AMA delegates tackle range of ethics topics, including xenotransplantation, genetics privacy

AMA delegates discuss ethical standards for new and old issues that physicians encounter.

By Tanya Albert, amednews staff. Jan. 1/8, 2001.

Orlando, Fla. -- From transplanting animal organs into humans to guarding a patient's genetic information, the AMA House of Delegates tackled ethical issues brought on by cutting-edge medical technology.

And delegates sought to give more guidance on issues that have been a part of the medical community for years, including the ethics of handling conflicts of interest in clinical trials and performing invasive procedures on the newly deceased.

Delegates to December's Interim Meeting voted to accept a Council on Ethical and Judicial Affairs report recommending that patients receiving animal organs or tissues be monitored for the rest of their lives, even if the organ is eventually removed.

"Many of the issues surrounding animal organs are similar to any other transplant, including allocation and public education," said CEJA member Robert Sade, MD, a cardiothoracic surgeon in Charleston, S.C. "But there are unique problems."

Xenotransplantation offers a way to solve organ shortages that have thousands of people waiting for transplants. But one of the risks is that humans could be exposed to new infectious diseases currently found in animals but unknown to humans.

HIV is perhaps an example of disease transmission from animals to humans, said Michael A. Williams, MD, neurologist at The Johns Hopkins Hospital in Baltimore and chair of the AMA Council on Scientific Affairs.

The CEJA report also recommended that children and incompetent adults not be allowed to participate in clinical trials unless they are terminally ill and there are no other treatment options.

While physicians agreed it was important to follow patients for life to watch for unpredictable problems, some disagreed that children and incompetent adults should be excluded from trials unless they were terminally ill because they wouldn't have the options that other patients had.

But the majority of delegates said it was an important ethical exception.

"The children and incompetent adults exception is an important safeguard," Dr. Williams said. "The risks are terribly unknown. ... One has to be cautious of when it's worthy to commit someone who can't make a decision for themselves."

As biotechnology and pharmaceutical companies increase the money they provide for clinical trials that involve physicians, delegates adopted guidelines that help physicians manage their conflicting roles of investigator and clinician.

Potential problems exist, particularly when there are financial incentives for conducting trials and recruiting subjects, the CEJA report said. Physicians should:

Participate as investigators only when it relates to their scope of practice and medical expertise.
Be familiar with the ethics of research and participate only if it does not impose undue patient risks.
Disclose the source of funding for the trial and financial incentives.
Differentiate between the physician's role as clinician and investigator if the physician continues to treat a patient eligible to enroll as a subject.

But there was some debate about the best way to explain to the patient how the two roles differ and what the patient should expect.

The report said the differentiation is "best achieved when someone other than the treating physician obtains the participant's informed consent to participate in the trial."

But some physicians said another doctor might not always be available to explain that to a patient.

"And often there is no one better than the physician doing research to talk to the patient," said Richard Gimpelson, MD, a Missouri gynecologist.

Family practice physician Julie A. Komarow, MD, of Everett, Wash., said it's best for the patient to talk to the clinician-investigator physician and an outside physician.

"It's important to get both perspectives," said Dr. Komarow, who appreciated hearing both sides when she received a stem cell transplant.

In other ethical issues delegates:

Voted to study the issue of using deceased patients for training or other educational purposes and develop guidelines for the practice.

Accepted a report that recommended standards to protect genetic information in clinical data banks, including releasing a patient's genetic information only with a patient's consent or in compliance with a warrant or other court order; providing the minimum amount of information necessary when the judicial system requests it; and making it unethical to use information for other instances, such as research, unless appropriate ethical guidelines are followed and an individual gives informed consent.

Created a Specialty Section Council on Genetics to provide a forum for discussion among AMA members with a common interest in issues related to genetics.