ArticleBMC medical ethics2019
Huge variation in obtaining ethical permission for a non-interventional observational study in Europe.
Article in BMC medical ethics, 2019. 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.
- Requirement for written informed consent and selection bias in a chart-review prostate cancer study.American journal of epidemiology · 2026Article
- Guideline for secondary use of health records within Norwegian and EU regulatory frameworks.NPJ digital medicine · 2026Article
- Radiology-based artificial intelligence for predicting targeted therapy response in pan-cancer: a comprehensive review.Journal of translational medicine · 2025Review
- Considerations for Patient Privacy of Large Language Models in Health Care: Scoping Review.Journal of medical Internet research · 2025Article
- Evaluating health and social care integration in England's Pioneer programme: The challenges of undertaking research in service delivery and research regulatory systems that are not fit for purpose.Journal of health services research & policy · 2025Article
- Retrospective Radiology Research: Do We Need Informed Patient Consent?Journal of bioethical inquiry · 2025Article
- Principles for Good Practice in the Conduct of Non-interventional Studies: The View of Industry Researchers.Therapeutic innovation & regulatory science · 2023Article
- Outcomes of patients aged ≥80 years with respiratory failure initially treated with non-invasive ventilation in European intensive care units before and during COVID-19 pandemic.Annals of intensive care · 2023Article
- Data-driven sudden cardiac arrest research in Europe: Experts' perspectives on ethical challenges and governance strategies.Resuscitation plus · 2023Review
- Towards trust-based governance of health data research.Medicine, health care, and philosophy · 2023Article
- Retrospective observational studies: Lights and shadows for medical writers.Acta bio-medica : Atenei Parmensis · 2022Review
- Difficulties experienced by endodontics researchers in conducting studies and writing papers.Restorative dentistry & endodontics · 2022Article
- Consent is a confounding factor in a prospective observational study of critically ill elderly patients.PloS one · 2022Observational
- You Can't Have AI Both Ways: Balancing Health Data Privacy and Access Fairly.Frontiers in genetics · 2022Article
- The Development of a Nationwide, Multicenter Electronic Database for Spinal Instrumentation Surgery in Japan: Japanese Spinal Instrumentation Society Database (JSIS-DB).Healthcare (Basel, Switzerland) · 2021Article
- Improving research ethics review and governance can improve human health.Journal of the Royal Society of Medicine · 2021Article
- A review of the sampling methodology used in studies evaluating the effectiveness of risk minimisation measures in Europe.Pharmacoepidemiology and drug safety · 2021Review
- Record linkage of population-based cohort data from minors with national register data: a scoping review and comparative legal analysis of four European countries.Open research Europe · 2021Article
- Key components and IT assistance of participant management in clinical research: a scoping review.JAMIA open · 2020Article
- Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
18 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundEthical approval (EA) must be obtained before medical research can start. We describe the differences in EA for an pseudonymous, non-interventional, observational European study.
methodsSixteen European national coordinators (NCs) of the international study on very old intensive care patients answered an online questionnaire concerning their experience getting EA.
resultsN = 8/16 of the NCs could apply at one single national ethical committee (EC), while the others had to apply to various regional ECs and/or individual hospital institutional research boards (IRBs). The time between applying for EA and the first decision varied between 7 days and 300 days. In 9/16 informed consent from the patient was not deemed necessary; in 7/16 informed consent was required from the patient or relatives. The upload of coded data to a central database required additional information in 14/16. In 4/16 the NCs had to ask separate approval to keep a subject identification code list to de-pseudonymize the patients if questions would occur. Only 2/16 of the NCs agreed that informed consent was necessary for this observational study. Overall, 6/16 of the NCs were satisfied with the entire process and 8/16 were (very) unsatisfied. 11/16 would welcome a European central EC that would judge observational studies for all European countries. DISCUSSION: Variations in the process and prolonged time needed to get EA for observational studies hampers inclusion of patients in some European countries. This might have a negative influence on the external validity. Further harmonization of ethical approval process across Europe is welcomed for low-risk observational studies.
conclusionGetting ethical approval for low-risk, non-interventional, observational studies varies enormously across European countries.
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.