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HRPP (Human Research Policy & Procedures) Manual

Institutional Review Board (IRB) Guidebook

The purpose of this policy and procedure is to provide a basic description of UNMC’s Human Resea...

Updated 4 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 4 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 4 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 4 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 4 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 4 months ago by Robert A Lewis

7.2 Use of Human Biological Material in Research

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

Last Revised: 1/25/2018 1.0 Purpose The purpose of this policy and procedure is to describe the O...

Updated 4 months ago by Robert A Lewis

7.1 Banking Human Biological Material

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

Last Revised: 1/25/2018 1.0 Purpose The purpose of this policy and procedure is to describe the O...

Updated 4 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 4 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 4 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 4 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 4 months ago by Robert A Lewis

6.1 Research Involving Investigational and Marketed Drugs

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

Last Revised: 1/24/2024 1.0 Purpose The purpose of this policy and procedure is to describe the O...

Updated 4 months ago by Robert A Lewis

5.7 Obtaining Informed Consent from Non-English Speaking Persons, or Persons with Additional Needs or Vulnerabilities

HRPP Policies and Procedures Section 5: Informed Consent

Last Revised: 11/12/2024 1.0 Purpose The purpose of this policy is to describe the Organization’s...

Updated 4 months ago by Robert A Lewis

5.6 Exceptions from Informed Consent Requirements for Emergency Research

HRPP Policies and Procedures Section 5: Informed Consent

Last Revised: 3/5/2018 1.0 Purpose The purpose of this policy and procedure is to describe the Or...

Updated 4 months ago by Robert A Lewis

5.5 Use of the Short Form Consent Document

HRPP Policies and Procedures Section 5: Informed Consent

Last Revised: 11/30/2022 1.0 Purpose The purpose of this policy is to describe the Organization’s...

Updated 4 months ago by Robert A Lewis

5.4 Waiver of Requirement to Obtain Signed Consent Form

HRPP Policies and Procedures Section 5: Informed Consent

Last Revised: 12/11/2024 1.0 Purpose The purpose of this policy is to describe the Organization’s...

Updated 4 months ago by Robert A Lewis

5.3 Use of a Remote Consent Process

HRPP Policies and Procedures Section 5: Informed Consent

Last Revised: 2/9/2024 1.0 Purpose The purpose of this policy and procedure is to describe the Or...

Updated 4 months ago by Robert A Lewis

5.2 Waiver or Alteration of Informed Consent and HIPAA Authorization

HRPP Policies and Procedures Section 5: Informed Consent

Last Revised: 2/7/2024 1.0 Purpose The purpose of this policy is to describe the Organization’s r...

Updated 4 months ago by Robert A Lewis

4.3 Research Involving Prisoners

HRPP Policies and Procedures Section 4: Vulnerable Populations

Last Revised: 01/17/2024 1.0 Purpose The purpose of this policy and procedure is to describe the ...

Updated 4 months ago by Robert A Lewis