Legal liability for injury to research subjects.
In Weiss vs Solomon, the heirs of a subject who died while a volunteer in a nontherapeutic study successfully sued the investigator and his university-affiliated hospital. Without referring to any 'standard of practice', including the MRC Guidelines, the judge found the principal investigator and the hospital (for its research ethics committee) equivalently responsible for not disclosing a rare but fatal complication caused by fluorescein dye and not adequately screening the subject, who suffered from undisclosed hypertropic cardiomyopathy. From the point of view of research institutions, members of research committees, and the investigators themselves, the judgement has left serious uncertainty and ambiguity concerning their responsibilities for subject selection and safety, and disclosure for the purposes of informed consent.
Glass
K C
KC
McGill Centre for Medicine, Ethics and Law, Montreal, Quebec.
Freedman
B
B
D002986:Clinical Trials as Topic / Q000331:legislation & jurisprudence*; D035881:Compensation and Redress; D030881:Disclosure; D028744:Ethics Committees, Research; D019793:Fluorescein; D005451:Fluorescein Angiography; D005452:Fluoresceins / Q000009:adverse effects*; D005456:Fluorescent Dyes / Q000009:adverse effects*; D006323:Heart Arrest / Q000139:chemically induced*; D006801:Humans; D007258:Informed Consent / Q000331:legislation & jurisprudence; D016365:Liability, Legal; D008297:Male; D008875:Middle Aged; D033281:Nontherapeutic Human Experimentation; D018579:Patient Selection; D035842:Research Subjects; D018570:Risk Assessment; D012307:Risk Factors
D005452:Fluoresceins; D005456:Fluorescent Dyes; D019793:Fluorescein