Institute for Biomedical Ethics, University of Basel, Bernoullistrasse 28, 4056, Basel, Switzerland.
Institute for Biomedical Ethics, University of Basel, Basel, Switzerland.
Global Health. 2018 Jan 8;14(1):1. doi: 10.1186/s12992-017-0319-4.
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.
本评论旨在按照联合国可持续发展目标的政策目标，探讨国际卫生研究指南的各项规定在多大程度上促进全球卫生研究中的能力建设和公平伙伴关系。我们的评估发现，在资源有限的情况下，合作研究伙伴关系的治理，特别是能力建设，受到限制，但随着《国际医学科学理事会（CIOMS）涉及人类健康相关研究的国际伦理准则》（2016 年）实施指导意见的实施，情况有所改善。然而，在国家立法、行业和伦理准则以及监管规定方面，需要更加明确，以解决国际卫生研究伙伴关系中固有的结构不平等和权力失衡问题。值得注意的是，主要的行业伦理准则——人用药物注册国际协调会议（ICH）良好临床规范（ICH-GCP）并没有为伦理伙伴关系治理提供支持。鉴于 ICH-GCP 准则在界定全球卫生研究伙伴的作用和责任方面具有战略价值，我们的结论是，这种治理应该规定创造包容、相互学习、透明和问责的公平环境的最低要求。在程序上，可以通过以下方式提供支持：i）与当地领导层共同制定研究议程，ii）能力评估，以及 iii）构建谅解备忘录（MoU）。此外，需要协调合作伙伴之间的能力建设要求，以支持良好的合作实践，并实现研究企业的公共卫生目标；改善当地的健康状况，减少全球卫生不平等。在这方面，为了在研究治理的来源之间建立一致性，ICH-GCP 应参考 CIOMS 伦理准则，将其作为合作伙伴关系的既定标准。此外，应更加承诺和支持协调、加强和执行要求公平伙伴关系和加强卫生系统的地方法律。
