IRB News Archive, 2013


Mon Dec 16 09:28:19 CST 2013

Dear Investigators and Research Personnel:

The Velos eResearch system is now upgraded to version 9.1.2 and functioning as required.

Key components of the weekend's upgrade include:

1. New look and feel for Velos (cascading menus versus current left hand menus). Users can navigate to the various screens with less key strokes.

2. New fields will interface between Velos and eIRB to improve data consistency across the systems.

Updated online Training materials and details on these improvements can be found on the Tips, Tricks and Updates page under Quick Links at the bottom right corner of the Velos Homepage.

If you have bookmarked the link to Velos in your "Favorites" the old link will no longer work.

The updated URL is: https://velos.swmed.edu/velos/jsp/ereslogin.jsp

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

Shiby Antony

Sr. Business Analyst/Project Manager

Office of Academic Information Systems

UT Southwestern Medical Center at Dallas

(O) - 214.648.4039


Tue Sep 10 15:02:40 CDT 2013

The following message is sent via the IRB Listserv at the request of the Office of Clinical Research Facilitation.

Dear Investigators and Research Personnel:

Effective September 15, 2013, the Office of Clinical Research Facilitation will begin charging administrative start-up and modification fees (Fees) on industry sponsored studies as follows:

· Initial Clinical Trials OCRF Start Up Fee = $5000

· Clinical Trials Coverage Analysis (CTCA)

· Modifications Fee

– Less than 3 hours = $250

– 3 hours but less than 6 hours = $500

– Greater than 6 hours = $750

· Contracting Services (CS)

· Contract Amendment Fee

– Less than 3 hours = $250

– 3 hours but less than 6 hours = $500

– Greater than 6 hours = $750

The fees will be assessed on new studies for which the contract and budget have not been finalized. For ongoing studies, OCRF will work with the sponsor to determine if the contract allows for revision in Fees and will be handled accordingly. The department will not be responsible for any deficits in Fees for contracts executed prior to September 15, 2013, or where OCRF has agreed not to apply the updated rates. We recognize that many studies are in process; therefore, we will work on a case-by-case basis to implement this new rate structure. Investigators submitting applications for new industry-sponsored clinical trials need to include a line item in the budget that reflects these charges.

In preparing budgets for new industry sponsored studies, investigators should include the amount of the Fees to be incurred during each year of trials. These fees are in addition to any costs that, investigators may need to include for administrative activities provided by the study team, such as preparation of the CTCA Velos form, and related administrative transactions as part of study initiation. Please note that CTCA and CS fees are charged even if subjects are never enrolled, the study terminates before milestones are met, expenditures exceed income, or a contract is never finalized. Additionally, these fees are exclusive of IRB fees, pharmacy fees or administrative fees assessed by Parkland or Children's.

If you have any questions, please contact Doug Arrington the Office of Clinical Research Facilitation at http://lists.utsouthwestern.edu/mailman/listinfo/irb-researchershttp://lists.utsouthwestern.edu/mailman/listinfo/irb-researchers> or 214-648-6449.

Angela R. Charboneau Wishon, J.D.

Vice President for Research Administration

UT Southwestern Medical Center

214-648-0455


Thu Aug 29 14:06:41 CDT 2013

Dear Investigators and Research Staff:

It gives us great pleasure to announce our "NEW" listserv for the Office of Clinical Research Facilitation. It is self-subscribe service. Please go to URL http://lists.utsouthwestern.edu/mailman/listinfo/clinical-research to subscribe or go to Office of Clinical Research Facilitation website at the right side of the main web page click "Subscribe to our Mail List".

The Office of Clinical Research Facilitation cordially invites you to the Risk Based Monitoring training on September 3, 2013 in D1.200, South Campus.

We will facilitate discussions around risk based monitoring in clinical research. Our presenter Lynette Westbrook, from the IRB Office, will discuss the Aug. 2011 Guidance for Monitoring of Clinical Research.

To enroll in one of the sessions (9AM or 10:30AM) please login to My Learning in PeopleSoft to register. Once you are successfully logged in, please select "browse catalog" then select the category "Research", and search for catalog item "Risk Based Monitoring (ORCF_Risk)". If you have any questions, please contact the Office of Clinical Research Facilitation at http://lists.utsouthwestern.edu/mailman/listinfo/irb-researchershttp://lists.utsouthwestern.edu/mailman/listinfo/irb-researchers> or 214-648-6449. We look forward to seeing you there, Sept. 3rd.

Thank you,

Mary Weyant, RN, BSN

Asst. Director

Office of Clinical Research Facilitation

The University of Texas Southwestern Medical Center

Bass Center Tower II, BL9.100

5323 Harry Hines Blvd.

Dallas, Texas 75390-9105

Phone: 214-648-9877

Fax: 214-648-4474


Mon Jul 29 12:21:27 CDT 2013

The IRB has approved revisions to the "Adverse Events and Other Reportable Events" policy which go into effect today. A copy of the policy is attached and is also available on the IRB website at: http://www.utsouthwestern.net/intranet/research/research-administration/irb/study-management/adverse-events.html. (Please note: At this time, UTSW credentials are required to access the policy on-line. We are working to update the public website to provide access for our non-UTSW colleagues.)

This guidance is intended to assist the research community in determining the types of events that are reportable to the IRB. The primary changes to the policy are:

1. Local Adverse Event Reporting Criteria: It will no longer be necessary to report local serious adverse events that are expected or unrelated to the research.

2. Data Safety Monitoring: Clarification is provided on the requirements for data safety monitoring and reporting. Investigators are responsible for assuring that the IRB is made aware of significant new information that arises during the course of a study. Data Safety Monitoring Reports should be reported to the IRB, even when no problems have been identified and the DSMB has recommended continuation of the trial as designed. In the absence of a formal DSMB/DSC, the PI should provide reports to the IRB in accordance with the approved Data Safety Monitoring Plan.

3. Audits and Monitoring Reports: Clarification is provided on the types of audits and monitoring activities that must be reported to the IRB. In addition to audits conducted by federal oversight agencies such as FDA and OHRP, investigators must notify the IRB office should the Sponsor, or any internal monitoring or compliance group, have findings that result in a protocol modification or other corrective action(s) to protect subjects, indicate serious or continuing non-compliance, or involve other regulatory actions.

As a follow up to this announcement, this new IRB Reportable Events Policy will be discussed at the Research Matters presentation at 12 noon on Wednesday, September 4, in lecture hall D1.602.

As always, the IRB staff is available to answer any questions you may have.

Call the main IRB number at 214-648-3060

Diane Sheppard, R.N.

Director, Research Protections

U.T. Southwestern Medical Center

214-648-6417 (office)

214-648-2171 (fax)


Tue Jan 15 14:18:39 CST 2013

Dear Investigators and Research Personnel:

Effective February 1, 2013, Research Administration will increase the Institutional Review Board (IRB) fees on industry-sponsored studies as follows:

Initial Review - Full Committee: $3000

Initial Review - Expedited: $1000

Continuing Reviews - Full Committee: $1500

Continuing Reviews - Expedited: $500

Fees will not be charged for modifications to approved studies, adverse event reporting, or for the review of exempt studies.

The increased IRB fees will be assessed on new studies for which the contract and budget have not been finalized. For ongoing studies, Research Administration will work with the sponsor to determine if the contract allows for modifications in IRB fees and will handle accordingly. The department will not be responsible for any deficits in IRB fees for contracts executed prior to February 1, 2013, or where Research Administration has agreed not to apply the updated rates. We recognize that many studies are in process; therefore, we will work on a case-by-case basis to implement this new rate structure.

Investigators submitting applications for new industry-sponsored clinical trials need to include a line item in the budget that reflects these charges.

In preparing budgets for new industry sponsored studies, investigators should include the amount of the IRB fees to be incurred during each year of the trial. These fees are in addition to any costs the investigator might want to include for administrative activities provided by the study team, such as preparation of the IRB applications and related administrative transactions. Please note that IRB fees are charged even if subjects are never enrolled, the study terminates before milestones are met, expenditures exceed revenue, or a contract is never finalized.

There has not been an increase in IRB fees since they were initially instituted in 2003. After reviewing fee structures at similar institutions, we remain in line or below the average. As always, we do not charge for IRB review of federally funded, non-profit, or unsponsored studies.

If you have any questions, please contact the Office of Clinical Research Facilitation at http://lists.utsouthwestern.edu/mailman/listinfo/irb-researchers or 214-648-6449.

Angela R. Charboneau Wishon, J.D.

Vice President for Research Administration

UT Southwestern Medical Center

214-648-0455