gator” (National Bioethics Advisory Committee, 2001, p. 33), which is inconsistent with a central tenet of research ethics: that volunteers are autonomous agents, free to choose whether to participate or to withdraw from a study. Adopting the term “participant” addresses this by suggesting that the volunteer is a willing partner in the research enterprise. However, as pointed out by some members of NBAC, many persons who are enrolled in studies are not free and equal participants, and the use of the term “participant” may send a false signal that less vigilance is needed to protect human research participants. Furthermore, the term “participant” does not accurately apply to children, particularly infants and very young children, who are too young even to assent to research. Overall, the term “participant” conveys the aspiration of reducing the power imbalance between researchers and the persons they study. The committee was mindful of these views in its deliberations and in its conclusions and recommendations. The committee has adopted the term participant when referring to general research protection issues, including the federal regulations, but we have retained the term subject when referring specifically to children given the inability of most children to be “free and equal participants.”
As noted in Chapter 1, an analysis of the merits of the Grimes case or the court’s ruling is beyond the charge to this committee: the committee’s consideration of the study and ruling is limited to an analysis of the broad and complex ethical issues raised by the case that are pertinent to research on housing health hazards involving children. This chapter presents the committee’s rationale for embracing the balancing of risks and benefits reflected in the federal regulations and rejecting the suggestion that parents not be allowed to enroll children in research that does not offer the prospect of direct benefit (“nontherapeutic” research), core issues raised by the ruling. Other issues raised by the case, including research involving vulnerable populations, the informed consent process, and research oversight, form part of the basis for more detailed discussion in later chapters of the report.
Grimes v. Kennedy Krieger Institute has become a key case in the recent history of concern about ethical issues in research. The federal government began overseeing research that involves human participants in 1974, creating a framework for independent review of research protocols and requiring informed consent from participants to assure that research would be conducted in an ethically responsible manner. The regulations that the U.S. Department of Health and Human Services (DHHS) and other federal agencies adopted were based primarily on the recommendations of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. The commission reviewed the available