RESEARCH : Schizophrenic’s Case Spurs Review of Consent Guidelines
The voices simply would not stop. In the end, Greg Aller was forced to listen. Following the commands of an unseen master, he says, he walked out to the highway, stuck out his thumb and started hitchhiking to the nation’s capital to assassinate the President.
Aller, a schizophrenic, never made it to the White House that day in 1989. But his case has become a rallying point for federal regulators seeking to tighten the rules governing medical experiments on mentally incapacitated or unconscious patients.
Aller, a college student who volunteered to receive a new antipsychotic medication, claims UCLA researchers administered and then withdrew the drug without first getting his consent and without fully explaining their objectives. When they halted treatment, he says, his symptoms returned. He started to believe government agents were chasing him. He thought there were hidden cameras in his living room. He tried to kill his parents.
UCLA Medical Center officials say the study was designed to identify factors that might help predict the need for short-term outpatient medication and was not intended to cause relapses.
“I believe that the researchers viewed people with schizophrenia as subhuman,” Aller testified at a recent congressional hearing. “I doubt whether any doctor who works at the UCLA Medical Center would ever allow a son or daughter to become a subject in this experiment.”
An inquiry into the UCLA experiments by the Health and Human Services Department’s Office of Protection from Research Risks found “insufficiencies” in documents that were supposed to ensure that patients understood the goals--and risks--of the study. School officials say they have since improved record-keeping and plan to create a monitoring board to oversee studies involving patients with serious psychiatric disorders.
Federal regulators warn that much of the blame for inadequate disclosure and consent resides with government health agencies, not with the universities and hospitals that conduct the experiments. The National Institutes of Health and the Food and Drug Administration have issued contradictory rules that blur the ethical boundaries of clinical research, critics say.
NIH, which last year spent $5.5 billion to finance research involving human subjects, has devised a set of fairly rigid rules designed to ensure that informed consent is obtained. Researchers are permitted to waive consent rules only if an experiment involves no more than “minimal risk”--defined as the level of harm encountered in everyday life.
The FDA’s regulations are considerably looser, critics say. The agency, for example, allows physicians to waive consent requirements if the patient is facing a life-threatening emergency.
In any case, experts say, the experiment on Aller would not have passed either standard.
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Most hospitals and universities go to local review boards to get approval for medical studies and experiments. But without a single, comprehensive directive from the federal government, boards may misinterpret or ignore the rules, approving studies without requiring informed consent.
Clinical investigators and drug firms have devised their own rules in some instances. Lack of agreement on common standards poses a serious risk to patient safety, says Rep. Ron Wyden (D-Ore.), whose subcommittee convened a hearing on the problem in May.
Some experts want Congress to create a national review board to regulate federally funded research involving humans. The panel would design research policies and police local review boards, which are susceptible to conflicts because board investigators often serve on the faculties or staffs of the institutions they regulate.
FDA and NIH officials have pledged to try to reconcile their conflicting policies. They expect to hold a workshop this summer for patients, physicians and ethicists to discuss safeguards for comatose patients and other consent issues.
