Important instructions for completing and submitting paperwork to the Office of Research Administration (ORA).
- Original documents should be submitted single-sided, no staples. All other copies can be doubled sided using staples.
- The principal investigator must sign all submissions.
- Complete the IRB checklist prior to submission.
- All paperwork should be complete and correct at time of submission.
- A copy of all supporting documents (i.e., protocol, grant, consent/assent forms, recruitment materials, etc.) must be attached.
- Submit your initial protocol by the 3rd Friday of the month in order to have it on the agenda for the following month.
- Submit continuing review report two months prior of the expiration day to avoid study termination.
- Keep good records! You should have a study file that contains all study-related information.
- All members of the research team involved with the clinical research project must complete the CITI training. The IRB will not grant final approval of a new protocol unless required training has been completed.
- If you have any questions regarding these forms please contact the Office of Research Administration at 512-324-7991.
NOTE: These forms may be used for both UTMB and Seton IRB submissions.
IRB SubmissionAll Submissions |
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IRB Submission Checklist NEW! |
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IRB Action Request Form (last update 09/26/07) |
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| Initial Submission Forms | ||
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Protocol Table Of Contents (last update 09/28/07) |
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Research Proposal Template (last update 10/12/07) |
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Documentation of Compliance with Educational Mandate for Conducting Research with Human Subjects |
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Initial Submission for Exempt Review NEW! |
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Initial Submission For Full Board or Expedited Review NEW! |
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| Annual IRB Renewal or Study Closure | ||
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Study Status Report (last update 10/04/07) |
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Study Closure Form (last update 08/30/07) |
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| Sample Consent/Permission/Assent Form | ||
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Adult Informed Consent Template (last updated 06/14/07) |
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Pediatric Informed Consent Template (last updated 06/14/07) |
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Child Assent Form Template (last updated 07/20/08) |
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| Model language for IRB Consent Clauses Regarding the use of Contraception |  Download PDF |
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Request for Tissue/Data Repository NEW! |
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| Modification Forms/Adverse Events/Unanticipated Problem/Protocol Deviations | ||
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Adverse Event Reporting Form (last updated 04/21/08) |
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| Protocol Deviation Form (last updated 06/30/08) | ||
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Request for Protocol or Consent Modifications NEW! |
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| Request for Change of Principal Investigator NEW! | ||
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Request for Change Study Personnel NEW! |
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| Additional Study Team Personnel Sheet (last updated 04/11/08) | ||
| Vulnerable Population Forms | ||
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Application for Inclusion of Pregnant Women as Research Subjects NEW! |
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| Application for Inclusion of Prisoners as Research Subjects NEW! | ||
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Application for Inclusion of Children as Research Subjects NEW! |
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| Application for Inclusion of Mentally Impaired Subjects NEW! | ||
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Application for Inclusion of Fetuses or Neonates as Research Subjects NEW! |
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| Additional Forms | ||
| Translator Declaration NEW! | Download PDF |
 Download Word doc |
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Miscellaneous Requests NEW! |
Download Word doc |
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| Additional Collaborator Page NEW! | Download PDF |
Download Word doc |
| UTMB FORMS | ||
| Austin Multi-Institutional Review Board (AMIRB) Submission | ||
| Contact: Sue Peixotto P.O.Box 27782 Austin, Texas 78755-7782 512-342-0310 phone/Fax speixotto@austin.rr.com |
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CRSC SubmissionAll Submissions |
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Clinical Research Steering Committee Initial Submission Form (last update 06/26/07) |
Download Word doc |
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| Anticipated Study Budget Template | Download PDF |
Download Word doc |
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Patient Load Form (last update 08/17/07) |
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Instructions for Patient Load Form |
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Services and Procedures Request Form (last update 09/03/08) |
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Drug/Device Checklist NEW! |
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Seton is proud to have four hospitals – the only hospitals in Central Texas - that have earned the