Schizophrenia: Consenting adults ...

Apathy, hallucinations, inappropriate emotions, and confused or paranoid thoughts rank among the central symptoms of schizophrenia. Nonetheless, a new study suggests that determined investigators can help people suffering from this disorder discern the pros and cons of participating in research.

Scientists and clinicians have raised concerns about the ability of individuals with severe psychiatric conditions to grasp the risks and benefits of research projects they're asked to take part in. For example, up to one-half of hospitalized patients with schizophrenia and one-quarter of those with major depression exhibit markedly impaired judgment in interviews conducted shortly after their admission (SN: 1/7/95, p. 8).

Schizophrenia sufferers, however, understand and remember much about proposed clinical trials alter exposure to thorough procedures for gaining their "informed consent," contends a research team led by psychiatrist Donna A. Wirshing of the West Los Angeles Veterans Affairs Medical Center.

The researchers recruited 49 psychiatric patients diagnosed with schizophrenia who were already participating in ongoing trials of several antipsychotic medications. An experimenter first read to each patient an informed-consent document concerning an upcoming randomized clinical trial. A researcher then administered a survey that Wirshing's team devised to gauge how well volunteers understood what they had heard.

Surveys probed for knowledge about the study's procedures and goals, patients' available choices as participants, their physicians' responsibilities to the investigation, and potential ill effects of antipsychotic drugs that were to be given in the trial.

Five patients answered all survey questions correctly on an initial test. For the rest, a researcher immediately explained any items that were answered incorrectly and administered the survey again. Another 26 patients correctly answered all questions on a second try, and 18 did so after three or more attempts.

One week later, all the volunteers still answered most survey items correctly, the scientists report in the November American Journal of Psychiatry. This finding held even for patients displaying the most severe thought disturbances and hallucinations.

In an accompanying editorial, psychiatrist Paul S. Appelbaum of the University of Massachusetts Medical School in Worcester remarks that other tactics to boost psychiatric patients' capacity to consent to research should also be explored. These include involving family members in the teaching process and using instructional videotapes, he says.