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

与工业界签订的教师咨询协议中的限制性条款（第一阶段）

• 批准号: 8146109
• 负责人: Michelle Marie Mello
• 金额: $ 12.49万
• 依托单位: HARVARD SCHOOL OF PUBLIC HEALTH
• 依托单位国家: 美国
• 财政年份: 2010
• 资助国家: 美国
• 起止时间: 2010-09-20 至 2013-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8146109
• 关键词: Address; Administrator; Agreement; Area; Award; Clinical Trials; Collaborations; Complex; Confidentiality; Consult; Contracts; Counseling; Development; Ensure; Ethical Analysis; Ethics; Exercise; Exploratory/Developmental Grant; Faculty; Fostering; Freedom; Funding; Guidelines; Health; Health Technology; Human Resources; Industry; Industry Collaboration; Informal Social Control; Institution; Investigation; Judgment; Legal; Legal Rights; Link; Measures; Medical; Methodology; Methods; Nature; Outcome; Perception; Phase; Policies; Prevalence; Process; Public Health Schools; Reporting; Research; Research Personnel; Rights; Sampling; Structure; Surveys; Telephone Interviews; Typology; Work; Writing; experience; interest; medical schools; member; novel; research and development; response; tool

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.

学术研究人员和私营公司之间的咨询关系是新健康技术研究和开发过程中学术/行业合作的重要和有价值的形式。然而，如果管理不当，这种关系可能会威胁到学术环境中合作健康研究的完整性。教师与行业执行的咨询协议可能包含限制顾问及其学术合作者的法律的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的顾问和管理人员报告说，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关于教师咨询关系的机构监督做法，并进行试点工作，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。（1）电话采访美国医学院和公共卫生学院的175名研究管理人员，询问他们对教员咨询协议的审查和监督实践以及他们为内容分析目的提供教员咨询协议副本的能力;（2）对75名教员进行了一项试验性调查，以了解他们提供咨询协议副本的能力;（3）开发了两种调查工具，以使院校管理人员和教员顾问对各种限制性条款的道德可接受性作出规范性判断;及（4）发展R 01应用程序，以资助管理这两项调查工具。第一阶段将产生一个类型学的限制性条款;一个严格的方法来调查这些条款的普遍性和主要利益相关者的看法，他们的可接受性;关于教师咨询协议的机构监督的程度和性质的新发现;和规范的论点和反对这些关系的机构监督的道德分析。第二阶段将得出第一批经验性结论，说明咨询协议中限制性条款的普遍性以及关键利益攸关方对各种条款的接受程度的道德规范。它也将导致书面工具，机构管理人员可以使用审查教师咨询协议 公共卫生关系：学术研究人员与私人公司签订的咨询协议可能包含限制顾问及其学术合作者的法律的权利和学术自由的条款。拟议的项目将调查医学院和公共卫生学校对教员咨询关系的机构监督做法，并开展试点工作，对教员和机构管理人员进行一项调查研究，了解咨询协议中限制性条款的普遍性和道德可接受性。

项目成果

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

除了经济利益冲突之外：对医学院和公共卫生学院教师咨询协议的机构监督。

• DOI: 10.1371/journal.pone.0203179
• 发表时间: 2018
• 期刊: PloS one
• 影响因子: 3.7
• 作者: Mello,MichelleM;Murtagh,Lindsey;Joffe,Steven;Taylor,PatrickL;Greenberg,Yelena;Campbell,EricG
• 通讯作者: Campbell,EricG