RESEARCH ETHICS

Establishment & Mandate of the Mary Mediatrix Medical Center-Research Ethics Review Committee (MMMC-RERC)

The MMMC-RERC is an independent body created by the MMMC under the Medical Director of the Hospital, whose responsibility is to ensure the protection of the 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 MMMC-RERC has the authority to approve, require modifications to, or disapprove research protocols and related documents as well as to ensure compliance with its relevant procedures after approval.

The MMMC-RERC reviews and monitors health research that involves:

History of the MMMC-RERC

Mary Mediatrix Medical Center- Research Ethics Review Committee formerly the Institutional Review Board/ Research Ethics Committee was established in 2007. Dr. Robert Magsino, the President and CEO (former Medical Director) of Mary Mediatrix Medical Center (MMMC), appointed Dr. Narcisa Sonia Comia to be the Chair of the Research Ethics Committee. Having no experience at all in Research Ethics, she was assisted by Dr. Tito Atienza, a seasoned investigator at Veterans Memorial Medical Center.

Mr. Jherrist Gorayeb, was head of the marketing department of MMMC at that time, but a nurse by profession was the first recruited member. Since there should be at least five (5) members, Dr. Narcisa Sonia Comia invited a male pediatrician, a female cardiologist, a retired engineer, and a former member of the Good Samaritan to complete the team. The ethics committee was then called MMMC Institutional Review Board (IRB). There was no office, no secretariat, and definitely no Standard Operating Procedure to guide them. To aid the need for secretariat staff as well as the office, Ms. Sheryl Paradero, the secretariat staff of the Department of Medicine, was requested to also serve as the secretariat of the IRB. During that time, IRB shared an office and equipment with the Department of Medicine.

During its first year of existence, one protocol was received and approved. In the next few years, more pharmaceutical-sponsored research protocols were submitted and approved by MMMC-IRB. The members increased to seven (7).

One time, as informed by Dr. Tito Atienza, Japanese auditors came to do a site visit at Mary Mediatrix to check how MMMC-IRB functions, where and how files are being kept, and how many members MMMC-IRB has. In preparation for their visit, an office was thus given to IRB equipped with a desktop computer and cabinets with locks and keys.

Later on, more and more protocols were submitted. By 2011, MMMC-IRB already had a Chairman, a Co-chair, a member secretary, four members, and a full-time secretariat. For the creation of the SOP, an SOP workshop was attended by the Chair, Co-Chair, and Member Secretary. By the last quarter of 2012, the first version of SOP was approved by the former Medical Director, Dr. Robert Magsino. Another SOP workshop was attended in March 2014 and towards the end of August 2014, SOP version 2 was submitted to the Medical Director for approval.

Since the formation of the MMMC-IRB, it has approved more than sixty (60) industry-sponsored clinical trials and to date we still have 33 ongoing trials.

The name MMMC-IRB has been replaced by MMMC Research Ethics Review Committee (RERC). Currently, RERC is composed of nine (9) members.

Acknowledgment

The Mary Mediatrix Medical Center – Research Ethics Review Committee (MMMC-RERC) would like thank Dr Rommel Lojo, our Medical Director, for his unwavering support and belief in this committee to achieve its goal and purpose.

This SOP however, will not be possible without the help of the institutions that help us shape this manual. In no particular order, we would like to thank the following institutions, University of the Philippines Research Ethics Board, Veterans Memorial Medical Center Institutional Review Board, ‘Amang’ Rodriquez Memorial Medical Center Hospital Research/ Bioethics Review Board, and the Department of Health for making our task possible and achievable.

Finally, we would like to thank the members of the MMMC – RERC, past and present, for all the time, effort, and dedication. Without them the committee will cease to exist.

Standard Operating Procedure (SOP)

Chapters:

I. Structure and Composition

II. Types of Review and Initial Review Procedures

III. Post – Approval Review

IV. Meetings

V. Documentation and Management of Files and Archiving

VI. Site Monitoring

VII. Management of Queries/Complaints/Notifications

VIII. Writing and Revising Standard Operating Procedure

Appendix

HDERBERT ARELLANO, MD

Position: Chairman
Profession: IM – Endocrinologist
Affiliation to MMMC: Consultant
Date of Appointment: July 2023

VON ANDRE MEDINA, MD

Position: Vice Chairman
Profession: Internal Medicine
Affiliation to MMMC: Consultant
Date of Appointment: July 2023

OSCAR PAULO MERTOLA, MD

Position: Chairman
Profession: IM – Endocrinologist
Affiliation to MMMC: Consultant
Date of Appointment: July 2023

NARCISA SONIA COMIA, MD

Position: Member-Institutional
Profession: IM – Hematologist/Oncologist
Affiliation to MMMC: Consultant
Date of Appointment: July 2023

MARY WARREN ILAGA, MD

Position: Member-Institutional
Profession: Neurology Psychiatry
Affiliation to MMMC: Consultant
Date of Appointment: July 2023

WILFREDO LIANGCO, MD

Position: Member-Institutional
Profession: Medical Oncology
Affiliation to MMMC: Consultant
Date of Appointment: April 2015

REV. FR. REY SALVADOR

Position: Non-medical member
Profession: Priest
Affiliation to MMMC: Non-affiliated
Date of Appointment: October 2019

IMEI JOY CAJULIS

Position: Non-medical member
Profession: Licensed Psychometrician
Affiliation to MMMC: Non-affiliated
Date of Appointment: December 2022

MARIA ASSUMPTA TAN

Position: Non-medical member
Profession: Retired Bank Manager
Affiliation to MMMC: Non-affiliated
Date of Appointment: October 2023

GERALD NATANAUAN, MD

Position: Independent Consultant
Profession: Rheumatologist
Affiliation to MMMC: Consultant
Date of Appointment: September 2023

ELVIN GARCIA, MD

Position: Independent Consultant
Profession: Pulmonologist
Affiliation to MMMC: Consultant
Date of Appointment: September 2023

ANNE CLARISSE MAE MARASIGAN, MD

Position: Independent Consultant
Profession: Nephrologist
Affiliation to MMMC: Consultant
Date of Appointment: October 2023

CHRISTIAN ALLEN ROXAS, MD

Position: Independent Consultant
Profession: Pediatric-Pulmonologist
Affiliation to MMMC: Consultant
Date of Appointment: October 2023

Meeting Schedule

CUT-OFF DATE OF SUBMISSION: 15 SEPTEMBER 2025
FULL BOARD MEETING: 29 SEPTEMBER 2025

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Research Ethics