IRB News Archive, 2012


Wed Aug 29 17:20:54 CDT 2012

Dear Investigators and Research Personnel:

Pursuant to a recent survey conducted by The Joint Commission (TJC) at University Hospital-St. Paul it was noted that all research consent forms must now include the time the consent was signed by all parties.

In order to assist in implementing this new requirement we have developed the following plan which will go into effect immediately:

1. The consent form templates have been revised and uploaded to the IRB Forms page on the IRB website. Please remember it is best to always download the consent form template from the IRB website in order to have the most current document when drafting new consents.

2. For studies that are already approved and do not currently include the time field, please handwrite the time next to the date when obtaining consent until the consent form can be revised to include the new field.

3. For studies that are already approved, please begin to update the consent forms to include this new field at either the next modification or continuing review, whichever comes first. The IRB staff will monitor this when modifications or continuing reviews are submitted and will require the time field be added prior to approval.

Please note that this requirement will apply to all research consents regardless of the performance site.

Please forward this message to your colleagues who may not be subscribed to the IRB Listserv.

Thank you for your attention to this matter. If you have any questions, please do not hesitate to contact the IRB Office at 214-648-3060.

Diane Sheppard, R.N.

Director, Research Protections

U.T. Southwestern Medical Center

214-645-8245 (office)

214-645-6426 (fax)



Thu Aug 23 12:56:41 CDT 2012

Dear Covered Individual*:

UT Southwestern is required to be in compliance with the new PHS Conflict of Interest (COI) Policy<http://ecfr.gpoaccess.gov/cgi/t/text/text-idx?c=ecfr&sid=f67ea01984581d3934103b5074c05500&rgn=div5&view=text&node=42:1.0.1.4.22&idno=42#42:1.0.1.4.22.6> by August 24, 2012 and has updated its Financial Conflicts of Interest in Research Policy<http://www.utsouthwestern.edu/edumedia/edufiles/research/COI_assets/res-401-conflicts-interest-research-071112.pdf> to meet the requirements of the new regulations. You may click here to view the Summary of Major Changes<http://grants.nih.gov/grants/policy/coi/summary_of_major_changes.doc> which includes required COI training.

Now that the annual collection of 2012 Statements of Financial Interests is nearing completion, UT Southwestern will deploy the second phase of the new COI requirements. UT System and NIH Policy require that Covered Individuals complete a COI training course every four years. We have developed a new, web-based training course on the CITI (Collaborative Institutional Training Initiative<http://www.citiprogram.org/>) site specifically for UT Southwestern to meet this requirement.

Beginning August 24, 2012, a Covered Individual must have a current Statement of Financial Interests on file in UT Southwestern's COI Office and must have completed the CITI COI training before a PHS-funded award may be established. You may click this link<http://www.citiprogram.org/> to go directly to the CITI site to initiate your COI training. Instructions for completing the required training may be found on UT Southwestern's COI Office website under COI Training<http://www.utsouthwestern.edu/research/research-administration/conflict-of-interest/training.html>. COI training not completed by the time of a PHS-funded award will cause a hold on research funding until the training requirement is met.

Covered Individuals who do not have an upcoming new or renewal PHS-funded award have until December 31, 2012 to complete the required COI training. Please note that if you have completed prior UT Southwestern COI training within the previous two years, you are still required to complete the new CITI COI training.

Thank you in advance for your continued assistance and cooperation with this important institutional requirement. If you have questions, please contact Sheria Oswalthttp://lists.utsouthwestern.edu/mailman/listinfo/irb-researchers> in the COI Office or call 214-648-5398.

Angela R. Charboneau Wishon, J.D.

Vice President for Research Administration

UT Southwestern Medical Center

5323 Harry Hines Blvd. BL9.100

Dallas, TX 75390-9105

(o) 214-648-0455

*A Covered Individual is defined as all Faculty, study team members, IACUC, IRB, and COI Committee members, Research Grants and Contracts staff and Technology Development staff).


Fri Feb 24 10:43:36 CST 2012

Dear Study Teams,

As we expand and improve on our clinical research infrastructure, we will be rolling out new policies and procedures related to the management of our clinical research studies. Our next step is to track all participants of clinical research in our clinical trials management system, Velos, a plan that will be implemented over the coming months. This will include an interface from Velos to Epic that will flag the UTSW patients that are on research studies when appropriate.

Training for registering participants in Velos and setting up the study in Velos for the Velos-Epic interface will be provided by Academic Information Systems.

For training information:

-Online Training: eResearch Training

-Classroom Training:

-Login into MyLearning by navigating to https://my.swmed.org/

-Click on Training in the top left corner

-Under My Learning click on Search Catalog. In the Search the

Catalog field type the title of the class: eResearch Patient Registration (EREPR)

Questions related to this initiative should be directed to:

Policy and requirements - Angela Wishon, JD, Vice President of Research Administration or Diane Sheppard, Director of Human Protections.

System (Velos/Epic) and training - Dipti Ranganathan, Assistant Vice President of Academic Information Systems or Melody Bell, Project Manager, Academic Information Systems.

Note: for Simmons Comprehensive Cancer Center (SCCC) Studies

For SCCC studies, the interface between Velos and Epic will be set for existing studies as of February 27, 2012 with the assistance of the CRO. For questions or further information contact Erin Fenske, Associate Director, CRO Administration.

Angela R. Charboneau Wishon, J.D.

Vice President for Research Administration

UT Southwestern Medical Center

214-648-0455


Mon Jan 30 11:33:18 CST 2012

Dear Investigators and Research Personnel,

We are excited to announce the launch of a new Find a Clinical Trial (FaCT) web-based recruitment tool which went live over the weekend. Information displayed on the new web page will be populated directly from your study data entered into Velos and eIRB.

For your study to display in FaCT, you will first need to set your IRB approved study status in Velos to "Active/Enrolling." Once completed your study information will be automatically displayed on the FaCT web page. It is no longer necessary to submit a separate form for approval in order to utilize this recruitment tool. Please see the attached document which outlines the step-by-step instructions on changing your study status in Velos.

When your study is closed to enrollment, simply update the status in Velos to "Closed to Enrollment" and your study will automatically be removed from the website.

To see the new FaCT site, please visit: http://www.utsouthwestern.edu/fact

For comments or questions, please contact either:

Kimberly Taylor at http://lists.utsouthwestern.edu/mailman/listinfo/irb-researchers

Kathleen Wilkinson at http://lists.utsouthwestern.edu/mailman/listinfo/irb-researchers

IRB at http://lists.utsouthwestern.edu/mailman/listinfo/irb-researchers