title: Consent rule in EU clinical trial directive triggers concern. Experts fear new consent guidance could harm patients' rights and leave hospital staff at risk of litigation.
authors.forename: Stephen
authors.initials: S
authors.lastname: Pincock
mesh_terms: D002986:Clinical Trials as Topic / Q000331:legislation & jurisprudence* / Q000592:standards; D005062:European Union / Q000458:organization & administration*; D019983:Guideline Adherence / Q000331:legislation & jurisprudence*; D006801:Humans; D007258:Informed Consent / Q000331:legislation & jurisprudence*; D008318:Malpractice; D028701:Patient Rights; D010564:Personnel, Hospital / Q000592:standards; D019727:Proxy / Q000331:legislation & jurisprudence*; D012955:Societies, Medical; D006113:United Kingdom