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Building a More Connected DSMB: Better Integrating Ethics Review and Safety Monitoring
Citation
Eckstein, LG, Building a More Connected DSMB: Better Integrating Ethics Review and Safety Monitoring, Accountability in Research: policies and quality assurance, 22, (2) pp. 81-105. ISSN 0898-9621 (2015) [Refereed Article]
Copyright Statement
Copyright 2014 Taylor and Francis
DOI: doi:10.1080/08989621.2014.919230
Abstract
Data and Safety Monitoring Boards (DSMBs) have become an increasingly common
feature of clinical trial oversight, yet a paucity of legal or ethical frameworks govern
these Boards’ composition or operation, or their relationship with other actors
with monitoring responsibilities. This paper argues that prevailing structural gaps
are impeding harmonized systems for monitoring the ongoing ethical acceptability of 10
clinical trials. Particular tensions stem from DSMBs’ sweeping discretion in deciding
whether and when to recommend that a trial should be terminated or amended based
on safety and efficacy information. This discretion becomes especially challenging in
light of DSMBs’ monopoly over emerging trial data, which prevents Institutional Review
Boards, sponsors, and investigators from participating in certain pivotal and ethically 15
charged decisions. To address these disconnects, I advocate for strengthened pre-trial
and post-trial communication in addition to innovative strategies to support DSMB
decision making through the life of a trial.
Item Details
Item Type: | Refereed Article |
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Keywords: | clinical trials, data monitoring, Data Safety and Monitoring Boards, human subjects protection, Institutional Review Board, research ethics |
Research Division: | Law and Legal Studies |
Research Group: | Public law |
Research Field: | Public law not elsewhere classified |
Objective Division: | Law, Politics and Community Services |
Objective Group: | Justice and the law |
Objective Field: | Justice and the law not elsewhere classified |
UTAS Author: | Eckstein, LG (Dr Lisa Eckstein) |
ID Code: | 92940 |
Year Published: | 2015 (online first 2014) |
Web of Science® Times Cited: | 9 |
Deposited By: | Faculty of Law |
Deposited On: | 2014-07-02 |
Last Modified: | 2015-05-05 |
Downloads: | 0 |
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