A controversial proposed clinical trial in Guinea-Bissau has been suspended, according to Ole Skøtt, dean of the faculty of health sciences at the University of Southern Denmark (SDU). The trial, co-funded by the US Centers for Disease Control and Prevention (CDC), is designed to test overall health effects of a birth dose of the hepatitis B vaccine. The study would be run by the Guinea-Bissau-based Bandim Health Project.
“Regarding the planned hepatitis B study in Guinea-Bissau, the Faculty of Health Sciences at the University of Southern Denmark has, in light of the criticism that has been raised, decided to place the study on full hold until its ethical basis has been clarified further,” Skøtt told BioXconomy.
He added that the World Health Organization (WHO) Research Ethics Review Committee will review the trial. The WHO previously released a statement detailing “significant concerns regarding the study’s scientific justification, ethical safeguards, and overall alignment with established principles for research involving human participants.”
The announcement comes after two troubling reports in The Guardian and the Danish outlet Weekendavisen. The articles detail additional concerns about how the SDU-affiliated Bandim won ethical approval at the national level. Meanwhile, they highlight researchers around the world who wonder why Danish laws do not comport with the Declaration of Helsinki, which would require approval from the sponsoring and host country to move ahead.
‘A friends club’
BioXconomy previously reported that there were irregularities with the initial approval process in Guinea-Bissau, as highlighted by the country’s minister of health, Quinhin Nantote.
For instance, Rolling Stone revealed that the committee continued to apply the signature of Cunhate Na Bangna, former president of the ethics board, on approval documents long after he resigned from his position. Additionally, the six-member committee had only four sitting members at the time of approval.
Now, Weekendavisen has revealed that one of the remaining four board members – Cesário Lourenço Martins – is a senior researcher at the Bandim Health Project. The report says that, according to committee secretary Mouhammed Djicó, Martins would recuse himself during evaluations of any Bandim ethics submissions. Yet sources told The Guardian that the committee operated like “a friends club,” indicating a blurred line between Bandim and the ethics committee.
We have also become aware that there may be issues relating to conflicts of interest in relation to the approval granted by the local ethics committee in Guinea-Bissau.
Another source went further, alleging that Bandim “is the government.” Bandim itself is subject to little oversight as it does not have an external review board, per Weekendavisen.
The news that a Bandim staff member is also on the Bissau-Guinean ethics committee raises questions of impartiality. In the best-case scenario where the Bandim staff member did recuse himself from decision making, that would mean approval was granted by just three people – all of whom have a preexisting relationship with Martins.
Skøtt said this news is part of what drove the university to pause the trial.
“We have also become aware that there may be issues relating to conflicts of interest in relation to the approval granted by the local ethics committee in Guinea-Bissau for the hepatitis B project,” he told us. “This is also part of the reason why we have chosen to request an independent assessment of the study from the WHO Research Ethics Review Committee.”
Legal disconnect
Skøtt offered insight into how the university has carried out its investigation into the Bandim trial.
“With regard to the Danish research ethics committee system, we have previously contacted both the relevant Regional Committee on Health Research Ethics and the National Committee on Health Research Ethics to determine whether they could consider the matter,” he said. “However, both bodies have stated that, under Danish law, they do not have the mandate to assess a project that has been approved by a local ethics committee in another country.”
Trials are only subject to notification in Denmark if trial-related procedures take place here.
Shanna Majland-Munch, jurist at the Regional Committees on Health Research Ethics for Southern Denmark, told BioXconomy that their inquiry into the “notification requirement” for the trial is ongoing. “We have not heard back from lægemiddelstyrelsen [Danish Medicines Agency] as of yet.”
She added that, for now, there are no plans to change ethical approval processes moving forward unless there is a shift in legislation.
“Regarding the future approval process, we refer to the Danish law that regulates the area, which is The Act on Research Ethics Committees,” she said. “According to this, trials are only subject to notification in Denmark if trial-related procedures take place here. We cannot process the projects according to provisions in declarations, including the Helsinki Declaration, which have not yet been implemented in Danish legislation.”
Kim Østrøm, press officer at the Danish Medicines Agency, told us Danish authorities cannot comment further on the matter due to the general election scheduled for March 24.
In the US, Department of Health and Human Services (HHS) officials have been defiant in the face of international criticism. Their previous standing response regarding the trial has been that “the CDC is funding a gold-standard, independent study designed to answer questions about the broader health effects of the hepatitis B vaccine.”
The comments contradicted the views of Paul Offit, director of the Vaccine Education Center at the Children’s Hospital of Pennsylvania and co-inventor of the rotavirus vaccine, and several other experts BioXconomy has spoken to for previous stories. They pointed out that the vaccine has been in use for decades. In that time, it has demonstrated proven efficacy in preventing mother-to-baby transmission with little in the way of negative side effects.
They argue that, in light of existing evidence, it is unethical to withhold a birth dose from half of the trial participants.
HHS officials struck a more distancing tone when BioXconomy reached out for comment for this story. They said that the CDC is looking into whether the trial could still receive proper approval in Guinea-Bissau – but made no mention of the trial’s scientific merit.
You can read our previous coverage of the proposed hepatitis B trial here: 1, 2, 3. This article has been updated to reflect that Bandim is SDU-affiliated on March 17, 2026.