On February 2007, the Department of Science and Technology issued DOST Administrative Order No. 001 requiring all institutions that conduct health research to establish review committees that shall be in-charge of ethical evaluation and monitoring of research involving human participants. It also required all research protocols for the conduct of biomedical and behavioral researches involving human subjects to be submitted to ethics review committee for coordination, comment, guidance and approval. This administrative order was endorsed by the Department of Health through Memorandum Circular No. 2007-0035. As a Level II teaching and training hospital under the Department of Health, the hospital established the Governor Celestino Gallares Memorial Hospital Institutional Review Board in compliance to said memorandum circular.

 

The Gov. Celestino Gallares Memorial Hospital Institutional Review Board was initially created on September 30, 2011 through Hospital Personnel No. 274-A s. 2011 issued by then Chief of Hospital Dr. Nenita M. Po and which took effect on October 1, 2011. The Chairperson was Dr. Vivina Chiu who was also the Chairman of the Department of Pediatrics. Most of the members of the IRB were consultants from Cebu City, Dr. Emerson Donaldo an Internist, Dr. Cheryl Bullo a Pediatrician and Dr. Crisol Tabarejo an Epidemiologist from the DOH Regional Health Office. Other members were Dr. Emma Dominguez of the Department of Pediatrics, Rev. Fr. Valentino Pinlac and Atty. Miriam Garrote who was later on replaced by Atty. Aureliano Marcus Trabajo, III. After the retirement of Dr. Vivina Chiu sometime in 2012, the IRB became inactive.

The clamor of the different accredited clinical departments that researches of resident trainees undergo ethical review for it to be accepted by the different specialty societies initiated the reorganization of the IRB. It was on August, 2014 that the Gov. Celestino Gallares Memorial Hospital Institutional Review Board was reorganized through Hospital Personnel No. 251 s. 2014. The newly established IRB was composed of Dr. Valeria Sulatra as Chairman, Dr. Nonaluz Pizarras as Vice-chair, Dr. Anabella Oncog as Member-secretary and the following as members: Dr. Edgardo Epe, Dr. Luci Dianne Elemeos, Mrs. Diana Perpetua, Atty. Peter Emman Mende, Rev. Fr. Valentino Pinlac as the non-affiliated non-scientific member and Dr. Manuel Emerson Donaldo as the non-affiliated scientific member.

On 2016 the IRB applied for registration and level I accreditation with the PHREB. It was granted level I accreditation for one year.

With the change in hospital management, giving good support to the IRB in terms of staff, office supplies and equipment, and training the IRB worked for a level II accreditation in 2018. Membership to the IRB was increased from 7 to 15 to include doctors representing the four major clinical areas (Internal Medicine, OB-Gyne, Pedia, Surgery and Family Medicine), 2 nurses and 3 non-scientific and 2 non-affiliated members. After attending a seminar on SOPs, an SOP committee was formed which took on the task of reviewing and revising the old SOPs to conform to the 2017 version of the DOH Standard Operating Procedures for Hospital Research Ethics Committees.

On August 14, 2018 a new Hospital Order No. 087-B, s. of 2018 was issued by the Medical Center Chief, Dr. Mutya Kismet T. Macuno on the establishment of the hospital IRB with the mandate to review research protocols of hospital employees, trainees and affiliates and researches that will be conducted in the hospital whether investigator or sponsor initiated to ensure protection and safety of human participants in research.

Ethical Framework of Gov. Celestino Gallares Memorial Hospital Institutional Review Board
The Gov. Celestino Gallares Memorial Hospital Institutional Review Board (GCGMH IRB) is guided in its reflection, advice, and decision by the ethical principles as follows:

  • Respect for Persons – principle that states that individuals should be treated as autonomous agents, and persons with diminished autonomy are entitled to protection.
  • Beneficence – principle that requires investigators to protect participants from harm and secure their well-being.
  • Justice – principle that refers to the sense of “fairness in distribution” and “what is deserved.”

Source: Belmont Report, 1979

a. It is guided by the ethical principles and procedures as expressed in the following international guidelines:

  • Declaration of Helsinki (2013 and subsequent revisions)
  • International Conference on the Harmonization of Good Clinical Practice (ICH-GCP)
  • CIOMS 2016
  • Standards and Operational Guidance for Ethics Review of Health-Related Research with Human Participants (2011) by the World Health Organization (WHO)

b. The GCGMH IRB will function in accordance with national laws, regulations, and guidelines.

  • National Ethical Guidelines for Health Research by the Philippine Health Research Ethics Board (PHREB)
  • Administrative Orders from DOH, Philippine FDA, and other relevant agencies

c. The GCGMH IRB adopts its own standard operating procedures based on:

  • Operational Guidelines for Ethics Committees That Review Biomedical Research (2000) by the World Health Organization (WHO)
  • DOH-REC SOP Template
  • PHREB SOP Workbook

d. The GCGMH IRB adheres to national and international ethical standards and recognizes that the protocols it approves may have undergone review and approved by other ethics committees including the Single Joint Research Ethics Board (SJREB) prior to their implementation in specific sites.

e. In evaluating protocols and ethical issues, the IRB is cognizant of the diversity of laws, cultures, and practices governing health research in various local sites/countries around the world.

f. It attempts to inform itself, whenever possible, of the regulations and requirements of sponsor countries conducting global protocols in the Philippines; and of the requirements and conditions of various localities where a proposed Gov. Celestino Gallares Memorial Hospital research is being considered.

g. The GCGMH IRB will take the initiative to be informed, as appropriate, by current state-of-the-art researches and publications of the impact of the research that it has approved.

 


Contact Information

 

GCGMH Institutional Review Board

Gov. Celestino Gallares Memorial Hospital, Miguel Parras Street, Tagbilaran City 6300 Bohol, Phils.
Telephone No: (038) 411-4868 / 411-4869 local 282
Email Address: gcgmhirb@gmail.com

 

VALERIA S. SULATRA, MD, MPH, CSEE

Chair, GCGMH Institutional Review Board
Gov. Celestino Gallares Memorial Hospital, Miguel Parras Street, Tagbilaran City 6300 Bohol, Phils.
Telephone No: (038) 411-4868 / 411-4869 local 282
Mobile No: 09173040221
Email Address: gcgmhirb@gmail.com