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IRB News & Updates

Institutional Review Board (IRB) Guidebook

Congruency, Consent, and Recruitment Materials Dec 13th, 2024 In order to assure that subject inj...

Forms

Institutional Review Board (IRB) Guidebook

The following sections (located in the menu below will assist researchers by providing various to...

1.2 Authority Granted to the IRB by the Organization

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

Last Revised: 5/28/2021 1.0 Purpose The purpose of this policy and procedure is to describe the a...

1.4 UNMC Ceding Review to an External Central IRB

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

Last Revised: 1/22/2024 1.0 Purpose The purpose of this policy and procedure is to describe the O...

1.8 Investigational Activities Requiring IRB Review and Approval

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

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

1.12 Sponsored Research

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

Revised: 6/12/2024 1.0 Purpose The purpose of this policy is to describe the Organization’s requi...

1.14 Research Subject to Department of Defense Regulatory Requirements

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

Last Revised: 1/10/2024 1.0 Purpose The purpose of this policy and procedure is to specify the Or...

1.15 Research Subject to Department of Justice Regulatory Requirements

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

Last Revised: 4/20/2016 1.0 Purpose The purpose of this policy and procedure is to specify the Or...

1.21 Post-Approval Monitoring of Research

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

Last Revised: 2/28/2018 1.0 Purpose The purpose of this policy and procedure is to describe the O...

1.23 HRPP Training Requirements

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

Last Revised: 8/17/2022 1.0 Purpose The purpose of this policy is to describe the Organization’s ...

1.26 PI Qualifications and Responsibilities

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

Last Revised: 6/27/2022 1.0 Purpose The purpose of this policy and procedure is to describe the q...

1.27 Research Personnel Qualifications and Responsibilities

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

Last Revised: 2/18/2019 1.0 Purpose The purpose of this policy and procedure is to describe the q...

1.31 Observers at IRB Meetings

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

Last Revised: 2/26/2018 1.0 Purpose The purpose of this policy and procedure is to describe the O...

1.34 Emergency Preparedness for the Office of Regulatory Affairs and IRBs

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

Last Revised: 8/31/2023 1.0 Purpose The purpose of this policy is to describe the Emergency Prepa...

3.11 Collecting Data from Pregnant Partners of Research Subjects

HRPP Policies and Procedures Section 3: Special Issues

Last Revised: 9/9/2019 1.0 Purpose The purpose of this policy is to describe the Organization’s r...

4.1 Additional Protections for Vulnerable Populations

HRPP Policies and Procedures Section 4: Vulnerable Populations

Last Revised: 1/26/2018 1.0 Purpose The purpose of this policy and procedure is to describe the O...

5.1 Obtaining Informed Consent From Research Subjects

HRPP Policies and Procedures Section 5: Informed Consent

Last Revised: 1/8/2025 1.0 Purpose The purpose of this policy is to describe the Organization’s r...

8.2 Review of Study Related Complaints

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

Last Revised: 5/8/2023 1.0 Purpose The purpose of this policy is to describe the process for repo...

8.3 Review of Unanticipated Problems Involving Risk to the Subject or Others

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

Last Revised: 5/8/2023 1.0 Purpose The purpose of this policy is to describe the process for repo...

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. ...

HRPP Investigator Guidance Series

Institutional Review Board (IRB) Guidebook Education & Resources

This page serves as a hub for all of the Investigator Guidance Series documents. Each document is...