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 September 2024
012

Observation of Consent Process January 2021
013

Legally Authorized Representatives, Children, and Guardians July 2024
020

Incoming Items February 2024
021

Pre-Review January 2021
023

All Emergency Use, Compassionate Use (Device Only) and IRB Waiver for Individual Patient Expanded Access (Drug Only) Review September 2024
024

New Information February 2024
025

Investigations January 2021
026

Suspension or Termination Issued Outside of Convened IRB January 2022
027

All Emergency Use, Compassionate Use (Device Only) and IRB Waiver for Individual Patient Expanded Access (Drug Only) Post-Review July 2021
030

Designated Reviewers July 2023
031

Non-Committee Review Preparation January 2021
032

Non-Committee Review Conduct February 2024
040

IRB Meeting Preparation January 2021
041

IRB Meeting Conduct July 2021
042

IRB Meeting Attendance Monitoring January 2021
043

IRB Meeting Minutes February 2024
044

Not Otherwise Approvable Research July 2024
050

Conflicting Interests of IRB Members July 2022
051

Consultation July 2021
052

Post-Review February 2024
055

IRB Review of Financial Conflicts of Interest April 2023
060

Annual Evaluations of the HRPP September 2021
061

Ongoing Evaluations of the HRPP July 2021
063

Expiration of IRB Approval January 2021
064

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

Quality Assurance of IRB Performance January 2021
066

Human Research Education and Training July 2024
070

IRB Records January 2021
071

HRPP Toolkit Management February 2024
072

IRB Records Retention February 2024
080

IRB Formation and Registration February 2024
081

IRB Removal January 2021
082

IRB Membership Appointment January 2022
083

IRB Membership Removal January 2022
084

IRB Meeting Scheduling and Notification January 2021
090

Informed Consent Process for Research September 2024
091

Written Documentation of Consent September 2024
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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