History teaches that more may be required, at least in the court of public opinion. The adverse publicity, litigation, and ultimate settlement of claims arising from the study of partial lead abatement strategies conducted in Baltimore by investigators at the Kennedy Krieger Institute are illustrative. An appropriate metric for the NCS may be whether the study is acceptable in its entirety to the research participants and to society. Even though each individual step arguably poses no more minimal risk when considered independently, it is important to recognize that this study in the aggregate will be quite burdensome and intrusive for the participants.
A major issue is what information about their own health and development participants will receive. The research plan recognizes that casting the NCS as a strictly observational study is not desirable and that providing information is important for its own sake as well as useful as a means of increasing retention of participants (NCS Research Plan, Vol. 1, Sec. 12.7). The plan states that participants will be given routine information, such as growth parameters and hematocrits. On a purely mechanical level, the plan needs to clarify whether assays will be conducted pursuant to the requirements of the Clinical Laboratories Improvements Amendments of 2007, since conveying noncompliant laboratory results that may influence participants’ health care behavior may actually be illegal.
With regard to assessments of participants’ health and development, the plan is to provide to participants with findings that are “clinically relevant and actionable,” with the caveat that results of genetic tests will be offered to participants and not automatically conveyed (NCS Research Plan, Vol. 1, Sec. 12.7.1). While laudable in many ways, this plan for sharing information warrants further development. The concept of “clinically relevant and actionable” needs to be defined. The research plan and the IRB draft document provide insufficient detail about how decisions will be made about what to disclose, saying only that these decisions will be made centrally to ensure uniformity throughout the country (IRB draft, Sec. 9.4). One measure of the uncertainty that is still present for this important aspect of the study is the statement that “the use of NCS fetal ultrasounds for identification of fetal defects remains under discussion” (IRB draft, Sec. 3.3).
An additional problem is that the point of the NCS is to identify previously unknown factors that influence the health of children. The critical but unacknowledged question, then, is what parents and children need to be told about emerging research findings. The research plan needs to address this issue and indicate whether the NCS plans to rely on standards that have been previously been articulated by such bodies as the National Bioethics Advisory Commission (1999). The NCS documents show little awareness