References
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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...
1.5 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...
1.4 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...
1.8 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 ...
1.22 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 ...
1.30 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...
2.1 Submission for Items for Review by the IRB
Last Revised: 7/19/2022 1.0 Purpose The purpose of this policy is to describe Organization’s requ...
3.4 Use of Protected Health Information in Research
Last Revised: 4/9/2018 1.0 Purpose The purpose of this policy and procedure is to describe the Or...
4.4 Research Involving Children
1.0 Purpose The purpose of this policy is to describe the Organization’s requirements for resear...
4.6 IRB Review of Research Involving Subjects with Impaired Decision-Making Capacity
1.0 Purpose The purpose of this policy is to describe the Organization’s requirements for IRB rev...
4.7 Research Involving Employees of the Organization and Students as Subjects
1.0 Purpose The purpose of this policy and procedure is to describe the Organization’s requiremen...
5.2 Waiver or Alteration of Informed Consent and HIPAA Authorization
Last Revised: 2/7/2024 1.0 Purpose The purpose of this policy is to describe the Organization’s r...
5.4 Waiver of Requirement to Obtain Signed Consent Form
Last Revised: 12/11/2024 1.0 Purpose The purpose of this policy is to describe the Organization’s...
6.1 Research Involving Investigational and Marketed Drugs
Last Revised: 1/24/2024 1.0 Purpose The purpose of this policy and procedure is to describe the O...
6.2 Research Involving Investigational and Marketed Devices
Last Revised: 1/23/2024 1.0 Purpose The purpose of this policy and procedure is to describe the O...
8.1 Review of Adverse Events and Adverse Device Effects
Last Revised: 5/4/2023 1.0 Purpose The purpose of this policy is to describe the process for repo...
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 repo...
8.3 Review of Unanticipated Problems Involving Risk to the Subject or Others
Last Revised: 5/8/2023 1.0 Purpose The purpose of this policy is to describe the process for repo...
3.5 Subject Recruitment Through Advertisements
Last Revised 12/11/2024 For an abbreviated version intended for investigators, coordinators, and ...
7.3 Data Registries
Last Revised: 4/16/2025 1.0. Purpose The purpose of this policy is to describe the Organization’...
Table of Contents
Section 1: General Human Research Protection Program Polices 1.1 Human Research Protection Progra...
4.1 Additional Protections for Vulnerable Persons
Last Revised: 4/16/2025 1.0 Purpose The purpose of this policy is to describe the Organization’s ...