Requirements for Review

Basic requirements for the Application of Ethical Clearance:

  • NEC Form 3 (http://nec.pchrd.dost.gov.ph/index.php/download)
  • 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
  • Endorsement from a government agency, addressed to the NEC Chair
  • 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.)
 

 

Please submit the documents through the Philippine Health Research Ethics Portal (PHREP), https://phrep.healthresearch.ph/