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临床研究中的财务利益冲突政策:临床研究人员面临的问题。

Financial conflict-of-interest policies in clinical research: issues for clinical investigators.

作者信息

Boyd Elizabeth A, Cho Mildred K, Bero Lisa A

机构信息

Department of Clinical Pharmacy, University of California, San Francisco, 94143, USA.

出版信息

Acad Med. 2003 Aug;78(8):769-74. doi: 10.1097/00001888-200308000-00002.

Abstract

As industry sponsorship of clinical research grows, investigators' personal financial relationships with those sponsors are under increasing scrutiny. The federal government, some states, and many universities have enacted conflict-of-interest policies to monitor and regulate investigators' financial relationships. Little is known, however, about investigators' awareness of or support for these policies or their attitudes toward regulatory efforts. To explore the possible implications of conflict-of-interest policies for clinical researchers, the authors interviewed active clinical investigators at two institutions where the conflict-of-interest policies differ. The most striking feature of the interviews was the range of perceptions and attitudes expressed by clinical investigators and their implications for administrators, professional societies, and policymakers concerned with conflicts of interest. Fewer than half of the interviewed investigators could accurately describe their campus' conflict-of-interest policy. Many investigators felt that professional societies, the public, and individual investigators were appropriate monitors of conflicts of interest. Many investigators recognized the general risks associated with conflicts of interest, but felt that they personally were not at risk. A fundamental challenge facing administrators and policymakers is to demonstrate to all investigators, both clinical and nonclinical, that the potential for bias, pressure and conflict is relevant to all investigators with industry relationships.

摘要

随着临床研究的行业赞助不断增加,研究人员与这些赞助商的个人财务关系受到越来越多的审查。联邦政府、一些州和许多大学已经制定了利益冲突政策,以监督和管理研究人员的财务关系。然而,对于研究人员对这些政策的认识或支持情况,以及他们对监管努力的态度,我们却知之甚少。为了探究利益冲突政策对临床研究人员可能产生的影响,作者采访了两所利益冲突政策不同的机构中的在职临床研究人员。访谈中最显著的特点是临床研究人员表达的各种看法和态度,以及这些看法和态度对关注利益冲突问题的管理人员、专业协会和政策制定者的影响。不到一半的受访研究人员能够准确描述他们所在院校的利益冲突政策。许多研究人员认为专业协会、公众和研究人员个人都是利益冲突的合适监督者。许多研究人员认识到利益冲突带来的一般风险,但觉得自己个人不存在风险。管理人员和政策制定者面临的一个根本挑战是,要向所有临床和非临床研究人员证明,偏见、压力和冲突的可能性与所有与行业有关系的研究人员都相关。

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