Multi-site comparison of factors influencing progress of African insecticide testing facilities towards an international Quality Management System certification.

BACKGROUND: Insecticidal mosquito vector control products are vital components of malaria control programmes. Test facilities are key in assessing the effectiveness of vector control products against local mosquito populations, in environments where they will be used. Data from these test facilities must be of a high quality to be accepted by regulatory authorities, including the WHO Prequalification Team for vector control products. In 2013-4, seven insecticide testing facilities across sub-Saharan Africa, with technical and financial support from Innovative Vector Control Consortium (IVCC), began development and implementation of quality management system compliant with the principles of Good Laboratory Practice (GLP) to improve data quality and reliability. METHODS AND PRINCIPLE FINDINGS: We conducted semi-structured interviews, emails, and video-call interviews with individuals at five test facilities engaged in the IVCC-supported programme and working towards or having achieved GLP. We used framework analysis to identify and describe factors affeting progress towards GLP. We found that eight factors were instrumental in progress, and that test facilities had varying levels of control over these factors. They had high control over the training programme, project planning, and senior leadership support; medium control over infrastructure development, staff structure, and procurement; and low control over funding the availability and accessibility of relevant expertise. Collaboration with IVCC and other partners was key to overcoming the challenges associated with low and medium control factors. CONCLUSION: For partnership and consortia models of research capacity strengthening, test facilities can use their own internal resources to address identified high-control factors. Project plans should allow additional time for interaction with external agencies to address medium-control factors, and partners with access to expertise and funding should concentrate their efforts on supporting institutions to address low-control factors. In practice, this includes planning for financial sustainability at the outset, and acting to strengthen national and regional training capacity.

Guidance and conceptual tools to inform the design, selection and evaluation of research capacity strengthening interventions.

This practice note presents four conceptual tools intended to support the design, selection and evaluation of research capacity strengthening (RCS) programmes in low-income and middle-income country settings. The tools may be used by a wide range of RCS stakeholders, including funders, implementing parties and programme evaluators, to guide decision-making in lieu of largely as yet unavailable empirical evidence. The first conceptual tool guides decision-making regarding RCS intervention design, focusing specifically on the combination and integration of potential intervention activities. The second conceptual tool provides a framework for assessing the implementation challenges of potential RCS interventions in terms of: (1) the overall cost of implementing the proposed intervention in a given context; (2) the length of time required to complete full implementation of the proposed intervention in a given context and (3) the level of control the implementing partners would have over the proposed intervention in a given context. The third conceptual tool provides a means to consider the anticipated impact of potential RCS interventions in order to inform selection decisions (ie, which out of a number of potential RCS intervention options may be most impactful in a given setting given the intervention design and implementation challenges). The fourth and final tool is designed to support the evaluation of a collective RCS effort, whether that be multiple RCS interventions delivered within the context of a single or continuous programme or multiple RCS programmes delivered in a common setting.

Developing laboratory capacity for Good Laboratory Practice certification: lessons from a Tanzanian insecticide testing facility.

Background: With increasing insecticide resistance in malaria-endemic countries there is an urgent need for safe and effective novel vector control products. To improve the capacity of facilities that test insecticides in sub-Saharan Africa, a programme is supporting seven facilities towards Good Laboratory Practice (GLP) certification, the globally recognized standard for quality management system (QMS) for the conduct of non-clinical and environmental studies. The World Health Organization (WHO) GLP Handbook provides guidance on a stepwise approach to implement a GLP compliant QMS. This study assesses auditor GLP checklists and timings outlined in the WHO GLP Handbook in the real-life context of a Tanzanian insecticide-testing facility, evaluating their implementation in this context. Methods and Principle Findings: We conducted document review and semi-structured interviews with staff at all levels of the test facility to explore factors that influenced progress towards GLP certification. We found that while auditor GLP checklists underemphasised computer systems, they were otherwise broadly applicable. Factors that delayed time to completion of GLP certification included the need for extensive infrastructure improvements, the availability of regional expertise related to GLP, the capacity of national and regional external systems and services to meet GLP compliance requirements, and training development required for Standard Operating Procedure implementation. Conclusion: The standards required for full GLP compliance are rigorous, with an expected completion timeline to implementation of 24 months. This study shows that in low and middle-income countries this timeline may be unrealistic due to challenges related to infrastructure development and lack of regional capacity and expertise. We recommend a comprehensive gap analysis when starting a project, including these areas which are beyond those recommended by the WHO GLP Handbook. These challenges can be successfully overcome and the experience in Tanzania provides key lessons for other facilities seeking GLP certification or the development of similar QMS.

Ripple effects of research capacity strengthening: a study of the effects of a project to support test facilities in three African countries towards Good Laboratory Practice certification.

Background: Strengthening capacity for public health research is essential to the generation of high-quality, reliable scientific data. This study focuses on a research capacity strengthening project supporting seven test facilities in Africa conducting studies on mosquito vector control products towards Good Laboratory Practice (GLP) certification. It captures the primary effects of the project on each facility's research capacity, the secondary effects at the individual and institutional level, and the ripple effects that extend beyond the research system. The relationships between effects at different levels are identified and compared to an existing framework for the evaluation of research capacity strengthening initiatives. Methods: To capture the views of individuals engaged in the project at all levels within each facility, a maximum-variation purposive sampling strategy was used. This allowed triangulation between different data sources. Semi-structured interviews were conducted with individuals in three facilities and a combination of email and remote video-call interviews were conducted with individuals at two further facilities. Results: We found that, despite a focus of the GLP certification project at the institutional level, the project had effects also at individual (including enhanced motivation, furtherment of careers) and national/international levels (including development of regional expertise). In addition, we detected ripple effects of the project which extended beyond the research system. Conclusion: This study shows that research capacity strengthening interventions that are focussed on institutional level goals require actions also at individual and national/international levels. The effects of engagement at all three levels can be amplified by collaborative actions at the national/international level. These findings show that research capacity strengthening projects must develop plans that address and evaluate impact at all three levels. Capturing the ripple effects of investment in research capacity strengthening should also be planned for from the beginning of projects to support further engagement of all stakeholders.

Strengthening research management and support services in sub-Saharan African universities and research institutions.

Background: International development partners and research councils are increasingly funding research management and support (RMS) capacity strengthening initiatives in sub-Saharan Africa (SSA) as part of a broader investment in strengthening national and regional research systems.  However, the evidence-base to inform RMS capacity strengthening initiatives is limited at present. This research note presents a synthesis of 28 RMS capacity assessments completed in 25 universities/research institutions from across 15 SSA countries between 2014 and 2018.  Methods: All 28 capacity assessments were completed following a standardised methodology consisting of semi-structured interviews conducted with research and research support staff at the respective institution as well as document reviews and observation of onsite facilities. Data were extracted from the 28 reports detailing the findings of each assessment according to a framework synthesis approach. Results: In total, 13 distinct capacity gap categories emerged from across the 28 RMS capacity assessment reports.  Almost all the institutions assessed faced significant gaps in RMS capacity within and across each of these 13 categories. The 13 categories were not independent of each other and were often closely inter-connected. Commonalities were also evident across multiple categories, the two most obvious of which were severe fiscal constraints and the often-complex bureaucracy of the institutional operating environment. Conclusions: The synthesis findings reveal multiple, commonly shared RMS capacity gaps in universities and research institutions across SSA. No single intervention type, or focus, would be sufficient to strengthen capacity across all 13 areas; rather, what is needed to facilitate a significant shift in RMS capacity within such SSA universities and research institutions is a combination of interventions, consisting of differing levels of cost and complexity, variously led (or supported) by both internal and external actors.