Research - Ethical Participation by Family Physicians
Medical research is defined in this document as research to create new knowledge to improve patient care and associated activities. Members of the AAFP are encouraged to become involved in medical research. Research participation may provide benefits such as expanding medical knowledge, increasing job satisfaction, and improving patient care. Participation also carries responsibilities and potential pitfalls. The physician must be aware of the quality and purpose of the proposed research, including the sponsorship, scientific merit, possible conflicts of interest, and other ethical considerations.
The following are common standards for ethical research:
a. A peer-reviewed protocol reflecting a well-designed, scientific methodology should be available for all studies.
b. For all studies involving human subjects, there should be approval by an Institutional Review Board (IRB), in some cases, a waiver may be granted by the IRB, e.g., non-obtrusive survey work. The IRB should be based at a recognized institution, free from possible conflicts of interests.
c. The sponsoring and funding entities should be fully disclosed to the participating researchers. They should be recognized entities such as government agencies, academic departments of family medicine, practice-based research networks or pharmaceutical corporations' research divisions.
d. Participants in clinical studies should be selected from appropriate populations without regard to race, ethnicity, economic status, or gender. Women, children, and minorities should be included in clinical studies applicable to their health issues.
e. A clinical investigator should demonstrate the same concern for the safety and welfare of study participants as is required of a physician caring for patients in clinical practice.
f. Voluntary informed consent should be obtained in writing from all participants. When physicians are the subjects under study, informed consent should be obtained from them.
g. Physician and participant confidentiality should be assured unless specific rights have been waived. Safeguards must be undertaken to preserve such confidentiality and to limit scrutiny of the health information to aims directly related to the approved study.
The following are recommendations regarding conflicts of interest in medical research:
a. Studies sponsored by the marketing divisions of pharmaceutical firms should be critically appraised to ascertain whether medical research or marketing research is the aim of the study. While marketing research may be rigorously designed and employ high caliber research methods, the primary motive behind marketing research is improved sales, not improved patient care.
b. When the purpose of a research study is unclear, a full protocol, plans for publication and peer review, and proposed outcomes of the research should be discussed before a physician decides to participate.
c. When a physician is both the investigator and the physician caring for a patient who is eligible to enroll in a study, the informed consent process must differentiate between the two roles. Ideally, a third person should obtain the consent. The sources of study funding and any financial incentives offered to the investigator must be disclosed.
d. Any financial compensation received from the trial sponsors must be commensurate with the efforts of the physician performing the research.
e. Honoraria, expense reimbursement, travel and other payments from industry (e.g. pharmaceutical or medical device companies) for research-related activities shall be in accordance with guidelines from the Code of Medical Ethics of the AMA: Ethical Guidelines for Gifts to Physicians from Industry:
- 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.
- Expenses may be paid for meetings that 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 such as meals or social events held as part of the conference.
- Physicians may be compensated for time and travel expenses to participate in focus groups sponsored by industry as long as the focus groups serve a genuine and exclusive research purpose and are not used for promotional purposes.
These guidelines cannot cover every eventuality. Individual physicians should continue to use their good judgment and integrity in deciding to participate or decline working in a particular study. If a physician is in doubt as to the ethical nature of a study or advisability of participating, consultation is recommended with an uninvolved IRB, or a local ethics committee. (1992) (2014 COD)