“Ethical Clearance for Researches involving Human Subjects”
Research Ethics Board of Health (REBH) has been formed in Ministry of Health to protect human subjects in any research or studies. 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 the 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 two weeks.
Documents required for initial review are:
- In pursuance to Officer Order No. MoH/SEC/33/2014/-15/7021 dated 12th May, 2015, please submit a copy of administrative clearance from the Ministry of Health.
- Application Form for Initial Review (It can be downloaded from http://www.health.gov.bt/357-2/ Also, it’ll be provided on request)
- 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 questionnaire, forms, guides. etc.) – Please write dated version number on it
- Curriculum Vitae of all Investigator(s).
- Informed Consent Form and Information Sheet both in Dzongkha and English languages – Please write dated version number on it.
- For minor subjects (less than 18 years):
- Informed Assent Form and Information Sheet both in Dzongkha and English languages, and
- Informed Consent Form and Information Sheet both in Dzongkha and English languages for their parents/legal guardians
Submit both hard and soft copies of all above documents to the Secretariat of REBH at Health Research and Epidemiology Unit, Policy and Planning Division – Ministry of Health.
For more details please visit http://www.health.gov.bt/357-2/ OR contact Mr. Mongal Singh Gurung (email@example.com), Dr Pakila Drukpa (firstname.lastname@example.org), Ms Tashi Dema (email@example.com) OR contact at 02-322602/328091 ext-333
* 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
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
REBH Forms for Download
- 1 APPLICATION FORM for INITIAL REVIEW
- 2 APPLICATION FORM for RESUBMITTED PROTOCOL REVIEW
- 3 APPLICATION FORM for CONTINUING REVIEW
- 4 APPLICATION FORM FOR PROTOCOL AMENDMENT REVIEW
- 5 STUDY ASSESSMENT FORM
- 6 ASSESSMENT REPORT FORM
- 7 RESUBMITTED PROTOCOL REVIEW FORM
- 8 FORMAT FOR REVIEW OF RESEARCH REPORT
- 9 FINAL REPORT REVIEW LETTER TEMPLATE
- 10 DOCUMENT RECEIPT FORM
- 11 CONTENTS OF A SUBMITTED PACKAGE
- 12 SERIOUS ADVERSE EVENT REPORT
- 13 UNEXPECTED ADVERSE EVENT SUMMARY REPORT
- 14 SAFETY REPORT REVIEW FORM
- 16 DEVIATION _ NON-COMPLIANCE _ VIOLATION RECORD
- 17 REQUEST FOR REVISION OF AN SOP
- 18 STUDY TERMINATION MEMORANDUM
Guidelines and SOPs of REBH
- Informed consent Form_Template
- Guidelines for writing a research proposal
- Standard Operating Procedures of REBH Version 06
REBH Board Members