The SECRET project addresses structural weaknesses in research ethics governance in Uganda and Ethiopia, where expanding clinical research activity is not yet matched by fully institutionalised accreditation systems, harmonised regulatory coordination, or sustainable digital infrastructures. Ethiopia lacks a consolidated national REC accreditation framework, while Uganda requires strengthened integration between ethics oversight, regulatory authorities, and clinical trial registration systems. These gaps affect review efficiency, transparency, compliance with international standards, and protection of research participants.
In the broader African and global context — characterised by increasing regulatory complexity, mandatory trial registration, and Good Clinical Practice (GCP) requirements — robust ethics governance is essential for research credibility, public trust, and responsible international collaboration. SECRET contributes to this strategic agenda by combining regulatory capacity building, digital innovation, and institutional strengthening, while integrating governance and systems perspectives from the social sciences to enhance accountability and sustainability.
The pathway to impact is structured around four interdependent objectives:
Objective 1: Establish a national REC accreditation system in Ethiopia.
With technical support from the Uganda National Council for Science and Technology, a national accreditation committee was constituted and governance tools were adapted to the Ethiopian context. The next phase includes benchmarking, finalisation of the accreditation framework, and pilot accreditation of two RECs. This establishes formalised quality assurance and national oversight mechanisms.
Objective 2: Strengthen REC capacity for clinical trial review and oversight.
Structured training materials were developed and delivered to three RECs (two in Uganda, one in Ethiopia). Training covered protocol assessment, informed consent evaluation, safety oversight, and emergency review procedures. Upcoming practical “sit-in” sessions and development of expedited review pathways will consolidate applied competence. This enhances preparedness for complex and outbreak-related trials.
Objective 3: Link national systems to the Pan African Clinical Trials Registry (PACTR).
Technical and stakeholder groundwork has been completed for establishing a Ugandan clinical trial registry linked to PACTR. This will improve transparency, compliance with global registration requirements, and coordination between ethics and regulatory authorities.
Objective 4: Strengthen digital submission and review systems.
To improve efficiency and sustainability, the project supports digitalisation of protocol submission and management. Following sustainability assessments, the approach shifted to in-country hosting and locally maintained systems. In Ethiopia, in-house systems are under development; in Uganda, uptake of the National Research Information Management System is being reinforced.
Collectively, these objectives establish a coherent governance framework linking accreditation, review quality, registry transparency, and digital infrastructure. Expected impacts include improved review timeliness and quality, strengthened regulatory credibility, enhanced research integrity, and greater regional alignment with international standards.
