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Innovative therapies include the use of
unconventional dosages of standard medications, previously untried applications
of known procedures, and the use of approved drugs for non-approved 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 . Informed consent
is particularly important; patients must understand that the therapy is not
standard treatment.
Scientific
Publication
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.
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.
Conclusion
We hope that this Manual will help physicians, whether they
are clinicians, educators, or research scientists, to address some of
the challenging ethical dilemmas that confront them each day. The Manual
is written for physicians by a physician organization as we attempt to
find our way through difficult terrain. Our ultimate intent is to improve
the quality of care provided to patients and to give an account of the
conduct of the virtuous physician in whom patients and the public may
justifiably place their trust.
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