Federal regulations and the future of research in human and medical genetics.

Recent events in genetics research have generated questions about the efficacy of federal regulations that govern the conduct of biomedical research, particularly genetics research. The regulatory definitions of "human subject" and "private information" that have governed the conduct of research for two decades are presently under scrutiny because of ambiguities created by the methods of family studies in human and medical genetics. Geneticists customarily collect family history information for the purposes of tracking and characterizing genes in large families. Amassing family history information usually entails asking human subjects about the health status of collateral relatives. Whether these relatives should be regarded as human subjects for the purposes of giving informed consent is the issue that has triggered wide debate and an exhaustive re-examination of federal regulations and guidelines. The purpose of this article is threefold. First, a review of the development of current federal regulations provides a foundation and a point of departure for resolving current issues in genetics research. Second, a review of customary practices in genetics research furthers thought regarding regulations or guidelines to address specific issues in genetics. Third, it asserts that any new regulations or guidelines must provide appropriate protections for human subjects and their families while simultaneously supporting appropriate activities in genetics research.