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5.7 Obtaining Informed Consent from Non-English Speaking Persons, or Persons with Additional Needs or Vulnerabilities

1.0 Purpose The purpose of this policy is to describe the Organization’s requirements for the pr...

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...

1.29 ClinicalTrials.gov Reporting

1.0 Purpose The purpose of this policy is to describe the requirements for registration of clini...

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 ...

6.4 Emergency Use of a Test Article

1.0 Purpose The purpose of this policy is to describe the requirements for utilization of a test...

4.2 Research Involving Pregnant Women, Human Fetuses, and Neonates (Nonviable or of Uncertain Viability)

1.0 Purpose The purpose of this policy is to describe the Organization’s requirements for IRB re...

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 re...

3.2 Data and Safety Monitoring

1.0 Purpose The purpose of this policy is to describe the Organization’s requirements for data a...

1.28 External Investigator Assurance

1.0 Purpose The purpose of this policy is to describe the Organization’s requirements for initia...

1.7 IRB Member, Consultant, Staff and Guest Conflict of Interest Identification and Management

1.0 Purpose The purpose of this policy is to describe the Organization’s requirements for the id...

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...

1.4 UNMC Ceding Review to an External Central IRB

1.0 Purpose The purpose of this policy and procedure is to describe the Organization’s requireme...

3.5 Subject Recruitment Through Advertisements

1.0 Purpose The purpose of this policy is to describe the Organization’s requirements for recrui...

4.4 Research Involving Children

1.0 Purpose The purpose of this policy is to describe the Organization’s requirements for resea...

1.22 Assessment of the Effectiveness and Efficiency of the HRPP

1.0 Purpose The purpose of this policy is to describe the Organization’s requirements for assess...

5.5 Use of the Short Form Consent Document

1.0 Purpose The purpose of this policy is to describe the Organization’s requirements for use of...

2.2 Full IRB Review

1.0 Purpose The purpose of this policy is to describe the Organization’s requirements for: 1) su...

3.3 Privacy Interests and Confidentiality of Research Data

1.0 Purpose The purpose of this policy is to describe the Organization’s requirements for 1) pro...

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...

1.23 HRPP Training Requirements

1.0 Purpose The purpose of this policy is to describe the Organization’s requirements and opport...