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机构审查委员会(IRB)是否做得正确?如何评估这一点。

Is Institutional Review Board (IRB) Doing Its Job Right? How To Assess This.

机构信息

Shaukat Khanum Memorial Cancer Hospital and Research Centre, Lahore, Pakistan.

出版信息

J Pak Med Assoc. 2023 Jul;73(7):1416-1435. doi: 10.47391/JPMA.7157.

DOI:10.47391/JPMA.7157
PMID:37469053
Abstract

OBJECTIVE

To audit the performance of the institutional review board at a cancer hospital.

METHODS

The retrospective study was conducted at the Shaukat Khanum Memorial Cancer Hospital and Research Centre, Lahore, Pakistan, in 2021, and comprised all records of the institutional review board from 2005 to 2021. The audit was based on a tool created by the Association for the Accreditation of Human Research Protection Programmes, and elements evaluated included terms of reference, membership lists, review records, meeting minutes, institutional research guidelines as well as other relevant policies.

RESULTS

The institutional review board was found to be in 100% compliance with all the elements set forth in the Association for the Accreditation of Human Research Protection Programmes. The institutional review board was found to be an independent body with a diverse membership and the chairman was always an unaffiliated member. It had defined processes in line with relevant laws and guidelines. Review of research studies was devised to promote the ethical conduct of research.

CONCLUSION

Though a self-assessment, the audit objectively showed that the institutional review board was in cent per cent compliance with the evaluation instrument developed and used by the Association for the Accreditation of Human Research Protection Programmes. Nevertheless, it still needs further discussion as to how high levels of efficiency and performance of institutional review boards ultimately provide a higher degree of protection to human research participants.

摘要

目的

审计一家癌症医院的机构审查委员会的绩效。

方法

本回顾性研究于 2021 年在巴基斯坦拉合尔的 Shaukat Khanum 纪念癌症医院和研究中心进行,纳入了 2005 年至 2021 年机构审查委员会的所有记录。审计依据的是认证协会人类研究保护计划制定的工具,评估的内容包括职权范围、成员名单、审查记录、会议记录、机构研究准则以及其他相关政策。

结果

机构审查委员会在符合认证协会人类研究保护计划设定的所有要素方面达到了 100%。机构审查委员会被认为是一个独立的机构,成员具有多样性,主席始终是一个无关联的成员。它有符合相关法律和准则的明确流程。审查研究计划旨在促进研究的道德行为。

结论

尽管这是一次自我评估,但审计客观地表明,机构审查委员会在符合认证协会人类研究保护计划制定和使用的评估工具方面达到了 100%。然而,仍需要进一步讨论机构审查委员会的高效率和高性能如何最终为人类研究参与者提供更高程度的保护。

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