est Africa is increasingly recognized as a valuable and promising region for clinical trials, offering genetically diverse populations. Examples of this genetic diversity include: 1) Sickle cell trait adaptation: The HbS mutation in the β-globin gene shows varying frequencies across West African populations, reflecting diverse malaria exposure patterns; 2) Bangande genetic isolation: The Bangande people, speakers of the Bangime language isolate in Central-Eastern Mali, show genetic isolation from surrounding populations, with an estimated mean time of divergence of 9,900 years ago; and 3) HbC trait distribution: The HbC trait, a relatively recent mutation limited to West Africa, occurs at high frequencies (>20%) in central Ghana and Burkina Faso. These populations are crucial for addressing global health needs, as they allow researchers to study diseases with varying genetic predispositions and treatment responses. Addressing health disparities and developing treatments tailored to specific populations requires diverse participation in clinical research, ensuring that medical advancements benefit all communities. However, the region’s unique linguistic and cultural landscape presents significant challenges to the informed consent process, a cornerstone of ethical research.

The World Health Organization (WHO) defines informed consent as a process involving the explanation of all relevant clinical trial details—its purpose, procedures, potential risks, and benefits—to ensure full participant comprehension. Informed consent is more than a signature on a form; it represents an ongoing dialogue. It ensures respect for the potential participant’s autonomy, cultural values, and right to make informed decisions about their health. This decision is documented via an informed consent form (ICF). While stringent regulatory frameworks like the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use – Good Clinical Practice (ICH-GCP) are paramount, their practical application in West Africa faces hurdles due to linguistic and cultural factors. This article explores these complexities, examines CRO-implemented solutions, and proposes improvements to harmonize regulations with local realities, fostering ethical clinical research and ensuring respect for participant autonomy.

The Informed Consent Conundrum in West Africa

• Regulatory Framework and the Challenge: ICH-GCP mandates freely given informed consent before trial enrollment, documented in writing via an ICF. The ICF must be in a language the participant understands. For illiterate participants, an impartial witness ensures that oral information aligns with the written consent and that comprehension is verified. While straightforward in developed regions, West Africa, with European official languages (French, English, Portuguese) and predominantly oral local languages, presents a significant implementation challenge. Balancing regulatory requirements with local contexts requires a nuanced approach that respects cultural sensitivities.
• The Linguistic Labyrinth: Linguistic diversity forms a critical barrier. In countries like Mali, Senegal, and Côte d’Ivoire, many local languages lack written forms and are passed down orally. This makes adhering to ICH-GCP’s requirement for an ICF in a language the participant can read and understand difficult. This contrasts with Central African countries like Cameroon and the Democratic Republic of Congo, where many local languages have written forms used in education and religious contexts, simplifying written informed consent. The oral tradition in West Africa necessitates innovative solutions that effectively convey complex medical information.
• Ethical, Legal, and Regulatory Dilemmas: Official languages used in legal, educational, and governmental contexts often differ from languages spoken in rural or tribal communities. This creates a disconnect between ICFs and participant comprehension. Audits have revealed participants signing ICFs in French or English despite limited understanding, raising ethical concerns about consent validity and potentially undermining the integrity of the research. It is crucial to prioritize comprehension over mere compliance.

Bridging the Gap: Practical Solutions in Action

• Multipronged Translation Approach: To address this, CROs in West Africa employ a pragmatic approach to ensure that participants understand the informed consent process while complying with regulations, translating the ICF into the local language(s), even without a standardized written form. This proactive approach demonstrates a commitment to ethical research practices and prioritizes the well-being of participants.
• Translation and Back-Translation: The process begins with translating the ICF from the official language into the local language by someone literate in both. Since formal translation institutions may not exist, translations are often carried out by community members, ensuring the translations are culturally appropriate and understandable. Accuracy is ensured via back-translation, validating the integrity of the translated content and minimizing the risk of misinterpretation. Although AI-enabled translation could help mitigate this risk, AI has not yet been tested for local language translations, particularly in research. This could be a great step and add value, if it could be implemented. A tailored approach will have to be identified, as most of these languages are mainly spoken. However, working with existing “great speakers” (locally acceptable griots, as we call them, knowledgeable of both languages) could be a viable approach.
• Audio-Visual Aids and Community Engagement: Along with written translation, the ICF is audio-recorded in the local language. This, with the written ICF, is submitted for ethics committee approval. CROs prepare SOPs to describe how the audio format fits into the entire ICF process at the site. Community engagement ensures cultural appropriateness, fostering trust and collaboration between researchers and participants, which are crucial for successful and ethical research.

The Informed Consent Process in Practice

Participants gather for a briefing in the local language, creating a welcoming and inclusive environment where they feel comfortable asking questions and expressing their concerns. The ICF audio recording is played, followed by discussion and clarification, ensuring that participants can voice their concerns and have them addressed by knowledgeable study staff. Individual sessions address questions privately, allowing participants to clarify individual concerns in a confidential setting. Satisfied participants sign the ICF in the official language, with an impartial witness present if they are illiterate. This ensures informed and voluntary decisions.

Ethical Considerations and Future Improvements

These approaches are effective. Feedback obtained during chronic disease trials, where community engagement teams are pillars, show that participants well understand the trial, its objectives, why we need their participation, etc. Participants’ retention rates are high with fewer lost to follow-up, and when information is provided to the communities about the primary results of the trial, community leaders and members who did not even witness the trial show good knowledge of what was going on at the research site. Even during the ICF process, when subjects complete the listening of audio tapes, or view a video in the local language, they express satisfaction. The types of questions they ask attest to their understanding.

On the other hand, there are limitations. Participants may sign forms in a less-comprehended language, relying on oral explanations. Skepticism from external auditors, particularly from Western countries, may arise, emphasizing the need for greater transparency and robust documentation. Improving the process involves formalizing translation/back-translation, engaging language experts, and developing standardized written forms for oral languages. Regulatory agencies could provide explicit guidance for obtaining informed consent where literacy and language barriers are prevalent, such as in West Africa. Building expertise, resources, and regulatory frameworks is paramount to solving current challenges faced. To this goal, the Clinical Trials Innovative Summit (TCIS AFRICA) serves as a valuable converging point for clinical researchers, medical professionals, CROs, pharmas, regulatory agencies, and academia to network and exchange achievements, milestones, and challenges. Future improvements may involve integrating technology (e.g., digital platforms for real-time data management, electronic case report forms, wearable devices, smartphone applications, telemedicine systems, direct-to-patient approaches, social media recruitment tools, medical device trials, cloud-based data storage solutions, and simulation tools for trial optimization) to enhance comprehension and engagement. This could include the use of interactive multimedia tools to explain complex concepts.

A Path Forward for Ethical Research in West Africa

West Africa offers immense potential for advancing global health through clinical research. CROs’ innovative approaches demonstrate a commitment to ethical practices. By formalizing these practices, strengthening frameworks, and empowering communities, we can ensure ethical, impactful research benefiting both the region and the global community. This ensures that trials meet the highest ethical standards, advance knowledge, and improve health outcomes worldwide, while upholding the rights and dignity of all participants, and promoting trust between researchers and communities.

To learn more about this topic, plan to attend DIA’s Middle East & Africa (MEA) Conference.