Back to Chapter 7 Research & Innovation
Opinion 7.1.1

Physician Involvement in Research

Download PDF

Biomedical and health research is intended to contribute to the advancement of knowledge and the welfare of society and future patients, rather than to the specific benefit of the individuals who participate as research subjects.

However, research involving human participants should be conducted in a manner that minimizes risks and avoids unnecessary suffering. Because research depends on the willingness of participants to accept risk, they must be able to make informed decisions about whether to participate or continue in a given protocol. 

Physician researchers share their responsibility for the ethical conduct of research with the institution that carries out research. Institutions have an obligation to oversee the design, conduct, and dissemination of research to ensure that scientific, ethical, and legal standards are upheld. Institutional review boards (IRBs) as well as individual investigators should ensure that each participant has been appropriately informed and has given voluntary consent. 

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. 

To fulfill these obligations, individually, physicians who are involved in research should: 

  1. Participate only in those studies for which they have relevant expertise. 
  2. Ensure that voluntary consent has been obtained from each participant or from the participant’s legally authorized representative if the participant lacks the capacity to consent, in keeping with ethics guidance. This requires that: 
    1. prospective participants receive the information they need to make well-considered decisions, including informing them about the nature of the research and potential harms involved; 
    2. physicians make all reasonable efforts to ensure that participants understand the research is not intended to benefit them individually; 
    3. physicians also make clear that the individual may refuse to participate or may withdraw from the protocol at any time. 
  3. Assure themselves that the research protocol is scientifically sound and meets ethical guidelines for research with human participants. Informed consent can never be invoked to justify an unethical study design. 
  4. Demonstrate the same care and concern for the well-being of research participants that they would for patients to whom they provide clinical care in a therapeutic relationship. Physician researchers should advocate for access to experimental interventions that have proven effectiveness for patients. 
  5. Be mindful of conflicts of interest and assure themselves that appropriate safeguards are in place to protect the integrity of the research and the welfare of human participants. 
  6. Adhere to rigorous scientific and ethical standards in conducting, supervising, and disseminating results of the research. 
AMA Principles of Medical Ethics: I, II, III, V
Read the Principles

Council Reports

Related Opinions

See All Opinions
Opinion 1.1.1

Patient-Physician Relationships

At the heart of medicine lie relationships founded in a “covenant of trust” between patient and physician in which physicians commit themselves to responding to the needs and promoting the welfare of patients.
Opinion 1.2.11

Ethically Sound Innovation in Medical Practice

When physicians participate in developing and disseminating innovative practices, they act in accord with professional responsibilities to advance medical knowledge, improve quality of care, and promote the well-being of individual patients and the larger community.
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 2.1.2

Decisions for Adult Patients Who Lack Capacity

Physicians should engage patients whose capacity is impaired in decisions involving their own care to the greatest extent possible, including when the patient has previously designated a surrogate to make decisions on his or her behalf.
Opinion 3.2.1

Confidentiality

Physicians have an ethical obligation to preserve the confidentiality of information gathered in association with the care of the patient. With rare exceptions, patients are entitled to decide whether and to whom their personal health information is disclosed.
Opinion 4.1.3

Third-Party Access to Genetic Information

Patients who undergo genetic testing have a right to have their information kept in confidence, and a variety of state and federal laws prohibit discrimination by employers, insurers, and other third parties based on genetic information.
Opinion 6.3.1

Xenotransplantation

Xenotransplantation, i.e., using organs or tissues from nonhuman animal species for transplantation into human patients, is a possible novel means of addressing the shortage of transplantable organs that can pose distinctive ethical challenges with respect to patient safety and public health.
Opinion 11.2.2

Conflicts of Interest in Patient Care

Under no circumstances may physicians place their own financial interests above the welfare of their patients. Treatment or hospitalization that is willfully excessive or inadequate constitutes unethical practice.