Office of the Institutional Review Board

Policies and Procedures

Note: 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 

Obtaining Informed Consent

 

Written Documentation of Consent

Merged into Obtaining Informed Consent SOP

 

 

Purview and Training Policies

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

UTHSCSA Specific Module

 

 

Review Mechanisms/Outcomes Policies

Online Glossary of Human Research Terms

 

Complaints Policy and Procedure

 

Conduct of IRB Meetings Policy and Procedure

 

Continuation Review Policy and Procedure

 

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

 

Device Effects (UADE) Policy and Procedure

 

Exempt Research Policy and Procedure

 

HIPAA in Research Policy and Procedure

 

Identification and Recruitment of Participants Policy and Procedure

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

Initial Review of Research Policy and Procedure

 

IRB Approval of Research Policy and Procedure

 

Modifications and Amendments Policy and Procedure

 

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

 

Repository Policy and Procedure

 

Review Fees Memoranda

 

Suspension or Termination of Research Policy and Procedure

 

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

 

 


Special Requirements Policies

Online Glossary of Human Research Terms

 

DoD Research Policy and Procedure

 

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

 

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

 

Humanitarian Use Device (HUD) Policy and Procedure

 

Informed Consent Policy and Procedure

Related Guidance:
Guidance on Observation of the Consenting Process

Planned Emergency Research Exception from Informed Consent Requirements Policy and Procedure

Related Guidance: Planned Emergency Research

Research Involving a Device Policy and Procedure

 

Research Involving a Drug Policy and Procedure

 

Research Involving Individuals with Impaired Decision-Making Ability Policy and Procedure

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

Subject Payments for Studies Involving Minors Policy and Procedure

 


 


Recordkeeping and External Reporting Policies

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

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

Online Glossary of Human Research Terms

 

Cooperative 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

 

 


 


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