Institutional Review Board (IRB)

UTHSC

What's New?

Check out our new Researcher Tools (checklists and editable forms to facilitate compliance) on our Tools and Guides page and our latest policy revisions on our Standard Operating Procedures page. 

We Want Your Feedback! 

Take a brief non-research survey on your interaction with the IRB staff and with iMedRIS during your last electronic IRB submission.

Educational/Training Opportunities

The UTHSC IRB offers 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:

  • Cooperative Agreements & Collaborations [Wednesday, June 29, 2016 at 12 noon in Hamilton Eye Institute’s Freeman Auditorium, 930 Madison Ave., 3rd floor]
  • When are you engaged in research? [Wednesday, August 31, 2016 at 12 noon in Hamilton Eye Institute’s Freeman Auditorium, 930 Madison Ave., 3rd floor]
  • How to submit Continuation & Revision Applications [Wednesday, November 30, 2016 at 12 noon in Hamilton Eye Institute’s Freeman Auditorium, 930 Madison Ave., 3rd floor]

For information on other iMedRIS training opportunities, please visit the Training page.

IRB Tip

Do I have to file anything else along with the original signed consent form document in my research file?

YES, Federal regulations require the investigator to maintain “case histories,” including the case report forms and supporting documentation (sources of documents).  Source documentation is the medical/dental record of the subject before, during, and after the trial. It confirms the eligibility criteria of the subject in the given trial and documents the progress of the subject from consenting until the subject completes the study.  The FDA states that the overall purpose of the source document is “to document the existence of the subjects and to substantiate the integrity of the trial data collected.” You may consult the Researcher Tools to create your research records on our Tools & Guides page.

IRB Tip Archive (common questions and problem areas)