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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...

3.5 Subject Recruitment Through Advertisements

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

Developing a Budget

Considerations for Preparing a Budget For studies that require a grant or contract, the Investig...

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...

4.4 Research Involving Children

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

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...

1.18 Review and Approval of HRPP Policies and Procedures

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

1.19 IRB Signature Authority

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

1.32 Confidentiality of the Review Process

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

1.31 Observers at IRB Meetings

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

1.27 Research Personnel Qualifications and Responsibilities

1.0 Purpose The purpose of this policy and procedure is to describe the qualifications and respo...

1.13 Compliance with ICH-GCP Guidelines

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

2.5 Criteria for IRB Approval

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

3.13 Use of Placebo or Wash-Out of Effective Therapy in Clinical Trials

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

3.14 Phase I and First-in-Human Studies

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

3.15 Managing Radiographic Incidental Findings in Human Subjects Research

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

3.12 Ethical Access

1.0 Purpose The purpose of this policy is to define ethical access and to describe the Organizat...