title: Research infrastructure and IRB/FDA requirements.
authors.affiliation: Office for Human Research Protections, 6100 Executive Boulevard, Rockville, MD 20892-7507, USA. jc423y@nih.gov
authors.forename: J
authors.initials: J
authors.lastname: Cohen
mesh_terms: D002986:Clinical Trials as Topic / Q000331:legislation & jurisprudence / Q000592:standards; D006805:Human Experimentation; D006801:Humans; D011329:Prisoners; D011330:Prisons; D011367:Professional Staff Committees; D012107:Research Design; D012109:Research Support as Topic; D014481:United States; D014483:United States Dept. of Health and Human Services; D014486:United States Food and Drug Administration