APA Criticizes Draft Report Concerning Use of Cognitively Impaired Subjects

The National Bioethics Advisory Commission (NBAC) has released a draft report on psychiatric research with cognitively impaired subjects.

The report was released on the World Wide Web on July 1, three weeks after a congressional hearing that questioned the adequacy of institutional review boards (IRBs) in policing psychiatric research.

The commission was soliciting commentary as Psychiatric News went to press.

"The mere presence of a mental disorder should not lead to a presumption that a person is incapable of making a decision regarding participation in research," the report states. "Yet sometimes these conditions impair the decision-making capacity required to give a valid informed consent. . . ."

The draft report recommends that IRBs

• include persons familiar with the mentally ill and issues germane to this population;



• explain clearly how each subject's capacity for informed consent will be addressed;



• explain clearly how investigators have assessed the risks to prospective subjects;



• abide by any dissent to research participation expressed by a subject;



• inform a subject if they are found incapable of informed consent;



• develop protocols for subjects whose decision-making capacity may wax and wane during a study;



• require periodic reconsent during protracted studies;



• establish a role for a legally authorized representative who can make decisions about continuing or stopping a subject's participation; and



• develop internal and external audit and disclosure mechanisms.

The draft report also recommends that in research of "greater than minimal risk" that is not potentially beneficial to subjects, the IRB should not approve the research unless the potential subject has provided informed consent.

Paul Appelbaum, M.D., chair of APA's Ethics Appeals Board, prepared APA's response.

There should be no distinction between those impaired by mental disorders and those impaired by neurologic disorders, trauma, metabolic abnormalities, or other conditions, Appelbaum contended. "Persons with other disorders affecting decision-making capacity are no less worthy of the protection suggested by the commission in this report," he said. Limiting the commission's focus to those with mental disorders "not only deprives these other patients of needed protections, but also perpetuates the stigmatization of all mentally ill persons as uniquely incapable of making decisions on their own behalf."

Appelbaum criticized some of the recommendations.

Bluntly telling a subject that he or she is mentally incompetent may cause unnecessary distress, Appelbaum commented. A diplomatic approach that reinforces patients' sense of control over their lives should be employed, he said.

Rather than requiring periodic reconsent by research subjects, subjects should instead be reinformed of their right to discontinue participation without going through a formal reconsent, he suggested.

Similarly, the recommendations as formulated raise the risk that a momentary expression of dissent during a long-term study could cause the subject to be dropped from the study. "I think it is important not to conclude from a single episode of refusal. . .that the subject has thereby precluded any further involvement in the study," Appelbaum said. "Investigators should be free to return to subjects at some later point to ascertain their willingness to cooperate with the same or other parts of the study."

The recommendation involving research of greater than minimal risk that is not potentially beneficial to subjects is "unlikely to materially protect subjects," said Appelbaum, "but will prevent the conduct of useful research." This is so because "the threshold for exceeding minimal risk is set at a very low level," he observed. For example, questionnaire studies in which subjects are asked about sexual practices or drug use and studies in which MRI scans are performed are deemed to exceed minimal risk, he noted.

In the related matter of research planning involving individuals with fluctuating decision-making capacity or prospective incapacity, Appelbaum, citing the example of someone in early-stage Alzheimer's, finds the NBAC's recommendation unduly restrictive since it could exclude potential subjects from authorizing future research while they are still competent.

Despite these criticisms, said Appelbaum, "there is almost no recommendation in this report that might not be appropriate in some circumstance." His concerns "relate to attempts to apply such measures across the board to whole categories of studies that encompass a diverse range of investigations with widely varying risks to subjects." Such blanket recommendations are likely to stifle valuable research.

The NBAC draft report, titled, "Research Involving Subjects with Mental Disorders That May Affect Decision-Making Capacity," may be found on the Web at www.bioethics.gov.