Abstract

Current United States’ policy requires federally funded research studies involving human subjects to be approved by an interdisciplinary committee called an institutional review board (IRB). IRBs exist to protect the safety and welfare of human subjects participating in research studies. Although oversight of human subjects research and, consequently, IRBs, is governed by federal regulations, the operation of IRBs remain largely mysterious to those other than IRB members themselves. This Note reviews the establishment of both United States regulations and international guidelines governing human subjects research, the changing environment of biomedical research, and potential reforms for improving the efficiency and efficacy of ethical review performed by IRBs. Part I of this Note reviews the establishment of the federal regulations governing human subjects research that originates in the United States as well as the ethical principles that guided their creation. Part II presents current policies governing the structure and function of IRBs and also describes potential policy revisions relevant to the function of IRBs. Part III examines current controversies regarding research oversight systems. Finally, Part IV offers recommendations for improving human research subject oversight.

Keywords: Institutional Review Boards, Human Subject Research, Biomedical Research