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...