About IERB
LCP-IERB Guidelines
SOP
List of Forms
Organizational Chart
The Lung Center of the Philippines – Institutional Ethics Review Board is dedicated in providing quality health care through research.
An independent body created by the LCP under the Office of the Executive Director, whose scope of work and responsibility is to ensure the protection of rights, safety and well being of human subjects involved in health related research and to provide public assurance of that protection. In accordance with applicable national/international regulations, the LCP-IERB has the authority to approve, require modifications to, or disapprove researches.
The Lung Center of the Philippines- Institutional Ethics Review Board reviews and monitors health researchers that involve LCP patients done within the LCP, or using LCP facilities.
a) initiated by LCP staff (consultants/residents/fellows; nurses and
other hospital staffb) pharmaceutically sponsored researches, wherein the Primary
Investigators are LCP staff
LCP-IERB post fire was re-established in 2003. Historically, approximately 20-25 research protocols are reviewed annually more than half are protocols submitted by trainees (fellows and residents), the rest are pharmaceutically sponsored clinical trials with funding.
The LCP-IERB Standard Operating Procedures (SOP) has adapted the Department of Health SOP. It has incorporated provisions of the existing guidelines of the LCP-IERB and the ICH-GCP. This is a revision made from the February 27, 2009 SOP.
- Policies and Guidelines on local (on-site) safety reporting
- Policies and Guidelines on informed consent for research involving children
- Guidelines on Reporting Adverse Events
| I. SOP 1 - Standard Operating Procedures (Structure and Composition) | |||
| 1. | LCPIERB Letter 1 (A) - 2018 | : Invitation Letter to Regular Member |
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| 2. | LCPIERB Letter 1 (A2) - 2018 | : Invitation Letter to Alternate Member | |
| 3. | LCPIERB Letter 1 (A3) - 2018 | : Invitation Letter to Independent Consultant | |
| 4. | LCPIERB Letter 1 (B) - 2018 | : Appointment Letter of Chairman | |
| 5. | LCPIERB Letter 1 (C) - 2018 | : Appointment Letter of Vice - Chairman | |
| 6. | LCPIERB Letter 1 (D) - 2018 | : Appointment Letter of Secretary | |
| 7. | LCPIERB Letter 1 (E) - 2018 | : Appointment Letter of Regular Member | |
| 8. | LCPIERB Letter 1 (E2) - 2018 | : Appointment Letter of Alternate Member | |
| 9. | LCPIERB Letter 1 (E3) - 2018 | : Appointment Letter of Independent Consultant | |
| 10. | LCPIERB Letter 1 (F) - 2018 | : Confidentiality Agreement and Conflict of Interest Disclosure Form | |
| 11. | LCPIERB Form 1 (G) - 2013 | : Curriculum Vitae | |
| 12. | LCPIERB Letter 1 (H) - 2014 | : Training Record of an IERB Member |
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| 13. | LCPIERB Form 1 (I) - 2014 | : Training Request | |
| II. SOP 2 - Standard Operating Procedures (Initial Review Procedures) | |||
| 1. | LCPIERB Form 2 (A) - 2018 | : Document Receipt Form | |
| 2. | LCPIERB Form 2 (B) - 2018 | : Application Form for Protocol Review | |
| 3. | LCPIERB Form 2 (C) - 2018 | : Checklist Form | |
| 4. | LCPIERB Form 2 (D) - 2015 | : Protocol Summary Sheet | |
| 5. | LCPIERB Form 2 (E) - 2018 | : Protocol Evaluation Form | |
| 6. | LCPIERB Form 2 (F) - 2015 | : Informed Consent Evaluation Form | |
| 7. | LCPIERB Form 2 (G) - 2015 | : Protocol Document Review Form | |
| 8. | LCPIERB Form 2 (H) - 2018 | : Checklist for Clinical Trial Outside LCP by LCP PI | |
| 9. | LCPIERB Form 2 (I) - 2018 | : Checklist for Clinical Trial Outside LCP by Non-LCP PI | |
| 10. | LCPIERB Form 2 (J) - 2018 | : Certificate of Exemption from Review | |
| 11. | LCPIERB Form 2 (K) - 2018 | : Protocol Resubmission Form | |
| III. SOP 3 - Standard Operating Procedures (Post Approval Procedures) | |||
| 1. | LCPIERB Form 3 (A) - 2018 | : Serious Adverse Event Report Form | |
| 2. | LCPIERB Form 3 (B) - 2018 | : Protocol Amendment Application Form | |
| 3. | LCPIERB Form 3 (C) - 2018 | : Continuing Review Application / Progress Report Form | |
| 4. | LCPIERB Form 3 (D) - 2018 | : Study Protocol Non-Compliance Report Form | |
| 5. | LCPIERB Form 3 (E) - 2018 | : Request/Query/Complaints Report Form | |
| 6. | LCPIERB Form 3 (F) - 2018 | : Early Study Termination Application Form | |
| 7. | LCPIERB Form 3 (G) - 2018 | : Site Visit Report Form | |
| 8. | LCPIERB Form 3 (H) - 2018 | : Final Report Form | |
| IV. SOP 4 - Standard Operating Procedures (Documentation and Archiving) | |||
| 1. | LCPIERB Letter 4 (A) - 2018 | : Notice of Review | |
| 2. | LCPIERB Letter 4 (B) - 2018 | : Acknowledgment Letter | |
| 3. | LCPIERB Template 4 (C) - 2014 | : Notice of Meeting | |
| 4. | LCPIERB Template 4 (D) - 2018 | : Minutes of the Meeting | |
| 5. | LCPIERB Form 4 (E) - 2018 | : Protocol Document Review Form | |
| 6. | LCPIERB Form 4 (F) - 2018 | : Informed Consent Evaluation Form | |
| 7. | LCPIERB Letter 4 (G) - 2018 | : Notification of LCPIERB Decision | |
| 8. | LCPIERB Letter 4 (H) - 2018 | : Approval Letter to the Study Protocol | |
| 9. | LCPIERB Letter 4 (I) - 2014 | : Notice of Site Visit | |
| 10. | LCPIERB Letter 4 (J) - 2018 | : Reminder Letter for Continuing Review/Final Report | |
| 11. | LCPIERB Letter 4 (K) - 2018 | : Action Letter (Request Information) to Continuing Review Application/Final Report/ Study Protocol Non-compliance Report/SAE Report/Early Study Termination Report/ Site Visit | |
| 12. | LCPIERB4 Letter (L) - 2018 | : Action Letter to Study Protocol Resubmission/Amendments | |
| 13. | LCPERB4 Letter (M) - 2018 | : Approval Letter to the Study Protocol Amendment Application | |
| 14. | LCPIERB4 Letter (N) - 2018 | : Notification Letter for Continuing Review Application / Study Protocol Non-Compliance Report / SAE and SUSAR Report / Site Visit Report | |
| 15. | LCPIERB Letter 4 (O) - 2014 | : Archiving Notification | |
| 16. | LCPIERB Form 4 (P) - 2013 | : Borrowers Log | |
| 17. | LCPIERB Form 4 (Q) - 2018 | : Letter of Exemption from Ethical Review | |
| 18. | LCPIERB Letter 4 (R) - 2018 | : Confidentiality Agreement for Guests/Observers Form | |
