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

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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.