Current Announcements
Message from Dr. Good to COM Clinical Research Faculty and Staff
To the COM Research Faculty and Staff:
Our efforts involving Clinical Trials Compliance (CTC) continue to move in a positive direction. Partnerships among our clinical research faculty and staff, research administration, Faculty Group Practice and Shands Hospital are growing stronger as we endeavor to understand and support the complex processes, systems and needed training associated with CTC.
Performing safe and valuable clinical research is important to the UF
Health Science Center and the College of Medicine. We must also meet regulatory requirements that help to guarantee we are engaging in ethical and compliant business practices. UF and all of our partners in clinical research share in this responsibility. I am grateful for the dedication of our research teams and clinical service providers to fiscal integrity and protecting our research participants, faculty, staff and environment.
As our commitment and success in clinical research grows, so does the effort needed to ensure we are following sound and efficient CTC processes. The CTC, as part of the Research Administration and Compliance Office, continue to build their support services and I encourage you to review the CTC website for helpful information on processes, tools, forms and to register for essential training.
Soon, CTC will join our required compliance training activities as we carry on this important work. Please contact Yvonne Brinson, Assistant Dean, Research Administration and Compliance or contact her office at 352-273-5946 early in your clinical trial planning for help in navigating the CTC process.
Thank you for your continued commitment and support.
Michael L. Good, MD
Interim Dean, College of Medicine
back to top NEW IRB Submission Requirement
The terms of the fiscal language in the ICF and the Clinical Trial contract must be consistent. There has been an unacceptably high percentage of IRB approved informed consent forms (both IRB-01 and WIRB) that seriously conflicted with the terms of the UF-Sponsor contract or conflicted within the ICF. The offices of Research Administration and Compliance (RAC), Division of Sponsored Research (DSR) , and the IRB have worked together to rectify this issue – including benchmarking how other institutions address the issue, as well as polling some of UF’s more experienced research groups as to how they deal with the local system. The IRB, DSR, and RAC have agreed to implement a serial submission process to (1) help ensure subjects are properly informed and billed, (2) decrease changes to the ICF after patients have already enrolled (3) minimize the possibility of billing non-compliance, and (4) reduce workload and cost to the PI, RAC, and IRB if ICF and/or the Clinical Trial Agreement (CTA) are in error and must be corrected.
As a result, follow these steps:
- As soon as you intend to conduct research that involves any drugs, substances, devices or clinical services (i.e. blood draws, tissue samples, lab tests, clinical examinations), you should submit the completed RAC packet (includes the Study Initiation Checklist for Research with Human Subjects - http://ctc.health.ufl.edu/freqUsed/freq_used_forms.shtml) to the RAC.
NOTE: This process applies to all studies regardless of funding, including unfunded research or UF internally funded research. The only exemption is research conducted by VA personnel that only involves VA facilities, resources, and/or subjects.
- After RAC receives a completed packet, RAC will assess the information and give the researcher a “Financial Language Assessment” (FLA) form. You must have this RAC-signed form to submit your project to IRB-01 or WIRB.
- IRB-01 is revising the Introductory Questionnaire (IQ) to request the FLA form any time the research involves any drugs, substances, devices or clinical services (excluding solely VA ). This request will be placed at the beginning of the IQ to alert the PI of this new requirement. Without the completed FLA form, IRB-01 will return your clinical services research submission.
NOTE:
- You should ensure the language in the ICF you submit to IRB-01 is consistent with what is recommended in FLA form. Otherwise the IRB may not be able to approve the study.
- WIRB will be instructed not to accept research from UF-Gainesville faculty or staff without the FLA form.
RAC, DSR, and the IRB are extremely concerned that this process may cause delays in approval of clinical research. Several of UF’s larger research groups already follow this process voluntarily with little to no impact to the time it takes to begin the research. Researchers, however, must be proactive and provide a completed RAC packet to RAC as soon as possible to initiate the compliance review process. RAC, DSR, and the IRB will monitor the time to get research approved and may take additional steps if the current process causes excessive delays.
As of this moment IRB-01 is unable to approve research without the RAC’s assessment. If you are working on a new study that involves any drugs, substances, devices or clinical services, you should submit your completed RAC packet to the RAC office ASAP to obtain the required FLA.
The new IQ will be available on Monday 10/12/09 and should be downloaded and used for all new studies. You may continue to submit the most recent version of the IQs through Friday October 30th, 2009 (particularly if you have already started working on a new study). However, please note the IRB cannot approve the research unless you obtain and provide the RAC’s FLA form.
On and after Monday November 2nd, 2009 IRB-01 will return any submissions that do not provide the RAC FLA or fail to use the newest version of the IQ.
A “Brown Bag” seminar, scheduled for
Tuesday October 13th from 12 PM to 1:30 PM
McKnight Brain Institute room LG110A
This meeting will be devoted to this and any other topics of interest.
For answers to questions please contact:
DSR:
Tom Walsh
twalsh@ufl.edu
(352) 392-1582
IRB:
Michael Mahoney
mmahoney@ufl.edu
(352) 846-1706
RAC:
Yvonne Brinson
ybrinson@ufl.edu
273-5946
