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1.13 Compliance with ICH-GCP Guidelines

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

Last Revised: 2/2/2018 1.0 Purpose The purpose of this policy and procedure is to describe the Or...

1.14 Research Subject to Department of Defense Regulatory Requirements

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

Last Revised: 1/10/2024 1.0 Purpose The purpose of this policy and procedure is to specify the Or...

1.26 PI Qualifications and Responsibilities

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

Last Revised: 6/27/2022 1.0 Purpose The purpose of this policy and procedure is to describe the q...

1.27 Research Personnel Qualifications and Responsibilities

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

Last Revised: 2/18/2019 1.0 Purpose The purpose of this policy and procedure is to describe the q...

2.4 IRB Review of Changes in Previously Approved Research

HRPP Policies and Procedures Section 2: Process of Review

Last Revised 1/18/2025 1.0 Purpose The purpose of this policy is to describe the Organization’s r...

3.11 Collecting Data from Pregnant Partners of Research Subjects

HRPP Policies and Procedures Section 3: Special Issues

Last Revised: 9/9/2019 1.0 Purpose The purpose of this policy is to describe the Organization’s r...

5.3 Use of a Remote Consent Process

HRPP Policies and Procedures Section 5: Informed Consent

Last Revised: 2/9/2024 1.0 Purpose The purpose of this policy and procedure is to describe the Or...

5.4 Waiver of Requirement to Obtain Signed Consent Form

HRPP Policies and Procedures Section 5: Informed Consent

Last Revised: 12/11/2024 1.0 Purpose The purpose of this policy is to describe the Organization’s...

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

HRPP Policies and Procedures Section 5: Informed Consent

Last Revised: 11/12/2024 1.0 Purpose The purpose of this policy is to describe the Organization’s...

6.4 Emergency Use of a Test Article

HRPP Policies and Procedures Section 6: FDA Regulated Research/Drugs...

Last Revised: 1/22/2024 1.0 Purpose The purpose of this policy is to describe the requirements fo...

6.5 Expanded Access to Investigational Drugs and Devices for Treatment Use

HRPP Policies and Procedures Section 6: FDA Regulated Research/Drugs...

Last Revised: 1/23/2024 1.0 Purpose 1.1. The purpose of this policy and procedure is to describe...

Table of Contents

HRPP Policies and Procedures

Section 1: General Human Research Protection Program Polices 1.1 Human Research Protection Progra...

1.4 UNMC Ceding Review to an External Central IRB

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

Last Revised: 5/15/2025 1.0 Purpose The purpose of this policy is to describe the Organization’s ...

4.6 IRB Review of Research Involving Subjects with Impaired Decision-Making Capacity

HRPP Policies and Procedures Section 4: Vulnerable Populations

Last Revised: 11/27/2024 1.0 Purpose The purpose of this policy is to describe the Organization’s...