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2.8 Limited IRB Review
1.0 Purpose The purpose of this policy is to describe the Organization’s requirements and proced...
1.15 Research Subject to Department of Justice Regulatory Requirements
1.0 Purpose The purpose of this policy and procedure is to specify the Organizations requirement...
2.4 IRB Review of Changes in Previously Approved Research
1.0 Purpose The purpose of this policy and procedure is to describe the Organization’s requireme...
2.1 Submission for Items for Review by the IRB
1.0 Purpose The purpose of this policy is to describe Organization’s requirements for submission...
1.33 Posting of Clinical Trial Consent Forms
1.0 Purpose The purpose of this policy and procedure is to describe the Organization’s requireme...
1.29 ClinicalTrials.gov Reporting
1.0. Purpose The purpose of this policy is to describe the requirements for registration and co...
1.30 Use of the Rapid Response IRB
1.0 Purpose The purpose of this policy and procedure is to describe the criteria for use of, and...
1.26 PI Qualifications and Responsibilities
1.0 Purpose The purpose of this policy and procedure is to describe the qualifications and respo...
1.24 HRPP Training Requirements for IRB Members
1.0 Purpose The purpose of this policy is to describe the Organization’s requirements for traini...
1.23 HRPP Training Requirements
1.0 Purpose The purpose of this policy is to describe the Organization’s requirements and opport...
1.21 Post-Approval Monitoring of Research
1.0 Purpose The purpose of this policy and procedure is to describe the Organization’s requireme...
1.17 Retention of Research Records
1.0 Purpose The purpose of this policy is to describe the requirements for retention of research...
1.5 Requirements for Research Conducted with International Sites
1.0 Purpose The purpose of this policy is to describe the Organization’s requirements for resear...
1.3 UNMC IRB Serving as the Single IRB for Multisite Research
1.0 Purpose The purpose of this policy and procedure is to describe the Organization’s requireme...
1.1 Human Research Protection Program (HRPP)
1.0 Purpose The purpose of this policy and procedure is to provide a basic description of the Or...
8.7 Reporting Incidents to Institutional Officials and Federal Agencies
1.0 Purpose The purpose of this policy is to describe the Organization’s requirements to ensure ...
Institutional Review Board
Introduction The UNMC Institutional Review Board (IRB) reviews all human subject protocols condu...
Human Subjects Protection Training
Required Human Subjects Protection Training All research personnel planning to conduct human sub...
8.1 Review of Adverse Events and Adverse Device Effects
1.0 Purpose The purpose of this policy is to describe the process for reporting research related...
8.3 Review of Unanticipated Problems Involving Risk to the Subject or Others
1.0 Purpose The purpose of this policy is to describe the process for reporting potential unanti...