Restrictive Provisions in Faculty Consulting Agreements with Industry (Phase I)

描述(由申请人提供)：学术研究人员和私营公司之间的咨询关系是新卫生技术研究和开发过程中学术/行业合作的一种重要和有价值的形式。然而，如果不明智地管理，这种关系可能会威胁到学术环境中合作卫生研究的完整性。教师与产业界签署的咨询协议可能包含限制顾问及其学术合作者的合法权利和学术自由的条款。例如，他们可能会将顾问实验室的工作分配给公司。定期审查咨询协议的机构的法律顾问和管理人员报告称，此类条款很常见，但从未进行过实证研究。该项目的目的是研究美国医学院和公共卫生学院在教师咨询关系方面的机构监督做法，并开展试点工作，以更广泛地调查咨询协议中限制性条款的普遍性和道德可接受性。本申请为该项目的第一阶段寻求资金，该阶段包括以下活动：(1)对美国医学院和公共卫生学院的175名研究管理人员进行电话采访，了解他们对教师咨询协议的审查和监督做法，以及他们为内容分析目的提供教师咨询协议副本的能力；(2)对75名教师进行初步调查，了解他们提供咨询协议副本的能力；(3)开发两种调查工具，以促使机构管理人员和教师顾问对各种限制性条款的伦理可接受性做出规范性判断；以及(4)开发R01应用程序，以资助这两个调查工具的管理。第一阶段将制定限制性条款的类型学；调查此类条款的普遍性以及关键利益相关者对其可接受性的看法的严格方法；关于教师咨询协议机构监督的范围和性质的新发现；以及对支持和反对这些关系的机构监督的规范性论点的伦理分析。第二阶段将就咨询协议中限制性条款的盛行情况以及关键利益攸关方关于各种条款的可接受性的道德规范产生第一个经验结论。它还将产生书面工具，机构管理人员可以使用这些工具来审查教员咨询协议 公共卫生相关性：学术研究人员与私营公司签署的咨询协议可能包含限制顾问及其学术合作者的合法权利和学术自由的条款。拟议的项目将调查医学和公共卫生学校关于教师咨询关系的机构监督做法，并对教师和机构管理人员进行关于咨询协议中限制性条款的普遍性和道德可接受性的调查研究的试点工作。

DESCRIPTION (provided by applicant): Consulting relationships between academic researchers and private companies are an important and valuable form of academic/industry collaboration in the research-and-development process for new health technologies. When not wisely managed, however, such relationships can threaten the integrity of collaborative health research in the academic setting. Consulting agreements that faculty execute with industry may contain provisions that restrict the legal rights and academic freedom of the consultant and his/her academic collaborators. For example, they may assign the company rights over the work of the consultant's lab. Legal counsel and administrators at institutions that routinely review consulting agreements report that such provisions are common, yet they have never been empirically studied. The aim of this project is to study institutional oversight practices at U.S. medical schools and schools of public health concerning faculty consulting relationships and to perform pilot work for a broader investigation of the prevalence and ethical acceptability of restrictive provisions in consulting agreements. The present application seeks funding for Phase I of the project, which encompasses the following activities: (1) telephone interviews with 175 research administrators at U.S. medical schools and public health schools regarding their review and oversight practices for faculty consulting agreements and their ability to provide copies of faculty consulting agreements for purposes of content analysis; (2) a pilot survey of 75 faculty members regarding their ability to provide copies of their consulting agreements; (3) development of two survey instruments to elicit normative judgments from institutional administrators and faculty consultants about the ethical acceptability of various restrictive provisions; and (4) development of an R01 application to fund administration of these two survey instruments. Phase I will produce a typology of restrictive provisions; a rigorous methodology for investigating the prevalence of such provisions and key stakeholders' perceptions of their acceptability; novel findings regarding the extent and nature of institutional oversight of faculty consulting agreements; and an ethical analysis of the normative arguments for and against institutional oversight of these relationships. Phase II will produce the first empirical findings about the prevalence of restrictive provisions in consulting agreements and ethical norms among key stakeholders about the acceptability of various provisions. It will also result in written tools that institutional administrators can use to review faculty consulting agreements PUBLIC HEALTH RELEVANCE: Consulting agreements that academic researchers execute with private companies may contain provisions that restrict the legal rights and academic freedom of the consultant and his/her academic collaborators. The proposed project will investigate institutional oversight practices at medical and public health schools concerning faculty consulting relationships and conduct pilot work for a survey study of faculty and institutional administrators concerning the prevalence and ethical acceptability of restrictive provisions in consulting agreements.