The Dysregulation of Human Subjects Research
- Norman Fost, MD, MPH;
- Robert J. Levine, MD
- Author Affiliations: University of Wisconsin School of Medicine and Public Health, Madison (Dr Fost); and Yale University School of Medicine, New Haven, Connecticut (Dr Levine).
- Corresponding Author: Norman Fost, MD, MPH, Department of Pediatrics, University of Wisconsin Hospital, 600 Highland Ave, Madison, WI 53792 (ncfost{at}facstaff.wisc.edu).
Since this article does not have an abstract, we have provided the first 150 words of the full text.
- KEYWORDS:
- ETHICS COMMITTEES, RESEARCH
- HEALTH INSURANCE PORTABILITY AND ACCOUNTABILITY ACT
- RADIATION INJURIES
- RESEARCH SUBJECTS
- SAFETY MANAGEMENT
- UNITED STATES GOVERNMENT AGENCIES
- UNITED STATES FOOD AND DRUG ADMINISTRATION
The regulatory system for protecting human subjects in research in the United States is increasingly dysfunctional. While many critics assert that research participants are inadequately protected,1-2 there are increasing concerns that the system is overregulated, with more time and expense devoted to activities of marginal utility in protecting human research participants.3-6 In some cases these activities actually appear to be reducing protections for participants in research, by diverting energy that could be spent on more fruitful tasks and by creating disincentives to institutional review board (IRB) membership.
Undeniably the early history of research involving human subjects was dominated by scandals, including widespread egregiously unethical behavior by US physician investigators.7 In 1973, 7 years after the US government required IRBs for federally funded research, many institutions were found to be performing only perfunctory reviews.8
By 1983 a presidential commission9 found the IRB …
