Doctoral Dissertation Research: Measuring the Impact of the Legal and Regulatory Task Environment on Biomedical IRB Performance

University Of California-Berkeley, Berkeley CA

Investigators

Abstract

More than 2.3 million Americans participate in clinical trials annually. The groups that oversee and approve the scientific and ethical appropriateness of clinical research projects, institutional review boards ("IRBs"), are empirically understudied and largely invisible to the public and research participants. Using a mixed methods approach, this study explores how biomedical IRBs translate flexible regulatory mandates into operational activities, as well as how IRBs respond to environmental pressures. It will shine a light on IRBs, which will increase public literacy and engagement around science and health policy issues, and empower patients. The investigation proceeds in two phases: first, administration of a national survey to IRB members for quantitative analysis, and second, observation of and semi-structured interviews with a purposive sample of biomedical IRBs and IRB members for qualitative analysis. This project extends theoretical understandings of organizational responses to law and regulation, and contributes practical knowledge about IRBs.