title: Protecting clinical research and human participants: considerations for domestic and foreign clinical trials.
abstract: In recent years there has been a shift in focus from national and international "Ethics Influentials" related to the approval of life-saving therapies to a national and international reassessment of the conduct of clinical trials and human subject protection. Due to intense and ongoing pressure from several groups (including the media, patients and families, tort lawyers, patient advocacy groups, ethicists, and government advisory bodies), there are several initiatives underway to revise ethical standards for the conduct of clinical trials. This article discusses the need for an integrated approach to improving the ethical conduct of clinical trials as well as the need to promote the equally important ethical consideration of efficient approval of safe and effective life-saving medical therapies.
authors.affiliation: Quintiles Transnational Corp.
authors.forename: Judith E
authors.initials: JE
authors.lastname: Beach
mesh_terms: D026683:Advisory Committees; D002170:Canada; D002986:Clinical Trials as Topic / Q000941:ethics / Q000331:legislation & jurisprudence / Q000592:standards*; D033161:Government Regulation; D017408:Guidelines as Topic; D006381:Helsinki Declaration; D006805:Human Experimentation / Q000941:ethics / Q000331:legislation & jurisprudence / Q000592:standards*; D006801:Humans; D038622:Internationality; D006113:United Kingdom; D014481:United States; D014486:United States Food and Drug Administration