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 as many are currently under revisions. Please call the Office of the IRB at 210-567-2351 with any questions concerning current policy.

Instructions:

Always return to this webpage to create new submissions to ensure you are using the most current Policies.

 

Section 1:  Alphabetical Listing of All Policies

Section 2:  Purview and Training [Determination of IRB Approval, Membership, Education, Off-site Research]

Section 3:  Review Mechanisms/Outcomes [Full Board, expedited, Exempt, Continuation, Modification, UPIRSO, HIPAA, Noncompliance, Suspenstion-Termination]

Section 4:  Special Requirements [Consent, Drugs, Devices, Emergency use]

Section 5:  Recordkeeping and External Reporting [Records, Reporting, Minutes, sudy Closure ]

Section 6:  Quality Improvement & Assessment

Section 7:  Coordination

Guidance

 

Section 1

Alphabetical Listing of Policies

--GLOSSARY OF OIRB TERMS

Complaints Policy and Procedure

Conduct of IRB Meetings Policy and Procedure

Continuation Review Policy and Procedure

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

Drafting Written Policies and Guidance Policy and Procedure

Emergency Use of an Unapproved Investigational Device Policy and Procedure

Emergency Use of an Unapproved Investigational Drug Policy and Procedure

Emergency Use of HUD

Evaluation of IRB Membership Policy and Procedure

Exempt Research Policy and Procedure

FAQ – UTHSCSA IRB Affiliated Researchers

FAQ – VA & IIMS Researchers

GLOSSARY OF OIRB TERMS

HIPAA in Research Policy and Procedure

Inactivate Study Policy and Procedure

Informed Consent Policy and Procedure

Initial Review of Research at a Convened Meeting Policy and Procedure

Initial Review of Research by Expedited Process Policy and Procedure

Instructions “How to Register with CITI”

IRB Member and Consultant Conflict of Interest Policy and Procedure

IRB Membership Policy and Procedure

IRB Minutes Policy and Procedure

IRB Review of Research Policy and Procedure

Modifications and Amendments Policy and Procedure

Noncompliance Policy and Procedure

PI Self Assessment Program Policy and Procedure

Planned Emergency Research Policy and Procedure

Privacy and Confidentiality in Identification and Recruitment of Participants Policy and Procedure

Receiving and Routing Research Submissions Policy and Procedure

Recordkeeping Policy and Procedure

Reporting Policy and Procedure

Repository Policy and Procedure

Research Ethics Education Policy and Procedure

Research Involving a Device Policy and Procedure

Research Involving a Drug Policy and Procedure

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

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

UTHSCSA Specific Module

When the Investigator is also the Sponsor

Back to Table of Contents

Section 2

Purview and Training Policies

--GLOSSARY OF OIRB TERMS

Drafting Written Policies and Guidance Policy and Procedure

Evaluation of IRB Membership Policy and Procedure

FAQ – UTHSCSA IRB Affiliated Researchers

FAQ – VA & IIMS Researchers

Instructions “How to Register with CITI”

IRB Member and Consultant Conflict of Interest Policy and Procedure

IRB Membership Policy and Procedure

Research Ethics Education Policy and Procedure

UTHSCSA Specific Module

Back to Table of Contents

Section 3

Review Mechanisms/Outcomes

--GLOSSARY OF OIRB TERMS

Complaints Policy and Procedure

Conduct of IRB Meetings Policy and Procedure

Continuation Review Policy and Procedure

Exempt Research Policy and Procedure

HIPAA in Research Policy and Procedure

Initial Review of Research at a Convened Meeting Policy and Procedure

Initial Review of Research by Expedited Process Policy and Procedure

Privacy and Confidentiality in Identification and Recruitment of Participants Policy and Procedure

Receiving and Routing Research Submissions Policy and Procedure

Repository Policy and Procedure

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

Back to Table of Contents

Section 4

Special Requirements

--GLOSSARY OF OIRB TERMS

Emergency Use of an Unapproved Investigational Device Policy and Procedure

Emergency Use of an Unapproved Investigational Drug Policy and Procedure

Planned Emergency Research Policy and Procedure

Emergency Use of HUD

Informed Consent Policy and Procedure

Research Involving a Device Policy and Procedure

Research Involving a Drug Policy and Procedure

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

Back to Table of Contents

Section 5

Recordkeeping and External Reporting

--GLOSSARY OF OIRB TERMS

Inactivate Study Policy and Procedure

IRB Minutes Policy and Procedure

Recordkeeping Policy and Procedure

Reporting Policy and Procedure

Back to Table of Contents

Section 6

Quality Improvement & Assessment

--GLOSSARY OF OIRB TERMS

Evaluation of IRB Membership Policy and Procedure

PI Self Assessment Program Policy and Procedure

Back to Table of Contents

Section 7

Coordination

--GLOSSARY OF OIRB TERMS

Coordination with Other Committees or Offices Policy and Procedure

Cooperative Off-Site Research Policy and Procedure

Back to Table of Contents

If you have questions concerning submission of a research protocol for IRB review, please call the Office of the IRB at 210-567-2351.