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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 crated 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 staff

b) 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.

LCP-IERB Guidelines

 

List of Forms

I.  SOP 1 - Standard Operating Procedures (Structure and Composition) 
1. LCPIERB Letter 1 (A) - 2013 :  Invitation to Regular Members
  2. LCPIERB Letter 1 (A2) - 2013 :  Invitation to Alternate Members
3. LCPIERB Letter 1 (A3) - 2013 :  Invitation to Independent Consultant
4. LCPIERB Letter 1 (B) - 2013 Appointment of IERB Chair
5. LCPIERB Letter 1 (C) - 2013 Appointment of IERB Vice-Chair
6. LCPIERB Letter 1 (D) - 2013 Appointment of Secretary
7. LCPIERB Letter 1 (E) Appointment of IERB Member
8. LCPIERB Letter 1 (E2) Appointment of Alternate Member
9. LCPIERB Letter 1 (E3) Appointment of Independent Consultant
10. LCPIERB Letter 1 (F) - 2013 Confidentiality and Conflict of Interest Agreement
11. LCPIERB Form 1 (G) - 2013 :  Curriculum Vitae
  12. LCPIERB Letter 1 (H) - 2013  :  Training Record of an IERB Member 
  13.  LCPIERB Form 1 (I) - 2014  :  Training Request
II.  SOP 2 - Standard Operating Procedures (Protocol Review) 
1. LCPIERB Form 2 (A) - 2015 Document Receipt Form
2. LCPIERB Form 2 (B) - 2015 Application Form for Protocol Review
3. LCPIERB Form 2 (C) - 2015 Checklist
4. LCPIERB Form 2 (D) - 2015 Protocol Summary Sheet
5. LCPIERB Form 2 (E) - 2015 Protocol Evaluation
6. LCPIERB Form 2 (F) - 2015 Informed Consent Evaluation
7.  LCPIERB Form 2 (G) - 2015  :  Protocol Document Review  
       
III.  Post Approval Procedures 
1. LCPIERB Form 3 (A) - 2015 Serious Adverse Event
2. LCPIERB Form 3 (B) - 2015 Protocol Amendment Application
3. LCPIERB Form 3 (C) - 2015 V.2 Progress Report
4. LCPIERB Form 3 (D) - 2015 :  Deviation Non-Compliance/Violation Report
5. LCPIERB Form 3 (E) - 2014 Request/Query Record
6. LCPIERB Form 3 (F) - 2015 Study Termination
7. LCPIERB Form 3 (G) - 2015 Site Visit Report
8. LCPIERB Form 3 (H) - 2015 Final Report
IV.  Documentation and Archiving 
1. LCPIERB 4 (A) Notice of Review
2. LCPIERB 4 (B) Acknowledgment
3. LCPIERB 4 (C) Notice of Meeting
4. LCPIERB 4 (D)  Minutes of Meeting
5. LCPIERB 4 (E) Protocol Document Review 
6. LCPIERB 4 (F) Informed Consent Evaluation
7. LCPIERB 4 (G) Notification of IERB Decision
8. LCPIERB 4 (H) Approval
9. LCPIERB 4 (I) Site Visit
10. LCPIERB 4 (J) Reminder Letter for Continuing Review/ Final Report
11. LCPIERB 4 (K) Notification Letter (Request Information) 
12. LCPIERB 4 (L) Action Letter to Study Protocol Resubmission/
   Amendment
13. LCPERC Letter 4 (M) - 2014 Approval Letter for Study Protocol Amendment Request
14. LCPIERB 4 (N) Notification Letter No Further Action to Continuing Review     Application, Deviation AE Site Visit 
15. LCPIERB 4 (O) Archiving Notification
16. LCPIERB 4 (P)  Borrowers Log