Human Subject Research SOPs

Revised SOPs Coming Soon
Our Standard Operating Procedures (SOPs) are currently being revised to reflect recent changes to the Common Rule. Please continue to visit this page to view the latest versions of our documents as they become available. For questions about SOPs, contact the Office of Research Compliance.

Use these links to quickly navigate to one of the following sections of IRB documents:


SOP IRB 001 IRB Authority, Membership and Permanent Positions (Adobe PDF)

SOP IRB 002 IRB Member Education (Adobe PDF)

SOP IRB 003 Review of Research (Adobe PDF)

SOP IRB 003.1 Review of Research - Non-Mercer Investigator (Adobe PDF)

SOP IRB 003.2 Protocol Review Member Request (Adobe PDF)

SOP IRB 004 Criteria for Approval (Adobe PDF)

SOP IRB 004.1 Deceptive or Incomplete Disclosure Research (Adobe PDF)

SOP IRB 004.2 Criteria for Internet Research (Adobe PDF)

SOP IRB 004.3 Case Studies (Adobe PDF)

SOP IRB 004.4 Oral History (Adobe PDF)

SOP IRB 005 Non Local Review (Adobe PDF)

SOP IRB 006 Continuing Review (Adobe PDF)

SOP IRB 007 SR - NSR Determinations (Adobe PDF)

SOP IRB 008 Review of Protocols Involving Biologics (Adobe PDF)

SOP IRB 009 Appeal of IRB Decisions (Adobe PDF)

SOP IRB 010 Humanitarian Use Devices (Adobe PDF)

SOP IRB 011 Expedited Reviews (Adobe PDF)

SOP IRB 012 Exemption from IRB Review (Adobe PDF)

SOP IRB 012.1 Qualitiy Improvement Activities (Adobe PDF)

SOP IRB 013 Conflict of Interest (Adobe PDF)

SOP IRB 014 Confidentiality - Anonymity (Adobe PDF)

SOP IRB 014.1 Confidentiality - Guests (Adobe PDF)

SOP IRB 014.2 Confidentiality - Breaches (Adobe PDF)

SOP IRB 015 Serious Adverse Event Reporting (Adobe PDF)

SOP IRB 016 Review of Safety Alerts (Adobe PDF)

SOP IRB 017 Additional Protections - Pregnant Women, Fetuses, In Vitro Fertilization (Adobe PDF)

SOP IRB 018 Additional Protections - Prisoners (Adobe PDF)

SOP IRB 019 Additional Protections - Children and Minors (Adobe PDF)

SOP IRB 019.1 Additional Protections - Wards (Adobe PDF)

SOP IRB 020 Additional Protections - Cognitavely Impaired (Adobe PDF)

SOP IRB 021 Additional Protections - Vulnerable Populations (Adobe PDF)

SOP IRB 021.1 Persons with Mental Disabilities or Impaired Decision Making Capacity (Adobe PDF)

SOP IRB 026 Emergency Use (Adobe PDF)

SOP IRB 026.1 Investigation Medical Devices (Adobe PDF)

SOP IRB 027 Protocol Deviation Reporting (Adobe PDF)

SOP IRB 028 Informed Consent (Adobe PDF)

SOP IRB 028.1 Infomed Consent - Oral (Adobe PDF)

SOP IRB 028.2 Waiver of Informed Consent (Adobe PDF)

SOP IRB 028.3 Informed Consent - Foreign Language (Adobe PDF)

SOP IRB 028.4 Informed Consent - Info Sheet (Adobe PDF)

SOP IRB 028.5 Informed Consent - Phone Consent (Adobe PDF)

SOP IRB 030 Emergency Exemption from Informed Consent (Adobe PDF)

SOP IRB 031 HHS Inspections of the IRB (Adobe PDF)

SOP IRB 032 Review of Advertisements (Adobe PDF)

SOP IRB 033 Submission Requirements (Adobe PDF)

SOP IRB 034 Voting Requirements (Adobe PDF)

SOP IRB 035 Certificates of Confidentiality (Adobe PDF)

SOP IRB 036 Compassionate Use (Adobe PDF)

SOP IRB 037 Communication from the IRB (Adobe PDF)

SOP IRB 038 Non-Compliance / Complaint Procedures (Adobe PDF)

SOP IRB 040 Audits of Investigators / Sites (Adobe PDF)


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Certification and Training SOPs

SOP HIPAA 001 Guidance on HIPAA Compliance for Research (Involving the Use of PHI) (Adobe PDF)

SOP HIPAA 002 Incorporating HIPAA Language in Informed Consents (Adobe PDF)

SOP HIPAA 003 Handling HIPAA Complaints (Adobe PDF)

SOP HIPAA 004 Procedure for Signing a HIPAA Authorization (Adobe PDF)

SOP HIPAA 005 HIPAA Awareness Training and Education (Adobe PDF)

SOP CITI 001 CITI Training Verification (Adobe PDF)


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Administrative SOPs

SOP ADM 001 Writing and Revising SOPs (Adobe PDF)

SOP ADM 003 Management of the IRB Staff (Adobe PDF)

SOP ADM 004 Signatory Authority (Adobe PDF)

SOP ADM 004.1 Signatory Authority - IRB App for Study Approval (Adobe PDF)

SOP ADM 005 IRB Staff Training and Education (Adobe PDF)

SOP ADM 009 IRB Meetings (Adobe PDF)

SOP ADM 010 Notification and Tracking (Adobe PDF)

SOP ADM 011 Record Keeping (Adobe PDF)

SOP ADM 012 Facilitating Sponsor Audits (Adobe PDF)

SOP ADM 013 IRB Minutes (Adobe PDF)

SOP ADM 014 IRB Training Files (Adobe PDF)

SOP ADM 015 Review of Qualification of Clinical Investigators (Adobe PDF)

SOP ADM 016 IRB Appointment Process (Adobe PDF)


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