Patient Outcomes Research Teams (PORTS) Managing Conflict of Interest (1991) / Chapter Skim
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PORTs are large multidisciplinary, multi-institutional projects that employ larger and more diverse groups of researchers than is typical in health services research. Each PORT includes academic and practicing community-based health care providers and has expertise in pertinent clinical specialties, literature synthesis, research design, epidemiology, biostatistics, economics, decision analysis, survey research, data management, and research dissemination.
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was asked to convene a committee to provide points for the agency and PORTs to consider in anticipating and managing conflicts of interest. The ninemember committee, which represented expertise in medical center and research administration, health services and clinical research, law, medical sociology, ethics, pharmaceutical and device manufacturing, and regulation-commissioned background papers and convened a one-and-a-halfday workshop to discuss issues relevant to conflicts of interest in PORTs.
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These professional conflicts of interest need not be conscious decisions on the part of an investigator; nevertheless, intellectual attachment or commitment to a particular scientific theory pose possible conflicts. Financial relationships that may give rise to conflicts of interest take two typical forms for clinical researchers.
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PORTs are a new hybrid entity which encompasses academic medical research leading to peer-reviewed scientific findings and a "quasi-regulatory role directly related to public policy and health insurance payment questions. This hybrid responsibility confers special expectations on PORTs and argues for well-defined, irreproachable standards to address the appearance of conflict of interest as well as its actual occurrence.
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Although differing in their starting points and in their effect on particular research projects, each model can incorporate similar means of reducing or managing the effects of a conflict of interest: mandatory disclosure, mechanisms of financial distancing, selfregulation, defining categories of acceptable activities and implementing oversight of such activities, and defining unacceptable activities and implementing prohibitions or, when necessary, sanctions. POINTS TO CONSIDER This report suggests points for consideration by PORTs and their institutions, AHCPR, the health services research community, industry, and Congress regarding conflicts of interest in outcomes research.
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· PORTs of necessity rely heavily on observational studies, incomplete data bases, and qualitative outcomes, and their findings are no substitute for traditional clinical trials and should not be the sole basis for clinical or public policy decisions. · Outcomes research (and PORTs in particular)
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Outcomes research as exemplified by PORTs holds out the promise of greatly improving the value and effectiveness of the health care system. The fear of unresolvable conflict of interest should not inhibit commitment to outcomes research or the continued evolution of what must be seen as a bold new "social invention" on the part of Congress.
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