Initial Review Process

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 Section. Also, it’ll be provided on request.
  4. Protocol Summary Sheet; It can be downloaded from IRB Forms Section. 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 from IRB Forms Section) 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 (Application Form for Protocol Amendment Review from IRB Forms Section)

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: irb@kgumab.edu.bt.

For more details, please contact IRB Secretariat/Member Secretary (irb@kgumsb.edu.bt) OR IRB Chairperson (zimba.letho@fnph.edu.bt).

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.