Skip to main content

Section 1: General Human Research Protection Program Policies

1.1 Human Research Protection Program (HRPP)

Last Revised: 1/16/2023 1.0 Purpose The purpose of this policy and procedure is to provide a basi...

1.2 Authority Granted to the IRB by the Organization

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

1.3 UNMC IRB Serving as the Single IRB for Multisite Research

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

1.4 UNMC Ceding Review to an External Central IRB

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

1.5 Requirements for Research Conducted with International Sites

Last Revised: 5/9/2023 1.0 Purpose The purpose of this policy is to describe the Organization’s r...

1.6 IRB Composition, Leadership, Qualifications, and Responsibilities

Last Revised: 2/15/2025 1.0 Purpose The purpose of this policy and procedure is to describe the O...

1.7 IRB Member, Consultant, Staff and Guest Conflict of Interest Identification and Management

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

1.8 Investigational Activities Requiring IRB Review and Approval

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

1.9 Resources Necessary to Protect Subjects

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

1.10 Scientific and Other Committee Review of Research

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

1.11 HRPP Access to Legal Counsel

Last Revised: 2/11/2025 1.0 Purpose The purpose of this policy is to describe the Organization’s ...

1.12 Sponsored Research

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

1.13 Compliance with ICH-GCP Guidelines

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

1.14 Research Subject to Department of Defense Regulatory Requirements

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

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

1.16 ORA Record Keeping Requirements

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

1.17 Retention of Research Records

Last Revised: 6/30/2022 1.0 Purpose The purpose of this policy is to describe the requirements fo...

1.18 Review and Approval of HRPP Policies and Procedures

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

1.19 IRB Signature Authority

Last Revised: 10/7/2022 1.0 Purpose The purpose of this policy is to describe the Organization’s ...

1.20 Community Involvement in Outreach Activities and Community Based Participatory Research (CBPR)

Last Revised: 1/17/2024 1.0 Purpose The purpose of this policy is to describe the Organization’s ...

1.21 Post-Approval Monitoring of Research

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

1.22 Assessment of the Effectiveness and Efficiency of the HRPP

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

1.23 HRPP Training Requirements

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

1.24 HRPP Training Requirements for IRB Members

Last Revised: 7/14/2022 1.0 Purpose The purpose of this policy is to describe the Organization’s ...

1.25 Financial Conflicts of Interest

Last Revised 1/22/2024 1.0 Purpose The purpose of this policy is to describe the Organization’s p...

1.26 PI Qualifications and Responsibilities

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

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

1.28 External Investigator Assurance

Last Revised: 12/3/2022 1.0 Purpose The purpose of this policy is to describe the Organization’s ...

1.29 ClinicalTrials.gov Reporting

Last Revised: 3/20/2023 1.0. Purpose The purpose of this policy is to describe the requirements ...

1.30 Use of the Rapid Response IRB

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

1.31 Observers at IRB Meetings

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

1.32 Confidentiality of the Review Process

Last Reviewed: 1/12/2018 1.0 Purpose The purpose of this policy and procedure is to describe the ...

1.33 Posting of Clinical Trial Consent Forms

Last Revised: 9/18/2019 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

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