title: Legal liabilities in research: early lessons from North America.
abstract: The legal risks associated with health research involving human subjects have been highlighted recently by a number of lawsuits launched against those involved in conducting and evaluating the research. Some of these cases have been fully addressed by the legal system, resulting in judgments that provide some guidance. The vast majority of cases have either settled before going to trial, or have not yet been addressed by the courts, leaving us to wonder what might have been and what guidance future cases may bring. What is striking about the lawsuits that have been commenced is the broad range of individuals/institutions that are named as defendants and the broad range of allegations that are made. The research community should take this early experience as a warning and should reflect carefully on practices where research involving human subjects is concerned.
authors.affiliation: Bioethics Department, The Hospital for Sick Children, The University of Toronto Joint Centre for Bioethics, Toronto, Canada. randi.zlotnik-shaul@sickkids.ca.
authors.forename: Randi
authors.initials: R
authors.lastname: Zlotnik Shaul
authors.forename: Shelley
authors.initials: S
authors.lastname: Birenbaum
authors.forename: Megan
authors.initials: M
authors.lastname: Evans
mesh_terms: D002986:Clinical Trials as Topic / Q000009:adverse effects / Q000331:legislation & jurisprudence; D035881:Compensation and Redress; D016265:Conflict of Interest / Q000331:legislation & jurisprudence; D004345:Drug Industry / Q000331:legislation & jurisprudence; D006076:Government; D019983:Guideline Adherence; D006761:Hospitals; D006805:Human Experimentation / Q000331:legislation & jurisprudence*; D006806:Human Rights / Q000331:legislation & jurisprudence; D006801:Humans; D007258:Informed Consent / Q000331:legislation & jurisprudence; D016365:Liability, Legal; D009656:North America; D012108:Research Personnel / Q000331:legislation & jurisprudence*; D035842:Research Subjects; D015871:Scientific Misconduct / Q000331:legislation & jurisprudence