Patient Outcomes Research Teams (PORTS) Managing Conflict of Interest (1991) / Chapter Skim
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6 Points to Consider
6 Points to Consider
Pages 69-92
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From page 69... ...
As the committee considered conflicts of interest that may arise from both financial and nonfinancial sources-, two conclusions emerged. First, regarding financial relationships, the committee recognizes that AHCPR cannot assume the role of sole supporter of PORTs and PORT investigators.
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From page 70... ...
PORTs, which combine research with involvement in clinical medicine, need to pay special attention to the appearance as well as the reality of conflict of interest, given the relevance of PORT findings to physician-patient interactions and policymaking and the consequent public scrutiny to which PORT research methods and findings will be exposed. Real or apparent conflicts of interest involving sources of support, other activities of PORT members, and the adequacy of representation of differing viewpoints will be primary targets for critics.
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From page 71... ...
CONSIDERATIONS FOR PORTS AND THEIR INSTITUTIONS Attributes of Conflict-of-Interest Management At this stage in the evolution of PORTs the committee believes it is more important to describe the attributes of a good conflict-of-interest management process than to devise specific rules. Such a process should include the following elements: 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 processes for responding to disclosures; and emphasis on the role of the principal investigator in managing conflicts.
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From page 72... ...
These duties are comparable to those of investigators engaging in other forms of research, but PORT investigators may need help and resources to assist them in understanding potential areas of conflict that could prevent them from carrying out these duties. The committee assumes professional integrity on the part of PORT investigators; it assumes further that PORT researchers place a high value on independence in the conduct of their work and on maintaining collegiality.
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From page 73... ...
Stated Expectations for Ear) and Complete Disclosure Requirements for regular, detailed, and mandatory financial disclosure that includes relevant information about researchers, spouses (or companions)
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From page 74... ...
Other ties, such as consulting and management positions, would be given greater scrutiny if the positions involved a direct role in the evaluation or testing of actual or prospective products. A self-denying rule of the type voluntarily adopted by several major clinical research projects in recent years, whereby key scientific participants agree to forgo all financial ties to interested businesses during such studies, provides credibility for PORT studies (although not a qualitatively different credibility than would prohibition)
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From page 75... ...
Whether the conflict-of-interest processes and policies of the lead institution are acceptable to members of PORTs at other institutions is an issue to be raised and resolved early in a PORT project. Each PORT should consider the following areas: the provision of a mechanism for open discussion among its members of potential conflicts and biases, clear identification in advance of the means by which differences in the interpretation of data will be presented and managed, and ground rules established in advance on access to PORT data both within the group and by outside researchers.
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From page 76... ...
Well-negotiated agreements with outside research sponsors might include specific attention to the following: · selection of subjects (to avoid competition for participants with other secondary protocols) ; · direction and control of the research (if external sponsorship depends, for instance, on interim results to determine incremental funding, discontinued funding by that source will jeopardize the PORrs continued study of that alternative technology)
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From page 77... ...
For example, the IOM committee learned of one clinical department in which a research ethics committee operating under the aegis of the department chair has examined several difficult issues: seeking third-party payment for "experimental" clinical procedures undertaken in the context of a randomized trial; deciding when ~state-of-the-art" treatments should be used for randomized trials rather than implemented nonexperimentally to "keep pace with the progress of medicines; and the advisability or inadvisability of "finder fees" for residents who recruit subjects into trials. None of these questions yields a single best answer under all foreseeable circumstances.
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From page 78... ...
methodology and findings by other, non-PORT health services researchers. A separate consideration is how to protect PORT researchers from petty or unwarranted accusations.
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From page 79... ...
The PORTs' nquasiregulatory~ role requires that they be scrupulous about any appearance of conflicts of interest and have well-formulated policies for dealing with them. Nevertheless, like other forms of scientific investigation, PORT research is best carried out by people complying with the basic objectives of science; consequently, rules and regulations that excessively constrain that process add little and may actually impede it.
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From page 80... ...
It seems reasonable that PORT researchers (and their immediate families, including minor dependents) should not generally be equity holders in firms producing technologies used for the conditions being studied because such holding would be considered too strong a source of bias.
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From page 81... ...
In the case of AHCPR and outcomes research, such duplicate funding might provide greater credibility for PORT methodology generally and for a particular PORrs work if two such PORTs had similar findings. Indust~g-Sponsored Research Although the committee believes it is too soon to issue detailed regulations, at some point AHCPR may find it necessary to provide specific guidance regarding industry-sponsored research.
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From page 82... ...
Such rules would allow the PORT to exploit its own research efforts in conducting and performing original analyses without precluding timely reanalysis by others, including PORT members acting independently. To become accessible resources for research, the PORT data sets need unusually well:developed documentation, recommended Test analysisn routines, code books, and so forth.
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From page 83... ...
PORTs and their institutions should be encouraged to develop a common understanding of what constitutes a conflict of interest. Development of such an understanding might eventually negate the need for specific rules regarding permissible behaviors; conversely, it might lay a foundation on which a sensible set of rules might be built.
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From page 84... ...
There may also be a role for infrastructures similar to those used in multicenter clinical trials, such as policy boards and data management committees. For clinical trials these structures are specified in the instructions from the funding agency and judged as part of the application, but it is not clear who sets, or should set, the policies for such groups.
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From page 85... ...
CONSIDERATIONS FOR INDUSTRY Just as there is a need for exchange of information and education within and among PORT researchers, there is a similar need among firms involved in funding academic research. Individual companies should consider establishing internal rules and standards of conduct comparable to university guidelines.
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From page 86... ...
. NIH and ADAMHA CRADA agreements permit only two special stipulations: a brief delay of publication to allow companies to file patent applications or intellectual property applications, and nondisclosure by investigators of information marked by the company as "confidential" (NIH/ADAMHA, 1989a,b)
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From page 87... ...
The first is whether information shared with any party is to be shared with all, because to provide any information that is publicly available to one party but not another might give a competitive advantage. This issue might be particularly troublesome for a PORT researcher in his or her capacity as a consultant where one's professional obligation is to provide the best information to a client.
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From page 88... ...
Congress should be alert to the fact that if outcomes research becomes well established and respected as a health services research activity, lower federal funding levels in later years will almost surely drive research teams toward private compensatory relationships with device and pharmaceutical manufacturers or toward other sources of funding, such as private insurers, whose primary motivation may be to find ways to reduce health care expenditures. CONCLUDING REMARKS This study was initiated following a request from the (then)
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From page 89... ...
A fear that conflicts of interest may arise in PORTs 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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From page 90... ...
· Generally, PORT researched (and their immediate families, including minor dependents) should not be equity holders in firms that produce technologies used for the conditions being studied.
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From page 91... ...
. Grant specifications should require that both internal and bona fide external investigators and analysts have reasonable and timely access to PORT data.
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