Use of placebo in the control arm of a study deprives these patients of the accepted therapy for a period of time. As such, the use of a placebo control will more easily be justified as the severity and number of negative side effects of standard therapy increase.
In certain situations and with special safeguards, it can be appropriate to provide experimental treatment without a participant’s informed consent. To protect the rights and welfare of participants in research on emergency medical interventions, physician-researchers must ensure that the experimental intervention has a realistic probability of providing benefit equal to or greater than standard care and that the risks associated with the research are reasonable in light of the critical nature of the medical condition and the risks associated with standard treatment.
Physicians engaged in international research may encounter differing cultural traditions, economic conditions, health care systems, and ethical or regulatory standards and traditions than in the US. While fundamental requirements to ensure scientifically sound research and to protect the welfare, safety, and comfort of human participants apply in any research setting, physicians who are involved in international research may need to address special concerns about selection of research topic, study design, informed consent, and the impact of the research on the participating community
Maternal-fetal research must balance the health and safety of the woman who participates and the well-being of the fetus with the desire to develop new and innovative therapies. Physicians engaged in maternal-fetal research should demonstrate the same care and concern for the pregnant woman and fetus that they would in providing clinical care.
The use of fetal tissue for research purposes raises a number of ethical considerations, including the degree to which a woman’s decision to have an abortion might be influenced by the opportunity to donate fetal tissue. Physicians who are involved in research that uses human fetal tissue have a responsibility to protect the interests of pregnant women as well as the integrity of science.
In general, genetic manipulation should be reserved for therapeutic purposes. Efforts to enhance “desirable” traits are contrary to the ethical tradition of medicine. In addition to fundamental ethical requirements for the appropriate conduct of research with human participants, research in gene therapy or genetic engineering must put in place additional safeguards to vigorously protect the safety and well-being of participants and future generations.
Human participants who contribute to research involving DNA databanks have a right to be informed about the nature and scope of the research and must give consent for how their information may be used.
Physicians who conduct research using stem cells obtained from any source must, at a minimum, adhere to institutional review board requirements, ensure that the research is carried out with appropriate oversight and monitoring, and ensure that the research is carried out with appropriate informed consent.
Physicians involved in research with human biological materials should disclose potential commercial applications to the tissue donor, obtain informed consent to use biological materials in research from the tissue donor, and share profits from the commercial use of human biological materials with the tissue donor.
Physicians who care for patients with serious, life-threatening illness for whom standard therapies have failed, are unlikely to be effective, or do not exist, should familiarize themselves with access to investigational therapies through the U.S. Food and Drug Administration’s “expanded access” program to be better able to engage in shared decision making with patients.