Code of Medical Ethics Opinion 7.1.4
Increasing numbers of physicians, both within and outside academic health centers, are becoming involved in partnerships with industry to conduct biomedical and health research. As they do so, physicians must be mindful of the conflicts such engagement poses to the integrity of the research and the welfare of human participants. In addition to financial conflicts of interest created by incentives to conduct trials and recruit subjects, physicians must be sensitive to the differing roles of clinician and investigator, which may require them to balance dual commitments to participants and science. This conflict of commitment is particularly acute when a physician-investigator has treated or continues to treat a patient who is eligible to enroll as a participant in a clinical trial the physician is conducting.
Minimizing and mitigating conflicts of interest in clinical research is imperative if the medical community is to justify and maintain trust in the medical research community.
Physicians who engage in research should:
(a) Decline financial compensation that awards in excess of the physician’s research efforts and does not reflect fair market value. Physicians should not accept payment solely for referring patients to research studies.
(b) Ensure that the research protocol includes provision for funding participants’ medical care in the event of complications associated with the research. A physician should not double-bill a third-party payer for additional expenses related to conducting the trial if he or she has already received funds from a sponsor for those expenses.
(c) As part of the informed consent process, disclose to prospective participants the nature and source of funding and financial incentives offered to the investigators. This disclosure should be included in any written consent materials.
(d) Avoid engaging in any research where there is an understanding that limitations can be placed on the presentation or publication of results by the research sponsor.
(e) Refrain from knowingly participating in a financial relationship with a commercial entity with whom they have a research relationship until the research relationship ends and the research results have been published or otherwise disseminated to the public.
(f) Disclose material ties to companies whose products they are investigating or other ties that create real or perceived conflicts of interest to:
- Institutions where the research will be carried out
- Organizations that are funding the research
- Any journal or publication where the research results are being submitted
(g) Physicians who have leadership roles in institutions that conduct biomedical and health research as well as the entities that fund research with human participants should promote the development of guidelines on conflicts of interest that clarify physician-investigators responsibilities.
AMA Principles of Medical Ethics: II, IV, V
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