The report says difficulties that researchers encounter when implementing federal regulations usually can be traced to three underlying problems: insufficient guidance about interpretation and implementation of regulations; inadequate attention by scientific investigators and IRBs to special rules for pediatric research; and the intrinsically subjective nature of the criteria for evaluating proposed research, especially criteria concerning the degree of risk.
Categorizing and evaluating risks are among the most challenging tasks for reviewers of studies involving children, the report notes. The committee was asked to consider the regulatory definition of "minimal risk" in the context of such studies. Fewer restrictions are placed on pediatric research that involves minimal risk. In general, federal policies say the term means that the probability and magnitude of harm or discomfort anticipated in research are not greater than what people ordinarily encounter in their daily lives or during routine physical or psychological examinations and tests.
In weighing possible harm from pediatric research protocols, reviewers should compare potential research risks with those commonly encountered by healthy, average children, the committee concluded. It is not acceptable for research to expose children to higher levels of risk simply because they are already imperiled by illness, unsafe neighborhoods, or other aspects of their daily lives.
IRBs should make explicit determinations about each regulatory criterion required for the approval of research protocols involving children, and document those decisions, the report adds. To
Contact: Vanee Vines
The National Academies