How Research Ethics Boards Should Monitor Clinical Research

ACCOUNTABILITY IN RESEARCH-POLICIES AND QUALITY ASSURANCE(2020)

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摘要
The objective of this commentary is to provide a framework and ethical justification for a more proactive model of continual, active monitoring of research. We outline what the increased monitoring should consist of, and the practical constraints associated with executing these monitoring functions. We also defend the idea that adequate post-initial-review monitoring requires greater REB involvement, rather than trust and researcher's assurances.
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关键词
Continual monitoring, clinical research, Research Ethics Boards, Institutional Review Boards, subject safety and research integrity
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