New AAO policy regarding the need to disclose stock options as a financial conflict of interest
Jonathan H. Talamo, M.D.
Assistant Clinical Professor of Ophthalmology, Harvard Medical School
Boston, MA
Financial conflicts of interest in the practice of medicine are amongst the most difficult ethical issues facing our profession today. Financial conflicts can arise in virtually any professional activity engaged in by ophthalmologists. For that reason, the Academy’s Code of Ethics includes two rules that are on point:
Rule of Ethics 15: Conflict of Interest. A conflict of interest exists when professional judgment concerning the well-being of the patient has a reasonable chance of being influenced by other interests of the provider. Disclosure of a conflict of interest is required in communications to patients, the public, and colleagues.
Rule of Ethics 11: Commercial Relationships. An ophthalmologist's clinical judgment and practice must not be affected by economic interest in, commitment to, or benefit from professionally related commercial enterprises.
The problem of financial conflicts has become particularly troublesome in the context of clinical trials research. A financial conflict of interest in this setting may be best described as a condition, rather than a particular behavior. In other words, individuals who might stand to gain financially by compromising the integrity of their work have a conflict of interest whether or not they actually engage in affirmative misconduct.1
With the ever-increasing frequency of entrepreneurial partnerships between industry and clinicians within both academic and private practice settings, the practice of compensating clinical investigators with equity in the form of stock or stock options has become more common. While this may occur within the context of a consulting relationship with an established company, it is conceivable that such an arrangement could also involve start-up companies whose stock may not be publicly traded. Because stock options may have little or no value unless the study results are favorable, they create financial incentives which may more severely bias the actions of individuals conducting clinical trials than traditional forms of compensation, which tend to come in the form of consulting agreements, research support, or cash payments based on patient enrollment that remain fixed in value whatever the eventual outcome of the research. While in some instances the payment of clinical investigators with stock options for research or other services by an industry sponsor such as a medical device or pharmaceutical company may be legitimate, it creates a potential serious conflict in the fiduciary role of the physician in patient care.
An analogous situation exists within the legal system, where a judge must remove him or herself from cases involving entities in which he or she has a financial interest so as to maintain impartiality and the public trust: one could make a strong argument that physicians who perform clinical research should behave in a similar fashion.2
The federal government and NIH have for decades maintained a policy limiting financial interest and mandating disclosure of conflicts by federal employees and recipients of federal funding.3 Many major research universities have recognized and addressed this problem in the past,4 but as approximately 60% of clinical research in the United States is now performed in a community based setting, there is an acute need for clearer standards of conduct at the level of medical professional societies. In a recent task force report on individual financial conflicts of interest in human subjects research, the American Association of Medical Colleges strongly recommended against compensation of clinical investigators with stock or stock options by industry sponsors, whether or not these conflicts of interest are disclosed.5 Similar language contained in recent guidelines offered by the U.S. Department of Health and Human Services and the New England Journal of Medicine reaffirm this recommendation.6,7
Recognizing the potential conflict posed by stock options, the Academy’s Ethics Committee recently recommended to the Academy’s Board of Trustees that the Academy’s Advisory Opinion on “Disclosure of Professionally Related Commercial Interests” be amended.8 In support of its proposal, the Ethics Committee stated that: "…the provision of stock options for clinical researchers, device developers, and industry spokespersons has become common, but not often publicly disclosed... This practice is antithetical to unbiased research and development and is a disclosable interest… to patients, the public and colleagues regarding the nature of one's commercial relationships." At its October 2002 meeting, the Board of Trustees adopted the revised Advisory Opinion, which now specifically states that for purposes of required disclosures, “stock options shall be considered to be the ownership of an interest in an entity even if they have not been exercised or they are not currently exercisable.” Members should note that the disclosure requirement is not limited to clinical researchers, but applies to all members in all professionally related contexts. The full Advisory Opinion may be found on the Academy’s website here.
Although these expanded ethical rules regarding our professional conduct as Academy members may seem unduly restrictive to some, it is my belief that it is not the intent of the Academy to create policy that interferes with mutually beneficial business partnerships between industry and clinicians or academic institutions. Indeed, the Academy has no desire to limit members in their commercial or professional relations in any way, except insofar as these relations clearly endanger the principles of honesty, fair dealing, and quality care towards patients. Rather, policies which improve guidance for individual conduct in the setting of financial conflicts of interest should increase the chance that such relationships do not compromise scientific integrity, the well-being of research subjects and, last but not least, the public trust.
References
Thompson DF. Understanding financial conflicts of interest. N Engl J Med 1993;329:573-6.
ABA Model Code of Judicial Conduct Canon 3 (adopted 1972).
Responsibility of applicants for promoting objectivity in research. 42 C.F.R. 50.601-607. 1999.
Lo B, Wolf LE, Berkelely A. Conflict of interest policies for investigators in clinical trials. N Engl J Med 2000;343:1616-20.
Task Force on Financial conflicts of interest in clinical research. Report of individual financial interest in human subjects research. American Association of Medical Colleges. December, 2001. (www.aamc.org)
U.S. Dept. of Health and Human Services. Relationships in clinical research: Issues for institutions, clinical investigators and IRBs to consider when dealing with issues of financial interests and human subject protection. January 10, 2001. (http://ohrp.osophs.dhhs.gov/human)
Drazen JM, Curfman GD. Financial associations of authors. N Engl J Med 2002;346(24):1901-1902.
American Academy of Ophthalmology. Advisory Opinion of The Code of Ethics: Disclosures of professionally related commercial interests. October 2002. (www.aao.org)
Disclosure: Dr. Talamo was an Ethics Committee member from 1997 to 2003. He currently practices in Boston, Massachusetts.
