Research, Ethical Behavior for Physicians
The AAFP policy combines those elements applicable to research from the AMA Council on Ethical and Judicial Affairs Report F (December 1990) entitled "Gifts to Physicians from Industry" with further policy originally developed by the AAFP Committee on Research.
The AMA Guidelines and AAFP Position Paper on Proprietary Practices (originally developed by the Committee on Research in 1992) outline ethical behavior for physicians. In particular, attention is called to AMA Guideline 4, Sections b, d, e, and f:
(b) If the company invites physicians to visit its facilities for review and comment on a product, to discuss their independent research projects or to explore the potential for collaborative research, may the company pay travel expenses and an honorarium?
If the physician is providing genuine services, reasonable compensation for time and travel expenses can be given. However, token advisory or consulting arrangements cannot be used to justify compensation.
(d) If a company convenes a group of physicians to recruit clinical investigators or convenes a group of clinical investigators for a meeting to discuss their results, may the company pay for their travel expenses?
Expenses may be paid if the meetings serve a genuine research purpose. One guide to their propriety would be whether the NIH conducts similar meetings when it sponsors multi-center clinical trials. When travel subsidies are acceptable, the guidelines emphasize that they be used to pay only for "reasonable" expenses. The reasonableness of expenses would depend on a number of considerations. For example, meetings are likely to be problematic, if overseas locations are used for exclusively domestic investigators. It would be inappropriate to pay for recreation or entertainment beyond the kind of modest hospitality described in this guideline.
(e) How can a physician tell whether there is a "genuine research purpose?"
A number of factors can be considered. Signs that a genuine research purpose exists include the facts that there are: (1) a valid study protocol, (2) recruitment of physicians with appropriate qualifications or expertise, and (3) recruitment of an appropriate number of physicians in light of the number of study participants needed for statistical evaluation.
(f) May a company compensate physicians for their time and travel expense when they participate in focus groups?
Yes. As long as the focus groups serve a genuine and exclusive research purpose and are not used for promotional purposes, physicians may be compensated for time and travel expenses. The number of physicians used in a particular focus group or in multiple focus groups should be an appropriate size to accomplish the research purpose, but no larger. [Appendix H] (2002) (2008)