IRB Reform

Abstract

We have come a long way since the 1960s, when ethical questions about research involving human subjects brought the issue to national attention. Nonetheless, the current system for safeguarding people who volunteer for clinical trials is under stress because of the unprecedented growth in clinical research.¹³ Since 1995, federal funding for research has more than doubled. From 1997 to 2000, the estimated number of participants in federally funded research increased from 7 million to almost 12 million⁴ (and Seto B: personal communication). Privately sponsored clinical research has grown at a similar pace.⁵ To paraphrase Snyderman and Holmes, as our . . .