The Illinois White Paper - Improving the System for Protecting Human Subjects: Counteracting IRB Mission Creep

Abstract

This White Paper reports on two years' work by a group convened by the Center for Advanced Study at the University of Illinois, following an invitational, national, interdisciplinary conference Human Subject Policy Conference: An Examination of the Interaction Between Human Subject Protection Regulations and Research Outside the Biomedical Sphere. We describe the pernicious effects of mission creep on the work of Institutional Review Boards, which is diverting the attention of some IRBs from critical ethical oversight in favor of often-meaningless paperwork. We make recommendations to help the IRB system focus its efforts on those research projects most in need of careful ethical review to protect human subjects of and participants in research. The recommendations include the idea that some methodologies do not need advance review and approval by IRBs and that there are procedural changes that can strengthen the core missions of IRBs. We hope that this paper will further the discussion about what reasonable procedures can be instituted to provide improved ethical protection for people who participate in research projects.