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HRPP Investigator Guidance Series

Institutional Review Board (IRB) Guidebook Guidance & Resources

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

Updated 2 days ago by Robert A Lewis

HRPP (Human Research Protection Program) Policies

Institutional Review Board (IRB) Guidebook

The purpose of this policy is to provide a basic description of UNMC’s Human Research Protection ...

Updated 2 days ago by Robert A Lewis

IRB News & Updates

Institutional Review Board (IRB) Guidebook

New Biomedical/Social Behavioral IRB Application Rollout The new version of the Biomedical/Social...

Updated 2 days 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 2 days ago by Robert A Lewis

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...

Updated 2 days ago by Robert A Lewis

Table of Contents

HRPP Policies and Procedures

Section 1: General Human Research Protection Program Polices 1.1 Human Research Protection Progra...

Updated 2 days ago by Robert A Lewis

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...

Updated 2 days ago by Robert A Lewis

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...

Updated 2 days 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 2 days ago by Robert A Lewis

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...

Updated 2 days ago by Robert A Lewis

2.3 Expedited Review

HRPP Policies and Procedures Section 2: Process of Review

Last Revised 1/24/2024 1.0 Purpose The purpose of this policy is to describe the Organization’s r...

Updated 2 days ago by Robert A Lewis

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...

Updated 2 days ago by Robert A Lewis

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...

Updated 2 days ago by Robert A Lewis

1.26 PI Qualifications and Responsibilities

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

Last Revised: 6/11/2025 1.0 Purpose The purpose of this policy is to describe the qualifications ...

Updated 2 days ago by Robert A Lewis

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...

Updated 2 days ago by Robert A Lewis

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...

Updated 2 days ago by Robert A Lewis

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...

Updated 2 days ago by Robert A Lewis

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...

Updated 2 days ago by Robert A Lewis

1.10 Scientific and Other Committee Review of Research

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

Last Revised: 4/8/2025 1.0 Purpose The purpose of this policy is to describe the Organization’s r...

Updated 2 days ago by Robert A Lewis

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 ...

Updated 2 days ago by Robert A Lewis