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HRPP Step 4

What happens to my application once submitted?

Once your application is submitted and it has received its unique IRB number, the IRB Review Process begins.

1. Pre-Review

Once submitted, the Research Compliance Administrator will ensure that the application is complete and in keeping with the IRB’s requirements. You may be asked to make changes to the application and study documents during this time. This phase may take several rounds.

Once the Administrator has determined that the submission is complete, it will be sent to the IRB Chair for determination or review pathway; Exempt, Expedited or Full Board Review.

2. Review Type(s)

Studies Not Requiring Full Board Review (Exempt or Expedited)

Exempt Determination:

  • If the study poses little to no risks and fits in one of theexempt categories the submission is reviewed by the Chair for an Exempt Determination.
  • The study investigator may be asked by the Chair to make  additional changes to secure final determination.
  • This process may require several rounds of revisions and reviews. Plan accordingly.
  • Once the Chair is satisfied with the submission, the final determination letter will be sent to the Primary Investigator via email.
  • Very IMPORTANT: although Exempt Studies are determined not to fall under the purview of the IRB, thus do not expire or require filing a Continuing Review Form, investigators are still REQUIRED TO SUBMIT AN ANNUAL UPDATE FORM so the IRB can ensure no changes had been made that could affect the determinations category and/or studies are closed out in an appropriate manner.
  • It is the responsibility of the Investigator to SUBMIT the ANNUAL UPDATE FORM at least 30 DAYS PRIOR TO THEYEARLY ANNIVERSARY of determination to irb@tamusa.edu. .

Exempt Review:

  • If the study does not meet the criteria for an exempt determination, poses minimal risks, and fits in one of the expedited categories the Chair may request submission be sent to appropriate IRB members for review.
  • The IRB reviewers will ensure that the criteria for approval are met.
  • The study investigator may be asked by the reviewers to make  additional changes to secure approval.
  • This process may require several rounds of revisions and reviews. Plan accordingly.
  • Once reviewers are satisfied, submission is forwarded to Chair for final determination/approval.
  • The final approved protocol, approval memo and any stamped materials will be sent to the Primary Investigator via email.
  • Protocols approved under the expedited Review pathway, shall expire one year from approval (unless PI request shorter time period) and REQUIRE FILING EITHER a Continuing Review Form if the PI wishes to continue the study or a Closure Form submitted to officially close-out the study.

It is the responsibility of the Investigator to SUBMIT the appropriate FORM at least 30 DAYS PRIOR TO THEEXPIRATION DATE to irb@tamusa.edu.

Full Board Review:

  • If the study presents more than minimal risks to participants, or if the Chair determines that the study does not qualify for Exempt or Expedited Review, the study will be referred to the convened board for Full Board Review.
  • The submission will be assigned By the IRB Chair to two IRB members for review.
  • If the reviewers have questions, concerns or request edits, they will be relayed to the Investigator to be addressed, to the reviewers’ satisfaction, before the reviewers request the protocol be placed on the agenda for the next full board meeting.
  • The project will be presented at a convened IRB meeting for discussion/determination.
  • The review board convenes once a month, typically on the third Friday of each month. See schedule.
  • The study will receive one of the following outcomes by the IRB:
    • Approval
    • Modifications required to Secure Approval,
    • Deferred (the application lacks information or significant details but may be resubmitted after modifications), or
    • Disapproved

 
3. Post Review

  • For all review pathways, the review outcome will be communicated to the investigator via the administrator.
  • If modifications or clarifications are requested, the application will be sent back to the investigators to revise and the process will start over. The revised application will be reassessed but the research compliance administrator and then routed back to the person requesting modifications (Chair or original reviewer). 
  • When the study is approved, an approval letter, approved protocol, (stamped-when applicable) study materials and stamped consent forms will be sent to the investigator.