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Good collaborative practice: reforming capacity building governance of international health research partnerships

机译:良好的协作做法:改革国际卫生研究伙伴关系的能力建设治理

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摘要

In line with the policy objectives of the United Nations Sustainable Development Goals, this commentary seeks to examine the extent to which provisions of international health research guidance promote capacity building and equitable partnerships in global health research. Our evaluation finds that governance of collaborative research partnerships, and in particular capacity building, in resource-constrained settings is limited but has improved with the implementation guidance of the International Ethical Guidelines for Health-related Research Involving Humans by The Council for International Organizations of Medical Sciences (CIOMS) (2016). However, more clarity is needed in national legislation, industry and ethics guidelines, and regulatory provisions to address the structural inequities and power imbalances inherent in international health research partnerships. Most notably, ethical partnership governance is not supported by the principal industry ethics guidelines – the International Conference on Harmonization Technical Requirements for Registration of Pharmaceutical for Human Use (ICH) Good Clinical Practice (ICH-GCP). Given the strategic value of ICH-GCP guidelines in defining the role and responsibility of global health research partners, we conclude that such governance should stipulate the minimal requirements for creating an equitable environment of inclusion, mutual learning, transparency and accountability. Procedurally, this can be supported by i) shared research agenda setting with local leadership, ii) capacity assessments, and iii) construction of a memorandum of understanding (MoU). Moreover, the requirement of capacity building needs to be coordinated amongst partners to support good collaborative practice and deliver on the public health goals of the research enterprise; improving local conditions of health and reducing global health inequality. In this respect, and in order to develop consistency between sources of research governance, ICH-GCP should reference CIOMS ethical guidelines as the established standard for collaborative partnership. Moreover, greater commitment and support should be given to co-ordinate, strengthen and enforce local laws requiring equitable research partnerships and health system strengthening.
机译:根据联合国可持续发展目标的政策目标,本评论旨在研究国际卫生研究指南的规定在多大程度上促进了全球卫生研究中的能力建设和公平的伙伴关系。我们的评估发现,在资源有限的环境中,协作研究合作伙伴关系的治理(尤其是能力建设)是有限的,但随着国际医学组织理事会制定的《涉及人类的健康相关研究国际伦理准则》的实施指南得到了改善科学(CIOMS)(2016)。但是,国家立法,行业和道德准则以及监管规定需要更加明确,以解决国际卫生研究合作伙伴关系固有的结构性不平等和权力失衡问题。最值得注意的是,道德伙伴关系治理不受主要行业道德准则(即用于人用药品注册(ICH)良好临床实践(ICH-GCP)的国际协调技术要求会议)的支持。鉴于ICH-GCP指南在定义全球卫生研究合作伙伴的作用和责任方面的战略价值,我们得出结论,这种治理应规定最低要求,以创造一个包容,相互学习,透明和负责任的公平环境。在程序上,这可以通过以下方式得到支持:i)与当地领导层共享研究议程; ii)能力评估; iii)构建谅解备忘录(MoU)。此外,需要在合作伙伴之间协调能力建设的要求,以支持良好的合作规范并实现研究企业的公共卫生目标;改善当地健康状况并减少全球健康不平等。在这方面,为了使研究治理的来源之间保持一致,ICH-GCP应该参考CIOMS道德准则作为合作伙伴关系的既定标准。此外,应给予更大的承诺和支持,以协调,加强和执行需要公平研究伙伴关系和加强卫生系统的地方法律。

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