Ethics Opinions

In the context of prospective organ donation from an anencephalic newborn, physicians may ethically provide ventilator assistance and other medical therapies that are necessary to sustain organ perfusion and viability until such time as a determination of death can be made in accordance with accepted medical standards, but may only retrieve and transplant the organs of an anencephalic newborn after such determination of death.

Organ transplantation is unique in that it involves two patients, donor and recipient, both of whose interests must be protected. Concern for the patient should always take precedence over advancing scientific knowledge.

Organ transplantation allocation decisions should be guided by ethically sound and clinically relevant standards. Non-medical factors should not be considered when making allocation decisions for scarce resources such as organs.

Donation of needed organs to specified recipients has long been permitted in organ transplantation. Directed organ donation policies that produce a net gain of organs for transplantation and do not unreasonably disadvantage other transplant candidates are ethically acceptable.

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.

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