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“Ethical Clearance for Research(es)/Studies involving Human Participants”

The Institutional Review Board (IRB) has been established in the Khesar Gyapo University of Medical Sciences of Bhutan (KGUMSB) mainly to facilitate ethical clearance for research1 involving human subjects/participants2. In addition, IRB anticipates to protect human subjects/participants in any research or study.

Since its establishment in July 2021, students, faculties of KGUMSB and its affiliated institutes, must obtain Ethical Approval from the IRB prior conducting the research/study. To date, and as per the existing agreement and understanding between REBH-MoH, and IRB-KGUMSB, the scope of review is limited to providing ethical approval for study protocol(s) involving the three teaching hospitals – JDWNRH (Thimphu), ERRH (Monggar), and CRRH (Gelephu). Any study that includes sites beyond these three teaching hospitals must be submitted to REBH through the Bhutan Health Research Portal (BHRP) system for full ethical review.

Any health or medical related study/research carried out without prior Ethical Approval will be considered void or nullified. In the interest of the human participants’ protection, IRB may take actions for such incident.

The IRB is a Human Research Ethics Committee, established under the auspices of KGUMSB responsible for reviewing an ethical acceptability of research. It has a special responsibility for oversight of the conduct of ethical reviews so that quality and consistency of its processes are maintained in compliance with professional and ethical standards of SIDCER-FERCAP.

The primary role of IRB is to safeguard the rights, safety, dignity and well-being of all actual and potential research participants. This also includes protecting participants from physical, psychological, social/cultural, economic and legal risks of harm.

The guiding principles in making this decision are those of:

    • I = Integrity;
    • R = Respect for persons;
    • B = Beneficence; and
    • J = Justice.

The Full-Board Review Meeting (FBRM) is scheduled 4 times (January, March, July & November) in a year. All documents pertaining ethics application must reach the IRB Secretariat at least two weeks before the scheduled meetings. Full-Board reviews takes about a month and the expedited review process takes about two weeks duration, on average.

Footnotes:

1The 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.

2Research involving human subjects/participants 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.

Documents required for Initial Review are:

    1. Please submit a copy of administrative clearance obtained from Policy & Planning Division (PPD) of the Ministry of Health (MoH);
    2. Please submit all relevant site(s) clearance(s);
    3. Application Form for Initial Review; It can be downloaded from: IRB Forms Menu. Also, it’ll be provided on request;
    4. Protocol Summary Sheet; It can be downloaded from: IRB Forms Menu. Also, it’ll be provided on request;
    5. Research Protocol/proposal including the itemized budget and research project schedule or timeline (Final version) – Please write dated version number on it;
    6. Research/study tools (e.g. Final version of the questionnaire, forms, guides. etc.) – Please write dated version number on it;
    7. Curriculum Vitae (CV) of all Investigator(s), including Co-Investigators;
    8. Information Sheet and Informed Consent Form (IFC), in both English and translated Dzongkha languages – Please write dated version number on it.
    9. For second (subsequent) reviews (resubmission with major or Minor reviews) please fill in the resubmitted review application form (Application Form For Resubmitted Protocol Review (2_APPLICATION FORM for RESUBMITTED PROTOCOL REVIEW) and submit the revised protocol (highlight the changes made in the revised protocol).
    10. For amendment review, PI must submit the revised protocol (highlight the changes made) along with application form for amendment review (4_APPLICATION FORM for PROTOCOL AMENDMENT REVIEW).

Specific IFC requirements:

    1. For participants ≥ 18 year:
      • Informed Consent
    2. For participants 12 to 18 years:
      • Informed Consent from the parent(s) or legal guardian
      • Informed Assent from the participant
    3. For participants 7 to <12 years:
      • Informed Consent from the parent(s) or legal guardian
      • Verbal Informed Assent from the participant
    4. For participants <7 years:
      • Informed Consent from the parent(s) or legal guardian
    5. For participants who are incompetent to give informed consent:
      • Informed Consent from the parent(s) or legal guardian
      • Informed Assent from the participant
    6. For illiterate:
      • Provision for thumb impress
      • Provision for witness
    7. A statement by the researcher or person taking consent declaring that the informed consent is appropriately administered.

Submit all above documents to the Secretariat of IRB at Research & Innovation Division (RID)-MECRIT, KGUMSB through Email ID: (irbkgumsb@gmail.com).

For more details, please contact IRB Secretariat/Member Secretary (irbkgumsb@gmail.com) OR IRB Chairperson (zimba.letho@gmail.com) OR visit (https://www.kgumsb.edu.bt/?page_id=3715).

SCOPE OF IRB REVIEW AND ACTION LETTERS: Please note that IRB 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.

  • IRB Secretariat will acknowledge the document receipt through an email or provide a copy of the Document Receipt Form. Therefore, please ensure that you get either a document receipt form or an Email Acknowledgment from the IRB Secretariat. If you don’t receive a Document Receipt Form or an Email Acknowledgment within three working days then it would mean that the IRB has not received your protocol package. In such cases, we would request you to follow up with IRB secretariat at the aforementioned contact information.
  1. Application Form For Initial Review [AF/03-008/01]: (1_APPLICATION FORM for INITIAL REVIEW)
    1.1. Protocol Summary Sheet Checklist of items [AF/04-008/01]: (1.1_PROTOCOL SUMMARY SHEET_Checklist-of-Items)
    1.2. Application Form For Initial Review of Case Study Case Series [AF/05-008/01]: (1.2_APPLICATION FORM for INITIAL REVIEW of CASE STUDY CASE SERIES)
  2. Application Form For Re-submitted Protocol Review [AF/02-013/01]: (2_APPLICATION FORM for RESUBMITTED PROTOCOL REVIEW)
  3. Application Form For Continuing Review [AF/01-015/01]: (3_APPLICATION FORM for CONTINUING REVIEW)
  4. Application Form For Protocol Amendment Review [AF/01-014/05]: (4_APPLICATION FORM for PROTOCOL AMENDMENT REVIEW)
  5. Study Assessment Form [AF/01-012/01]: (5_STUDY ASSESSMENT FORM)
    5.1. Study Assessment Form For Case Study and Case Series [AF/02-012/01]: (5.1_STUDY ASSESSMENT FORM for CASE STUDY and CASE SERIES)
    5.2. Informed Consent Assessment Form [AF/03-012/06]: (5.2_INFORMED CONSENT ASSESSMENT FORM)
  6. Assessment Report Form [AF/04-012/01]: (6_ASSESSMENT REPORT FORM)
  7. Resubmitted Protocol Review Form [AF 01-013/01]: (7_RESUBMITTED PROTOCOL REVIEW FORM)
  8. Format For Review Of Research Report [AF/02-015/01]: (8_FORMAT FOR REVIEW OF RESEARCH REPORT)
  9. Final Report Review Letter Template1 [IRB/PN/yyyy/xxx]: (9_FINAL REPORT REVIEW LETTER TEMPLATE_01)
  10. Document Receipt Form [AF/02-008/01]: (10_DOCUMENT RECEIPT FORM)
  11. Contents Of Submitted Packages [AF/01-008/01]: (11_CONTENTS OF A SUBMITTED PACKAGE)
  12. Serious Adverse Event Report [AF/01-019/01]: (12_SERIOUS ADVERSE EVENT REPORT)
  13. Unexpected Adverse Event Summary Report [AF/02-019/01]: (13_UNEXPECTED ADVERSE EVENT SUMMARY REPORT)
  14. Safety Report Review Form [AF/03-019/01]: (14_SAFETY REPORT REVIEW FORM)
  15. Deviation Non-Compliance Violation Record [AF/01-016/01]: (15_DEVIATION NON-COMPLIANCE VIOLATION RECORD)
  16. Request For Revision of an SOP [AF/05-001/01]: (16_REQUEST FOR REVISION OF AN SOP)
  17. Study Termination Memorandum [AF/01-018/01]: (17_STUDY TERMINATION MEMORANDUM)
  18. Study Completion Report Form [F/01-016/01]: (18_STUDY COMPLETION REPORT FORM)
  19. Document Request Form [AF/01-025/01]: (19_DOCUMENT REQUEST FORM)
  20. Guide to Placebo Justification [ANNEX 11]: (20_GUIDE TO PLACEBO JUSTIFICATION)

Standard Operating Procedures (SOPs) of IRB [Chapters-wise Download]:

  1. Chapter 1: Preparing Standard Operating Procedures (SOPs) & Guidelines for Review Board (IRB):
  2. Chapter 2: Constituting an Ethics Board/ Institutional Review Board (IRB):
  3. Chapter 3: Initial Review Procedures:
  4. Chapter 4: Protocol Amendments, Continuing Review & End of Study:
  5. Chapter 5: Monitoring Protocol Implementation:
  6. Chapter 6: Monitoring and Evaluation of Adverse Events:
  7. Chapter 7: Site Monitoring:
  8. Chapter 8: Preparation of Review Meeting Agenda and Communication Records:
  9. Chapter 9: Managing Study Files:
  10. Chapter 10: Evaluating an IEC/IRB:
  11. Glossary: (11.1-chap_sop-irb)

Relevant Guidelines, templates, ToR & others:

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