Research
Research ethics process concerning the revised hepatitis B study in Guinea-Bissau
The Faculty of Health Sciences provides an account of the process surrounding the research ethics assessment of the revised hepatitis B study, including the assessment in Guinea-Bissau, the supplementary assessment at SDU, the subsequent institutional decision and the current status of the project.
The planned hepatitis B study in Guinea-Bissau has been the subject of significant research ethics and scientific criticism and extensive public and international debate. The Faculty of Health Sciences at the University of Southern Denmark therefore provides an account of the process and of the various research ethics assessments and decisions that have formed part of it.
The original and revised protocols
It is important to distinguish between two versions of the study protocol. The original protocol was the version that was criticised earlier in 2026, including through concerns raised publicly by WHO. In response to the criticism, the researchers revised the protocol.
The revised protocol was subsequently reviewed and approved by the relevant research ethics committee in Guinea-Bissau in July 2026.
Under the current Danish rules, there is no general requirement for an additional Danish research ethics assessment when a research project conducted abroad has obtained the relevant ethical approval in the country where the research is to take place.
The latest version of the Declaration of Helsinki, however, states that when research is conducted internationally in collaboration between institutions in different countries, the research protocol should be reviewed by research ethics committees in both the sponsoring country and the host country.
The Faculty of Health Sciences therefore considered it important that the revised protocol should also undergo a supplementary, independent research ethics assessment from a Danish perspective, even though the Faculty was not legally required to obtain such an assessment.
Attempts to obtain an external assessment
The Faculty first explored whether the assessment could be conducted within the statutory Danish research ethics committee system.
Both the relevant Regional Research Ethics Committee and the National Committee on Health Research Ethics stated that they were unable to undertake such a supplementary assessment within the Danish system.
The Faculty then approached WHO’s Research Ethics Review Committee and specifically asked the committee to conduct an independent ethical assessment of the study. This request was made, among other reasons, in light of the concerns WHO itself had previously raised regarding the original protocol.
WHO stated that, under its mandate and Rules of Procedure, its Research Ethics Review Committee cannot provide external assessments of research projects that are not WHO projects. WHO therefore did not conduct a research ethics assessment of the revised protocol and referred, among others, to the European Network of Research Ethics Committees, EUREC.
The Faculty subsequently approached EUREC with the same request. EUREC likewise stated that it was unable to conduct, facilitate or commission an independent ethical assessment of the project.
The Faculty was therefore in a situation where it considered a supplementary, independent research ethics assessment of the revised protocol important, but none of the Danish or international bodies that had been approached were able to undertake the task.
As Danish law did not require an additional Danish assessment, the alternative would have been to rely on the research ethics approval already obtained in Guinea-Bissau.
SDU established a supplementary research ethics assessment
SDU instead decided to establish an additional institutional framework for research ethics assessment.
On 16 April 2026, SDU’s Executive Board decided to establish a general framework under which health research conducted outside the EU/EEA under SDU’s responsibility or with significant SDU involvement may undergo an independent research ethics assessment by SDU’s Research Ethics Committee, REC, as a supplement to the ethical assessment in the country where the research is conducted. The decision was subsequently presented to the University Council and communicated to REC.
The framework therefore goes beyond what is currently required under Danish law.
REC’s assessment of the revised protocol
It was within this general framework that the revised hepatitis B protocol was subsequently submitted to REC.
REC is an independent and advisory body. The committee carries out research ethics assessments and provides recommendations, but it does not have decision-making authority as to whether a research project may proceed.
REC assessed the revised protocol with input from external experts and reached a positive research ethics assessment in September 2026. The external experts’ contributions formed part of the professional input to the committee’s deliberations. The final research ethics assessment was made by REC itself.
On the basis of REC’s positive assessment, the Dean of the Faculty of Health Sciences made the institutional decision on 7 October 2026 that the project could proceed.
REC’s assessment was advisory and therefore not formally binding. The institutional decision-making authority rested with the Dean.
Current status of the study
The research ethics approval in Guinea-Bissau and REC’s positive research ethics assessment at SDU were not in themselves sufficient for the study to be initiated. In addition, authorisation from the relevant authorities in Guinea-Bissau was required.
The authorities in Guinea-Bissau have now rejected the implementation of the study in its current form, and the researchers have announced that the study has been cancelled.
The study was not initiated. No participants were enrolled, and no vaccinations were administered as part of the study.
Roles and responsibilities
The scientific and research ethics basis of research is assessed through relevant, independent academic and professional processes. The responsibility of University management is to ensure that the appropriate assessment processes are in place and, on that basis, to make the institutional decision.
The scientific conduct of the research is the responsibility of the researchers. As an institution, the University is responsible for the frameworks and procedures governing research carried out under the University’s responsibility.
SDU has raised the issue with the Danish Minister for Health
The process has also highlighted a more general issue in Danish research ethics regulation.
The principle in the Declaration of Helsinki that research should undergo research ethics review in both the sponsoring country and the host country has not been incorporated into Danish legislation in a way that enables the statutory Danish research ethics committee system to conduct a supplementary Danish assessment in situations where a project has already obtained ethical approval in another country.
SDU has therefore established its own institutional framework for supplementary research ethics assessment of relevant health research conducted outside the EU/EEA.
However, in the University’s view, it is relevant to consider whether responsibility for such supplementary assessments should rest solely with each individual university.
On 12 October 2026, SDU therefore wrote to the Danish Minister for Health and asked the Ministry to consider whether the principle set out in the Declaration of Helsinki should be reflected in Danish legislation, including whether Danish research ethics committees should in future be able to conduct supplementary research ethics assessments of health research carried out abroad under the responsibility of a Danish research institution.
Further information
The revised study protocol and further material concerning the scientific design of the study are publicly available on the Bandim Health Project website: