The Guinea-Bissau Hepatitis B Study: What it Reveals About Research Ethics and Clinical Trial Oversight in Africa
Yasir Jamal Bakare and Chioma Nnamani
In a country where nearly one in five people is estimated to be living with hepatitis B, a proposed clinical trial that withholds the hepatitis B birth dose from some newborns to observe differences in health outcomes has drawn scrutiny and raised ethical concerns about how clinical research is conducted and regulated across Africa.
The study, led by the Bandim Health Project, aims to examine the health impacts of the hepatitis B vaccine on infants who receive it at birth compared to those following Guinea-Bissau’s current immunisation schedule, which begins at six weeks. Researchers involved argue that the trial does not remove existing vaccines as half of the children receive an additional hepatitis B vaccine at birth that is not yet part of the national program. Critics, however, insist that withholding a proven, life-saving intervention in a high-prevalence country is unethical under standard global ethical frameworks. Beyond the specifics of this trial, the debate points to a wider concern in Africa about how ethical decisions are made, especially when studies are designed and financed by external partners.
In Guinea-Bissau, the hepatitis B virus poses a serious risk, particularly for infants. Babies exposed at birth are more likely to develop chronic infection, increasing their chances of liver disease or cancer later in life.
The World Health Organization recommends that newborns receive a hepatitis B vaccine within 24 hours of birth. Administered on time, the dose has been shown to prevent an estimated 70–95% of mother-to-child transmission, and more than 115 countries have incorporated it into their national immunisation schedule. Guinea-Bissau, however, currently administers the vaccine at six weeks, with plans to introduce the birth dose by 2028.
It is within this gap between global recommendation and national policy that the current trial has taken shape. Instead of using available resources to expand immediate protection for newborns, the study randomise access to the birth dose, giving some babies the vaccine at birth while others continue the routine six-week schedule, a design intended solely to aid researchers observe how the timing of vaccination affects health outcomes. This approach has raised ethical concerns, as international research standards, including the Declaration of Helsinki, state that participants in medical research should not be denied access to interventions already proven to be effective.
Beyond science, the Guinea-Bissau controversy has reignited debates around global health ethics, double standards in clinical research, and whether trials that would undergo strict regulatory review in high-income countries are more easily advanced in low-resource settings and questions about whether this particular study met the scientific and ethical safeguards required under the relevant national oversight frameworks.
Ethics Is Not One-Size-Fits-All
The controversy surrounding the hepatitis B vaccine study in Guinea-Bissau draws attention to a fundamental reality, that ethical approval in global health research cannot be entirely procedural. Beyond clearance, it must consider local epidemiology, historical experience, mutual agreements, and asymmetries between sponsors and host communities, including differences in resource and decision-making power that affect community participation and access to benefits.
A similar concern surfaced during the COVID-19 pandemic, when a study on ethics review in public health research identified perceived inequities and mistrust despite full regulatory compliance, suggesting that procedural approval alone does not address questions of equity and community perspectives in research ethics.
Africa’s research history also provides important lessons. From the 1996 Pfizer trial of the antibiotic drug Trovan in Kano to HIV prevention trials later stopped in Cameroon, some studies that had initially received ethical approval were subsequently criticised for failing to adequately reflect local realities or ensuring equitable benefit. These experiences show that a study considered acceptable elsewhere cannot be applied in a higher-risk setting without careful adaptation to the local context.
Regional Safeguards: African Institutions as Ethical Gatekeepers
If ethics must align with local realities, then the question becomes institutional: who sets the standards of what is acceptable?
Across Africa, regional bodies are taking ownership of research oversight, using their authority to define acceptable standards and safeguard local interests. One example is the African Vaccine Regulatory Forum (AVAREF) which provides a platform for joint ethics and regulatory review of vaccine and clinical trial applications, bringing national regulators and ethics committees together to strengthen technical scrutiny and harmonise standards.
This expanding institutional role extends beyond AVAREF. In response to an enquiry from Africa Health Watch on its role in ethical oversight, the West African Health Organization (WAHO) emphasised that, under its ECOWAS mandate, it serves as a convening and harmonising body, rather than a passive observer. Through the West African Network of National Ethics Committees, WAHO supports alignment of national reviews with shared standards and facilitates joint assessments when research protocols raise concerns, helping to reduce the risk of sponsors exploiting regulatory gaps in individual countries.
At the continental level, the Africa CDC has also clarified its role. During a briefing, Director General Jean Kaseya stressed that for any clinical study to take place, authorisation must be granted by the host country. He also noted that Africa CDC’s role is limited to providing regulatory and ethical review support rather than replacing national authorities. In a separate Africa CDC weekly press briefing, Dr. Mosoka Papa Fallah, Acting Director of the Science and Innovation Directorate, outlined plans to establish an independent continental platform of African scientists and ethicists to advise on complex or contested studies.
“We are working on a concept to have this continental body of prominent African scientists and ethicists that will be around from multiple countries. Whenever countries have an issue or need an external opinion to guide and advise them on ethics or the scientific rigor for any study, they can consult. We are working internally...... In the couple of coming weeks or so, we'll launch it. It will be an independent body of scientists that can always be available to Africans to review studies that are coming up”.
~ Dr. Mosoka Papa Fallah
Together, these responses signal a shift in Africa’s research landscape, with regional and continental bodies increasingly taking ownership of ethical oversight and providing guidance to ensure studies are conducted responsibly within the continent.
Why This Matters
Countries across Africa are at an important inflection point in how research is conducted and governed. As clinical trials expand and external research bodies continue to seek research partnerships in high-burden settings across the African continent, the tension between advancing science and protecting participants is becoming more visible. In settings where resources are limited, and disease burden is high, ethical standards cannot quietly bend under the weight of urgency or scarcity.
Regional bodies such as WAHO and Africa CDC are well placed to further strengthen their roles in supporting national regulatory and ethics review systems for clinical trials. Alongside these institutions, the African Vaccine Regulatory Forum (AVAREF) provides a valuable platform for joint ethics and regulatory assessments, bringing national regulators and ethics committees together to review complex trial protocols and share expertise. Through regional coordination, technical guidance and platforms for independent scientific exchange, they can help promote more consistent standards and reinforce the principle that research conducted in African countries is shaped with local leadership and aligned with regionally defined priorities.