title: Confronting conflict: addressing institutional conflicts of interest in academic medical centers.
abstract: Individual conflicts of interest are rife in healthcare, and substantial attention has been given to address them. Yet a more substantive concern-institutional conflicts of interest ("ICOIs") in academic medical centers ("AMCs") engaged in research and clinical care-have yet to garner sufficient attention, despite their higher stakes for patient safety and welfare. ICOIs are standard in AMCs, are virtually unregulated, and have led to patient deaths. Upon review of ICOIs, we find a clear absence of substantive efforts to confront these conflicts. We also assess the Jesse Gelsinger case, which resulted in the death of a study participant exemplifying a deep-seated culture of institutional indifference and complicity in unmanaged conflicts. Federal policy, particularly the Bayh-Dole Act, also creates and promotes ICOIs. Efforts to address ICOIs are narrow or abstract, and do not provide for a systemic infrastructure with effective enforcement mechanisms. Hence, in this paper, we provide a comprehensive proposal to address ICOIs utilizing a "Centralized System" model that would proactively review, manage, approve, and conduct assessments of conflicts, and would have independent power to evaluate and enforce any violations via sanctions. It would also manage any industry funds and pharmaceutical samples and be a condition of participation in public healthcare reimbursement and federal grant funding. The ICOI policy itself would provide for disclosure requirements, separate management of commercial enterprise units from academic units, voluntary remediation of conflicts, and education on ICOIs. Finally, we propose a new model of medical education-academic detailing-in place of current marketing-focused "education." Using such a system, AMCs can wean themselves from industry reliance and promote a culture of accountability and independence from industry influence. By doing so, clinical research and treatment can return to a focus on patient care, not profits.
authors.affiliation: Institute of Health Law Studies, California Western School of Law, USA.
authors.forename: Bryan A
authors.initials: BA
authors.lastname: Liang
authors.forename: Tim
authors.initials: T
authors.lastname: Mackey
mesh_terms: D000046:Academic Medical Centers / Q000941:ethics / Q000331:legislation & jurisprudence; D035843:Biomedical Research / Q000941:ethics* / Q000331:legislation & jurisprudence; D016265:Conflict of Interest / Q000331:legislation & jurisprudence; D004345:Drug Industry / Q000941:ethics / Q000331:legislation & jurisprudence; D026724:Ethical Review / Q000331:legislation & jurisprudence / Q000592:standards*; D017408:Guidelines as Topic; D006801:Humans; D007373:Interinstitutional Relations; D011640:Public Policy; D014481:United States