Do research procedures pose relatively greater risk for healthy persons than for persons with schizophrenia?
Federal regulations governing human research suggest that potential harms and discomforts of research be considered in relation to the risks normally encountered in daily life or in routine examinations. No data regarding relative risks of research exist for persons with schizophrenia. We surveyed psychiatrists (N = 68) to assess their perceptions of the risk associated with 12 research procedures in 2 categories, that is, evaluation- and intervention-type procedures. Psychiatrists were asked to rate "risks compared to usual daily risks" for people with schizophrenia and, separately, for healthy people. For healthy research volunteers, psychiatrists rated 2 of 5 evaluation procedures and none of the intervention procedures as posing fewer risks than daily life. One evaluation procedure and 2 intervention procedures were rated as similar to daily risks for healthy research volunteers. For volunteers with schizophrenia, psychiatrists rated 4 of the 5 evaluation procedures and 1 intervention procedure as conferring less risk than everyday life. For 1 of 5 evaluation procedures and 5 of 7 intervention procedures, the risks associated with the procedures were centered close to the benchmark for those faced every day by persons with schizophrenia. Psychiatrists in this study viewed research procedure risks as closer to the daily risks encountered by persons with schizophrenia than by healthy persons. Because federal regulations benchmark research studies as "minimal risk" if they are analogous to the usual risks of everyday life, this finding may have important implications for the evaluation of psychiatric protocols.
Roberts
Laura Weiss
LW
Department of Psychiatry and Behavioral Medicine, Medical College of Wisconsin, 8701 Watertown Plank Road, Milwaukee, WI 53226, USA. robertsl@mcw.edu
Dunn
Laura B
LB
Green Hammond
Katherine A
KA
Warner
Teddy D
TD
D000328:Adult; D035843:Biomedical Research / Q000941:ethics / Q000592:standards*; D005260:Female; D006304:Health Status; D006805:Human Experimentation / Q000331:legislation & jurisprudence* / Q000592:standards*; D006801:Humans; D007258:Informed Consent; D008297:Male; D012559:Schizophrenia / Q000188:drug therapy / Q000628:therapy*