Benilde REU Resources

SOP 1: Preparation and Revision of Standard Operating Procedures (click here)

SOP 2A: Constituting Benilde Research Ethics Committee (click here)

     BRERC Form No. 2.1 Confidentiality Agreement Form (click here)

     BRERC Form No. 2.2.1 Disclosure of Conflict-of-Interest Agreement (BRERC Members and Consultants) (click here)

     BRERC Form No. 2.2.2 Disclosure of Conflict-of-Interest Agreement (for Investigators) (click here)

     BRERC Form No. 2.3.1 Nomination Form for BRERC Membership (click here)

     BRERC Form No. 2.3.2 Curriculum Vitae (click here)

     BRERC Form No. 2.3.3 Invitation Letter for BRERC Nominees (click here)

SOP 2B: Appointment of Independent Consultants (click here)  

     BRERC Form No. 2.1 Confidentiality Agreement Form (click here)

     BRERC Form No. 2.2.1 Disclosure of Conflict-of-Interest Agreement (BRERC Members and Consultants) (click here)

     BRERC Form No. 2.2.2 Disclosure of Conflict-of-Interest Agreement (for Investigators) (click here)

     BRERC Form No. 2.3.2 Curriculum Vitae (click here)

     BRERC Form No. 2.3.3 Invitation Letter for BRERC Nominees (click here)

SOP 3: Disqualification of BRERC Member (click here)

     BRERC Form No. 3.1 Letter of Disqualification Decision for BRERC Member (click here)  

SOP 4A: Management of Research Documents for Initial Review (click here)

     BRERC Form No. 4.1.1 Research Ethics Review Checklist (click here)

     BRERC Form No. 4.1.2 Application Form for Ethics Review of a Research Proposal (click here)

     BRERC Form No. 4.1.3 Checklist for Exemption of Review (click here)

     BRERC Form No. 4.1.4 Certificate of Exemption Template (click here)

     BRERC Form No. 4.1.5 Post-Research Compliance Report (click here)

     BRERC Form No. 4.1.6 Referral Letter for External Research Ethics Committee (click here)

     BRERC Form No. 4.1.7 Non-Disclosure Agreement (click here)

     BRERC Form No. 5.2 Review Checklist for Informed Consent Form and Process (click here)

SOP 4B: Review of Resubmissions (click here)

     BRERC Form No. 4.2.1 Log of Research Submissions (click here)

     BRERC Form No. 4.2.2 Decision Letter for Review of Resubmissions (click here)

SOP 5: Full Review (click here)

     BRERC Form No. 5.1 Reviewer's Worksheet (click here)

     BRERC Form No. 5.2 Review Checklist for Informed Consent Form and Process (click here)

     BRERC Form No. 4.2.1 Log of Research Submissions (click here)

     BRERC Form No. 5.3 Log of Post-Approval Submissions (click here)

     BRERC Form No. 5.4 Application for Extension of Ethical Clearance (Continuing Review) (click here)

     BRERC Form No. 5.5 Application Form for Ethics Review of Progress Reports (click here)

     BRERC Form No. 5.6 Application Form for Ethics Review of Protocol Deviation / Violation (click here)

     BRERC Form No. 5.7 Application Form for Ethics Review of Reportable Negative Event Report (click here)

     BRERC Form No. 5.8 Early Termination Report (click here)

     BRERC Form No. 5.9 Application Form for Ethics Review of Amendments (click here)

     BRERC Form No. 5.10 Application Form for Ethics Review of Final Report (click here)

     BRERC Form No. 5.11 Research Protocol Amendment Form (click here)

     BRERC Form No. 5.12 Informed Consent Revision Form (click here)

     BRERC Form No. 5.13 Certificate of Approval for Initial Review (click here)

     BRERC Form No. 5.14 Research Ethics Clearance (click here)

SOP 6: Expedited Review (click here)

     BRERC Form No. 5.1 Reviewer's Worksheet (click here)

     BRERC Form No. 5.2 Review Checklist for Informed Consent Form and Process (click here)

     BRERC Form No. 4.2.1 Log of Research Submissions (click here)

     BRERC Form No. 5.14 Research Ethics Clearance (click here)

SOP 7A: Preparations for a Meeting (click here)

     BRERC Form No. 7 Provisional Agenda Template (click here)

SOP 7B: Conduct of Meeting (click here)

     BRERC Form No. 7 Provisional Agenda Template (click here)

     BRERC Form No. 7.2.1 BRERC Meeting Attendance Sheet (click here)

     BRERC Form No. 7.2.2 Study Protocol Assessment Worksheet for BRERC Members (click here)

     BRERC Form No. 2.1 Confidentiality Agreement Form (click here)

     BRERC Form No. 2.2.2 Disclosure of Conflict-of-Interest Agreement (for Investigators) (click here)

     BRERC Form No. 5.2 Review Checklist for Informed Consent Form and Process (click here)

     BRERC Form No. 8 Minutes of the Meeting (click here)

     BRERC Form No. 10.1.1 Decision Letter for Management of Communication (click here)

SOP 8: Preparation of Minutes of the Meeting (click here)

     BRERC Form No. 8 Minutes of the Meeting (click here)

SOP 9A: Monitoring and Continuing Review (click here)

     BRERC Form No. 5.1 Reviewer's Worksheet (click here)

     BRERC Form No. 5.2 Review Checklist for Informed Consent Form and Process (click here)

     BRERC Form No. 5.3 Log of Post-Approval Submissions (click here)

     BRERC Form No. 5.4 Application for Extension of Ethical Clearance (Continuing Review) (click here)

     BRERC Form No. 5.5 Application Form for Ethics Review of Progress Reports (click here)

     BRERC Form No. 5.6 Application Form for Ethics Review of Protocol Deviation / Violation (click here)

     BRERC Form No. 5.7 Application Form for Ethics Review of Reportable Negative Event Report (click here)

     BRERC Form No. 5.8 Early Termination Report (click here)

     BRERC Form No. 5.9 Application Form for Ethics Review of Amendments (click here)

     BRERC Form No. 5.10 Application Form for Ethics Review of Final Report (click here)

     BRERC Form No. 5.11 Research Protocol Amendment Form (click here)

     BRERC Form No. 5.12 Informed Consent Revision Form (click here)

     BRERC Form No. 5.13 Certificate of Approval for Initial Review (click here)

     BRERC Form No. 5.14 Research Ethics Clearance (click here)

SOP 9B: Management of Appeals (click here)

     BRERC Form No. 9.2.1 Research Ethics Appeal Form (click here)

     BRERC Form No. 10.1.1 Decision Letter for Management of Communication (click here)

SOP 9C: Conduct of Site Visits (click here)

     BRERC Form No. 5.2 Review Checklist for Informed Consent Form and Process (click here)

     BRERC Form No. 9.3.1 Site Visit Report Form (click here)

     BRERC Form No. 10.1.1 Decision Letter for Management of Communication (click here)

SOP 10A: Management of Communication (click here)

     BRERC Form No. 10.1.1 Decision Letter for Management of Communication (click here)

     BRERC Form No. 10.1.2 Ethical Clearance Template (click here)

SOP 10B: Management of Queries and Complaints (click here)

     BRERC Form No. 10.2.1 Log of Queries and Complaints (click here)

     BRERC Form No. 10.2.2 Participant Complaint Form (click here)

SOP 11: Management of BRERC Files (click here)

     BRERC Form No. 4.2.1 Log of Research Submissions (click here)

     BRERC Form No. 5.3 Log of Post-Approval Submissions (click here)

SOP 12: Management of Access to Confidential Files (click here)

     BRERC Form No. 12.1 Application Form for Access to Confidential Files (click here)

     BRERC Form No. 12.2 Third-Party Data Access Request Form (click here)

     BRERC Form No. 12.3 Log of Access to Confidential Files (click here)

SOP 13: Training of Benilde Research Ethics and Review Committee (BRERC) Members (click here)

     BRERC Form No. 13 Ethics Training Certification Record (click here)

SOP 14: Compensation of the BRERC Members, Non-Affiliate, Consultants, and Community Representatives (click here)

     BRERC Form No. 8 Minutes of the Meeting (click here)

• Philippine Health Research Ethics Board (PHREB): Online Training Request Portal (click here)

• Collaborative Institutional Training Initiative (CITI Program): Human Subjects Research Training (click here)

• Global Health Training Centre: Essential Elements of Ethics (click here)

National References

• National Ethical Guidelines for Research Involving Human Participants (NEGRIHP 2022) (click here)

• Philippine Health Research Ethics Board (PHREB) (click here)

International References

Guidelines and Codes of Best Practice

• Nuremberg Code (click here)

• Declaration of Helsinki (World Medical Association) (click here)

• CIOMS: International Ethical Guidelines for Health-related Research Involving Humans  (click here)

• CIOMS: International Ethical Guidelines for Biomedical Research Involving Human Subjects (2002) (click here)

• CIOMS: International Ethical Guidelines for Epidemiological Research Involving Human Subjects (2009) (click here)

• UNAIDS/WHO, Ethical Considerations in Biomedical HIV Prevention Trials (2007) (click here)

• UNESCO Universal Declaration on Bioethics and Human Rights (2005) (click here)

• Nuffield  Council on Bioethics: The Ethics of Research Related to Healthcare in Developing Countries (2002) (click here)

• The Belmont Report (U.S. Department of Health & Human Services) (click here)

• WHO Standards and Operational Guidance for Ethics Review of Health-Related Research with Human Participants (click here)

Statutes and Regulations

• The Universal Declaration of Human Rights (click here)

• Integrated Addendum to ICH E6 (R1) Guideline for Good Clinical Practice (click here)

• ICH Guidelines on Choice of Control Groups and Related Issues in Clinical Trials (2000) (click here)

• Council of Europe. Convention on Human Rights and Biomedicine (1997) (click here)

• Additional Protocol to the Convention on Human Rights and Biomedicine, concerning Biomedical Research (CETS No. 195) (click here)

• Directive of the European Parliament and of the Council (click here) 

• The Common Rule (45 CFR Part 46) (click here)

• United States Food and Drug Administration Regulations for the Protection of Human Subjects (click here)