3. Ethics Committee (EC)/Institutional Review Board (IRB)

3.1 Provide a list of documents needed to be submitted for EC/IRB review and approval including the number of copies and/or translations as relevant. 

The PNHRS and the Philippine Health Research Ethics Board (PHREB) issued the National Ethical Guidelines for Health and Health-Related Research in 2006. This document was then updated in August 2017 ("National Ethical Guidelines"). Aside from providing for the establishment of ERCs, the National Ethical Guidelines provide for the following requirements for the approval of ethical and technical review of clinical trial protocols from the ERCs: 

1. Application for review, which may be a formal letter or part of an application form as described in the committee's standard operating procedure, addressed to the research ethics committee.
2. Clearance from technical/ethical reviews from other committees (if applicable).
3. Research protocol that includes the title of the proposal, significance of the study, literature review, objectives of the study, methodology and procedure, inclusion and exclusion criteria, ethical considerations, and data analysis.
4. Informed consent and assent documents as provided in the National Ethical Guidelines. The informed consent and assent documents must be both in English and in a language appropriate to the level of understanding of the research participant as provided for in the National Ethical Guidelines. A sample template of statements to be written in an informed consent form (ICF) is also found in the same guidelines. 
5. Study tools (questionnaires, case report form, posters, advertisements for recruitment).
6. Study drug / medical device information, such as investigator brochures, published literature, and medical device manufacturer’s design, if relevant.
7. Curriculum vitae of the researcher and co-researchers, which shall also include the relevant training and proof of their GCP training (in the case of a clinical drug trial).
8. Statement on the presence or absence of conflict of interest of the researcher.
9. Information on funding, sponsors, institutional affiliations, and potential conflicts of interest.
10. Contracts and approval of relevant offices: Memorandum of Agreement (MOA) if the study is collaborative in nature; Materials Transfer Agreement (MTA); Intellectual Property Approval; and Investigational Device Exemption (IDE), when relevant.
11. Study/protocol budget.
12. The number of copies of the protocol package that is required by the committee for its review. The protocol must contain at least the following: 
    1. Administrative information about the study, such as about the researcher or investigator(s), sponsor(s), monitor(s), other qualified medical expert(s), diagnostic laboratories, and research institutions involved.
    2. Background information regarding the study, relevant past and current research findings and references to such information and data, and potential risks and benefits.
    3. Background information regarding the drug under investigation, the reason for the indicated route of administration, dosage, periods of treatment, population to be studied, a declaration regarding compliance with good clinical practice, and regulatory requirements.
    4. Objectives and purpose.
    5. Study design, which substantially determines the scientific integrity of the trial and the reliability of the data and includes the matters specifically provided for in the National Ethical Guidelines. 
    6. Selection and withdrawal of research participants, which include inclusion, exclusion, and withdrawal criteria.
    7. Informed consent of adult study participants or their minor children, and assent of adolescent participants with informed consent of their parents or legally authorized representative (LAR).
    8. Research participants’ therapy or treatment and monitoring procedures. 
    9. Efficacy parameters, methods, and timing. 
    10. Safety parameters, methods, timing, and procedures for recording and reporting, as well as monitoring adverse reactions.
    11. Safety measures for research participants when they withdraw/or are withdrawn from the study. 
    12. Plan for data and statistical analysis.
    13. Information regarding direct access to study data and documents for monitoring, audits, institutional ethics committee reviews, and regulatory inspections. 
    14. Ethical considerations. 
    15. Data management and record keeping. 
    16. Financing and insurance. 
    17. Dissemination and publication plans and procedures.
    18. Clinical trial participants’ information sheet/brochure, if applicable.

Pharmaceutical Data should also be provided to ascertain the quality and safety of the Investigational Product and to protect clinical trial subjects. FDA needs to ensure that the IP’s CMC and manufacturing process comply with acceptable standards (GMP):

• GMP statement from manufacturing/Certificate from Regulatory Body
• Certificate of Analysis
• Stability Data (storage conditions)
• Manufacturing Data & Formulation
• Product labeling (coded & labeled: blinding)

The Investigator’s Brochure should be provided containing information regarding the safety and efficacy of the drug as follows: 

Safety Data

• Non-Clinical Studies
• Pharmacology; PK/PD studies
• Toxicology Studies
• Marketing Experience, Periodic Safety Update Reports (PSUR), product status if marketed abroad
• Risks and ADR anticipated

Efficacy Data

• PK/PD Data in Human Subjects
• In-house preliminary data
• Summaries of clinical trial studies conducted (Phase I, II, III)
• Published clinical data

3.2 Time required for EC/IRB review and approval process and turnaround time if any query is raised during the review process.

The timeline of IRB/ERB for decision-making on the approval of a trial should not exceed 60 days.

3.3 Does EC/IRB have any fast-track or expedited review process?

In 2023, the FDA issued a circular outlining a new fast-track process for clinical trial approvals. This pathway allows for reliance on approval in other territories and reduces the approval time from 60 days to 10 days. The pathway is intended to support the fast track of approvals for clinical trials in cases of public health emergencies and emerging infectious diseases. 

FDA Circular No. 2023-004

3.4 Does EC/IRB need to be registered and/or accredited/approved by RA/CA?

An ERB/IRB is accredited based on the Philippine Health Research Ethics Board (PHREB) recommendation.

3.5 How frequently do EC/IRB meet?

The schedule of each EC/IRB differs. Most committees meet at least monthly. 

3.6 Is any additional approval required apart from the EC/IRB (e.g. scientific committee, subject matter expert committee, etc.)?

No.

3.7 Please describe the process of the EC/IRB submission for clinical trial approval.

The overall process is as follows: 

1. The initial step involves the submission of an electronic application to the FDA which will issue the Permit for the ethical and technical review of the clinical trial protocol to be done by an accredited ERB/ERC. 
2. The accredited ERB/ERCs should be guided by the following conditions:
   1. Fees to be charged per project as fees for technical and ethical review by the ERB/ERC will be standardized as SIXTY THOUSAND PESOS. This amount will be subject to regular review every two years.
   2. The timeline for the review from acceptance to completion should not exceed 60 days.
   3. The institutions will ensure that the individuals who will conduct the review process must have established competence in their areas of specialization and properly disclose conflicts of interest. Participation in the review process, by its nature, grants access to privileged information and thus, is subject to exercising confidentiality on the details of the documents submitted for review by the study sponsor. Reviewers and the study sponsor must adhere to a strict code of ethical conduct that ensures the independence of reviewers and objectivity as a basis for decisions.
3. FDA coordinates closely with the ERB/ERCs during the process and will be provided information on the progress of the review and all pertinent matters of the review.
4. The FDA will give the final decision to approve or deny an application based on the recommendation, submitted in written format, from the ERB/ERC review. A document granting approval for the conduct of a clinical trial based on the completed technical and ethical review by the ERB/ERC will be issued by the FDA to the study sponsor.

3.8 What is the relevant EC/IRB fee in local currency/USD? (e.g., is the fee different for notification/approval, initial submission, amendment, study with IMPD and study without IMPD, investigator site addition, etc.)?

The fees are standardized as SIXTY THOUSAND PESOS. This amount is subject to regular review every two years.

(At the time of publishing, sixty thousand pesos = USD 1090)

https://www.fda.gov.ph/wp-content/uploads/2021/08/FDA-Circular-No.-2012-007.pdf 

3.9 Does EC/IRB accept checks or can payment be made electronically? Please provide details on (1) A/C number; (2) A/C Name; (3) Sort Code; (4) Swift Code; (5) Bank address, etc. Where can remittance advice notices be sent?

Most ethics committees still accept checks, but some are now moving to electronic payment transfers. 

3.10 Is there any guidance tool available for making electronic applications? If yes, provide the link and/or step-by-step instructions.

Each IRB will have a different submission process but, generally, the application is submitted electronically. The linked Circular outlines the general requirements for submission and the process. There are no guidance tools available for online submission specifically.

3.11 Does EC/IRB require any mock screens/screenshots of participant-facing material on the app? If yes, do these need to be submitted in the local language?

Yes. Where patient-facing materials are electronic, screenshots should be provided.

3.12 Does the EC/IRB have any template or specific element requirements on ICF and/or other participant-facing materials?

Yes, a template is available. See Appendix K: Informed Consent Form Template for Clinical Studies.

3.13 Is there any guidance tool on participant compensation including clinical study-related injury per local requirements?

The Philippines National Ethical Guidelines state: 

“Clinical care and compensation of participants 

In case of occurrence of unexpected/adverse skin reaction, the investigator shall assess the severity of the reaction, complete the required safety report (e.g., SAE, SUSAR), and start the appropriate therapy promptly. 

Investigators shall ensure that research participants who suffer an injury as a result of their participation are entitled to free medical treatment for such injury, and to such financial or other forms of assistance that would compensate them equitably for any resultant impairment.”

http://49.231.15.21/deptw13/upload/files/hercF256312041721022781.pdf

3.14 Are there any specific local safety reporting requirements for clinical studies?

Please refer to Section 2.15 of this guidebook.

3.15 Does the EC/IRB require any periodic study reporting?

The Sponsor or CRO shall submit a study progress report annually (within the second quarter of the year ending on June 30) to the FDA, provided that the clinical trial has been approved for at least 12 months until the study ends. An interim report should be submitted for each protocol. 

https://www.fda.gov.ph/wp-content/uploads/2021/08/Administrative-NO.-2020-0010.pdf