen, responding to their questions and concerns (including those not explicitly expressed), and—particularly when the research does not offer the prospect of direct benefit—recognizing when children do not want to participate. Even when federal guidelines do not require the child’s assent, investigators should still inform children (as appropriate given the circumstances) about what will happen and answer any questions that the child may have.
As children mature, they can participate more fully in discussions and decisions about their participation in research, although the involvement of parents is still required and prudent in most situations. Older adolescents may not have the legal capacity to make decisions in their own right, but the research reviewed here generally suggests that their level of comprehension of research approaches that of adults. Many aspects of the assent process can be similar to the consent process for adults if that process has been designed to accommodate people of various educational, social, and cultural backgrounds. For children and adolescents as well as adults, physical incapacity or distress related to serious illness may limit the extent to which they are involved.
Fisher (2003) has described a general approach to assent that aims for a “goodness-of-fit” between children’s maturing skills and the assent processes. Because children have limited experience exercising their rights in response to requests from adults (especially in educational, medical, or unfamiliar settings), the assent process should be designed to demonstrate that participation is voluntary and dissent will not be penalized. In some cases, tutorials on research procedures and protections may be an appropriate element of the assent process. Opportunities for supported decision making that involves a parent-child discussion can also be created; a facilitator may be helpful in such a discussion. The broad objective is to create assent contexts and processes that minimize stress, encourage children’s involvement in decisions about their participation in research, and ensure that their wishes and concerns are adequately communicated and considered.