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J Empir Res Hum Res Ethics. 2016 Jul;11(3):203-13. doi: 10.1177/1556264616657452. Epub 2016 Jun 30.
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J Empir Res Hum Res Ethics. 2024 Feb;19(1-2):37-47. doi: 10.1177/15562646231221259. Epub 2023 Dec 17.
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Using theory of change frameworks to develop evaluation strategies for research engagement: results of a pre-pilot study.运用变革理论框架制定研究参与度评估策略：预试点研究结果。
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Using theories of change to design monitoring and evaluation of community engagement in research: experiences from a research institute in Malawi.运用变革理论设计对研究中社区参与的监测与评估：来自马拉维一家研究机构的经验
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本文引用的文献

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Towards a Science of Community Stakeholder Engagement in Biomedical HIV Prevention Trials: An Embedded Four-Country Case Study.迈向生物医学艾滋病毒预防试验中社区利益相关者参与的科学：一项四国嵌入式案例研究。
PLoS One. 2015 Aug 21;10(8):e0135937. doi: 10.1371/journal.pone.0135937. eCollection 2015.
2
A realist evaluation of community-based participatory research: partnership synergy, trust building and related ripple effects.基于社区参与式研究的现实主义评价：伙伴关系协同效应、信任建立及相关连锁反应。
BMC Public Health. 2015 Jul 30;15:725. doi: 10.1186/s12889-015-1949-1.
3
Evaluating community engagement in global health research: the need for metrics.评估全球卫生研究中的社区参与：对衡量指标的需求。
BMC Med Ethics. 2015 Jul 1;16:44. doi: 10.1186/s12910-015-0033-9.
4
Community engagement and the human infrastructure of global health research.社区参与与全球卫生研究的人力基础架构
BMC Med Ethics. 2014 Dec 13;15:84. doi: 10.1186/1472-6939-15-84.
5
Ethical issues in genomic research on the African continent: experiences and challenges to ethics review committees.非洲大陆基因组研究中的伦理问题：伦理审查委员会的经验和挑战。
Hum Genomics. 2014 Aug 21;8(1):15. doi: 10.1186/s40246-014-0015-x.
6
Using qualitative comparative analysis (QCA) in systematic reviews of complex interventions: a worked example.在复杂干预措施系统评价中运用定性比较分析（QCA）：一个实例
Syst Rev. 2014 Jun 20;3:67. doi: 10.1186/2046-4053-3-67.
7
Engaging communities in tuberculosis research.社区参与结核病研究。
Lancet Infect Dis. 2013 Jun;13(6):540-5. doi: 10.1016/S1473-3099(13)70042-2. Epub 2013 Mar 24.
8
The exploitation of "Exploitation" in the tenofovir prep trial in Cameroon: Lessons learned from media coverage of an HIV prevention trial.喀麦隆替诺福韦预防试验中“剥削”问题的探讨：从媒体对一项艾滋病预防试验的报道中吸取的教训
J Empir Res Hum Res Ethics. 2010 Jun;5(2):3-19. doi: 10.1525/jer.2010.5.2.3.
9
Community engagement in research: frameworks for education and peer review.社区参与研究：教育和同行评审框架。
Am J Public Health. 2010 Aug;100(8):1380-7. doi: 10.2105/AJPH.2009.178137. Epub 2010 Jun 17.
10
Towards a framework for community engagement in global health research.迈向全球健康研究中的社区参与框架。
Trends Parasitol. 2010 Jun;26(6):279-83. doi: 10.1016/j.pt.2010.02.009. Epub 2010 Mar 17.

制定结核病临床药物试验中良好参与性实践的伦理结果评估框架。

Developing a Framework for Evaluating Ethical Outcomes of Good Participatory Practices in TB Clinical Drug Trials.

作者信息

MacQueen Kathleen M, Eley Natalie T, Frick Mike, Mingote Laia Ruiz, Chou Alicia, Seidel Stephanie S, Hannah Stacey, Hamilton Carol

机构信息

FHI 360, Durham, NC, USA

FHI 360, Durham, NC, USA.

出版信息

J Empir Res Hum Res Ethics. 2016 Jul;11(3):203-13. doi: 10.1177/1556264616657452. Epub 2016 Jun 30.

DOI:10.1177/1556264616657452
PMID:27368311
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC5389451/
Abstract

Good Participatory Practice Guidelines for TB Drug Trials (GPP-TB) were issued in 2012, based on similar guidelines for HIV prevention and reflecting growing acceptance of the importance of community engagement and participatory strategies in clinical research. Though the need for such strategies is clear, evaluation of the benefits and burdens are needed. Working with a diverse group of global TB stakeholders including advocates, scientists, and ethicists, we used a Theory of Change approach to develop an evaluation framework for GPP-TB that includes a clearly defined ethical goal, a set of powerful strategies derived from GPP-TB practices for achieving the goal, and outcomes connecting strategies to goal. The framework is a first step in systematically evaluating participatory research in clinical trials.

摘要

《结核病药物试验良好参与性实践指南》（GPP-TB）于2012年发布，其基于类似的艾滋病毒预防指南，并反映出临床研究中对社区参与和参与性策略重要性的认可度不断提高。尽管此类策略的必要性显而易见，但仍需对其益处和负担进行评估。我们与包括倡导者、科学家和伦理学家在内的众多全球结核病利益相关者合作，采用变革理论方法为GPP-TB制定了一个评估框架，该框架包括明确界定的伦理目标、一套源自GPP-TB实践以实现该目标的有力策略，以及将策略与目标相联系的结果。该框架是系统评估临床试验中参与性研究的第一步。