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在发展中国家进行的 HIV 研究的期刊文章中报告 IRB 审查情况。

The reporting of IRB review in journal articles presenting HIV research conducted in the developing world.

机构信息

Columbia University College of Physicians and Surgeons-Psychiatry, 1051 Riverside Drive, New York, NY 10032, USA.

出版信息

Dev World Bioeth. 2011 Dec;11(3):161-9. doi: 10.1111/j.1471-8847.2011.00306.x. Epub 2011 Jul 25.

Abstract

OBJECTIVES

We investigated how often journal articles reporting on human HIV research in four developing world countries mention any institutional review boards (IRBs) or research ethics committees (RECs), and what factors are involved.

METHODS

We examined all such articles published in 2007 from India, Nigeria, Thailand and Uganda, and coded these for several ethical and other characteristics.

RESULTS

Of 221 articles meeting inclusion criteria, 32.1% did not mention IRB approval. Mention of IRB approval was associated with: biomedical (versus psychosocial) research (P=0.001), more sponsor-country authors (P=0.003), sponsor-country corresponding author (P=0.047), mention of funding (P<0.001), particular host-country involved (P=0.002), journals having sponsor-country editors (P<0.001), and journal stated compliance with International Committee of Medical Journal Editors (ICMJE) guidelines (P=0.003). Logistic regression identified 3 significant factors: mention of funding, journal having sponsor-country editors and research being biomedical.

CONCLUSIONS

One-third of articles still do not mention IRB approval. Mention varied by country, and was associated with biomedical research, and more sponsor country involvement. Recently, some journals have required mention of IRB approval, but allow authors to do so in cover letters to editors, not in the article itself. Instead, these data suggest, journals should require that articles document adherence to ethical standards.

摘要

目的

我们调查了在四个发展中国家(印度、尼日利亚、泰国和乌干达)的人类艾滋病毒研究报告的期刊文章中,有多少篇提到了任何机构审查委员会(IRB)或研究伦理委员会(REC),以及涉及哪些因素。

方法

我们检查了 2007 年发表的所有来自这些国家的符合纳入标准的此类文章,并对这些文章进行了编码,包括几个伦理和其他特征。

结果

在符合纳入标准的 221 篇文章中,32.1%没有提到 IRB 批准。提到 IRB 批准与以下因素有关:生物医学(而非心理社会)研究(P=0.001)、更多的发起国作者(P=0.003)、发起国对应作者(P=0.047)、提到资金(P<0.001)、特定的东道国(P=0.002)、有发起国编辑的期刊(P<0.001)和期刊声明符合国际医学期刊编辑委员会(ICMJE)指南(P=0.003)。逻辑回归确定了 3 个重要因素:提到资金、期刊有发起国编辑和研究是生物医学。

结论

仍有三分之一的文章没有提到 IRB 批准。提到的情况因国家而异,与生物医学研究以及更多的发起国参与有关。最近,一些期刊要求提到 IRB 批准,但允许作者将其放在给编辑的信中,而不是文章本身。相反,这些数据表明,期刊应要求文章记录遵守伦理标准的情况。

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