Short description of REC system in Belarus

Model. Belarus has established an institutional model of ethics review: ethical assessment and oversight of research projects are supposed to be performed on a local level at institutions, accredited by the Ministry of Health (MoH) of Belarus (these are medical universities, specialized health research institutions, hospitals and out-patient facilities – totally 113 institutions as for October 2022 [A list of the institutions, accredited by the Ministry of Health for conducting clinical trials in Belarus. Mode of access: click here to view]). RECs can only be established in state health care organizations and research institutions. All local RECs are equal in their functions and responsibilities.

National Bioethics Committee (NBC) was established in 2006 to coordinate and oversight the activity of local RECs, and is supposed to serve as an appeal body for RECs decisions. It is also supposed to serve as a consultative organ providing advice and informational support to local RECs and other organizations on wide spectrum of bioethical issues.

Scope. In Belarus, clinical trials of drugs and medical devices (CDT) are the only type of biomedical research which is legally required to be subjected to ethics review (mandatory review). However, it is left to RECs discretion to expand the scope of ethical review to other types of biomedical studies with human participants, as well as animal studies and research on biomaterials, but a committee decision in this case is just of advisory character and might not be followed.

Structure. The document of the MoH “On clinical trials of drugs” (adopted in 2020, mode of access: click here to view) specify the requirements to REC functions, composition and membership. According to these documents, RECs are composed of employees of organizations which establish them. However, it is recommended that non-affiliated members and lay members are to be included in REC membership as independent experts. Membership of REC is needed to be approved by the head of an organization where REC is established. Disclosure of conflict of interests is required for all REC members before reviewing protocols, but no procedures on managing conflict of interest in decision-making exist.

There are no established requirements for education of RECs members, and no resources are provided for this. RECs have no operational budget, their reviews are free of charge for investigators, no payment is provided for REC members for their work.

Procedures. The procedures of RECs in Belarus are based on standards of Good Clinical Practice of Eurasian Economic Union (adopted in 2016, mode of access: click here to view). In the current form, they are assembled in standard operational procedures (SOPs) to ensure uniformity of RECs’ operations.

In case of multi-center study there is a need for approval issued by all local RECs from each research site.

Networking between RECs. There are no established mechanisms of networking between RECs, and no informal mechanisms for such cooperation are in place.

Transparency. There are no publicly available databases or registers with detailed information about accepted and refused clinical trials, and there is no obligation for researchers to register CDT into the EU or international databases.

Several local RECs have web-sites with links to application forms and description of standard operation procedures.

Current legislative and regulatory acts relevant to research ethics review in Belarus.
• 1) Constitution of the Republic of Belarus (1994), mode of access: click here to view
• 2) Law on Safety of Genetic Engineering (2005), mode of access: click here to view
• 3) Law on Drugs (amended in 2009), mode of access: click here to view
• 4) Law on Health Care System (amended in 2010), mode of access: click here to view
• 5) Law on Transplantation of Human Organs and Tissues (amended in 2011), mode of access: click here to view
• 6) National Strategy of Sustainable Development (2015), mode of access: click here to view
• 7) Order of the Ministry of Health “On clinical trials of drugs” (2020), mode of access: click here to view

Authors: Andrei Famenka, Hanna Seliazniova, Mikalai Halabarodzka, Andrei Tsiatserkin and Andrej Vitushka.