Abnormal findings in "normal" research volunteers.
We report three cases in which medical students who participated in clinical studies as normal volunteers were discovered, during the course of the research, to have potentially serious abnormalities. Their previously unsuspected conditions included chronic persistent hepatitis, a lesion in the cerebral cortex, and seropositivity for hepatitis B and HIV antibodies. These findings were surprising and distressing to both subject and investigator, and raised questions of the need for institutional guidelines, and the potential legal liability of the investigator. We discuss how improvements in Informed Consent Forms might aid in reducing these problems, by alerting the researcher and the subject to the possibility that unsuspected disease might be discovered during the course of a clinical research study.
Phillips
M
M
Department of Medicine, Chicago Medical School, IL 60064.
Vazquez
A J
AJ
D000328:Adult; D001927:Brain Diseases; D002540:Cerebral Cortex / Q000473:pathology; D028741:Ethics Committees, Clinical; D028744:Ethics Committees, Research; D004992:Ethics, Medical; D005260:Female; D006679:HIV Seropositivity; D006262:Health; D006509:Hepatitis B / Q000175:diagnosis; D006514:Hepatitis B Surface Antigens / Q000032:analysis; D006521:Hepatitis, Chronic / Q000175:diagnosis; D006805:Human Experimentation; D006801:Humans; D007258:Informed Consent; D008297:Male; D008318:Malpractice; D018579:Patient Selection; D035842:Research Subjects; D035844:Researcher-Subject Relations; D013337:Students, Medical
D006514:Hepatitis B Surface Antigens