Institutional Review Board (IRB)
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!
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.
When should we re-consent subjects?
The basic criterion is this: Does the new material represent information that might affect the decision of a reasonable person about whether to continue participation in the study? The decision of a reasonable person might be affected by considerations that impact his or her values, goals, or interests. For example, changes in sub-investigators or the addresses of investigators would be unlikely to impact on the values, goals, or interests of study participants. Similarly, a protocol revision to utilize part of blood already being drawn to investigate the value of a new, prognostic biomarker is also unlikely to bear on the values, goals, or interests of subjects. On the other hand, the addition of an important new risk of the study drug or the inclusion of new invasive procedures in the study are examples of changes that may affect a reasonable person's determination of whether continued participation accords with his or her values, goals, and interests. When in doubt, just call the IRB office!
UTHSC IRB office
Memphis, TN 38163
Phone: (901) 448-4824
Fax: (901) 448-5103