The AMA was founded in part to establish the first national code of medical ethics. Today the Code is widely recognized as authoritative ethics guidance for physicians through its Principles of Medical Ethics interpreted in Opinions of AMA’s Council on Ethical and Judicial Affairs that address the evolving challenges of contemporary practice.
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.
