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7.1 Banking Human Biological Material
Last Revised: 10/7/2025 HRPP Policy 7.1 has been merged with HRPP policy 7.2 Please refer to HRPP 7.2 Collection, Storage and Use of Human Biological Material in Research
7.2 Collection, Storage and Use of Human Biological Material in Research
Last Revised: 9/24/2025 For an abbreviated version intended for investigators, coordinators, and study teams - please visit here: Collection, Storage, and Use of HBM in Research 1.0 Purpose The purpose of this policy is to describe the Organizations requiremen...
7.3 Data Registries
Last Revised: 4/16/2025 For an abbreviated version intended for investigators, coordinators, and study teams - please visit here: Data Registries 1.0. Purpose The purpose of this policy is to describe the Organization’s requirements for creation and operation...
8.1 Review of Adverse Events and Adverse Device Effects
Last Revised: 3/24/2026 1.0 Purpose The purpose of this policy is to describe the process for reporting research related Adverse Events (AEs) and Adverse Device Effects (ADEs) to the ORA and the IRB, and the process for review of AEs and ADEs. 2.0 Policy It i...
8.2 Review of Study Related Complaints
Last Revised: 5/8/2023 1.0 Purpose The purpose of this policy is to describe the process for reporting research related complaints to the ORA and the IRB, and the process for review of complaints. 1.1. For the purposes of this policy “complaints” includes pr...
8.3 Review of Unanticipated Problems Involving Risk to the Subject or Others
Last Revised: 8/6/2025 1.0 Purpose The purpose of this policy is to describe the process for reporting potential unanticipated problems (UPs) involving risk to the ORA and the IRB, and the process for review of potential UPs. 2.0 Policy It is the policy of th...
8.4 Review of Noncompliance by the PI, Study Team, and/or Subjects
Last Revised: 8/6/2025 1.0 Purpose The purpose of this policy is to describe the process for reviewing and reporting incidents of noncompliance by the PI, study team, and/or subjects. Noncompliance by the IRB and/or Other Components of the HRPP is addressed i...
8.5 Noncompliance by the IRB or Other Components of the HRPP
Last Revised: 5/9/2023 1.0 Purpose The purpose of this policy is to describe the process for reviewing and reporting incidents of noncompliance by the IRB and/or other components of the HRPP. 2.0 Policy It is the policy of the Organization that: 2.1. Report...
8.6 Study Hold, Suspension, and Termination
Last Revised: 1/20/2023 For an abbreviated version intended for investigators, coordinators, and study teams - please visit here: Study Holds, Suspension, and Termination 1.0 Purpose The purpose of this policy is to describe the process for study holds, study ...
8.7 Reporting Incidents to Institutional Officials and Federal Agencies
Last Revised: 8/1/2023 1.0 Purpose The purpose of this policy is to describe the Organization’s requirements to ensure prompt reporting of incidents to Institutional Officials, Federal Agencies (including OHRP and FDA) and other Common Rule Departments and Age...
Table of Contents
Section 1: General Human Research Protection Program Polices 1.1 Human Research Protection Program 1.2 Authority Granted by the Organization 1.3 UNMC Serving as Central IRB 1.4 UNMC Ceding Review to an External Central IRB 1.5 Requirements for Research Conduct...
6.5 Expanded Access to Investigational Drugs and Devices for Treatment Use
Last Revised: 1/23/2024 For an abbreviated version intended for investigators, coordinators, and study teams - please visit here: Expanded Access to Investigational Drugs and Devices 1.0 Purpose 1.1. The purpose of this policy and procedure is to describe the...