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The IRB Is Not a Data and Safety Monitoring Board

Bibliographic Data

ID13877286
AuthorsElizabeth A Bankert (Dartmouth College, corresponding author), Elizabeth Bankert, Robert Amdur, Robert J Amdur (0000-0002-9850-0964)
Year2000
Volume22
Issue6
Pages9-9
Publication date2000-11-01
Open AccessNo
TypeARTICLE
VenueIRB Ethics and Human Research (JOURNAL)
Journal identifiersISSN: 0193-7758 • E-ISSN: 2326-2222
PublisherHastings Center (PUBLISHER • US)
DOI10.2307/3563586
PMID11883486
OpenAlexW1926129295
LanguageEN
Citations received1
References cited1

At the November 1998 PRIM&R (Public Responsibility in Medicine and Research) and ARENA (Applied Research Ethics National Association) conferences a topic of interest in multiple sessions was the management of adverse event reports (AERs). Each year IRBs spend more time and energy reviewing AERs from multicenter trials. Many question the value of IRB review of AERs in this setting because the IRB does not have ac

Computer security · Biomedical Ethics and Regulation · Computer Science · Ethics in Clinical Research

  • Evaluation of Serious Adverse Event Reporting Forms for Clinical Trials

    Open Access•Heeyoung Lee, Cholong Park et al.•Journal of Empirical Research on…•2020

  • IRB Review of Adverse Events in Investigational Drug Studies

    Ernest D Prentice, Bruce Gordon et al.•IRB Ethics and Human Research•1997

Citations per year0.17
Citation span2020 - 2020 (1)
Highly citedNo

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Ethnos_APP • Open Source Project • MIT License • Frontend v2.0.0 • Privacy and Cookies • API Documentation: api.ethnos.app/docs • API Source Code: GitHub • DOI: 10.5281/zenodo.17049435 • Frontend Source Code: GitHub • DOI: 10.5281/zenodo.17050053 • cruz.rio.br • Expectantes Misericordiae