C01 - PLENARY: Taking Stock of the Research Ethics Oversight Ecosystem: Healthy Developments, Overgrowth, and Audit Culture

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The goal of this session is to consider how the ecosystem of research ethics oversight has grown (and perhaps overgrown) over the past 50 years, via a proliferation of approaches toward professionalism, accreditation, and efficiency that must balance the tension between appropriate maturation of the system and problematic tendencies toward "audit culture" in which the system loses sight of central goals. The session will begin with a "back to basics" historical reminder of why IRBs were developed and what problems they were intended to solve, followed by a brief discussion of recent governmental findings regarding quality and quality assessment. Speakers will then engage in an environmental assessment of the current IRB ecosystem, including the development of many programs and expectations that exceed regulatory requirements. Which of these developments represent true quality improvements and which might reflect "over-proliferation," considering what is necessary to reasonably protect research participants, current costs and burdens, and risks of over-bureaucratization and professional self-interest? Speakers will close with a discussion of what the ideal research ethics oversight ecosystem might look like and possible alternate approaches to its future.