Skip to main content

Recently Updated Pages

2.4 IRB Review of Changes in Previously Approved Research

HRPP Policies and Procedures Section 2: Process of Review

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

Updated 1 year ago by Robert A Lewis

2.1 Submission for Items for Review by the IRB

HRPP Policies and Procedures Section 2: Process of Review

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

Updated 1 year ago by Robert A Lewis

1.33 Posting of Clinical Trial Consent Forms

HRPP Policies and Procedures Section 1: General Human Research Prote...

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

Updated 1 year ago by Robert A Lewis

1.29 ClinicalTrials.gov Reporting

HRPP Policies and Procedures Section 1: General Human Research Prote...

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

Updated 1 year ago by Robert A Lewis

1.26 PI Qualifications and Responsibilities

HRPP Policies and Procedures Section 1: General Human Research Prote...

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

Updated 1 year ago by Robert A Lewis

1.24 HRPP Training Requirements for IRB Members

HRPP Policies and Procedures Section 1: General Human Research Prote...

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

Updated 1 year ago by Robert A Lewis

1.23 HRPP Training Requirements

HRPP Policies and Procedures Section 1: General Human Research Prote...

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

Updated 1 year ago by Robert A Lewis

1.21 Post-Approval Monitoring of Research

HRPP Policies and Procedures Section 1: General Human Research Prote...

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

Updated 1 year ago by Robert A Lewis

1.17 Retention of Research Records

HRPP Policies and Procedures Section 1: General Human Research Prote...

1.0 Purpose The purpose of this policy is to describe the requirements for retention of research...

Updated 1 year ago by Robert A Lewis

1.5 Requirements for Research Conducted with International Sites

HRPP Policies and Procedures Section 1: General Human Research Prote...

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

Updated 1 year ago by Robert A Lewis

1.1 Human Research Protection Program (HRPP)

HRPP Policies and Procedures Section 1: General Human Research Prote...

1.0 Purpose The purpose of this policy and procedure is to provide a basic description of the Or...

Updated 1 year ago by Robert A Lewis

8.7 Reporting Incidents to Institutional Officials and Federal Agencies

HRPP Policies and Procedures Section 8: AEs, Unanticipated Problems ...

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

Updated 1 year ago by Robert A Lewis

Institutional Review Board

Research Handbook Human Subject Research

Introduction The UNMC Institutional Review Board (IRB) reviews all human subject protocols condu...

Updated 1 year ago by Max V. Kuenstling

Human Subjects Protection Training

Research Handbook Human Subject Research

Required Human Subjects Protection Training All research personnel planning to conduct human sub...

Updated 1 year ago by Max V. Kuenstling

8.1 Review of Adverse Events and Adverse Device Effects

HRPP Policies and Procedures Section 8: AEs, Unanticipated Problems ...

1.0 Purpose The purpose of this policy is to describe the process for reporting research related...

Updated 1 year ago by Robert A Lewis

8.3 Review of Unanticipated Problems Involving Risk to the Subject or Others

HRPP Policies and Procedures Section 8: AEs, Unanticipated Problems ...

1.0 Purpose The purpose of this policy is to describe the process for reporting potential unanti...

Updated 1 year ago by Robert A Lewis

8.5 Noncompliance by the IRB or Other Components of the HRPP

HRPP Policies and Procedures Section 8: AEs, Unanticipated Problems ...

1.0 Purpose The purpose of this policy is to describe the process for reviewing and reporting in...

Updated 1 year ago by Robert A Lewis

Introduction to the Research Handbook

Research Handbook

Welcome to the University of Nebraska Medical Center, where research breakthroughs improve patien...

Updated 1 year ago by James Geiger

Developing a Budget

Research Handbook Human Subject Research

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

Updated 1 year ago by Max V. Kuenstling

3.2 Data and Safety Monitoring

HRPP Policies and Procedures Section 3: Special Issues

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

Updated 2 years ago by Robert A Lewis