Patient Outcomes Research Teams (PORTS) Managing Conflict of Interest (1991) / Chapter Skim
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3 Conflict of Interest
3 Conflict of Interest
Pages 27-46
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From page 27... ...
The concern with conflicts of interest arises in biomedical research because of the possibility that such conflicts, both real and perceived, may erode scientific objectivity and engender the loss of public trust (Barber, 1983, provides a general treatment; Relman, 1989~. Because PORTs conduct research for the public benefit, PORT researchers have fiduciary obligations to the public.
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From page 28... ...
All such interests may affect professional judgment and actions and thus constitute broader concerns than simply financial conflicts of interest. Several definitions of conflict of interest reviewed by the committee placed particular weight on the financial aspects of such conflicts.2 The committee took particular note of definitions of conflicts of interest that also addressed nonfinancial conflicts.
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From page 29... ...
Equity and Other Financial Relationships Financial interests can take several forms: · equity interests, including stock and stock options, in a company that markets drugs or devices that are held directly by the investigator or indirectly through various financial systems or holdings by relatives; · other profit-sharing arrangements; · management or executive positions with such companies; · royalties from licensing of intellectual property rights, including patents on inventions, copyrights (e.g., computer software) , and sale of other proprietary materials; and · consultant relationships and lectures for which honoraria are received.
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From page 30... ...
The research protocol may be devised by a drug company or other firm, designed by the investigator, or developed jointly; · Program consortia involving multiple projects in a broad field of interest, many participating researchers, and both industrial sponsors and state or federal agency sponsors; · Programs involving multiple projects and investigators but sponsored by a single company and without involvement by state or federal agencies; and · Technology transfer cooperative agreements between industry and a university to promote rapid commercialization of new inventions such as those in biotechnology. These last are of special interest to observers of PORTs because as PORTs develop special software, assessment instruments, and methods of dissemination of results, they may also engage in spin-off ventures.
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From page 31... ...
These outcomes may eventually lead to financial remuneration and increased financial security at some point, but this potential connection does not fully explain the intellectual satisfaction and similar psychological rewards not directly tied to academic advancement that can motivate researchers. Thus, professional conflicts of interest need not be conscious decisions on the part of the investigator.
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From page 32... ...
Some state laws, however, prohibited public university employees from receiving compensation or engaging in other employment related to the subject of their research. During the late 1980s attention focused on several egregious cases involving clinical trials in which investigators appeared to have substantial conflicts of interest (Booth, 1988; Marshall, 1990~.
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From page 33... ...
Because of their collected expertise, and the cost and time benefits of using existing patient cohorts, data, and investigative methodologies, drug and device manufacturers may offer financial support to PORTs that are willing to become involved in technology evaluations of the manufacturers' products. Such relationships may encounter the full spectrum of risks and benefits described above.
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From page 34... ...
The act requires workers in executive, legislative, and judicial branches to make information about their financial interests publicly available through the Office of Government Ethics. All federal employees at grade GS-16 or higher must file an annual Executive Personnel Financial Disclosure Report (SF 278~.
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From page 35... ...
The United States Pharmacopeial Convention The United States Pharmacopeial Convention is an independent, nongovernmental, nonprofit organization. Its Committee of Revision, which is composed of volunteer members, establishes and revises drug standards published in the United States Pharmacopeial the National Fonnulary, and drug information monographs.
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From page 36... ...
These include: any actions taken on the basis of reports that might later result in economic benefit or loss to particular individuals or groups; access to proprietary information; potential bias 3In the related area of pharmaceutical company influence on clinicians in academic health centers, some studies have found that both faculty and housestaff at teaching hospitals may have difficulty recognizing the degree to which actions by the pharmaceutical industry influence their own prescribing practices (Avorn et al., 1982) and the pervasiveness of such influence (Lurie et al., 1990~.
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From page 37... ...
National Institutes of Health Grants Policy The Public Health Service Grants Policy Statement entitled "Standards of Conduct for Employees" (Public Health Service, 1987:55) states that "recipient organizations must establish safeguards to prevent employees, consultants, or members of governing bodies from using their positions for purposes that are, or give the appearance of being, motivated by a desire for private financial gain.
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From page 38... ...
published reports based on their ad hoc committees' considerations of conflicts of interest and commitment. Because PORTs are based in academic medical centers, the subject of the two publications overlaps with that of this report but is not coextensive with the issues addressed by this committee.
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From page 39... ...
Under the guidelines, institutions must "develop procedures for full disclosure to the institution, and to the interested public, of financial and professional interests that may influence, or may be perceived to influence, research activity or other scholarly responsibilities" (AAMC, 1990:9~; implement enforcement procedures, including appropriate sanctions; assure management or resolution of conflicts of interest; respond expeditiously to questions raised; and avoid institutional conflicts of interest. A~4HC Guidelines The AAHC guidelines call for the development of policies identifying activities that require prior approval and activities for which disclosure is sufficient.
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From page 40... ...
The Hopkins guidelines ban ownership by a faculty member, a faculty member's spouse, and minor children of stocks or stock options in companies supporting a researcher's work, including the work of supeIvised faculty, nonfaculty employees, and students (Johns Hopkins University School of Medicine, 1990~. The Harvard guidelines elaborate on categories of sensitive situations that are subject to particular scrutiny, including equity interests, consulting income, executive positions tied to the investigator's research, and certain forms of sponsored research (Harvard University Faculty of Medicine, 1990~.
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From page 41... ...
Similarly, judges, in certain cases, recuse themselves because of a possible conflict of interest. During the IOM workshop, Arnold Relman noted that both the judicial system and clinical research bear responsibilities as public institutions: The public would not accept the fact that a judge, however honorable and impeccable his legal background and however open he is to judicial review later on, should preside over a trial in which he has significant interest in one of the contesting parties.
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From page 42... ...
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From page 43... ...
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From page 44... ...
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