Ethics Opinions

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 with oversight responsibilities in biomedical or health research have a responsibility to ensure that allegations of scientific misconduct are addressed promptly and fairly.

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.

Data obtained from cruel and inhumane experiments should virtually never be published. In the rare instances when ethically tainted data have been validated by rigorous scientific analysis and are the only data of such nature available, and human lives would certainly be lost without the knowledge obtained from the data, it may be permissible to use or publish findings from unethical experiments.

Physicians who develop medical innovations may ethically patent their discoveries or products but should not allow patents to languish or use patents to limit the availability of medical innovations.

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