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4.6 IRB Review of Research Involving Subjects with Impaired Decision-Making Capacity

HRPP Policies and Procedures Section 4: Vulnerable Populations

Last Revised: 11/27/2024 1.0 Purpose The purpose of this policy is to describe the Organization’s...

Updated 4 months ago by Robert A Lewis

4.5 Local 407 Panel Review of Pediatric Research

HRPP Policies and Procedures Section 4: Vulnerable Populations

Last revised: 2/19/2018 1.0 Purpose The purpose of this policy and procedure is to describe the O...

Updated 4 months ago by Robert A Lewis

4.4 Research Involving Children

HRPP Policies and Procedures Section 4: Vulnerable Populations

Last revised: 11/8/2022 1.0 Purpose The purpose of this policy is to describe the Organization’s...

Updated 4 months ago by Robert A Lewis

1.4 UNMC Ceding Review to an External Central IRB

HRPP Policies and Procedures Section 1: General Human Research Prote...

Last Revised: 5/15/2025 1.0 Purpose The purpose of this policy is to describe the Organization’s ...

Updated 4 months ago by Robert A Lewis

4.1 Additional Protections for Vulnerable Persons

HRPP Policies and Procedures Section 4: Vulnerable Populations

Last Revised: 4/16/2025 1.0 Purpose The purpose of this policy is to describe the Organization’s ...

Updated 5 months ago by Robert A Lewis

2.5 Criteria for IRB Approval

HRPP Policies and Procedures Section 2: Process of Review

Last Revised: 1/24/2018 1.0 Purpose The purpose of this policy and procedure is to describe the O...

Updated 5 months ago by Robert A Lewis

1.3 UNMC IRB Serving as the Single IRB for Multisite Research

HRPP Policies and Procedures Section 1: General Human Research Prote...

Last Revised: 4/21/2025 1.0 Purpose The purpose of this policy is to describe the Organization’s ...

Updated 5 months ago by Robert A Lewis

7.3 Data Registries

HRPP Policies and Procedures Section 7: Human Biologic Materials and...

Last Revised: 4/16/2025 1.0. Purpose The purpose of this policy is to describe the Organization’...

Updated 5 months ago by Robert A Lewis

3.5 Subject Recruitment Through Advertisements

HRPP Policies and Procedures Section 3: Special Issues

Last Revised 12/11/2024 For an abbreviated version intended for investigators, coordinators, and ...

Updated 5 months ago by Robert A Lewis

sIRB - Submission deadlines

Institutional Review Board (IRB) Guidebook Single & Central IRB

sIRB Submission Deadlines for New Submissions, Previously Tabled Protocols and Requests for Chang...

Updated 5 months ago by Robert A Lewis

Frequently Asked Questions (FAQ)

Institutional Review Board (IRB) Guidebook

Below are a number of commonly asked questions. The questions will either provide an answer or wi...

Updated 6 months ago by Robert A Lewis

Submission deadlines

Institutional Review Board (IRB) Guidebook

IRB Submission Deadlines for New Submissions, Previously Tabled Protocols and Requests for Change...

Updated 6 months ago by Robert A Lewis

Does my project require IRB review?

Institutional Review Board (IRB) Guidebook

To help you determine if your project constitutes Human Subject Research and requires IRB review,...

Updated 6 months ago by Robert A Lewis

Emergency Preparedness/Continuity of Operations Plan (EP/COOP)

HRPP Policies and Procedures

Last Revised: 9/1/2023 1.0 Emergency Preparedness /Continuity of Operations Plan (EP/COOP) 1.1. ...

Updated 6 months ago by Robert A Lewis

8.6 Study Hold, Suspension, and Termination

HRPP Policies and Procedures Section 8: AEs, Unanticipated Problems ...

Last Revised: 1/20/2023 1.0 Purpose The purpose of this policy is to describe the process for stu...

Updated 6 months ago by Robert A Lewis

8.5 Noncompliance by the IRB or Other Components of the HRPP

HRPP Policies and Procedures Section 8: AEs, Unanticipated Problems ...

Last Revised: 5/9/2023 1.0 Purpose The purpose of this policy is to describe the process for revi...

Updated 6 months ago by Robert A Lewis

6.5 Expanded Access to Investigational Drugs and Devices for Treatment Use

HRPP Policies and Procedures Section 6: FDA Regulated Research/Drugs...

Last Revised: 1/23/2024 1.0 Purpose 1.1. The purpose of this policy and procedure is to describe...

Updated 6 months ago by Robert A Lewis

6.4 Emergency Use of a Test Article

HRPP Policies and Procedures Section 6: FDA Regulated Research/Drugs...

Last Revised: 1/22/2024 1.0 Purpose The purpose of this policy is to describe the requirements fo...

Updated 6 months ago by Robert A Lewis

6.3 Humanitarian Use Device (HUD)

HRPP Policies and Procedures Section 6: FDA Regulated Research/Drugs...

Last Revised: 5/26/2021 1.0 Purpose The purpose of this policy and procedure is to describe the O...

Updated 6 months ago by Robert A Lewis

6.2 Research Involving Investigational and Marketed Devices

HRPP Policies and Procedures Section 6: FDA Regulated Research/Drugs...

Last Revised: 1/23/2024 1.0 Purpose The purpose of this policy and procedure is to describe the O...

Updated 6 months ago by Robert A Lewis