{"id":19406,"date":"2025-04-09T06:20:07","date_gmt":"2025-04-09T06:20:07","guid":{"rendered":"http:\/\/new.kgumsb.edu.bt\/?page_id=19406"},"modified":"2026-03-18T06:06:27","modified_gmt":"2026-03-18T06:06:27","slug":"irb","status":"publish","type":"page","link":"https:\/\/www.kgumsb.edu.bt\/index.php\/irb\/","title":{"rendered":"IRB"},"content":{"rendered":"\n\n\nInstitutional Review Board\n

\u201cEthical Clearance for Researches\/studies involving Human Participants<\/strong>\u201c<\/span><\/em><\/h1>\n\n\n\n\n\n\n\n\n\n\nThe 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.<\/span>\nSince 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\u2019 protection, IRB may take actions for such incident.<\/span>\nThe 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.\n<\/span>\nThe 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.\n<\/span>\nThe guiding principles in making this decision are those of:\n<\/span>\n\nI=Integrity
\nR=Respect for persons
\nB=Beneficence
\nJ=Justice
\n\nThe Board Meets 4 times (January, March, July & November<\/strong>) 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.\n<\/span>\n\n\n\n\n\nFootnotes\n<\/strong><\/span>\n\n1.<\/strong> The term \u201cresearch\u201d 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 \u201cresearch\u201d includes both medical and behavioural studies pertaining to human health.
\n2.<\/strong> Research involving human subjects\/participants includes:
\n\n\n2.1<\/strong> studies of a physiological, biochemical or pathological process, or of the response to a specific intervention \u2013 whether physical, chemical or psychological \u2013 in healthy subjects or patients;
\n2.2<\/strong> 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;
\n2.3<\/strong> studies designed to determine the consequences for individuals and communities of specific preventive or therapeutic measures; and
\n2.4<\/strong> studies concerning human health-related behaviour in a variety of circumstances and environments.
\n\n\n\n\n\n\n\nDocuments required for initial review are:<\/strong><\/span>\n\n1. Please submit a copy of administrative clearance obtained from Policy & Planning Division (PPD) of the Ministry of Health (MoH)\n2. Please submit all relevant site(s) clearance(s)\n3. Application Form for Initial Review. It can be downloaded from IRB Forms Section<\/em>. Also, it\u2019ll be provided on request.\n4. Protocol Summary Sheet; It can be downloaded from IRB Forms Section<\/em>. Also, it\u2019ll be provided on request;\n5. Research Protocol\/proposal including the itemized budget and research project schedule or timeline (Final version). Please write dated version number on it\n6. Research\/study tools (e.g. Final version of the questionnaire, forms, guides. etc.). Please write dated version number on it\n7. Curriculum Vitae (CV) of all Investigator(s), including Co-Investigators\n8. Information Sheet and Informed Consent Form (IFC), in both English and translated Dzongkha languages. Please write dated version number on it.\n9. 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<\/em>) and submit the revised protocol (highlight the changes made in the revised protocol)\n10. 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<\/em>)\n\nSpecific IFC Requirements:<\/strong><\/span>\n\n1. For participants \u2265 18 year:
– Informed Consent\n2. For participants 12 to 18 years:
– Informed Consent from the parent(s) or legal guardian
– Informed Assent from the participant\n3. For participants 7 to <12 years:
– Informed Consent from the parent(s) or legal guardian Verbal
– Informed Assent from the participant\n4. For participants <7 years:
Informed Consent from the parent(s) or legal guardian\n5. For participants who are incompetent to give informed consent:
– Informed Consent from the parent(s) or legal guardian
– Informed Assent from the participant\n6. For illiterate:
– Provision for thumb impress
– Provision for witness\n7. A statement by the researcher or person taking consent declaring that the informed consent is appropriately administered.\n\n

Submit all above documents to the Secretariat of IRB at Research & Innovation Division (RID)-MECRIT, KGUMSB through Email ID: irbkgumsb@gmail.com<\/em><\/strong>.\n<\/p>\n

For more details, please contact IRB Secretariat\/Member Secretary (irb@kgumsb.edu.bt<\/em><\/strong>) OR IRB Chairperson (zimba.letho@fnph.edu.bt<\/em><\/strong>).\n<\/p>\n

Scope of IRB Review AND Action Letters:<\/strong> <\/p>

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.<\/em><\/p>\n\n\n\n\n\n\nIRB 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\u2019t 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<\/span>\n\n\n\n\n\n\n\n1. Application Form For Initial Review [AF\/03-008\/01]\n1.1. Protocol Summary Sheet Checklist of items [AF\/04-008\/01]\n1.2. Application Form For Initial Review of Case Study Case Series [AF\/05-008\/01]\n2. Application Form For Re-submitted Protocol Review [AF\/02-013\/01]\n3. Application Form For Continuing Review [AF\/01-015\/01]\n4. Application Form For Protocol Amendment Review [AF\/01-014\/05]\n5. Study Assessment Form [AF\/01-012\/01]\n5.1. Study Assessment Form For Case Study and Case Series [AF\/02-012\/01]\n5.2. Informed Consent Assessment Form [AF\/03-012\/06]\n6. Assessment Report Form [AF\/04-012\/01]\n7. Resubmitted Protocol Review Form [AF 01-013\/01]\n8. Format For Review Of Research Report [AF\/02-015\/01]:\n9. Final Report Review Letter Template1 [IRB\/PN\/yyyy\/xxx]\n10. Document Receipt Form [AF\/02-008\/01]\n11. Contents Of Submitted Packages [AF\/01-008\/01]\n12. Serious Adverse Event Report [AF\/01-019\/01]:\n13. Unexpected Adverse Event Summary Report [AF\/02-019\/01]\n14. Safety Report Review Form [AF\/03-019\/01]\n15. Deviation Non-Compliance Violation Record [AF\/01-016\/01]\n16. Request For Revision of an SOP [AF\/05-001\/01]\n17. Study Termination Memorandum [AF\/01-018\/01]\n18. Study Completion Report Form [F\/01-016\/01]:\n19. Document Request Form [AF\/01-025\/01]\n20. Guide to Placebo Justification [ANNEX 11]\n\n\n\n\n\n\n\nStandard Operating Procedures (SOPs) of IRB [Chapters-wise Download<\/em>]<\/strong><\/span>\n\nTable of Contents (TOC)\nAnnexure List\n\nChapter 1: Preparing Standard Operating Procedures (SOPs) & Guidelines for Review Board (IRB)<\/strong><\/span>\n\n1.1. Writing, Reviewing, Distributing and Amending SOPs for Review Board [SOP\/001\/01]\n1.2. Preparation of Guidelines [SOP\/002\/01]\n\nChapter 2 : Constituting an Ethics Board\/ Institutional Review Board (IRB)<\/strong><\/span>\n\n2.1. Constituting an IRB [SOP\/003\/01]\n2.2. Confidentiality\/Conflict of Interest Agreements [SOP\/004\/01]\n2.3. Training Personnel and IRB Members [SOP\/005\/01]\n2.4. Selection of Independent Consultants [SOP\/006\/01]\n\nChapter 3 : Initial Review Procedures<\/strong><\/span>\n\n3.1. Determination of Research Qualifying from Exemption of Ethics Review [SOP\/007\/01]\n3.2. Management of Protocol Submissions [SOP\/008\/01]\n3.3. Expedited Reviews [SOP\/009\/01]\n3.4. Initial Review of Research\/ Application Protocols [SOP\/010\/01]\n3.5. Review of New Medical Devices Studies [SOP\/011\/01]\n3.6. Use of study Assessment Form [SOP\/012\/01]\n\nChapter 4 : Protocol Amendments, Continuing Review & End of Study<\/strong><\/span>\n\n4.1. Review of Resubmitted Protocols [SOP\/013\/01]\n4.2. Review of Protocol Amendments [SOP\/014\/01]\n4.3. Management of Protocol Continuing Reviews [SOP\/015\/01]\n4.4. Review of Final Reports [SOP\/016\/01]\n\nChapter 5 : <\/strong><\/span>Chapter 5: Monitoring Protocol Implementation<\/strong>\n\n5.1. Intervention in Protocol Deviation\/Non-Compliance\/Violation [SOP\/017\/01]\n5.2: Response to Research Participants\u2019 Request [SOP\/018\/01]\n5.3: Management of Study Termination [SOP\/019\/01]\n\nChapter 6 : <\/strong><\/span>Monitoring and Evaluation of Adverse Events<\/strong>\n\n6.1. Review of Serious Adverse Events (SAE) Reports [SOP\/020\/01]\n\nChapter 7 : <\/strong><\/span>Site Monitoring<\/strong>\n\n7.1 Site Monitoring Visits [SOP\/021\/01]\n\nChapter 8 : Preparation of Review Meeting Agenda and Communication Records<\/strong><\/span>\n\n8.1. Agenda Preparation, Meeting Procedures and Minutes [SOP\/022\/01]\n8.2. Emergency Meeting [SOP\/023\/01]\n8.3. Communication Records [SOP\/024\/01]\n\nChapter 9 : <\/strong><\/span>Managing Study Files<\/strong>\n\n9.1. Maintenance of Active Study Files [SOP\/025\/01]\n9.2. Archive and Retrieval of Documents [SOP\/026\/01]\n9.3. Maintaining Confidentiality of IRB\u2019s Documents [SOP\/027\/01]\n\nChapter 10 : Evaluating an IEC\/IRB<\/strong><\/span>\n\n10.1. Audit and Inspection of the IRB [SOP\/028\/01]\n\n\nGlossary\n\n\n\n\n\n\n\nRelevant Guidelines, Templates & Others<\/strong><\/span>\n\nPostgraduate (PG Residency Program) Thesis Guidelines\nInformed Consent Form Template_v1 (adapted from WHO guideline)\nHealth Research Priority List (2019-2023)\nIRB Terms of Reference (Prior to Adoption of the SOPs)\n\n\n\n\n\n\n\n\n","protected":false},"excerpt":{"rendered":"","protected":false},"author":1,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"pagelayer_contact_templates":[],"_pagelayer_content":"","footnotes":""},"class_list":["post-19406","page","type-page","status-publish","hentry"],"_links":{"self":[{"href":"https:\/\/www.kgumsb.edu.bt\/index.php\/wp-json\/wp\/v2\/pages\/19406","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.kgumsb.edu.bt\/index.php\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/www.kgumsb.edu.bt\/index.php\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/www.kgumsb.edu.bt\/index.php\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/www.kgumsb.edu.bt\/index.php\/wp-json\/wp\/v2\/comments?post=19406"}],"version-history":[{"count":95,"href":"https:\/\/www.kgumsb.edu.bt\/index.php\/wp-json\/wp\/v2\/pages\/19406\/revisions"}],"predecessor-version":[{"id":242082,"href":"https:\/\/www.kgumsb.edu.bt\/index.php\/wp-json\/wp\/v2\/pages\/19406\/revisions\/242082"}],"wp:attachment":[{"href":"https:\/\/www.kgumsb.edu.bt\/index.php\/wp-json\/wp\/v2\/media?parent=19406"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}