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36 Baylor L. Rev. 1 (1984)
Medical Research Involving Children: Some Legal and Ethical Issues

handle is hein.journals/baylr36 and id is 29 raw text is: BAYLOR LAW REVIEW VOLUME 36 WINTER, 1984 NUMBER 1 MEDICAL RESEARCH INVOLVING CHILDREN: SOME LEGAL AND ETHICAL ISSUES Dennig H. Langer, M.D., J.D.* The use of children as participants in clinical research studies is a sub- ject of considerable controversy. This article examines some of the legal and ethical aspects concerning the use of children in such studies. Much of the discussion concerns the difficulties in obtaining adequate informed consent from children (for example, whether a child is competent to de- cide on his own to participate in research studies and whether it is ethical for others, such as parents or guardians, to give consent for the child). This article will consider first the question of whether children should participate as research subjects, and the conclusion will be that, in circum- stances where the potential benefits exceed the potential risks, and when the child and his family or guardians are actively involved in the decision to participate, it may be ethically acceptable to involve children as research participants. Of course, informed consent is a prerequisite to research participation, and the law traditionally presumes that children are incom- petent to make independent decisions. Second, this article will undertake a review of varying standards in- volving research in children. The scientific standards for research are re- viewed: for research to be scientifically and ethically acceptable, the risks to the subjects must be minimized and reasonable in relation to the anti- cipated benefits, adequate informed consent must be sought, and the de- sign of the study must be such that it is likely that the scientific question will be answered. The federal regulations that govern the conduct of bio- medical and behavioral research involving children emphasize the same concerns as the scientific standards, though the regulations encourage re- search involving children. Although the Supreme Court decisions on the *Clinical Associate Professor, Section of Child Psychiatry, Department of Psychiatry, Indiana University School of Medicine. Associate Clinical Investigator, Eli Lilly and Com- pany, Indianapolis, Indiana. Columbia University, B.A., 1971; Georgetown University, M.D., 1975; Harvard University, J.D., 1983. The opinions or assertions contained herein are the private views of the author and are not to be construed as reflecting the views of the Indiana University School of Medicine or Eli Lilly and Company.

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