Dissertation Research: Research Ethics and Public Values Decision-Making: Implications for Human Subject Review

Georgia Tech Research Corporation, Atlanta GA

Investigators

Abstract

This SDEST dissertation research improvement grant intends to explain the decision-making process of Institutional Research Boards (IRBs) at six U.S. research universities and to relate IRB structures and processes to their efficiency and effectiveness. In many areas of science and technology, human subjects issues raise fundamental questions about balancing risks and benefits to research participants and to society. Established to ensure ethical standards in the implementation of research that involves human participants, IRBs consist of groups of scientists and nonscientists, from the research institution and the community. They can approve, alter, or prohibit research protocols. Over 1,800 IRBs exist in the U.S., with a variety of structures, processes, and institutional contexts. While recent studies have examined IRB workloads and efficiency, systematic theory-driven empirical research is lacking on the effects of varying compositions of membership and on how IRB decision-making varies from institute to institute. This research will examine the relationship of IRB composition with human subjects decision processes, primarily via personal interviews with IRB members from a sample of research universities. Through the interdisciplinary lens of policy studies, this research will contribute to the development of an IRB decision-making model based on decision theory, science and technology studies, risk theory, and participatory analysis.