ReviewBMC medical ethics2015
Ethical oversight in quality improvement and quality improvement research: new approaches to promote a learning health care system.
Review in BMC medical ethics, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 25 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
25 citing papers in PubMed.
- Trial
- Trial
- Available guidance for ethical challenges in learning health systems: an integrative literature review.Health research policy and systems · 2026Review
- Blueprint for clinical N-of-1 strategies with off-label precision treatments in monogenic epilepsies.Orphanet journal of rare diseases · 2025Review
- Prevention of unplanned extubation in neonatal patients: Protocol for a systematic review and meta-analysis.PloS one · 2025Article
- The Impact of Serialisation on Operational Efficiency and Productivity in Irish Pharmaceutical Sites.Therapeutic innovation & regulatory science · 2024Article
- Learning healthcare systems in cardiology: A qualitative interview study on ethical dilemmas of a learning healthcare system.Learning health systems · 2024Article
- The Role of Data Science in Closing the Implementation Gap.Critical care clinics · 2023Review
- Gathering speed and countering tensions in the rapid learning health system.Learning health systems · 2023Article
- Article
- Quality Improvement in Canadian Nephrology: Key Considerations in Ensuring Thoughtful Ethical Oversight.Canadian journal of kidney health and disease · 2022Article
- Ethical considerations in quality improvement: key questions and a practical guide.BMJ open quality · 2021Article
- Considerations for an integrated population health databank in Africa: lessons from global best practices.Wellcome open research · 2021Article
- Informed consent within a learning health system: A scoping review.Learning health systems · 2020Article
- From Doxastic to Epistemic: A Typology and Critique of Qualitative Interview Styles.Qualitative inquiry : QI · 2020Review
- What does 'quality' add? Towards an ethics of healthcare improvement.Journal of medical ethics · 2020Article
- Exploring the challenges of ethical conduct in quality improvement projects.Canadian oncology nursing journal = Revue canadienne de nursing oncologique · 2020Article
- Safety and efficacy of volume-based feeding in critically ill, mechanically ventilated adults using the 'Protein & Energy Requirements Fed for Every Critically ill patient every Time' (PERFECT) protocol: a before-and-after study.Critical care (London, England) · 2019Article
- Kenyan health stakeholder views on individual consent, general notification and governance processes for the re-use of hospital inpatient data to support learning on healthcare systems.BMC medical ethics · 2019Article
- Accommodating quality and service improvement research within existing ethical principles.Trials · 2018Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
5 authors.
Funding
Abstract
backgroundInstitutional review boards (IRBs) distinguish health care quality improvement (QI) and health care quality improvement research (QIR) based primarily on the rigor of the methods used and the purported generalizability of the knowledge gained. Neither of these criteria holds up upon scrutiny. Rather, this apparently false dichotomy may foster under-protection of participants in QI projects and over-protection of participants within QIR. DISCUSSION: Minimal risk projects should entail minimal oversight including waivers for informed consent for both QI and QIR projects. Minimizing the burdens of conducting QIR, while ensuring minimal safeguards for QI projects, is needed to restore this imbalance in oversight. Potentially, such ethical oversight could be provided by the integration of Institutional Review Boards and Clinical Ethical Committees, using a more integrated and streamlined approach such as a two-step process involving a screening review, followed by a review by committee trained in QIR. Standards for such ethical review and training in these standards, coupled with rapid review cycles, could facilitate an appropriate level of oversight within the context of creating and sustaining learning health care systems. We argue that QI and QIR are not reliably distinguishable. We advocate for approaches that improve protections for QI participants while minimizing over-protection for participants in QIR through reasonable ethical oversight that aligns risk to participants in both QI and QIR with the needs of a learning health care system.
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.