Three Cases of Illness During a Drug Trial in Healthy Volunteers
BMJ (British Medical Journal). 1987 Feb 28; 294(6571): 562-563.
During a double blind, randomized drug trial involving healthy, paid volunteers, three of the subjects developed an illness compatible with a diagnosis of serum sickness or of a viral illness. The double blind code was broken, the trial suspended, and an investigation begun, even though no other reactions had been reported from other trial centers. After the investigation revealed that a communicable viral infection was the probable cause of the illnesses, the trial was resumed and completed without ill effect. The authors conclude that healthy volunteers who become sick during a drug trial should be investigated by an informed physician not involved in the trial and that investigators must maintain a high index of suspicion for untoward effects. (KIE abstract)
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Incidental Findings Found in "Healthy" Volunteers During Imaging Performed for Research: Current Legal and Ethical Implications Booth, T C; Jackson, A; Wardlaw, J M; Taylor, S A; Waldman, A D (2010-06)Incidental findings found in "healthy" volunteers during research imaging are common and have important implications for study design and performance, particularly in the areas of informed consent, subjects' rights, clinical ...