title: Data safety monitoring boards: legal and ethical considerations for research accountability.
abstract: Those charged with assuring research accountability have little guidance as to how to best structure and manage data safety monitoring boards (DSMBs). One major concern is increased litigation surrounding human subject research which has led research institutions and those asked to serve on DSMBs to seek legal counsel regarding their risk of liability for DSMB activities. A major challenge is assessing the risk of potential liability. Yet, potential liability for DSMBs and their members has not been adequately addressed in the literature. The purpose of this article is to provide a legal and accountability analysis to begin to fill this gap. This article undertakes an analysis and exploration of the potential liability that exists for DSMBs and their members under negligence theory and discusses the means by which DSMBs and their members may avoid litigation or defend themselves in the face of a lawsuit. Research accountability implications of imposing liability, or not, on DSMBs are also considered. It is suggested that legislation be contemplated requiring sponsors to indemnify DSMBs and their members in the face of litigation.
authors.affiliation: University of Virginia School of Medicine, Charlottesville, Virginia 22908, USA. PJM7s@Virginia.edu
authors.forename: Patricia M
authors.initials: PM
authors.lastname: Tereskerz
mesh_terms: D035843:Biomedical Research / Q000941:ethics* / Q000331:legislation & jurisprudence*; D026661:Clinical Trials Data Monitoring Committees / Q000941:ethics* / Q000331:legislation & jurisprudence* / Q000458:organization & administration; D002986:Clinical Trials as Topic / Q000941:ethics / Q000331:legislation & jurisprudence; D006801:Humans; D016365:Liability, Legal; D008318:Malpractice; D014481:United States; D014486:United States Food and Drug Administration