The University of Texas at Austin
Institutional Review Board
Policies and Procedures Manual
Complete Manual
- 1.1 Background Information
- 1.2 Mission
- 1.3 Institutional Commitment
- 1.4 Human Subject Research Oversight
- 1.5 Purpose and Scope of the Manual
- 1.6 Applicability
- 1.7 Revision and Maintenance of the Manual
- 2.1 Definitions Applicable to All Sections of this Manual
- 3.1 Applicable Regulations and Laws
- 3.2 Institutional Review Board
- 3.2.1 Purpose
- 3.2.2 Designation and Authority
- 3.2.3 Composition and Appointment of the IRB
- 3.3 Term of Appointment
- 3.4 Committee Officers
- 3.5 Meetings
- 3.6 IRB Meeting Minutes
- 3.7 Confidentiality of the Review Process
- 3.8 Conflict of Interest
- 3.8.1 IRB Members – Convened Meeting
- 3.8.2 Designated Reviewers for Expedited Review
- 3.8.3 Examples of IRB Member COI
- 3.8.4 Principal Investigator
- 3.9 Interaction with Other University of Texas Components and Commencement of Research Activities
- 3.10 Types of Research Conducted at the University
- 3.11 Categories of Research Subjects
- 3.12 Determining if IRB Review is Required
- 3.12.1 Determination of Human Subject Research
- 3.12.2 Class Projects
- 3.12.3 Oral History Projects
- 3.13 Coded Private Information as Relates to Human Subject Research
- 3.14 Cooperative Activities
- 3.15 Undue Influence of the IRB or ORS Staff
- 3.16 Training Requirements
- 3.16.1 Researchers
- 3.16.2 IRB Members
- 3.16.3 DRC Members
- 3.16.4 ORS Staff
- 3.17 Roles and Responsibilities
- 3.17.1 Principal Investigators
- 3.17.2 Faculty Mentors/Sponsors
- 3.17.3 Departmental Review Committees
- 3.17.4 Institutional Official
- 3.17.5 Institutional Review Board
- 3.17.6 IRB Chair and Vice Chair
- 3.17.7 IRB Members
- 3.18 Monitoring/Verification of Compliance from Sources Other than the PI
- 3.19 Contacts for Questions, Concerns, Complaints or Input
- 3.20 Periodic Review of the HRPP and Participant Outreach Programs
- 3.20.1 HRPP
- 3.20.2 IRB Members and ORS Staff
- 3.20.3 Participant Outreach
- 3.21 Record Retention Policy at The University of Texas at Austin
- 4.1 General Recruitment Guidelines
- 4.2 Advertisements
- 4.3 Pre-screening
- 4.4 Recruitment of Students and Staff
- 4.5 Researchers Recruiting from Their Own Courses
- 4.5.1 Potential for Undue Influence
- 4.5.2 Reducing the Potential for Undue Influence
- 4.5.3 Exceptions
- 4.6 Subject Pools
- 4.7 Equitable Subject Recruitment
- 4.8 Compensation for Research Subjects
- 4.8.1 General Guidelines
- 4.8.2 Use of Lotteries
- 4.9 Finder's Fees and Bonus Payments
- 4.10 Costs to Research Subjects
- 4.11 Protection of Privacy for Subjects and Confidentiality of Subject Data
- 4.11.1 General
- 4.11.2 Considerations and Provisions to Protect Human Subject Privacy
- 4.11.3 Confidentiality Data Security Considerations
- 4.11.4 Protecting Subjects' Health Information
- 4.11.5 Certificates of Confidentiality
- 4.12 Use of Collected Data if a Subject Withdraws from a Study
- 4.13 Specimen Collection for Research Purposes
- 4.13.1 General Requirements
- 4.13.2 Additional Requirements for Adults
- 4.13.3 Additional Requirements for Children
- 5.1 Governing Principles/Regulations
- 5.2 Initial IRB Review at a Convened IRB Meeting
- 5.2.1 Submission and Review Schedule
- 5.2.2 Data and Safety Monitoring Plans
- 5.2.3 Assignment of Primary and Secondary Reviewers
- 5.2.4 Distribution of Submitted Materials to IRB Members
- 5.2.5 IRB Meeting Schedule
- 5.2.6 Presentation and Discussion of Protocols
- 5.2.7 Criteria for IRB Approval of Research
- 5.2.8 Scientific Review
- 5.2.9 Length of Approval Period
- 5.3 Research Appropriate for Expedited Review
- 5.3.1 Submission and Review Schedule
- 5.3.2 Submission Requirements/Materials Reviewed
- 5.3.3 Assignment of Expedited Reviewer
- 5.3.4 Reviewer Considerations
- 5.3.5 Applicability Criteria
- 5.3.6 Criteria for IRB Approval of Research
- 5.3.7 Scientific/Scholarly Review
- 5.3.8 Length of Approval Period
- 5.3.9 Reporting of Expedited Review to the IRB
- 5.4 Exempt Research
- 5.4.1 Exempt Research (Not FDA Regulated)
- 5.4.2 Exempt Research (FDA)
- 5.4.3 Criteria to Determine that Subjects of Exempt Research are Protected
- 5.4.4 Length of Approval Period
- 5.4.5 Modifications to Exempt Research
- 5.5 Possible IRB Protocol Determinations
- 5.6 Notification of Determinations
- 5.6.1 Full Board Review
- 5.6.2 Expedited Review
- 5.6.3 Exempt Research
- 5.7 Final Approval and Expiration Dates
- 6.1 General Policy
- 6.2 Elements of Informed Consent
- 6.3 Other Requirements for Obtaining Informed Consent
- 6.4 Documenting Informed Consent
- 6.4.1 Non-English Language Informed Consent and other Study Documents
- 6.4.2 Informed Consent Process for Online Survey-Based Research
- 6.5 Third Party/Surrogate Consent
- 6.6 Parental Permission/Child Assent
- 6.7 Waiver of Informed Consent and Waiver of Documentation of Consent
- 6.7.1 Waiver of Informed Consent
- 6.7.2 Waiver of Documentation of Consent
- 6.8 Authorization to Use or Disclose Protected Health Information
- 6.9 Waiver of Authorization for Use and Disclosure of PHI
- 6.10 Re-Consenting Subjects
- 6.11 Record Retention Requirements for Subject Consent Forms
- 7.1 Requirement for Continuing Review
- 7.2 Submission Requirements
- 7.3 Continuing Review of Research Appropriate for Expedited Review
- 7.3.1 Review of Protocol
- 7.3.2 Review of Materials
- 7.3.3 Reviewer Considerations
- 7.3.4 Possible IRB Protocol Determinations
- 7.3.5 Length of Approval Period
- 7.3.6 Notification of the IRB of Expedited Review
- 7.4 Continuing Review at an IRB Convened Meeting
- 7.4.1 Assignment of Primary and Secondary Reviewers
- 7.4.2 Distribution of Submitted Materials
- 7.4.3 Presentation and Discussion of Protocols
- 7.4.4 Possible IRB Determinations
- 7.4.5 Length of Approval Period
- 7.4.6 Third Party Observation
- 7.5 Criteria for IRB Approval of Research Continuation
- 7.6 Notification of IRB Determinations
- 7.7 Failure to Comply with Continuing Review Requirements - Lapsed Protocols
- 8.1 Requirement for Amendments
- 8.2 Submission Requirements
- 8.3 Assignment of Expedited Reviewer
- 8.4 Review of Amendment Requests
- 8.5 Possible IRB Protocol Determinations
- 8.6 Criteria for Approval of Amendments
- 8.7 Length of Approval Period
- 8.8 Notification of Investigators of IRB Determination
- 9.1 Principal Investigator Reporting Requirements
- 9.1.1 Reporting Determinations
- 9.1.2 Reporting Unanticipated Problems
- 9.2 Review of Unanticipated Problem Reports
- 9.2.1 Initial Review
- 9.2.2 Convened Meeting Review
- 9.3 Possible IRB Actions
- 9.4 University Reporting Requirements
- 9.5 Notification of Principal Investigators
- 10.1 General
- 10.2 Exemptions
- 10.2.1 For Exemption under 21 CFR 312.2(b)(1), the study must meet all of the following:
- 10.2.2 For Exemption under 21 CFR 312.2(b)(2), the study must meet all of the following:
- 10.2.3 For Exemption under 21 CFR 312.2(b)(3), the study must meet the following:
- 10.2.4 For Exemption under 21 CFR 312.2(b)(5), the study must meet the following:
- 10.2.5 Exemption for Bioavailability (BA) or Bioequivalence (BE) Studies
- 10.2.6 Exemption for Studies using Stable Isotopes
- 10.2.7 Dietary Supplements
- 10.3 Applying for and/or Filing an IND
- 10.4 Investigator Responsibilities
- 10.4.1 General
- 10.4.2 Lead Investigator of a Multi-Center Study
- 10.4.3 Additional Reporting Requirements
- 10.5 Emergency Use of an Investigational Drug or Biologic -FDA-Regulated Studies
- 10.6 Registering Applicable Clinical Trials
- 11.1 General
- 11.2 Abbreviated Requirements
- 11.3 Applying for and/or Filing an IDE
- 11.4 Exemptions
- 11.5 Significant/Non-significant Risk Determinations
- 11.6 Principal Investigator (PI) Responsibilities
- 11.7 In Vitro Diagnostic Devices
- 11.8 Emergency Use of Devices
- 11.9 Principal Investigator Responsibilities in Storage and Use of Investigational Devices
- 11.10 Registering Applicable Clinical Trials
- 12.1 Inclusion of Vulnerable Populations in Research Activities
- 12.2 Pregnant Women, Fetuses, and Neonates
- 12.2.1 Research Involving Fetuses and Neonates
- 12.2.2 IRB Review of Non-HHS Funded Research Involving Pregnant Women
- 12.2.3 IRB Review of HHS Funded Research Involving Pregnant Women
- 12.2.4 Research Not Otherwise Approvable that Presents an Opportunity to Understand, Prevent, or Alleviate a Serious Problem Affecting the Health or Welfare of Pregnant Women (45 CFR 46.207)
- 12.3 Research Involving Prisoners
- 12.3.1 IRB Review of Non-HHS Funded Research Involving Prisoners
- 12.3.2 IRB Review of HHS Funded Research Involving Prisoners
- 12.3.3 Requirements by Categories in Research Involving Prisoners
- 12.3.4 Subjects that Become Incarcerated During HHS Funded Research Study
- 12.3.5 Documentation and Certification of Research Involving Prisoners
- 12.4 Research Involving Children
- 12.4.1 IRB Review of HHS Funded Research Involving Children
- 12.4.2 Requirements by Category in Research Involving Children
- 12.4.3 IRB Review of Non-HHS Funded Research Involving Children
- 12.4.4 Assent/Permission Requirements for Research Involving Children
- 12.4.5 Exceptions to Assent Requirements for Research Involving Children
- 12.4.6 Waiver of Permission Requirements for Research Involving Children
- 12.4.7 Reimbursements to Children and/or Parents
- 12.4.8 When a Child Reaches the Age of Consent While Enrolled in a Study
- 12.4.9 Wards
- 12.5 Other Vulnerable Populations
- 12.5.1 Research Involving Decisionally Impaired Adults
- 12.5.2 Educationally/Economically Disadvantaged
- 13.1 Purpose
- 13.1.1 Principles for Community Based Research
- 13.2 References
- 14.1 General Researcher Considerations
- 14.2 Specific Principal Investigator Considerations
- 14.3 General Reviewer Considerations
- 14.4 Specific Principal Investigator and Reviewer Considerations
- 14.5 Exemptions
- 14.6 Risk Assessment
- 14.7 Informed Consent
- 14.8 International Research Involving Children
- 14.9 Communication with IRB/Ethics Committee and Faculty Sponsor
- 15.1 Background and Rationale
- 15.2 General Guidelines
- 15.3 Principal Investigator Requirements
- 15.4 Potential Risks
- 16.1 Survey Research
- 16.2 Internet Research
- 17.1 Collection and Storage of Genetic Materials
- 17.1.1 Previously Acquired Samples
- 17.1.2 Prospectively Acquired Anonymous Samples
- 17.1.3 Identified Samples
- 18.1 Human Embryonic Stem Cells (See Section 2: Definitions)
- 18.1.1 Applicable Guidance, Regulations, and Laws
- 18.1.2 Human Embryonic Germ Cells Derived from Fetal Tissue
- 18.1.3 Ineligible Research Involving hESC or Human Induced Pluripotent Stem Cells
- 18.2 Research with Adult Stem Cells
- 18.3 IRB Review Requirements
- 19.1 Purpose
- 19.2 Use of Protected Health Information
- 19.3 De-identified PHI
- 19.4 Identifiable PHI
- 19.5 Waiver of the Requirement for Obtaining Authorization
- 20.1 Applicability
- 20.2 Review and Oversight
- 20.3 Considerations and Requirements
- 20.3.1 IRB Review
- 20.3.2 Informed Consent Documentation
- 20.3.3 Submittal Agreements
- 20.3.4 Usage Agreements
- 20.3.5 Certificate of Confidentiality
- 20.4 Repository Requirements
- 21.1 General
- 21.2 Requirement for a Data and Safety Monitoring Plan
- 21.3 Types of Data and Safety Monitoring Plans
- 21.4 Components of DSMPs
- 21.5 IRB Review of DSMP
- 22.1 Reporting to the IRB
- 22.2 Response to Report
- 22.2.1 Inquiry
- 22.2.2 IRB Investigation
- 22.2.3 Examples of Serious and Ongoing/Continuing Noncompliance
- 22.2.4 Possible IRB Actions
- 22.2.5 Noncompliance that is Not Serious or Ongoing
- 22.2.6 Reporting to IO and Others
- 23.1 Reasons for Suspension or Termination
- 23.2 Authority to Suspend or Terminate Research Activities
- 23.2.1 Principal Investigator
- 23.2.2 IRB Chair
- 23.2.3 IRB
- 23.2.4 Institutional Officer and Departmental Review Committee
- 23.3 Notification of Suspension or Termination
- 23.4 Lifting a Suspension or Termination
- 24.1 Requirements for Researchers to Report to the IRB
- 24.2 Reporting Requirements for the Institution
- 24.2.1 General
- 24.2.2 Notification of the IO
- 24.2.3 Notification of Regulatory and Sponsoring Agencies
- 24.2.4 Contents of the Report
- 25.1 Department of Defense (DoD)
- 25.1.1 Scientific Review
- 25.1.2 Education Requirements
- 25.1.3 Research Monitor Required: More than Minimal Risk Studies
- 25.1.4 Research Involving International Citizen Populations
- 25.1.5 Waiver of Consent and Exception from Informed Consent in Emergency Medicine
- 25.1.6 Multi-site or Collaborative Research Requirements
- 25.1.7 Provisions for Research Related Injury
- 25.1.8 Research Involving US Military Personnel as Research Subjects
- 25.1.9 Research Involving Prisoners of War
- 25.1.10 Additional DoD Review Prior to Initiation of the Study
- 25.2 Department of Education (ED)
- 25.2.1 Family Educational Rights and Privacy Act (FERPA) 34 CFR Part 99
- 25.2.2 Exception to Written Permission for Records Release under FERPA
- 25.2.3 Protection of Pupil Rights Amendment PRPA (34 CFR Part 98)
- 25.2.4 Additional Requirements for School Research Not Funded by the ED
- 25.2.5 Other Conditions Pertaining to Waivers of Parent Permission or Informed Consent
- 25.3 Department of Energy (DoE)
- 25.3.1 Personally Identifiable Information
- 25.3.2 Description of Processes
- 25.4 Department of Justice (DoJ)
- 25.4.1 Principal Investigator Responsibilities
- 25.4.2 Bureau of Prisons
- 25.4.3 Research Proposals
- 25.4.4 Informed Consent
- 25.5 Environmental Protection Agency (EPA)
- 25.5.1 Research Involving Intentional Exposure of Any Human Subject
- 25.5.2 Observational Research Involving Pregnant Women and Fetuses
- 25.5.3 Observational Research of Children Not Involving Greater Than Minimal Risk
- 25.5.4 Observational Research of Children Involving Greater Than Minimal Risk
- 25.5.5 Final Review by EPA
- 25.5.6 Research Not Conducted or Supported By Any Federal Agency
