HRPP Policies and Procedures
The policy manual for human subjects research at UNMC.
Table of Contents
Section 1: General Human Research Protection Program Polices 1.1 Human Research Protection Progra...
Section 1: General Human Research Protection Program Policies
1.1 Human Research Protection Program (HRPP)
Last Revised: 1/16/2023 1.0 Purpose The purpose of this policy and procedure is to provide a basi...
1.2 Authority Granted to the IRB by the Organization
Last Revised: 5/28/2021 1.0 Purpose The purpose of this policy and procedure is to describe the a...
1.3 UNMC IRB Serving as the Single IRB for Multisite Research
Last Revised: 4/21/2025 1.0 Purpose The purpose of this policy is to describe the Organization’s ...
1.4 UNMC Ceding Review to an External Central IRB
Last Revised: 5/15/2025 1.0 Purpose The purpose of this policy is to describe the Organization’s ...
1.5 Requirements for Research Conducted with International Sites
Last Revised: 5/9/2023 1.0 Purpose The purpose of this policy is to describe the Organization’s r...
1.6 IRB Composition, Leadership, Qualifications, and Responsibilities
Last Revised: 2/15/2025 1.0 Purpose The purpose of this policy and procedure is to describe the O...
1.7 IRB Member, Consultant, Staff and Guest Conflict of Interest Identification and Management
Last Revised: 9/25/2024 1.0 Purpose The purpose of this policy is to describe the Organization’s ...
1.8 Investigational Activities Requiring IRB Review and Approval
Last Revised: 5/9/2023 1.0 Purpose The purpose of this policy is to describe the investigational ...
1.9 Resources Necessary to Protect Subjects
Last Revised: 1/16/2025 1.0 Purpose The purpose of this policy is to describe the Organization’s ...
1.10 Scientific and Other Committee Review of Research
Last Revised: 4/8/2025 1.0 Purpose The purpose of this policy is to describe the Organization’s r...
1.11 HRPP Access to Legal Counsel
Last Revised: 2/11/2025 1.0 Purpose The purpose of this policy is to describe the Organization’s ...
1.12 Sponsored Research
Revised: 6/12/2024 1.0 Purpose The purpose of this policy is to describe the Organization’s requi...
1.13 Compliance with ICH-GCP Guidelines
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
Last Revised: 1/10/2024 1.0 Purpose The purpose of this policy and procedure is to specify the Or...
1.15 Research Subject to Department of Justice Regulatory Requirements
Last Revised: 4/20/2016 1.0 Purpose The purpose of this policy and procedure is to specify the Or...
1.16 ORA Record Keeping Requirements
Last Revised: 01/17/2024 1.0 Purpose The purpose of this policy is to describe the Organization’s...
1.17 Retention of Research Records
Last Revised: 6/30/2022 1.0 Purpose The purpose of this policy is to describe the requirements fo...
1.18 Review and Approval of HRPP Policies and Procedures
Last Revised: 11/13/2024 1.0 Purpose The purpose of this policy is to describe the Organization’s...
1.19 IRB Signature Authority
Last Revised: 10/7/2022 1.0 Purpose The purpose of this policy is to describe the Organization’s ...
1.20 Community Involvement in Outreach Activities and Community Based Participatory Research (CBPR)
Last Revised: 1/17/2024 1.0 Purpose The purpose of this policy is to describe the Organization’s ...
1.21 Post-Approval Monitoring of Research
Last Revised: 2/28/2018 1.0 Purpose The purpose of this policy and procedure is to describe the O...
1.22 Assessment of the Effectiveness and Efficiency of the HRPP
Last Revised: 9/25/2024 1.0 Purpose The purpose of this policy is to describe the Organization’s ...
1.23 HRPP Training Requirements
Last Revised: 8/17/2022 1.0 Purpose The purpose of this policy is to describe the Organization’s ...
1.24 HRPP Training Requirements for IRB Members
Last Revised: 7/14/2022 1.0 Purpose The purpose of this policy is to describe the Organization’s ...
1.25 Financial Conflicts of Interest
Last Revised 1/22/2024 1.0 Purpose The purpose of this policy is to describe the Organization’s p...
1.26 PI Qualifications and Responsibilities
Last Revised: 6/11/2025 1.0 Purpose The purpose of this policy is to describe the qualifications ...
1.27 Research Personnel Qualifications and Responsibilities
Last Revised: 2/18/2019 1.0 Purpose The purpose of this policy and procedure is to describe the q...
1.28 External Investigator Assurance
Last Revised: 12/3/2022 1.0 Purpose The purpose of this policy is to describe the Organization’s ...
1.29 ClinicalTrials.gov Reporting
Last Revised: 3/20/2023 1.0. Purpose The purpose of this policy is to describe the requirements ...
1.30 Use of the Rapid Response IRB
Last Revised: 10/17/2024 1.0 Purpose The purpose of this policy is to describe the constitution o...
1.31 Observers at IRB Meetings
Last Revised: 2/26/2018 1.0 Purpose The purpose of this policy and procedure is to describe the O...
1.32 Confidentiality of the Review Process
Last Reviewed: 1/12/2018 1.0 Purpose The purpose of this policy and procedure is to describe the ...
1.33 Posting of Clinical Trial Consent Forms
Last Revised: 9/18/2019 1.0 Purpose The purpose of this policy and procedure is to describe the O...
1.34 Emergency Preparedness for the Office of Regulatory Affairs and IRBs
Last Revised: 8/31/2023 1.0 Purpose The purpose of this policy is to describe the Emergency Prepa...
Section 2: Process of Review
2.1 Submission for Items for Review by the IRB
Last Revised: 7/19/2022 1.0 Purpose The purpose of this policy is to describe Organization’s requ...
2.2 Full IRB Review
Last Revised: 10/13/2022 1.0 Purpose The purpose of this policy is to describe the Organization’s...
2.3 Expedited Review
Last Revised 1/24/2024 1.0 Purpose The purpose of this policy is to describe the Organization’s r...
2.4 IRB Review of Changes in Previously Approved Research
Last Revised 1/18/2025 1.0 Purpose The purpose of this policy is to describe the Organization’s r...
2.5 Criteria for IRB Approval
Last Revised: 1/24/2018 1.0 Purpose The purpose of this policy and procedure is to describe the O...
2.6 Exempt Research
Last Revised: 1/7/2024 1.0 Purpose The purpose of this policy and procedure is to describe the Or...
2.7 Continuing Review of Research
Last Revised 1/12/2024 1.0 Purpose The purpose of this policy is to describe the Organization’s r...
2.8 Limited IRB Review
Last Revised: 6/5/2023 1.0 Purpose The purpose of this policy is to describe the Organization’s r...
2.9 Closure of On-Going Research
Last Revised: 08/10/2023 1.0 Purpose The purpose of this policy is to describe the criteria for, ...
Section 3: Special Issues
3.1 Assessing the Need for Increased Monitoring, Interim Continuing Review, and Verification from Sources Other than the PI
Last Revised: 1/2/2018 1.0 Purpose The purpose of this policy and procedure is to describe the Or...
3.2 Data and Safety Monitoring
Last Revised 12/22/2022 1.0 Purpose The purpose of this policy is to describe the Organization’s ...
3.3 Privacy Interests and Confidentiality of Research Data
Last Revised 1/21/2024 1.0 Purpose The purpose of this policy is to describe the Organization’s r...
3.4 Use of Protected Health Information in Research
Last Revised: 4/9/2018 1.0 Purpose The purpose of this policy and procedure is to describe the Or...
3.5 Subject Recruitment Through Advertisements
Last Revised 12/11/2024 For an abbreviated version intended for investigators, coordinators, and ...
3.6 Subject Recruitment Through Direct Invitation
Last Revised: 3/12/2025 1.0 Purpose The purpose of this policy is to describe the Organization’s ...
3.7 Finder’s Fees and Recruitment Bonuses
Last Revised: 1/26/2018 1.0 Purpose The purpose of this policy and procedure is to describe the O...
3.8 Research Subject Compensation and Reimbursement
Last Revised: 7/3/2024 1.0 Purpose The purpose of this policy is to describe the Organization’s r...
3.9 Contraception Requirements
Last Revised: 5/5/2025 1.0 Purpose The purpose of this policy is to describe the contraception re...
3.10 Pregnancy Testing
Last Revised: 7/9/2025 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
Last Revised: 9/9/2019 1.0 Purpose The purpose of this policy is to describe the Organization’s r...
3.12 Ethical Access
Last Revised: 3/5/2025 1.0 Purpose The purpose of this policy is to define ethical access and to ...
3.13 Use of Placebo or Wash-Out of Effective Therapy in Clinical Trials
Last Revised: 2/7/2018 1.0 Purpose The purpose of this policy and procedure is to describe the Or...
3.14 Phase I and First-in-Human Studies
Last Revised: 2/5/2018 1.0 Purpose The purpose of this policy and procedure is to describe the Or...
3.15 Managing Radiographic Incidental Findings in Human Subjects Research
Last Revised: 2/28/2018 1.0 Purpose The purpose of this policy and procedure is to describe the O...
Section 4: Vulnerable Populations
4.1 Additional Protections for Vulnerable Persons
Last Revised: 4/16/2025 1.0 Purpose The purpose of this policy is to describe the Organization’s ...
4.2 Research Involving Pregnant Women, Human Fetuses, and Neonates (Nonviable or of Uncertain Viability)
Last Revised: 9/25/2024 1.0 Purpose The purpose of this policy is to describe the Organization’s ...
4.3 Research Involving Prisoners
Last Revised: 01/17/2024 1.0 Purpose The purpose of this policy and procedure is to describe the ...
4.4 Research Involving Children
Last revised: 11/8/2022 1.0 Purpose The purpose of this policy is to describe the Organization’s...
4.5 Local 407 Panel Review of Pediatric Research
Last revised: 2/19/2018 1.0 Purpose The purpose of this policy and procedure is to describe the O...
4.6 IRB Review of Research Involving Subjects with Impaired Decision-Making Capacity
Last Revised: 11/27/2024 1.0 Purpose The purpose of this policy is to describe the Organization’s...
4.7 Research Involving Employees of the Organization and Students as Subjects
Last Revised: 1/29/2018 1.0 Purpose The purpose of this policy and procedure is to describe the O...
Section 5: Informed Consent
5.1 Obtaining Informed Consent From Research Subjects
Last Revised: 1/8/2025 1.0 Purpose The purpose of this policy is to describe the Organization’s r...
5.2 Waiver or Alteration of Informed Consent and HIPAA Authorization
Last Revised: 2/7/2024 1.0 Purpose The purpose of this policy is to describe the Organization’s r...
5.3 Use of a Remote Consent Process
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
Last Revised: 12/11/2024 1.0 Purpose The purpose of this policy is to describe the Organization’s...
5.5 Use of the Short Form Consent Document
Last Revised: 11/30/2022 1.0 Purpose The purpose of this policy is to describe the Organization’s...
5.6 Exceptions from Informed Consent Requirements for Emergency Research
Last Revised: 3/5/2018 1.0 Purpose The purpose of this policy and procedure is to describe the Or...
5.7 Obtaining Informed Consent from Non-English Speaking Persons, or Persons with Additional Needs or Vulnerabilities
Last Revised: 11/12/2024 1.0 Purpose The purpose of this policy is to describe the Organization’s...
Section 6: FDA Regulated Research/Drugs & Devices
6.1 Research Involving Investigational and Marketed Drugs
Last Revised: 1/24/2024 1.0 Purpose The purpose of this policy and procedure is to describe the O...
6.2 Research Involving Investigational and Marketed Devices
Last Revised: 1/23/2024 1.0 Purpose The purpose of this policy and procedure is to describe the O...
6.3 Humanitarian Use Device (HUD)
Last Revised: 5/26/2021 1.0 Purpose The purpose of this policy and procedure is to describe the O...
6.4 Emergency Use of a Test Article
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
Last Revised: 1/23/2024 1.0 Purpose 1.1. The purpose of this policy and procedure is to describe...
Section 7: Human Biologic Materials and Data Registries
7.1 Banking Human Biological Material
Last Revised: 1/25/2018 1.0 Purpose The purpose of this policy and procedure is to describe the O...
7.2 Use of Human Biological Material in Research
Last Revised: 1/25/2018 1.0 Purpose The purpose of this policy and procedure is to describe the O...
7.3 Data Registries
Last Revised: 4/16/2025 1.0. Purpose The purpose of this policy is to describe the Organization’...
Section 8: AEs, Unanticipated Problems and Compliance
8.1 Review of Adverse Events and Adverse Device Effects
Last Revised: 5/4/2023 1.0 Purpose The purpose of this policy is to describe the process for repo...
8.2 Review of Study Related Complaints
Last Revised: 5/8/2023 1.0 Purpose The purpose of this policy is to describe the process for repo...
8.3 Review of Unanticipated Problems Involving Risk to the Subject or Others
Last Revised: 5/8/2023 1.0 Purpose The purpose of this policy is to describe the process for repo...
8.4 Review of Noncompliance Involving the PI or Study Personnel
Last Revised: 3/6/2024 1.0 Purpose The purpose of this policy is to describe the process for revi...
8.5 Noncompliance by the IRB or Other Components of the HRPP
Last Revised: 5/9/2023 1.0 Purpose The purpose of this policy is to describe the process for revi...
8.6 Study Hold, Suspension, and Termination
Last Revised: 1/20/2023 1.0 Purpose The purpose of this policy is to describe the process for stu...
8.7 Reporting Incidents to Institutional Officials and Federal Agencies
Last Revised: 8/1/2023 1.0 Purpose The purpose of this policy is to describe the Organization’s r...
Emergency Preparedness/Continuity of Operations Plan (EP/COOP)
Last Revised: 9/1/2023 1.0 Emergency Preparedness /Continuity of Operations Plan (EP/COOP) 1.1. ...