Institutional Review Board Rules

I10 8

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Abstract

Almost every major United States university requires faculty members and students who wish to do research on “human subjects” to submit proposals to Institutional Review Boards (IRBs). These university Boards/committees, composed of faculty from various disciplines and a local community representative, have the authority to reject, modify or approve research proposals. If unapproved research is nevertheless conducted, IRBs can discipline the researcher and prevent publication. This authority extends to any research, funded or unfunded, that intends to create generalizable knowledge about humans. The origin of the IRB system stemmed from moral outrage over abuses committed by some Nazi scientists and certain medical and psychological experiments that harmed subjects in the United States and elsewhere. The IRB rules were codified in the Belmont Report and adopted by the U.S. Department of Health and Human Services for federally funded research in the 1970s and 1980s. Since then other professional associations and most universities have also adopted them, regardless of the funding source. IRB rules require researchers to treat all human subjects with “autonomy, beneficence and justice,” making no exception for those persons who have violated the legal or moral standards of society. The key to the process is fully informed consent of subjects which may make it impossible to obtain information from those who wish hide conduct or opinions and thus can frustrate attempts to understand truths that may benefit the larger society. Despite a consensus that universities should not permit research that risks harming vulnerable populations (children, mentally ill, prisoners, etc.), IRBs have created rules controlling research regarding the general population that far exceed legal proscriptions against libel and slander and are much more restrictive than any rules applying to non-university research. As a practical matter, the IRB process makes some kinds of research, which is otherwise frequently carried out by journalists or in think tanks, very difficult to do in academic settings. IRBs have the power to censor both inquiry and publication. State sponsored or encouraged censorship is always controversial in American society and particularly so in universities. This paper will explore the legal and intellectual issues raised by the IRB rules and discuss their application to various disciplines (biomedical, behavioral, history, public policy, and journalism). It concludes that the IRB process and rules should be modified for most forms of public policy and journalistic research.