Ethics report recommends restrictions on research with people with impaired decision-making ability

Researchers interested in studying the underpinnings of mental illness and other brain disorders will have a few more regulations to adhere to if the recommendations of a presidentially appointed ethics panel are implemented.

After months of debate, the National Bioethics Advisory Commission in November released a draft of its report on 'Research Involving Persons with Mental Disorders that May Affect Decision-making Capacity.'

The report recommends a series of actions to protect psychiatric patients from becoming victims of ethically dubious research. But, if all of the recommendations are implemented, it may also limit researchers' ability to conduct certain types of studies, including some types of treatment evaluation and studies of the basic mechanisms of disorders such as depression, schizophrenia, autism and Alzheimer's disease, say psychological researchers.

For researchers, one of the more controversial of the panel's 20 recommendations is the call for the creation of a permanent federal panel that would review certain types of research proposals before they are submitted to funding agencies. In particular, the panel would review proposals for studies that presented 'more than minimal risk' to mentally ill patients and offered no prospect of benefiting them directly. Research under this category would include brain imaging studies investigating the basic mechanisms underlying mental illness and brain disease, say researchers.

For one, researchers wanted the panel to define more than two levels of risk-minimal and greater than minimal-to account for a moderate amount of risk, says Christine Hartel, PhD, APA associate executive director for science.

Also, such a review panel would add another, unnecessary, layer to an already rigorous review process, says psychologist John Grabowski, PhD, director of the Substance Abuse Research Center and professor in the department of psychiatry and behavioral sciences at the University of Texas-Houston. Any research proposals involving human participants must first be reviewed for ethical issues by Institutional Review Boards (IRBs) set up at universities and other research institutions. Then, during regular grant review at funding agencies such as the National Institutes of Health (NIH), reviewers again assess the ethical implications of the research.

Grabowski, who doesn't deny the need for ethical reviews, asks, 'We've already got two excellent levels of review-what would we benefit from another?'

In addition, any such national panel would likely become overburdened, which would further delay the review process, say researchers.

Other recommendations from the report include:

o All IRBs that regularly consider grant proposals involving people with mental disorders should include at least two members of the mental health community.

o Researchers should not target mentally ill people for studies that can be conducted just as well with people better able to consent.

o Researchers must honor participants' desire to decline to participate or to withdraw from a study at any time.

o Researchers should carefully determine whether people who consent to a study truly understand the study design as well as the risks and benefits of participating.

o A family member or other approved guardian can enroll a decisionally impaired person in research without that person's consent, if the research is not unreasonably risky and offers the prospect of direct therapeutic benefit to the person.

The panel failed to reach consensus on the ethics of two specific types of research: studies that use a placebo design-assigning some patients to a no-therapy control condition and thereby withholding therapy; and studies that exacerbate symptoms through the administration of psychosis-inducing drugs. The panel called for the Institute of Medicine to examine the ethics of these types of studies.

At press time, the bioethics commission was working on the final wording of the report, which was expected out in late December. Once complete, the report was expected to be sent to the U.S. Department of Health and Human Services for review and discussions about implementation of all or some of the recommendations.

NIH is withholding comment on the report until it's final. But prior to the report's release, NIH officials, including NIH Director Harold Varmus, MD, and National Institute of Mental Health Director Steven Hyman, MD, met with members of the bioethics commission to emphasize the need to have an ethics code that doesn't cripple mental health research.

APA is also withholding judgment until it sees how the report's recommendations are handled legislatively, says Hartel, adding that the Science Directorate will work to ensure that the final ethics rules protect patients while also allowing good research to continue.

To view the entire report visit the advisory panel's web page at bioethics.gov/cgi-bin/bioeth_counter.pl.

-B. Azar

Cover Page for this Issue

Read our privacy statement and Terms of Use

Cover Page for this Issue

PsychNET®
© 1999 American Psychological Association

APA Home Page . Search . Site Map