ArticleEthics & human research2019
Public Comments on the Proposed Common Rule Mandate for Single-IRB Review of Multisite Research.
Article in Ethics & human research, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 papers.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
7 citing papers in PubMed.
- Review
- Local context review by single institutional review boards: Results from a modified Delphi process.Journal of clinical and translational science · 2025Article
- Article
- Rethinking the role of Research Ethics Committees in the light of Regulation (EU) No 536/2014 on clinical trials and the COVID-19 pandemic.British journal of clinical pharmacology · 2022Review
- Key lessons and strategies for implementing single IRB review in the Trial Innovation Network.Journal of clinical and translational science · 2022Article
- Stakeholder Experiences with the Single IRB Review Process and Recommendations for Food and Drug Administration Guidance.Ethics & human research · 2021Article
- Single IRB Review and Local Context Considerations: A Scoping Review.Ethics & human researchArticle
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
3 authors.
Funding
Abstract
We reviewed the public comments submitted in response to the Department of Health and Human Services' (DHHS's) original and revised proposal for mandated single-IRB review of federally funded multisite research to see who responded to the proposed mandate and to determine what they said and how the agency addressed the public comments in its revised proposal. Our analysis indicates that support for the single-IRB mandate was limited. The most common argument against the proposed mandate came from those concerned with the loss of site-specific institutional review board (IRB) review of the protocol for a multisite study to address issues relevant to local context. Concerns were also raised that the single-IRB approach would replace one inefficient system (that entails, for example, multiple reviews of a single study) with another potentially inefficient system (involving the negotiation and management of multiple interinstitutional agreements). Empirical research about the implementation of DHHS's final rule-and the separate rule of the National Institutes of Health-mandating single-IRB review is needed to determine whether the single-IRB model achieves the stated goals.
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.