Who can apply for NEC Review
Research Protocols endorsed by government agencies wherein:
1. Proponents whose institution has no PHREB-accredited research ethics committee (REC)
2. Graduate students whose institution has no PHREB-accredited REC, and whose research is nationwide in scope in terms of participants
Basic requirements for the Application of Ethical Clearance:
- Letter Request for Review addressed to NEC Chair
- Endorsement from a government agency, addressed to the NEC Chair
- NEC Form 3 (http://nec.pchrd.dost.gov.ph/
index.php/download) - Full Proposal / Study Protocol that includes section on Ethical Considerations and Dissemination Plan
- Informed Consent and Assent Forms (whichever is applicable)
- Study Forms (Survey Questionnaire, Interview/FGD Guide Questions, Case Report Form)
- Certificate of Approval from a Technical Review Panel that indicates scientific soundness based on reasonableness of the research question, SMART (Specific, Measurable, Attainable, Realistic, Time-bound) objectives, appropriateness of the study design, exclusion and inclusion criteria, collection data and statistical analysis
- Institutional Ethical Review (if researcher is from a foreign institution)
- CV of proponent and research staff
- The NEC has an application fee of PhP 5,000.00 and review fee of PhP 10,000.00.
Requirements for Post-Approval Requests
For Extension of Ethical Clearance:
1. Request Letter addressed to the NEC Chair
2. NEC Form 11 – Application for Extension of Ethical Clearance
For Review of Reports:
1. NEC Form 12A – Application Form for Ethics Review of Progress Reports
2. NEC Form 12B - Application for Ethics Review of Protocol Deviation or Violation
3. NEC Form 12C - Application for Ethics Review of Reportable Negative Event Report
4. NEC For 12D - Early Termination Report
5. NEC Form 14 – Application Form for Ethics Review of Final Report
For Review of Amendments:
1. Request Letter addressed to the NEC Chair
2. NEC Form 13 – Application Form for Ethics Review of Amendments
3. Amended Documents (Full Proposal, Informed Consent Form, etc.)