EvaluatorsGuidetoIRB - EVALUATION 10.1177\/019384102236520 Oakes EVALUATORS REVIEWGUIDE OCTOBER TO THE 2002 IRB Having an Institutional Review Board(IRB

EvaluatorsGuidetoIRB - EVALUATION 10.1177/019384102236520...

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10.1177/019384102236520EVALUATION REVIEW / OCTOBER 2002Oakes / EVALUATOR’S GUIDE TO THE IRBHaving an Institutional Review Board (IRB) review and monitor the use of human subjects isnow fundamental to ethical research. Yet social scientists appear increasingly frustrated with theprocess. This article aims to assist evaluators struggling to understand and work with IRBs. Theauthor theorizes why IRBs frustrate and insists there is only one remedy: We must accept thelegitimacy of IRB review and (a) learn more about IRB regulations, imperatives, and the newpressures on them; and (b) educate IRBs about social scientific methodologies and empiricallydemonstrable risks. A research agenda and tips are offered.RISKS AND WRONGS INSOCIAL SCIENCE RESEARCHAn Evaluator’s Guide to the IRBJ. MICHAEL OAKESUniversity of MinnesotaAn Institutional Review Board (IRB) is a committee of five or morediverse individuals who review research protocols and monitor ongoing stud-ies to ensure the protection of human research subjects. IRBs are typicallylocal and therefore presumed to understand the concerns of the communitywhere research is conducted. Although almost always part of a research orga-nization, to be legitimate an IRB must operate independently of its authoritystructure. Although federal regulations must be adhered to and IRBs have theauthority to disapprove research, modern IRBs aim to work with, educate,and learn from researchers on how best to protect human research subjects.443AUTHOR’S NOTE:This article was improved by comments and criticisms from several col-leagues. Thanks to Debbie Bernat, Paul Bernhardt, Heather Britt, Amy Davis, Kelli Komro, MikeMiller, Katie Schmitz, the University of Minnesota’s Social Science IRB, and an anonymousreviewer. I remain indebted to Peter H. Rossi for continued support, encouragement, example,and necessary honesty. The usual caveats apply. Address correspondence to Michael Oakes,Division of Epidemiology, University of Minnesota, 1300 South 2nd Street, Suite 300, Minneap-olis, MN 44545-1015; phone: 612-624-6855; fax: 612-624-0315; and e-mail: [email protected]epi.umn.edu.EVALUATION REVIEW, Vol. 26 No. 5, October 2002443-479DOI: 10.1177/019384102236520© 2002 Sage Publications
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The horrific experiments conducted by otherwise revered Nazi doctorsforced the courts, the medical community, and the public to consider the pro-tection of human research subjects (Annas and Grodin 1992). But the effectof the trial, by which seven were executed, and the resultant Nuremberg Codewas imperceptible in the United States (Moreno 1997; Rothman 1994).Americans believed that its physician-researchers acted in accordance withtheir Hippocratic Oath and that “voluntary consent” was unnecessary in asociety with a long and untarnished history of medical research (Moreno1997). The belief was defective.The Tuskegee study, which began in the 1930s and lasted until 1972, with-held treatment and information from a group of 399 poor Black men sufferingsyphilis infections (Jones 1993; Peckman 2001). subjects were unaware thatthey were being denied treatment and did not give informed consent. Other
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