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 inform...
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BMC
2025-05-01
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| Series: | BMC Medical Ethics |
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| Online Access: | https://doi.org/10.1186/s12910-025-01226-0 |
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| author | Matea Valešić Marta Čivljak Livia Puljak |
| author_facet | Matea Valešić Marta Čivljak Livia Puljak |
| author_sort | Matea Valešić |
| collection | DOAJ |
| description | 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. |
| format | Article |
| id | doaj-art-7292a36d8fa14700b49c95378c958fa1 |
| institution | OA Journals |
| issn | 1472-6939 |
| language | English |
| publishDate | 2025-05-01 |
| publisher | BMC |
| record_format | Article |
| series | BMC Medical Ethics |
| spelling | doaj-art-7292a36d8fa14700b49c95378c958fa12025-08-20T01:53:15ZengBMCBMC Medical Ethics1472-69392025-05-012611810.1186/s12910-025-01226-0Informed consent and ethics committee involvement in case reports and case series: cross-sectional meta-research studyMatea Valešić0Marta Čivljak1Livia Puljak2Center for Evidence-Based Medicine, Department of Nursing, School of Medicine, Catholic University of CroatiaCenter for Evidence-Based Medicine, Department of Nursing, School of Medicine, Catholic University of CroatiaCenter for Evidence-Based Medicine, Department of Nursing, School of Medicine, Catholic University of CroatiaAbstract 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.https://doi.org/10.1186/s12910-025-01226-0Case ReportsCase SeriesEthicsInformed ConsentInstitutional Review BoardMeta-Research |
| spellingShingle | Matea Valešić Marta Čivljak Livia Puljak Informed consent and ethics committee involvement in case reports and case series: cross-sectional meta-research study BMC Medical Ethics Case Reports Case Series Ethics Informed Consent Institutional Review Board Meta-Research |
| title | Informed consent and ethics committee involvement in case reports and case series: cross-sectional meta-research study |
| title_full | Informed consent and ethics committee involvement in case reports and case series: cross-sectional meta-research study |
| title_fullStr | Informed consent and ethics committee involvement in case reports and case series: cross-sectional meta-research study |
| title_full_unstemmed | Informed consent and ethics committee involvement in case reports and case series: cross-sectional meta-research study |
| title_short | Informed consent and ethics committee involvement in case reports and case series: cross-sectional meta-research study |
| title_sort | informed consent and ethics committee involvement in case reports and case series cross sectional meta research study |
| topic | Case Reports Case Series Ethics Informed Consent Institutional Review Board Meta-Research |
| url | https://doi.org/10.1186/s12910-025-01226-0 |
| work_keys_str_mv | AT mateavalesic informedconsentandethicscommitteeinvolvementincasereportsandcaseseriescrosssectionalmetaresearchstudy AT martacivljak informedconsentandethicscommitteeinvolvementincasereportsandcaseseriescrosssectionalmetaresearchstudy AT liviapuljak informedconsentandethicscommitteeinvolvementincasereportsandcaseseriescrosssectionalmetaresearchstudy |