American College of Physicians - Research
Medical progress and improved patient care depend on innovative and vigorous research. The basic principle of research is honesty, which must be assured by institutional protocols. Fraud in research must be condemned and punished. Honesty and integrity must govern all stages of research, from the initial grant application to publication of results. Reviewers of grant applications and journal articles must respect the confidentiality of new ideas and information; they must not use what they learn from the review process for their own purposes, and they should not misrepresent the ideas of others as their own.
Scientists have a responsibility to gather data meticulously; to keep impeccable records of work done; to interpret results objectively, not force them into preconceived molds or models; to submit their work to peer review; and to report new knowledge. Self-aggrandizement, public acclaim, recognition by professional peers, or financial gain should never be primary motivations in scientific research (61).
The medical profession must assume responsibility for assuring that research is potentially of significant value and ethically conducted. Benefits and risks of research must be distributed fairly, and particular care must be taken to avoid exploitation of vulnerable populations. Research participants must be instructed about the nature of the research; consent from the research participant or an authorized representative (62) must be truly informed and given freely; research must be planned thoughtfully, so that it has a high probability of yielding useful results; risks to patients must be minimized; and the benefit-to-risk ratio must be high enough to justify the research effort.
Each institution that receives federal support for research on humans is required to create an institutional review board. All proposed clinical research, regardless of the source of support, should be approved by the local institutional review board to assure that the research plans are reasonable and that research participants are adequately protected.
Although this formal system of review is designed to protect research participants, the premise on which all ethical research is based is mutual trust and respect between research participants and researchers. This premise requires that physician-investigators involved in designing or carrying out research have primary concern for the potential participants in these investigations.
Although the responsibility for assuring reasonable protection of human research participants resides with the investigators and the local institutional review board, the medical profession as a whole also has responsibilities. Clinical investigation is fraught with opportunities for conflicts to arise.
Physicians should avoid situations in which they are rewarded for particular outcomes. Physician-investigators may find themselves in dual roles with respect to patients who are also research participants. The health and welfare of the patient must always be the physician's primary consideration. Physicians who refer patients for participation in research protocols must be satisfied that the program follows established ethical guidelines, provides for realistic informed consent, gives reasonable assurances of safety, and has an acceptable benefit-to-risk ratio. If the risks of the research become too great or if continued participation cannot be justified, the physician must be willing to advise the patient to withdraw. Physicians-of-record should not abdicate overall responsibility for patients whom they have referred to a research project. Giving finder's fees to individual physicians for referring patients to a research project generates an unethical conflict of interest (63).
Research on delivery of health services raises issues about the protection of participants that have not yet been well examined. Researchers, physicians, and patients should thoughtfully balance the merits of innovation and the available means to monitor and protect research participants.
Innovative Medical Therapies
The use of innovative medical therapies falls along the continuum between established practice and research. Innovative therapies include the use of unconventional dosages of standard medications, previously untried applications of known procedures, and the use of approved drugs for nonapproved indications. The primary purpose of innovative medical therapies is to benefit the individual patient. Clinicians will confront the ethical issues of innovative practice more frequently than the ethical problems of medical research. Important medical advances have emerged from successful innovations, but innovation should always be approached carefully. Medical therapy should be treated as research whenever data are gathered to develop new medical information and for publication. When an innovative therapy has no precedent, consultation with peers, an institutional review board, or another expert group is necessary to assess the risks of the innovation, the probable outcomes of not using a standard therapy, and whether the innovation is in the patient's best interest (64). Informed consent is particularly important; patients must understand that the therapy is not standard treatment (65).
Authors of research reports must be sufficiently acquainted with the work being reported that they can take public responsibility for the integrity of the study and the validity of the findings, and they must have substantially contributed to the research itself. Sources of funding for the research project must be disclosed to potential collaborators in the research and must be included in the manuscript for publication (see the section on conflicts of interest).
Scientists build on the published work of other researchers and can proceed with confidence only if they can assume that the previously reported facts on which their work is based have been reported accurately. All scientists have a professional responsibility to be honest in their publications. They must describe methods accurately and in sufficient detail, report only observations that were actually made, make clear in the manuscript which information derives from the author's work and which comes from others (and where it was published), assure readers that research has been carried out in accordance with ethical principles, and assign authorship only to persons who merit and accept authorship (66).
Plagiarism is unethical. Incorporating the words of others or one's own published words, either verbatim or by paraphrasing without appropriate attribution, is unethical and may have legal consequences.
Public Announcement of Research Discoveries
In this era of rapid communication and intense media and public interest in medical news, it has become common for clinical investigators or their institutions to call press conferences and make public announcements of new research developments. Although it is desirable for the media to obtain accurate information about scientific developments, researchers should approach public pronouncements carefully and use language that does not invite misinterpretation or unjustified extrapolation.
In general, press releases should be issued and press conferences held only after the research has been published in a peer-reviewed journal or presented in a proper and complete abstract so that the details of the study are available to the scientific community. Statements of scientists receive great visibility. An announcement of preliminary results, even couched in the most careful terms, is frequently reported by the media as a "breakthrough." Care must be taken to avoid raising false public expectations and embarrassing the scientists involved, both of which reduce the credibility of the scientific community as a whole.