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 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.