Introduction
Public Health Emergencies (PHEs) are events that pose significant threats to population health at local, national, or global levels.1,2 Their frequency and impact have increased in recent decades, including events such as H1N1 influenza (2009), Ebola (2013–2015; 2018–2020), poliomyelitis (2014 to present), Zika (2016), and COVID-19 (2020–present).3–5 These emergencies affect millions annually, causing illness, deaths, and disruption of essential services such as healthcare, water, and sanitation.4,5 As a result, countries have prioritized strengthening regulatory preparedness to support effective responses.
Research regulatory systems are essential during PHEs to ensure that studies meet ethical, legal, and safety standards.4 However, these systems often face challenges in emergency contexts, including gaps in policies, institutional processes, and operational tools. In developing countries, these challenges are compounded by limited preparedness, such as weak adoption of reliance mechanisms, fast-tracking procedures, and flexible pharmacovigilance systems.6 In Africa, over 1,910 outbreaks were reported between 1970 and 2019, highlighting persistent vulnerability to emerging and re-emerging diseases.7,8 Uganda remains particularly at risk due to its proximity to epidemic hotspots, multiple transmission belts, high population growth, and refugee influx.9
The COVID-19 pandemic intensified pressure on research regulatory systems, requiring rapid coordination of expedited reviews for studies on prevention, diagnosis, and treatment across Africa.10 In Uganda, the Uganda National Council for Science and Technology (UNCST) and Research Ethics Committees (RECs) introduced adaptive measures, including expedited reviews, virtual meetings, digital submissions, and the National Guidelines for Conduct of Research during Coronavirus Disease, 2020.
Despite these responses, there is limited empirical evidence on how COVID-19 affected Uganda’s research regulatory system. Key gaps include its effects on REC operations, researcher–regulator interactions, digital transitions, and changes in oversight, workload, communication, and funding. This study addresses these gaps by examining stakeholders’ perceptions of facilitators, barriers, and regulatory adaptations during the pandemic, providing insights to inform more resilient research governance in future PHEs.
Methods
A qualitative descriptive design11,12 was adopted, utilizing in-depth interviews, focus group discussions (FGDs), and key informant interviews. This approach is appropriate for systematically describing stakeholders’ perceptions of facilitators, barriers, and regulatory adaptations, as well as their experiences of ethical research conduct and oversight during the COVID-19 pandemic, without seeking to explain causal mechanisms. The study relied on retrospective participant accounts, capturing perceptions of events prior to data collection. It was conducted across seven districts in Uganda: Gulu, Mbale, Mbarara, Bushenyi, Wakiso, Mukono, and Kampala with participants drawn from all UNCST-accredited Research Ethics Committees (RECs) in March 2023.
At the time of the study, UNCST had 35 accredited RECs, of which 29 were operational between March 2020 and March 2023; for each REC, one Chairperson and one administrator participated. Participants were drawn from UNCST-accredited RECs, ensuring representation from both national and institutional committees. The study included four stakeholder groups within the research regulatory ecosystem: Research Ethics Committee Chairpersons, Research Ethics Committee administrators, researchers involved in COVID-19, and representatives of national regulatory authorities. These groups were selected because they are directly involved in implementing and overseeing research regulatory systems at both institutional and national levels, providing insights into the facilitators and barriers to conducting research in Uganda during public health emergencies such as COVID-19. In total, 56 participants were included: 16 REC Chairpersons, 11 researchers, 24 REC administrators, and 5 NRA representatives (one from UNHRO, two from NDA, and two from UNCST).
Participants in the focus group discussions (FGDs) were REC administrators, with each REC represented by one administrator. A total of four FGDs were conducted, each comprising six participants (total n = 24). The FGDs were stratified by host institution and type of research reviewed into four categories: (i) hospital-based RECs, (ii) education institution-based RECs, (iii) RECs primarily reviewing social sciences and humanities protocols, and (iv) RECs primarily reviewing medical and health sciences protocols.
In addition, 16 REC Chairpersons and 11 researchers participated in in-depth interviews, and 5 key informant interviews were conducted. These sample sizes fall within recommended qualitative ranges (3–6 FGDs, 5–15 key informants, and 10–30 in-depth interviews),13 and thematic repetition across stakeholder groups indicated adequate information power and saturation.
Inclusion criteria:
Participants who provided informed consent, REC administrators and Chairpersons who were actively serving in their positions at the time of the study, and researchers who were leading clinical trials between March 2020 and March 2023 during the COVID-19 and Ebola public health emergencies were included in the study.
Exclusion criteria:
Individuals who did not provide informed consent; REC administrators and Chairpersons who were not actively serving in their roles during the study period; researchers who were not involved in leading clinical trials during the specified period; and members of newly accredited RECs without experience of research conduct and oversight during the COVID-19 pandemic.
Purposive, criterion-based sampling was used to recruit participants based on their roles and experience within the research regulatory system. Participants’ information was accessed from the database of Uganda National Council for Science and Technology, which was thereafter used to reach out to the participants through either phone calls or emailing. The enrolled participants were engaged in respect of their convenient time schedules.
Data collection methods were tailored to participant groups: Research Ethics Committee administrators participated in focus group discussions, Research Ethics Committee Chairpersons and researchers in in-depth interviews, and representatives of national regulatory authorities in key informant interviews. Data were collected using structured, method-specific guides covering experiences of research conduct and regulation during public health emergencies, implementation of the National Research Information Management System, perceived facilitators and barriers, and adaptations in oversight processes. Key informant interviews involved representatives from the Uganda National Council for Science and Technology, the National Drug Authority (NDA), and the Uganda National Health Research Organization (UNHRO).
Major themes across data collection methods included, focus group discussions with REC administrators: operational changes, barriers, digital transformation and NRIMS experiences, coping strategies, opportunities, and recommendations. In-depth interviews with REC Chairpersons and researchers highlighted operations, challenges, regulatory support, online application improvements, guideline effectiveness, and preparedness recommendations. Key informant interviews with national regulatory authorities emphasized regulatory adaptations, challenges, digital systems, opportunities, and strengthening research governance. Collectively, these themes capture facilitators, barriers, and adaptations in Uganda’s research regulatory system during COVID-19.
Interviews and focus group discussions were conducted by the principal researcher and trained research assistants in private, quiet locations convenient for participants. Focus group discussions were facilitated by at least two research assistants, behavioral and social scientists from Makerere University College of Health Sciences, trained in qualitative methods, human subject protection, and Good Clinical Practice. One assistant moderated the discussion while the other documented group dynamics, non-verbal cues, and interaction patterns. To minimize potential power imbalances, participants were reminded of confidentiality and the voluntary nature of participation.
All interviews and focus group discussions were conducted in English, lasting approximately 45–60 minutes. Interviews were conducted either in-person or virtually via videoconferencing with participants’ consent and audio-recorded. Recordings were transcribed verbatim and securely stored on password-protected computers accessible only to the research team.
Data was analyzed using the thematic analysis framework outlined by Braun and Clarke,14,15 which facilitated systematic coding, identification of themes, and interpretation of insights across the different participant groups, opinions, and experiences. Data analysis began with repeated reading of all transcripts to achieve familiarity with the data. Coding was conducted manually by examining the text word by word, with phrases or sentences highlighted and assigned shorthand labels (code). An inductive approach was used, allowing codes to emerge from the data rather than being predetermined. Similar codes were grouped into clusters, with some codes merged during the process, and these clusters were subsequently organized into themes. Two analysts independently coded the transcripts, and any discrepancies in code definitions were resolved through discussion and reference to the original data to ensure consistency. The resulting themes were then reviewed, refined, defined, and named to provide a clear interpretation of the data. Study findings are presented using these themes, supported by illustrative quotations from participants to reflect stakeholder perspectives.
Ethical considerations and consent
Ethical and scientific approval was obtained from the National HIV/AIDS Research Committee (NARC-2023-10), and final clearance was sought from the Uganda National Council for Science and Technology (UNCST) for registration and approval (SS2192ES). The administrative clearances were sought from UNCST, NDA, and UNHRO before the commencement of any study activity. The UNCST, NARC, and the research team ensured that the study was conducted ethically, and in compliance with the national and international guidelines for research involving Humans as Research Participants.16 Written informed consent was obtained from all study participants before they were enrolled in the study, and no minors were enrolled in the study. Only the approved study protocol, informed consent forms, and study tools were used when conducting the study.
Results
Theme 1: Institutional and procedural adaptations
Despite COVID-19 challenges, several institutional adaptations sustained research activities. Key measures included the development of tailored research guidelines, implementation of risk management plans, and prioritization of urgent projects.
Development of research guidelines
“So, in that period, guidelines were put in place on how to implement research during, during pandemic, such a in a period like COVID-19 when it happened. Okay. So those guidelines, before I go to the implementation” (FGD 1, REC Administrators). “We didn’t know how people are going to move between places, how people are going to interact and engage. So, the guidelines were important …” (IDI 01, REC Chairperson).
Implementation of risk management plans
“At least as a REC, we did that, we encouraged the researchers to do those. I think the other time around the same time, the thing that came out was the risk mitigation. COVID-mitigation basically should be for things beyond COVID. But specifically, we used to ask that researchers include, COVID-19, risk assessment, and mitigation plan” (IDI 04, REC Chairperson).
“I think there were elements of protection, uh, procedures for protecting the researcher, but also, the population” (IDI 02, Researcher).
“We had to put in place risk management plans to ensure that research activities did not expose people to unnecessary danger” (FGD 2, REC Administrators).
Prioritization of urgent research projects
“… the REC received, uh, a submission on a project regarding COVID-19, which required RECs to put in place quick means on how to make sure that that project is reviewed. Because it was something which required, maybe what, how can I say it? Uh, it required, uh, a quick response so that, because it was an issue of saving life, and by then the, the researchers who were linked to COVID-19 were more of saving life other than, uh, maybe other than treatment and whatever” (FGD 1, REC Administrators).
Theme 2: Digital transition and challenges
“And then, you know, also thinking about how we support researchers online, the business of going to their offices or the business of bringing hard copy, hard copies. Documents for signing and delivery and all that stopped ceased” (IDI 06, REC Chairperson).
Transitioning to online processes posed challenges: long-serving REC members struggled with digital literacy.
“One of the challenges was, um, members had to review via online, and that was so challenging because it was like the first-time people were used to the physical meetings, and it was somehow dragging the REC decisions” (FGD 1, REC Administrators).
Poor internet connectivity caused delays and rescheduled meetings
“One of the major challenges was, you know, the internet connectivity. Uh, for some of the things really understand the quality, the quality of the internet would be poor because some old, for instance, yeah. We live in areas where, because of the infrastructure, sometimes they have poor quality of the internet. And so the interruptions, sometimes, uh, was difficult. We couldn’t hear what somebody was saying and, and that, you know, sometimes the meetings would stretch longer than planned because, um, sometimes the internet would go off for some individuals while somebody speaking or something presenting. And so you, you had to organize another meeting to finish the ones, the protocols that were not discussed, discussed. That was one of the challenges” (IDI 03, REC Chairperson).
Theme 3: Impacts on continuity, oversight, and workload
“I think COVID-19 taught us that it’s, it’s possible to review a clinical trial in a short time. Yes. And I think that is a good thing because before then you would take your time to review a clinical trial. But COVID-19 orders that it was possible to review in a short time. In a short time” (KII 02, Regulator).
“Like it made us UNCST to shift now from the hard copy, uh, to the, to the online, but also in terms of uh, being, being alert. And I’m happy that that is coming up because it has made us to like to be alert that in case of the similar, similar issue or similar emergency, we need to be awake” (KII 03, Regulator).
Barriers included temporary halts of some studies due to travel restrictions or budgetary constraints.
“… so particularly, I’ll speak for my Research Ethics Committee. Yes. So, I already said the studies went down. Mm. And also, some of the studies closed, uh, because of the budgetary, you know, like already said, transport had to go up for participants. But then remember, this is a study that had been approved before the pandemic. So, they were running on that budget” (KII 01, Regulator).
“The other challenge was to do with, uh, resource constraints. You know, because of the overwhelming workload, very many people are bringing in protocols or proposals, covid related, and even the numbers were so high. So, in one way or the other, the overwhelming workload also is related with something to do with resource” (FGD 2, REC Administrators).
“So, you know, an environment where you are in a virtual meeting, you’re at home with families, how small children running around like that, that was also one of the challenges” (FGD 2, REC Administrators).
Movement restrictions limited oversight and compliance monitoring
“… we’re not sure whether our researchers would adhere to this risk mitigation strategies that they were submitting. You know, it’s another thing to submit, but we could not verify that what they have submitted is what we are doing. So, I think that it was a challenge to ensure that the PIs were adhering to the mitigation plan, although they had submitted. So, it was a difficult time” (IDI 03, REC Chairperson).
“There are some who are resistant to the idea of all the time meeting online. We are saying, yeah, but we need to be in the same room. We need to be together; can we postpone this until the lockdown is over?” (IDI 06, REC Chairperson).
Theme 4: Financial and communication barriers
“What I’m saying is, let me assume that my initial budget was X, but then in following the guidelines for such during COVID, the IPC measure and things like that, they would increase my budget” (IDI 05, Researcher).
“But you can imagine that, and this is not the fault of the direct or the National Council, but you can imagine that this increased study costs or studies which were already running, our budgets were already set, but it was necessary under those circumstances” (IDI 09, Researcher).
Communication gaps regarding new guidelines caused delays and confusion
“So most of the times they would submit protocols without the COVID-19 risk mitigation plan. And then you had to tell them to prepare it. And then they’re like, so, but what is this? Then, you have to refer them to UNCST websites, for this. So it affected, it delayed our review process at the REC level, largely because of limited awareness amongst the researchers” (IDI 02, Researcher).
Discussion
The discussion interprets the study findings in relation to existing literature, structured around the four themes identified in the Results. Emphasis is placed on participant perceptions, distinguishing new insights from known findings, and highlighting distinctive aspects of the Ugandan context.
Theme 1: Institutional and procedural adaptations
Participants stated that the formulation of national research guidelines helped streamline protocol reviews and guide ethical research conduct, in contrast supporting collaboration among regulatory bodies and expediting review processes. Notably, these adaptations were perceived as helpful rather than definitively ensuring outcomes. Comparable benefits of structured guidelines have been observed in sustaining HIV clinical trials elsewhere.17
Participants also observed that prioritization of urgent COVID-19 research projects facilitated timely data generation to inform public health responses.18 What is distinctive in Uganda is the coordinating role of the Uganda National Council for Science and Technology, the interaction among different types of Research Ethics Committees, and engagement with stakeholders involved in the implementation of clinical trials in Uganda.18 Notwithstanding these facilitators, challenges such as disruptions to ongoing studies and procedural modifications were reported, emphasizing the partial and context-dependent nature of adaptations.19
Theme 2: Digital transition and challenges
Shifting from physical submissions to online platforms enabled remote engagement between researchers and ethics committees, supporting continuity during travel restrictions.17,20 Conversely, participants highlighted challenges in digital adoption, including difficulties among long-serving REC members and unreliable internet connectivity causing delays.18 These challenges are coherent with reports from other African countries, including Ghana and Nigeria,21 though European countries with established digital infrastructure experienced fewer disruptions.22 Participants highlighted that digital transformation was only partially effective, varying by REC type and individual capacity. This aligns with global reports noting cybersecurity and accessibility concerns in Germany and the United States.23
Theme 3: Impacts on continuity, oversight, and workload
Participants explained temporary halts of research, delays in approvals, and increased workloads due to high volumes of protocol submissions. Movement restrictions and COVID-19 infections among reviewers further contributed to backlogs.24,25 Although similar challenges occurred internationally, rapid decision-making alongside maintaining ethical standards was also reported in Germany.26,27 Participants perceived these disruptions as highlighting the vulnerability of regulatory processes to external shocks and the importance of contingency planning, consistent with recommendations from global health organizations.23,28
Theme 4: Financial and communication barriers
Limited budgets and reduced funding were reported to significantly affect research conduct, including covering internet costs for online meetings.29 Unlike some European countries that increased support for research adaptation,30 Uganda faced continued financial constraints. Participants also emphasized limited awareness among researchers about guideline changes, contributing to delays and partial non-compliance with REC expectations.24,31 In contrast, structured government-led communication in countries such as China and South Korea facilitated to mitigate these challenges.29
Limitations
The interviews took a lot of time due to the sensitivity of dealing with respondents’ emotions about what happened during the COVID-19 pandemic and restrictions. The recall bias rose because of trying to remember the various experiences and operations of the RECs since March 2020. Conversely, these limitations were minimized by careful selection of the research questions, choosing an appropriate data collection method, and ensuring that the strategies to maintain rigor in the conduct and reporting of the study findings were followed. Trained research assistants who knew how to create a good rapport with participants before the interview and put emphasis on maintaining the privacy and confidentiality of the research participants were used.
Conclusion
The COVID-19 pandemic exposed both challenges and opportunities within Uganda’s research ecosystem, that hindered and accelerated the research conduct respectively. These adaptations demonstrated the potential for more efficient and resilient research processes. Hence, strengthening communication, digital capacity, and funding mechanisms are essential for sustaining research continuity during future public health emergencies.
