| Health-related research, surveys, program evaluations, and operational studies contribute significantly to evidence-based health policy and service delivery. With increasing research activities conducted by government agencies, academic institutions, development partners, and independent researchers, it is necessary to strengthen ethical compliance, transparency, and coordination for health-related research conducted in Bhutan in line with national and international best practices. The Research Ethics Board of Health (REBH) serves as the national independent body responsible for the ethical review and oversight of health research involving human participants, identifiable health data, or human biological materials in Bhutan in line with the National Health Policy 2011. The Health Information and Research Division (HIRD) provides secretariat support to the REBH. The Ministry of Health has established the Bhutan Health Research Portal (BHRP) as the online national platform for ethics review management and research registration, and to facilitate public access to approved research protocols and reviewed study summary reports. To further strengthen ethical compliance and transparency in health-related research, the Ministry of Health hereby issues the following directives: 1. Researchers conducting health-related research involving human participants, identifiable health data, or human biological materials shall provide evidence of research ethics training completed within five (5) years prior to undertaking such research. 2. All such research conducted in Bhutan shall obtain ethical approval prior to the commencement of data collection or study implementation. No health-related research involving human participants, identifiable health data, or human biological materials shall be conducted without a valid ethics approval issued through the Bhutan Health Research Portal (BHRP). 3. Subsequently, REBH shall ensure that essential information on all approved protocols and study summary reports, including those approved by IRBs, is publicly accessible through the Bhutan Health Research Portal (BHRP), subject to applicable confidentiality requirements. 4. Publications arising from health-related research conducted in Bhutan shall cite the BHRP approval (registration) number issued for the study. 5. All IRBs operating in Bhutan including REBH shall observe the principle of mutual recognition of ethics review decisions, while respecting institutional jurisdictions, avoiding duplication, and facilitating communication. 6. REBH shall establish and maintain a system for all the IRBs in Bhutan to ensure quality and compliance with accepted standards for IRBs. (Pemba Wangchuk) Health Secretary |