Standard Operating Procedures – Human Research Protection Program

Standard operating procedures (SOPs) describe policies and procedures related to IRB review, management, or function.

IRB members and staff use SOPs to enhance compliance with federal, state, and local requirements.

001

Definitions October 2025
012

Observation of Consent Process January 2021
013

Legally Authorized Representatives, Children, and Guardians July 2024
020

Incoming Items January 2025
021

Pre-Review October 2025
023

All Emergency Use, Compassionate Use (Device Only) and IRB Waiver for Individual Patient Expanded Access (Drug Only) Review October 2025
024

New Information July 2025
025

Investigations October 2025
026

Suspension or Termination Issued Outside of Convened IRB July 2025
027

All Emergency Use, Compassionate Use (Device Only) and IRB Waiver for Individual Patient Expanded Access (Drug Only) Post-Review October 2025
030

Designated Reviewers October 2025
031

Non-Committee Review Preparation October 2025
032

Non-Committee Review Conduct October 2025
040

IRB Meeting Preparation October 2025
041

IRB Meeting Conduct October 2025
042

IRB Meeting Attendance Monitoring October 2025
043

IRB Meeting Minutes October 2025
044

Not Otherwise Approvable Research January 2025
050

Conflicting Interests of IRB Members July 2022
051

Consultation October 2025
052

Post-Review October 2025
055

IRB Review of Financial Conflicts of Interest April 2023
060

Annual Evaluations of the HRPP October 2025
061

Ongoing Evaluations of the HRPP October 2025
063

Expiration of IRB Approval January 2021
064

NIH Genomic Data Sharing (GDS) Institutional Certification July 2022
065

Response Plan for Emergencies – Disasters Impacting the HRPP July 2025
066

Human Research Education and Training January 2025
067

Quality Assurance of IRB Performance October 2025
070

IRB Records October 2025
071

HRPP Toolkit Management February 2024
072

IRB Records Retention February 2024
080

IRB Formation and Registration July 2025
081

IRB Removal July 2025
082

IRB Membership Appointment October 2025
083

IRB Membership Removal January 2022
084

IRB Meeting Scheduling and Notification October 2025
090

Informed Consent Process for Research October 2025
091

Written Documentation of Consent July 2025
105

OHRP FDA Written Procedure Crosswalk October 2025
108

Study Specific Emergency – Disaster Risk Mitigation Planning July 2025
801

Establishing Authorization Agreements July 2022
802

Establishing Agreements for Individuals July 2022
803

Validating Requests to Serve October 2024
804

Validating Requests to Cede July 2022
805

Review of Cede Updates July 2022

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