Regulating clinical research: informed consent, privacy, and IRBs.

Abstract

During the past two decades, the United States has experienced dramatic developments in the area of biomedical research. Expanding budgets, augmented computer capabilities, and the Human Genome Project have all significantly enhanced research capabilities. Consequently, the number of research projects conducted in this country is ever growing, and the enrollment of an adequate number of human subjects is becoming an increasingly challenging task. Clinical research involving human participants is governed by federal regulations that have been promulgated by the Department of Health and Human Services (DHHS) and the Food and Drug Administration (FDA). In light of the proliferation of medical research, however, an increasing number of critics are voicing serious concerns about inadequate enforcement of the regulations and unacceptable research risks. In recent years, several subjects have died as a result of treatment received in clinical trials and several well-publicized lawsuits have been filed against researchers, research institutions, and Institutional Review Boards (IRBs). Intensifying concerns about both human subject welfare and potential liability are stimulating urgent calls for regulatory reforms. This symposium issue article provides a brief historical overview of Twentieth Century research abuses and the development of regulatory oversight in the United States. It discusses informed consent, IRBs, and the regulations that govern them. Finally, it analyzes contemporary deficiencies in the regulatory system and offers recommendations for reform.