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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 1 month 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 1 month 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 1 month 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 1 month 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 1 month 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 1 month 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 1 month 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 1 month 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 1 month 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 1 month 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 1 month 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 1 month 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 1 month 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 1 month ago by Robert A Lewis

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...

Updated 1 month ago by Robert A Lewis

Report a research problem or complaint

Institutional Review Board (IRB) Guidebook

Report a problem Report a problem securely and confidentially through the UNMC Human Subjects Res...

Updated 1 month ago by Robert A Lewis

1.18 Review and Approval of HRPP Policies

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

Last Revised: 11/13/2024 1.0 Purpose The purpose of this policy is to describe the Organization’s...

Updated 1 month ago by Robert A Lewis

cIRB - Forms & Links

Institutional Review Board (IRB) Guidebook Single & Central IRB

Note: the UNMC IRB cannot answer questions related to external IRB processes or applications. Con...

Updated 1 month ago by Robert A Lewis

1.28 External Investigator Assurance

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

Last Revised: 10/7/2025 1.0 Purpose The purpose of this policy is to describe the Organization’s ...

Updated 1 month ago by Robert A Lewis

1.13 Compliance with ICH-GCP Guidelines

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

Last Revised: 10/17/2025 1.0. Purpose The purpose of this policy is to describe the Organization’...

Updated 1 month ago by Robert A Lewis