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December 18, 1998
After months of debate, the National Bioethics Advisory Commission (NBAC) released its final draft report and recommendations on conducting research with psychiatric subjects last month in Washington, D.C. In spite of APA's lobbying efforts, "The NBAC is still recommending several changes in psychiatric research practices that will stigmatize individuals with mental disorders and impede progress in our understanding of these disorders without providing meaningful protections to research participants," Jay Cutler, director of APA's Division of Government Relations commented to Psychiatric News.
The report, Research Involving Persons with Mental Disorders that May Affect Decisionmaking Capacity, was being finalized at press time before being sent to President Bill Clinton.
APA will continue to oppose the report's narrow focus on individuals with impaired decision-making capacity (Psychiatric News, November 20) and several commission recommendations concerning research that involves greater than minimal risk.
Cutler criticized the NBAC recommendation to "create a new federally appointed body to determine the parameters of acceptable research practices. This would politicize the research process and likely lead to deadlock on controversial issues, thus blocking critically needed research," he said.
The Secretary of the Department of Health and Human Services would convene a federal panel on research involving persons with impaired decision making to review and approve protocols from Institutional Review Boards (IRBs) that involve greater than minimal risk without the prospect of direct benefit, according to the press statement. The panel would also develop guidelines so IRBs can approve certain categories of risk using specific research techniques.
The NBAC justified asking the federal government to adopt new regulations in a statement issued last month. "We do not believe that the added regulations will inappropriately impede research or excessively burden researchers. By articulating the conditions under which research should take place, NBAC hopes to give investigators the tools they need to appropriately protect the public from harm," according to the statement.
The NBAC also did not adopt a graduated approach to research risk as APA had recommended, but maintains a two-tier approach: minimal risk and greater than minimal risk.
One recommendation APA finds troubling involving research protocols that involve greater than minimal risk is that an IRB should presume that the study will need to use an appropriate independent assessment of the subject's capacity to decide whether to participate in the study.
"This presumes that independent capacity assessments are always needed in cases of greater than minimal research," said Cutler.
"These ill-considered recommendations detract from the positive ones that APA welcomes. For example, the need for additional research planning for persons with fluctuating capacity or prospective incapacity is a helpful recommendation," Cutler noted.
To view a copy of the final draft report and recommendation, visit the NBAC Web site