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)
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 with International Sites
1.0 Purpose The purpose of this policy is to describe the Organization’s requirements for resear...
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, Staff and Guest Conflict of Interest Identification and Management
1.0 Purpose The purpose of this policy is to describe the Organization’s requirements for the id...
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 is to describe the Organization’s requirements for resear...
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 Outreach Activities and Community Based Participatory Research (CBPR)
1.0 Purpose The purpose of this policy is to describe the Organization’s outreach activities to ...
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 is to describe the Organization’s procedures for identifi...
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 is to describe the Organization’s requirements for initia...
1.29 ClinicalTrials.gov Reporting
1.0. Purpose The purpose of this policy is to describe the requirements for registration and co...
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...
1.34 Emergency Preparedness for the Office of Regulatory Affairs and IRBs
1.0 Purpose The purpose of this policy is to describe the Emergency Preparedness and Continuity ...
Section 2: Process of Review
2.1 Submission for Items for Review by the IRB
1.0 Purpose The purpose of this policy is to describe Organization’s requirements for submission...
2.2 Full IRB Review
1.0 Purpose The purpose of this policy is to describe the Organization’s requirements for: 1) su...
2.3 Expedited Review
1.0 Purpose The purpose of this policy is to describe the Organization’s requirements for using ...
2.4 IRB Review of Changes in Previously Approved Research
1.0 Purpose The purpose of this policy and procedure is to describe the Organization’s requireme...
2.5 Criteria for IRB Approval
1.0 Purpose The purpose of this policy and procedure is to describe the Organization’s criteria ...
2.6 Exempt Research
2.6 Exempt Research 1.0 Purpose The purpose of this policy and procedure is to describe the Org...
2.7 Continuing Review of Research
1.0 Purpose The purpose of this policy is to describe the Organization’s requirements for contin...
2.8 Limited IRB Review
1.0 Purpose The purpose of this policy is to describe the Organization’s requirements and proced...
2.9 Closure of On-Going Research
1.0 Purpose The purpose of this policy is to describe the criteria for, and process of, closing ...
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 is to describe the Organization’s requirements for 1) pro...
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 is to describe the Organization’s requirements for recrui...
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 and Reimbursement
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
4.1 Additional Protections for Vulnerable Populations
1.0 Purpose The purpose of this policy and procedure is to describe the Organization’s requireme...
4.2 Research Involving Pregnant Women, Human Fetuses, and Neonates (Nonviable or of Uncertain Viability)
1.0 Purpose The purpose of this policy is to describe the Organization’s requirements for IRB re...
4.3 Research Involving Prisoners
1.0 Purpose The purpose of this policy and procedure is to describe the Organization’s requireme...
4.4 Research Involving Children
1.0 Purpose The purpose of this policy is to describe the Organization’s requirements for resea...
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 requireme...
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 re...
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 requireme...
Section 5: Informed Consent
5.1 Obtaining Informed Consent From Research Subjects
1.0 Purpose The purpose of this policy is to describe the Organization’s requirements for the pr...
5.2 Waiver or Alteration of Informed Consent and HIPAA Authorization
1.0 Purpose The purpose of this policy is to describe the Organization’s requirements for granti...
5.3 Use of a Remote Consent Process
1.0 Purpose The purpose of this policy and procedure is to describe the Organization’s requireme...
5.4 Waiver of Requirement to Obtain Signed Consent Form
1.0 Purpose The purpose of this policy and procedure is to describe the Organization’s process f...
5.5 Use of the Short Form Consent Document
1.0 Purpose The purpose of this policy is to describe the Organization’s requirements for use of...
5.6 Exceptions from Informed Consent Requirements for Emergency Research
1.0 Purpose The purpose of this policy and procedure is to describe the Organization’s requireme...
5.7 Obtaining Informed Consent from Non-English Speaking Persons, or Persons with Additional Needs or Vulnerabilities
1.0 Purpose The purpose of this policy is to describe the Organization’s requirements for the pr...
Section 6: FDA Regulated Research/Drugs & Devices
6.1 Research Involving Investigational and Marketed Drugs
1.0 Purpose The purpose of this policy and procedure is to describe the Organization’s requireme...
6.2 Research Involving Investigational and Marketed Devices
1.0 Purpose The purpose of this policy and procedure is to describe the Organization’s requireme...
6.3 Humanitarian Use Device (HUD)
1.0 Purpose The purpose of this policy and procedure is to describe the Organization’s requireme...
6.4 Emergency Use of a Test Article
1.0 Purpose The purpose of this policy is to describe the requirements for utilization of a test...
6.5 Expanded Access to Investigational Drugs and Devices for Treatment Use
1.0 Purpose 1.1. The purpose of this policy and procedure is to describe the requirements for ut...
Section 7: Human Biologic Materials and Data Registries
7.1 Banking Human Biological Material
1.0 Purpose The purpose of this policy and procedure is to describe the Organization’s requireme...
7.2 Use of Human Biological Material in Research
1.0 Purpose The purpose of this policy and procedure is to describe the Organizations requiremen...
7.3 Data Registries
1.0 Purpose The purpose of this policy and procedure is to describe the Organization’s requireme...
Section 8: AEs, Unanticipated Problems and Compliance
8.1 Review of Adverse Events and Adverse Device Effects
1.0 Purpose The purpose of this policy is to describe the process for reporting research related...
8.2 Review of Study Related Complaints
1.0 Purpose The purpose of this policy is to describe the process for reporting research related...
8.3 Review of Unanticipated Problems Involving Risk to the Subject or Others
1.0 Purpose The purpose of this policy is to describe the process for reporting potential unanti...
8.4 Review of Noncompliance Involving the PI or Study Personnel
1.0 Purpose The purpose of this policy is to describe the process for reviewing and reporting in...
8.5 Noncompliance by the IRB or Other Components of the HRPP
1.0 Purpose The purpose of this policy is to describe the process for reviewing and reporting in...
8.6 Study Hold, Suspension, and Termination
1.0 Purpose The purpose of this policy is to describe the process for study holds, study suspens...
8.7 Reporting Incidents to Institutional Officials and Federal Agencies
1.0 Purpose The purpose of this policy is to describe the Organization’s requirements to ensure ...
Emergency Preparedness /Continuity of Operations Plan (EP/COOP)
1.0 Emergency Preparedness /Continuity of Operations Plan (EP/COOP) 1.1. Purpose The UNMC Offi...