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2006-2008 Archive -- IRB News and Updates

September 2008 - iMedRIS
The UTHSC IRB began using iMedRIS, a web-based system that allows investigators to submit research applications electronically. The UTHSC IRB is no longer accepting paper applications; therefore, all new studies must be sumitted electronically via iMedRIS. For studies that were initially approved on paper, these studies must be registered (converted from a paper study to an electronic study) in iMedRIS prior to the submission of any revisions, renewals, adverse events, etc. Step by step instructions for registering a study in iMedRIS are available on the UTHSC IRB website. For the next year, the UTHSC IRB office will continue to offer a few paper forms, such as a revision application (Form 2), adverse event form (Form 4), and a Report of Termination (Form 7). These forms may only be used by studies that were initially approved on paper and have not been registered within the electronic system, iMedRIS, on a limited basis.

August 2008 - New Consent Form Templates were developed
The UTHSC IRB updated the consent form templates to include standard formatting and wording. In addition, the templates now contain hidden texts that are instructions/reminders to the writers. Also, when submitting a non-English consent form for IRB review and approval, the non-English consent form must be accompanied by a Translator's Declaration. This form states that the non-English consent form is a true and exact copy of the English version of the consent form.

July 1, 2008 - Revised Fee Schedule
The UTHSC IRB updated the fee schedule. The updated fees apply only to trials supported by pharmaceutical firms and other for-profit entities that are submitted on or after July 1, 2008. All research projects that were submitted prior to July 1, 2008 will continue to follow the fee schedule of a one-time global IRB fee. There will continue to be no charge for federal, foundation, investigator-initiated, or university supported research. See the UTHSC IRB website under IRB Fee for more information.

November 15, 2006 - New Requirements for Human Subjects Protection Certification
The UTHSC IRB transitioned from the online course "Protecting Human Research Subjects" available via Blackboard to the CITI training modules at www.citiprogram.org. Note: The CITI training modules must be renewed every 3 years. You will receive an email notification from CITI notifying you that your Human Subjects' Protection training needs to be updated. For more information regarding the CITI program, contact Patricia S. Kerby, MPA, Compliance Officer with the Office of Human Subjects Protection at 448-1869 or a kperby@uthsc.edu.

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