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Data Safety Monitoring Boards: Legal and Ethical Considerations for Research Accountability

TitleData Safety Monitoring Boards: Legal and Ethical Considerations for Research Accountability
Publication TypeJournal Article
Year of Publication2010
AuthorsTereskerz, PM
JournalAccountability in Research: Policies & Quality Assurance
Volume17
Issue1
Pagination30-50
Type of ArticleArticle
Publication Languageeng
ISSN Number08989621
Accession Number47657948
KeywordsACTIONS , Data , ethics , Law , Legislation , research , TRIAL
AbstractThis article looks at some of the challenges facing data safety monitoring boards (DSMBs), especially with the increased risk of litigation surrounding human subject research. The author provides a legal and accountability analysis 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.
NotesTereskerz, Patricia M. 1; Email Address: PJM7s@Virginia.edu; Affiliations: 1: University of Virginia School of Medicine, Charlottesville, Virginia, USA.; Issue Info: Jan2010, Vol. 17 Issue 1, p30; Thesaurus Term: RESEARCH institutes; Thesaurus Term: LEGISLATION; Subject Term: ACTIONS & defenses; Subject Term: TRIAL practice; Author-Supplied Keyword: data safety monitoring; Author-Supplied Keyword: ethics; Author-Supplied Keyword: law ; Company/Entity: DATA Safety Monitoring Board (Organization); Number of Pages: 21p; Document Type: Article
DOI10.1080/08989620903520313
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