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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 10 months ago by Robert A Lewis

Adverse Event Reporting

Institutional Review Board (IRB) Guidebook Procedures

Adverse Events (AEs) An Adverse Event is defined by the NIH as: Any untoward or unfavorable medic...

Updated 10 months ago by James Geiger

1.9 Resources Necessary to Protect Subjects

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

Last Revised: 1/16/2025 1.0 Purpose The purpose of this policy is to describe the Organization’s ...

Updated 10 months ago by Robert A Lewis

1.16 ORA Record Keeping Requirements

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

Last Revised: 01/17/2024 1.0 Purpose The purpose of this policy is to describe the Organization’s...

Updated 10 months ago by Robert A Lewis

1.22 Assessment of the Effectiveness and Efficiency of the HRPP

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

Last Revised: 9/25/2024 1.0 Purpose The purpose of this policy is to describe the Organization’s ...

Updated 10 months ago by Robert A Lewis

1.23 HRPP Training Requirements

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

Last Revised: 8/13/2025 1.0 Purpose The purpose of this policy is to describe the Organization’s...

Updated 10 months ago by Robert A Lewis

1.30 Use of the Rapid Response IRB

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

Last Revised: 10/17/2024 1.0 Purpose The purpose of this policy is to describe the constitution o...

Updated 10 months ago by Robert A Lewis

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

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

Last Revised: 8/6/2025 1.0 Purpose The purpose of this policy is to describe the process for repo...

Updated 10 months ago by Robert A Lewis

8.7 Reporting Incidents to Institutional Officials and Federal Agencies

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

Last Revised: 8/1/2023 1.0 Purpose The purpose of this policy is to describe the Organization’s r...

Updated 10 months 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 10 months 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 10 months 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 10 months 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 10 months 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 10 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 10 months 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 10 months 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 11 months 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 11 months ago by Robert A Lewis

cIRB - Fees

Institutional Review Board (IRB) Guidebook Single & Central IRB

Please visit our IRB Fees page located here.

Updated 11 months ago by Robert A Lewis

sIRB - Fees

Institutional Review Board (IRB) Guidebook Single & Central IRB

For information regarding the fee schedule for Single IRB studies, please contact sirb@unmc.edu. ...

Updated 11 months ago by Robert A Lewis