Conflict of Interest in Medical Research, Education, and Practice (2009) / Chapter Skim
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From page 1... ...
Such conflicts of interest threaten the integrity of scientific investigations, the objectivity of professional education, the quality of patient care, and the public's trust in medicine. This Institute of Medicine report examines conflicts of interest in medical research, education, and practice and in the development of clinical practice guidelines.
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Surveys show the breadth and diversity of relationships between industry and physicians, researchers, and educators in academic and community settings. For example, • gifts from drug companies to physicians are ubiquitous; • visits to physicians' offices by drug and medical device company representatives and the provision of drug samples are widespread; • many faculty members receive research support from industry, and industry funds the majority of biomedical research in the United States; • many faculty members and community physicians provide scientific, marketing, and other consulting services to companies; and some serve on company boards of directors or on industry speakers bureaus; and • commercial sources provide about half of the total funding for accredited continuing medical education programs.
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Department of Justice by medical device and pharmaceutical companies to avoid prosecution for alleged illegal payments or gifts to physicians; • companies and academic investigators not publishing negative results from industry-sponsored clinical trials or delaying publication for over a year after the completion of a trial; • academic researchers putting their names on manuscripts, even though they first became involved after the data were collected and analyzed and after the first drafts were written by individuals paid by industry; and • professional societies and other groups that develop clinical practice guidelines choosing not to disclose their industry funding and not to reveal the conflicts of interest of the experts who draft the guidelines. Although the causes of these situations are various and their extent is unclear, they highlight the tension that may exist between financial relationships with industry and the primary missions of medical research, education, and practice.
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Critics of conflict of interest policies have also charged that the great majority of individuals who have not acted in an unethical manner may be subjected to onerous regulations and tacit conclusions that they are culpable of misconduct until proven otherwise. Responding to the situations and concerns outlined above, the Institute of Medicine appointed a committee to investigate and develop a consensus report on conflicts of interest in medical research, education, and practice and in the development of clinical practice guidelines.
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Reflecting concerns that were raised during the planning of the project and the central issues in debates and policies on conflicts of interest in medicine, the committee focused on financial relationships involving pharmaceutical, medical device, and biotechnology companies. Although it did not investigate in depth the conflicts of interest associated with different physician payment arrangements or with physician referral of patients to facilities in which they have an ownership interest, the committee recognized the seriousness of those types of conflicts and the difficulties that policy makers have encountered in trying to eliminate or manage them.
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Primary interests include promoting and protecting the integrity of research, the quality of medical education, and the welfare of patients. Secondary interests include not only financial interests -- the focus of this report -- but also other interests, such as the pursuit of professional advancement and recognition and the desire to do favors for friends, family, students, or colleagues.
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In an academic medical center, the relevant groups would include faculty, medical staff, students, residents, fellows, members of institutional committees (e.g., institutional review boards, formulary committees, panels developing practice guidelines, and device purchasing committees) , and senior institutional officials.
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Unless institutions are informed of these relationships, they cannot identify conflicts of interest or determine whether additional steps -- such as the elimination or management of the conflict -- are needed to reduce the risk of bias or a loss of public trust. Recommendations 3.1 and 3.2 are similar to the recommendations made in other reports on conflict of interest; but they extend to all institutions that carry out medical research, medical education, clinical care, and practice guideline development.
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Congress to create a national program that requires pharmaceutical, medical device, and biotechnology companies and their foundations to publicly report payments to physicians, 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. Although many details will need to be worked out, the information should be readily available on a secure, searchable public website that allows the identification and aggregation of all payments that an individual or institution receives from all companies.
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Additional studies on financial relationships in nonclinical research, their risks and consequences, and the ways in which institutions identify and respond to these relationships would help establish an evidence base that could be used to guide judgments about policies in this area. CONFLICTS OF INTEREST IN UNDERGRADUATE, GRADUATE, AND CONTINUING MEDICAL EDUCATION Chapter 5 presents strong evidence that relationships with industry are pervasive in undergraduate, graduate, and continuing medical education.
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Recommendation 5.3 calls for a broad-based consensus development process to propose a new system of funding accredited continuing medical education that is free of industry influence, enhances public trust in the integrity of the system, and provides high-quality education. Some members of the committee supported a total end to industry funding, but others were concerned
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Even if education providers trim their expenses, the costs of accredited continuing medical education would likely increase for many physicians, which could be an economic burden for some physicians, for example, those in rural areas. CONFLICTS OF INTEREST AND MEDICAL PRACTICE As is the case in medical research and education, evidence shows that relationships with industry are widespread among physicians in practice.
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CONFLICTS OF INTEREST AND DEVELOPMENT OF CLINICAL PRACTICE GUIDELINES Financial relationships with companies affected by clinical practice guidelines are common both for groups convening expert panels to develop guidelines and for the individuals serving on those panels. Groups often do not make public their conflict of interest policies, their sources of funding for guideline development, or the financial relationships of the panel members.
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Similarly, public and private health plans and accreditation and certification bodies could avoid the use of clinical practice guidelines that lack information that allows users to identify conflicts of interest and assess the risks that they pose. INSTITUTIONAL CONFLICTS OF INTEREST Institutional conflicts of interest arise when an institution's own financial interests or the interests of its senior officials pose risks to the integrity of the institution's primary interests and missions.
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Recommendation 8.2 calls for NIH to develop regulations requiring institutions covered by the 1995 PHS regulations to adopt institutional conflict of interest policies. THE ROLE OF SUPPORTING ORGANIZATIONS In carrying out medical research and education, providing patient care, and developing practice guidelines, physicians, researchers, and the institutions in which they work are part of complex intersecting systems.
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Congress; pharmaceutical, medical device, for the reporting of company and biotechnology companies payments Medical research 4.1 Restrict participation of Academic medical centers and other research researchers with conflicts of institutions; medical researchers interest in research with human participants
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SUMMARY 17 TABLE S-1 Continued Recommendation Number and Topic Primary Actors Medical education 5.1 Reform relationships with Academic medical centers and teaching hospitals; industry in medical education faculty, students, residents, and fellows 5.2 Provide education on conflict of Academic medical centers and teaching hospitals; interest professional societies 5.3 Reform financing system for Organizations that created the accrediting continuing medical education program for continuing medical education and other organizations interested in high-quality, objective education Medical practice 6.1 Reform financial relationships Community physicians; professional societies; with industry for community hospitals and other health care providers physicians 6.2 Reform industry interactions Pharmaceutical, medical device, and with physicians biotechnology companies Clinical practice guidelines 7.1 Restrict industry funding and Institutions that develop clinical practice conflicts in clinical practice guidelines guideline development 7.2 Create incentives for reducing Accrediting and certification bodies, formulary conflicts in clinical practice committees, health insurers, public agencies, and guideline development other organizations with an interest in objective, evidence-based clinical practice guidelines Institutional conflict of interest policies 8.1 Create board-level responsibility Institutions that carry out medical research and for institutional conflicts of education, clinical care, and clinical practice interest guideline development 8.2 Revise PHS regulations to require NIH policies on institutional conflicts of interest Supporting organizations 9.1 Provide additional incentives Oversight bodies and other groups that have a for institutions to adopt and strong interest in or reliance on medical research, implement policies education, clinical care, and practice guideline development 9.2 Develop research agenda on NIH, Agency for Healthcare Research and conflict of interest Quality, and other agencies of the U.S. Department of Health and Human Services
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RECOMMENDATION 3.4 The U.S. Congress should create a national program that requires pharmaceutical, medical device, and biotechnology 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.
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RECOMMENDATION 5.1 For all faculty, students, residents, and fellows and for all associated training sites, academic medical centers and teaching hospitals should adopt and implement policies that prohibit • the acceptance of items of material value from pharmaceutical, medical device, and biotechnology companies, except in specified situations; • educational presentations or scientific publications that are controlled by industry or that contain substantial portions written by someone who is not identified as an author or who is not properly acknowledged; • consulting arrangements that are not based on written contracts for expert services to be paid for at fair market value; • access by drug and medical device sales representatives, except by faculty invitation, in accordance with institutional policies, in certain specified situations for training, patient safety, or the evaluation of medical devices; and • the use of drug samples, except in specified situations for patients who lack financial access to medications. Until their institutions adopt these recommendations, faculty and trainees at academic medical centers and teaching hospitals should voluntarily adopt them as standards for their own conduct.
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RECOMMENDATION 6.2 Pharmaceutical, medical device, and biotechnology companies and their company foundations should have policies and practices against providing physicians with gifts, meals, drug samples (except for use by patients who lack financial access to medications) , or other similar items of material value and against asking physicians to be authors of ghostwritten materials.
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From page 21... ...
the developer's conflict of interest policies, the sources and amounts of funding for the guideline, and the relevant financial interests of guideline panel members, if any; • the National Guideline Clearinghouse to require that all clinical practice guidelines accepted for posting describe (or provide an Internet link to) the developer's conflict of interest policies, the sources and amounts of funding for development of the guideline, and the relevant financial interests of guideline panel members, if any; and • accrediting and certification organizations, public and private health plans, and similar groups to avoid using clinical practice guidelines for performance measures, coverage decisions, and similar purposes if the guideline developers do not follow the practices recommended in this report.
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The rules should require the reporting of identified institutional conflicts of interest and the steps that have been taken to eliminate or manage such conflicts. RECOMMENDATION 9.1 Accreditation and certification bodies, private health insurers, government agencies, and similar organizations should develop incentives to promote the adoption and effective implementation of conflict of interest policies by institutions engaged in medical research, medical education, clinical care, or practice guideline development.
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