Recommended Principles to Guide Academy-Industry Relationships

Part I: General Principles to Guide Academy-Industry Relationships University-Wide (1–7)

117 Detailed Discussion of the 56 Recommended Principles The AAUP recommendations include: GENERAL PRINCIPLES, which may be applied university-wide, that cover core academic norms and standards,such as authenticity of authorship,publication rights,and academic autonomy;they also address broad areas of academy-industry engagement,such as student education and training,financial conflicts of interest, and intellectual property management. TARGETED PRINCIPLES that address specific types of academy-industry engagement, including strategic corporate alliances, industry-sponsored clinical trials, and academy-industry interactions at academic medical centers. Some repetition has been necessary to ensure adequate explanation of the individual principles. Definition of a “significant” financial interest As noted in the Summary of Recommendations, throughout this report the AAUP defines a financial interest to be “significant” if it is valued at or above $5,000 per year and it is not controlled or managed by an independent entity such as a mutual or pension fund. This definition is consistent with the definitions and de minimis threshold for financial disclosure established by the US Department of Health and Human Services in its 2011 conflict of interest disclosure rules (Department of Health and Human Services, 42 CFR Part 50, 45 CFR Part 94,“Responsibility of Applicants for Promoting Objectivity in Research for which Public Health Service Funding is Sought and Responsible Prospective Contractors,” Federal Register, vol. 76, no. 165,August 25, 2011, available at: http://www.gpo.gov/fdsys/pkg/FR-2011-08-25/pdf/2011-21633.pdf ).The relevant sections of these DHHS rules are reprinted in full at the end of the Summary of Recommendations for easy reference. 118 DETAILED DISCUSSION OF THE 56 RECOMMENDED PRINCIPLES Part i. General Principles to Guide Academy-Industry Relationships University-Wide (1–7) PrinciPle 1: faculty Governance the university must preserve the primacy of shared academic governance in establishing campuswide policies for planning, developing, implementing, monitoring, and assessing all donor agreements and collaborations , whether with private industry, government, or nonprofit groups. faculty, not outside sponsors, should retain majority control over the campus management of such agreements and collaborations. Threats to faculty control over research and teaching as well as violations of good shared governance practices run through many of the case studies and risk categories associated with academy-industry engagement we have reviewed.Academy-industry partnerships play a vital role in funding research and bring many additional benefits.Yet in the face of mounting COI and commercial threats to academic freedom and research integrity, the time has come for stronger faculty input and guidance in this broad arena.Establishing the standards we recommend will strengthen university policymaking in this growing area of outside donor collaborations, safeguard academic freedom and professionalism, and engender greater campuswide support and public trust. The AAUP recommends the following corrective and preventative measures: • The faculty collectively through the academic senate should have a direct role in formulating the campuswide policies, principles, and standards that will guide all donor agreements and collaborations, including those forged with private industry, government, and nonprofit groups. We mean “assessment” above to refer not only to negotiation of a contract ’s content but also to the ongoing evaluation of a project and the review of a project after it has concluded. DETAILED DISCUSSION OF THE 56 RECOMMENDED PRINCIPLES 119 • University policies should draw and build on these recommendations. • To ensure that all forms of academy-industry engagement are addressed in an effective and comprehensive manner across campus, these policies should cover the university proper as well as any affiliated medical schools, hospitals, institutes, foundations, associations, and centers. • No external relationships, donor agreements, or university-industry collaborations should be allowed to intrude on academic governance, or contravene existing academic policies or collective bargaining agreements . • Most donor agreements can be formulated to comply with these campuswide standards and protocols without advance senate approval. But because of their potential to exert disproportionate influence, the senate should be explicitly involved in the development and final approval of any large-scale,multi-year strategic corporate alliances.Large-scale SCAs are covered in detail in PartVI of this report. Too often faculty governing bodies are shut out of policy making and other negotiations surrounding the formation of academy-industry partnerships , even when these partnerships have a direct bearing on research and other academic matters traditionally considered faculty responsibilities.This is particularly true with SCAs, which often emerge from one department or institute without supervision, oversight, input, or evaluation by collective faculty governing...