Research Consent Form (Philippines)

A Research Consent Form in the Philippines evidences that consent has been freely given, identifying exactly what has been agreed to and by whom.

The Philippine research consent framework aligns with internationally recognized instruments: the Declaration of Helsinki (World Medical Association, as amended in Fortaleza 2013), the Belmont Report (1979), and the CIOMS International Ethical Guidelines for Health-Related Research Involving Humans (2016). Under PHREB NEG 2017 Section 5 (Informed Consent), no research involving human participants may proceed unless the researcher has obtained valid, documented informed consent or — where applicable — a waiver of consent duly approved by an accredited Institutional Review Board (IRB) or Ethics Review Committee (ERC).

Philippine IRBs and ERCs accredited by PHREB include those at the University of the Philippines Manila Research Ethics Board (UPMREB), the De La Salle Health Sciences Institute Research Ethics Committee (DLSHSI-REC), the Ateneo School of Medicine and Public Health Research Institutional Ethics Committee (AMSPH-RIEC), and research ethics boards at St. Luke's Medical Center, Makati Medical Center, the Philippine Heart Center, and the Philippine General Hospital (PGH). For non-health research in the social sciences, CHED Memorandum Order No. 53-2016 (Research Ethics Manual for Higher Education Institutions) supplements PHREB guidelines.

The PHREB NEG 2017 requires the ICF to be written in Filipino or English at a reading level comprehensible to the participant, with verbal explanation before signing. A witness must sign the ICF where the participant cannot read, and a copy must be given to the participant. For studies involving minors (below 18 years), parent or legal guardian consent is required plus the minor's assent if 7 years or older, per PHREB NEG 2017 Section 11 and the Family Code (EO 209).

The NPC under RA 10173 requires research institutions processing personal data to maintain data protection policies, appoint a Data Protection Officer (DPO) registered with the NPC if processing sensitive personal information or data of 250 or more data subjects, and implement organizational, physical, and technical security measures under NPC Circular 16-01. Research institutions conducting clinical trials must also comply with the Philippine FDA's Good Clinical Practice (GCP) requirements under RA 9711 (FDA Act of 2009) and FDA Circular No. 2013-016. The Research Consent Form serves as documentary proof of participants' informed and voluntary consent to both research procedures and personal data processing, creating a complete audit trail for PHREB accreditation review, NPC compliance verification, and Philippine FDA inspection. Forms-legal.com provides this Research Consent Form (Philippines) template as a starting point aligned with PHREB NEG 2017 and RA 10173 requirements.

A Research Consent Form in the Philippines is required whenever an individual or institution conducts any research involving human participants, as defined broadly by PHREB NEG 2017 to include systematic investigations — experimental or observational — designed to develop or contribute to generalizable knowledge.

Clinical trials: Sponsor-investigators conducting clinical trials of investigational drugs, biologics, or medical devices subject to Philippine FDA regulations under RA 9711 must obtain FDA-reviewed written informed consent using an ICF template before any study-related procedures — a mandatory GCP requirement under FDA Circular No. 2013-016 and ICH E6 R2 guidelines adopted by the Philippine FDA.

Public health and epidemiological studies: Observational studies and surveys funded by DOST, DOH, PhilHealth under RA 11223, WHO, NIH, or USAID require PHREB-accredited ERC approval and individual participant consent before data collection.

Indigenous peoples research: Community-based participatory research in ancestral domain areas involving indigenous cultural communities requires both Free, Prior and Informed Consent (FPIC) under RA 8371 (Indigenous Peoples Rights Act of 1997) administered by the National Commission on Indigenous Peoples (NCIP) and individual participant ICFs.

Academic theses and dissertations: Graduate and undergraduate researchers at CHED-supervised higher education institutions collecting primary data from human respondents — whether through surveys, interviews, focus groups, or observations — must obtain ethics review from their institution's ERC and obtain participant consent forms before data collection, per CHED Memorandum Order No. 53-2016.

Vulnerable populations: Research involving pregnant women, prisoners, persons with mental illness, economically disadvantaged individuals, OFWs, and other vulnerable groups requires enhanced consent protections and additional PHREB safeguards under NEG 2017 Chapter 10 — including independent consent monitoring and additional IRB oversight.

Biometric and health data collection: Any research collecting biological specimens (blood, urine, tissue, genetic material), accessing identifiable health records, or processing biometric identifiers requires explicit consent under Section 13 of RA 10173 for sensitive personal information, and compliance with PHREB NEG 2017 Section 8 on biological specimens and genetic data. The Philippine FDA's Center for Drug Regulation and Research (CDRR) and Center for Device Regulation, Radiation Health and Research (CDRRHR) also review ICFs for clinical trials involving investigational drugs and medical devices under RA 9711 before study initiation.

A Philippine Research Consent Form compliant with PHREB NEG 2017 and RA 10173 must contain the following elements to constitute legally and ethically valid informed consent.

Study Information Header: Full title of the research study, name and contact details of the principal investigator and co-investigators, name and PHREB accreditation number of the IRB or ERC that reviewed and approved the study, study sponsor, and the ethics review approval or reference number.

Purpose and Background: Plain language explanation of why the research is being conducted, what problem it addresses, and how the participant was selected — satisfying PHREB NEG 2017's requirement that participants understand the study's societal relevance before consenting.

Procedures: Chronological and precise description of what the participant will be asked to do, number of study visits or sessions required, estimated total time commitment, and whether procedures involve physical contact, biological sampling, or linkage to health records maintained by PhilHealth or private hospitals.

Risks and Discomforts: Disclosure of all foreseeable risks — physical, psychological, social, legal, and economic — with quantified probability where known (citing published adverse event rates from prior studies), and description of mitigation measures including availability of medical care at the researcher's expense for research-related injuries under PHREB NEG 2017 Section 9.

Benefits and Compensation: Distinction between direct benefits to the participant and anticipated societal benefits, avoiding overstated therapeutic benefit (prohibited undue inducement under PHREB NEG 2017 Section 6), and disclosure of any financial payment or reimbursement ensuring it is proportionate and not coercive.

Confidentiality and Data Privacy: Specification of personal data collected, legal basis under Section 12 or 13 of RA 10173, data storage method (de-identified, coded, or anonymized), retention period, DPO name and contact, organizations with data access (sponsors, co-investigators, FDA, PHREB), and confirmation of data subject rights under Sections 16-18 of RA 10173 — including the right to file a complaint with the NPC.

Voluntary Participation and Withdrawal: Unambiguous statement that participation is entirely voluntary and withdrawal is possible at any time without penalty, loss of benefits, or adverse consequences — required by Declaration of Helsinki Paragraph 26 and PHREB NEG 2017 Section 5.3.

Contact Information: Principal investigator's phone number and email, IRB/ERC contact for ethics questions, and independent PHREB contact for complaints at [email protected].

Signature Block: Participant's name, signature, and date; researcher's certification; witness signature where the participant cannot read (required under PHREB NEG 2017 Section 5); and for minor participants — parent or guardian consent plus a separate minor's assent form as annexes per PHREB NEG 2017 Section 11 and Articles 211–216 of the Family Code (EO 209).

Language and Readability: PHREB NEG 2017 requires the ICF to be written in Filipino or English at a reading level appropriate for the target participant population — typically Grade 6 to Grade 8 reading level for community-based studies. Technical jargon must be avoided or explained in plain language. For studies involving participants in regional communities, a translated version in the local dialect (Cebuano, Ilocano, Hiligaynon, or other Philippine languages) may be required by the accredited IRB or ERC.

Copy for Participant: PHREB NEG 2017 Section 5.2 requires that a signed copy of the ICF be provided to the participant immediately after signing. This ensures the participant retains a record of what they consented to and how to contact the research team or the IRB or ERC if questions arise. The forms-legal.com Research Consent Form (Philippines) template incorporates all PHREB NEG 2017 and RA 10173 mandatory elements for PHREB-accredited ERC submission.