Initial Review

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: http://www.mecrit.bt/irb-forms; Also, it’ll be provided on request;
4. Protocol Summary Sheet; It can be downloaded from: http://www.mecrit.bt/irb-forms;  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, in both English and translated Dzongkha languages – Please write dated version number on it:
   
   • For participants ≥ 18 year
     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 impress
     Provision for witness
     
   • A statement by the researcher or person taking consent declaring that the informed consent is appropriately administered.

Submit both hard and soft copies of all above documents to the Secretariat of IRB at Research & Innovation Unit, Medical Education Centre for Research Innovation and Training (MECRIT), KGUMSB.

For more details, please visit: www.mecrit.bt/irb OR https://www.kgumsb.edu.bt/?page_id=3715

Email: IRB Secretariat (irbkgumsb@gmail.com) OR Member Secretary (tj@kgumsb.edu.bt) OR IRB Chairperson (karmatenzin@kgumsb.edu.bt);

Contact at: 02-328990 ext# 2146 (Office Hours)