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2010 Archive -- IRB News and Updates

November 2010 - IRB Policies Updated
In August and November of 2010, the IRB reviewed and revised many policies. Please visit the “Policies” link on the left to view all of the recently revised policies.

November 8, 2010 - UT Le Bonheur Pediatric Specialists, Inc.
If you are a researcher who will be part of the new physician group, UT Le Bonheur Pediatric Specialists, Inc. (ULPS), effective January 1, 2011, please note that there are some changes that will be required of your research project. These changes may be taken care of in one of two ways - you may submit a Form 2 – Change Request & Amendments for expedited review, or alternatively, you may wait and receive the appropriate recommendations from the IRB office at the time of your study’s renewal.

Revisions to your currently approved study may include updating the study site location in the electronic application (Section 1200) and changing the consent form(s) to include (a) updating the location of your research; (b) updating the Compensation and Treatment for Injury section to replace UTMG with ULPS; and (c) updating the Confidentiality section to replace UTMG with ULPS. If you have a research study that was initially approved under the paper system, you may need to update your project descriptors as well to include (a) changing the address on page 1; (b) updating the location of the research under Study Site; and (c) replacing UTMG with ULPS in the Confidentiality section.

Should you have any questions regarding these upcoming changes do not hesitate to contact the IRB office at 901.448.4824.

September 9, 2010 - Study Assistant relabeled Project Assistant
In an effort to more accurately identify all electronic submissions to the Institutional Review Board (IRB) within the iMedRIS system, the “Study Assistant” module will be relabeled “Project Assistant.” This change will update all labels for “Study/Studies” to “Project/Projects.”

Note: To locate any of your studies/projects you should click the “Project Assistant” button and then click, “My Projects.”

September 9, 2010 - Study/Project (Form 1) Application
The “study” text variations have been changed to “study/project,” and “studies/projects” throughout the application.

September 8, 2010 - Routing Form for Attachments and Signatures
In an attempt to differentiate between the “(Form 1) Application” and “Routing Form” (the routing form comes after the Form 1 application and includes a place for you to attach documents and include signature assignments), the text has been changed to a blue color throughout the Routing Form.

September 8, 2010 - PI Response to Review
The PI Response to Review form has been simplified by merging the multiple sections into one. The first green bar containing the initial routing form and attachments has been removed.  An updated “Guide to using the New Application (Form 1) PI Response Form” has been posted to the IRB’s iMedRIS “Guides & Tips” webpage (http://www.uthsc.edu/research/research_compliance/IRB/guides.php). If you have printed a copy of these instructions please remember to update your copy with the new instructions.

September 8, 2010 - Sign and Submit
Submission Forms ending with a “Form Completed --- Close Form” have been updated to only include a “Sign and Submit” button. Many of the investigators/coordinators completing the submissions listed below believed that they had submitted the forms to the IRB when in fact they had only completed the form and closed it. The change will eliminate the confusion by continuing with the submit procedures instead of simply closing the form. The change appears on the following forms:

  • Form 2: Change Request & Amendments
  • Form 3: Continuing Review Submission Form
  • Form 4a: Report Local Adverse Events
  • Form 4b: Reportable External AE (IND - Medwatch)
  • Form 4c: Reportable Problem or Protocol Deviation-Violation
  • Form 4d: Non-Reportable Local or External Adverse Events or Problems
  • Form 4e: Methodist Hospital and Lebonheur Children's Hospital Adverse Event
  • Form 6: Advertising Recruitment Materials
  • Form 7: Study Closure
  • Form 8 – HIPAA (PI Sign Off)
  • PI Response to Review
  • Submit Data Safety Monitoring Reports
  • Submit Miscellaneous Documents
  • Documents from Primary IRB

June 29, 2010 – Research Participant Information Added to Website
The section of our website entitled “For Research Participants” was created for our current and potential research participants. It includes a concern/complaint form, which can be submitted anonymously. In addition, many resources have been listed that subjects or potential subjects may find helpful.

June 1, 2010 – Routing and Signoff Guide Created
A routing, signoff, and workflow tracking guide has been created and can be found at http://www.uthsc.edu/research/research_compliance
/IRB/docs/RoutingSignoffandTrack.pdf. This guide includes instructions on how to route your submission to the IRB, send your submission to others for their signatures, and track the submission once you have sent it for signatures.

May 15, 2010 – New Board Member Guide Created
A step-by-step review guide for Board Members has been created and can be found at http://www.uthsc.edu/research/research_compliance
/IRB/docs/BoardMemberGuide.pdf. This guide explains how to set your meeting availability, navigate the system, complete a reviewer form, access the PI’s response to review, find the meeting agenda, etc.

May 4, 2010 - IRB Website Revamped
Our website has been redesigned. It has been broken down into sections (General Information, For Researchers, & For Board Members) so that, depending on your role, you can find information more readily. We’ve also included steps on our home page (at http://www.uthsc.edu/research/
research_compliance/IRB/index.php) that one may need to take prior to submitting an application to the IRB, such as securing a UT Net ID and password, getting access to our electronic system (iMedRIS), understanding training (CITI) requirements, and becoming informed of our affiliate institutions’ requirements. Please browse through our site, as many other changes have been made as well.

May 1, 2010 – Tracked Changes Guide Created
A tracked changes guide has been created and can be found at http://www.uthsc.edu/research/research_compliance/IRB/docs/
MicrosoftWordTrackChanges.pdf. This guide includes instructions on how to track changes in Microsoft Word (2007 & 2008), how to accept all changes in order to create a “clean” document, etc.

April 27, 2010 – SOP Change
The UTHSC IRB has revised Standard Operating Policy (SOP) #6, “INFORMED CONSENT OF NON-ENGLISH SPEAKING SUBJECTS” (found at http://www.uthsc.edu/research/research_compliance/IRB/docs
/sops/SOP06.pdf). Please review the revised policy, as new information has been added, such as “the interpreter… must be physically present during the informed consent interview.”

April 2010 – Le Bonheur Name Change
Le Bonheur has changed its name from “Le Bonheur Children’s Medical Center” to “Le Bonheur Children’s Hospital.” Remember to use “Le Bonheur Children’s Hospital” throughout your consent forms, if applicable.

April 7, 2010 - IRB Meeting Time Change
Committee 1 of the Board will now meet at 8:00 a.m. on the first Wednesday of each month instead of at 7:00 a.m. (Please check the Meeting Schedules page for holiday exceptions.)

February 15, 2010 - Ethics and Regulation library
The CTSI's RCARE (Regulatory Compliance and Research Ethics) unit has posted a brand new, valuable resource for those involved in research. Go to https://ctsi.uthsc.edu/rcare_links.php to access their Ethics and Regulation Library. You can click on the letters of the alphabet at the top of the page in order to directly reach a topic, or you can scroll down the page through the topics, listed from A to Z. Under each topic you may find UT system policy; UTHSC policy; UTHSC IRB policy and guidance; Federal regulations and guidance; and professional policy and guidance. If you have trouble finding a topic or know of a resource that is not listed, please contact Kimberly Prachniak at 448-5060.


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