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3 Policies on Conflict of Interest: Overview and Evidence
Pages 62-96

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From page 62...
... . In addition, a number of academic medical centers, professional societies, medical journals, and other institutions have revised their policies in recent years.
From page 63...
... . He has also argued that continuing medical education disclosure policies mainly serve to protect bureaucrats rather than students, are based on ideology rather than evidence, and "are deeply disrespectful of physicians and researchers" (Stossel, 2008, p.
From page 64...
... Much of the research and descriptive information located by the committee examined the policies of academic institutions and medical journals; but the recommendations apply broadly to all institutions engaged in medical research, medical education, clinical care, or practice guideline development. The specific elements of the policies may vary according to the size, complexity, and other characteristics of different types of institutions (e.g., academic medical centers, professional societies, patient advocacy groups, and nursing homes)
From page 65...
... Relationships disclosed: go to Step 2. Step 2 Evaluate the disclosures -- in light of the individual's responsibilities or specific activities (e.g., research, teaching, and patient care)
From page 66...
... . In addition, the faculty of public institutions will likely be covered by state conflict of interest policies. The committee found few reviews or studies documenting and comparing the conflict of interest policies of institutions engaged in medical research, medical education, or clinical care.
From page 67...
... Consistent with the conceptual framework outlined in Chapter 2, disclosures should provide sufficient information about the nature, scope, duration, and monetary value of relationships to allow institutions to assess the risk that secondary interests might unduly influence judgments about research, clinical care, education, or other primary interests. The committee distinguished disclosure to the physician's or researcher's institution from disclosure beyond the institution, for example, to patients, research participants, or the public. One rationale for disclosure -- especially public disclosure -- is the deterrence of questionable or inappropriate relationships.
From page 68...
... It then turns to evidence about the effectiveness of disclosure. Presence and Scope of Disclosure Requirements Medical schools  The most recent comprehensive study of medical school conflict of interest policies reports on a 2003 AAMC survey of member schools (response rate of 82 percent)
From page 69...
... also reported on variations in disclosure policies. Forty-eight percent of medical schools had policies that mentioned the disclosure of researchers' financial conflicts of interest to research participants.
From page 70...
... Fifty-seven percent reported that they published disclosures for all articles. Earlier studies reported that the percentage of biomedical journals with disclosure policies was lower (see, e.g., McCrary et al.
From page 71...
... It found little information on such policies in its initial search of organizational websites and other resources. To the extent that these groups engage in activities such as the development of clinical practice guidelines or the provision of accredited continuing medical education, many of the recommendations in Chapter 7, in this chapter, and elsewhere in this report will apply.
From page 72...
... . Administrative Burden of Disclosure Policies Disclosure to multiple organizations with various policies can clearly be burdensome for individuals who have received multiple grants, write many papers, serve on various committees and advisory panels, and make many continuing medical education presentations.
From page 73...
... . Some other government-led initiatives to streamline regulatory policies and practices mention conflict of interest policies and practices but generally do not identify them as a critical issue or problem.10 The committee found examples of efforts to make it easier for individuals to comply with disclosure policies. For example, to assist their employees in determining whether they have a relationship with a "substantially affected organization" (as described in NIH intramural conflict of interest policies)
From page 74...
... . (The Senate committee staff obtained the data through separate inquiries to companies and medical schools and then compared the responses.)
From page 75...
... If a national system of public disclosure of payments by pharmaceutical, medical device, and biotechnology companies is enacted, institutions could verify the disclosures that they receive. Monitoring and Enforcement The committee found no peer-reviewed studies on the monitoring or enforcement of disclosure requirements specifically or conflict of interest policies generally.
From page 76...
... . AAMC has recommended that academic medical centers specify the possible sanctions for noncompliance with policies governing conflicts of interest in research involving human subjects and then regularly assess compliance (e.g., through internal audit mechanisms and other self-evaluation strategies)
From page 77...
... One study found that journal readers found an article to be less "interesting, important, relevant, valid, and believable" when the authors were disclosed to be employees of a (fictitious) pharmaceutical company instead of employees of an ambulatory care center (Chaudhry et al., 2002, p.
From page 78...
... . ������������������������������������������������������� In a survey of participants in clinical trials for the treatment of cancer, more than 70 percent of the respondents would still have enrolled in the clinical trial even if the researcher had financial ties to the pharmaceutical company sponsoring the trial or had received royalty payments (Hampson et al., 2006)
From page 79...
... PROHIBITING OR ELIMINATING CONFLICTS OF INTEREST Prohibition as a Preventive Strategy Some institutions have conflict of interest policies that prohibit certain financial relationships outright because their risks are considered to greatly outweigh any potential benefits. As described further in Chapter 5, a 2008 report by AAMC recommended that academic medical centers prohibit a wide range of financial relationships with industry.
From page 80...
... . To cite another example, AAMC recommends that medical schools set a "rebuttable presumption that an individual who holds a significant financial interest in research involving human subjects may not conduct such research .
From page 81...
... Eighty-one percent of the medical schools responding to the AAMC survey allowed investigators with a significant financial interest to conduct research involving human participants when compelling circumstances exist. Only 61 percent of the respondents indicated that they had adopted the rebuttable presumption or a similar strategy, and only 26 percent indicated that they had a definition of the compelling circumstances or similar conditions that would allow rebuttal of the presumption.
From page 82...
... Some specific advice on assessing the severity of conflicts of interest is available. The AAMC-AAU report on conflict of interest in research involving human subjects describes several considerations that should be taken into account when the risks and possible benefits of allowing an investigator with a conflict of interest to participate in such research are assessed (AAMC-AAU, 2008)
From page 83...
... Management Strategies Survey data indicate that medical schools employ various strategies to manage conflicts of interest in research (Table 3-2)
From page 84...
... At one of the committee's public meetings, an experi 17 Financial ties were most often with pharmaceutical companies or biotechnology companies. Across the seven campuses involved in the analysis, payment for consulting activities accounted for 54 percent of the financial disclosures, equity holdings accounted for 38 percent of the disclosures, payment for talks accounted for 14 percent, scientific advisory board membership accounted for 13 percent, membership on a company's board of directors accounted for 12 percent, and being a company founder accounted for 7 percent.
From page 85...
... Although 14 percent believed that the school's policies hindered their own research agenda, 82 percent believed that it had no effect. Among the respondents who actually had a financial relationship that was subject to committee review, 91 percent said that they were satisfied with how the review was handled, but some of the remaining 9 percent who were not satisfied had very negative attitudes toward the process.
From page 86...
... . The IOM committee's review of the policies and other information on conflict of interest from academic medical centers and universities showed that they vary considerably in the informational resources that they make available to their faculty and staff.
From page 87...
... of the conflicts that were identified, NIH lacks important information that it needs to oversee and enforce PHS regulations. Also in 2008, NIH announced the development of and began testing an electronic reporting and tracking tool that that would allow grantee institutions to prepare and submit required conflict of interest reports and search past reports.
From page 88...
... The details of the policies may vary, depending on an institution's mission and other characteristics, but certain features are fundamental to credible and meaningful conflict of interest policies. RECOMMENDATION 3.1  Institutions that carry out medical re search, medical education, clinical care, or practice guideline develop ment should adopt, implement, and make public conflict of interest policies for individuals that are consistent with the other recommenda tions in this report.
From page 89...
... So that those who rely on academic medical centers, medical journals, professional societies, patient advocacy groups, and other institutions may assess an institution's conflict of interest policies, the policies should be publicly available, for example, on the institution's website. Although the details will vary, it is also important for institutions to disseminate and explain their policies to those who are subject to them.
From page 90...
... Recommendations in Chapters 4, 5, 6, and 7 provide guidance about the elimination or management of conflicts of interest in the contexts of medical research and education, patient care, and practice guideline development, respectively. RECOMMENDATION 3.2 As part of their conflict of interest poli cies, institutions should require individuals covered by their policies, including senior institutional officials, to disclose financial relationships with pharmaceutical, medical device, and biotechnology companies to the institution on an annual basis and when an individual's situation changes significantly.
From page 91...
... . In addition to requiring disclosure of conflicts of interest to the institutional review board and the other entities listed in the recommendation, policies may also cover additional disclosures, for example, to entities responsible for continuing medical education program oversight.
From page 92...
... To achieve greater consistency in institutional disclosure requirements, Recommendation 3.1 calls for a broad-based national consensus development process. This undertaking would be convened by national organizations representing academic medical centers, other health care providers, physicians, and researchers and would also include representatives of professional societies; consumer and patient advocacy groups; accreditation, certification, and licensing agencies; medical journals and organizations of medical journal editors; health plans and insurers; government agencies, including NIH and the FDA; and organizations with expertise in database development and management.
From page 93...
... The software would then format the information as needed for disclosures for various purposes (e.g., submission to an academic medical center or a medical journal)
From page 94...
... RECOMMENDATION 3.4 The U.S. Congress should create a national program that requires pharmaceutical, medical device, and biotechnol ogy companies and their foundations to publicly report payments to physicians and other prescribers, biomedical researchers, health care institutions, professional societies, patient advocacy and disease-specific groups, providers of continuing medical education, and foundations created by any of these entities.
From page 95...
... Implementing regulations would need to specify clear definitions and exact categories for the reporting of payments. The consensus-building activity proposed in Recommendation 3.3 could contribute to this specification and promote consistency with institutional disclosure policies.
From page 96...
... Recommendations in the Following Chapters The recommendations in this chapter call for institutions to adopt conflict of interest policies consistent with the recommendations in this report and for individual and cooperative institutional efforts and legislative actions to strengthen policies on the disclosure of individual and institutional financial relationships with industry. The next four chapters of this report offer additional recommendations related to policies and practices in the specific areas of medical research, medical education, patient care, and the development of clinical practice guidelines.


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