Multi country training to strengthen leadership among administrative staff of research ethics committees and national regulatory bodies in the East African Community

Clinical research in the East African Community (EAC) has expanded significantly in response to epidemics, increasing the complexity and workload. Research ethics committee (REC) and National research regulatory (NRA) members involved in leadership and administrative work play a vital role in managing daily operations, yet often lack adequate training and support in this area. Earlier capacity building efforts have largely overlooked these unique responsibilities. The training program aimed to strengthen the participant’s personal effectiveness and leadership skills (PELS). This study evaluated the early effectiveness of PELS by assessing changes in participants’ knowledge scores and exploring participants’ perceptions of applying the acquired skills in their work. A four-month blended training program was implemented from March 2024 to March 2025 in six EAC partner states, namely, the Republics of Burundi, Kenya, Rwanda, South Sudan, Tanzania, and Uganda. We engaged stakeholders to inform curriculum development. Forty stakeholders from the six EAC partner states informed curriculum revision, and an eight-member Training Advisory Committee (TAC) reviewed and approved the revised curriculum. Participants were evaluated using pre- and post -training assessments. Data from the training assessments were downloaded as a Comma Separated Value (CSV) file, cleaned in Microsoft Excel, and exported to STATA 15 for analysis. We performed descriptive analyses and presented findings using percentages and frequencies. Paired t-tests were conducted to assess the significance of pre-test and post-test differences in knowledge scores, with p < 0.05 considered statistically significant. Participant feedback was collected during and after the training and analysed qualitatively using conventional content analysis identify recurring themes. One hundred twenty-nine (129) participants from six partner states participated in the training. Of these, 50.4% were females. Uganda had the highest participation (31.8%), while Tanzania had the lowest (10.1%). The overall mean score for foundational knowledge rose from 63.7% at pre-test to 84.4% at post-test, representing a 20.7% point improvement. In addition, participant qualitative feedback revealed three key themes: ethical leadership and conflict management, teamwork and client service, and self-management and initiative. The multi-country PELS training programme was associated with substantial improvement in participants’ foundational knowledge scores, with participant feedback also indicating perceived application of leadership, communication, conflict management, customer service, and self-management skills in the workplace. These findings suggest that a stakeholder-informed blended training approach can provide useful early capacity strengthening for personnel supporting research ethics and regulatory administration in the EAC. Continued institutional support, refresher training, and longer-term evaluation will be important to determine whether these early gains are sustained and translate into improvements in routine research administration.

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Publication Details

Journal
BMC Medical Education
Published
2026-09-28
DOI
https://doi.org/10.1186/s12909-026-10441-1
Primary Topic
Ethics in Clinical Research
Type
article
Field-Weighted Citation Impact
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article

Multi country training to strengthen leadership among administrative staff of research ethics committees and national regulatory bodies in the East African Community

Mathius Amperiize, Jeremiah Kidola, Steve Wandiga, Helen Byomire Ndagije et al.
BMC Medical Education
Ethics in Clinical Research
article

Multi country training to strengthen leadership among administrative staff of research ethics committees and national regulatory bodies in the East African Community

Mathius Amperiize, Jeremiah Kidola, Steve Wandiga, Helen Byomire Ndagije, Novat Twungubumwe, Vincent Mutabazi, Pauline Byakika‐Kibwika, Stephen Okoboi, Lina S. Mathew, Provia Ainembabazi, Joseph Walter Arinaitwe, Belinda Twesigye, Soazic Gardais, Hellen Opolot, Beth Mutumba, Lydia Mpanga Sebuyira, Barbara Castelnuovo, Ramadhan Nyandwi
article en

Abstract

Clinical research in the East African Community (EAC) has expanded significantly in response to epidemics, increasing the complexity and workload. Research ethics committee (REC) and National research regulatory (NRA) members involved in leadership and administrative work play a vital role in managing daily operations, yet often lack adequate training and support in this area. Earlier capacity building efforts have largely overlooked these unique responsibilities. The training program aimed to strengthen the participant’s personal effectiveness and leadership skills (PELS). This study evaluated the early effectiveness of PELS by assessing changes in participants’ knowledge scores and exploring participants’ perceptions of applying the acquired skills in their work. A four-month blended training program was implemented from March 2024 to March 2025 in six EAC partner states, namely, the Republics of Burundi, Kenya, Rwanda, South Sudan, Tanzania, and Uganda. We engaged stakeholders to inform curriculum development. Forty stakeholders from the six EAC partner states informed curriculum revision, and an eight-member Training Advisory Committee (TAC) reviewed and approved the revised curriculum. Participants were evaluated using pre- and post -training assessments. Data from the training assessments were downloaded as a Comma Separated Value (CSV) file, cleaned in Microsoft Excel, and exported to STATA 15 for analysis. We performed descriptive analyses and presented findings using percentages and frequencies. Paired t-tests were conducted to assess the significance of pre-test and post-test differences in knowledge scores, with p < 0.05 considered statistically significant. Participant feedback was collected during and after the training and analysed qualitatively using conventional content analysis identify recurring themes. One hundred twenty-nine (129) participants from six partner states participated in the training. Of these, 50.4% were females. Uganda had the highest participation (31.8%), while Tanzania had the lowest (10.1%). The overall mean score for foundational knowledge rose from 63.7% at pre-test to 84.4% at post-test, representing a 20.7% point improvement. In addition, participant qualitative feedback revealed three key themes: ethical leadership and conflict management, teamwork and client service, and self-management and initiative. The multi-country PELS training programme was associated with substantial improvement in participants’ foundational knowledge scores, with participant feedback also indicating perceived application of leadership, communication, conflict management, customer service, and self-management skills in the workplace. These findings suggest that a stakeholder-informed blended training approach can provide useful early capacity strengthening for personnel supporting research ethics and regulatory administration in the EAC. Continued institutional support, refresher training, and longer-term evaluation will be important to determine whether these early gains are sustained and translate into improvements in routine research administration.

BMC Medical Education
Mbarara University of Science and Technology (UG), University of Washington (US), Université du Burundi (BI), University of Bahr El-Ghazal (SS), MTN (Uganda) (UG), Kenya Medical Research Institute (KE), Infectious Diseases Institute (UG), Uganda National Council for Science and Technology (UG), National Institute for Medical Research (TZ), Ministry of Health (RW), Epicentre, East African Health Research Commission (BI), National Drug Authority (UG)
European and Developing Countries Clinical Trials Partnership
Partnerships for the goals
Openalex Percentile: Top 9%
Ethics in Clinical Research
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