ReviewAJOB empirical bioethics
Reliance agreements and single IRB review of multisite research: Concerns of IRB members and staff.
Review in AJOB empirical bioethics. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 18 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
18 citing papers in PubMed.
- Blind spots: The hidden challenges of conducting multisite intervention research.Contemporary clinical trials communications · 2026Article
- Responses to Commentaries on "Ethics as if Your Life Depended on It".Journal of empirical research on human research ethics : JERHRE · 2026Article
- Review
- Evolving roles of Data Coordinating Centers in multisite research: Challenges and adaptations from a rapid scoping review.Journal of clinical and translational science · 2026Review
- Ten years of Central IRB review for an NIH-funded large clinical trial network by an academic IRB: The NIH StrokeNet experience.Journal of clinical and translational science · 2026Article
- Regulatory Issues in Electronic Health Records for Adolescent HIV Research: Strategies and Lessons Learned.JMIR formative research · 2024Article
- Implementation of single IRB review for multisite human subjects research: Persistent challenges and possible solutions.Journal of clinical and translational science · 2023Article
- Aligning clinical research ethics with community-engaged and participatory research in the United States.Frontiers in public health · 2023Review
- Enhancing Reciprocity, Equity and Quality of Ethics Review for Multisite Research During Public Health Crises: The Experience of the COVID-19 Clinical Research Coalition Ethics Working Group.The Journal of law, medicine & ethics : a journal of the American Society of Law, Medicine & Ethics · 2023Article
- Demonstration Project: Transitioning a Research Network to New Single IRB Platforms.Ethics & human research · 2022Article
- Using single IRB consultations to meet the educational needs of investigative teams.Contemporary clinical trials communications · 2022Article
- Article
- Article
- The IRB Reliance Exchange (IREx): A national web-based platform for operationalizing single IRB review.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
- When IRBs Say No to Participating in Research about Single IRBs.Ethics & human research · 2020Article
- An overview of ethical review committees in Japan: examining the certification applications of ethical review committees.Nagoya journal of medical science · 2019Article
- Reducing the Single IRB Burden: Streamlining Electronic IRB Systems.AJOB empirical bioethicsArticle
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
6 authors.
Funding
Abstract
The new National Institutes of Health (NIH) Policy on the Use of a Single Institutional Review Board (sIRB) for Multi-Site Research was adopted primarily to simplify and speed the review of complex multisite clinical trials. However, speeding review requires overcoming a number of obstacles. Perhaps the most substantial obstacle is the time and effort needed to develop reliance agreements among the participating sites. We conducted 102 semistructured interviews with sIRB personnel, including directors, chairs, reviewers, and staff, from 20 IRBs that acted as sIRBs for multisite research, including 6 commercial/independent sIRBs, and 10 university-based academic and 4 federal sIRBs. Almost without exception, the interviewees agreed that reliance agreements were complex, difficult to develop, and time-consuming. A major problem for relying sites was that different agreements specified different responsibilities for the relying sites. Attitudes differed about whether these problems will be resolved as IRB staff and managers become more experienced with sIRBs. However it is clear that the process of developing reliance agreements must be simplified. Federal assistance in standardizing at least some sections of reliance agreements might reduce the difficulties involved.
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.