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Criteria for Participation in Sponsored Research, Definitions (1999)

Members of the AAFP are strongly encouraged to become involved with research. Participation in research promises significant benefits, including: expanding medical knowledge, increasing job satisfaction, and improving patient care.

Participation also carries certain responsibilities and potential pitfalls. The policy that follows outlines guidelines for ethical research behavior for family physicians.

This document was prepared by the AAFP Committee on Research in response to an AAFP Board referral to "delineate the criteria for bona fide scientific research to enable family physicians to distinguish valid office-based research from promotional efforts of proprietary entities."

Definitions

  • Medical Research: Medical research, as defined in this document, means research to create new knowledge primarily aimed toward improved patient care and its associated activities.
  • Marketing Research: Marketing research is meant to encompass research practices (including such techniques as focus groups, interviews, and detailing) that are primarily aimed toward obtaining information that would result in the improved sales of a particular product. While these ventures may be rigorously designed and of higher caliber research, the primary motive behind marketing research is improved sales, not improved patient care.
  • Phase IV Pharmaceutical Studies: After a drug is released, studies may be performed to evaluate its effectiveness and adverse effects in actual practice. Many times these studies are sponsored by pharmaceutical corporations and may involve physicians in the community. Such studies can be important because of the wider populations evaluated and community context in which they may take place. Participation in such studies can be rewarding, but should be done in accordance with the AMA Annotated Guidelines on Gifts to Physicians from Industry (herein referred to as the AMA Guidelines).
  • Post-marketing Research: After a drug or device is actually on the market, many corporations will conduct ongoing research as to its benefits. This may take the form of Phase IV pharmaceutical studies or other means of monitoring drug effectiveness, usage, and harms.
  • Promotion: Promotion is defined as the marketing of a particular drug or agent. This may take the form of straightforward "detailing" of drugs, advertising, or in some cases less transparent actions such as the awarding of merchandise, trips, or other tangible rewards for prescribing a particular drug. [Appendix H]
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