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. 

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:

  • Thursday, (to be rescheduled) – Information Security will discuss the acceptable, secure ways to store and transfer confidential subject data and subject PHI with identifiers. (GEB A204)
  • Wednesday, April 29, 2015, 12:00 noon - Consent Process: What do I need to know? (GEB A204)
  • Thursday, June 4, 2015, 12:00 noon - iMedRIS
  • Wednesday, July 29, 2015, 12:00 noon - Common Audit Findings
  • Wednesday, September 30, 2015, 12:00 noon - Creating & Maintaining Research Records
  • Thursday, November 12, 2015, 12:00 noon - Selected Hot Topic

Registration for IRB Insights

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)