Nabyonga-Orem Juliet, Asamani James Avoka, Makanga Micheal
Inter-Country Support Team for Eastern and Southern Africa, UHC Life Course Cluster, World Health Organization, 82-86 Enterprise/Glenara Roads, Highlands, P.O Box CY 348; Causeway, Harare, Zimbabwe.
The European & Developing Countries Clinical Trials Partnership (EDCTP), Anna van Saksenlaan 51, 2593 HW, The Hague, The Netherlands.
Health Res Policy Syst. 2021 Jan 22;19(1):11. doi: 10.1186/s12961-020-00676-9.
The developments in global health, digital technology, and persistent health systems challenges, coupled with global commitments like attainment of universal health coverage, have elevated the role of health research in low- and middle-income countries. However, there is a need to strengthen health research governance and create a conducive environment that can promote ethics and research integrity and increase public trust in research.
To assess whether the necessary structures are in place to ensure health research governance.
Employing a cross-sectional survey, we collected data on research governance components from 35 Member States of the World Health Organization (WHO) African Region. Data were analysed using basic descriptive and comparative analysis.
Eighteen out of 35 countries had legislation to regulate the conduct of health research, while this was lacking in 12 countries. Some legislation was either grossly outdated or too limiting in scope, while some countries had multiple laws. Health research policies and strategies were in place in 16 and 15 countries, respectively, while research priority lists were available in 25 countries. Overlapping mandates of institutions responsible for health research partly explained the lack of strategic documents in some countries. The majority of countries had ethical committees performing a dual role of ethical and scientific review. Research partnership frameworks were available to varying degrees to govern both in-country and north-south research collaboration. Twenty-five countries had a focal point and unit within the ministries of health (MoH) to coordinate research.
Governance structures must be adaptive to embrace new developments in science. Further, strong coordination is key to ensuring comprehensiveness and complementarity in both research development and generation of evidence. The majority of committees perform a dual role of ethics and scientific review, and these need to ensure representation of relevant expertise. Opportunities that accrue from collaborative research need to be seized through strong MoH leadership and clear partnership frameworks that guide negotiations.
全球卫生、数字技术的发展以及持续存在的卫生系统挑战，再加上诸如实现全民健康覆盖等全球承诺，提升了低收入和中等收入国家卫生研究的作用。然而，有必要加强卫生研究治理，营造一个能够促进伦理和研究诚信并增强公众对研究信任的有利环境。
评估是否具备确保卫生研究治理的必要结构。
我们采用横断面调查，从世界卫生组织（世卫组织）非洲区域的35个成员国收集了有关研究治理组成部分的数据。使用基本描述性和比较分析方法对数据进行了分析。
35个国家中有18个国家有规范卫生研究行为的立法，而12个国家则没有。一些立法要么严重过时，要么范围过于有限，而一些国家有多项法律。分别有16个和15个国家制定了卫生研究政策和战略，25个国家有研究优先事项清单。负责卫生研究的机构职责重叠在一定程度上解释了一些国家缺乏战略文件的原因。大多数国家设有伦理委员会，履行伦理和科学审查的双重职责。研究伙伴关系框架在不同程度上可用于管理国内和南北研究合作。25个国家在卫生部设有协调研究的联络点和单位。
治理结构必须具有适应性，以接纳科学领域的新发展。此外，强有力的协调是确保研究发展和证据生成的全面性和互补性的关键。大多数委员会履行伦理和科学审查的双重职责，这些委员会需要确保相关专业知识的代表性。需要通过卫生部的有力领导和指导谈判的明确伙伴关系框架来抓住合作研究带来的机遇。
