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Abstract
Background:
Informed consent is intended to protect participants, yet evidence shows persistent comprehension gaps in sub-Saharan Africa, particularly regarding randomization, risks, and distinctions between research and care. Language barriers, complex documentation, and constrained healthcare access may compromise voluntariness. African countries also remain underrepresented in global trials, raising concerns about structural influences on consent.
Methods:
We analyzed interventional trials registered on ClinicalTrials.gov to April 2026, comparing African countries (n = 3,515) with the United States (n = 159,433). Shannon entropy assessed distribution across African settings; sponsorship and reporting practices were also examined.
Results:
The United States registered ~45 times more trials. Within Africa, trials were highly concentrated. Prior studies indicate limited participant understanding and context-driven enrollment, while researchers report challenges adapting externally designed protocols.
Interpretation:
Concentration and external funding shape consent processes, often privileging standardized templates over local realities, potentially undermining meaningful consent.
Limitations and Conclusions:
Registry data limit insight into consent quality. Structural inequities highlight the need for locally grounded, context-sensitive research governance.
References
1. Iseselo MK, Tarimo EAM. Comprehension of informed consent and voluntary participation in HIV clinical trials in Tanzania. BMC Med Ethics. 2024.
2. Kazembe DM, Woldeamanuel Y, Abay SM. Researchers’ perspectives on informed consent comprehension in Malawi. BMC Med Ethics. 2024.
3. Li Y, Bowen DJ, Yu JH. Ethical challenges in informed consent in Sub-Saharan Africa. BMC Med Ethics. 2025.
This work is licensed under a Creative Commons Attribution 4.0 International License.
Copyright (c) 2026 Sebudde Nicholus, Ivan Mutyaba, Huzaifah Mutyaba, Tom Okade, Martina Uisso, Shamim Nabidda, Tukamushaba Bruce, Eghaghe Osadebamwen Nibokum, Munyole Samuel, Kirabo Jireh, Musoke Muhammad, Ruchius Philbert, Amumpaire Olivia, Njeodo Njongang Vigny, Marakiya Moetlediwa, Michael Bosiako Antwi, Christine Muhumuza, Fadumo Said Hassan, Rhoda Chikula, Amina Mohamud Fidow, Anna Nakirabira, Mukisa Paul Brian, Natinael Berhane, Tulengerayo Joshua, Muhammad Murtala Yusuf, Joy Osifo, Ssenfuma Ronnie