Institutional Review Board Procedures Manual for Faculty, Staff, and Student Researchers with Human Participants
Complete Manual
Section 1: Introduction
1.0 Purpose and Scope of Manual
1.1 Applicability
1.2 Mission Statement
1.3 Administration of Research Ethics-Federal
1.4 Applicable State of Texas Laws
1.5 Administration of Research Ethics - The University of Texas
1.6 Designation of the Institutional Review Board
1.7 The Institutional Review Board
1.8 Departmental Review Committees (DRC)
Section 2: The Institutional Review Board
2.0 General IRB Policies
2.0.1 Functions and Responsibilities
2.0.2 Confidentiality of the Review Process
2.0.3 Research Determinations
2.0.4 Undue Influence of IRB Members or HRPP Staff
2.0.5 Suspension & Termination Policy
2.0.6 Reporting Policy
2.0.7 IRB Resources
2.1 Meetings
2.2 IRB Minutes
2.3 Approval Timeframes
2.3.1 Expiration and Inactive Notices
2.4 Protocol Files
2.5 Consultants
2.6 IRB Advisory Committee
2.7 HRPP Complaints, Feedback, Concerns, and Issues
Section 3: General Research Procedures
3.0 Extramural Research
3.1. Public and/or Published Data Sets Not Subject to Human Participants Review
3.2 Guidelines for Research Protocols Requiring Collection and Storage of Genetic Materials
3.3. Scientific Merit
3.4 Confidentiality
3.5 Privacy
3.6 Protecting Participants' Health Information
3.7 Conflict of Interest
3.8 Records Retention Requirements
3.9 Guidelines for Payment of "Finder's Fees" for Research Participant Recruitment
3.10 Guidelines on Compensation for Research Participants
3.10.1 Guidelines for Research Advertisement Content
3.11 Equitable Recruitment
3.12 Funded / Sponsored Research
Section 4: Training in the Protection of Human Participants
4.0 Background (NIH Policy on Required Training in Research Ethics)
4.1 The University of Texas at Austin's Policy for Required Training in Human Participants Ethics
4.2 Alternative Sources of Information on Human Subjects Ethics
4.3 Online Training Verification
4.4 Additional Ethical Training Resources
4.5 Training for IRB Members
4.6 Training for DRC Members
4.7 Training for ORS Staff Members
Section 5: Informed Consent of Research Participants
5.0 Informed Consent
5.1 Elements of Informed Consent / Assent Forms
5.2 Additional Consent Information for Different Types of Studies
5.3 Elements of a Consent / Authorization Using Personal Health Information (PHI)
5.4 Waiver of Authorization for the Use and Disclosure of Personal Health Information (PHI)
5.5 Documentation of Informed Consent
5.6 Waiver of Documentation of Informed Consent
5.7 Waiver of Informed Consent
Section 6: Initial IRB Review of a Research Proposal Involving Human Participants
6.0 Requirements for Initial IRB Review
6.1 Submission Schedule Requirements
6.2 Initial Evaluation of Submitted Projects
6.3 Exempt Research Review Process
6.3.1 Categories of Research that may be Reviewed By The IRB Through an Exempt Review Procedure
6.3.2 Categories of Research that May be Reviewed by the IRB through an Exempt Review Procedure
6.3.3 Research populations for which the exempt determinations may not be used
6.3.4 PI Assurance Statement
6.3.5 Procedures for Exempt Determination
6.4 Expedited Research Review Process
6.4.1 Categories of Research that may be Reviewed by the IRB Through an Expedited Review Procedure
6.5 Greater Than Minimal Risk Protocols
6.5.1 Primary Reviewer Checklist
6.6 Appeal of Decisions Made by the Institutional Review Board
6.7 Non-Compliance with IRB Polices, Procedures, or Decisions
6.7.1 Non-Compliance Reviewer Form
Section 7: Continuing a Research Project
7.0 The Continuing Review Procedure
7.1 Greater Than Annual Continuing Review
7.2 Amendments to Protocols
7.3 Identification and Reporting of Unanticipated Problems
7.4 Quality Improvement & Monitoring (Peer Review Committee)
7.4.1 Procedures for Quality Improvement & Monitoring
7.5 Policy & Procedures for Data Safety Monitoring Plans (DSMP)
Section 8: Procedures for Research with Vulnerable Populations
8.0 Inclusion of Pregnant Women, Human Fetuses, and Neonates in Research
8.1 Inclusion of Prisoners in Research
8.2 Inclusion of Children in Research
8.3 Requirements for Consent and Assent Involving Children
8.4 Inclusion of Adults who Lack Decision-Making Capacity in Research
8.5 Inclusion of University of Texas at Austin Students and Staff in Research
8.6 Subject Pools
8.7 Student Class Projects
Appendices
Appendix E: This appendix is intentionally left blank. This space is reserved for future use.
Appendix G: Required Proposal Format
Appendix H: Application for Continuing Review
Appendix I: Application to Amend a Research Protocol
Appendix J: Unanticipated Problem Form
Appendix M: Exempt Review Checklist
Appendix N: Expedited Review Checklist
Appendix O: Noncompliance Review Form
Appendix P: Four-Part Human Participant Training Tutorial