Institutional Review Board

“Ethical Clearance for Researches/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. 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-FERCAP3.

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

J=Justice

The Board Meets 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

1. 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.

2. Research involving human subjects/participants includes:

2.1 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;

2.2 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;

2.3 studies designed to determine the consequences for individuals and communities of specific preventive or therapeutic measures; and

2.4 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 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: irbkgumsb@gmail.com.

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.

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