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 Progr...
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: 11/13/2024 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: 1/22/2024 1.0 Purpose The purpose of this policy and procedure is to describe the O...
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: 6/27/2022 1.0 Purpose The purpose of this policy and procedure is to describe the q...
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 1.0 Purpose The purpose of this policy is to describe the Organization’s ...
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: 11/21/2017 1.0 Purpose The purpose of this policy and procedure is to describe the ...
3.10 Pregnancy Testing
Last Revised: 1/8/2018 1.0 Purpose The purpose of this policy and procedure is to describe the Or...
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 Populations
Last Revised: 1/26/2018 1.0 Purpose The purpose of this policy and procedure is to describe the O...
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
1.0 Purpose The purpose of this policy is to describe the Organization’s requirements for resear...
4.5 Local 407 Panel Review of Pediatric Research
1.0 Purpose The purpose of this policy and procedure is to describe the Organization’s requiremen...
4.6 IRB Review of Research Involving Subjects with Impaired Decision-Making Capacity
1.0 Purpose The purpose of this policy is to describe the Organization’s requirements for IRB rev...
4.7 Research Involving Employees of the Organization and Students as Subjects
1.0 Purpose The purpose of this policy and procedure is to describe the Organization’s requiremen...
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: 3/2/2018 1.0 Purpose The purpose of this policy and procedure is to describe the Or...
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. ...