Informed consent and ethics committee involvement in case reports and case series: cross-sectional meta-research study.

Abstract

Background: Although 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.

Methods: This 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.

Results: This 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.

Conclusion: The 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.