Office of the Institutional Review Board
IRB Office Staff

Policies and Procedures

Note: Updated: 12/08/2016. Posted Policies and Procedures on this website do not represent an all inclusive list. Not all current policies are posted online and some may be under revision. Please call the Office of the IRB at 210-567-8250 with any questions concerning current policy.

 

Vice President for Research Policy

Study Reviews for Human Research

 

 

Standard Operating Procedures 

Informed Consent Process

 

Written Documentation of Consent

 

 

 

Purview and Training Policies

--GLOSSARY OF OIRB TERMS

  Online Glossary of Human Research Terms

IRB Member and Consultant Conflict of Interest Policy and Procedure

 

Membership of the IRB Policy and Procedure

 

Policy on Policies Policy and Procedure

 
IRB Education Policy and Procedure Related OCR Policy:
Human Subjects Protection and Ethics Education Policy
doc for PC

UTHSCSA Specific Module

  doc for PC

 

Review Mechanisms/Outcomes Policies

--GLOSSARY OF OIRB TERMS

  Online Glossary of Human Research Terms

Complaints Policy and Procedure

  doc for PC

Conduct of IRB Meetings Policy and Procedure

  doc for PC

Continuation Review Policy and Procedure

  doc for PC

Determining Whether an Activity is Research Involving Human Participants Policy and Procedure

  doc for PC

Device Effects (UADE) Policy and Procedure

  doc for PC

Exempt Research Policy and Procedure

  doc for PC

HIPAA in Research Policy and Procedure

  doc for PC

Identification and Recruitment of Participants Policy and Procedure

Related Guidance:
Guidelines for Advertising for Research Subjects
Guidance on UT Medicine Patient Recruitment
doc for PC

Initial Review of Research Policy and Procedure

  doc for PC

IRB Approval of Research Policy and Procedure

  doc for PC
IRB Review Fees Memorandum   IRB Review Fees Memorandum

Modifications and Amendments Policy and Procedure

  PDF document

Receiving, Routing, and Administrative Review of UTHSCSA IRB Submissions Policy and Procedure

  PDF document

Repository Policy and Procedure

  PDF document

Suspension or Termination of Research Policy and Procedure

  PDF document

Unanticipated Problems Involving Risk to Subjects or Others (UPIRSO) And Unanticipated Adverse Device Effects (UADE) Policy and Procedure

  PDF document

 


Special Requirements Policies

--GLOSSARY OF OIRB TERMS

  Online Glossary of Human Research Terms
DoD Research Policy and Procedure   doc for PC

Emergency Use of an Investigational Drug or Device Article Policy and Procedure

  PDF document

Expanded Access Treatment Use of an Unapproved Investigational Drug/Biologic Policy and Procedure

  PDF document

Humanitarian Use Device (HUD) Policy and Procedure

  doc for PC

Informed Consent Policy and Procedure

Related Guidance:
Guidance on Observation of the Consenting Process
Checklist for Elements of an Information Sheet
Checklist for Elements of Informed Consent
Waivers and Alterations
doc for PC

Planned Emergency Research Exception from Informed Consent Requirements Policy and Procedure

  PDF document

Research Involving a Device Policy and Procedure

  PDF document

Research Involving a Drug Policy and Procedure

  PDF document

Research Involving Individuals with Diminished Autonomous Decision-Making Capacity Policy and Procedure

  PDF document

 


Recordkeeping and External Reporting Policies

--GLOSSARY OF OIRB TERMS

  Online Glossary of Human Research Terms
Deviations and Violations Policy  

IRB Minutes Policy and Procedure

 

Noncompliance Policy and Procedure

 

Recordkeeping Policy and Procedure

 

Reporting Policy and Procedure

 

Study Inactivation Policy and Procedure

 

 

Quality Improvement & Assessment Policies

--GLOSSARY OF OIRB TERMS

  Online Glossary of Human Research Terms

Evaluation of IRB Membership Policy and Procedure

 

PI Self Assessment Program Policy and Procedure

 
Quality Assurance and Improvement Program Policy and Procedure  

 


Coordination Policies

--GLOSSARY OF OIRB TERMS

  Online Glossary of Human Research Terms

Cooperative Off-Site Research Policy and Procedure

 

Coordination with Other Committees or Offices Policy and Procedure

 

 

 

Guidance & HOP/OCR Policies

  Guidance

  HOP and OCR Policies applicable to IRB, IRB Members and Investigators

 

 

Alphabetical Listing of Policies

Complaints Policy and Procedure

  doc for PC

Conduct of IRB Meetings Policy and Procedure

  doc for PC

Continuation Review Policy and Procedure

  doc for PC

Cooperative Off-Site Research Policy and Procedure

 

Coordination with Other Committees or Offices Policy and Procedure

 

Determining Whether an Activity is Research Involving Human Participants Policy and Procedure

  doc for PC
Deviations and Violations Policy  

Device Effects (UADE) Policy and Procedure

  doc for PC
DoD Research Policy and Procedure   doc for PC

Emergency Use of an Investigational Drug or Device Article Policy and Procedure

  PDF document

Evaluation of IRB Membership Policy and Procedure

  PDF document

Exempt Research Policy and Procedure

  doc for PC

Expanded Access Treatment Use of an Unapproved Investigational Drug/Biologic Policy and Procedure

  PDF document

GLOSSARY OF OIRB TERMS

  Online Glossary of Human Research Terms

HIPAA in Research Policy and Procedure

  doc for PC

Humanitarian Use Device (HUD) Policy and Procedure

  doc for PC

Identification and Recruitment of Participants Policy and Procedure

Related Guidance:
Guidelines for Advertising for Research Subjects
Guidance on UT Medicine Patient Recruitment
doc for PC

Informed Consent Policy and Procedure

Related Guidance:
Guidance on Observation of the Consenting Process
Checklist for Elements of an Information Sheet
Checklist for Elements of Informed Consent
Waivers and Alterations
doc for PC

Initial Review of Research Policy and Procedure

  doc for PC

IRB Approval of Research Policy and Procedure

  doc for PC
IRB Education Policy and Procedure Related OCR Policy:
Human Subjects Protection and Ethics Education Policy
doc for PC

IRB Member and Consultant Conflict of Interest Policy and Procedure

 

IRB Minutes Policy and Procedure

 
IRB Review Fees Memorandum   IRB Review Fees Memorandum

Membership of the IRB Policy and Procedure

  doc for PC

Modifications and Amendments Policy and Procedure

  PDF document

Noncompliance Policy and Procedure

 

PI Self Assessment Program Policy and Procedure

 

Planned Emergency Research Exception from Informed Consent Requirements Policy and Procedure

  PDF document

Policy on Policies Policy and Procedure

 
Quality Assurance and Improvement Program Policy and Procedure  

Receiving, Routing, and Administrative Review of UTHSCSA IRB Submissions Policy and Procedure

  PDF document

Recordkeeping Policy and Procedure

 

Reporting Policy and Procedure

 

Repository Policy and Procedure

  PDF document

Research Involving a Device Policy and Procedure

  PDF document

Research Involving a Drug Policy and Procedure

  PDF document

Research Involving Individuals with Diminished Autonomous Decision-Making Capacity Policy and Procedure

  PDF document

Study Inactivation Policy and Procedure

 

Suspension or Termination of Research Policy and Procedure

  PDF document

Unanticipated Problems Involving Risk to Subjects or Others (UPIRSO) And Unanticipated Adverse Device Effects (UADE) Policy and Procedure

  PDF document

UTHSCSA Specific Module

  doc for PC

 


If you have questions concerning submission of a research protocol for IRB review, please call the Office of the IRB at 210-567-8250.