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 who are involved in any role in research with human participants have an ethical obligation to ensure that participants’ interests are protected and to safeguard participants’ welfare, safety, and comfort.
Physicians must ensure that the participant (or legally authorized representative) has given voluntary, informed consent before enrolling a prospective participant in a research protocol. The obligation to obtain informed consent arises out of respect for persons and a desire to respect the autonomy of the individual.
Well-designed, ethically sound research aligns with the goals of medicine, addresses questions relevant to the population among whom the study will be carried out, balances the potential for benefit against the potential for harm, employs study designs that will yield scientifically valid and significant data, and generates useful knowledge.
Minimizing and mitigating conflicts of interest in clinical research is required in order to justify and maintain trust in the medical research community.
Physicians have an ethical responsibility to learn from and contribute to the total store of scientific knowledge. When they engage in biomedical or health research, physicians have obligations as scientists, which include disseminating research findings.
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
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.
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.
