ArticleEthics & human research2021
Stakeholder Experiences with the Single IRB Review Process and Recommendations for Food and Drug Administration Guidance.
Article in Ethics & human research, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 8 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
8 citing papers in PubMed.
- Responses to Commentaries on "Ethics as if Your Life Depended on It".Journal of empirical research on human research ethics : JERHRE · 2026Article
- A comparison of institutional review board models and study efficiency in the Environmental influences on Child Health Outcomes Cohort Consortium.Contemporary clinical trials · 2026Observational
- Exploring ethical considerations in medical research: Harnessing pre-generated transformers for AI-powered ethics discussions.PloS one · 2025Article
- Implementation of single IRB review for multisite human subjects research: Persistent challenges and possible solutions.Journal of clinical and translational science · 2023Article
- Demonstration Project: Transitioning a Research Network to New Single IRB Platforms.Ethics & human research · 2022Article
- Article
- Using single IRB consultations to meet the educational needs of investigative teams.Contemporary clinical trials communications · 2022Article
- An Innovative Approach to Building an Effective and Efficient Pediatric Trial Network.Hospital pediatrics · 2022Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
4 authors.
Funding
Abstract
The revised Common Rule requires using a single institutional review board (sIRB) for U.S.-based, multisite, nonexempt, federally conducted or supported research with human participants. The 21st Century Cures Act directs the Department of Health and Human Services (HHS) to harmonize differences between HHS and the U.S. Food and Drug Administration (FDA) regulations governing research with humans. Anticipating that the FDA may update its 2006 centralized IRB guidance, we conducted interviews with 34 stakeholders engaged in FDA-regulated clinical research to identify benefits and challenges of using sIRBs and to gather recommendations for revising the FDA's guidance. The main benefits were consistency and standardization, speed and efficiency, and streamlining and simplification. The main challenges were uncertainty at local institutions, including addressing local context; decreased timeliness of the research review process; variable processes; and insufficient communication. Several recommendations for FDA guidance focused on the local context and communication plans. Findings suggest that the sIRB review process may be gaining efficiency although challenges remain.
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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.