Challenges and pathways to herbal ethical approval: an institutional case study of a randomized controlled trial on...

Clinical trials are essential for validating the safety and efficacy of traditional medicines; however, their conduct in Africa is significantly hindered by resource constraints, a lack of standardized regulatory frameworks, and insufficient guidance for navigating complex ethical review processes. This study addresses the knowledge gap regarding the practical experience of obtaining multi-country regulatory and ethical approvals for herbal clinical trials. A qualitative case study design was employed to document the regulatory and ethical review processes for a randomized controlled trial of Moringa oleifera Lam. leaf supplementation in HIV-positive adults receiving antiretroviral therapy. Data were synthesized from institutional correspondence, ethical reviews, and communication records with the University of KwaZulu-Natal in South Africa, Aminu Kano Teaching Hospital, and the National Agency for Food and Drug Administration and Control in Nigeria. This study highlights the challenges of managing multi-country regulatory systems, particularly in the absence of harmonized guidelines for herbal research. The findings suggest that inter-institutional collaboration and adherence to rigorous Good Clinical Practice (GCP) standards are critical for the successful conduct of herbal trials. The review process revealed significant differences in turnaround times, documentation requirements, and query complexities across the involved institutions. In conclusion, this study emphasizes the need for regionally harmonized, risk-based regulatory frameworks for herbal medicines. Sharing practical experience is vital for building capacity. This enables researchers to better navigate institutional bureaucracies and advance high-quality clinical research in developing countries.