Medical ethicists meeting in Baltimore yesterday unveiled a 20-point national proposal aimed at better protecting people with mental disorders who take part in medical research.
The draft report, which will be formally considered Tuesday by the National Bioethics Advisory Commission at a meeting in Miami, calls for a raft of new regulations as well as a standing federal panel to weigh in on research involving individuals with impaired decision-making skills.
Although the plan may undergo some last-minute revisions this week, it is expected to be approved.
The issue is among the most contentious topics in medical ethics, and patient advocacy groups and others who described the plan as weak yesterday are preparing for a fight.
"This proposal has serious flaws," said Dr. Adil E. Shamoo, a biomedical ethics professor at the University of Maryland School of Medicine.
He said loopholes in the plan would continue to allow high-risk experiments on cognitively impaired people.
"These experiments should either never be done or else be done only in extreme, unique and rare circumstances," Shamoo said.
In research projects in Maryland and a number of other states, patients with schizophrenia have agreed to take a chemical that revived symptoms of the illness, including hallucinations and feelings of paranoia.
Other patients have agreed to go off their medications for lengthy periods so researchers could observe their decline and test treatments at various stages.
In many cases, those people are not able to comprehend the risks in making such decisions, advocates for the mentally disabled maintain.
Federal guidelines offer protections for other groups considered vulnerable in research, including prisoners and children.
But there are no regulations that specifically protect people with mental disorders that impair their decision-making.
The independent review boards that routinely evaluate research protocols cannot be relied on to make balanced decisions because they are part of the institution that stands to benefit from the research, critics say.
James Childress, a commission member who helped write the report, discussed the proposal point by point yesterday in Baltimore at the Friends Research Institute's National Ethics Conference at the Marriott Inner Harbor Hotel.
"I would be surprised if we had unanimity on all issues," Childress said.
But he remained optimistic that the plan would be approved.
"Research can't go forward in this area unless we have federal rules and regulations and guidelines in place," Childress said.
"Much of the strength of this report is its reflection of a range of views."
Critics also worried yesterday that the proposed standards would exclude from the protections people who are impaired by Alzheimer's or other diseases that are not mental disorders but affect cognition.
Once approved by the commission, which was appointed by President Clinton, the plan will be forwarded to the Department of Health and Human Services.
The draft plan calls for standards to:
Avoid using individuals with mental disorders in studies when other subjects can be enlisted.
Justify the research when people with mental disorders participate, and describe how risk to them will be minimized.
Thoroughly evaluate the risks and potential benefits for people involved in the research.
Notify people believed to lack decision-making ability before notifying a relative or a legal representative acting in their behalf.
Strengthen protections for individuals when someone is authorized to decide for them.
Enlist family and friends of incapacitated people as part of the health care team.
It also calls for research by the National Institutes of Health into assessing decision-making capacity, and tougher regulations by states.
The Maryland attorney general's office has drafted a similar plan, said Jack Schwartz, chief counsel.
That proposal would require extensive disclosures about projects involving people with impaired cognitive abilities and would create more specific definitions about who can qualify as a legal representative to act on behalf of those people.
Pub Date: 11/15/98