NCPHS - Research Involving Children

In spite of the diversity of views reflected in the foregoing statements, our recommendations were adopted almost unanimously. The dissenting statement of Commissioner Turtle reflects a sharp disagreement, however, and requires some comment since it is based, I believe, on a misunderstanding of Recommendation (5).

The Commission has adopted a conservative definition of "minimal risk," i.e., the risk of harm that is normally encountered in the daily lives, or in the routine medical or psychological examination, of healthy children. Virtually the entire Commission is in agreement that a "minor" or "slight" additional risk over that normally encountered may ethically be presented in very limited circumstances by research not intended to benefit directly the children who are subjects. These limited circumstances are commensurability of experience, likelihood of yielding generalizable knowledge about the subjects' disorder, and importance of that knowledge for understanding or treating such disorder. Further, provision must be made. when appropriate, for the participation of parents in such research involving their children.

Recommendation (5) contemplates research into the nature and treatment of disorders that specifically afflict children. The limited circumstances under which such research may be approved under Recommendation (5) clearly indicate that the research must be related to the disorder or condition affecting those subjects who are involved. Such research cannot by its very nature be conducted on normal subjects. Accordingly. Mr. Turtle's statement that the Commission's recommendations require research presenting more than minimal risk to be carried out on sick children merely because they are al- ready subject to such risk, and his contention that the recommendation would shift involvement in such research from normal to sick children. are both incorrect. The Commission's intention in Recommendation (5), and the likely effect of this recommendation, are clearly not to encourage any unnecessary involvement of sick children in research, but rather to permit the conduct of research intended to develop important knowledge of disease states from which certain children suffer and for which research they are the only appropriate subject