Ask the Ethicist - Drafting Guidelines for Clinical Practice

Question: I am a glaucoma specialist with consulting and research- funding relationships in the pharmaceuticals industry. I have been asked to participate in a panel of academic experts to draft guidelines for the medical treatment of glaucoma for an HMO. What are my ethical obligations regarding disclosure of my financial relationships with pharmaceutical manufacturers?

Answer: A central concept of modern medical ethics is that a physician’s recommendation for care should be made with the patient’s interests foremost in mind, without being compromised by self-interest, other obligations or loyalties. Good ethical practice and the Academy’s Code of Ethics require adequate management of conflicts of interest that could potentially alter unbiased clinical judgment in patient care. As articulated in Rule 15 of our Code of Ethics, this applies to counseling the individual patient, as well as communications to the public and to colleagues.

Clinical guidelines by their very nature potentially affect the care of many patients, especially if compliance with the recommendations is eventually required by HMOs or other health care entities as a condition of participation or reimbursement. Clearly, drafting clinical care guidelines is a very responsible activity that ideally should be based on the broadest possible foundation of unbiased medical evidence, without the influence of bias.

If a conflict arising from personal or institutional financial benefit from a relevant industry exists, that conflict must be disclosed to others on the panel and managed appropriately, ideally by recusal from all aspects of the panel discussion that could be affected. Under some conditions, any participation in such a panel may pose irreconcilable conflicts and may require that one decline participation.

Attention to the principles of disclosure and management of conflicts of interest will help assure that clinical guidelines are based on the best clinical and scientific evidence, without being tainted by biased personal opinion or commercial interests.

To submit a question or for more information, contact the Ethics Committee staff at ethics@aao.org.