Informed Consent in Research

Informed consent is an essential safeguard in research. The obligation to obtain informed consent arises out of respect for persons and a desire to respect the autonomy of the individual deciding whether to volunteer to participate in biomedical or health research. For these reasons, no person may be used as a subject in research against his or her will.

1. Ascertaining that the individual has decision-making capacity.
2. Reviewing the process and any materials to ensure that it is understandable to the study population.
3. Disclosing:
   1. the nature of the experimental drug(s), device(s), or procedure(s) to be used in the research;
   2. any conflicts of interest relating to the research, in keeping with ethics guidance;
   3. any known risks or foreseeable hazards, including pain or discomfort that the participant might experience;
   4. the likelihood of therapeutic or other direct benefit for the participant;
   5. that there are alternative courses of action open to the participant, including choosing standard or no treatment instead of participating in the study;
   6. the nature of the research plan and implications for the participant;
   7. the differences between the physician’s responsibilities as a researcher and as the patient’s treating physician.

   In certain situations, with special safeguards in keeping with ethics guidance, the obligation to obtain informed consent may be waived in research on emergency interventions.

   AMA Principles of Medical Ethics: I, III, V

   Council Reports

   Related Opinions

   Opinion 2.1.1

   Informed Consent

   Informed consent to medical treatment is fundamental in both ethics and law. Patients have the right to receive information and ask questions about recommended treatments so that they can make well-considered decisions about care.

   Opinion 7.3.1

   Ethical Use of Placebo Controls in Research

   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.

   Opinion 7.3.2

   Research on Emergency Medical Interventions

   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.