Previous Listserv Announcements
Date: Mon Dec 17 15:55:04 2007
Subject:Important Announcement - Clinical Trials Registration Requirements
Dear Investigators and Research Personnel,
On September 27, 2007, Public Law (PL) 110-85 expanded the scope of clinical trials that must be registered on the ClinicalTrials.gov website. For most sponsored research, the sponsor (and not the local PI) will be responsible for registering a trial. For investigator-initiated trials, the responsibility to register rests with the PI. All investigators should acquaint themselves with the registration requirements to avoid violating PL 110-85.
Summary
Clinical trials are eligible for registration after IRB approval is obtained and prior to beginning enrollment. Multi-site and multi-sponsored trials need to be registered only once. The lead
organization should take responsibility for registration. Applicable clinical trials must be registered by the later of December 26, 2007 or 21 days after the first patient is enrolled.
Applicable clinical trials include:
trials of drugs and biologics (controlled clinical investigations, other than Phase 1 trials); and
trials of devices (controlled trials with devices, other than small feasibility studies, and pediatric post-market surveillance).
Exceptions:
(a) data for trials ongoing as of September 27, 2007 that do not involve a ?serious or life threatening disease or condition? must be registered by September 27, 2008; and
(b) trials that involve a ?serious or life threatening disease or condition, are initiated before September 27, 2007, and have a completion date* prior to December 26, 2007, are not subject to the these legal requirements, although the ICMJE** requirements would still apply.
*Completion date means the date that the final subject was examined or received an intervention for the purposes of final collection of data for the primary outcome, whether the clinical trial concluded according to the pre-specified protocol or was terminated.
**The International Committee of Medical Journal Editors (ICMJE) will
consider a paper for publication only if the trial was registered before the enrollment of the first patient. In addition to the above trials, the ICMJE mandate includes, ?trials that prospectively assign human subjects to intervention and comparison groups to study the
cause-and-effect relationship between a medical intervention and a health outcome.? In addition, to drugs, biologics and devices, the term intervention includes surgical procedures, behavioral treatments and process-of-care changes.
For more information regarding the required data elements and
instructions on the registration process, please visit the website at:
http://prsinfo.clinicaltrials.gov/ .
Diane Sheppard, R.N.
Manager, Institutional Review Board
UT Southwestern Medical Center at Dallas
Phone: 214-648-3060
Fax: 214-6482171
Date: Mon Nov 12 10:11:27 2007
Dear Investigators and Research Personnel,
The IRB is pleased to introduce a new streamlined method for managing the Find a Clinical Trial (FaCT) on-line study recruitment system (www.utsouthwestern.edu/utsw/cda/dept226287/files/308724.html). FaCT uses ERGO as an electronic tool to post recruitment ads for open and recruiting studies, thereby facilitating the ad approval process. The FaCT system has been a fast and convenient way for Principal Investigators to post a recruitment ad to the university's website for almost a year now.
FaCT has now been enhanced to allow the PI (or his/her designee) to remove an ad from FaCT when the study enrollment is complete. Once logged into ERGO (www.ergo.utsouthwestern.edu), users can select the "Clinical Trials Study Recruitment" link and choose either "Add a New Ad" or "Remove an Existing Ad."
Please contact the IRB at 214-648-3060 if you have any questions relating to FaCT or ERGO.
Date: Wed Oct 3 09:19:17 2007
Dear Investigators and Research Personnel,
The IRB is pleased to announce several new guidance documents now available on the IRB website. Please refer to the IRB website for the most current information and templates available. You may wish to discard old templates saved to your desktop.
A list of the most recent additions to the IRB website and links are provided below:
1. Project Summary Guidance and Template
To reduce stipulations and to assist investigators, we have created a new template and guidance on writing one of the most critical parts of the IRB submission: the Project Summary. The guidance is all inclusive, meaning that all the sections will not necessarily apply to every study. Access the new Project Summary Guidance and template from the IRB forms page:
http://www8.utsouthwestern.edu/utsw/cda/dept27777/files/55431.html
2. Reporting Protocol Violations and Deviations Guidance
Federal regulations require that no changes be made to research protocols without prior IRB approval, except when necessary to eliminate apparent immediate hazards to subjects. Unauthorized changes need to be reported to the IRB. For more information and reporting guidelines, visit the Study Management section of the IRB website: http://www8.utsouthwestern.edu/vgn/images/portal/cit_56417/61/42/396528Reporting_Protocol_Deviations_and_Violations_final.doc
3. Use of Human Biological Specimens in Research Policy
This policy clarifies the circumstances under which human biological specimens may be used for research purposes, and describes the oversight requirements that correspond to the intended research use(s). The new policy is found under the Special Topics section of the IRB website:
http://www8.utsouthwestern.edu/vgn/images/portal/cit_56417/18/58/414068IRB_Use_of_Specimens_Policy_Final.doc
4. PI Eligibility and Responsibility Policy Revisions
Revisions to the policy expand the criteria for who may serve as PI on a study. More information on PI eligibility and when a Faculty Sponsor is required may be found in the Getting Started section of the IRB website:
http://www8.utsouthwestern.edu/utsw/cda/dept27777/files/282171.html
5. Certificate of Confidentiality Guidance
When research involves sensitive identifiable information, the IRB may ask a researcher to apply for a Certificate of Confidentiality (COC). Guidance for obtaining a COC is available in the Special Topics section of the IRB website:
http://www8.utsouthwestern.edu/vgn/images/portal/cit_56417/56/21/401370COC_Guidance_v3.doc
Please contact the IRB directly with any questions about the new forms, policies and guidance documents. Please do not respond directly to this Listserv message.
Date: Tue Oct 30 17:13:55 2007
Dear Investigators and Research Personnel,
In an effort to comply with tax laws and reduce confusion, the IRB has partnered with the Accounting Department to implement a new policy for making payments to study participants.
The policy describes how to request payments and includes specific instructions regarding subjects who do not have, or do not wish to disclose, a Social Security Number.
For your convenience, we also have developed a form that you may use to request subject payments from the Accounting Department. The form and guidance are posted on the Forms Page on the IRB website at: www.utsouthwestern.edu . (Scroll down on the forms page to "Other Forms" to find the links.)
This topic will be on the Admin. Management Council agenda in November. Please feel free to forward this message to your departmental administrator if they have questions regarding check requests for research subject payments.
Please contact me directly at diane.sheppard@utsouthwestern.edu or 214-648-5486 if you have any questions.
Dear Investigators and Research Personnel:
This is a reminder that the new informed consent document and HIPAA Authorization form should be used for new protocol applications submitted after December 31, 2006. The new consent form and HIPAA authorization templates can be found on the IRB's website at: www.utsouthwestern.edu/irb at the "forms" link. We recommend that you remove any old consent templates from your desktop and use only the most current version from the IRB site. Note: Studies submitted for Clinical Sciences Pre-review prior to January 1, 2006 may be accepted using the old templates but every effort should be made to get the IRB submission in right away. The following message was sent on November 2, 2006: The IRB is pleased to announce the release of new and improved templates for the informed consent document and the HIPAA authorization. The new forms follow a user-friendly question and answer format that has been found to be easier for subjects to understand. The sample text and guidance in the forms were drafted and refined with input from investigators, study coordinators, IRB members and others. Effective today, we ask that the new templates be used for submission of new protocol applications. Since many of you may have new protocols in development using the old forms, there will be a 60-day grace period, during which documents drafted using the old templates will still be accepted for IRB review. Beginning January 1, 2007, all new protocol submissions must use the new templates. Please note that protocols submitted for continuing review need not be revised to conform to the new template model. However, investigators who wish to convert their approved consent forms may do so either at continuing review or via a modification request at any time. The new consent form and HIPAA authorization templates can be found on the IRB's web site at: www.utsouthwestern.edu/irb and click on the "forms" link.
Diane Sheppard, R.N.
Manager, Institutional Review Board UT Southwestern Medical Center at Dallas
Phone: 214-648-3060
Fax: 214-6482171
Dear Investigators and Research Personnel,
Federal regulations (45 CFR 46.101) describe six categories of research that may qualify for exempt status. Exempt status means that the activities meet the federal definition of human research but pose so little risk that they need not undergo a complete IRB review and approval process. At UT Southwestern, proposed studies falling into one or more of the exempt categories are required to undergo review by an IRB Chair or designee to verify that the research meets the criteria for exemption. The IRB is pleased to announce new guidance for the submission of exempt studies. This guidance is intended to assist investigators in preparing documentation for IRB submission. Thorough documentation will assist the IRB in verifying exempt status in a timely manner and reduce the need to contact investigators for additional information. The guidance may be found on the IRB website at: http://www8.utsouthwestern.edu/utsw/cda/dept27777/files/69427.html The IRB home page may be found at: www.utsouthwestern.edu/irb Please contact me at diane.sheppard@utsouthwestern.edu or 214-648-5486 with questions or comments. PLEASE DO NOT REPLY DIRECTLY TO THIS MESSAGE. Diane Sheppard, R.N. Manager, Institutional Review Board UT Southwestern Medical Center at Dallas Phone: 214-648-3060 Fax: 214-6482171
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Dear Investigators and Research Coordinators:
In an effort to streamline processes and increase efficiency, the IRB has adopted a new policy regarding the review of Off-Site Research. Research that meets the limited criteria outlined below will now require only registration with the UT Southwestern IRB and need not undergo a dual review. Research eligible for IRB registration only: 1. Research performed by any UT Southwestern personnel that is to occur solely at the Veterans Administration Medical Center (VAMC) at Dallas under VAMC IRB approval. 2. Research conducted by UT Southwestern students and trainees under another Institution’s IRB approval when all of the following apply: a. the student or trainee will be listed on an IRB-approved protocol at the study site; b. UT Southwestern is not the recipient of funding for the conduct of the study; and c. the research is conducted entirely at the other site. For more information, please see the complete policy and instructions for submitting a study for IRB registration on the website at: http://www8.utsouthwestern.edu/utsw/cda/dept238840/files/320424.html
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