ArticleJournal of empirical research on human research ethics : JERHRE2019
"You Really Do Have to Know the Local Context": IRB Administrators and Researchers on the Implications of the NIH Single IRB Mandate for Multisite Genomic Studies.
Article in Journal of empirical research on human research ethics : JERHRE, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 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
5 citing papers in PubMed.
- Capacity Development of Research Ethics Administrators: Scoping Review.Journal of empirical research on human research ethics : JERHRE · 2022Article
- Using single IRB consultations to meet the educational needs of investigative teams.Contemporary clinical trials communications · 2022Article
- The IRB Reliance Exchange (IREx): A national web-based platform for operationalizing single IRB review.Journal of clinical and translational science · 2022Article
- Transdisciplinary Perspectives on Precision Medicine.Health equity · 2021Article
- Perspectives of Researchers and Research Team Members Regarding Their Experience with sIRBs.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
8 authors.
Funding
Abstract
In 2016, the U.S. National Institutes of Health (NIH) announced a new policy requiring single institutional review board (sIRB) review for multisite studies. However, adherence to the new policy requires the separation of regulatory institutional review board (IRB) work per Federal guidance from site-specific local compliance concerns. In particular, genomic research is subject to a wide range of state laws, institutional requirements, and local population preferences. In this qualitative study, we explored the anticipated needs of genomics researchers and IRB administrators around implementing the policy. We observed multiple uncertainties, particularly about intersite communication processes, sIRB selection processes, and roles of the reviewing IRB and local sites regarding local context information relevant to genomics. Optimal implementation of the NIH policy may require additional guidance for researchers and IRB administrators.
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.