It is important for the physician to accurately identify the type and purpose of the proposed research, including the sponsorship, possible conflicts of interest, and ethical considerations. As noted above, there is a fine line among research seeking new medical knowledge and other promotional activities disguised as research. While there is no litmus test of ethical research, some of the following are suggested features of bona fide studies. The following are some characteristics of ethical research:
a. A written protocol with scientific rationale and peer-review should be available for all projects.
b. The protocol should reflect a well-designed, scientific methodology.
c. For all studies involving humans as subjects, there should be approval of the study by an Institutional Review Board (IRB) with multiple-project assurance, if applicable, or the local physician's IRB. In some cases, a waiver may be granted by the IRB, e.g., non-obtrusive survey work. A copy of the IRB approval should be provided to all participants. Ideally, the IRB should be based at a recognized institution of higher learning, free from possible conflicts of interest. The sponsoring entity should be fully disclosed to the participating researcher, and should involve a recognized research entity such as a Department of Family Medicine Research Network or Pharmaceutical Corporation's Research Division. "Research studies" sponsored by the Marketing Divisions of Pharmaceutical Firms should be critically appraised to ascertain whether promotion, basic research or marketing research is the aim of the study. Where such information is unclear, a full protocol, plans for publication and peer review, and proposed outcomes of the research should be discussed.
d. If marketing research is being conducted, participation should be in accordance with AMA Guidelines.
e. Honoraria, expense reimbursement, travel and other rewards shall be in accordance with AMA Guidelines.
f. Informed consent should be obtained from all physicians if they are the subjects under study.
g. Physician and participant confidentiality should be assured unless specific rights are waived by patients and/or physicians. Safeguards must be undertaken to preserve such confidentiality and to limit scrutiny of the medical record and collected information to aims directly related to the approved study.
h. Scientific review by and participation of qualified researchers from the perspective of both content and methodology suggests appropriate care, rigor and seriousness of the research design and proposed project.
i. If a physician is in doubt as to the ethical nature of a study or proposed participation in an investigation, consultation is recommended with an uninvolved IRB, Department of Family Medicine familiar with the research and ethical issues involved, or the national AAFP.
j. These guidelines cannot cover every eventuality. Individual physicians will have to continue to use their good judgment and integrity in deciding to participate or decline working in a particular study.