Patients rely on us to provide the best patient care possible independent from the undue influence of the medical device and pharmaceutical industries. Our patients and the public expect objectivity minimizing both actual and perceived industry conflicts of interest (COI).
The AUA has adopted policies that are in compliance with the Council of Medical Specialty Societies (CMSS). This COI policy dictates the appropriate industry interactions at all levels of our professional society, this includes research, clinical activity and educational presentations at any venue. In addition, the Journal of Urology® has specific publication policies governing transparency in disclosure, industry conflicts and author participation.
The purpose of this review is to outline areas where the AUA membership is exposed to potential COI and to provide clarification in these areas.
General Membership Industry Interactions
Appropriate and professional physician and industry interactions can and do improve the quality of patient care, research, and education; it is also possible that appropriate interactions can lead to a decrease in the cost of health care and can enhance the public trust in science and medicine. Policies to protect the public and establish appropriate and professional interactions continue to evolve. While many of these regulations vary by state and institution, they generally limit interactions, or promote greater transparency in connection with interactions that could result in either the actual or perceived improper influence on clinical decisions. As a member of the AUA, it is important to be aware of these ethical rules and guidelines and to be proactive in managing COI. Increased disclosure of physician-industry contacts through mechanisms such as the federal Open Payments website could help document COI, but only if the data is reliable and sufficiently granular that the reported interactions are accurate and the nature and the reason for the interaction is clear.
In addition to complying with relevant laws, regulations and guidelines regarding physician-industry interactions, AUA members should adhere to the following principles:
- Compensation: Receiving personal gifts and payment for entertainment are inappropriate. Direct compensation for services rendered, e.g., consulting fees and payments for advisory board participation, should be provided at fair market value. Educational content should be free from outside modification or manipulation and conform to the standards of the Accreditation Council for Continuing Medical Education. Educational content in a non-CME industry-sponsored course should identify the company sponsoring the event and present accurate information consistent with U.S. Food and Drug Administration (FDA) guidelines.
- Pharmaceutical samples: Pharmaceutical samples should never be sold, used by clinicians, clinical staff, or given to family and friends. AUA members are encouraged to develop methods for securing, monitoring and documenting patient usage and side effects.
- Patient Consent and Confidentiality: While industry representatives may be permitted to attend clinical patient encounters in the clinic or operating room, it should be limited to those circumstances where industry presence is of substantial benefit to the patient care and treatment with the industry associated product. Their attendance and role should be fully disclosed to the patient prior to their presence, and patient confidentiality must be ensured.
- Non-FDA Approved Treatments: AUA has endorsed FDA's long-standing position that a drug or device label is in no way intended to regulate or restrict the ability of practicing physicians to use the drug or device for other purposes consistent with their medical knowledge and professional judgment. Nevertheless, counseling patients to participate in non- FDA approved treatments, particularly when occurring outside of one's geographic practice, i.e. in another country, requires that AUA members provide both accurate informed consent and disclosure of any and all compensation agreements. Fee splitting is illegal and unethical. If the urologist was reimbursed for providing treatment outside one's geographic area, then there should be no charge for follow-up care after the patient returns home.
- Research Studies: Participation in industry-supported drug or device studies should involve evaluation and approval of the study by an institutional research review board (IRB). Funding should be paid to an institution or individual practice. A properly executed research informed consent should always be part of an industry supported research project.
Providing full and fair disclosure to patients and to colleagues is the key to responsible and effective management of actual or perceived conflicts of interest.
AUA Board of Directors, Fall 2010
Board of Directors, October 2015 (Revised)