VETERANS MEMORIAL MEDICAL CENTER     

INSTITUTIONAL REVIEW BOARD

Contact Information:

Trunk Line: (+632) 89276426 to 31 local 1344

Email Address: This email address is being protected from spambots. You need JavaScript enabled to view it. and This email address is being protected from spambots. You need JavaScript enabled to view it.

Address: Ward 18, North Avenue, Diliman, Quezon City

PHREB Registration No.: 08-047

INTRODUCTION

In 2010 the VMMC-Institutional Review Board (VMMC-IRB) evolved from the Ethics Committee (established in 1979) by virtue of VMMC Memo Order # 58 dated                                           02 November 2010.

The VMMC-IRB is composed of medical/scientific professionals and non-medical/ non-scientific members working together in a committee that safeguards the rights, safety, and well-being of all subjects involved in a clinical trial and providing public assurance of that protection.

The VMMC - IRB adheres to the Ethical Principles of the following:

·         World Medical Association Declaration of Helsinki (WMA-DoH)

·         International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use: ICH Harmonised Tripartite
Guideline for Good Clinical Practice E6 (R1)

·         Council for International Organization of Medical Sciences International Ethical
Guidelines for Biomedical Research Involving Human Subjects (CIOMS-
Biomedical)

·         Council for International Organization of Medical Sciences International Ethical
Guidelines for Epidemiological Studies (CIOMS-Epidemiology)

·         National Ethical Guidelines for Health and Health-Related Research 2017

·         Department of Science and Technology (DOST) Administrative Order 001

·         Series of 2007 requiring ethics review of all health researches involving human participants

·         Department of Science and Technology (DOST) Administrative Order 001
Series 2008 requiring all Ethics Review Committees (ERB)/Institutional Review Committees (IRB) to register with the Philippine Health Research Ethics Board (PHREB)

·         Commission on Higher Education (CHED)Memorandum Order 34 Series 2007 in support of the DOST memorandum requiring all academic institutions engaged in human research to establish ethics review boards/committees

·         Registered with the Philippine Health Research Ethics Review (PHREB) on August 13, 2013 (Registration No. 08-047).

STANDARD OPERATING PROCEDURES AND FORMS

Chapter I: STRUCTURE AND COMPOSITION (downloadable)

1.  OBJECTIVES

The SOP describes the organizational framework for the structure and composition of the Veterans Memorial Medical Center - Institutional Review Board (VMMC-IRB). It supersedes the document known as “Veterans Memorial Medical Center - IRB Guidelines” which governed the functioning of the old Ethics Committee of the institution. This SOP also describes and provides the procedures, templates, and forms that are related to the nomination, appointment, training, and compensation of members of the Board, as well as identifying the persons who should read, agree to, sign and date these forms. Privacy and confidentiality documentation is likewise decided.

2.  SCOPE

The SOP applies to the stated functions of the VMMC-IRB, as it carries out its task of providing an independent review of research protocols involving human participants that are submitted to the IRB by consultant-physicians, resident and fellow-trainees, students, hospital staff and employees of the VMMC for clinical trials or researches done within the hospital or institution alone.

This SOP describes the basic ethical principles and values on which the VMMC-IRB is based, the composition and appointment of the IRB members and the duties and responsibilities of IRB personnel, including attendance, training and disclosure of conflict of interest.

·         VMMC-IRB Form 1-A: Medical or Scientific Member Notification and Appointment (downloadable)

·         VMMC-IRB Form 1-B: Non-Medical or Lay Member Notification and Appointment(downloadable)

·         VMMC-IRB Form 1-C: Curriculum Vitae (downloadable)

·         VMMC-IRB Form 1-D: Confidentiality Agreement and Conflict of Interest Disclosure (downloadable)

·         VMMC-IRB Form 1-E: Training Record (downloadable)

·         VMMC-IRB Form 1-F: Service Agreement for Independent Consultants (downloadable)

Chapter II: INITIAL REVIEW  (downloadable)

• VMMC-IRB Form 2-A1: Review Checklist for Initial Review Application (downloadable)
• VMMC-IRB Form 2-A2: Review Checklist for Resubmission and Amendment   (downloadable)
• VMMC-IRB Form 2-B: Registration and Application Form (downloadable)
• VMMC-IRB Form 2-C: Study Protocol Assessment Form (downloadable)
• VMMC-IRB Form 2-D: Informed Consent Assessment Form (downloadable)
• VMMC-IRB Form 2-E: Meeting Agenda (downloadable)
• VMMC-IRB Form 2-F: Review of Resubmitted Study Protocol Form (downloadable)
• VMMC-IRB Form 2-G: Confidentiality Agreement for Guests or Observers (downloadable)
• VMMC-IRB Form 2-H: Transmittal Letter (downloadable)

Chapter III: POST-APPROVAL REVIEW  (downloadable)

• VMMC-IRB Form 3-A: Study Protocol Amendment Submission Form (downloadable)
• VMMC-IRB Form 3-B: Additional Study Material for Approval Form (downloadable)
• VMMC-IRB Form 3-C: Continuing Review Application Form (downloadable)
• VMMC-IRB Form 3-D: Final Report Form (downloadable)
• VMMC-IRB Form 3-E: Study Protocol Deviation or Non-Compliance Report (downloadable)
• VMMC-IRB Form 3-F: Early Study Termination Application Form (downloadable)
• VMMC-IRB Form 3-G: Site Visit Report Form (downloadable)
• VMMC-IRB Form 3-H: Serious Adverse Event(s) Report (downloadable)
• VMMC-IRB Form 3-I: Notice of Site Visit (downloadable)
• VMMC-IRB Form 3-J: Study Participant Queries or Complaints (downloadable)

Chapter IV: DOCUMENTATION AND ARCHIVING  (downloadable)

• VMMC-IRB Form 4-A: Format of the Minutes of the Meeting (downloadable)
• VMMC-IRB Form 4-B: Certification of Approval (downloadable)
• VMMC-IRB Form 4-C: Action Letter to Study Protocol Submission/Resubmissions/ Amendments (downloadable)
• VMMC-IRB Form 4-D: Letter for Clarificatory Interview (downloadable)
• VMMC-IRB Form 4-F: Notification Letter (Request Information) to Continuing Review Application/Final Report/Deviation/Site Visit (downloadable)
• VMMC-IRB Form 4-G: Archiving Notification (downloadable)
• VMMC-IRB Form 4-H: Notification Letter for Site Visit (downloadable)
• VMMC-IRB Form 4-I: Borrowers Log (downloadable)
• VMMC-IRB Form 4-J: Confidentiality Agreement for Non-Members Requesting for Copies of VMMC-IRB Documents (downloadable)
• VMMC-IRB Form 4-K: Log of Request for Copies of Documents (downloadable)
• VMMC-IRB Form 4-M: Notification Letter (Uphold Approval) for Continuing Review Application, Deviation/Non-compliance/Violation Report/SAE or SUSAR Report/Site Visit Report
• VMMC-IRB Form 4-N: Submission Log (downloadable)
• VMMC-IRB Form 4-O: Reminder Letter for Continuing Review Application (downloadable)
• VMMC-IRB Form 4-P: Reminder Letter for Late Submission of Continuing Review Application (downloadable)
• VMMC-IRB Form 4-Q: Letter  for Non-Submission of Progress Reports/Continuing Review Application (downloadable)

Chapter V: PREPARING STANDARD OPERATING PROCEDURES (downloadable)

• VMMC-IRB Form 5-A: SOP Template (downloadable)
• VMMC-IRB Form 5-B: SOP Cover Page (downloadable)
• VMMC-IRB Form 5-C: Request for Revision of an SOP (downloadable)
• VMMC-IRB Form 5-D: Document History (downloadable)

References (downloadable)

Glossary (downloadable)

For CLINICAL TRIAL AGREEMENT (CTA) signatories:

The Sponsor prepares the tri-partite clinical trial agreement (CTA) to be signed by the Sponsor, Principal Investigator and VMMC Director

Composition of VMMC-IRB Members

From February 1, 2021 – January 31, 2023

*Legend:               L: Lay Member     N.I.: Non-Institutional Member