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 double 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.
IRB SubmissionAll Submissions |
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SIRB Action Request Form |
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| Initial Submission Forms | ||
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Protocol Table Of Contents |
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Research Proposal Template |
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Initial Submission for Exempt Review |
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Initial Submission For Full Board or Expedited Review |
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| Annual IRB Renewal or Study Closure | ||
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Study Status Report |
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| Sample Consent/Permission/Assent Form | ||
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Adult Informed Consent Template |
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Pediatric Informed Consent Template |
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Waiver or Alteration of Informed Consent |
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Pediatric Assent Form |
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| Model language for IRB Consent Clauses Regarding the use of Contraception | ||
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Request for Tissue/Data Repository |
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| Modification Forms/Adverse Events/Unanticipated Problem/Protocol Deviations | ||
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Adverse Event Reporting Form |
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| Protocol Deviation Form | ||
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Request for Protocol or Consent Modifications |
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| Request for Change of Principal Investigator | ||
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Request for Change Study Personnel |
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| Additional Study Team Personnel Sheet | ||
| Vulnerable Population Forms | ||
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Application for Inclusion of Pregnant Women as Research Subjects |
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| Application for Inclusion of Prisoners as Research Subjects | ||
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Application for Inclusion of Children as Research Subjects |
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| Application for Inclusion of Mentally Impaired Subjects | ||
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Application for Inclusion of Fetuses or Neonates as Research Subjects |
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| Additional Forms | ||
| Translator Declaration |  Download Word doc |
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Miscellaneous Requests |
Download Word doc |
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| Additional Collaborator Page | Download Word doc |
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CRSC SubmissionAll Submissions |
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Seton CRSC Submission Form |
Download Word doc |
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Patient Load Form |
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Instructions for Patient Load Form |
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