The Far Eastern University – Dr. Nicanor Reyes Medical Foundation (FEU – NRMF) has for its vision, the pursuit of excellence in medical and paramedical education, quality health care services, and relevant research. Indeed, research has become a sine qua non in all aspects of sciences if they are to evolve and progress. Medical research is no exception to this rule. Research in medicine takes an extra special role because it utilizes human participants. Thus, while research is a necessary tool for the advancement of medical science, it too must ensure ample protection and safeguard the dignity, rights, safety, and well-being of all human participants in research. Several national and international guidelines aimed specifically at protecting human participants have been developed so as they will not be placed in jeopardy.

The FEU – NRMF Institutional Ethics Review Committee (IERC) addresses ethical issues in research involving human participants. The committee reviews all research protocols by principal investigators (PI), including PI-Initiated (FEU – NRMF faculty, consultant, resident/fellow-in-training, student) studies and Sponsor-Initiated studies done in this institution prior to implementation. For PI-initiated studies, a technical review approval from this institution is required prior to ethics review. The FEU-NRMF IERC may also review studies where the research site is outside the scope of authority of FEU-NRMF and the PI is a non-FEU-NRMF personnel, provided that a technical review of the study has been accomplished in their institution and an official of the institution signifies capability to provide oversight in research site. For purposes of organization, the FEU – NRMF IERC is a subcommittee of the Research Center for Development, which coordinates researches from both the FEU – NRMF Medical Center and the FEU – NRMF Institute of Medicine. However, it must be emphasized that the committee’s actions, including composition, procedures, and decision-making, are independent of political, institutional, professional, and market influences, as embodied in the World Health Organization – Operational Guidelines for Ethics Committees that Review Biomedical Research (2011). It utilizes the World Medical Association (WMA) Declaration of Helsinki as its guiding principle in reviewing research protocols.

The FEU-NRMF IERC had developed this Standard Operating Procedures (SOP), pursuant to Section 12 of the Philippine National Health Research System (PNHRS) Act of 2013, which states that the Philippine Health Research Ethics Board (PHREB), created under DOST Special Order No. 091 s. 2006, shall ensure adherence to the universal principles for the protection of human participants in research studies conducted in the Philippines.

The FEU – NRMF IERC has mainly adapted the University of the Philippines Manila Research Ethics Board SOP because of their close similarity in structure and organization as academic institutions which are closely associated with their respective medical centers that provide health care to patients, as well as being a training institution for specialty and subspecialty medical and paramedical practice. Other sources of information include the Philippine National Ethical Guidelines for Health and Health-Related Research (2017), Makati Medical Center – Institutional Review Board SOP, “The SOP Workbook” (2020) of PHREB, and the technical expertise of the current FEU – NRMF IERC Members.

Process of Online Submission to the FEU-NRMF IERC:

1. Go to https://www.feu-nrmf.ph/foundation/forms and download the necessary forms required for your submission. 

2. For Initial Review and Resubmissions, accomplish the forms and attach the necessary requirements as stated in the Review Checklist Form 2(A) in SOP 2. For Post-Approval Submissions, see SOP 3.

3. Send the submission package via e-mail to [email protected].  The secretariat will send a Receipt Notice within 1-2 working days. State the type of submission and IERC Code (if applicable) in the subject of your email.

4. If the submission package is complete, you will receive an e-mail notification of acceptance by the FEU-NRMF IERC, along with the assigned IERC Code, detailed information on the submission process, cut-off dates and review status.

Administrative Orders and Memoranda

1. PNHRS Law (RA 105321) - Institutionalizing the PNHRS

2. DOST Special Order 091 Series of 2006 - Creation of PHREB

3. DOST Special Order 091-A Series of 2006 - Amendment, Creation, Additional Function of PHREB

4. CHED Memorandum Order (CMO) No. 34, Series of 2007 - Policy Requirement in the Conduct of Health Research. Involving Human Subjects and Participants

5. DOST Administrative Order 001 Series of 2007 - Requirement for Review of all Health Researches involving Human Subjects and Participants

6. DOST Administrative Order 001 Series of 2008 - Registration of all ERCs at the PHREB

7. Joint DOST, CHED, and UPM Memorandum Order 001 Series of 2012 Requirement for Ethical Review of Health Research Involving Human Participants

8. Joint DOST-PCHRD, DOH, CHED and UPM NIH Administrative Order no. 001 - IRR of RA 10532

9. PHREB Memorandum for RERC Registration and Accreditation - Registration and Accreditation of ERCs in the Philippines

10. DOH Department Circular no. 2015-0059 - RERCs Registration and Accreditation

11. CHED RERC Memorandum 2015 - Accreditation of all Ethics Review Committees of Higher Education Institutions

12. PHREB-NCIP Memorandum of Understanding - Ethics Review of Research involving Indigenous Cultural Communities or Indigenous Peoples as Participants

13. Memorandum No. 2017-001 - Policies and Regulations regarding Research involving Indigenous Peoples or Indigenous Cultural Communities

Local Guidelines

1. National Ethical Guidelines for Health and Health-Related Research (2017)

2. National Ethical Guidelines for Health and Health-Related Research (2017)

3. PHREB (Philippine Health Research Ethics Board) SOP Workbook (2020)

4. Single-Joint Research Ethics Board (SJREB) Standard Operating Procedures (2021)

International Guidelines

1. International Ethical Guidelines for Health-related Research Involving Humans (2016)

2. International Ethical Guidelines for Epidemiological Studies (2009)

3. Declaration of Helsinki (2003)

4. International Conference of the Harmonization of Good Clinical Practice R2 (2016)

5. Standards and Operational Guidance for Ethics Review of Health-Related Research with Human Participants (2011)