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Abstract

Digital platforms for ethics review (DPER) are transforming research ethics globally, yet their benefits, challenges, and readiness for digital autonomy still need to be explored. This study examined the perspectives of researchers, research ethics committee (REC) members, and secretariats in Kenya through six in-depth interviews and two focus group discussions (N = 18). Thematic analysis revealed that DPER was considered to enhance efficiency, communication, and cost-effectiveness. However, concerns were raised about data security, platform rigidity, and limited training. Addressing these challenges and involving stakeholders in system design is essential for achieving digital autonomy. The findings emphasise the need for strategies to enhance DPER adoption and functionality, ensuring effective and secure research ethics oversight in the evolving digital landscape.

Keywords

African context digital platforms for ethics review DPER digital autonomy ethics review Kenya perspectives research ethics committee RECs qualitative

Introduction

The ethics review process plays a pivotal role in safeguarding participants’ rights and ensuring the ethical conduct of research. Research ethics committees (RECs) have traditionally relied on paper-based and email systems to facilitate the review process. However, these methods have been increasingly associated with inefficiencies, including prolonged turnaround times, mismanagement of documents, and limited process tracking (Larson et al., 2004; Whitney et al., 2008). Such challenges hinder the timely completion of reviews, often demotivating researchers and delaying critical research initiatives (Mbabe et al., 2021; Mokgatla et al., 2017).

The digital transformation of ethics review processes through platforms known collectively as Digital Platforms for Ethics Review (DPER) presents a potential solution. DPER includes cloud-based systems, web applications, and other digital tools designed to streamline ethics review processes by allowing real-time tracking, automating workflows, and enhancing stakeholder communication. Internationally, the transition from paper-based to digital platforms for ethics review has been widely discussed, with a growing body of evidence supporting the benefits and complexities of DPER. These platforms are increasingly seen as essential tools to improve efficiency, standardisation, and transparency in research ethics governance.

Studies from high-income settings have demonstrated substantial benefits of digital platforms in managing ethics reviews. Smith and Gronseth (2011) found that implementing a digital IRB system at the Mayo Clinic reduced turnaround times by 35%. Similarly, Wang et al. (2021) documented improvements in quality control and efficiency using a human research protection system in China. Rahimzadeh (2018) explored the application of blockchain technology to promote secure, auditable, and decentralised ethics review processes, particularly for multi-institutional studies. The potential of distributed ledger technologies lies in enhancing transparency, security, and institutional autonomy. Despite these advantages, concerns remain. Global literature underscores challenges such as poor user-friendliness (Bowser & Tsai, 2015), usability issues, and a lack of context-specific design. A recurring theme in the literature is the significance of inclusive system design. Detlor and Wilson (2015) stress that platforms should be developed around user needs to promote adoption.

Africa's experience, particularly through platforms like RHInnO Ethics, provides a valuable case study. Mokgatla et al. (2017) and Kombe et al. (2019) discovered that implementing automated systems in Kenya, Uganda, and South Africa improved administrative processes, reduced review times, and improved stakeholder communication. Early adopters, such as Strathmore University in Kenya, utilising platforms like RHInnO Ethics, have reported shorter turnaround times and improved operational efficiency, with some studies estimating a decrease of up to 56% in processing times (Kombe et al., 2019; Mokgatla et al., 2017).

Despite these advancements, the uptake of DPER remains inconsistent across Africa, raising questions about whether RECs are ready to transition to digital autonomy fully. Digital autonomy in this context refers to the capacity of RECs to independently operate and control digital platforms for ethics review, encompassing tools such as web-based applications, cloud-based systems, and virtual meeting spaces like Zoom or Google Meet. These platforms facilitate critical aspects of the ethics review process, including submission, feedback, and decision-making, eliminating reliance on paper-based or email systems (Asmar et al., 2020). The ethics review process is a comprehensive workflow involving researchers, administrative staff, and RECs, focusing on iterative exchanges to refine and approve applications (Page & Nyeboer, 2017).

This study addresses this gap by exploring Kenya's readiness for ethical review processes for digital autonomy. Specifically, it examines critical stakeholders’ perspectives and experiences, including REC members, researchers, and secretariat staff, on the adoption, benefits, and concerns arising from DPER. Using a qualitative approach, the research aims to uncover factors that facilitate or hinder this transition and to propose recommendations for enhancing the efficiency and effectiveness of digital platforms in the ethics review process. By addressing these issues, the study contributes to ongoing efforts to modernise research ethics infrastructure, fostering a more efficient and inclusive review process for all stakeholders.

Methods

This study employed qualitative research, enabling an in-depth understanding of stakeholder interactions, attitudes, and practices. This provided rich, narrative-based insights crucial for addressing the study's objectives.

The primary researcher is a Kenyan academic, research ethics practitioner, and a member of the Research Ethics Committee (REC) secretariat. With direct experience in submitting and managing the review of research protocols using traditional methods and DPER, the researcher offers an insider's perspective on the ethics review process. This dual role informed the study's design, facilitated participant access and shaped the interpretation of findings. Throughout the research process, the researcher remained reflexive and attentive to potential biases, upholding objectivity, credibility, and ethical integrity.

Sampling and Recruitment

Participants were purposively selected to ensure the representation of diverse experiences with traditional and digital ethics review methods. Inclusion criteria for REC members required at least two years of experience, while researchers needed to submit at least one proposal for ethical review within the last three years. Participants were recruited through professional networks and approached via email and telephone to invite voluntary participation.

The final sample consisted of 18 participants, including six in-depth interviews and two focus group discussions, deemed appropriate for this study's exploratory qualitative nature. This sample size aligns with established qualitative research standards prioritising depth of insight over breadth (Braun & Clarke, 2006). Purposive sampling ensured representation from key stakeholder groups, including REC members, researchers, and secretariat staff with varied experiences in ethics review processes. The sample provided data adequacy and thematic saturation, as no new themes emerged in the later stages of analysis, suggesting that the dataset was sufficient to comprehensively address the study's objectives.

Data Collection

This study employed individual in-depth interviews (IDIs) and focus group discussions (FGDs), two widely accepted methods in qualitative research (Fossey et al., 2002), to explore perspectives on DPER. Six IDIs were conducted with REC members and secretariat staff, while two FGDs were held with researchers, some of whom also served on RECs. Sessions were conducted virtually or in person via Zoom or Google Meet, audio-recorded with participants’ consent, and transcribed verbatim.

The IDIs utilised a semi-structured format (DiCicco-Bloom & Crabtree, 2006), which allowed the researcher to explore individual perceptions, practices, and ethical concerns in depth. This format facilitated a deep engagement with personal experiences, attitudes, and interpretations of traditional and digital ethics review methods (Fontana & Frey, 2000; Kvale & Brinkmann, 2009). The interview guide consisted of open-ended questions regarding submission processes, platform experiences, and ethical issues, such as data protection.

The FGDs were structured to capture group dynamics and share reflections on the ethics review. Two groups were convened: one composed of researchers experienced with DPER and the other consisting of users of traditional systems. This multiple-category approach (Krueger & Casey, 2004) allowed for comparative insights into user experiences. FGDs offered opportunities for participants to engage, challenge, and refine each other's views in real-time, generating nuanced, group-level data (Leung & Savithiri, 2009; Nyumba et al., 2018). The FGD guides included open-ended prompts to stimulate debate about uptake, effectiveness, and concerns related to ethics review methods.

Data Analysis

Data analysis utilised Braun and Clarke's (2006) six-step approach to thematic analysis, employing Atlas.ti software. These steps included familiarising the transcripts, coding, developing themes, refining, naming, and reporting. Coding was conducted inductively and deductively to balance data-driven insights with the study's research questions. To ensure analytical rigour, IDI and FGD data were analysed separately to reflect their distinct units of analysis: individual narratives versus collective experiences. This separation preserved each method's unique contributions and enhanced the validity of the findings (Clarke & Braun, 2017). While the initial data analysis was conducted by Brenda Odero, an iterative approach was adopted, where both authors reviewed codes and themes in an ongoing manner. In this way, both authors interrogated and approved the final list of codes and themes presented in this paper. Codes were then reviewed for connections and grouped into sub-themes that reflected barriers, facilitators, and perceptions of DPER. The final thematic structure was established through iterative discussions and refinements. (Appendix 1).

Results

This study explored the perspectives and experiences of researchers, REC members, and secretariat staff on using DPER in Kenya. Their narratives revealed a complex, yet insightful picture of the benefits and challenges associated with DPER, which were organised into five thematic areas.

Benefits Associated with DPER

Efficiency and Turnaround time: I think it will help us to streamline the process.”

A strong theme that emerged across most of the participant's interviews related to the notion that adopting digital platforms for ethics reviews significantly reduces the turnaround time of the review process. Specifically, amongst those with experience, digital approaches were found to minimise the need for physical document handling, thereby saving time and reducing operational costs. Participants noted the convenience of submitting applications online, which also proved to be cost-effective and more efficient: For example:

“…THE TURNAROUND TIME. Then I save time in terms of, I do not have to physically move from one place to another, submitting my documents, and saving on the cost of printing…” [P1, FGD2, researcher]

‪“One of the biggest [benefits] is like (.) turnaround time… we reduced turnaround time when … when we went (.) electronic (.) 90 DAYS. 90 DAYS when we were doing paper… Some move them faster than that. Some will delay a bit, a little bit, [but] on average, when we introduce the system, we reduced up to 67 [days].” [P1, IDI, member]

Another participant described the value of DPER to reduce meeting costs further, viewing it as a better option for financial sustainability:

“… In as much as there's some money that you spend in accessing the system or in buying the system, it is more… It is cheaper than when you decide to go the paper way because there are some printing costs. There are some courier services. Maybe you want to send the document, so there are some courier services. Maybe some costs of the meeting. But now, when you are virtually again, you see, that's another way of using the digital platforms. And again, you don’t need to hire conference rooms; you don’t need to buy people, tea, lunch, and snacks.” [P1, IDI, member]

Relatedly, digital platforms were thought to streamline the ethics review process. Participants noted that DPER facilitated remote attendance of REC meetings and helped reduce the backlog, making the entire review process faster and more efficient. Beyond tracking protocols and acting as a database, digital systems were seen as essential tools for easing workloads on researchers and reviewers alike:

“I think it will help us to streamline the process in terms of timelines… The same will apply to setting out the documents or reviewers and getting feedback. I STRONGLY BELIEVE IT WILL REALLY HELP IN TERMS OF THE TIMELINES FOR THIS ERC.” [P3, IDI, secretariat]

“It helps reduce the backlog, for most of the researchers and reviewers. All they must just [do is] create an account and upload their documents and everything else is done by the reviewers, without the researcher having to keep writing in there, going back and forth, and sending letters. I was saying that it lessens the burden on the researchers, where the researcher must keep following up and taking documents to the committee.” [P6, FGD1, researcher]

In addition to logistical savings, participants noted the environmental benefits of digital platforms due to reduced paper use. The shift away from paper-based systems helped align the ethics review process with broader sustainability goals, as articulated below:

“And then number 2, practically, trees. Paper – environmental. We are being told each time, REDUCE YOUR USE OF PAPER, REDUCE YOUR USE OF PAPER. So ideally and practically, it is cheaper and better to go online.” [P2, IDI, member]

“When you look at the environmental impacts of printing out paper, you find that using a digital platform helps us be able to be more sustainable in the long run, in terms of cost, in terms of environmental sustainability as well.” [P1, FGD1, member]

Enhanced Communication and Data Management: “It's quick and the communication is quick for you to get”

Following the previous sub-theme, DPER were thought to facilitate communication between researchers, RECs and secretariats by improving management and tracking of applications, feedback loops, and status updates. These improvements were then considered valuable in promoting transparent and timely reviews. Participants highlighted the DPER's capacity for real-time data monitoring, which is instrumental in shaping research trends and informing policy changes.

“The experience has been rewarding, to say the least, because we receive a lot of applications and sometimes, we have new members coming into the committee… So, I think it's become like a database of some sort, where it can be used as a tool for learning so that people can understand more about the processes, the procedures, and the policies that guide the ethics, the ethics committee…[P2, FGD1,researcher]

“…This portal earmarks and of course can track the protocols that came in at addressing the human subjects … [P5, IDI, member]

With improved feedback loops and transparency in timely reviews, the use of DPER were also thought to enhance the precision of feedback provided to researchers. Participants noted that feedback through DPER was often more direct and specific, facilitating clearer communication. One participant shared:

“…like, the responses are, they are very precise. Or rather, you know you don’t have to get so much information, because I think, for us, the digital platform has a max of this number of words. So, you get the specific information that you need and that communication, if you need communication or something that needs clarification. It's quick and the communication is quick for you to get.” [ P2, FGD1, researcher]

Concerns Associated DPER

While the participants generally welcomed the use of DPER, they also reflected on the challenges that they faced when using, or considering using, digital platforms.

Privacy, Security and Confidentiality Concerns: “You know, systems can be hacked”

A primary concern that emerged across the participants’ narratives related to the mistrust they felt towards DPER. Participants reported that “systems can be hacked” (P1, IDI) and questioned the safety of their intellectual property in sharing information digitally.

“You know, systems can be hacked, systems can be … not like paper; when you lock it in your room, no one else can get it…” [P1, IDI, member]

‪Issues of confidentiality, you know, having access to their documents, how are we able to contain that? Indeed, it's only the reviewers who will have access to it and such.” [P3, IDI, secretariat]

‪“How secure is my data? I’ve also received some links on the same [one] you sent your proposals, and you received some emails asking you some questions and you wonder where this has come from. Where have they gotten my information or information about PIs?” [P3, FGD2, researcher]

‪“Of course, cybersecurity is one of the key things coming in and people can easily walk in tomorrow, you do it, and out tomorrow, out there you find information all over… For example [name], has a certain idea and [name] being sharp the way she is, runs with this information. Before you realise [it], you find that information out there; already that article has been, researched and published. And you ask yourself, huh? Or someone goes and uses it for fundraising, you get [it]?” [P5, IDI, member]

Evidently, in the above extracts, there is increased concern for the potential of an ethical breach when information is shared digitally regarding privacy and confidentiality. Participants thus questioned, ‘how secure? or how safe?’ their data and the information shared with research ethics committees (RECs) would be when using these platforms. This is perhaps best illustrated in the participants reflections stipulated below:

“And I understand everything about protecting and the need for confidentiality and they [RECS] need to ensure that the data that's coming in is well protected for whichever subject is being looked at out there because everything starts from the protocol that's being submitted.” [P4, IDI, secretariat]

“We give too much information for review; we give you a whole protocol. All the questionnaires, all the documents, everything, and then you are left wondering. How? How secure? How safe? Is somebody else going to take your protocol and, you know, do a study out of it? We don’t have that. Like, we are not given that surety. And that is my biggest concern.” [P6, FGD1, researcher]

Technological and Operational Constraints: “the system is still not able to accommodate everything”

While the participants generally valued DPER for its efficiency (see previous section), some also described the technical limitations of the DPER, including issues with document uploads and platform inflexibility.

A recurring theme entailed the limitations of digital platforms to “not [be] able to accommodate everything”. This generally referred to the difficulties the participants encountered when uploading various supporting documents or when they needed to remove and replace versions of documents. For example:

“…one of the issues that I experienced was, sometimes, the documents that were required, searching for them, that some would be missing, some would not be easily found, or some would be uploaded in a format that was not easy for the reviewer to find to locate.” [P3, FGD1, member]

“I also find that the systems that come, because they were not made with the people who are going to use them, are a little bit rigid and there are certain things they cannot do.[…]” [P5, FGD 1, member & researcher]

“And then finally, in one committee, we have three different systems of dealing with applications because the online one cannot accept the other two[…]” [P5, FGD 1, member & researcher]

As implied in the last extract and below, some participants explained that, although DPER were available, certain RECs still used traditional approaches to circumvent challenges and facilitate the application or review process. Using both traditional and digital approaches also seemed to have been favourable when RECs transitioned towards solely using DPER:

“… We are going to, because (.) we are in the transition phase of going online, (.) all these other applications that are coming through email will eventually be processed through the system. It's only that the system is still not able to accommodate everything. So, we are doing it in phases. So, it is a work in progress.” [P1, IDI, member]

Lack of Training: “ensure that the people are well apprised of the platform”

Linked to the previous theme, the participants’ narratives suggests that there is a lack of capacity and not enough training to adopt digital platforms in the ethics review process. Many thus identified “proper training” as an important need to address some of the usage challenges and to promote better use and engagement with digital platforms. For example:

“So, if you’re going to go to digital space, then be prepared also to do some bit of proper training along that particular [system] and just ensure that the people are well apprised of the platform, but then again, it also comes with its technology. You also need to have a support team just geared towards solving the client-related problems, if necessary.” [P5, IDI, member]

“I don’t know if there were IT people or what or if they had gone through it for them, it was very easy, but generally, it did not TAKE in the first time. Even the second time. And for both platforms, we’ve had to have smaller sessions to get us on board. And I would like to (…) up till now on both platforms, I still get stuck. And I still say I can’t find this or where do I find the other?” [P5, FGD1, member & researcher]

“[…]the people coming up with the platform need to find means of clarifying, concepts or terms that are not familiar when submitting because we as researchers don’t know what some terms mean in the platform when applying. If there are some notes beneath, those could clarify and make the process of application simple.” [P4, FGD1, member]

For others, a reluctance or slow adoption of digital platforms was linked to a hesitance to adopt new technologies:

“You don’t want to change. You are too used to the old way of doing things. It is not just the old guys. Some old guys will receive it by email and will give you very good comments by email and written by email. Some young guys if it is not physical – ‘I’m not bothered’ [describing an attitude]. So, you can’t say whether it is the old or young or new faculty or old faculty. It varies. Some guys adopt these things quickly, [for] others it's slow” [P2, IDI, member]

‪“Recently we went for a brainstorming with the ERC that we work with and that was after the government's directive to have all systems, all government systems, digitalised. And you know, we’re giving our perspective on the transition, and we could still feel, you know, some bit of reluctance even from their end, especially when it comes to the issue of letters being signed.” [P3, FGD2, researcher]

Discussion

Drawing on perspectives from researchers, REC members, and REC secretariats, this study found that Digital Platforms for Ethics Review (DPER) were widely perceived to enhance efficiency, reduce turnaround times, improve communication, and lower administrative costs, while also supporting better tracking, data management, and environmental sustainability. However, concerns about data privacy, platform rigidity, limited training, and mistrust in digital systems persisted, alongside operational barriers such as inflexible designs and insufficient user engagement in system development. Insights from both individual and group data revealed a complex interplay of readiness, resistance, and potential in the shift toward digital autonomy in ethics review processes. These findings are now discussed in relation to the existing literature.

Using DPER Streamlines the Review Process

The literature supports the positive impact of DPER on reducing turnaround time. By minimising the need for physical handling, such as printing and transporting documents, research shows that DPER significantly accelerates the review process (Detlor & Wilson, 2015; Mbabe et al., 2021; Mokgatla et al., 2017; Wang et al., 2021). This streamlining effect shortens review timelines and reduces stakeholders’ workload, enhancing the efficiency and efficacy of ethics review systems. For instance, in the Mayo Clinic case study, a new pre-award and Institutional Review Board system decreased turnaround time from 37 to 24 days, significantly lowering resource demands (Smith & Gronseth, 2011).

With increased research studies, and thus a greater need for ethics review within the African context (Omutoko et al., 2023; Schoeman, 2019), using a DPER would help reduce workload and administrative costs for research stakeholders. Mokgatla et al. (2017) reported that a study done in 25 African RECs and 8 using DPER reported reduced administrative workload and costs. Furthermore, participants reported the ethics review system's streamlining, efficiency, and efficacy using DPER (Detlor & Wilson, 2015; Mokgatla et al., 2017; Rahimzadeh, 2018).

Amongst the participants who used DPER, digital platforms were also considered valuable in improving communication with different research stakeholders. Previously, communication, feedback loops, and status updates between RECs and research stakeholders could have been faster during the ethical review, where some reviewers would share handwritten forms, which secretariats then needed to type. This certainly slowed down the flow of communication and feedback to the researchers. According to Mbabe et al. (2021) and Mokgatla et al. (2017), using DPER allows swifter communication sharing, status updates, and reminder updates on the ethics review process among the research stakeholders.

Additionally, findings emphasise that DPER provides enhanced monitoring, tracking, and data management capabilities compared to traditional methods. Digital platforms allow for auditing and trend analysis across studies, offering valuable insights for policymaking. Unlike traditional methods, such as email, comprehensive oversight of the ethics approval process becomes more feasible with DPER, as noted in prior research (Mbabe et al., 2021; Mokgatla et al., 2017; Rahimzadeh, 2018). Biggs and Marchesi (2013) highlighted that email-only systems, while a step forward, failed to address deeper inefficiencies in ethics review processes. They advocated for comprehensive digital platforms, which streamlined document handling, reduced paper waste, and enabled faster, more collaborative communication between committees and researchers. This shift was key to improving workflow and reducing delays in approving research protocols.

Can Digital Platforms be Trusted?

The culture of mistrust in research can stem from historical and systemic disparities (Sankar et al., 2003). This mistrust is not just toward individuals but also toward the policies and motives of institutions when deploying any platform (Petrakaki, 2017). Participants’ concerns revolved around the lack of data privacy and confidentiality, data sharing, data ownership (intellectual property), cyber-attacks, hacking, data security, and plagiarism.

The findings highlight the importance of blockchain technology in safeguarding all research data and ensuring transparency in a DPER. Blockchain technology is a decentralised, distributed ledger system that securely records transactions across a network of computers. Once network participants verify, each transaction is grouped into a “block,” added to a chronological “chain” of previous blocks, forming an immutable record. This structure ensures data integrity and transparency, as altering any single block would require consensus from most of the network, making unauthorised changes virtually impossible. Originally developed as the underlying technology for Bitcoin, blockchain has evolved to support various applications beyond cryptocurrencies, including smart contracts, supply chain management, and secure data sharing (Nakamoto, 2008; Rahimzadeh, 2018; Zheng et al., 2017). Rahimzadeh (2018) indicates that blockchain technology can significantly improve the consistency and reporting quality of REC decisions in collaborative studies while promoting secure data sharing and ensuring responsible access through encryption, pseudonymisation, and so much more. Using blockchain technology's secure and encrypted features, platforms dedicated to ethics review can safeguard sensitive information against unauthorised access or leaks. This protection is critical due to the nature of confidential data often involved in the ethics review process. Additionally, blockchain technology supports anonymising applicant identities without compromising the process's integrity, thus balancing the need for transparency and privacy concerns (Taherdoost, 2022).

Data security and confidentiality questions also underscore the importance of implementing the Kenya Data Protection Act (2019) when using any DPER. This Act focuses on safeguarding the privacy and rights of individuals through the control of the collection, processing, storage, and sharing of personal data. It provides data protection principles, rights flowing from such for the individual whose personal data is in question, and accountability for controllers and processors to ensure lawful and secure processing. It also sets up an Office of the Data Protection Commissioner to oversee enforcement, with accompanying penalties for breach, ensuring that personal data is handled responsibly and transparently. The identified risks included privacy rights, data consent, and the confidentiality of individuals’ information while using DPER. It is, therefore, important that DPERs comply with the law.

In the current study, participants noted the operational challenges they faced in using DPER, often referring to the rigidity of the platforms. Indeed, as Detlor and Wilson (2015) pointed out, ‘one size does not fit all’ when adopting DPER. Regardless of the volume of protocols being submitted for ethics review, a fully-fledged, robust, and customisable DPER must be developed to ensure functionality, adequate review, transition, and focus on the contextual needs of research stakeholders (Detlor & Wilson, 2015; also see Bowser & Tsai, 2015). COHRED's HRWeb and MARC teams designed an information management system (IMS) called RHinnO for RECs to manage and streamline review procedures, proposal submission pathways, and operational processes. However, further research is required to understand the utility of this platform and others within the African context.

Training and Awareness are Required to Promote the Uptake of DPER

Great efforts have been made to strengthen research ethics in Africa, with substantial emphasis on training the review process for all relevant stakeholders (Ndebele et al., 2014). Still, reluctance to adopt DPER remains, as shown in this study. Apart from issues of mistrust, reluctance to adopt DPER also stemmed from the participants’ preference to use new technologies.

Awareness-raising activities on the value of DPER and training on how to incorporate DPER are thus imperative to promote the uptake. Some participants found it difficult to navigate DPER systems, which made it difficult each time they reviewed and/or submitted their research. According to Bowser and Tsai (2015), testing and user feedback are necessary to ensure that challenges faced in the system are noted and iterations done on the platform. Mbabe et al. (2021) developed a prototype digital workflow system to address inefficiencies in the ethical clearance process at the University of the Western Cape, South Africa. The system-digitised applications enabled automated tracking and feedback and minimised delays caused by manual errors. Testing showed it improved process efficiency and stakeholder communication, though areas like mobile compatibility and notification systems required refinement. The study demonstrated the potential for streamlined ethical approvals in research, with future iterations aimed at entirely replacing the manual system and validating its impact through comparative analysis.

This could also allow for focused training on what the users need help with when navigating the DPER.

Best Practices

This study provides context-specific insights into using DPER within the Kenyan research ethics landscape. By exploring the experiences of researchers, REC members, and secretariat staff, the findings highlight the perceived benefits of DPER in improving efficiency, communication, and data management while revealing concerns about data security, platform rigidity, and limited user training. These issues underscore the need for contextually tailored digital solutions that consider Kenya's research environment's infrastructural, cultural, and institutional realities.

The results suggest that while there is readiness and enthusiasm for digital transformation among ethics stakeholders, achieving full digital autonomy will require deliberate investments in training, trust-building, and user-centred design. Efforts to strengthen digital infrastructure must be guided by national regulatory frameworks, such as Kenya's Data Protection Act (2019), and informed by ongoing engagement with REC personnel and researchers. While the findings may hold relevance for other settings, further comparative research is necessary before generalising these results beyond Kenya. Future studies could explore cross-national applications of DPER in similar contexts to identify shared barriers and best practices.

Based on the study findings, the following best practices are proposed to guide the effective adoption and implementation of DPER:

Enhancing Training and Support: Institutions should provide targeted training for researchers, REC members, and secretariat staff to improve user proficiency and confidence in navigating DPER systems. Regular workshops, user-friendly guides, and technical support are critical to addressing platform-specific challenges.

Customisable and User-Centric Systems: DPER should accommodate diverse document types, include adaptable features to meet evolving research trends, and integrate user feedback to reduce operational rigidity. Stakeholder collaboration in system development is essential.

Strengthening Data Security and Privacy: To address concerns about data breaches and intellectual property theft, robust cybersecurity measures must be implemented. Adherence to legal frameworks, such as Kenya's Data Protection Act (2019), is vital to maintaining trust and ensuring ethical compliance.

Hybrid Transition Models: For institutions still reliant on traditional methods, a phased approach that combines digital and paper-based processes can facilitate smoother transitions. This approach should include infrastructure investment and gradual system integration.

Research Agenda

There remains a limited body of research examining the perspectives and lived experiences of research stakeholders, such as researchers, REC members, and secretariat staff, on using DPER in Kenya. Most existing studies focus on technical implementation rather than stakeholder engagement, particularly in the Kenyan context. As digital systems are increasingly integrated into national research infrastructures, further Kenya-specific qualitative and quantitative research is needed to better understand how DPER platforms can be adapted, improved, and scaled within local institutional and regulatory environments. While Kenya has established data protection legislation, such as the Data Protection Act (2019), challenges related to implementation and enforcement persist due to limited resources and varying levels of institutional readiness. Addressing these gaps will require technological innovation, strategic investment in capacity building, and stakeholder involvement to ensure that digital platforms align with Kenya's research governance priorities.

Future research should explore:

Long-Term Impact of DPER: Investigate the effects of DPER adoption on efficiency, stakeholder satisfaction, and ethics review outcomes over time.

Cultural and Contextual Adaptation: Conduct comparative studies across diverse geographical and institutional settings can reveal best practices for customising DPER systems.

Ethical and Legal Considerations: Examine the implications of data privacy, ownership, and security in DPER environments, particularly with blockchain technology and artificial intelligence.

Scalability and Sustainability: Assess the feasibility of scaling DPER in resource-constrained settings, identifying cost-effective solutions to support adoption.

Collaborative Research Initiatives: Foster cross-institutional partnerships to share anonymised data, user experiences, and insights supporting a global knowledge base on digital ethics review practices.

Educational Implications

The findings highlight the need to integrate digital ethics review competencies into training programs for diverse audiences:

For researchers: Workshops on preparing and submitting applications via DPER systems can enhance efficiency and compliance.

For REC Members and Staff: Tailored training on system navigation, data protection, and digital ethics (techno ethics) is essential.

For policymakers and the Public: Awareness campaigns can foster trust in DPER and highlight its benefits for research governance.

Incorporating DPER themes into academic curricula and professional development programs will ensure that future stakeholders are equipped to navigate digital ethics review platforms effectively.

Supplemental Material

sj-docx-1-jre-10.1177_15562646251380741 - Supplemental material for From Paper to Platform: Ethics Review in a Digital Age – A Kenyan Case

Supplemental material, sj-docx-1-jre-10.1177_15562646251380741 for From Paper to Platform: Ethics Review in a Digital Age – A Kenyan Case by Brenda Adhiambo Odero and Candice Groenewald in Journal of Empirical Research on Human Research Ethics

Footnotes

Acknowledgements

This research was supported by the Fogarty International Centre of the National Institutes of Health under Award Number R25TW001599, the University of KwaZulu-Natal Biomedical Research Ethics Committee, and local Kenyan ethics review committees. The authors thank the SARETI Program team for their invaluable support and the study participants’ significant contributions. The findings and conclusions presented here are those of the authors and do not necessarily reflect the views of the National Institutes of Health or the supporting institutions.

Author's Note

This research was undertaken while Brenda Adhiambo Odero was employed at Strathmore University and completing her Master's program at the University of KwaZulu-Natal. She has since graduated and continues as an Honorary Research Fellow at the University of KwaZulu-Natal. The author is no longer affiliated with Strathmore University.

ORCID iDs

Brenda Adhiambo Odero

Candice Groenewald

Ethical Considerations

Ethical approval was obtained from the University of KwaZulu-Natal Biomedical Research Ethics Committee (BREC/00005014/2022), local Kenyan ethics review committees: The Aga Khan University-Institutional Scientific and Ethics Review Committee (ISERC) (2023/ISERC-57); Strathmore University ISERC; SU-ISERC (1597/23)], and the NACOSTI research permit (NACOSTI/P/23/24235) that permits data collection in Kenya. Participants provided informed consent, with assurances of voluntary participation, confidentiality, and the right to withdraw at any stage. Data storage adhered to Kenya's ), ensuring the security and privacy of research materials.

Funding

The authors disclosed receipt of the following financial support for the research, authorship, and/or publication of this article: This research was supported by the Fogarty International Centre of the National Institutes of Health under Award Number R25TW001599.

Declaration of Conflicting Interests

The authors declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

Supplemental Material

Supplemental material for this article is available online.

Author Biographies

Brenda Adhiambo Odero is a researcher specialising in health research ethics, focusing on technology and AI ethics in health care and using digital tools in ethical oversight. She is an Honorary Research Associate at the University of KwaZulu-Natal (UKZN). She trains in research ethics and the use of technology in health research. Her primary research interests lie in the intersection of technology and ethical governance in low- and middle-income countries. In this study, Ms Odero led the investigation of stakeholder perspectives and played a key role in analysing how digital platforms can improve ethics review processes in Kenya.

Candice Groenewald is a Chief Research Specialist in the Centre for Community-Based Research at the Human Sciences Research Council of South Africa. She is an Honorary Research Associate at the University of KwaZulu-Natal (UKZN) and a Module coordinator, lecturer and postgraduate supervisor as part of the South African Research Ethics Training Initiative (SARETI) master's programme at UKZN. She is a former recipient of the Mail & Guardians ‘200 Young South Africans under 35 awards under the category of Health (2019). In 2023, she became a Y2-rated social scientist with the National Research Foundation of South Africa in Psychology. She specialises in interpersonal, phenomenological, and mental health research associated with adolescent development and well-being, family well-being and youth in adversity. She holds a wide array of methodological expertise with a keen interest in how meaningful partnerships can be developed through research to promote in-depth and applied understandings of the challenges and opportunities for young people and their families.

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