Research is one aspect where MCU-FDT Medical Foundation, Inc. has been taking initiatives in improving its quality and standards by training students and residents as well as in the methods and principles of conducting research. Its’ mission is not just to develop competent graduates but to produce morally upright ethical healthcare providers.

An Institutional Review Board or Ethics Review Committee exist to safeguard the rights, safety, dignity and well-being of participants in research. Towards this end, the MCU -FDT Medical Foundation, Inc. Institutional Review Board (MCU-FDTMF IRB)  improves the capacity of its members to ensure that they are all equipped with the knowledge and skills that will make each member competent and efficient in making quality review of research documents, in accordance with the existing national and international guidelines.

The MCU-FDTMF IRB is required to adopt Standard Operating Procedures (SOPs) approved by or on behalf of its appointing authority. Members and staff are all required to act in accordance with its SOPs and is ultimately accountable to the Executive Vice President for its governance in this respect.

The MCU-FDTMF IRB reviews proposed and ongoing research involving human participants. It exists to protect the rights and safety of human subjects who participate in research studies. The process begins before participants are recruited for a study. The study protocol must satisfy the three basic principles of the Belmont Report: (1) autonomy (legally effective informed consent is obtained, unless the requirements for waiver of informed consent are met by adequate and appropriate methods in accordance with the provisions of applicable regulations), (2) beneficence (avoiding harm to subjects and maximizing the benefits compared with the risks of participation), (3) justice (the selection of subjects is equitable and is representative of the group that will benefit from the research). Once the study protocol is approved, the IRB is charged with overseeing the research from an ethics perspective. This oversight usually is exercised through two mechanisms. First, participants are provided with a means of contacting the IRB directly if they have concerns, and, second, the IRB conducts periodic reviews of the study to monitor the research progress and address any ethical issues. The review process usually occurs annually. Although rarely used, the IRB can carry out additional reviews and actively conduct surprise inspections of the research records.

HISTORY

The Manila Central University – Filemon D. Tanchoco, Sr. Medical Foundation, Inc. established the MCU-FDT Medical Foundation, Inc. Institutional Review Board (MCU-FDTMF IRB) in its pursuit to incorporate research in its activities. It was organized in 2002 under the office of the Vice President for Development and Alumni Affairs, headed by Dr. Lutgarda C. Quito.  The first appointed chair was Dr. Esperanza Rivera. In 2005, she was succeeded by Dr. Ponciano Bernardo, both were former Medical Directors of the institution. In 2009, Dr. Ma. Lilybeth Tanchoco chaired the IRB where guidelines on the conduct of research were created and implemented. GCP certificates were required among investigators, consultants, fellows, residents and students alike. The composition of the IRB was organized and improved based on the requirements set forth by the Philippine Health Research Ethics Board (PHREB). It was in 2011, when the MCU-FDTMF IRB was granted recognition by PHREB.

In June 2015, Dr. Ma. Lilybeth Tanchoco was appointed as Dean of the College of Medicine. She was re-appointed to a position of Member and the Chairmanship was given to Dr. Ma. Rosario Bonagua through an official appointment from the Executive Vice President. It was during her time that the MCU-FDTMF IRB applied for accreditation and as required, MCU-FDTMF IRB SOP Version 1 was created using the DOH template.

In January 2016, members and staff revised the SOP formulating MCU-FDTMF IRB SOP Version 2 following the suggestions in the PHREB Accreditation Report. It was granted Level 3 Accreditation for 3 years on March 7, 2016.

MCU-FDTMF IRB SOP Version 2 was revised to include updates on current ethical guidelines to ensure adherence to local, national and international principles. One of the updates included in the 2018 Version 3 of MCU-FDTMF IRB SOP is the “Exempt from Review” process, wherein protocols need not undergo expedited or full board review after preliminary review.

The board applied for PHREB re-accreditation and was visited on May 8-10, 2019, headed by Prof. Edlyn Jimenez of the University of the Philippines, Manila.

As part of the board’s mission to adhere with the local and international guidelines, a workshop on SOP Training shall be part of the yearly initiatives of the MCU-FDTMF IRB.

Vision

  • To be recognized internationally as an ethics review board that will serve as a model in the review of medical research and clinical drug studies in the country.

Mission

  • To develop and implement policies which uphold and advance the current standards for the ethical conduct of research involving humans.
  • To safeguard the rights and welfare of human participants with due consideration to ethnic and cultural issues.
  • To provide integrated, effective, efficient and compliant systems for ethics review and oversight of research in the institution.
  • To support investigators and reviewers throughout the ethics review and compliance processes.

INSTITUTIONAL REVIEW BOARD (IRB) MEMBERS

Chair                          :           Ma. Rosario Bonagua, MD

Co-chair                     :           Erwin Palisoc, MD

Member-Secretary   :           Rosalie Remedios Ramirez, MD

Members:

Merlina Cabrera, MD

Benjamin Jose Quito, MD

Ma. Geraldine Ramos, MD

Sr. Ma. Soledad ng Porta Vaga, SSVM

John Rey Macindo, RN

Rolando De Leon, MD

Julieta Dizon, MD

IRB Secretariat         :           Marilyn Salvador