Law Summary
Purpose
- To prescribe the procedures and guidelines that facilitate collaboration, cooperation, and convergence among all health research stakeholders.
- To achieve the objectives of RA 10532 through coordinated efforts.
Construction and Interpretation
- Any doubts in implementation or interpretation shall favor promoting cooperation and integration among stakeholders.
- Emphasis is on convergence of health research efforts contributing to evidence-informed policies.
Declaration of Policy
- The State prioritizes protection and promotion of people’s right to health.
- PNHRS’s mission is to create an enabling environment for health research that informs health policy and actions.
- The system facilitates engagement among all health research stakeholders.
Definitions
- Key terms defined include: "Act," "Health," "Health Research Stakeholders," "Health Research Community," "Health System," "International organizations/networks," "National and Regional Unified Health Research Agenda," "PCHRD," "PHREB," "PNHRS," "Research," "Research for Health," and "Universal Health Care."
- These definitions frame the scope and operation of the health research system.
Institutionalization of the PNHRS
- PNHRS was initiated through MOUs among DOST, DOH, CHED, and UP Manila-NIH.
- It is institutionalized within the mandate of the PCHRD as the national coordinating body for health research.
Objectives of the PNHRS
- Link health research to health system needs.
- Maximize benefits from health research investments.
- Promote transparency, good governance, and ethical management in health research.
- Foster national and international partnerships.
- Ensure sustainability of resources for health research.
Formulation of Research Agenda
- Research agendas align with societal and national priorities including science, education, and health goals.
- National and regional agendas direct programs, funding, and activities strategically.
Benefit Determination
- Health research must align with the country’s health agenda and address emerging issues.
- Research outcomes should improve health results and optimize resource use.
Resource Sustainability
- PNHRS implementing institutions must allocate annual budgetary resources to support programs.
- Public and private members of PNHRS Network must similarly allocate resources.
- Additional funding can come from government revenues and contributions by local, national, or international organizations.
Composition of the PNHRS
- Institutionalized within PCHRD mandate.
- Consists of Governing Council, Steering Committee, Technical Working Committees, and Secretariat.
- Health research community is considered an indispensable partner.
PNHRS Governing Council
- The highest policymaking body composed of key government officials and five private sector representatives.
Private Sector Representatives
- Five representatives appointed by the President for two-year terms.
- Four governed by EO 128; the fifth represents a recognized health civil society organization.
Governing Council Meetings
- Meetings follow the procedures established for the PCHRD Governing Council.
Powers and Functions of the Governing Council
- Set policies and directions.
- Review and approve long-term plans and research agendas.
- Approve research programs.
- Create committees as needed.
Governing Council Guidelines
- Develops internal rules for reviewing and approving research programs.
PNHRS Secretariat
- Headed by PCHRD Executive Director who oversees program implementation.
- Provides technical and administrative support in research management, capacity building, research information, communication and utilization, finance, and administration.
Secretariat Staffing and Budget
- Included within PCHRD’s staffing and budget frameworks.
Steering Committee
- An advisory group to the Governing Council chaired by the PCHRD Executive Director.
- Comprised of key directors from government agencies and PNHRS technical working committees.
Functions of the Steering Committee
- Recommend policies.
- Oversee implementation and fund allocation.
- Coordinate technical working committees.
- Monitor and report progress to the Governing Council.
Steering Committee Guidelines
- Responsible for promulgating guidelines for its meetings.
Technical Working Committees (TWC)
- Established based on research themes aligned with the country’s health needs and WHO building blocks.
- Develop and monitor strategic plans.
- Coordinate closely with stakeholders and Secretariat.
- Number of TWCs may vary depending on needs.
Interrelationships within PNHRS
- The Governing Council is the highest policymaking body.
- Day-to-day operations subsumed under PCHRD mandate.
- Engagement through advisory bodies and working groups to include broader health research community.
Philippine Health Research Ethics Board (PHREB)
- Ensures adherence to universal ethical principles protecting human research participants.
- Functions include:
- Formulating and updating ethical guidelines regularly.
- Developing guidelines for ethics review committees (ERCs) establishment and management.
- Monitoring and evaluating ERC performance through Regional Ethics Monitoring Boards.
- Promoting functional and effective ERCs through registration and accreditation.
- Advising the PNHRS Governing Council on ethical issues.
- Initiating discourse on ethical research matters.
- Networking with local and international bodies.
- All human subject research must undergo ethics review by duly accredited ERCs before implementation.
Regional Health Research Systems
- PNHRS framework mirrored regionally through health research consortia.
- Regional systems address research agenda, human resource development, research conduct, dissemination, resource mobilization, and management.
- Strategies to ensure equitable resource distribution and sustained commitment.
- Inter-regional collaboration encouraged through joint projects and activities.
Monitoring, Evaluation, Accountability, and Reporting
- Regular M&E mechanism by Governing Council via Secretariat.
- Development and approval of M&E plans with performance indicators.
- Mandatory registration of all health researches in the Philippine Health Research Registry and dissemination to national repository (HERDIN).
- Development of policies to institutionalize participation.
- Annual report of accomplishments presented during the PNHRS Week.
Amendments and Review
- Amendments to the rules require written approval by all implementing agencies.
- The IRR shall be reviewed every three years.
Repealing and Separability Clauses
- Prior inconsistent rules repealed or modified accordingly.
- Any invalid provision does not affect the validity of the remaining rules.
Effectivity
- Rules take effect 15 days after publication and filing with the UP Law Center.
These comprehensive provisions collectively establish an organized, cooperative, ethical, and sustainable national health research system in the Philippines, aligned with national priorities and global best practices.