Clinical trials and legal jeopardy.
On neither side of the Atlantic have research ethics committees found a satisfactory way of ensuring that all serious side-effects of new treatments being studied are noted and reported to them, without being deluged in reports of minor adverse events. The author of the following paper is probably the leading historian of psychopharmacology: he discusses the issue, and its implications for RECs, in the light of the serious side-effects of the new generation of SSR antidepressants.
North Wales Department of Psychological Medicine, University of Wales College of Medicine, Hergerst Unit, Bangor, Gwynedd LL57 2PW.
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Healy
D000928:Antidepressive Agents / Q000009:adverse effects; D003866:Depressive Disorder / Q000188:drug therapy; D004345:Drug Industry / Q000331:legislation & jurisprudence; D028744:Ethics Committees, Research / Q000458:organization & administration*; D005473:Fluoxetine / Q000009:adverse effects*; D006801:Humans; D016365:Liability, Legal; D016032:Randomized Controlled Trials as Topic / Q000331:legislation & jurisprudence*; D013405:Suicide; D006113:United Kingdom
D000928:Antidepressive Agents; D005473:Fluoxetine
Biomedical and Behavioral Research; Eli Lilly; Legal Approach