Ethics review for sale? Conflict of interest and commercial research review boards

被引:64
作者
Lemmens, T
Freedman, B
机构
[1] Univ Toronto, Fac Law, Toronto, ON M5S 2C5, Canada
[2] McGill Univ, Montreal, PQ H3A 2T5, Canada
关键词
D O I
10.1111/1468-0009.00185
中图分类号
R19 [保健组织与事业(卫生事业管理)];
学科分类号
摘要
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.
引用
收藏
页码:547 / +
页数:40
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