Journal of Continuing Education in the Health Professions



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CURRENT ISSUE BACK ISSUES SUBSCRIBE ADVERTISE ABOUT JCEHP FOR AUTHORS JCEHP AWARD SEARCH (Members only) FULL-TEXT		Volume 21 (4) Volume 21, Issue 4, Fall 2001 J Contin Educ Health Prof 2001; 21(4):238-246 ISSUES IN RESEARCH Federal regulations and the future of research in human and medical genetics Pelias MZ A b s t r a c t 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. Lessons for Practice Recent events in the conduct of research in human and medical genetics form the foundation for a re-examination of federal regulations that define human subjects for the purposes of obtaining or waiving informed consent. Comprehensive and accurate research in human and medical genetics depends on the accurate collection of family history information and construction of family history charts. This information is personal but is usually hearsay and common knowledge in the family. It may be private in the view of the family and within the definitions of federal regulations. New guidelines, currently under consideration by the Office for Human Research Protections of the U.S. Department of Health and Human Services, must provide rigorous protection for family history information and procedures that will protect both the interests of research subjects and their families as well as the interests of the research community. MeSH Terms: Bioethics; Facility Regulation and Control; Genetic Privacy; Guidelines; Human Experimentation; Informed Consent; Medical History Taking; Pedigree; Research Publication Type: Review
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