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 Type:	Refereed Article
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:	Law
Research Field:	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:	7
Deposited By:	Faculty of Law
Deposited On:	2014-07-02
Last Modified:	2015-05-05
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