SAN JUAN DE DIOS EDUCATIONAL FOUNDATION, INC. INSTITUTIONAL REVIEW BOARD (SJDEFIIRB)

The SJDEFIIRB was established on April 23, 2010 in order to integrate all existing ethics committees in San Juan de Dios Hospital Community under a single research ethics board as well as to provide independent guidance, advice, and decision on health research or other specific research protocols involving human subjects. Dr. Camilo Roa was appointed as SJDEFIIRB Chair and under his watch, SJDEFIIRB was granted a certificate of registration by the Philippine Health Ethics Board (PHREB) furthermore, the Strategic Initiative for Developing Capacity in Ethical Review — Forum for Ethical Review Committees in the Asian and Western Pacific Region (SIDCER-FERCAP) awarded its recognition to SJDEFIIRB for compliance to ICH Guidelines, GCP standards, CIOMS Guidelines, WHO Standards for Operational Guidance for Ethics Review and Health-related Research and Surveying and Evaluating Ethical Review Practices, EC/IRB Standard Operating Procedures, and Local Regulations and Standards in Ethical Review. The SICEER-FERCAP recognition was awarded during the 15th FERCAP International Conference in Nagasaki University Sakamoto Campus, Nagasaki, Japan.

In 2015, as part of the boards independence as its main task was to review research protocols submitted by the hospital staff, SJDEFIIRB was transferred from the Vice President for Health Service Office to the Office of the President and Dr. Roger Arcangel was appointed as SJDEFIIRB Chair. Under the purview of Dr. Arcangel, SJDEFIIRB oversight was expanded to consultants, residents, faculty, personnel, and students doing research in SJDEFI (Hospital and College); to non-SJDEFI researchers doing research in SJDEFI; and to non-SJDEFI researchers doing research in non-SJDEFI sites with no local ethics review committee (as mandated by the Philippine Health Research Ethics Board).

Dr. Rose Pulido (+) was appointed as Chair in 2019 and under her leadership, the SIDCER-FERCAP renewed its recognition to SJDEFIIRB on November 27, 2019 during the 19th FERCAP International Conference at the Universiti Sains Malaysia, Penang, Malaysia.

In March 24, 2020, the Philippine Health Research Ethics Board re-accredited SJDEFIIRB as one of the Level III Research Ethics Committees in our country which was awarded virtually due to the COVID-19 pandemic.

The COVID-19 pandemic brought major changes in SJDEFIIRB membership and the loss of Dr. Rose Pulido to the dreaded virus created a vacuum in leadership. IRB meetings were conducted via video conference, new members were inducted in the board and Dr. Camilo Roa as well as Dr. Alice Sun-Cua were appointed as interim chairs to continuously serve the stakeholders of SJDEFIIRB.

In November 9, 2020, Mr. Julian Corpus III was appointed as the new chair and standard operating procedures was aligned to the needs of the time such as the inclusion of alternate members to serve as a substitute for a regular IRB member and to ensure that the IRB has the appropriate expertise to review research; initiated digital transformation to optimize processes and services; and lastly, instituted a 10-day turn-around-time (10-Day TAT) for reviewing COVID-19 related protocols in accordance to FDA Circular No. 2020-029 and PHREB Resolution on the Review of Research for Proposals during COVID-19.

Ethical Basis

• The IRB recognizes that the protocols it approves may also be approved by national and/or local ethics committees prior to their implementation in specific localities.
• In evaluating protocols and ethical issues, the IRB is aware of the diversity of laws, cultures and practices governing research and medical practices in various countries around the world.
• It attempts to inform itself where possible of the requirements and conditions of the various localities where proposed SJDEFI research is being considered.
• The IRB also seeks to be informed, as appropriate, by national/local ethics committees and researchers of the impact of the research it has approved.
• The IRB is guided in its reflection, advice, and decision by the ethical principles expressed in the Declaration of Helsinki (1964 and subsequent revisions).
• It makes further reference to the National and International Ethical Guidelines for Biomedical Research Involving Human Subjects (CIOMS), the Belmont Report, and the European Convention on Human Rights and Biomedicine.
• The IRB establishes its own standard operating procedures based on the Operational Guidelines for Ethics Committees That Review Biomedical Research (WHO), the WHO & ICH Guidelines for Good Clinical Practice and the local regulations.
• The IRB seeks to fulfill the requirements for international assurances and is established and functions in accordance with the national law and regulations.
• WMA Declaration of Taipei on Ethical Considerations Regarding Health Databases and Biobanks 2016
• Philippine Health Research Ethics Board Standard Operating Procedures 2020
• National Ethical Guidelines for Research Involving Human Participants 2022
• W.H.O. Tool for Benchmarking Ethics Oversight of Health-Related Research Involving Human Participants. Geneva: World Health Organization; 2023. License: CC BY-NC-SA 3.0 IGO.