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Data Safety Monitoring Boards: Legal and Ethical Considerations for Research Accountability
| Title | Data Safety Monitoring Boards: Legal and Ethical Considerations for Research Accountability |
| Publication Type | Journal Article |
| Year of Publication | 2010 |
| Authors | Tereskerz, Patricia M. |
| Journal | Accountability in Research: Policies & Quality Assurance |
| Volume | 17 |
| Issue | 1 |
| Pagination | 30-50 |
| Type of Article | Article |
| Publication Language | eng |
| ISSN Number | 08989621 |
| Accession Number | 47657948 |
| Keywords | ACTIONS , Data , ethics , Law , Legislation , research , TRIAL |
| Abstract | This 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. |
| Notes | Tereskerz, 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 |
| DOI | 10.1080/08989620903520313 |
