INTRODUCTION:

Batangas Medical Center (BatMC), as a tertiary government hospital, is a regional referral center and a training hospital. The center is a potential research hub.  Different specialties and subspecialties are affiliated in the hospital. Patients from the provinces in Southern Tagalog are prospective participants to different research studies like clinical trials. 

In line with this and with the recommendation of the Department of Health, BatMC established a research ethics committee that will ensure the research study is scientifically sound and follows high ethical standards. Thus, BatMC Research Ethics Review Committee is committed to the promotion of transparency and integrity of the study, and the rights and safety of the participants.

BatMC RERC adheres to the international and national guidelines in performing its key functions like reviewing the scientific merit of the research protocol, assessing its ethical considerations, safeguarding the participants and their rights, monitoring the conduct of research and maintaining high ethical standards.

ESTABLISHMENT AND MANDATE OF THE BATANGAS MEDICAL CENTER – RESEARCH ETHICS REVIEW COMMITTEE (BATMC – RERC) 

The Batangas Medical Center – RERC is an independent body created under the Medical Center Chief 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 BATMC-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 BATMC-RERC review and monitor health researches that involve:

• BATMC patients, done within the BATMC, or using BATMC facilities, including those initiated by BATMC active, associate active, and visiting staff, residents/fellow in training and other hospital staff

• Pharmaceutical industry sponsored research using BATMC facilities, BATMC patients in cooperation with BATMC active/associate active/visiting staff.

• BATMC-RERC may review health related research protocols from other academic institutions

• BATMC-RERC may review researches referred from the PNHRS, PHREB, DOH,SJREB, industry organizations, other academic institutions on the conditions that the host hospital/institution where the proposal will be done accepts the review of Batangas Medical Center RERC and agrees to abide the rules and regulations that the Batangas Medical Center RERC follows (based on PHREB and FERCAP rules).The other research sites also agree to provide the necessary environment to ensure the safe and ethical conduct of the research, including oversight and stewardship functions as necessary as they agree to monitor procedures that the Committee may deem necessary.  These conditions should be written in document and signed by other hospitals/institutions that accept Batangas Medical Center RERC review.

HISTORY OF THE BATANGAS MEDICAL CENTER RESEARCH ETHICS REVIEW COMMITTEE:

In line with the Department of Health (DOH) initiative in organizing the DOH Research Ethics    Committee (DREC) provided for under D.O. 255-1s 2002 dated October 2, 2002, a functional institutional ethics review committee was established for the first time at Batangas Regional Hospital. This was first presented in a meeting held at the office of    the Chief of Hospital on April 29, 2004. The meeting was presided by Dr. Belinda Kalaw who acted as the chair in the presence of Dr. Eleanor Gamo, the Chief of Hospital   together with other non-hospital personnel including Sr. Ma. Catalina Santos, RGS, Rev. Fr. Ramon M. Manalo, Bro. Camilo C. Cabreros. The agenda during this meeting was the committee’s policies, functions and duties and remunerations for non-BRH (Batangas Regional Hospital) members. No subsequent follow up meeting was held.

The Research Ethics Review Committee was again revived on November 19, 2010 by virtue of Hospital Order no. 244 s. 2010 issued by Dr. Renato Dimayuga who was the new Chief of Hospital then.  The members of the committee were: Dr. Belinda Kalaw as chairperson, Dr. Angelita Babao-Villena as co-chair, Dr. Teresita Risalyn Villanueva as Secretary, Dr. Ramoncito Magnaye and Ms Mary Eileen Carandang.  The members who were not personnel of BRH were Atty. Gregorio Moraleja, Miss Rona Tadeja, Mr. Camil Cabreros and Marilou Cua.

The Institutional Research Committee was recognized in December 2011 and due to the illness of the Chair, Dr. Belinda Kalaw, the leadership was turned over to Dr. Angelita Babao Villena as Chair and a new membership lineup was appointed.  There were physicians added to the committee as representatives of their Departments namely – Dr. Onofre Concepcion for Anesthesia, Dr. Rhodora Madrid Reyes for Internal Medicine.  The layperson included was Ms. Anita Aguirre.  The previous non-BRH members did express interest in renewing their membership.  During a meeting it was discussed the following agenda that the (1) tenure of office should be 2 years (2) two meetings were to be scheduled to review researches of resident physicians during the months of March and November (3) it was also mentioned that only non-BRH members will receive a 2000 pesos per meeting per year as remuneration (4) the training office and Office Secretary will act as secretariat.

The committee followed the guidelines set by the National Ethical Guidelines for Health Research 2006 as stated:

1. To evaluate the conduct of research in accordance with provisions of the Helsinki Declaration and the NEC Guidelines on the conduct of Biomedical research in the Institution.

2. To determine the acceptability of specific research proposals based on the organizational commitments and regulations, local laws, standards of professional conduct and practice, community mores, values and needs.

3. To promote research integrity by identification and resolution of conflicts of interest.

      4. To establish appropriate mechanisms in all stages of the research.

This reorganization was affirmed by virtue of Hospital Order no.16 – As. 2012 issued by Dr. Arceli Hernandez who was then acting as Officer in Charge and Chief of Hospital on January 20, 2012.  On the same day, a meeting was presided by Dr. Angelita Babao-Villena who reviewed the background, membership, policies and guidelines.  It was agreed upon that training residents should pass their research protocol to the hospital’s research committee which will recommend the review to the Hospital Research Ethics Committee specifically those researches involving human subjects.  Only research proposals of residents will be entertained for review. 

On February 7, 2013, another meeting was held.  The membership was reviewed.  Dr. Jesus Fernandez replaced Dr. Ramoncito Magnaye as representative for the Dept. of Surgery. The honorarium for the laypersons was raised to 2000 pesos per person for a total of 16k annually for the two laypersons. The budget for the year was laid out including expenses for communication and secretary. Mrs. Anita Aguirre (layperson) tendered her resignation as member.

On April 18-19, 2013, Dr. Jess Fernandez attended a seminar on Research Ethics hosted by the Health Research and Development Consortium Region IVA and held at the De La Salle Health Research Institute.

On April 14, 2014, another meeting was held to recognize the committee due to the retirement of Dr. Babao-Villena, the chairperson and Dr. Onofre Concepcion.

A member of the IERC– Atty Moraleja had an untimely demise; hence a replacement for the position of lawyer for the committee was discussed.

It was the unanimous decision of the group that Dr. Rhodora Madrid-Reyes was the new chairperson who was subsequently appointed by the Medical Center Chief II Dr. Ramoncito Magnaye. It was proposed that the committee should apply for accreditation as it has already reviewed several researches.

Over the years, members attended various training on research ethics to improve its expertise and to standardize its operating policies.

The Philippine Health Research Ethics Board (PHREB) granted the BatMC RERC a provisional Level 2 accreditation in 2016, after which a three (3) year accreditation was granted for the period 2017 to 2019. Furthermore, by virtue of the Department of Health Administrative Order 2019-0049, the BatMC RERC started participating in the Single Joint Review Ethics Board in 2019. 

In March 2021, BatMC RERC was granted a one (1) year Level 3 accreditation paving the way for the acceptance of clinical trials in the hospital. In the same year, the BatMC RERC received recognition from the Forum for Ethical Review Committees in Asia and the Pacific (FERCAP).

Upon a year of transition period, new affiliated and non- affiliated members were appointed to RERC.  On January 1, 2022, Dr. Alfonso Syoei R. Yoshida was the newly appointed chairperson of RERC. On April 12, 2022, the Philippine Health Research Ethics Board (PHREB) granted BatMC RERC a three (3) year Level 3 accreditation from 2022-2025.

Approved Protocols: