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 act 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. Protocols that require to be reviewed by the full board shall be discussed during the above-mentioned regular board meeting. However, protocols should have been submitted to the REBH through BHRP two weeks before the board meeting dates.
Footnotes::
1. * 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.
2. ** Research involving human subjects includes:
1. 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.
2. 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;
3. studies designed to determine the consequences for individuals and communities of specific preventive or therapeutic measures; and
4. studies concerning human health-related behaviour in a variety of circumstances and environments.
3. All related documents should be submitted as single file [e.g CV of all investigators should be submitted as a single file] |
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This Bhutan Health Research Portal was lauched on April 9th, 2024 by Hon'ble Health Secretary. It marks a significant milestone in the advancement of healthcare through strengthening of health research system in Bhutan. The pivotal features of the portal are its web-based ethical review system and a national health research registry which bring a much-needed efficiency, transparency and accountabiliy in research governance. The system was developed with support of the World Health Organization (WHO). Important Note:
Henceforth, REBH and IRB will be using Bhutan Health Research Portal (BHRP) for ethical review of health-related research protocols. For more information, please contact the REBH Secretariat at rebhsecretariat@gmail.com or IRB Secretariat at irbkgumsb@gmail.com Thank you for you cooperation _______________________________________________________________________________ |
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