IRB Submission Guide

Getting Started with the IRB

If you’re new to or unfamiliar with the IRB submission process, this page will provide information on how to complete the electronic applications for new studies, continuing reviews, and amendments. Here you’ll find detailed instructions for using IRBaccess to submit the electronic applications as well as guidelines to ensure that you’ve provided a complete submission to the IRB.

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What to Submit for IRB Approval

Forms, templates, and guidance documents are available at the IRB Forms page. Study-specific materials will need to be provided by the researcher.

New Study

New Study submissions must include:

  • IRB electronic application
  • Study proposal document
  • Consent forms
  • Recruitment materials
  • Data collection instruments (surveys, interview questions, stimuli, etc.)
  • Other forms or documents utilized with human subjects
  • Research personnel list for New Study

Tutorial video: How to submit a new study in IRBaccess 

Continuing Review

Continuing Review submissions must include all current IRB approved study documents, even if they have not changed since the last review:

  • Electronic continuing review application
  • Study proposal document
  • Consent forms
  • Recruitment materials
  • Data collection instruments (surveys, interview questions, stimuli, etc.)
  • Other forms or documents utilized with human subjects
  • DSMB/DSMP Report (if applicable)
  • Research personnel list for Continuing Review

Amendment

Amendment submissions must include:

  • Electronic amendment application
  • Amendment summary form
  • Research personnel list (if applicable)
  • Revised IRB proposal or other documents impacted by the proposed research modification
  • Newly developed documents that support the proposed research modification

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Departmental Review Committee or Chair (DRC) Approval

Many academic areas have Departmental Review Committees (DRC). The DRC is responsible for reviewing studies within their respective departments. The principal investigator must obtain DRC approval before submitting an application to the IRB. DRCs should review the study summary or application page for scholarly merit and completeness, including ensuring all documents have been provided. In regard to scholarly merit, DRCs should consider the following:

  • Is the rationale for the study clearly stated and is the rationale scientifically sound?
  • Are the aims and corresponding hypothesis clearly stated and is the primary outcome (and secondary outcomes, as appropriate) clearly defined?
  • Is the question or hypothesis being tested providing important knowledge to the field and is the design of the study appropriate for the questions that are posed?
  • Are statistical considerations, including sample size and justification, estimated accrual and duration, and statistical analysis clearly described and adequate to meet the study objectives?

To see if there are any actions waiting for your response, first log in to your IRBaccess inbox: https://research.utexas.edu/irbaccess/action/signoff

Your inbox may contain new study, continuing review, and/or amendment applications. After reviewing the submission, click on either “approve” or “do not approve.” Applications cannot be submitted without DRC approval. Unapproved submissions will return to the principal investigator.

Check your inbox frequently.

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Faculty Sponsor Approval

Faculty Sponsors hold an important role in assisting students who are planning or are in the process of submitting IRB applications. They must be actively involved in the student’s research, from protocol design to data analysis and report preparation. Faculty sponsors should provide recommendations about research design aimed at reducing the risk to human subjects while also serving as a point of contact for human subject concerns and questions. A faculty sponsor is required for all students conducting human subjects research, and are also required for some faculty and staff. The faculty sponsor must approve the application prior to IRB submission.

To see if there are any actions waiting for your response, first log in to your IRBaccess inbox: https://research.utexas.edu/irbaccess/action/signoff

Your inbox may contain new study, continuing review, and/or amendment applications. After reviewing the submission, click on either “approve” or “do not approve.” Once you’ve approved the submission, the application will be electronically routed to your DRC for review and approval. Unapproved submissions will return to the principal investigator.

Check your inbox frequently.

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