Interim Institutional Review Board (I-IRB) for Postgraduate Thesis Ethics Review

The Medical Education Centre for Research Innovation and Technology (MECRIT) under the auspices of Khesar Gyalpo University of Medical Sciences of Bhutan (KGUMSB) has instituted Interim IRB mainly to facilitate smooth conduct of Postgraduate (PG) Thesis as a part and parcel of their academic course requirements. The main responsibility of I-IRB is to ensure that all academic thesis conducted by the PG students are to ethical and scientific standards. In addition, the I-IRB will strive to ensure integrity in all researches/studies conducted by upholding the principles of ethical research in all its forms, giving oversight to due diligence of non-standard researches, and reviewing the outcome of investigations into research misconduct, among others.

As a researcher(s), it is of utmost importance that individuals, specifically the Primary Investigator (PI) are well aware of the ethical conduct of medical, clinical or social research/study in their academic role. Also be informed of the policy and guidelines pertaining the academic misconduct, such as ‘Plagiarism’ defined and adhered by the respective faculty within the KGUMSB.

Always be reminded to follow three basic ethical principles enshrined in the widely known Belmont Report (April, 1979), which serves as a basis for the Biomedical and behavioral research, such as:

1. Respect for persons: ensure recognition of human dignity through legitimate informed consent process, addressing adequate information, ease of comprehension and total voluntariness to participate in the study;
2. Beneficence: protecting people in research from any forms of harms, while maximizing possible benefits of the research and in any circumtances minimize possible or potential harms;
3. Justice: fairly distribute the benefits and burdens of research among groups of populace, and averting any biases in terms of gender/sex, race, social status, other demographic and social background. 

To submit your research/study protocol for initial ethics review, following documents are mandatory:

1. Administrative clearance from Chief Planning Officer, PPD, Ministry of Health (MoH) and relevant study site(s) – such as, Medical Superintendent for JDWNRH, National Statistics Bureau for surveys, Chief Operations Officer, RBP/RBG/RBA for sites involving Military institutions, etc.;
2. Application Form for Initial Review – please download from URL: http://www.mecrit.bt/wp-content/uploads/iirb2020/1-APPLICATION-FORM-for-INITIAL-REVIEW.docx
3. Protocol Summary sheet – please download from URL: http://www.mecrit.bt/wp-content/iirb2020/1.1-PROTOCOL-SUMMARY-SHEET-CHECKLIST.docx
4. Research Protocol or Proposal, including the itemized budget and study timeframe (Final version); please write dated version number on it;
5. Research/ study tools, such as research questionnaires, forms, guides, etc.; please write dated version number on it;
6. Curriculum Vitae (CV) of all Investigator(s);
7. Information sheet and Informed Consent Form (in English and Dzongkha translated languages); please write dated version number on it:

    – For participants 18 years and above: Informed Consent.

    – For participants 12 to 18 years: Informed consent from the parent(s) or legal guardian AND Informed Assent from the participant;

    – For participants 7 to less than 12 years: Informed consent from the parent(s) or legal guardian AND Verbal  Informed Assent from the participant.

    – For participants less than 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 AND Informed Assent from the participant.

    – For illiterate: Provision for thumb impression AND Provision for witness.

    – A statement by the researcher or person taking consent declaring that the informed consent is appropriately administered.

8. Evidence of GCP training (only in case of clinical trials).

9. Others (PIs specify)……………………

Please, submit both hard and soft copies of all above documents to the Secretariat I-IRB at MECRIT, OOP Bldg., KGUMSB.

For further details, please visit www.mecrit.bt OR contact Mr. Cheku Wangchuk  (cheki123@kgumsb.edu.bt), Mr. Tshering JAMTSHO (tj@kgumsb.edu.bt), Dr Tika Ram Adhikari (tradhikari@jdwnrh.gov.bt) OR Call: 77431073.

Document receipt form or Email acknowledgemet: The I-IRB Secretariat will either provide a copy of the Document Receipt Form or will acknowledge the document receipt through an email. Therefore, please ensure that you get either the document receipt form or email from I-IRB Secretariat. If you didn’t receive Document Receipt Form or Email Acknowledgement within three working days then it would mean that I-IRB has not received your protocol package. In such cases, we would request you to follow up with I-IRB Secretariat, contact information stated above.

Scope of the I-IRB review and Action letter: Please note that I-IRB will be only reviewing the scientific and ethical soundness of the research/study. The PI(s) 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.

I-IRB Forms for Download:

1. 1_Initial Review application form
2. 1.1_Protocol Summary Sheet-checklist of items
3. 2_Resubmitted Protocol Review application form
4. 3_Continuing Review application form
5. 4_Protocol Amendment Review application form
6. 5_Study Assessment form
7. 5.2_Informed Consent Assessment form
8. 6_Assessment Report form
9. 7_Resubmitted Protocol Review form
10. 8_Review of Research Report format
11. 9_Final Report Review Letter template
12. 10_Document Receipt form
13. 11_Contents of submitted package
14. 12_Serious Adverse Event report
15. 13_Unexpected Adverse Event Summary report
16. 14_Safety Report Review form
17. 16_Deviation_Non-Compliance, Violation record
18. 17_Request for Revision of SOP
19. 18_Study Termination memorandum

Guidelines and template(s):

1. Thesis preparation guidelines for PG Residency programme
2. Informed Consent form template_v6 -WHO 

Note: All potential researchers are requested henceforth, to submit their research/study ethics protocol to IRB, MECRIT, KGUMSB.