title: Ethics review for sale? Conflict of interest and commercial research review boards.
abstract: 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 are essential because of the absence of clear substantive rules in 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 the research review system will reinforce public trust in the process.
authors.affiliation: Faculty of Law, University of Toronto, 78 Queen's Park, Toronto, Ontario, Canada M5S 2C5. lemmens@utoronto.ca
authors.forename: T
authors.initials: T
authors.lastname: Lemmens
authors.forename: B
authors.initials: B
authors.lastname: Freedman
mesh_terms: D002170:Canada; D016265:Conflict of Interest; D026724:Ethical Review; D028744:Ethics Committees, Research / Q000191:economics / Q000331:legislation & jurisprudence / Q000592:standards; D004991:Ethics, Institutional; D005060:Europe; D006805:Human Experimentation; D006801:Humans; D014481:United States