Human Research Protection Program (HRPP)

Standard Operating Procedures (SOP)

  • 1.1 Mission
  • 1.2 Organizational Authority
  • 1.3 Definitions
  • 1.4 Ethical Principles
  • 1.5 Regulatory Compliance
  • 1.6 International Council on Harmonization-Good Clinical Practice (ICH-GCP)
  • 1.7 Federalwide Assurance (FWA)
  • 1.8 Research Under the Auspices of the Organization
  • 1.9 Written policies and procedures
  • 1.10 University of Virginia HRPP Structure
    • 1.10.1 Institutional Official
    • 1.10.2 Director of the HRPP
    • 1.10.3 HRPP Staff
    • 1.10.4 Institutional Review Board (IRB)
    • 1.10.5 General Counsel’s Office
    • 1.10.6 Department Chairs and/or Organizational Leaders and their Designees
    • 1.10.7 The Investigator
    • 1.10.8 Other Related Units
      • 1.10.8.1 Sponsored Programs Administration
      • 1.10.8.2 University of Virginia Investigational Drug Service (UVA IDS)
      • 1.10.8.3 University of Virginia Cancer Center Protocol Review Committee (PRC)
      • 1.10.8.4 University of Virginia Neonatal ICU Protocol Review Committee
    • 1.10.9 Relationship Among Components
    • 1.10.10 Study-Specific Coordination
  • 1.11 Multi-Site Research Projects and IRB Authorization/Reliance Agreements
    • 1.11.1 UVA engaged in only a part of a Multi-Site Research Project
    • 1.11.2 Each research site obtains IRB Approval from their IRB
    • 1.11.3 UVA Relies on a non- UVA IRB as the IRB of Record
    • 1.11.4 UVA IRB serves as IRB of Record for non-UVA Sites
    • 1.11.5 UVA PI serves as Overall PI or UVA serves as the Data Coordinating Center
pdf - Chapter 1
  • 2.1 External Monitoring, Audit, and Inspection Reports
  • 2.2 Investigator Compliance Reviews
  • 2.3 IRB Compliance Reviews
  • 2.4 HRPP Quality Assessment and Improvement
pdf - Chapter 2
  • 3.1 Training / Ongoing Education of IRB Chair, Members, and Staff
  • 3.2 Training / Ongoing Education of Investigators and Research Team
    • 3.2.1 Initial Education
    • 3.2.2 Continuing Education and Recertification
pdf - Chapter 3
  • 4.1 IRB Authority 35
  • 4.2 Roles and Responsibilities
    • 4.2.1 Chair of the IRB
    • 4.2.2 Vice Chair of the IRB
    • 4.2.3 IRB Members
    • 4.2.4 Alternate members
    • 4.2.5 Subcommittees of the IRB
  • 4.3 IRB Membership
  • 4.4 Composition of the IRB
    • 4.4.1 Appointment of Members to the IRB
    • 4.4.2 IRB Registration Updates
  • 4.5 Use of Consultants
  • 4.6 Liability Coverage for IRB Members
  • 4.7 Reporting and Investigation of Allegations of Undue Influence
pdf - Chapter 4
  • 6.1 Limitations on Exemptions
  • 6.2 Categories of Exempt Research
  • 6.3 FDA Exemptions
  • 6.4 Procedures for Exemption Determination
pdf - Chapter 6
  • 7.1 Definitions [pdf]
  • 7.2 Expedited Review [pdf]
    • 7.2.1 Categories of Research Eligible for Expedited Review
    • 7.2.2 Expedited Review Procedures
    • 7.2.3 Informing the IRB
  • 7.3 Convened IRB Meetings [pdf]
    • 7.3.1 IRB Meeting Schedule
    • 7.3.2 Pre Review
    • 7.3.3 Primary and Secondary Reviewers
    • 7.3.4 Materials received by the IRB
    • 7.3.5 Quorum
    • 7.3.6 Meeting Procedures
    • 7.3.7 Guests
  • 7.4 Criteria for IRB Approval of Research [pdf]
    • 7.4.1 Risk/Benefit Assessment
      • 7.4.1.1 Scientific or Scholarly Review
    • 7.4.2 Equitable Selection of Subjects
      • 7.4.2.1 Recruitment of Subjects
    • 7.4.3 Informed Consent
    • 7.4.4 Data and Safety Monitoring
    • 7.4.5 Privacy and Confidentiality
      • 7.4.5.1 Definitions
      • 7.4.5.2 Privacy
      • 7.4.5.3 Confidentiality
    • 7.4.6 Vulnerable Populations
  • 7.5 Additional Considerations [pdf]
    • 7.5.1 Determination of Risk
    • 7.5.2 Period of Approval
    • 7.5.3 Review More Often Than Annually
    • 7.5.4 Independent Verification That No Material Changes Have Occurred
    • 7.5.5 Consent Monitoring
    • 7.5.6 Investigator Qualifications
    • 7.5.7 Investigator Conflicts of Interest (COI)
    • 7.5.8 Institutional Conflicts of Interest
    • 7.5.9 Significant New Findings
    • 7.5.10 Advertisements and Recruitment Materials
    • 7.5.11 Payments to Research Subjects
    • 7.5.12 Non-Monetary Gifts and Incentives
    • 7.5.13 State and Local Laws
  • 7.6 Possible IRB Actions [pdf]
  • 7.7 Continuing Review [pdf]
    • 7.7.1 Continuing Review Process
    • 7.7.2 Approval Considerations
    • 7.7.3 Convened Board Review
    • 7.7.4 Expedited Review
    • 7.7.5 Possible IRB Actions after Continuing Review
    • 7.7.6 Lapses in Continuing Review
  • 7.8 Modification of an Approved Protocol [pdf]
    • 7.8.1 Procedures
    • 7.8.2 Convened Board Review of Modifications
    • 7.8.3 Expedited review of Modifications
    • 7.8.4 Possible IRB Actions after Modification Review
    • 7.8.5 Protocol/Research Plan Exceptions
  • 7.9 Closing a Research Study [pdf]
  • 7.10 Failure to Respond [pdf]
  • 7.11 Appeal of IRB Decisions
  • 7.12 Research Previously Approved By Another IRB
  • 8.1 Suspension/Termination
  • 8.2 Investigator Hold
    • 8.2.1 Procedures
  • 8.3 Protection of Currently Enrolled Participants
pdf - Chapter 8
  • 9.1 UVA Investigator Responsibilities
  • 9.2 UVA IRB Responsibilities
  • 9.3 Responsibilities after the study is open to enrollment at UVA
pdf - Chapter 9
  • 10.1 IRB Records
  • 10.2 IRB Study Files
  • 10.3 The IRB Minutes
  • 10.4 IRB Membership Roster
  • 10.5 Documentation of Exemptions
  • 10.6 Documentation of Expedited Reviews
  • 10.7 Access to IRB Records
  • 10.8 Record Retention
pdf - Chapter 10
  • 11.1 Definitions
  • 11.2 Basic Requirements
  • 11.3 Informed Consent Process
  • 11.4 Determining a potential adult subject’s ability to consent to research
  • 11.5 Basic Elements of Informed Consent
  • 11.6 Documentation of Informed Consent
  • 11.7 Special Consent Circumstances
    • 11.7.1 Enrollment of persons with limited English-language proficiency
    • 11.7.2 Braille consent
    • 11.7.3 Consenting in American Sign Language (ASL)
    • 11.7.4 Consent
  • 11.8 Subject Withdrawal or Termination
  • 11.9 Waiver of Informed Consent
  • 11.10 Waiver of Documentation of Informed Consent
  • 11.11 Waiver of Informed Consent for Planned Emergency Research
    • 11.11.1 Definitions
    • 11.11.2 Procedures
    • 11.11.2.1 FDA-regulated Planned Emergency Research
    • 11.11.2.2 Planned Emergency Research Not Subject to FDA Regulations
pdf - Chapter 11
  • 12.1 Definitions
  • 12.2 Involvement of Vulnerable Populations
  • 12.3 Responsibilities
  • 12.4 Procedures
  • 12.5 Research Involving Pregnant Women, Human Fetuses and Neonates
    • 12.5.1 Research Involving Pregnant Women or Fetuses
      • 12.5.1.1 Research Not Conducted or Supported by DHHS
      • 12.5.1.2 Research Conducted or Supported by DHHS
    • 12.5.2 Research involving Neonates of Uncertain Viability or Nonviable Neonates
      • 12.5.2.1 Research Not Conducted or Supported by DHHS
      • 12.5.2.2 Research Conducted or Supported by DHHS
    • 12.5.3 Viable Neonates
    • 12.5.4 Research Involving, After Delivery, the Placenta, the Dead Fetus or Fetal Material
    • 12.5.5 Research Not Otherwise Approvable
      • 12.5.5.1 Research Not Conducted or Supported by DHHS
      • 12.5.5.2 Research Conducted or Supported by DHHS
  • 12.6 Research Involving Prisoners
    • 12.6.1 Applicability
    • 12.6.2 Minimal Risk
    • 12.6.3 Composition of the IRB
    • 12.6.4 Review of Research Involving Prisoners
    • 12.6.5 Incarceration of Enrolled Subjects
    • 12.6.6 Additional Duties of the IRB
    • 12.6.7 Certification to DHHS
    • 12.6.8 Waiver for Epidemiology Research
  • 12.7 Research Involving Children
    • 12.7.1 Allowable Categories
    • 12.7.2 Parental Permission and Assent
      • 12.7.2.1 Parental Permission
      • 12.7.2.2 Assent from Children
      • 12.7.2.3 Children Who are Wards
  • 12.8 Adults with Impaired Decision Making Capacity
pdf - Chapter 12
  • 13.1 Definitions
  • 13.2 FDA Exemptions
  • 13.3 Procedures
  • 13.4 Investigator Responsibilities
  • 13.5 Dietary Supplements
  • 13.6 Clinical Investigations of Drugs and Devices
    • 13.6.1 IND/IDE Requirements
      • 13.6.1.1 IND Exemptions
      • 13.6.1.2 IDE Exemptions
      • 13.6.1.3 Significant and Non-Significant Risk Device Studies
  • 13.7 Humanitarian Use Devices
    • 13.7.1 Definitions
    • 13.7.2 IRB Review Requirements
    • 13.7.3 Procedures
    • 13.7.4 Emergency Uses of HUDs
  • 13.8 Expanded Access to Investigational Drugs, Biologics, and Devices
    • 13.8.1 Expanded Access to Investigational Drugs and Biologics
    • 13.8.2 Expanded Access to Investigational and Unapproved Medical Devices
  • 13.9 Emergency Use
    • 13.9.1 Emergency Exemption from Prospective IRB Approval
    • 13.9.2 Emergency Exception from the Informed Consent Requirement
    • 13.9.3 Waiver of Informed Consent for Planned Emergency Research
pdf - Chapter 13
  • 14.1 Definitions
  • 14.2 Procedures
    • 14.2.1 Reporting
    • 14.2.2 Submission of Reports
    • 14.2.3 IRB Procedures for Handling Reportable Events
pdf - Chapter 14
  • 16.1 Definitions
  • 16.2 Reporting
  • 16.3 Review of Allegations of Non-compliance
  • 16.4 Review of Findings of Non-compliance
    • 16.4.1 Non-compliance that is not serious or continuing
    • 16.4.2 Serious or Continuing Non-compliance
    • 16.4.3 Final Review
pdf - Chapter 16
  • 19.1 Investigators
  • 19.2 Responsibilities
  • 19.3 Investigator Records
    • 19.3.1 Records
    • 19.3.2 Regulatory Records
    • 19.3.3 Record Retention
  • 19.4 Investigator Concerns
pdf - Chapter 19
  • 20.1 Definitions
  • 20.2 Responsibility
pdf - Chapter 20
  • 21.1 Researcher Conflicts of Interest
    • 21.1.1 Procedures
      • 21.1.1.1 Disclosure of Researcher COI
      • 21.1.1.2 Evaluation of COI
      • 21.1.1.3 Management of COI
    • 21.2 IRB Member Conflict of Interest
    • 21.3 Institutional Conflict of Interest
    • 21.4 Recruitment Incentives
pdf - Chapter 21
  • 22.1 Responsibility
  • 22.2 Outreach Resources and Educational Materials
  • 22.3 Evaluation
pdf - Chapter 22
  • 23.1 Definitions (per HIPAA Privacy Rule Booklet for Research)
  • 23.2 The IRB’s Role under the Privacy Rule
  • 23.3 Authorization
  • 23.4 Waiver or Alteration of the Authorization Requirement
  • 23.5 Activities Preparatory to Research
  • 23.6 Research Using Decedent's Information
  • 23.7 Future Uses: Databases and Repositories
  • 23.8 Corollary and Sub-studies
  • 23.9 De-identification of PHI under the Privacy Rule
  • 23.10 Limited Data Sets and Data Use Agreements
  • 23.11 Disclosing a Limited Data Set
  • 23.12 Accounting of Disclosures
pdf - Chapter 23

Last Modified: Wednesday, 02-Aug-2017 11:06:02 EDT