title: Individual researcher liability for clinical research on humans.
abstract: Despite international guidelines and federal regulations, a recent rash of problems in clinical trials have highlighted weaknesses in the oversight process. The federal regulatory system depends on self-policing by researchers and institutions. Because the existing system is overworked, applying common law forms of liability to clinical researchers may encourage improvements in this self-regulation. While research necessarily involves uncertainties, researchers have the greatest direct control over the implementation of the research protocol and the most extensive direct contact with subjects, and must bear corresponding responsibility for acts which fall below the standard of care. This paper argues that the existing FDA patient protections should be adopted as the standards of care for researchers. It examines the possible application of negligence, negligence per se, and fraud and misrepresentation claims against researchers.
authors.affiliation: Boston University School of Law, USA.
authors.forename: Ruth K
authors.initials: RK
authors.lastname: Miller
mesh_terms: D002986:Clinical Trials as Topic / Q000009:adverse effects* / Q000592:standards*; D030881:Disclosure / Q000592:standards; D028744:Ethics Committees, Research; D005607:Fraud / Q000331:legislation & jurisprudence; D033161:Government Regulation; D006801:Humans; D007258:Informed Consent / Q000592:standards; D016365:Liability, Legal; D008318:Malpractice / Q000331:legislation & jurisprudence; D012107:Research Design / Q000592:standards; D012108:Research Personnel / Q000331:legislation & jurisprudence*; D035842:Research Subjects / Q000331:legislation & jurisprudence; D035844:Researcher-Subject Relations; D014481:United States; D014486:United States Food and Drug Administration