IRB: Ethics & Human Research

How IRB Leaders View and Approach Challenges Raised by Industry-Funded Research

Many questions exist concerning how IRBs view and respond to challenges posed by industry-funded studies. These studies may be designed to benefit the funder more than science or society more broadly. Industry-funded studies may be “me-too” drug and post-marketing studies, or studies that raise questionable research practices such as incentive fees to physicians who enroll their patients in the studies. Additional concerns may arise when industry funders use Contract Research Organizations to review and manage their studies. In the study reported here, IRB leaders were interviewed to learn how they and their IRB respond to these challenges. Of interest was whether IRBs weigh low social benefit when reviewing industry-funded protocols, and if so, how, when and to what degree, and whether IRBs feel conflicted about reviewing industry-funded protocols based on their own views about the human research enterprise.

Key words/concepts: human subjects research, human research ethics, research regulation and oversight, regulations and guidelines for human subjects research, research review boards and committees, institutional review board (IRB), industry-funded studies

Robert Klitzman, “How IRB Leaders View and Approach Challenges Raised by Industry-Funded Research,” IRB: Ethics & Human Research 35, no. 3 (2013): 9-16.