Mentally disabled research subjects ‘need protection’ — Nature

October 16, 1997

NATURE

Mentally disabled research subjects ‘need protection’ by Meredith Wadman

p. 652

[Washington] When the US National Bioethics Advisory Commission (NBAC) convenes again on Sunday (19 October), it will wrestle with a difficult matter on which it is due to report by January. The commission’s human subjects subcommittee, which meets the same day, is charged with working out how to provide adequate protection for mentally disabled subjects, for whom no specific protection exists under federal regulations.

Two national commissions have recommended that the government adopts such protection – which already exists for pregnant women, fetuses, prisoners and children. But an early effort to introduce it was abandoned after an outcry from researchers. Patients’ advocates say this has led to widespread abuses, and are calling for stringent government measures to be adopted.

“Highly speculative, relapse-producing experiments may have served the interests of investigators, but they undermined the best medical interests of the subjects,” says Vera Hassner Sharav, director of Citizens for Responsible Care in Psychiatry and Research.

The seriousness of the advocates’ cause was brought home to members of NBAC’s human subjects subcommittee at a meeting last month where they heard harrowing testimony from former research subjects. They alleged cursory, inadequate or nonexistent informed consent procedures, abrupt withdrawal of medication, inducing psychosis, and restraint in locked wards.

Although several cases presented at the meeting involved private facilities, others involved research financed by the National Institute of Mental Health (NIMH), including one study at the Institute itself in Bethesda, Maryland. There, a former subject said he was presented with a notebook of consent forms three to four inches thick. “I was given no opportunity to read them [or] consider them. The doc turned the pages and I signed.”

Such a process “could not in a million years be characterized as Informed, voluntary consent,” said Alexander Capron, an NBAC member who is a bioethicist at the University of Southern California.

Rex Cowdry, acting deputy director of NIMH, said the Institute took the allegations “seriously”. He said the institute “is already actively involved in a broad examination of how we can assure that our research participants are well-infromed.”

But some NBAC members said it was important that protection for subjects hould not cripple research, “It also can be unethical not to do research,” said Arturo Brito, a paediatrician at the University of Miami.”