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December 2000 (Volume 78)
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Research review boards, established to protect the rights and welfare of human research subjects, have to ensure that conflicts of interest do not interfere with the ethical conduct of medical research. Private, commercial review boards, which increasingly review research protocols, are themselves affected by a structural conflict of interest. Within the regulatory setting, procedural conflict-of-interest rules research review and the reliance on the fairness and good judgment of institutional review board members. Current guidelines and regulations lack adequate conflict-of-interest rules and provide insufficient details on the substantive rules. Because commercial review boards are similar to administrative courts and tribunals, rules of administrative law on bias are applied to determine when a conflict of interest jeopardizes the purposes of research review; administrative law has always judged financial conflicts of interest severely. The structure of private review tends to breach a core principle of administrative law and procedural justice. Reform of research review system will reinforce public trust in the process.
Author(s): Trudo Lemmens; Benjamin Freedman
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Volume 78, Issue 4 (pages 547–584) DOI: 10.1111/1468-0009.00185 Published in 2000
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The Milbank Quarterly’s multidisciplinary approach and commitment to applying the best empirical research to practical policymaking offers in-depth assessments of the social, economic, historical, legal, and ethical dimensions of health and health care policy.