Oversight mechanisms for clinical research
Snyderman, R.; Holmes, E.W.
Science 287(5453): 595-597
2000
ISSN/ISBN: 0036-8075 PMID: 10691540 Document Number: 521366
In the United States, the need to conduct clinical research has far outstripped its research support infrastructures, training programs, and potentially the means for assuring the defense of human subjects. The increasing pool of biomedical research discoveries applicable to health, the rapid expansion of the pharmaceutical and biotechnology industries, and the progress toward evidence-based medicine ensure that clinical research will play an increasingly dominant part in the future of medical practice. The historic Tuskegee and Willowbrook studies, the recent report on radiation experiments performed without participant consent, and the tragic death of the patient in a recent gene therapy trial resulted in heightened public concerns and an increased scrutiny of clinical research. Given the expansion of clinical research, it is time for an extensive review of subject protection legislation and oversight that was developed in a very different era, and the aim should be an effective, simplified system that is intelligible, adaptable, and effective.