Abstract
Background
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.
Objective
To assess whether the necessary structures are in place to ensure health research governance.
Methods
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.
Results
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 Some legislation was either grossly outdated or too limiting in scope, while some countries had multiple laws.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.
Conclusion
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.
The Regulatory Role of Patents in Innovative Health Research and Its Translation from the Laboratory to the Clinic
