ReviewAnnals of family medicine
Human subjects issues and IRB review in practice-based research.
Review in Annals of family medicine. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 23 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
23 citing papers in PubMed, 48 citations in OpenAlex.
- PCORsearch: A scalable, user-centric platform for self-service cohort discovery and feasibility analysis of PCORnet data.Computational biology and chemistry · 2026Article
- Use of Practice-Based Research Networks in Massage Therapy Research.International journal of therapeutic massage & bodywork · 2024Article
- Aligning clinical research ethics with community-engaged and participatory research in the United States.Frontiers in public health · 2023Review
- Assessing the feasibility of using an electronic records database system in use in a group of private chiropractic clinics for practice-based research.The Journal of the Canadian Chiropractic Association · 2021Article
- Community Protections in American Indian and Alaska Native Participatory Research-A Scoping Review.Social sciences (Basel, Switzerland) · 2019Article
- Getting started in research, redefined: five questions for clinically focused physicians in family medicine.Family medicine and community health · 2019Article
- The development of large-scale de-identified biomedical databases in the age of genomics-principles and challenges.Human genomics · 2018Review
- Ethics Review for a Multi-Site Project Involving Tribal Nations in the Northern Plains.Journal of empirical research on human research ethics : JERHRE · 2016Article
- Practical issues in multi-lingual research.International journal of nursing studies · 2016Article
- Lessons learned in the growth and maturation stages of a community pharmacy practice-based research network: Experiences of the Medication Safety Research Network of Indiana (Rx-SafeNet).Innovations in pharmacy · 2015Article
- Researchers' perceptions of ethical challenges in cluster randomized trials: a qualitative analysis.Trials · 2013Article
- Practice-Based Research Network Infrastructure Design for Institutional Review Board Risk Assessment and Generalizability of Clinical Results.Therapeutic innovation & regulatory science · 2013Article
- Article
- Institutional review board and regulatory solutions in the dental PBRN.Journal of public health dentistry · 2010Article
- Use of electronic medical records in oncology outcomes research.ClinicoEconomics and outcomes research : CEOR · 2010Article
- Revisiting practice-based research networks as a platform for mental health services research.Administration and policy in mental health · 2009Article
- Lessons for non-VA care delivery systems from the U.S. Department of Veterans Affairs Quality Enhancement Research Initiative: QUERI Series.Implementation science : IS · 2009Article
- Duke Surgery Research Central: an open-source Web application for the improvement of compliance with research regulation.BMC medical informatics and decision making · 2006Article
- Bench-to-bedside review: human subjects research--are more standards needed?Critical care (London, England) · 2006Review
- Moving the frontiers forward: incorporating community-based participatory research into practice-based research networks.Annals of family medicineArticle
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 at 1 institution in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
purposeThis article explores the challenges that practice-based research networks (PBRNs) face with respect to the regulatory requirements for institutional review board (IRB) review and the protection of human subjects in research.
methodsWe used a regulatory and literature review, our previous research involving PBRN researchers, and our experience to identify issues in regulatory compliance and human subjects protections that present challenges to PBRNs and to suggest possible responses.
resultsWe identified 3 challenges that PBRNs face with respect to regulatory compliance and human subjects protections. First, ensuring compliance with federal regulations governing human subjects research across all participating practices may be difficult. Clinicians may be unfamiliar with the regulatory requirements and may not have access to an IRB that can provide the required protocol review; moreover, different IRBs may impose inconsistent requirements. Second, conducting research in the practice setting presents unique issues regarding identification of human subjects, consent, and confidentiality. Finally, the use of electronic databases across practices for research raises concerns about how to respect the wishes of participants when combining data and how to maintain confidentiality of data.
conclusionsPBRN research makes unique contributions to the clinical evidence base by collecting data in community settings where most clinical care is provided. Such research, however, also presents unique challenges to human subject protections and regulatory compliance. Addressing these challenges is necessary to maintain public trust in and support for PBRN research. With careful planning, these ethical and regulatory challenges can be overcome.
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.