Flying Blind: How Thorough are IRBs when Assessing Scientific Value?
IRB guidance materials vary in their coverage of scientific merit dimensions, with significant gaps in areas critical for assessing study quality. Strengthening guidance materials by including comprehensive instructions for all 15 dimensions could improve IRB assessments of scientific merit, thereby enhancing the ethical oversight of clinical trials.
Authors
- Spencer Phillips Hey (ORCID: https://orcid.org/0000-0003-4444-8213)
- Mark Yarborough (ORCID: https://orcid.org/0000-0001-8188-4968)
- C. Shum (ORCID: https://orcid.org/0000-0002-5440-0515)
- John H. Powers (ORCID: https://orcid.org/0000-0002-5150-5119)
- Melissa Ann Pighin
- Michael S. Wilkes (ORCID: https://orcid.org/0000-0002-8462-1423)
Institutions
- George Washington University (US)
- Prism Clinical Research (US)
- University of California, Davis (US)
Publication Details
- Journal
- Journal of General Internal Medicine
- Published
- 2024-12-20
- DOI
- https://doi.org/10.1007/s11606-024-09286-5
- Primary Topic
- Ethics in Clinical Research
- Type
- article
- Field-Weighted Citation Impact
- 0.00
Funders
- Arnold Ventures