{"title":"遵守尼日利亚医学期刊的研究参与者保护准则。","authors":"Adaora A Onyiaorah, Euzebus C Ezugwu","doi":"10.1186/s12910-025-01168-7","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>Stakeholders in medical research have roles in ensuring that research participants are protected. Medical journals play gatekeeping roles in the responsible conduct of research. They help guard against the publication of findings of unethical research, such as those with compromised participant welfare. Nigerian medical journals are being created to support the growing number of research enterprises. In this study, we aimed to determine the compliance of Nigerian medical journals with guidelines on research participant protection.</p><p><strong>Methods: </strong>This was a descriptive cross-sectional study of Nigerian medical journals and articles. We used a checklist to obtain information on journal characteristics and the presence of recommendations from the International Committee of Medical Journal Editors (ICMJE) on the protection of research participants in the journal instructions to authors and articles. The data were analysed via IBM SPSS version 23.</p><p><strong>Results: </strong>We studied 40 journals and 350 journal articles. Thirty-one (77.5%) journals required ethical approval and the Declaration of Helsinki statement in their instructions to the authors, while informed consent was present in 26 (65.0%) journals; 6 (15.0%) journals had no participant protection guidelines. Forty-one (11.7%) articles complied with all three recommendations on research participant protection, whereas 60 (17.1%) articles did not. Ethical approval was most common in 268 (76.6%) articles, whereas it was least common in statements on the Declaration of Helsinki in 50 (14.3%) articles. The presence of participant protection recommendations in instructions to authors was not associated with compliance with these recommendations in published articles (p > 0.05).</p><p><strong>Conclusion: </strong>Although there is fairly good compliance of Nigerian medical journals with research participant protection recommendations, there are still gaps, which highlight the need for remedial measures.</p>","PeriodicalId":55348,"journal":{"name":"BMC Medical Ethics","volume":"26 1","pages":"8"},"PeriodicalIF":3.0000,"publicationDate":"2025-01-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11753085/pdf/","citationCount":"0","resultStr":"{\"title\":\"Compliance with research participant protection guidelines by Nigerian medical journals.\",\"authors\":\"Adaora A Onyiaorah, Euzebus C Ezugwu\",\"doi\":\"10.1186/s12910-025-01168-7\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background: </strong>Stakeholders in medical research have roles in ensuring that research participants are protected. Medical journals play gatekeeping roles in the responsible conduct of research. They help guard against the publication of findings of unethical research, such as those with compromised participant welfare. Nigerian medical journals are being created to support the growing number of research enterprises. In this study, we aimed to determine the compliance of Nigerian medical journals with guidelines on research participant protection.</p><p><strong>Methods: </strong>This was a descriptive cross-sectional study of Nigerian medical journals and articles. We used a checklist to obtain information on journal characteristics and the presence of recommendations from the International Committee of Medical Journal Editors (ICMJE) on the protection of research participants in the journal instructions to authors and articles. The data were analysed via IBM SPSS version 23.</p><p><strong>Results: </strong>We studied 40 journals and 350 journal articles. Thirty-one (77.5%) journals required ethical approval and the Declaration of Helsinki statement in their instructions to the authors, while informed consent was present in 26 (65.0%) journals; 6 (15.0%) journals had no participant protection guidelines. Forty-one (11.7%) articles complied with all three recommendations on research participant protection, whereas 60 (17.1%) articles did not. Ethical approval was most common in 268 (76.6%) articles, whereas it was least common in statements on the Declaration of Helsinki in 50 (14.3%) articles. The presence of participant protection recommendations in instructions to authors was not associated with compliance with these recommendations in published articles (p > 0.05).</p><p><strong>Conclusion: </strong>Although there is fairly good compliance of Nigerian medical journals with research participant protection recommendations, there are still gaps, which highlight the need for remedial measures.</p>\",\"PeriodicalId\":55348,\"journal\":{\"name\":\"BMC Medical Ethics\",\"volume\":\"26 1\",\"pages\":\"8\"},\"PeriodicalIF\":3.0000,\"publicationDate\":\"2025-01-22\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11753085/pdf/\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"BMC Medical Ethics\",\"FirstCategoryId\":\"98\",\"ListUrlMain\":\"https://doi.org/10.1186/s12910-025-01168-7\",\"RegionNum\":1,\"RegionCategory\":\"哲学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q1\",\"JCRName\":\"ETHICS\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"BMC Medical Ethics","FirstCategoryId":"98","ListUrlMain":"https://doi.org/10.1186/s12910-025-01168-7","RegionNum":1,"RegionCategory":"哲学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"ETHICS","Score":null,"Total":0}
引用次数: 0
摘要
背景:医学研究的利益相关者在确保研究参与者受到保护方面发挥着作用。医学期刊在负责任的研究行为中起着守门人的作用。它们有助于防止发表不道德的研究结果,例如那些损害参与者福利的研究结果。正在创建尼日利亚医学期刊,以支持越来越多的研究企业。在这项研究中,我们旨在确定尼日利亚医学期刊对研究参与者保护指南的遵守情况。方法:对尼日利亚医学期刊和文章进行描述性横断面研究。我们使用了一个清单来获取关于期刊特征的信息,以及国际医学期刊编辑委员会(ICMJE)在给作者和文章的期刊说明中关于保护研究参与者的建议。数据采用IBM SPSS version 23进行分析。结果:我们研究了40种期刊和350篇期刊文章。31种(77.5%)期刊在作者指导中要求伦理批准和赫尔辛基宣言声明,26种(65.0%)期刊要求知情同意;6份(15.0%)期刊没有受试者保护指南。41篇(11.7%)文章遵守了所有三项关于研究参与者保护的建议,而60篇(17.1%)文章没有。伦理认可在268篇(76.6%)文章中最为常见,而在50篇(14.3%)关于赫尔辛基宣言的声明中最不常见。对作者的指导中存在的参与者保护建议与发表的文章中对这些建议的依从性无关(p > 0.05)。结论:尽管尼日利亚医学期刊对研究参与者保护建议的遵守情况相当好,但仍存在差距,这突出了采取补救措施的必要性。
Compliance with research participant protection guidelines by Nigerian medical journals.
Background: Stakeholders in medical research have roles in ensuring that research participants are protected. Medical journals play gatekeeping roles in the responsible conduct of research. They help guard against the publication of findings of unethical research, such as those with compromised participant welfare. Nigerian medical journals are being created to support the growing number of research enterprises. In this study, we aimed to determine the compliance of Nigerian medical journals with guidelines on research participant protection.
Methods: This was a descriptive cross-sectional study of Nigerian medical journals and articles. We used a checklist to obtain information on journal characteristics and the presence of recommendations from the International Committee of Medical Journal Editors (ICMJE) on the protection of research participants in the journal instructions to authors and articles. The data were analysed via IBM SPSS version 23.
Results: We studied 40 journals and 350 journal articles. Thirty-one (77.5%) journals required ethical approval and the Declaration of Helsinki statement in their instructions to the authors, while informed consent was present in 26 (65.0%) journals; 6 (15.0%) journals had no participant protection guidelines. Forty-one (11.7%) articles complied with all three recommendations on research participant protection, whereas 60 (17.1%) articles did not. Ethical approval was most common in 268 (76.6%) articles, whereas it was least common in statements on the Declaration of Helsinki in 50 (14.3%) articles. The presence of participant protection recommendations in instructions to authors was not associated with compliance with these recommendations in published articles (p > 0.05).
Conclusion: Although there is fairly good compliance of Nigerian medical journals with research participant protection recommendations, there are still gaps, which highlight the need for remedial measures.
期刊介绍:
BMC Medical Ethics is an open access journal publishing original peer-reviewed research articles in relation to the ethical aspects of biomedical research and clinical practice, including professional choices and conduct, medical technologies, healthcare systems and health policies.