Office of Research Administration Seton Institutional Review Board (SIRB) Forms

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Important instructions for completing and submitting paperwork to the Office of Research Administration (ORA).

  1. ALL submissions should contain one packet with only original documents and should be single-sided, with no staples. The extra copies of the packet can be double sided using staples.
  2. Each action item (initial, amendment, continuing review, etc.) must be its own submission and have its own Seton IRB Action Request Form.
  3. The principal investigator must sign all submissions.
  4. A copy of all supporting documents (i.e., protocol, consent/assent forms, recruitment materials, etc.) must be attached to the submission. Please see Seton IRB Submission Checklist for more details.
  5. ALL Full Board submissions - including initial protocols - should be submitted by the 3rd Friday of the month in order to have it on the FB agenda for the following month. Those submission deadlines can also be found here.
  6. Please be aware of those submission deadlines when submitting your study's continuing review in order to avoid study lapse.
  7. All members of the research team involved with any part of the clinical research project must complete the CITI training. The SIRB will not grant final approval of a new protocol unless required training has been completed all study personnel. Further details of the CITI training requirement can be found here.
  8. Keep good records! You should have a regulatory study file that contains all study-related information.
  9. All paperwork should be complete and correct at the time of submission. If it is not, your submission will not be considered viable until all required documents are submitted. For any questions regarding these forms or your submission, please contact the Office of Research Administration at 512-324-7991.

IRB Submission

All Submissions
SIRB Submission Checklist

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SIRB Action Request Form

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Initial Submission Forms

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

Study Status Report

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Sample Consent/Permission/Assent Form

Adult Informed Consent Template

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Pediatric Informed Consent Template

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Brief Informed Consent Form Template Download doc
Subject Informed Consent Checklist Template Download doc

Waiver or Alteration of Informed Consent

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Request for Waiver of HIPAA Authorization

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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

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 of Study Personnel

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Translator Declaration Download pdf
Vulnerable Population Forms

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

Miscellaneous Requests

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Additional Collaborator Page

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