Conflict of Interest in Medical Research, Education, and Practice (2009) / Chapter Skim
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2 Principles for Identifying and Assessing Conflicts of Interest
2 Principles for Identifying and Assessing Conflicts of Interest
Pages 44-61
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From page 44... ...
The goals of for-profit medical companies are to produce products that improve health and, at the same time, to ensure a financial return to shareholders. The primary goals of medicine include improving health by providing beneficial care to patients, conducting valid research, and offering excellent medical education.
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From page 45... ...
The principles do not directly yield decisions in particular cases or even rules that could be directly enforced, nor do they determine in advance the relative importance of all the values involved in making decisions. In applying them to particular policies and individual cases, there is no substitute for judicious practical judgment sensitive to the institutional context.
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From page 46... ...
Whatever the primary interests are, the point of regulating conflicts of interest is to try to ensure that secondary interests do not subvert physicians' and researchers' decisions and actions regarding those primary interests and do not undermine trust in their clinical or scientific judgment. Furthermore, medical institutions -- including medical schools, research institutes, professional societies, scientific journals, patient advocacy organizations, or government health agencies -- should also keep these primary interests paramount, as discussed further in Chapter 8.
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From page 47... ...
The standards for making such a judgment should be transparent and clearly specified in actual policies rather than in vague statements that professionals should avoid "undue influence." Subsequent chapters examine what situations or relationships may be considered inappropriate in research, patient care, medical education, and practice guideline development. Appendix C offers perspectives on conflicts of interest in other professions.
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From page 48... ...
Conflicts of commitment are closer to conflicts of interest. They often involve a conflict between what institutions view as employees' primary responsibilities to the institution and the employees' outside commitments, such as voluntary community service, participation in a political campaign, or teaching or conducting research for another institution.
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From page 49... ...
They most significantly guard against the risk that financial interests will have excessive weight in decisions about the conduct of research, teaching, the provision of patient care, and the development of practice guidelines. Such policies do not assume that any particular professional will necessarily let financial gain influence his or her judgment, nor do they imply that the individual researcher or physician is an unethical person.
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From page 50... ...
First, reliably ascertaining or inferring motives in this context is usually impossible for those assessing whether a relationship constitutes a conflict of interest. Generally, medical research, patient care, and education involve multiple considerations and many small judgments and decisions that are impractical to review; and even if they were reviewed, they would likely not yield a clear picture of the underlying motivation.
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From page 51... ...
Because it is both intrusive and usually impracticable to investigate motives and because the competent and timely appraisal of decisions is often difficult, it may be tempting to conclude that patients, the public, and researchers simply need to trust physicians. Trust is important, but generalized trust and reliance that medical professionals act in accord with primary professional interests may be difficult to maintain in the face of evidence that this trust is sometimes abused.
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From page 52... ...
If perceived conflicts are treated as different from the other (so-called actual) conflicts that the policy regulates, conduct that is perfectly proper can be unfairly called into question.
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From page 53... ...
Although absolute value is important, the secondary interest should generally be measured in relation to the typical income for the relevant class of professionals or in relation to the value of a research project, institutional budget, or medical practice. However, the monetary value of a secondary interest is not the only appropriate measure of its potential impact.
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From page 54... ...
This discretion is often limited by an independent oversight body, for example, a data and safety monitoring board, an independent panel that adjudicates adverse events, a medical monitor of adverse events, or an external auditor for data collection at individual research sites. Such oversight is usually
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From page 55... ...
Results from a pivotal trial of a novel type of therapy that may dramatically alter patient care are likely to have a larger scope than other trials that will influence care only at the margins. Thus, conflicts of interest in clinical trials deserve special attention because of the potentially large scope of their effects.
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From page 56... ...
In summary, an overall assessment of whether a financial relationship constitutes a conflict of interest and, if so, how severe it is and how it should be managed depends on several considerations: the importance of the financial or other relationship for furthering primary medical values, the likelihood and seriousness of possible harm to those primary values, and the availability of measures that can reduce the likelihood or severity of harm. Chapter 3 discusses such measures and also the procedures applied by universities and other institutions to identify, limit, and manage conflicts of interest.
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From page 57... ...
The criterion of proportionality should also be applied in individual situations when an assessment is made of whether a financial relationship constitutes a conflict of interest and, if there is a conflict, how it should be handled. For example, when a researcher's financial relationship with a company is evaluated, its expected benefits as well as its risks should be considered.
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From page 58... ...
For example, physicians have a countervailing privacy interest when it is proposed that their financial relationships (and perhaps those of their family members) be disclosed to the public, as noted in the discussion in Appendix F of public disclosure of personal information reported to academic medical centers and other institutions.
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From page 59... ...
Thus, just as a physician explains the rationale for clinical decisions to patients and researchers explain the rationale for research and research procedures, so too will leaders of accountable institutions explain their policies and their application to the individuals who are directly affected and respond to questions and suggestions. Taking responsibility for the consequences of individual or institutional actions and decisions may involve offering apologies or compensation to those harmed by these actions and acknowledging the appropriateness of penalties when a representative of the institution has acted improperly or illegally.
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From page 60... ...
Public Health Service grantees and policies recommended by the Association of American Medical Colleges allow institutions discretion in setting and implementing policies to take account of local circumstances, it is important to justify such variation in ways that are understandable by and plausible to affected individuals, oversight agencies, and the public. CONCLUSION The purposes of conflict of interest policies are expressed in the principles that hold that professionals should act to protect the primary interests of medical practice, education, and research and to maintain public confidence in the integrity of those activities.
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From page 61... ...
A conflict of interest is not an actual occurrence of bias or a corrupt decision but, rather, a set of circumstances that past experience and other evidence have shown poses a risk that primary interests may be compromised by secondary interests. The existence of a conflict of interest does not imply that any individual is improperly motivated.
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