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The Illinois White Paper

Improving the System for Protecting Human Subjects: Counteracting IRB "Mission Creep"

University of Illinois

Edward M. Bruner

University of Illinois

Nicholas C. Burbules

University of Illinois

Leon Dash

University of Illinois

Matthew Finkin

University of Illinois

Joseph P. Goldberg

University of Illinois

William T. Greenough

University of Illinois

Gregory A. Miller

University of Illinois

Michael G. Pratt

University of Illinois

Masumi Iriye

University of Illinois

Deb Aronson

University of Illinois

Our system of research self-regulation, designed to provide internal checks and balances for those who participate in research involving human subjects, is under considerable stress. Much of this crisis has been caused by what we call mission creep, in which the workload of IRBs has expanded beyond their ability to handle effectively. Mission creep is caused by rewarding wrong behaviors, such as focusing more on procedures and documentation than difficult ethical questions; unclear definitions, which lead to unclear responsibilities; efforts to comply with unwieldy federal requirements even when research is not federally funded; exaggerated precautions to protect against program shutdowns; and efforts to protect against lawsuits. We recommend collecting data. We also call for refinements to our regulatory system that will provide a set of regulations designed for non-biomedical research. This will enable IRBs to direct attention to the areas of greatest risk while intentionally scaling back oversight in areas of lesser risk. We recommend removing some kinds of activity from IRB review altogether. Our system, if not broken, is seriously straining at the seams. It is imperative that we have a respected and effective system in place to protect human research subjects, so that much-needed research into the causes and prevention of disease and other research expanding the boundaries of knowledge can proceed. We hope that this White Paper will further the discussion about what reasonable procedures can be instituted to help get IRBs back on track and do what they were originally meant to do—protect the rights and welfare of human subjects while allowing the research enterprise to progress and its benefits to society to accrue.

Key Words: human subjects of research • mission creep • federal regulation

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