Book Review: Conflict of Interest in Medical Research, Education, and Practice
David B. Resnik
David B. Resnik is a bioethicist and chair of the Institutional Review Board at the National Institute of Environmental Health Sciences, National Institutes of Health. He has published 7 books and 150 articles on ethical, philosophical, and legal issues in science, medicine, and technology.
Environ Health Perspect 118:a92-a92 (2010). http://dx.doi.org/10.1289/ehp.118-a92 [online 01 February 2010]
Concerns about the potentially corrupting influence of private industry on medical research, education, and practice have been growing since the 1970s, when the U.S. Congress passed the first anti-kickback law applying to medicine. Since then, Congress has banned self-referrals in medicine, enacted laws that regulate the commercialization of publicly funded biomedical research, and held hearings on conflicts of interest in biomedicine. Government agencies have issued policies concerning disclosure of financial interests in research, professional associations have published guidelines pertaining to financial relationships with industry, and scientific journals have developed conflict of interest policies.
The Institute of Medicine (IOM)’s Conflict of Interest in Medical Research, Education, and Practice makes an important contribution to the continuing debate about financial conflicts of interest in medicine. This report reviews empirical studies, analytic essays, regulations, and guidance documents concerning conflicts of interest in medical research and makes recommendations for researchers, educators, physicians, institutions, corporations, and government agencies. The report consists of nine chapters as well as appendices that examine particular topics in greater depth, such as the relevance of psychological research on subconscious biases to conflict of interest policies, and a comparative analysis of conflicts of interest in nonmedical professions.
Conflict of Interest in Medical Research, Education, and Practice
Institute of Medicine, Committee on Conflict of Interest in Medical Research, Education, and Practice, edited by Bernard Lo and Marilyn J. Field
Washington, DC:National Academies Press, 2009. 440 pp. ISBN: 978-0-309-13188-9, $54.95
To draft this report, the IOM assembled experts from various fields including medicine, public health, law, health policy, ethics, philosophy, and economics. The authors acknowledge that collaboration with industry is a double-edged sword: Collaboration can produce important benefits, but it can compromise the integrity of professional judgment and erode the public’s trust in medicine. In crafting their recommendations, the authors strike a balance between protecting medical research, education, and practice from the harmful effects of industry collaboration and avoiding unnecessary administrative burdens that could undermine the benefits of collaboration. They make judicious use of empirical evidence to support their conclusions and recommendations. When evidence was lacking, the authors developed arguments based on their own experience and judgment as well as different approaches found in the literature.
The IOM report makes 16 recommendations for reforming medicine, some of which would require radical changes. For example, the report recommends that all academic medical centers, teaching hospitals, and training sites prohibit faculty, students, residents, and fellows from accepting gifts from pharmaceutical, biotechnology, or medical device companies, except in some circumstances, and not allow drug and medical sales representatives to have access to faculty, except by invitation in specified situations. The IOM report also recommends that academic medical centers, hospitals, and training sites develop a new system of funding continuing medical education that is free from industry influence; that research institutions prohibit investigators from conducting research with human subjects if they have a significant financial interest related to a product that would be affected by the research, except when the investigator’s participation is essential for conducting the research; and that physicians in private practice refrain from accepting items of value from pharmaceutical, biotechnology, or medical device companies.
The report also contains a conceptual framework that provides a foundation for policy recommendations. This includes a definition of conflict of interest (“a set of circumstances that creates a risk that professional judgment or actions regarding a primary interest will be unduly influenced by a secondary interest”) and criteria for assessing conflict of interest policies, such as proportionality (does the policy focus on the most important conflicts and is the policy practical?), transparency (is the policy understandable to those to whom it applies?), accountability (does the policy have enforcement procedures?), and fairness (does the policy apply equally to all relevant people in similar situations?). The authors also discuss problems with interpreting and applying the notion of an apparent conflict of interest.
This comprehensive and insightful report will undoubtedly have considerable influence over research, scholarship, and policy development for years to come. It is highly recommended reading for physicians, medical researchers, and medical educators.
EHP is pleased to announce that Prenatal Exposure to Glycol Ethers and Neurocognitive Abilities in 6-Year-Old Children: The PELAGIE Cohort Study, published in EHP on 14 October 2016, has been selected by the Children’s Environmental Health Network (CEHN) as its May 2017 Article of the Month. CEHN Article of the Month summaries discuss the potential policy implications of current children’s environmental health research. The CEHN summary can be viewed here.
Among the Resources now available on our Children’s Health page is the text of Executive Order 13045, “Protection of Children from Environmental Health Risks and Safety Risks” (21 April 1997). The Executive Order noted the particular vulnerabilities of children to environmental hazards, codified the need to identify and alleviate such risks, and created the President’s Task Force on Environmental Health Risks and Safety Risks to Children to identify data resources and promote research in these areas. As we mark 20 years since the order was enacted, we can see how these efforts have produced important research and mitigation of hazards—a strong base for continued work on behalf of children’s environmental health.
EHP is excited to announce that, starting later in May 2017, the journal will transition from a traditional, issue-by-issue publishing model, to a new, article-by-article publishing model known as continuous publication. This is a more modern way of publishing an online journal, and one that should help to significantly improve EHP’s time to publication. (more…)