Institutional Review Board News - Older Announcements

UT Southwestern's participation in the Health Pavilion at VIVA Dallas! has grown over the years in numbers and the impact we have made with the Hispanic community.

The 2009 event is scheduled for August 8th and 9th where over 30,000 people are expected to attend.

If you are interested in learning more about participation in the 2009 VIVA Dallas, you are invited to reply to connie.rich@utsouthwestern.edu regarding your availability on the following dates and times:

The meeting will be scheduled on the date and time when a majority of the participants are available. An email confirming the meeting will be sent to you.

The following message is being distributed via the IRB Listserv at the request of Valeria Hart, Ph.D., Director of Clinical Research and Data Management at Parkland Heath and Hospital Systems. The message below contains important information for those conducting research at Parkland. Links to additional information and contact information is listed below.

Please do not reply directly to this e-mail.

Attention researchers and research staff: Parkland's Epic Go-Live on April 28th will include:

1. Inpatient Provider order entry (CPOE)
2. provider documentation
3. nursing admission and vital signs, I & O's data (nursing notes later '09)
4. medication administration record (MAR)
5. pharmacy system
***
Research orders and the processing will remain the same, i.e. on paper.
The IDS pharmacy staff will be entering any research drugs, the drug administration will be on the electronic MAR. Nurses and clerks will continue entry of orders for research labs, procedures, etc. taken off the research paper orders.

To be able to abstract your usual study data, you will need access to EPIC. The directions are below.

What do I need to do?
Log on to the Parkland CITI Portal prior to implementation to ensure that your User ID and password work. The link to the CITI portal is below.

http://citi.pmh.org/Citrix/MetaFrame/default/default.aspx

If you are located on Parkland's campus, click the Epic Hyperspace Icon as you normally do.
If you are on the UT or CMC campus, click the "Epic - Hyperspace - UT Users" icon. The instructions for UT or CMC access, along with a FAQ are located at this link:

http://intranet.pmh.org/infosec/communications/EPIC-Access-From-UT.pdf

Current Parkland EPIC users…
Make sure that you are able to logon to the CITI Web Portal. This may be something you do everyday or occasionally. If you are an occasional user, please confirm that your logon user ID and password work by logging onto the Parkland CITI Web Portal.

Users who have an ID, but have not logged on recently…
Logon using your Parkland user ID and password. If you work for UT or CMC your ID will be the same as your UT or CMC ID. If you do not know your password, call 214.590.5999 or x25999 for a password reset.

Users who do not have a Parkland user ID…
Each campus has established procedures for access requests. Please follow these procedures.

Procedures for UT employees

Call the Parkland Service Desk at x25999 or link to http://intranet.pmh.org/infosec/forms/UTSW_Access_request.pdfon the Parkland intranet to obtain directions.

Training Requirements

Every user must complete EPIC training prior to accessing the system. Your EPIC User ID will be created in a Not Trained Inactive status. Once training is complete, the Parkland IT Training group will activate the account.

To schedule training send email to CITI Training Registration in the GroupWise address book or pmh_citi_training_registration@parknet.pmh.org

Address Questions to the Parkland Service Desk x25999

IS Communications
Parkland Health & Hospital System
IS.Communications@parknet.pmh.org

Dear Investigators and Research Personnel,

The IRB is pleased to announce a new and improved ERGO NR3 form. The NR3 form is used to obtain permission to conduct human research at Children's Medical Center, Parkland, the University Hospitals (St. Paul and Zale Lipshy), and UT Southwestern Ambulatory Services.

The next RESEARCH MATTERS, will be held on Thursday, April 16, 2009, from 12:00 p.m. to 1 p.m., in Room D1.502. The speaker will be Anne Clark, Senior IRB Coordinator.

The Research Matters lectures are designed specifically for the research community and provide an educational forum for information on regulations, ethics, special research topics and IRB updates.

We look forward to seeing you there and appreciate the opportunity to support the research enterprise.

There is no need to pre-register. Certificates of participation will be available for attendees on site.

Diane Sheppard, R.N.
Manager, Institutional Review Board
UT Southwestern Medical Center at Dallas
Phone: 214-648-3060
Fax: 214-6482171

Children's Medical Center Research Department and the UT Southwestern IRB are sponsoring the annual Clinical Research Workshop on May 5, 2009 - How to Build Quality into your Program and Prepare for an FDA Audit.

The program will be presented by Michael R. Hamrell, PhD. Dr. Hamrell is a regulatory affairs professional with extensive experience in regulatory affairs, clinical research and drug development at FDA, NIH, and industry, emphasizing biotechnology and high risk diseases.

Accreditation: This program has been approved by the American Association of Critical Care Nurses (AACN) for 6.5 Contact Hours, CERP Category A, File number 00015061.

T. Boone Pickens Biomedical Building
UT Southwestern Medical Center
Room NG3.112

This program is free to our research community, but pre-registration is required. For more information and to register on-line please go to:

Diane Sheppard, R.N.
Manager, Institutional Review Board
UT Southwestern Medical Center at Dallas
Phone: 214-648-3060
Fax: 214-6482171

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

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.

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.

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.

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