91PORN

1.  Submit New Study Forms to “STVHCS R&D Administration” for pre-review in prior to IRB submission.  See
    
   • IRB submission / review is not allowed until VA Preliminary Review is complete.
   • Do not submit directly to “STVHCS R&D Committee” or “STVHCS R&D SRS/IBC Committee”.  
2. Study team will be notified through IRBNet when submission to the IRB is allowed.
3. After IRB approval, package will be unlocked to add/replace IRB approval letter and IRB approved documents.
4. Final privacy review will be conducted so study can be forwarded for Research & Development Committee (R&DC) review/approval.
5. Approval letter from ACOS for Research will be uploaded as a board document in IRBNet.
6. New Studies Checklist - Additional forms located under “Forms and Templates” in IRBNet
   • New Human Studies Checklist - Full Board, Expedited, and Exempt Studies

1. Submit New Study Forms to “STVHCS R&D Administration” and include IRB determination letter.  Do not submit directly to “STVHCS R&D Committee” or “STVHCS R&D SRS/IBC Committee”.  
2. Final privacy review (if required) will be conducted so study can be forwarded for Research & Development Committee (R&DC) review/approval.
3. Approval letter from ACOS for Research will be uploaded as a board document in IRBNet.
4. New Studies Checklists - Additional forms located under “Forms and Templates” in IRBNet
   • New Human Studies Checklist - Non-human and funded non-regulated research
   • New Human Studies Checklist - Unfunded non-regulated research

Please note that projects that receive a non-regulated research determination from the IRB (e.g., quality improvement, program evaluations, implementation research) do not need to be submitted to the R&D Service through IRBNet if they are unfunded.  If funded by a national VA Research Service (e.g., VA HSR&D) or non-VA entity (e.g., PCORI), the project should be submitted to the R&D Service via IRBNet.  IRB non-regulated research determinations for a funded project can be submitted to IRBNet after IRB determination.  If you think your project might be eligible for a non-regulated research determination (or are not sure), please contact the IRB. 

If you need to submit a continuing review for an existing project, you need to create a new package within the existing project. See . This will ensure that your submission is linked to the existing project.  DO NOT create a new project.

IRBNet reminder notifications indicate which form is required.  If unsure, review the instructions at the top of each form or contact VAHumanResearch@uthscsa.edu

• R&D Institutional Update Form
• R&D Continuing Review Application

If you need to submit a modification for an existing project, you need to create a new package within the existing project. See . This will ensure that your submission is linked to the existing project.  DO NOT create a new project.

The R&D Committee must approve all modifications/amendments of studies not followed by an IRB.  (e.g. research that is exempt from the common rule determined by a non-UTHSA IRB and/or research involving only non-human subjects data* or only animal data). 

For studies followed by an IRB, R&D Committee must approve 1) enrollment of non-Veterans at STVHCS (not previously approved), 2) changes in data access, use, disclosure, or storage; 3) addition or expanded use of institutional resources; 4) changes in PI or addition of Co-PI. 

• R&D Committee (R&DC) Amendment Application

If your amendment does not meet criteria indicated above, submit a summary of the changes (in the submission e-mail) and modified documents in IRBNet.  An acknowledgement will be received through IRBNet after administrative review.

If you need to submit a personnel change for an existing project, you need to create a new package within the existing project. See . This will ensure that your submission is linked to the existing project.  DO NOT create a new project.

Personnel are no longer listed on UTHSA IRB forms

All personnel changes should be submitted on the VA-Project Cover Sheet in IRBNet.

If you need to submit an inactivation for an existing project, you need to create a new package within the existing project. See . This will ensure that your submission is linked to the existing project.  DO NOT create a new project.

• Request for Inactivation Form