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中国涉及器官移植的同行评审出版物中报告供体来源和伦理审查的道德标准遵循情况:范围综述。

Compliance with ethical standards in the reporting of donor sources and ethics review in peer-reviewed publications involving organ transplantation in China: a scoping review.

机构信息

Department of Clinical Medicine and Department of Philosophy, Macquarie University, Sydney, New South Wales, Australia.

Department of Philosophy, Macquarie University, Sydney, New South Wales, Australia.

出版信息

BMJ Open. 2019 Feb 5;9(2):e024473. doi: 10.1136/bmjopen-2018-024473.

Abstract

OBJECTIVES

The objective of this study is to investigate whether papers reporting research on Chinese transplant recipients comply with international professional standards aimed at excluding publication of research that: (1) involves any biological material from executed prisoners; (2) lacks Institutional Review Board (IRB) approval and (3) lacks consent of donors.

DESIGN

Scoping review based on Arksey and O'Mallee's methodological framework.

DATA SOURCES

Medline, Scopus and Embase were searched from January 2000 to April 2017.

ELIGIBILITY CRITERIA

We included research papers published in peer-reviewed English-language journals reporting on outcomes of research involving recipients of transplanted hearts, livers or lungs in mainland China.

DATA EXTRACTION AND SYNTHESIS

Data were extracted by individual authors working independently following training and benchmarking. Descriptive statistics were compiled using Excel.

RESULTS

445 included studies reported on outcomes of 85 477 transplants. 412 (92.5%) failed to report whether or not organs were sourced from executed prisoners; and 439 (99%) failed to report that organ sources gave consent for transplantation. In contrast, 324 (73%) reported approval from an IRB. Of the papers claiming that no prisoners' organs were involved in the transplants, 19 of them involved 2688 transplants that took place prior to 2010, when there was no volunteer donor programme in China.

DISCUSSION

The transplant research community has failed to implement ethical standards banning publication of research using material from executed prisoners. As a result, a large body of unethical research now exists, raising issues of complicity and moral hazard to the extent that the transplant community uses and benefits from the results of this research. We call for retraction of this literature pending investigation of individual papers.

摘要

目的

本研究旨在调查报告中国器官移植受者研究的论文是否符合旨在排除发表涉及以下内容的研究的国际专业标准:(1) 使用来自已处决囚犯的任何生物材料;(2) 缺乏机构审查委员会(IRB) 批准;(3) 缺乏供体同意。

设计

基于 Arksey 和 O'Mallee 方法学框架的范围审查。

数据来源

从 2000 年 1 月至 2017 年 4 月,检索 Medline、Scopus 和 Embase。

入选标准

纳入发表在同行评议的英文期刊上的研究论文,报告中国大陆接受心脏、肝脏或肺移植的受者的研究结果。

数据提取和综合

作者经过培训和基准测试后,独立提取数据。使用 Excel 汇总描述性统计数据。

结果

445 项纳入研究报告了 85477 例移植的结果。412 项(92.5%)未报告器官是否来源于已处决的囚犯;439 项(99%)未报告器官来源是否同意进行移植。相比之下,324 项(73%)报告了 IRB 的批准。在声称没有涉及囚犯器官的论文中,有 19 项涉及 2010 年之前进行的 2688 例移植,当时中国没有志愿供体计划。

讨论

移植研究界未能实施禁止使用来自已处决囚犯的材料进行研究的伦理标准。结果,大量不道德的研究现在已经存在,引起了同谋和道德风险的问题,以至于移植界使用和受益于这项研究的结果。我们呼吁撤回这些文献,同时等待对个别论文进行调查。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/0f90/6377532/31a01249f414/bmjopen-2018-024473f01.jpg

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