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Institutional Review Board (IRB)

What's New?

2012 IRB Annual Report PDF icon

The UTHSC IRB has revamped the application form for all three types of review (exempt, expedited, and full Board) and has reworked the consent form templates. In an effort to simplify the application process, we have taken feedback from investigators and coordinators and made the applications shorter and easier to navigate by deleting subforms. Additionally, the consent forms no longer contain hidden text; rather, they now include highlighted instructions that you can delete as you go along. Call the IRB if you have any questions about the new application, and click on the “Consent Forms” tab on the left to download the new templates so that you can begin using them today!

Educational/Training Opportunities

The UTHSC IRB is now offering quarterly training sessions called IRB Insights. These sessions will be opportunities for researchers to learn more about human research protections and how to use the IRB electronic system, iMedRIS.

Mark your calendars for future IRB Insights opportunities:

  • Wednesday, 29 May: 10 Steps to Obtain UTHSC IRB Approval (Beginner Session); 12 p.m. in GEB Rm. A203
  • Wednesday, 31 July: I just submitted to the IRB. What now? (Beginner Session)
  • Wednesday, 30 October: Halloween Jeopardy

For information on other iMedRIS training opportunities and the CITI program, please visit the Training tab on the left.

IRB Tip

Continuing Review and Total number of subjects enrolled/accrued

Federal regulations set the criteria for IRB approval of research undergoing continuing review. Under these regulations, the investigators and the IRB are responsible for fulfilling specific requirements associated with the continuing review. In particular, investigators are responsible for submitting sufficient materials and information regarding their project so that the IRB is able to meet its regulatory obligations prior to the expiration date of the current IRB approval. The investigator meets these obligations through the submission of a Form 3 (Continuing Review Submission Form) via iMedRIS, the IRB electronic system.

As part of the continuing review of a research project, the IRB evaluates the number of subjects who have been enrolled or accrued to the study. Therefore, investigators must supply to the IRB the total number of subjects who have been enrolled or accrued to the study. Enrollment in a research study occurs when the consent form is signed, not when the subject is randomized. The total number of subjects enrolled in a research study also includes the number of subjects who failed screening procedures, subjects who were lost to follow-up, or subjects whose participation was terminated by the investigator.

Consider the following when calculating the total number of subjects who were enrolled or accrued to a study:

Formula thumbnail image

(click equation to enlarge)

IRB Tip Archive