INSTITUTIONAL REVIEW BOARD
The Bicol Regional Training and Teaching Hospital - Institutional Review Board (BRTTH-IRB) is the first and only Philippine Health Research Ethics Board (PHREB) Level III-accredited and Forum for Ethical Review Committees in Asia and the Western Pacific (FERCAP)-recognized ethics committee in the Bicol Region. Being in a charitable non-profit tertiary government hospital, the BRTTH-IRB promotes and regulates ethical research activities for the benefit of research participants and patients.This institution aims to integrate local and international research projects in addressing challenges, as well as health needs of the community. This is anchored to the BRTTH Mission to provide safe and quality healthcare services dynamically involved in advocacy, education, training, research and extension.
One of the strategies to accomplish the BRTTH mission is to ensure the involvement of appropriate and competent IRB manpower. The BRTTH-IRB composition has a diverse discipline to ethically augment its review process in accordance with the national and international ethics guidelines. To date, the committee has nine (9) core members, eleven (11) alternate members, five (5) external members, two (2) secretariat staffs and seventy (70) independent consultants. They are fully committed in the operations of the IRB, particularly in ethics review and other research-related undertakings.
Aside from the membership, the IRB ensures the establishment and consistent compliance to its Standard Operating Procedures (SOPs) that are tailor-fitted to BRTTH and carefully patterned from the DOH template. It illustrates step-by-step description of the different procedures for implementation of institutional policies that pertain to human protection, research ethics review, composition and mandate of the BRTTH-IRB. Among the most essential SOPs are: a.) Chapter 1 - IRB Structure and Composition, b.) Chapter 2 - Review Procedures, c.) Chapter 3 - IRB Monitoring Procedures, d.) Chapter 4 - Meeting Conduct, Documentation and Archiving, e.) Chapter 5 - Writing and Revising Standard Operating Procedures, and f.) Chapter 6 - Single Joint Ethics Review Board. Through these standard operating procedures, the IRB members and the readers will benefit from and fully maximize the services offered by the BRTTH-IRB.
ORGANIZATIONAL STRUCTURE
SERVICES:
| SERVICES: ETHICS REVIEW (type of protocol) | SCHEDULES | RATES | |
|---|---|---|---|
| Initial Review | Renewal | ||
| Sponsor initiated protocols | Weekdays except holidays and weekends | • Full board: Maximum of Php 50,000.00 | • Php 10,000.00 |
| • Expedited: Maximum of Php 30,000.00 | • Php 5,000.00 | ||
| Protocols from professional researchers (e.g., researchers from the academe, consultants affiliated to recognized local and international organizations, etc.) | Weekdays except holidays and weekends | • Full board: Maximum of Php 10,000.00 | • Php 5,000.00 |
| • Expedited: Maximum of Php 5,000.00 | • Php 2,500.00 | ||
| Protocols from trainees such as: hospital fellows, residents, graduate and undergraduate students | Weekdays except holidays and weekends | For trainees of the home institution, no fees shall be charged. For trainees of other institution, the following fees shall apply: • Undergraduate students whether full board or expedited: Max. of 1,000.00 |
• Php 500.00 |
| • Fellows, residents and graduate students: Max. of 5,000.00 | • Php 2,500.00 | ||
| The IRB shall collect an additional minimum fee of Php 1,000.00 or higher (depending on the bulk of papers) for the printing of online submitted documents (initial review and post-approval documents) especially to those researchers who cannot come physically to the IRB for the submission of hard copies. The following rates are based on the Department of Health Admin Order: 2017-0265. |
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BRTTH - Ethics Review Process
SOPs and FORMS
- CHAPTER 1: IRB Structure and Composition
- 1.1 Appointment of IRB Members
- 1.2 Appointment of Independent Consultants
- 1.3 Training of IRB Members and Staff
- CHAPTER 2: REVIEW PROCEDURES
- 2.1 Management of Initial Protocol Submissions
- 2.2 Use of Study Assessment Forms
- 2.3 Exempt from Review
- 2.4 Expedited Review
- 2.5 Full Board Review of Submitted Protocols
- 2.6 Review of Resubmission
- 2.7 Management of Appeals
- CHAPTER 3: IRB MONITORING PROCEDURES
- 3.1 Review of Protocol Amendment
- 3.2 Review of Progress Report
- 3.3 Review of Final Report
- 3.4 Review of Serious Adverse Event
- 3.5 Review of Protocol Violation/Deviation
- 3.6 Responding to Participant’s Request/Query
- 3.7 Site Visits
- 3.8 Review of Early Protocol Termination
- CHAPTER 4: MEETING CONDUCT, DOCUMENTATION AND ARCHIVING
- 4.1 Preparation of Meeting Agenda
- 4.2 Conduct of a Full Board Meeting
- 4.3 Preparation of Meeting Minutes
- 4.4 Communicating IRB Decision to PI/ Researcher
- 4.5 Management of Active Study Files, Documents, and Records
- 4.6 Archiving of Inactive Study Files
- 4.7 Maintenance of Confidentiality of Study Files and IRB Documents
- CHAPTER 5: WRITING AND REVISING STANDARD OPERATING PROCEDURES
- 5.1 Writing SOPs
- 5.2 Revising SOPs
- CHAPTER 6: SINGLE JOINT RESEARCH ETHICS BOARD
- 6.1 Authority, Composition, and Structure of SJREB
- 6.2 Joint Review of Initial Submission
- 6.3 Continuing Review Procedures
- 6.4 Documentation and Archiving
BRTTH - IRB Forms
- APPENDIX A
- Form 1.1 A Statement of Responsibilities of IRB Chair
- Form 1.1 B Statement of Responsibilities of IRB Vice-Chair
- Form 1.1 C Statement of Responsibilities of IRB Member-Secretary
- Form 1.1 D Statement of Responsibilities of IRB Member
- Form 1.1 E Statement of Responsibilities of IRB Secretariat Staff
- Form 1.1 F Statement of Responsibilities of Independent Consultant
- Form 1.2 Curriculum Vitae
- Form 1.3 Confidentiality and Conflict of Interest Agreement
- Form 1.4 Training Record of an IRB Member
- Form 1.5 Invitation to Independent Consultant
- APPENDIX B
- Form 2.1 Application for Initial Review
- Form 2.2 Protocol Summary Sheet
- Form 2.3 Protocol Assessment Form
- Form 2.4 Informed Consent Assessment Form
- Form 2.5 IRB Notice for Protocol Modification (for initial and continuing review)
- Form 2.6 Certificate of Approval
- Form 2.7 Certificate of Exemption from Ethics Review
- Form 2.8 Protocol Resubmission Form
- Form 2.9 Affidavit
- Form 2.10 Notice of Review
- Form 2.11 Assessment Form for Independent Consultant
- APPENDIX C
- APPENDIX D
- APPENDIX E
- APPENDIX F
BRTTH - IRB MEETING SCHEDULE FOR 2021
DATE : January 16, 2021
February 6, 2021
March 6, 2021
April 3, 2021
May 8, 2021
June 5, 2021
July 3, 2021
August 7, 2021
September 4, 2021
October 9, 2021
November 7, 2021
December 4, 2021
TIME: 8:00AM-12NN
VENUE: BRTTH Library
OFFICE CONTACTS:
Trunkline:
Local Extention: 4205
Email: This email address is being protected from spambots. You need JavaScript enabled to view it.
Mobile: 09457788490
Secretary/Point Person: Mr. Franco G. Velasco