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About Us

Philippine National Health Research System (PNHRS)

In 2005, the terms of reference of the different agencies participating in the PNHRS were consolidated into the PNHRS bill that was finally enacted into law in 2013 after 9 years of lobbying. The hard work involved in campaigning at the Philippine Congress to pass the bill into law should be properly credited to PCHRD led by Dr. Jaime C. Montoya, its Executive Director.

The Philippine National Health Research System Act of 2013 (RA 10532) institutionalized the memorandum of understanding among the DOST, DOH, CHED and UP Manila to work towards “improving the health status,, productivity and quality of life of Filipinos by (a) ensuring that health research is linked to the health system needs; (b) ensuring that investments in health research yield the most benefit; (c) promoting good governance among health research organizations through efficient, effective, transparent and ethical health research management system ; (d) engaging in national and international partnerships and networks for health research development and (e) ensuring sustainability of resources for health research.” It was generally assumed that research ethics was embedded in objectives (a), (b) and (c).

Philippine Health Research Ethics Board (PHREB)

The more explicit provision that referred to research ethics was in Section 12 of the law that adopted the DOST Special Order No. 091 s 2006 that created the Philippine Health Research Ethics Board (PHREB) to “ensure adherence to the universal principles for the protection of human participants in research” and shall, among other things:

Formulate/update guidelines for the ethical conduct of human health research;
Develop guidelines for the establishment and management of ethics review committees and standardization of research ethics review;
Monitor and evaluate the performance of institutional ethics review committees in accordance with procedures outlined in a prior agreement;
Promote the establishment of functional and effective ethics review committees;
Provide advice and make recommendations to the PNHRS Governing Council and other appropriate entities (including the Food and Drugs Administration[FDA]) regarding programs, policies, and regulations as they relate to ethical issues in human health research;
Initiate and contribute to discourse and discussions of ethical issues in human health research; and
Network with relevant local, national and international organizations.

Philippine Structural Framework for

Human Protection for Health Research

NATIONAL GOVERNANCE STRUCTURE FOR ETHICS REVIEW

PHREB ORGANIZATIONAL CHART

The Philippine Health Research Ethics Board (PHREB) has 12 members, including three ex-officio members, namely, the Department of Science and Technology (DOST)—PCHRD Executive Director, Commission on Higher Education (CHED) representative and the Department of Health (DOH) representative. Except for the ex-officio members, appointments shall be for a term of three years for the Chair and Co-Chair, and all other members shall have a term for two years. The members represent a balance of background, gender and disciplines (e.g., health research, philosophy, law, academe, medicine, public health/epidemiology, theology, social science and allied health sciences). There are also those who are from people’s organizations and the youth sector.

Below is the composition of PHREB for the year 2023 to 2026.

Philippine Health Research Ethics Board (PHREB)

Chair

Medicine

Sonia E. Bongala, MD

Chair, Committee on Standards and Accreditation

Chair, Committee on Networking

Vice Chair

Community

Ms. Carmen V. Auste

Chair, Committee on Patient, Family and Community Engagement

Members

Health Research

Ricardo M. Manalastas, Jr., MD

Chair, Committee on Information, Dissemination, Training and Advocacy

Social Science

Clemen C. Aquino, DPhil

Allied Health

Gemma N. Balein, DMD

Law

Atty. Alberto T. Muyot

Youth

Dr. Lorenzo Maria C. de Guzman

Theology

Rev. Rolex M. Cailing

Philippine Council for Health Research and Development

(ex-officio)

Jaime C. Montoya, MD

Department of Health

(ex-officio)

Mr. Pio Justin V. Asuncion, MPH, RN

PHREB Secretariat

DOST-PCHRD

Ms. Reichel Refuerzo

Ms. Pamela Miranda

Administrative Order 001 Series of 2008
Registration of all Ethics Review Committees at the Philippine Health Research Ethics Board

Administrative Order 001 Series of 2007
Requirement for Review of all health researches involving human subjects/participants

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Ethics in Research Involving Animals

Department of Agriculture Administrative Order no. 40 series of 1999

Rules and Regulations on the Conduct of Scientific Procedures Using Animals

Republic Act 10631

An Act Amending Certain Sections of RA 8485 otherwise known as the Animal Welfare Act of 1998

Republic Act 8485

An Act to Promote Animal Welfare in the Philippines otherwise known as "The Animal Welfare Act of 1998"

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PHREB POLICIES AND REQUIREMENTS FOR RESEARCH ETHICS TRAINING

PHREB POLICIES AND REQUIREMENTS FOR RESEARCH ETHICS TRAINING PROGRAMS

Date Effective: 11 June 2015

I. INTRODUCTION

Research ethics can be traced to the 1947 Nuremberg Code that came as an aftermath of the Nuremberg Trials in Germany. Research ethics was further articulated in the Declaration of Helsinki documents, the Universal Declaration of Human Rights, the 1974 Belmont Report, the CIOMS-WHO International Guidelines in Biomedical Research, and the 1996 ICH-GCP Guidelines in the conduct of clinical trials. All of these guidelines and standards were established in order to protect the dignity, welfare, and rights of human participants.

To comply with these guidelines, research protocols involving human participants must undergo review and be approved by an independent ethics committee before the commencement of recruitment of participants. For ethics review committees to do good and competent review, its members must be knowledgeable in the application of the international and national guidelines and standards and develop sensitivity in the recognition of ethical issues embedded in the protocols.

The Philippine Health Research Ethics Board (PHREB) aims to help establish and maintain functional Independent Ethics Review Committees with these competences. For this purpose, PHREB has identified the Committee on Information Dissemination, Training, and Advocacy (CIDTA).

II. GENERAL POLICY

Research ethics training programs must meet the standards set and be approved by PHREB-CIDTA in order to fulfill accreditation requirements of PHREB Committee on Standards and Accreditation (CSA).

1. All Chairs of Research Ethics Committees (RECs) should have basic ethics training.

2. All RECs must have training programs for members on basic research ethics and continuing ethics review.

3. Special Training for specific needs may be required by PHREB in its Accreditation Policies. For example, RECs that review clinical trials for FDA registration need their reviewers/members to be trained in Good Clinical Practice (GCP). On the other hand, RECs that review mostly social research may need training on social research ethics.

III. RESEARCH ETHICS TRAINING PROGRAMS

Research ethics training programs may be conducted by:

1. PHREB-CIDTA

2. Others

PHREB-CIDTA RESEARCH ETHICS TRAINING PROGRAMS

TYPES OF PHREB-SIDTA RESEARCH ETHICS TRAINING PROGRAMS

Basic Research Ethics

I. Target participants:

a. Researchers (including students)

b. Members of Ethics Review Committees (ERCs)

c. Research Advisers

d. Reviewers

II. Content:

a. Definition of Terms

b. Scientific Soundness

c. Research Ethics Principles (Beneficence, Non-Maleficence, Autonomy, Justice)

d. Declaration of Helsinki

e. Research Ethics Review

f. Informed Consent

g. Authorship

h. Review of the Research Proposal

i. Ethics Review Systems

j. Ethics Review Committees

k. Ethical Researcher

Good Research Practice

I. Target Participants:

a. ERC Members (ERC applying for level 3 accreditation)

b. Clinical Researchers

II. Content:

a. Definition of Terms

b. Review of different methodologies (e.g. social research)

c. Research Ethics Principles (Beneficence, Non-Maleficence, Autonomy, Justice)

d. Review of the Research Proposal

e. Nuremberg Code

f. National Ethical Guidelines (ERC composition)

g. ICH GCP

h. ERC – organization, function, and responsibilities

i. Vulnerable Population in Research

j. Standard Operating Procedures (SOPs)

Advanced/Focused Workshop (topics depend on need; one to 1½ days training )

Common Topics:

a. SOPs

b. Conflicts of Interest (COIs)

c. Informed Consent

d. ERCs

e. Training of Trainers

f. Training for Evaluators

1. Request Requirements of Research Ethics Training:

a. Submit completed Online Training Request Form (Form 2015-01) to the PHREB Secretariat

i. Name of requesting party

ii. Type of training program requested

iii. General profile of participants (minimum of 15 and maximum of 30 participants)

iv. Preferred Dates (minimum of one month from date of application)

Note: Postponements by requesting party will be considered as a new application

v. Training Venue

vi. Contact person and number

b. Four (4) complete research proposals (two weeks prior to approved schedule)

2. Responsibilities of requesting party

a. Training logistics (training venue, handouts, audio-visual equipment, food and drinks)

b. Transportation

c. Accommodation for resource persons and staff (if outside Metro Manila)

d. Honoraria of resource persons

RESEARCH ETHICS TRAINING PROGRAMS BY NON-PHREB-CIDTA

Recognition of the training program will depend on an evaluation of the submitted requirements and actual conduct of the training by a PHREB CIDTA representative

Procedure

1. Submission by requesting party at least one month before actual conduct of training.

a. Completed Recognition Request Form (Form 2015-02)

i. Name of requesting individual/institution

ii. Type of training program

iii. General profile of participants

iv. Date(s)

v. Training Venue

vi. Contact person and number

b. Description of the training program containing the following:

i. Objective: clearly stated and related to ethics in research

ii. Training Method: use of varied teaching-learning strategies that include didactics, workshops, small group discussions, etc.