Training on ethical review of clinical trials at Busitema University

A two-day training workshop was held from 25 to 26 September 2025 at Busitema University in Eastern Uganda for members of the University Research Ethics Committee (REC) on the review and oversight of clinical trials. The training aimed to enhance the members' knowledge of clinical trial designs, implementation, monitoring, and reporting of clinical trials in accordance with international and national regulatory standards. The workshop was opened by the Vice Chancellor of the University, Prof Paul Waako, with the Dean of the Faculty of Medicine, Prof Dan Kibuule, in attendance. He emphasized that such training workshops are very important for capacity building and research growth at the university.

Activities

The training followed a prior needs assessment, which guided the development of a training manual. At total of eleven REC members were trained using the developed training manual. The training combined interactive lectures and case discussions. Key sessions included:

• Ethics review of Randomized Controlled Trials (RCTs)

• Improving REC researcher communication, addressing challenges, and becoming an effective Institutional Review Board (IRB) member

• Optimising REC review of informed consent and assent in clinical trials

• Risk-benefit assessment in clinical trials

• Understanding adverse events and causality assessment concepts for REC oversight in clinical trails

• Managing research data and human biological materials

The facilitators of the workshop were drawn from the SECRET project personnel at Makerere University, National Drug Authority (NDA), and the Uganda National Health Research Organisation (UNHRO).

Outcomes

The training was well received by the members, who reported improved understanding of clinical trial procedures and ethical standards. The REC members also gave positive feedback, highlighting the relevance and practicality of the training. A pre-test and post-test were conducted for all trainees, with the test scores improving significantly after the training.