Abnormal findings in normal research volunteers. NLM AIDSLINE Important note: Information in this article was accurate in 1988. The state of the art may have changed since the publication date.

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Abnormal findings in normal research volunteers.

Controlled Clin Trials. 1987 Dec;8(4):338-42. Unique Identifier : AIDSLINE MED/88165967
Phillips M; Vazquez AJ; Department of Medicine, Chicago Medical School, IL 60064.

Abstract: 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.
Keywords: Adult Case Report Cerebral Cortex/PATHOLOGY Ethics, Medical Female Hepatitis B/DIAGNOSIS Hepatitis B Surface Antigens/ANALYSIS Hepatitis, Chronic Active/DIAGNOSIS Human *Human Experimentation HIV Seropositivity *Informed Consent Male Malpractice *Students, Medical JOURNAL ARTICLE

KWDadultcasereportcerebralcortex/pathologyethics,medicalfemalehepatitisb/diagnosishepatitisbsurfaceantigens/analysishepatitis,chronicactive/diagnosishumanKWDhumanexperimentationhivseropositivityKWDinformedconsentmalemalpracticeKWDstudents,medicaljournalarticle
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Copyright © 1988 - National Library of Medicine. Reproduced under license with the National Library of Medicine, Bethesda, MD.

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