IRR of RA 10532: Philippine Nat'l Health Research System

Legal basis and policy intent

The rules implement Republic Act No. 10532 by prescribing procedures and guidelines for implementing the Philippine National Health Research System (PNHRS).
The declared policy of the State is to protect and promote the right to health, instill health consciousness, and improve the quality of life of every Filipino through health research and development facilities (Rule 4).
The mission of the PNHRS is to create and sustain an enabling environment for health research toward evidence-based health-related policies and actions and to facilitate and enable engagement of stakeholders of the health research community (Rule 4).
All doubts in implementation, construction, and interpretation must be resolved to promote cooperation and collaboration and to integrate and converge health research efforts so that research contributes to evidence-based health-related policies and actions (Rule 3).
The rules direct the implementation to facilitate collaboration, cooperation, and convergence among stakeholders to achieve the objectives of the Act (Rule 2).

Core definitions and system terms

“Act” means RA 10532 (Rule 5(a)).
“Health” means a state of optimal physical, mental and social well-being and the ability to function at the individual level (Rule 5(b)).
“Health Research Stakeholders” include local and international public and private agencies/organizations, policymakers, the academe, medical and health societies, people’s organizations, and others concerned with and affected by health and development; it also covers international stakeholders, both individual and institutional (Rule 5(c)).
“Health Research Community” covers all stakeholders including policymakers, researchers, research institutions, funders/advocates of research, and users/beneficiaries of research results at local, national, and/or international levels (Rule 5(d)).
“International organizations” mean: (i) United Nations and its specialized agencies; (ii) ASEAN and its specialized agencies; (iii) international development and/or funding institutions recognized by the Philippine Government; and (iv) other international organizations/institutions covered by a headquarters agreement and/or an international treaty signed by the Philippine Government (Rule 5(f)).
“International Networks” mean formal and informal linkages, collaborations, assistance, cooperation, information sharing, and similar activities with non-Filipino individuals, institutions, universities, public or private research entities, and international organizations, subject to constitutional and legal limitations, provisions, and penal clauses (Rule 5(g)).
“National Unified Health Research Agenda (NUHRA)” is a set of research priorities determined by stakeholders addressing population health needs in relation to the health sector’s goal for universal health care; it is also the platform to advocate for local, national and international support; “National Health Research Agenda (NHRA)” has the same definition (Rule 5(h)).
“Philippine Council for Health Research and Development (PCHRD)” is a sectoral planning council of the DOST that provides central direction, leadership, and coordination in health science and technology and serves as the national coordinating body for health research (Rule 5(i)).
“Philippine Health Research Ethics Board (PHREB)” is the national policymaking body on health research ethics created under DOST Special Order No. 091 mandated to ensure that all phases of health research adhere to universal ethical principles protecting and promoting dignity of research participants (Rule 5(j)).
“Philippine National Health Research System (PNHRS)” is a framework anchored on the principles of Essential National Health Research: inclusiveness, participation, quality, equity, efficiency, and effectiveness, connecting and converging with wider health, economic, political, educational, and S&T systems, and operationalized through individuals and institutions involved in health research and development (Rule 5(k)).
“PNHRS Implementing Institutions” are the DOST, DOH, CHED, and UP Manila (Rule 5(m)).
“Regional Health Research Systems” include regional health research consortia or communities in all regions that mirror the PNHRS framework at the regional level (Rule 5(n)).
“Research” is development of knowledge to understand health challenges and mount improved responses; it covers the full spectrum of research in five (5) areas: (1) measuring the problem; (2) understanding causes; (3) elaborating solutions; (4) translating solutions/evidence into policy, practice and products; and (5) evaluating effectiveness (Rule 5(o)).
“Research for Health” / “Health research” is research seeking to understand the impact of health policies, programmes, processes, actions, or events from any sector to develop interventions preventing or mitigating impacts and contributing to universal health care, development goals, health equity, and better health for all (Rule 5(p)).
“Universal Health Care” is a focused approach ensuring all Filipinos—especially the poor—receive benefits of health reform, with financial risk protection through enrollment to PhilHealth and access to affordable and quality health care and services when needed (Rule 5(s)).
“Technical Working Committee” refers to PNHRS working committees aligned with research themes based on the country’s health needs and the six (6) building blocks of the World Health Organization (WHO) to attain universal health care (Rule 5(t)).

Institutionalization and governance structure

The PNHRS is institutionalized within the mandate of the PCHRD as the national coordinating body for health research (Rule 6).
The PNHRS is carried through the PCHRD and is implemented by the PNHRS implementing institutions (DOST, DOH, CHED, UP Manila) (Rule 6 and Rule 11).
The PNHRS structure consists of the Governing Council (GC), Steering Committee, Technical Working Committee (TWC), and Secretariat, as described in Section 9 of Republic Act No. 10532 (Rule 11).
The whole health research community is an indispensable partner and contributor to strengthen the PNHRS (Rule 11).
The PNHRS is governed by the PNHRS Governing Council, created under Executive Order (EO) No. 784 and EO No. 128, which serves as the Governing Council for the PNHRS (Rule 12).
The PNHRS Governing Council’s composition includes: the Secretary of DOST (Chair), Secretary of DOH (Co-Chair), CHED Chair, UP Manila Chancellor, National Nutrition Council Executive Director, PCHRD Executive Director, and five (5) private sector representatives (Rule 12).
The five (5) private sector representatives are appointed by the President for a term of two years; four representatives follow appointment criteria and terms under EO 128, Section 16, and the fifth represents a recognized health civil society organization (Rule 13).
The Governing Council’s meetings follow the existing procedures of the PCHRD Governing Council (Rule 14).

Governance functions and committee rules

The PNHRS Governing Council sets policies and directions for the PNHRS (Rule 15(a)).
The Governing Council periodically reviews and approves the PNHRS long-term plans and programs (Rule 15(b)).
The Governing Council evaluates and approves the National Unified Health Research Agenda (NUHRA) and identifies areas that serve as foci of the National Health Research Agenda (Rule 15(c)).
The Governing Council reviews, approves, or disapproves research programs (Rule 15(d)).
The Governing Council creates committees as needed to facilitate and ensure achievement of the PNHRS objectives (Rule 15(e)).
The Governing Council develops its own guidelines in reviewing, approving, and disapproving research programs (Rule 16).
The PCHRD Secretariat, headed by an Executive Director, serves as the Secretariat and provides technical and administrative support to TWCs, Steering Committee, and the Governing Council in: (a) R&D Management; (b) Institution Development; (c) Research Information, Communication and Utilization; and (d) Finance and Administration (Rule 17).
The PNHRS Secretariat organizational structure and staffing pattern are subject to approval of the Department of Budget and Management, while DOST-PCHRD determines the structure and staffing pattern and appoints officers and employees in accordance with civil service laws, rules, and regulations (Rule 18).
The PNHRS staffing and operations budget is incorporated in the PCHRD budget and provided for in the annual General Appropriations Act (Rule 18).

Steering committee and technical committees

The Governing Council creates a Steering Committee headed by the PCHRD Executive Director (Rule 19(a)).
The Steering Committee includes representatives from specific agencies and institutions: DOST-PCHRD; DOH-HPDPB; CHED-OPRKM; UP Manila-NIH; NEDA; PHREB; PHIC; Philippine Statistics Authority; PRC; DOTr-LTO; DENR-EMB; LGUs; and the chairs of relevant PNHRS TWCs (Rule 19(a)).
The Steering Committee may invite other government agencies and private sector representatives as resource persons if their contributions are critical to PNHRS programs (Rule 19(a)).
The Steering Committee recommends policies to the Governing Council, performs oversight on PNHRS implementation and harmonization and allocation of PNHRS funds, coordinates and harmonizes TWC activities, and monitors and reports program progress to the Governing Council (Rule 19(b)).
The Steering Committee promulgates its meeting guidelines and meets twice a year in the first and third quarters (Rule 20).
The Governing Council creates TWCs aligned with research themes based on the country’s health needs and the six (6) WHO building blocks to attain universal health care (Rule 21).
TWCs develop and monitor their respective strategic plans and work closely with stakeholders and the Secretariat (Rule 21).
The Governing Council increases or decreases the number of TWCs depending on circumstances, with recognition of existing TWCs on: research agenda management, capacity building, ethics, research utilization, resource mobilization, structure/organization, and monitoring and evaluation (Rule 21).
Chairs and members of TWCs serve for a term of two years, renewable for another term (Rule 21).
The Inter-Technical Working Committee Chairs (ITWCC) ensure alignment of PNHRS policies and programs with national and global health goals and: promote coordination among TWCs, provide a forum for best practices/lessons learned on system governance and program implementation issues, and recommend improvements to the Steering Committee (Rule 21).

Ethics board and ethics review requirements

The PHREB is the highest policymaking body for health research ethics created under DOST Special Order No. 091 (s. 2006) and ensures adherence to universal ethical principles protecting human participants (Rule 23).
PHREB formulates and updates ethical conduct guidelines; the National Ethical Guidelines for Health Research are updated every five years or whenever necessary, through a committee tasked for this purpose (Rule 23(a)).
All researches involving human participants must undergo ethical review and clearance before implementation to ensure safety, dignity, and well-being of research participants (Rule 23(b)).
Ethical review is undertaken by a Research Ethics Committee (REC) duly accredited by PHREB as provided in Joint Memorandum Order 2012-001 of DOST, DOH, CHED, and UPM-NIH and the Memorandum of Understanding with the National Commission for Culture and the Arts (NCCA) and the National Museum of the Philippines (NM) (Rule 23(b)).
PHREB develops guidelines for establishing and managing ethics review committees and standardizing research ethics review (Rule 23(b)).
PHREB monitors and evaluates institutional ethics review committee performance and establishes or designates Regional Ethics Monitoring Boards to supervise ethics review committees in their regional areas of responsibility (Rule 23(c)).
PHREB and the Regional Ethics Monitoring Boards develop and agree on indicators of good performance to ensure and monitor quality ethics review (Rule 23(c)).
PHREB promotes establishment of functional ethics review committees through standards included in the National Ethical Guidelines (Rule 23(d)).
PHREB accredits RECs and only PHREB-accredited RECs are allowed to conduct ethics review (Rule 23(d)).
PHREB maintains an updated registry of accredited RECs (Rule 23(d)).
PHREB determines and imposes accreditation fees, subject to approval of the Secretary of DOST (Rule 23(d)).
RECs are categorized as institution-based RECs (hospitals, academic and research institutions), government agency-based RECs, organization-based RECs, cluster RECs, research site-based RECs, and other RECs recognized by PHREB (Rule 23(d)).
PHREB provides advice and recommendations on ethical issues to the PNHRS Governing Council and other appropriate entities; initiates discourses; organizes fora and platforms; networks with local, national, and international organizations; and undertakes collaborative initiatives to foster ethical health research and protect participants and promote integrity of research data (Rule 23(e), (f), and (g)).
The National Ethical Guidelines incorporate standards for establishment and management of ethics review committees and standards for research ethics review (Rule 23(b)).

Regional systems and inter-regional collaboration

The PNHRS framework—cooperation, collaboration, strategic directions, and programs—is mirrored in all regions through a network of regional research consortia (Rule 24).
Each regional health research system addresses: health research agenda, human resource development in health research, conduct of researches, dissemination of research results, structure and organization, monitoring and evaluation, leadership and management (Rule 24).
The PNHRS Network is strengthened to ensure equitable distribution of health research resources and full coverage within regions (Rule 24).
Strategies to increase and sustain commitment of member institutions to participate and share resources are pursued (Rule 24).
Inter-regional collaboration is encouraged through joint projects, information and resource sharing, participation in, and hosting of, the annual Philippine National Health Research System Week celebration (Rule 25).

Monitoring, evaluation, accountability, reporting

Regular monitoring and evaluation is conducted by the Governing Council through the Secretariat to determine the PNHRS accountabilities to the contributing agencies (Rule 26).
All implementing institutions and regional health research consortia, including members of their networks or consortia, must regularly input into the PNHRS research databases and monitoring systems and must submit annual reports on health research activities and accomplishments regardless of funding source (Rule 26).
The Secretariat, with the Technical Working Committees and the Steering Committee, develops and implements a monitoring and evaluation plan with indicators, subject to approval by the Governing Council (Rule 27).
All health researches must be registered in the Philippine Health Research Registry, and when published, in the national repository called HERDIN (Rule 28).
The Secretariat develops and disseminates guidelines to enable institutions to share research information with these registries and databases (Rule 28).
The PNHRS Network and implementing institutions develop policies and guidelines to institutionalize and operationalize their participation in the PNHRS (Rule 29).
The Secretariat submits an annual report of PNHRS accomplishments to the Governing Council and the report is presented during the PNHRS Week celebration (Rule 30).

Amendments, review, separability, repeals, effectivity

Amendments to the rules must be done in writing by any of the implementing agencies and become effective only upon approval of all implementing agencies (Rule 31).
The IRR is reviewed every three (3) years (Rule 32).
If any provision or part of the rules is held invalid or unconstitutional, the remainder of the rules not otherwise affected remains valid and subsisting (Rule 33).
All existing rules and regulations, or parts thereof, that are contrary to or inconsistent with these rules are repealed or modified accordingly (Rule 34).
The rules take effect fifteen (15) days after publication in a newspaper of general circulation and upon filing at the UP Law Center in accordance with existing law (Rule 35).