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2009 Archive -- IRB News and Updates

December 1, 2009 - Updated initial and revision applications
The initial study application (Form 1) has been revised to include: Emergency Use of Drug, Biologic or Device; Compassionate Use of an Unapproved Medical Device; Treatment Use of an Unapproved Medical Device; and Treatment Use of an Unapproved Drug. Should you have any questions about when to complete these sections of the application, do not hesitate to contact the IRB office. In addition, the Revision Application (Form 2a) was updated to clarify the instructions included in the form.

September 17, 2009 - Updated Glossary of Lay Terms
The UTHSC IRB has updated the Glossary of Lay Terms. While this is certainly not an exhaustive list of medical terminology, the purpose of this glossary is to help the writers of consent forms with common terms or explaining medical terminology to the lay person in research studies. To access the updated Glossary of Lay Terms, click on Consent Forms on the left side of your screen.

September 2, 2009 - Signature Routing
The IRB has had a change in policy regarding the signature requirements on submissions. The signature requirement for initial submissions will remain the same: Principal Investigator (PI), all Co/Sub-Investigators, and the Department Chair if the PI is a UT employee/faculty member. For all other submissions related to your study, however, only the signature of the PI or a Co/Sub-Investigator is required.

September 1, 2009 - Revised consent form templates
All three of the consent form templates have been revised in Compensation and Treatment for Injury section. In addition, we have included an additional Conflict of Interest section. Please note that the new Conflict of Interest section should only be included in the consent form when a conflict of interest exists (blue text instructions have been included in the consent form templates). Click on the Consent Forms link on the left side of your screen to view the updated consent form templates.

July 1, 2009 - Updated IRB fee schedule
The IRB fee schedule has been revised. The updated fee schedule only applies to trials supported by pharmaceutical firms and other for-profit entities. Click on the IRB Fee link to the left side of your screen to view the updated information regarding IRB fees.

May 27, 2009 IRB Meeting
 The IRB meeting scheduled for May 27, 2009 has been cancelled. The IRB will meet in June as scheduled.

May 20, 2009 IRB Meeting
 The IRB meeting scheduled for May 20, 2009 has been cancelled.

May 19, 2009 Updating IRB Fee Schedule
 The IRB will be revising the fee schedule this summer. The updated fees will only apply to trials supported by pharmaceutical firms and other for-profit entities that are submitted on or after July 1, 2009. Be sure to check back here for more information regarding the changes in the IRB fee schedule.

May 18, 2009 - Revised policy regarding payment of IRB fees
 Effective May 18, 2009, the IRB will immediately release all approval letters. The IRB will no longer hold approval letters pending payment of the IRB review fee. However, you will note in the electronic system, that the status of the study will be listed as "Approved Awaiting Payment" until the IRB receives payment.

May 7, 2009 - Study Application Updated
The initial study application has been revised in iMedRIS. A few of the additions to the application include contact information for key research personnel, HUD questions, and a number of revisions to questions and answers. If your study application is currently in "Draft" format or if your study application has been approved, the next time you click to open the application you will be prompted to update your application to the new version. For information about updating your study application, follow the instructions outlined in the guide "iMedRIS Application Updated" listed under iMedRIS Guides & Tips.

May 6, 2009 - Reviewer form samples posted
Reviewer form samples for new applications, continuations, and revisions have been posted in iMedRIS. Printing these out and consulting them while reviewing all study documents may assist Board members in their electronic review, so that they know what questions will be asked without having to refer back and forth between the documents and the reviewer form on the computer. Board members must still complete the electronic reviewer form in its entirety. The samples are for referencing purposes only. To locate these samples, click on the "Help" button on the upper right-hand corner of the iMedRIS screen. They are located under "IRB Board" and are entitled, "Full Board New Application Reviewer Form," "Full Board Revision Reviewer Form," and "Full Board Continuation Reviewer Form."

April 6, 2009 - Initial study application was revised
The initial study application in iMedRIS was revised. The updated version of the initial study application now includes a section for waiver of informed consent involving emergency conditions. The local policy, which is consistent with Federal guidelines, regarding waiver of informed consent in emergency situations may be viewed on the UTHSC IRB website under Policies.

April 3, 2009 - Updated Investigator Handout
The handout that was provided to investigators and coordinators at iMedRIS training has been revised to reflect the current IRB submission schedule. The revised handout includes an example calendar for the timely submission and review of applications.

March 31, 2009 - Updated Repository Consent Form Template
The repository consent form template was revised in the Voluntary Participation section to include some minor administrative/editorial changes.

March 3, 2009 - iMedRIS update
iMedRIS was updated to Version 8.01 to include formatting changes in the applications, background changes and changes in the IRB Assistant tab.

February 27, 2009 - Updated policies regarding assent and the requirement of a witness signature on consent forms
The local assent policy was revised. There is a new IRB form that outlines the assent discussion that was completed by the person-obtaining assent. This new form should be added as the last page of the consent form.

The UTHSC IRB no longer requires the signature of a witness on consent form(s). In addition, several other changes were made to the signature page of the consent form templates, i.e., the inclusion of lines to print the names of the investigator, the subject, and the person obtaining consent, and lines to indicate the time each of the required signatures were completed.

February 21, 2009 - IRB Staff News
IRB Analyst Bonnie Binkley is engaged!!

February 11, 2009 - UTHSC IRB consolidates with Methodist Healthcare-Memphis Hospitals (MHMH) IRB
February 11, 2009 marked the first meeting of the consolidated UTHSC and MHMH IRB. Such an agreement supports the continuous development and improvement of medical education, research and public/community service programs of UTHSC and MHMH. As of this date, the UTHSC IRB will be the designated IRB for all protocols conducted at Methodist Healthcare-Memphis Hospitals and its affiliated entities. In addition, the UTHSC IRB is a designated IRB for research that is conducted at UTHSC, the Regional Medical Center at Memphis (the Med), and UT Medical Group, Inc.

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