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Assessments by Patients With Schizophrenia and Psychiatrists of Relative Risk of Research Procedures

OBJECTIVE: Schizophrenia studies involve diverse procedures with varying levels of risk. Federal regulations indicate that oversight of these protocols entails assessment of risk in relation to the risks encountered in everyday life. No data exist on comparing assessments of people with schizophrenia with those of psychiatrists regarding research procedure risks in relation to the usual risks of living with schizophrenia. METHODS: Structured interviews were given to 43 people with schizophrenia and a parallel written survey was given to 68 psychiatrists to compare assessments of relative risk. Twelve research procedures were rated to compare the risk of the procedure with everyday risks. Possible scores range from 1, much less risk, to 3, about the same, to 5, much more risk. RESULTS: People with schizophrenia and psychiatrists viewed filling out questionnaires, drawing a tube of blood, drawing a tube of blood for a genetic test, and having X-rays of the head as being less risky than usual daily risks. Psychiatrists saw showing a word or picture that is upsetting as being less risky than usual daily risks. In contrast, patients saw having a spinal tap, getting a new experimental medication, getting a medication that causes temporary symptoms of schizophrenia, and stopping usual medications for two weeks as being significantly more risky than usual daily risks, but psychiatrists rated only stopping usual medications for two weeks as being more risky than usual daily risks. CONCLUSIONS: Substantial congruence exists between patients and psychiatrists regarding their views of research procedure risks. Further work is needed to determine how these assessments may be used in evaluating protocols.

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