HRPP Policies and Procedures

The policy manual for human subjects research at UNMC.

Table of Contents

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 Serving as Central IRB for Multisite Research

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

1.4 UNMC IRB Ceding Review to an External 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 and procedure is to describe the Organization’s policy an...

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 and procedure is to describe the Organization’s requireme...

1.17 Retention of Research Records

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

1.18 Review and Approval of HRPP Policies and Procedures

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

1.19 IRB Signature Authority

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

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 and procedure is to describe the Organization’s requireme...

1.23 HRPP Training Requirements and Opportunities for Research Personnel

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

1.24 HRPP Training Requirements for IRB Members

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

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...

Section 2: Process of Review

Section 3: Special Issues

3.1 Assessing the Need for Increased Monitoring, Interim Continuing Review, and Verification from Sources Other than the PI

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

3.2 Data and Safety Monitoring

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

3.3 Privacy Interests and Confidentiality of Research Data

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

3.4 Use of Protected Health Information in Research

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 and procedure is to describe the Organization’s requireme...

3.6 Subject Recruitment Through Direct Invitation

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

3.7 Finder’s Fees and Recruitment Bonuses

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

3.8 Research Subject Compensation

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

3.9 Contraception Requirements

1.0 Purpose The purpose of this policy and procedure is to describe the contraception requiremen...

3.10 Pregnancy Testing

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

3.11 Collecting Data from Pregnant Partners of Research Subjects

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

3.12 Ethical Access

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

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...

Section 4: Vulnerable Populations

Section 5: Informed Consent

Section 6: FDA Regulated Research/Drugs & Devices

Section 7: Human Biologic Materials and Data Registries

Section 8: AEs, Unanticipated Problems and Compliance

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