Institutional Review Board
About us SOP Form About usWHO WE ARE AND WHAT WE DO
- Year PELI IRB was established: CY 2012
- PHREB Registration No. : L3-2018-043-02
- PHREB Level of PELI IRB: Level 3
- Effective Date: July 16, 2018
LEVEL 3 CERTIFICATE
What are Clinical Trials?
- Clinical trials are research studies that explore whether a medical strategy, treatment, or device is safe and effective for humans. These studies also may show which medical approaches work best for certain illnesses or groups of people. hlbi.nih.gov
Institutional Review Board (Definitions)
- INSTITUTIONAL REVIEW BOARD – An independent body constituted of medical, scientific, and non-scientific members, whose responsibility is to ensure the protection of the rights, safety and well-being of human subjects in a trial by, among other things, reviewing, approving, and providing continuing review of trial protocol and amendments and of the methods and material to be used in obtaining and documenting informed consent of the trial subjects. ICH-GCP E6 (R1) Other Names of Institutional Review Boards:
- Ethics Review Committee
- Institutional Ethics Review committee
- Research Ethics Board
- Ethical Review Board
Brief History of Peregrine Eye and Laser Institute – Institutional Review Board
Since its inception, research has been a key ingredient in Peregrine Eye and Laser Institute’s (PELI) aspirations to provide excellent, modern, evidence-based quality care to its patients. Only through responsive ethical researches can up-to-date interventions and better patient options become readily available to improve health outcomes. Without the benefit of researches, Filipino patients would suffer the indignity of having to settle for prehistoric modes of treatment and stagnant choices. This is one of the prime motivations in the establishment of the PELI Institutional Review Board in CY 2012. The IRB has provided ethical guidance and patient safeguards in the pursuit of responsive clinical researches that benefit not only PELI patients but all Filipinos nationwide. It is also pioneering in that it is one of a few institutional review boards outside the confines of a hospital setting. PELI researches have contributed positively to the entry of innovative solutions in the country as well as improved patient outcomes for many Filipinos.
With the growing complexities of numerous diseases, the evolution of basic sciences in the understanding of these disorders, and the endless possibilities of interactions between and among disease entities, the approach of PELI must equally evolve to be more holistic in order to serve the needs of its patients fully. It must also be facilitative in assessing innovative new medicines, medical supplies, and therapeutic interventions. These consequently place a burden on the institution to do more researches to remain true to its goal for its patients.
The value of being patient centric is at the heart of PELI. All researches should be designed to improve the quality of lives of patients, so too should these researches assure the safety and welfare of research participants, especially those trying out innovative treatment options. Patient rights must be continuously upheld in line with local and international ethical and regulatory standards.
In this regard, the IRB must also be responsive and must evolve to safeguard the interests of patients and research participants, among others. It should remain independent, well represented, and compliant with existing non-discriminatory public policies and regulatory standards. To this end, the IRB shall be improved and developed to be able to continuously achieve its duty to facilitate innovative researches without compromising ethics, patient safety, welfare and rights. PELI-IRB SOP Chap 1-Introduction
CONTACT
Staff Secretary: Cerelyn V. Lobramonte
PELI IRB trunk line: (+63) 8900-0115 loc. 113
PELI IRB e-mail address: irb@peregrineeye.com
PELI IRB address: PELI-IRB Rm., Basement 1, 50 Jupiter St., Brgy. Bel-Air, Makati City.
Standard Operating Procedures and Forms
Introduction (Click here to download)
Topics
- Introduction
- Vision and Mission of the Institution
- Structure and Mandate
- Abbreviation Index
- Glossary
Forms
- None
Topics
- Ethical Framework and Constitution of the IRB
- Appointment of the IRB Members
- Selection of Independent Consultants
- Employment of Staff Secretariat
Forms
- PELI IRB SOP Form 1.1 Confidentiality and Conflict of Interest Agreements 27 June 2017 (Download)
- PELI IRB SOP Form 1.3 Training Record 27 June 2017 (Download)
- PELI IRB SOP Form 1.4 Curriculum Vitae 27 June 2017 (Download)
Topics
- Management of Protocol Submissions
- Use of Study Assessment Forms
- Expedited Review
- Full-Board Review of Submitted Protocols
- Review of a Medical Device Study
- Informed Consent Process
- Assent from Children or Decision-Impaired Individuals
- General Recruitment Practices and Advertisements
Forms
- PELI IRB SOP Form 2.1 Application for Protocol Review 25 Oct 2017 (Download)
- PELI IRB SOP Form 2.2 Protocol Evaluation Form 27 June 2017 (Download)
- PELI IRB SOP Form 2.2.1 Protocol Evaluation Form For Technical Review 25 Oct 2017 (Download).
- PELI IRB SOP Form 2.2.2 Protocol Evaluation Form For Ethical Review 25 Oct 2017 (Download).
- PELI IRB SOP Form 2.3 Informed Consent Evaluation Form 27 June 2017 (Download)
- PELI IRB SOP Form 2.4 Declaration of Conflict of Interest 27 June 2017 (Download)
- PELI IRB SOP Form 2.9 Review of Resubmitted Study Protocol Form 27 June 2017 (Download)
- PELI IRB SOP Form 2.10 Letter of Under Taking 19 Oct 2017 (Download).
Topics
- Review of Serious Adverse Events
- Review of Amendments
- Review of Progress/Final Report
- Review of Protocol Violation/Deviation
- Responding to Participant Requests/ Queries
- Site Visits
- Review of Early Protocol Termination
- Suspension or Termination of IRB Approval
- Continuing Review Application
Forms
- PELI IRB SOP Form 3.1 Serious Adverse Event Form 25 Oct 2017 (Download)
- PELI IRB SOP Form 3.2 Protocol Amendment Form 27 June 2017 (Download)
- PELI IRB SOP Form 3.3 Progress Report Form 1 Feb 2016 (Download)
- PELI IRB SOP Form 3.4 Final Report Form 1 February 2016 (Download)
- PELI IRB SOP Form 3.5 Deviation Noncompliance Violation Report Form 25 Oct 2017 (Download)
- PELI IRB SOP Form 3.6 Request Query Record 27 June 2017 (Download)
- PELI IRB SOP Form 3.8 Early Study Termination Form 30 Aug 2013 (Download)
- PELI SOP Form 3.12 Continuing Review Application 1 Feb 2016 (Download)
Topics
- Meeting Agenda
- Minutes of the meeting
- Preparation of Communication Records
- Management of Active Study Files
- Archiving of Terminated, Inactive, or Completed Studies
- Maintenance of Confidentiality of Study Files and IRB Documents
Forms
- PELI IRB SOP Form 4.3 Confidentiality Agreement Form for Non-Members 27 June 2017 (Download)
Topics
- Writing SOPs
- Revising SOPs
