ArticleBMC medical ethics2025
Informed consent and ethics committee involvement in case reports and case series: cross-sectional meta-research study.
Article in BMC medical ethics, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 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
3 citing papers in PubMed.
- Writing a Case Report or Case Series: Practical Guidance for Clinicians and Researchers.Clinical case reports · 2026Article
- Ethical Oversight in Clinical Innovation: Navigating the Case Report Dilemma.Journal of orthopaedic case reports · 2026Article
- 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
3 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundAlthough the research should guarantee the protection of privacy and personal data, case reports and case series frequently lack the involvement of the ethics board and informed consent that includes the required information. This study aimed to analyze the reporting about informed consent and ethics committees in case reports and case series.
methodsThis cross-sectional meta-research study analyzed case reports and case series published in 2021, indexed in PubMed, and available as open-access articles. Extracted variables included authorship details, country, journal name, number of cases, and documentation of informed consent and ethics committee approval.
resultsThis study analyzed 2053 case reports and case series. Most articles (86%) reported a single case. Statements about informed consent were reported in 79% of cases. Informed consent was primarily obtained from patients (74%). Statements about an ethics committee were reported in 46% of articles. In 24% of articles, it was reported that approval was obtained from an ethics committee. Case reports were significantly more likely to include a statement on informed consent than case series. On the contrary, case series were significantly more likely to report ethics committee statements than case reports.
conclusionThe findings reveal inconsistencies in ethics reporting, with 46% of articles mentioning ethics committee involvement and varying justifications for exemption. While 79% of articles reported informed consent, further improvements in transparency and standardization are needed. Clear guidelines on ethical approval requirements and consent documentation should be established to enhance the quality and ethical rigor of case reports.
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.