Ministry of Health
Royal Government of Bhutan
Research Ethics Board of Health (REBH)
Ethical Clearance for Researches involving Human Subjects
Research Ethics Board of Health (REBH) has been formed in the Ministry of Health to protect human subjects in any research or study. Henceforth, all those conducting any health-related research*/study in Bhutan involving human subjects** must obtain Ethical Approval from REBH before conducting the research/study. Any health-related research/study done without Ethical Approval will be nullified or will not be possible to publish or present anywhere or REBH may take action in the interest of the human subjects.
The board meets in February, April, June, August, October, and December every year. All documents must reach the REBH secretariat at least two weeks before the scheduled meetings. From 2009 to 2015, the median duration for approval of protocols from the date of receiving application was 48 days. Even the expedited review process takes about two weeks.
Documents required for initial review which can be downloaded from REBH forms below:
- In pursuance to Office Order No. MoH/SEC/33/2014/-15/7021 dated 12th May, 2015, please submit a copy of administrative clearance from the Ministry of Health.
- Research Protocol/proposal including the itemized budget and research project schedule or timeline (Final version) – Please write dated version number on it
- Research/study tools (e.g. Final version of the questionnaire, forms, guides. etc.) – Please write dated version number on it
- Curriculum Vitae of all Investigator(s) (must be combined as one pdf document)
- Information Sheet and Informed Consent Form, in Dzongkha and English languages – Please write dated version number on it.
- For participants ≥ 18 years
- Informed Consent
- For participants 12 to 18 years
- Informed Consent from the parent(s) or legal guardian
- Informed Assent from the participant
- For participants 7 to <12 years
- Informed Consent from the parent(s) or legal guardian
- Verbal Informed Assent from the participant
- For participants <7 years
- Informed Consent from the parent(s) or legal guardian
- For participants who are incompetent to give informed consent
- Informed Consent from the parent(s) or legal guardian
- Informed Assent from the participant
- For illiterate
- Provision for thumb impression
- Provision for witness
- A statement by the researcher or person taking consent declaring that the informed consent is appropriately administered
6. For second (subsequent) reviews (resubmission with major or Minor reviews) please fill in the resubmitted review application form (Application Form For Resubmitted Protocol Review) and submit the revised protocol (highlight the changes made in the protocol)
7. For amendment review, PI must submit the revised protocol (highlight the changes made) along with application form for amendment review (Application Form For Protocol Amendment Review).
Submit all above documents to the Secretariat of REBH through online submission portal at https://bhutanhrp.moh.gov.bt
For more details please contact REBH Secretary (rebhsecretary@gmail.com) OR visit https://bhutanhrp.moh.gov.bt
SCOPE OF REBH REVIEW AND ACTION LETTERS: Please note that REBH only reviews the scientific and ethical soundness of the research/study. The PI shall be responsible to seek all other clearances/approvals required by the law/policy/executive order including permission from the study sites, and administrative approval before conducting the study
Footnotes:
- * The term “research” refers to a class of activity designed to develop or contribute to generalizable knowledge through a systematic investigation. Generalizable knowledge consists of theories, principles or relationships, or the accumulation of information on which they are based, that can be corroborated by accepted scientific methods of observation and inference. In the present context “research” includes both medical and behavioural studies pertaining to human health.
- ** Research involving human subjects includes:
- studies of a physiological, biochemical or pathological process, or of the response to a specific intervention – whether physical, chemical or psychological – in healthy subjects or patients;
- controlled trials of diagnostic, preventive or therapeutic measures in larger groups of persons, designed to demonstrate a specific generalizable response to these measures against a background of individual biological variation;
- studies designed to determine the consequences for individuals and communities of specific preventive or therapeutic measures; and
- studies concerning human health-related behaviour in a variety of circumstances and environments
REBH Forms for Download
- Application Form For Resubmitted Protocol Review
- Application Form For Protocol Amendment Review
- Application Form For Continuing Review
- Study Report Form
- Deviation Non-Compliance Violation Record
- Request Record Form
- Study Termination Memorandum
- Serious Adverse Event Report
- Unexpected Adverse Event Summary Report
- Document Request Form