Section 1: General Human Research Protection Program Policies

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...

1.2 Authority Granted to the IRB by the Organization

1.0 Purpose The purpose of this policy and procedure is to describe the authority granted by the...

1.3 UNMC IRB Serving as the Single IRB for Multisite Research

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

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...

1.5 Requirements for Research Conducted at International Sites

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

1.6 IRB Composition, Leadership, Qualifications, and Responsibilities

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

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

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

1.8 Investigational Activities Requiring IRB Review and Approval

1.0 Purpose The purpose of this policy is to describe the investigational activities that requir...

1.9 Resources Necessary to Protect Subjects

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

1.10 Scientific and Other Committee Review of Research

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

1.11 HRPP Access to Legal Counsel

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

1.12 Sponsored Research

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

1.13 Compliance with ICH-GCP Guidelines

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

1.14 Research Subject to Department of Defense Regulatory Requirements

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

1.15 Research Subject to Department of Justice Regulatory Requirements

1.0 Purpose The purpose of this policy and procedure is to specify the Organizations requirement...

1.16 ORA Record Keeping Requirements

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

1.17 Retention of Research Records

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

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...

1.20 Community Involvement in Research & Outreach Activities

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

1.21 Post-Approval Monitoring of Research

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

1.22 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...

1.23 HRPP Training Requirements

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

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...

1.25 Financial Conflicts of Interest

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

1.26 PI Qualifications and Responsibilities

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

1.27 Research Personnel Qualifications and Responsibilities

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

1.28 External Investigator Assurance

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 and procedure is to describe the requirements and procedu...

1.30 Use of the Rapid Response IRB

1.0 Purpose The purpose of this policy and procedure is to describe the criteria for use of, and...

1.31 Observers at IRB Meetings

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

1.32 Confidentiality of the Review Process

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

1.33 Posting of Clinical Trial Consent Forms

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

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