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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...
1.26 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...
1.1 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...
8.5 Noncompliance by the IRB or Other Components of the HRPP
1.0 Purpose The purpose of this policy is to describe the process for reviewing and reporting in...
Introduction to the Research Handbook
Welcome to the University of Nebraska Medical Center, where research breakthroughs improve patien...
Developing a Budget
Considerations for Preparing a Budget For studies that require a grant or contract, the Investig...
3.2 Data and Safety Monitoring
1.0 Purpose The purpose of this policy is to describe the Organization’s requirements for data a...