Beyond financial conflicts of interest: Institutional oversight of faculty consulting agreements at schools of medicine and public health

ImportanceApproximately one-third of U.S. life sciences faculty engage in industry consulting. Despite reports that consulting contracts often impinge on faculty and university interests, institutional approaches to regulating consulting agreements are largely unknown.ObjectiveTo investigate the nature of institutional oversight of faculty consulting contracts at U.S. schools of medicine and public health.DesignStructured telephone interviews with institutional administrators. Questions included the nature of oversight for faculty consulting agreements, if any, and views about consulting as a private versus institutional matter. Interviews were analyzed using a structured coding scheme.SettingAll accredited schools of medicine and public health in the U.S.ParticipantsAdministrators responsible for faculty affairs were identified via internet searches and telephone and email follow-up. The 118 administrators interviewed represented 73% of U.S. schools of medicine and public health, and 75% of those invited to participate.InterventionStructured, 15–30 minute telephone interviews.Main outcomes and measuresPrevalence and type of institutional oversight; responses to concerning provisions in consulting agreements; perceptions of institutional oversight.ResultsOne third of institutions (36%) required faculty to submit at least some agreements for institutional review and 36% reviewed contracts upon request, while 35% refused to review contracts. Among institutions with review, there was wide variation the issues covered. The most common topic was intellectual property rights (64%), while only 23% looked at publication rights and 19% for inappropriately broad confidentiality provisions. Six in ten administrators reported they had no power to prevent faculty from signing consulting agreements. Although most respondents identified institutional risks from consulting relationships, many maintained that consulting agreements are “private.”Conclusions and relevanceOversight of faculty consulting agreements at U.S. schools of medicine and public health is inconsistent across institutions and usually not robust. The interests at stake suggest the need for stronger oversight.

研究背景与意义：约三分之一的美国生命科学院系教职员工会从事行业咨询工作。尽管有报道称咨询合同往往会损害教职员工及大学的权益，但各机构针对咨询协议的监管方式仍鲜为人知。
研究目的：探究美国医学院与公共卫生学院针对教职员工咨询合同的机构监管性质。
研究设计：对机构管理人员开展结构化电话访谈。访谈内容涵盖教职员工咨询协议的监管性质（若存在），以及关于咨询属于私人事务还是机构事务的观点。采用结构化编码方案对访谈内容进行分析。
研究场景：美国所有经认证的医学院与公共卫生学院。
研究对象：通过网络搜索、电话及邮件跟进确定负责教职员工事务的管理人员。本次共访谈118名管理人员，覆盖美国73%的医学院与公共卫生学院，占受邀参与人数的75%。
干预措施：开展时长为15至30分钟的结构化电话访谈。
主要结局与测量指标：机构监管的普及率与类型；针对咨询协议中不当条款的处置措施；对机构监管的认知。
研究结果：三分之一的机构（36%）要求教职员工至少提交部分协议以供机构审查，36%的机构会根据请求审查合同，另有35%的机构拒绝审查合同。在设有审查机制的机构中，审查覆盖的议题差异显著。最常见的审查议题为知识产权（intellectual property rights）（64%），仅23%的机构审查出版权，19%的机构审查范围过宽的保密条款。六成管理人员表示，他们无权阻止教职员工签署咨询协议。尽管多数受访者认为咨询关系会带来机构风险，但许多人仍认为咨询协议属于“私人事务”。
研究结论与意义：美国医学院与公共卫生学院对教职员工咨询协议的监管在各机构间存在不一致，且通常不够完善。相关方的权益受损风险表明，亟需强化监管。