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

Ethical statement

Ethical approval to conduct this research study was obtained from the Liverpool School of Tropical Medicine Research Ethics Committee (approval number 18-041), the National Institute for Medical Research Tanzania (ref NIMR/HQ/R.8c/Vol./I/554), and the Centre Suisse de Recherches Scientifiques en Côte d'Ivoire Institute Review Board (ref 19-549). Institutions taking part remotely (i.e., interviews with members of research staff via Skype/email) provided an institutional approval document in lieu of in-country REC approval, as per point 3c of the LSTM’s Approval Processes for Network and Capacity Strengthening Studies.

Participants were informed about the research using participant information sheets²⁰. Written consent was obtained from each participant prior to undertaking an interview. For individuals in Francophone countries, all consent documentation (participant information sheets and consent forms) was provided in French. In Tanzania, consent documentation was provided optionally in both English and Swahili. All individuals were offered on-site translation into an alternative local language; however, this was not required for any interview participants.

Setting

This study encompasses five test facilities engaged in the testing of novel vector control products for the purpose of supporting malaria control programmes in Tanzania, Côte D’Ivoire and Burkina Faso. These test facilities are have all received investment and support from IVCC to achieve GLP certification, and are part of a wider programme of support for seven test facilities. Throughout the results and discussion below, findings relate to these five test facilities, although there are references to the benefits of being part of a group of seven institutions. The five test facilities (Table 1) included in this study encompass a diverse array of contexts. Kilimanjaro Christian Medical University College, Pan-African Malaria Vector Research Consortium (KCMUCo-PAMVERC), Tanzania, provides crucial information on how GLP certification can be achieved, being the first insecticide testing facility in Africa to do so. Comparison between East and West African contexts was facilitated through inclusion of Centre Suisse de Recherches Scientifques en Côte D’Ivoire (CSRS) and Institut de Recherche en Sciences de la Santé (IRSS), Burkina Faso. Comparison between government and non-government test facilities was facilitated through inclusion of National Institute for Medical Research (NIMR) Amani Centre, Tanzania and Ifakara Health Institute (IHI), Tanzania. These contrasting test facilities enhanced our ability to identify both direct and indirect effects of investments in developing a QMS. Generalisability of findings was assessed through using these facilities to compare effects of investment in QMS in a diverse range of contexts, including different national policy contexts and government/non-government supported test facilities.

Sampling

To capture the views of individuals who had exposure to the GLP certification process at all levels of these test facilities, a maximum-variation purposive sampling strategy was used²¹. This sampling method intentionally seeks to capture a wide range of views, to identify important shared patterns and points of contrast or conflict. For the purpose of this study, the key dimension of variation was role within the test facility, in recognition that this will have determined both which aspects of the GLP certification process individuals were involved with, and the tasks and duties required of them. Sampling included those who hold key roles within a test facility, as determined by a case-study conducted on the first test facility to achieve GLP certification, KCMUCo-PAMVERC²², as well as multiple representatives at each organisational level of the facility. This allowed triangulation between different data sources to determine the trustworthiness of findings. Test facility organograms were used to identify relevant participants, with guidance from stakeholders at IVCC and GLP project managers.

Data collection and analysis

Semi-structured interviews were conducted with individual staff members involved in the GLP process in three test facilities: KCMUCo-PAMVERC, NIMR Amani Centre, and CSRS. The interview topic guide²⁰ was developed based on previous studies of laboratory capacity strengthening⁸, with additional questions derived from findings from a case study of the GLP certification process at PAMVERC-KCMUCo²². One overarching question was specifically related to perceived effects of the project. However, due to the semi-structured nature of the interview, interview participants reflected on the effect of the project throughout the interview. Specific questions asked from the topic guide were matched to the roles and responsibilities of the interviewee. Interviews were audio-recorded and transcribed in full. All interviews were conducted in person, in a private room or office, by two researchers, one of whom had a technical understanding of GLP requirements in insecticide testing facilities and the other having systems evaluation experience. Whilst the lead researcher spoke basic French and Swahili, for interview participants who preferred to undertake the interview in a language other than English, a trusted colleague or research student sat in on the interview to aid with translation.

A combination of email and remote video-call interviews were conducted with individual staff members involved in the GLP process at two other test facilities, IRSS and IHI. This was necessitated by restrictions on travel and reduced working hours following the COVID-19 pandemic, which resulted in significant disruption from March 2019. The overarching questions asked in these interviews were retained from the semi-structured interview guide used for in-person interviews. Follow-up questions, where relevant, were conducted via video-call or email.

A framework analysis²³ was used to identify themes emerging from the interview transcripts following the five-step process of familiarization, identification of thematic framework, indexing, charting and mapping/interpretation. The framework identified was the Research Capacity Strengthening evaluation framework developed by Khisa et al., from African Population and Health Research Center, Nairobi, Kenya and Centre for Capacity Research, Liverpool School of Tropical Medicine, UK²⁴. This framework delineates the identified and envisioned effect of research capacity strengthening initiatives at the individual, institutional, and national/international level, developed from a review of the research capacity strengthening literature and refined in consultation with research capacity strengthening funders, implementers, managers and evaluators (Table 2).

This framework’s conceptualisation of research capacity strengthening initiatives happening at three levels, individual, institutional, and national/international, is rooted in the understanding that while these three levels have different foci, they are interconnected, with interventions at one level both influencing and being influenced by factors at other levels²⁵. Broadly speaking, at the individual level the focus is typically on the development of researchers and teams, at the institutional level the focus is on development of systems and processes within university departments or other organizations/institutions, and at the national/international level the focus is on influencing structural factors including policy, regulation and research networks^25,26.

Following familiarisation with the interview data, further themes were identified and incorporated into the framework, while retaining the individual, institution, and societal level structure. All interview transcripts were indexed using NVivo software version 11 (QSR International).

Individual level effects

Whilst the project was focused on the institution level, important effects were identified at the individual level. These included extensive training, strengthening of career prospects, furtherment of careers, structured working practices and enhanced work motivation.

There was a substantial increase in both breadth and depth in all training programmes. Training examples cited included 24 topics or areas, encompassing training related to QMSs, science specific training, training relating to safety, and business, leadership and life skills training. Training reached staff at all levels of the facility, including non-technical staff such as administrators, drivers, office attendants and gardeners, and was often specifically tailored to the needs of the test facility staff (Quotes: IND1). This training, combined with the practical experience of working in a GLP-compliant laboratory, was highly valued as enhancing career prospects. In all test facilities, staff took on additional responsibilities through, for example, leading on fire safety or chairing training committees.

Individuals felt an enhanced sense of professionalism and prestige associated with developing and working in a GLP-compliant test facility. This was reflected in seeing changes in vector control policies and practices informed by the work they had been involved with. This enhanced motivation amongst test facility staff at all levels, and technicians and non-scientific staff in particular felt that their work was more structured, meaningful and purposeful (Quotes: IND4). This motivation was enhanced further by an improved working environment following infrastructure improvements, including more working space, air conditioning, and better-quality workstations (Quotes: IND2).

Together, these effects positively impacted on career progression for individuals. Examples of career progressions and internal promotions within test facilities were cited across several locations, including promotion of laboratory technicians to laboratory supervisors, and laboratory supervisors to senior management positions. (Quotes: IND3)

Institutional level effects

At the institutional level, the GLP quality management system, infrastructural improvements of laboratories and offices, development of clearer and more effective organisational structures, more staff employed, and the transfer of GLP-standard practices to other studies were all identified as research capacity strengthening effects.

The development of a GLP-compliant quality management system and, at some test facilities, the achievement of GLP certification, is a clear outcome of the work undertaken through the IVCC project. Of the five test facilities included in this study, one has achieved GLP certification to date, and three have submitted their application for GLP certification to SANAS. As a result of support towards GLP compliance and certification, these test facilities were able to deliver national/internationally competitive research, with data meeting international standards. This effect extended also to non-GLP studies conducted at these test facilities, as best practice from GLP studies was applied to non-GLP studies by both scientists involved in the GLP project and other scientists within the institution, particularly with respect to study documentation and use of Standard Operating Procedures (SOPs). Thus, the overall quality of data generated at these test facilities was enhanced. (Quotes: INS3) Test facilities also identified broader effects on working practices, resulting from the implementation of GLP standards. In particular, increased structure in working practices resulting in benefits including cost savings on reagents, more effective problem solving, and better organisation of work throughout the test facility. (Quotes: INS5)

Career pathways were enhanced by strengthening the processes, policies, and documentation that surrounded organisational structure and human resources. Clearer organisational structures facilitated communication between individuals in different departments and at different levels within the test facility. This was supported through SOPs for regular, documented human resource support including appraisals and Curriculum Vitae review. Together, these had an additional effect on individuals’ sense of place and therefore, sense of value within the test facility. In some test facilities, new structures were put in place for requesting training for career development, and staff were adequately empowered to take up these opportunities. Across test facilities, but particularly in those that had achieved GLP certification, there were more job opportunities at the institution, with studies and investment attracted to the test facility. (Quotes: INS1)

In-house training programmes were developed and delivered across test facilities including general training in GLP awareness, Quality Assurance, training in SOPs, Health and Safety/Fire training, archiving training, leadership training, and computer system validation and usage. Training programmes were often developed by test facility staff following attendance at externally delivered training courses. Implementation of training was overseen by staff in a range of roles, as staff at all levels took on additional responsibilities. Test facility management noted that MSc and PhD students from institutions attached to their test facility had had the opportunity to train in a GLP environment, and this was a point of prestige for the institution. (Quotes: INS2)

Infrastructural improvements enhanced the research environment including laboratory, office and shared spaces. Areas that were built from scratch or were refurbished included: insecticide testing laboratories, molecular laboratories, insecticide spray rooms, bed net washing areas, insectaries and animal houses. Enhancements included installation of new equipment, improved separation between resistant and non-resistant mosquito strains in insectaries, construction of new facilities to allow new test types, increased space within existing laboratories, and enhancements to working conditions (e.g. new benching, stools, and wipe-clean tiled surfaces). Installation of new equipment, such as PCR machines, facilitated establishment of new assays and meant that testing of samples could be conducted in-house, reducing the time to obtaining results. Non-laboratory facilities built or refurbished included office spaces, communal break and training areas, facility archives and computer server rooms. For both laboratory and non-laboratory facilities, this enhanced the working environment, linked to individuals’ motivation, job satisfaction and pride in their jobs. (Quotes: INS4a)

The research environment was also strengthened through improvements in the procurement processes in some test facilities, and to IT infrastructure across all test facilities. Streamlined procurement processes included the implementation of quality management system practices initiated by the GLP project, in particular in the widespread use of SOPs. This simplified processes and made transfer of work responsibilities more seamless. IT infrastructure improvements were relevant across GLP and non-GLP studies, improving processes for accessing and storing study data, managing results in preparation for scientific reports and publications, and improving communication between staff within the test facility through more widespread use of email and installation of internal telephone systems. (Quotes: INS4b)

National/international level effects

At the national and international level, identified effects included sharing of best practices within consortia and linked institutions, and the development of regional expertise related to data management and quality assurance.

Test facilities saw increased support from national level institutions, including increased investment in infrastructure. This was often coupled with the expectation that they would now act as national centres of excellence, both as a model of best practice and as a provider of training in entomology and relevant SOPs. Increased engagement with research outputs at the national decision-making level was anticipated as the next stage of this enhanced relationship with national level institutions, alongside a belief that this would raise policymakers’ expectations of the test facilities’ performance. (Quotes: NAT1 and NAT2)

At a national and international level, the opportunity to meet and share experiences with collaborating test facilities allowed best practice to be shared throughout the network, although this was not always fully realised as test facilities sought to strike a balance between collaboration and retaining a competitive advantage as a provider of product testing services. For construction and renovation of infrastructure, best practice was shared between test facilities that were geographically close together, because the requirements for buildings were the same and because travelling to these test facilities to see the buildings in person was easier. Data management and quality assurance expertise that was developed by individuals in test facilities further along the path to GLP certification was also disseminated through the network. This was done formally through the project network, via training workshops and shared resources such as SOPs, and informally as these individuals acted in consultancy roles both within and outside of the institutions collaborating in the programme. Involvement in this network also raised the profile of individual test facilities, allowing these facilities to attract new studies and collaborators – including both GLP and non-GLP studies. (Quotes: NAT3)

Non-research capacity strengthening “ripple” effects

Ripple effects of the project beyond research capacity strengthening were widely reported for both individuals and the community surrounding the institutions. At the individual level, these were particularly focused on the transfer of skills developed through training and new practices associated with GLP to home lives. This was particularly true in test facilities that had broad and inclusive training programmes. Here, individuals noted how they had applied time management, organisation, and budgeting skills developed through the GLP project to managing their personal lives and households (Quotes: IND4).

Effects on communities surrounding the institution were rooted in often locally sourced solutions to challenges and, in particular, procurement and infrastructure development. By being locally based and finding local solutions, communities around the test facility saw investment in local businesses for consumables, construction materials and construction teams. Also reported was an increase in local employment as new studies were attracted, creating roles such as mosquito collection for experimental hut studies, and improvements in shared infrastructure such as roads. Test facility staff who recognised these effects in the community both took pride in these effects and valued them highly. (Quotes: NAT4).

Strengths and limitations

The strengths of this study are in the diversity of participants involved, capturing the views of staff filling a wide range of roles in five test facilities across three African countries. This approach ensured that effects meaningful to staff in diverse roles were reflected in the findings and offered a voice to staff less often heard within research teams, such as those of technicians and administrators. Furthermore, by using a qualitative approach, this study was able to richly describe the perceived effects of the GLP project and reveal and explain interactions between these effects.

This study is, however, limited by several factors. As no quantitative data is included in this study, numerical measures of change resulting from the GLP project are not possible. Instead, the study relies on the subjective experiences and opinions of individuals involved in the GLP project. With a grounding in a specific laboratory capacity strengthening project, caution should be exercised on generalising these findings to all research capacity strengthening projects. Test facilities were at different stages towards GLP certification and this study is unlikely, therefore, to have captured all of the effects of the GLP project. Further effects will likely be identified by staff as the test facilities progress through certification and begin to attract GLP studies. In addition, given the relatively small amount of time specifically dedicated to this question within interviews, it is likely that additional effects may have been identified given more interview time. Finally, changes had to be made to data collection methods due to the COVID-19 pandemic: the responses at the two test facilities that participated via email and video-call are likely to be more superficial due to reduced opportunities to ask follow-up questions on observations.

Underlying data

Transcriptions of interviews with facility staff are available from the research group on request (please email ccr@lstmed.ac.uk to request access), on a case by case basis for the purpose of informing further research and on the condition that it will not be published in part or in entirety. They have not been made available as a dataset because they cannot be de-identified without compromising anonymity and the ethical approval conditions for the project stated that only the research team would have access to the data.

Extended data

"Illustrative Quotes, Interview Guide and Information Sheets for: Developing laboratory capacity for Good Laboratory Practice certification: lessons from a Tanzanian insecticide testing facility", https://doi.org/10.7910/DVN/NADZPS, Harvard Dataverse, V2²⁰.

This project contains the following extended data:

Data are available under the terms of the Creative Commons Zero "No rights reserved" data waiver (CC0 1.0 Public domain dedication).