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Patient Outcomes Research Teams: Managing Conflict of Interest
Box 6.1 Framework for Discussion
Like other scientists, PORT researchers seek to maximize the validity of their inferences by identifying sources of bias and by minimizing the effects of those biases on their findings.
The varieties of PORT relationships with other entities are evolving, and any pitfalls resulting from financial and professional conflicts of interest cannot yet be well delineated.
PORTs may be exposed to accusations of conflict of interest because of connections to industry, professional associations, and the like, possibly with the intent of discrediting their findings when such results are at odds with the interests of other parties.
PORT investigators need guidance in recognizing a potential or real conflict of interest and knowing when to disclose it.
Each PORT or its home institution should have in place an appropriate mechanism by which relevant conflicts of interest and biases can be revealed and addressed.
Each prospective PORT should be required in its funding application to file copies of the conflict-of-interest policies of the home institution and of its proposed subcontractors and to describe the process it will use to manage conflicts of interest.
Requirements regarding conflict of interest should be at least as stringent as those that apply to clinical investigators. Where institutional rules distinguish between bench and animal research on the one hand and clinical trials on the other, PORTs should be subject to the rules that apply to the latter.
Methods of dealing with conflict of interest include disclosure, followed by assessment and management or, where essential to the integrity of the research, outright prohibition. The PORT members and their institutions are best placed to determine the process by which they will manage conflict. Important aspects of such a process include education about conflicts of interest for researchers, faculty, and students; clearly stated expectations for early and complete disclosure of relevant interests; well-formulated, well-implemented institutional process for responding to disclosures; and emphasis on the role of the principal investigator in managing conflicts.
Collaborative research agreements with industrial entities (firms) should ensure freedom to publish the outcomes of studies, whether favorable or unfavorable, and latitude for communication among PORT investigators and industry.
Generally, PORT researchers (and their immediate families, including minor dependents) should not be equity holders in firms that produce technologies used for the conditions being studied.