Financial relationships between institutional review board members and industry
Financial relationships between institutional review board members and industry
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DOI：
10.1056/nejmsa061457
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发表时间：
2006-11-30
影响因子：
158.5
通讯作者：
Koski, Greg
中科院分区：
文献类型：
--
作者：
Campbell, Eric G.;Weissman, Joel S.;Koski, Greg
背景：关于学术机构中行业和机构审查委员会(IRB)成员之间的财务关系的性质、程度和后果，人们知之甚少。方法：我们随机抽样调查了100个学术机构的893名IRB成员(回复率为67.2%)。问卷调查的重点是成员与行业的财务关系(例如，就业、董事会成员、咨询、版税收入和有偿演讲)。结果：我们发现，36%的IRB成员在过去一年中至少与行业有一种关系。在受访者中，85.5%的人表示他们从未认为另一名IRB成员与行业的关系以不适当的方式影响了他或她的IRB相关决策，11.9%的人表示他们认为这种情况很少发生，2.4%的人认为有时会发生，0.2%的人认为经常发生。78名受访者(15.1%)报告说，在过去一年中，至少有一项协议出现在他们的IRB之前，该协议是由他们与之有关系的公司或该公司的竞争对手赞助的，这两者都可被视为利益冲突。在这78名成员(62名有投票权的成员和16名无投票权的成员)中，57.7%的人报告他们总是向IRB官员披露这一关系，7.7%的人说他们有时会这样做，11.5%的人说他们很少这样做，23.1%的人说他们从来没有这样做过。在报告冲突的62名投票成员中，64.5%的人报告他们从未就议定书投票，4.8%的人说他们很少投票，11.3%的人说他们有时会这样做，19.4%的人说他们总是这样做。大多数受访者反映，具有行业工作经验的IRB成员的观点有助于审查行业赞助的协议。结论：IRB成员与行业之间的关系很常见，成员有时会参与与其有财务关系的公司赞助的协议的决策。应审查目前的法规和政策，以确保有适当的方法来处理因与工业的关系而产生的利益冲突。
BACKGROUND:Little is known about the nature, extent, and consequences of financial relationships between industry and institutional review board (IRB) members in academic institutions. We surveyed IRB members about such relationships.METHODS:We surveyed a random sample of 893 IRB members at 100 academic institutions (response rate, 67.2%). The questionnaire focused on the financial relationships that the members had with industry (e.g., employment, membership on boards, consulting, receipt of royalties, and paid speaking).RESULTS:We found that 36% of IRB members had had at least one relationship with industry in the past year. Of the respondents, 85.5% said they never thought that the relationships that another IRB member had with industry affected his or her IRB-related decisions in an inappropriate way, 11.9% said they thought this occurred rarely, 2.4% thought it occurred sometimes, and 0.2% thought it occurred often. Seventy-eight respondents (15.1%) reported that at least one protocol came before their IRB during the previous year that was sponsored either by a company with which they had a relationship or by a competitor of that company, both of which could be considered conflicts of interest. Of these 78 members (62 voting members and 16 nonvoting members), 57.7% reported that they always disclosed the relationship to an IRB official, 7.7% said they sometimes did, 11.5% said they rarely did, and 23.1% said they never did. Of the 62 voting members who reported conflicts, 64.5% reported that they never voted on the protocol, 4.8% said they rarely did, 11.3% said they sometimes did, and 19.4% said they always did. Most respondents reported that the views of IRB members who had experience working with industry were beneficial in reviewing industry-sponsored protocols.CONCLUSIONS:Relationships between IRB members and industry are common, and members sometimes participate in decisions about protocols sponsored by companies with which they have a financial relationship. Current regulations and policies should be examined to be sure that there is an appropriate way to handle conflicts of interest stemming from relationships with industry.