Remedies and Safeguards

The integrity of individual researchers is clearly the most important guard against the malevolent potential of conflicts of interest. But honesty alone may sometimes be insufficient, as damage can occur from unconscious bias and error as well as from conscious falsification. While all conflicts of interest have the potential to undermine a scientist's or an institution's primary goals of truth, objectivity, and openness, all conflicts do not pose the same degree of danger or require the same response. The danger of a particular conflict of interest depends both on how likely the arrangement is to corrupt the scientist's professional duty and on how much damage that corruption is likely to cause. Larger financial payments, and longer and closer relationships between researchers and business, will typically pose greater dangers than small financial incentives and one-time contacts with corporations (Thompson). While supervisory and regulatory measures can usually be tailored to the degree of the risk, there may be some situations in which the danger of harm to scientific integrity and society is so high that no protective measure can remedy it.

Universities might limit the amount of support they accept from industry, limit the amount of time that faculty may devote to outside endeavors, or prohibit particularly suspicious arrangements. In addition, research institutes can require the disclosure of all commercial links and interests and establish prospective administrative review of all proposals for outside funding (Varrin and Kukich; AAMC, 1990). Disclosure rules not only assist university officials and peers in policing conflicts of interest but may also make researchers more scrupulous in evaluating the potential bias in their own work. Researchers sometimes end or eschew questionable relationships rather than disclose them to the academic community. Some have argued, however, that today's institutional policies tend to advocate, inappropriately, disclosure alone, treating it as if it were a panacea. A number of prestigious universities and organizations in the United States proposed stringent conflict of interest policies in the early 2000s (Kelch; Kassirer). Many focus on individual conflicts of interest to the exclusion of institutional-level conflicts. By contrast, a group of Canadian authors, stimulated by widely publicized cases in their country of egregious institutional violations of academic freedom, have proposed elements of a conflict of interest policy that offers remedies for both levels of conflict (Lewis et al.). A policy on institutional conflicts of interest proposed in 2002 by the Association of American Medical Colleges (AAMC) locates responsibility for policing potential conflicts of interest within each university, whereas the Canadian group suggested that an appellate process involving a national group independent of any one university would be desirable (Lewis et al.; AAMC 2002). After developing a policy considered one of the most stringent in the nation, Harvard Medical School came under pressure to loosen its requirements, lest some of its most prestigious researchers move elsewhere (Angell). Bioethics programs in universities are part of the research enterprise and, according to some, should have policies to prevent conflicts of interest. Concerns have been expressed about paid consulting relationships between bioethics faculty and industry (Brody et al.).

Government agencies and professional publications also institute policies to guard against conflicts of interest.

The U.S. Food and Drug Administration and the National Institutes of Health require extensive disclosure of all advisers' commercial interests. Some professional journals demand that authors and reviewers disclose any commercial relationships that might be construed as creating conflicts of interest. According to this view, conflicts of interest should not automatically disqualify a reviewer or author, but the revelation will allow readers, editors, and administrators to scrutinize conclusions more carefully (Koshland). Other publications have adopted somewhat more stringent guidelines. The New England Journal ofMedicine, for example, has required that authors disclose their financial conflicts, that its editors have no financial interest in any business related to clinical medicine, and that authors of review articles and editorials have no financial connection to their topics (Relman). The Journal was later forced to admit, however, that many of its authors of review articles had evaded these requirements (Angell, Utiger, and Wood). A few observers warn that excessive concern over conflicts of interest and safeguards may hinder scientific progress and undermine the scientific objectivity that they are designed to preserve. These writers claim that focusing reviewers' and readers' attention on potential outside influences instead of the content of the data, findings, and ideas generates a subjective skepticism unrelated to the objective merit of the work (Rothman). In 2001, however, the editors of thirteen major medical journals decided that the problem was serious enough to demand a unified and even more stringent disclosure policy (Davidoff et al.).

Some observers argue that the physician-researcher's commercial ties should be revealed to the patient-subject through the mechanism of informed consent and to the investigator's institution through a formal reporting mechanism (Finkel). Finally, IRBs can scrutinize protocols that promise great financial rewards for physician-investigators.

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