Institutional Review Board (IRB)

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:

  1. I=Integrity;
  2. R=Respect for persons;
  3. B=Beneficence; and
  4. 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:
      • 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;
      • 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;
      • studies designed to determine the consequences for individuals and communities of specific preventive or therapeutic measures; and
      • studies concerning human health-related behaviour in a variety of circumstances and environments.
    3. SIDCER-FERCAP:
      The Strategic Initiative for Developing Capacity in Ethical Review (SIDCER) was founded in 2001 by the World Health Organization under the Special Programme for Research and Training in Tropical Diseases (WHO-TDR), in an effort to address the fundamental ethical gaps and challenges encountered in global health research.The Forum for Ethical Review Committees in the Asian and Western Pacific Region (FERCAP) was conceived in Bangkok, Thailand on 12 January 2000 after much thought and deliberation among a group of bioethicists and medical experts with the objective of fostering an improved understanding and better implementation of ethical review of behavioral and biomedical researches in the region. FERCAP is the result of the realization that ethics requires collective wisdom and there is need for a systems approach to address important health research issues in Asia and the Western Pacific.

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)

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

      • 1.2_Application Form For Initial Review Of Case Study Case Series [AF/05-008/01]
      • 5.1_Study Assessment Form For Case Study and Case Series [AF/02-012/01]

1. Terms of Reference (ToR) of IRB [TOR Version_1.3]
2. STANDARD OPERATING PROCEDURES (SOPs) of IRB [Full Download]
3. CHAPTERWISE STANDARD OPERATING PROCEDURES (SOPs) of IRB:

Table of Contents: [TOC]

Chapter 1: Preparing Standard Operating Procedures (SOPs) & Guidelines for Review Board/ IRB

  • 1.1: Writing, Reviewing, Distributing and Amending SOPs for Review Board [SOP/001/01]
  • 1.2: Preparation of Guidelines [SOP/002/01]

Chapter 2: Constituting an Ethics Board/ Institutional Review Board (IRB)

Chapter 3: Initial Review Procedures

  • 3.1: Determination of Research Qualifying from Exemption of Ethics Review [SOP/007/01]
  • 3.2: Management of Protocol Submissions [SOP/008/01]
  • 3.3: Expedited Reviews [SOP/009/01]
  • 3.4: Initial Review of Research/ Application Protocols [SOP/010/01]
  • 3.5: Review of New Medical Devices Studies [SOP/011/01]
  • 3.6: Use of study Assessment Form [SOP/012/01]

Chapter 4: Protocol Amendments, Continuing Review & End of Study

Chapter 5: Monitoring Protocol Implementation

  • 5.1: Intervention in Protocol Deviation/Non-Compliance/Violation [SOP/017/01]
  • 5.2: Response to Research Participants’ Request [SOP/018/01]
  • 5.3: Management of Study Termination [SOP/019/01]

Chapter 6: Monitoring and Evaluation of Adverse Events

  • 6.1: Review of Serious Adverse Events (SAE) Reports [SOP/020/01]

Chapter 7: Site Monitoring

Chapter 8: Preparation of Review Meeting Agenda and Communication Records

Chapter 9: Managing Study Files

Chapter 10: Evaluating an IEC/IRB

Chapter 11: [Glossary]

Relevant guidelines, templates and others:

    • Postgraduate (PG Residency Program) Thesis guidelines: [Download]
    • Informed Consent Form Template_v1 (adapted from WHO guideline): [Download]
    • Health Research Priority List (2019-2023): [Download]
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