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VA Human Research - South Texas Veterans Health Care System (STVHCS) 

VAIRRS is the VA's enterprise version of IRBNet, a web-based software used by administrators, committee members, and researchers for electronic protocol submission/management and review and oversight of research.

All submissions (e.g., new protocols, amendments, continuing reviews, closures) must be submitted electronically via VAIRRS. E-mail and hard copy submissions will not be accepted.  The only documents that should not be uploaded into VAIRRS are Financial Conflict of Interest (FCOI) forms (send by email according to the instructions on the applicable new study checklist below).  

New Study Submission  
-Full Board
-Expedited
-Exempt

  1.  Submit New Study Forms to “STVHCS R&D Administration” for pre-review in IRBNet prior to IRB submission.  See Training Energizer: Researcher 1
    • 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

New Study Submission
-Non-Human
-Non-Regulated Research

  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. 

Continuing Review for an Existing Project

If you need to submit a continuing review for an existing project, you need to create a new package within the existing project. See Training Energizer: Researcher 2. 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

Amendment/ Modification for an Existing Project

If you need to submit a modification for an existing project, you need to create a new package within the existing project. See Training Energizer: Researcher 2. 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.

Personnel Change for an Existing Project

If you need to submit a personnel change for an existing project, you need to create a new package within the existing project. See Training Energizer: Researcher 2. 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.

Inactivation for an Existing Project

If you need to submit an inactivation for an existing project, you need to create a new package within the existing project. See Training Energizer: Researcher 2. This will ensure that your submission is linked to the existing project.  DO NOT create a new project.

  • Request for Inactivation Form

 

 

IRBNet Registration and Training - gov.irbnet.org 

Investigators can self-register for a VAIRRS account from virtually any computer and submit protocols at gov.irbnet.org.  VAIRRS does not require a connection to the VA network.

New Registration & User Profile Instructions

  • Training Energizer: New User Registration  (create account, manage affiliations, maintain training records)

Help Documents For Researchers/Study Coordinators

  • Training Energizer: Researcher 1  (create, share and submit a project; access review decisions & board documents)
  • Training Energizer: Researcher 2  (post-submission topics; create a new package for modifications, renewals, etc.)
  • VA Central IRB Submission  (accepting all IRB submission in IRBNet)

STVHSC Standard Operating Procedures

23-42    Documentation of Research Study Procedures in the Patients’ Health Record
18-50    Handling of Research Suspensions and Terminations
19-13    Training and Research Clearance  
21-20    Handling of Research Non-Compliance and/or Reportable Incidents/Unexpected Events Involving Research Safety and Laboratory Security
22-21    Laboratory Security
22-26    Human Subject Concerns / Complaints / Allegations of Research
22-39    Human Subjects Research Recruitment and Advertising
22-48    Reporting of Unanticipated Problems Involving Risks to Subjects and Others (UPIRSO), Unanticipated Adverse Device Effects (UADE), and Adverse Events (AE)
22-49    Handling of Research Non-Compliance Involving Human Subjects
22-52    Protocol Management for VA Approved Human Subject Research Projects
23-22    Managing Financial Conflict of Interest in Research 
23-29    Training for Research involving Human Subjects
23-37   

Correspondence and Communication between the Research and Development (R&D) Office and Components of the Human Research Protection Program and Regulatory Agencies 

23-43    Procedures for Submission, Review and Approval of Research Projects

Contacts

  • Human Studies - VAHumanResearch@uthscsa.edu or Concierge Service Appointment 
  • Research Funding/Grants or New Research Investigator– Judith.Manning@va.gov to setup appointment with Associate Chief of Staff for Research
  • Research privileges (e.g. Training / WOC / IPAAs) -  Thomas.Sierra@va.gov and Elian.HolguinDiaz@va.gov 
  • Safety research subcommittee (SRS/IBC) and/or lab-only studies - VHASTXSafetyIACUC@va.gov

 

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UT Health San Antonio

8403 Floyd Curl Dr
San Antonio, TX 78229

210-567-8270
vpr@uthscsa.edu

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