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Informed Consent Language and Structural Inequity in African Clinical Trial Governance: A Cross-Sectional Audit

Authors

  • Musoke Muhammad
  • Ivan Mutyaba Makerere University, School of Public Health Kampala, Uganda
  • Huzaifah Mutyaba Makerere University, School of Public Health Kampala, Uganda
  • Tom Okade Makerere University School of Public Health, Uganda
  • Martina Uisso Muhimbili University of Health and Allied Sciences, Dar es Salaam, Tanzania
  • Shamim Nabidda Makerere University, School of Public Health Kampala, Uganda
  • Tukamushaba Bruce Makerere University, School of Public Health Kampala, Uganda
  • Eghaghe Osadebamwen Nibokum Makerere University, School of Public Health Kampala, Uganda
  • Munyole Samuel
  • Kirabo Jireh
  • Ruchius Philbert Department of Pediatrics and Child Health, Muhimbili National Hospital (MNH), Dar es Salaam, Tanzania
  • Sebudde Nicholus
  • Amumpaire Olivia Makerere University, School of Public Health Kampala, Uganda
  • Njeodo Njongang Vigny Makerere University, School of Public Health Kampala, Uganda
  • Michael Bosiako Antwi Makerere University, School of Public Health Kampala, Uganda
  • Christine Muhumuza Makerere University, School of Public Health Kampala, Uganda
  • Fadumo Said Hassan Makerere University, School of Public Health Kampala, Uganda
  • Rhoda Chikula
  • Amina Mohamud Fidow Makerere University, School of Public Health Kampala, Uganda
  • Anna Nakirabira Makerere University, School of Public Health Kampala, Uganda
  • Mukisa Paul Brian Makerere University, School of Public Health Kampala, Uganda
  • Natinael Berhane
  • Tulengerayo Joshua
  • Muhammad Murtala Yusuf
  • Joy Osifo Makerere University, School of Public Health Kampala, Uganda
  • Ssenfuma Ronnie Makerere University, School of Public Health Kampala, Uganda

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.

Cover of Volume 2, Issue 4

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Published

2026-06-06

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Issue

Vol. 2 No. 4: June 2026

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Methods Note

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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

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This work is licensed under a Creative Commons Attribution 4.0 International License.

Articles in Synthesis are published under the Creative Commons Attribution 4.0 International (CC BY 4.0) licence. Authors retain copyright.

How to Cite

Informed Consent Language and Structural Inequity in African Clinical Trial Governance: A Cross-Sectional Audit. (2026). Synthesis, 2(4). https://synthesis-medicine.org/index.php/journal/article/view/46

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