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The Office of Research Support (ORS) does not administer or oversee HOP policy 5-2011* or training related to the policy. ORS administers HOP policy 7-1210, “Promoting Objectivity in Research by Managing, Reducing or Eliminating Financial Conflicts of Interest” so if you conduct research and have:

  1. Not submitted a Financial Interest Disclosure (FID), you will need to complete mandatory training and file a FID. Instructions for completing these requirements are located at http://www.utexas.edu/research/rsc/coi/training.html.
  2. Previously submitted a FID, you are not required to complete additional training nor re-disclose the same information to comply with the UTS 180/HOP 5-2011 policy requirements.   However, you may have other responsibilities under that policy.

*If you have questions concerning the other policy, HOP policy 5-2011, “Conflicts of Interest, Conflicts of Commitment, & Outside Activities,” you should contact the Provost’s Office evpp_coi@austin.utexas.edu.

The University of Texas at Austin
Institutional Review Board
Policies and Procedures Manual

PDF Document Complete Manual

Recent Changes

The following sections of the Policies and Procedures Manual have been recently updated:

May 15, 2014

  • 5.4.3 Criteria to Determine that Subjects of Exempt Research are Protected

Section 1: Introduction

  • 1.1 Background Information
  • 1.2 Mission
  • 1.3 Institutional Commitment
  • 1.4 Human Subjects Research Oversight
  • 1.5 Purpose and Scope of the Manual
  • 1.6 Applicability
  • 1.7 Revision and Maintenance of the Manual

Section 2: Definitions

  • 2.1 Definitions Applicable to All Sections of this Manual

Section 3: General Policies and Procedures

  • 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 Subjects Research
    • 3.12.2 Class Projects
    • 3.12.3 Oral History Projects
  • 3.13 Coded Private Information as Relates to Human Subjects Research
  • 3.14 Cooperative Activities
  • 3.15 Undue Influence of the IRB or ORS Staff
  • 3.16 Training Requirements
    • 3.16.1 Researchers and Research Staff
    • 3.16.2 IRB Members and Chairs
    • 3.16.3 Department Review Committee (DRC) Members
    • 3.16.4 ORS Staff
  • 3.17 Roles and Responsibilities
    • 3.17.1 Principal Investigators
    • 3.17.2 Faculty 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

Section 4: Subject Recruitment and Participation

  • 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 Subjects 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

Section 5: Initial IRB Review of Research Activities

  • 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/Scholarly 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

Section 6: Informed Consent

  • 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 Use of a Short Form Written Consent Document
      • 6.4.2.1 When following DHHS regulations the IRB must determine
      • 6.4.2.2 When following FDA Regulations the IRB must determine
    • 6.4.3 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
    • 6.8.1 Required Elements
  • 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

Section 7: Continuing Review of Human Subjects Research Activities

  • 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 Documents
    • 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

Section 8: Amendment of Human Subjects Research Activities

  • 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

Section 9: Reporting Unanticipated Problems

  • 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

Section 10: Research with Investigational Drugs

  • 10.1 General
  • 10.2 Exemptions
    • 10.2.1 For Exemption under 21 CFR 312.2(b)(1)
    • 10.2.2 For Exemption under 21 CFR 312.2(b)(2)
    • 10.2.3 For Exemption under 21 CFR 312.2(b)(3)
    • 10.2.4 For Exemption under 21 CFR 312.2(b)(5)
    • 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

Section 11: Research with Investigational Devices

  • 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

Section 12: Vulnerable Populations

  • 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

Section 13: Community Based Research

  • 13.1 Purpose
    • 13.1.1 Principles for Community Based Research
  • 13.2 References

Section 14: Transnational Research

  • 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

Section 15: Research Using Deceptive Or Incomplete Disclosure

  • 15.1 Background and Rationale
  • 15.2 General Guidelines
  • 15.3 Principal Investigator Requirements
  • 15.4 Potential Risks

Section 16: Research Utilizing Surveys and Internet Research

  • 16.1 Survey Research
  • 16.2 Internet Research

Section 17: Genetic Materials

  • 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

Section 18: Stem Cell Research

  • 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

Section 19: Health Record Research

  • 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

Section 20: Human Tissue and Data Repositories for Research Use

  • 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

Section 21: Data and Safety Monitoring in Research

  • 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

Section 22: Protocol Deviations and Noncompliance

  • 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

Section 23: Suspensions and Terminations

  • 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

Section 24: Reporting Requirements

  • 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

Section 25: Additional Requirements for Federal Agency Funded Research

  • 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
    • 25.1.11 Reporting Requirements
    • 25.1.12 Records Accessibility
  • 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
    • 25.3.3 Researcher Reporting Requirements
  • 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