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尼日利亚医学期刊对研究参与者保护指南的遵守情况。

Compliance with research participant protection guidelines by Nigerian medical journals.

作者信息

Onyiaorah Adaora A, Ezugwu Euzebus C

机构信息

Bioethics Unit, Institute of Public, Health University of Nigeria Enugu Campus, Enugu, Nigeria.

Department of Ophthalmology, Nnamdi Azikiwe University, Awka, Nigeria.

出版信息

BMC Med Ethics. 2025 Jan 22;26(1):8. doi: 10.1186/s12910-025-01168-7.

Abstract

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.

摘要

背景

医学研究中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。医学期刊在研究的负责任开展中发挥把关作用。它们有助于防止发表不道德研究的结果,例如那些损害参与者福利的研究。尼日利亚正在创办医学期刊以支持不断增加的研究企业。在本研究中,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

这是一项对尼日利亚医学期刊和文章的描述性横断面研究。我们使用一份清单来获取有关期刊特征以及医学期刊编辑国际委员会(ICMJE)在作者指南和文章中关于研究参与者保护建议的存在情况的信息。数据通过IBM SPSS 23版进行分析。

结果

我们研究了40种期刊和350篇期刊文章。31种(77.5%)期刊在其作者指南中要求获得伦理批准和《赫尔辛基宣言》声明,而26种(65.0%)期刊中有知情同意的相关内容;6种(15.0%)期刊没有参与者保护指南。41篇(11.7%)文章符合所有三项关于研究参与者保护的建议,而60篇(17.1%)文章不符合。伦理批准在268篇(76.6%)文章中最为常见,而在关于《赫尔辛基宣言》声明的文章中最少见,有50篇(14.3%)。作者指南中存在参与者保护建议与已发表文章中对这些建议的遵守情况无关(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有相当好的遵守情况,但仍存在差距,这突出表明需要采取补救措施。

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