Institutional Review Board News - Older Announcements

This message is distributed via the IRB Listserv at the request of Susan Partridge, BSN, MBA, Vice President, Clinical Research Parkland Health and Hospital System.

Effective immediately, all research consent forms obtained at Parkland must include the date and the time the consent was signed. Following each signature and date on the consent form, insert the time right next to the date.

This process meets the requirements for CMS (Centers for Medicare and Medicaid Services) for proper consent form execution (procedure A-0238).
Thank you for your prompt attention to this important requirement.

Anna Barden, RN, MHR, MBA, CPHRM, CHRC
Compliance Manager, Clinical Research
Parkland Health & Hospital System
Telephone: 214-590-6723
anna.barden@phhs.org

Dear Investigators and Research Personnel,

1. To set the stage for future upgrades, Velos systems are increasing the number of required fields to register and update studies. Interfaces with Epic, Grants, and reporting will require the following additional fields to be completed on the Summary tab:
•Primary Research Coordinator
•Specialty
•Phase
•Research Funding Type (for example, Private-For Profit)
•Blinding

2. Also on the Study Summary Tab, please be sure to verify that the study has the field named “Org. Affiliated with Study” selected correctly.
•If the study is related to the Cancer Center, the organization selected should be “Simmons Comprehensive Cancer Center”,
•It is very important for NCI reporting to list “Simmons Comprehensive Cancer Center” in this field; Otherwise, the study will not be included in the reports and study counts for NCI.
•For all other non-cancer studies, the dropdown should reflect the department associated with the study (Generally the PI’s primary organization) not having your department listed here will affect your department’s reports.

3. Patient Enrollment in Velos
•Currently, Cancer Studies requires Patient Enrollment and patients in these studies should be enrolled under the organization “Simmons Comprehensive Cancer Center”.
•If you would like to enroll patients in Velos, training options are available by contacting Kimberly Taylor at Kimberly.Taylor@UTSouthwestern.edu

For questions regarding these changes, please contact Thomas Spencer at Thomas.Spencer@UTSouthwestern.edu

Thomas Spencer, MBA

Manager of Operations
Office of Academic Information Systems
UT Southwestern Medical Center at Dallas
Ph: 214-645-7143
Fax: 214.645-7376
Web:http://www.utsouthwestern.edu/eResearch
Help:http://eresearchtraining.swmed.edu/

***The following message is sent at the request of Drs. Greg Fitz, Robert Toto, and Scott Grundy***

The Clinical and Translational Research Center (CTRC), formerly the GCRC, is the patient-oriented research component of the University's Clinical and Translational Science Award (CTSA).

* Inpatient Unit on Parkland 7 West: 24 hour-a-day/7-day-a week nursing coverage
* Outpatient Clinic on Aston Center's 8th floor: Monday - Friday nursing coverage

* Professional staff trained in clinical research
* Clinic space for investigators and their personnel to conduct human research studies
* Dietician services and a metabolic kitchen
* Facilities for blood and body fluid collection and processing
* Guidance on regulatory issues, laboratory processing and study safety

***We need you to fill out the attached questionnaire so the CTRC can better serve your needs. Broader utilization of the CTRC will enhance the likelihood of future NIH support***

Approximately 3000 human studies are approved by the UTSW-IRB but only one tenth use the CTRC.

Please be as specific as possible regarding your experience(s) with the CTRC so we can better meet your research needs.

The questionnaire can be emailed to Kathleen.wilkinson@utsouthwestern.edu or can be accessed online (UTSW users only) at http://reynoldsweb.swmed.org/Checkbox/Survey.aspx?s=ffebe57af88a44f7a021b7e4811b5715

Diane Sheppard, R.N.
Director, Research Protections
U.T. Southwestern Medical Center
214-645-8245 (office)
214-645-6426 (fax)
diane.sheppard@utsouthwestern.edu

The Research Software Core provides a single site for users to determine which software packages are available for use by research personnel at UT Southwestern. The core's goal is to provide software that will benefit researchers at low or no cost. This is accomplished through bulk purchases and low-cost buy-in to campus-wide licenses. The core is supported by the Deans of both the Graduate and Medical Schools and by Information Resources. It is advised by a committee of faculty and staff and administered by Academic Information Systems.

The Research Software Core is pleased to announce new partnerships with the UT Southwestern Medical Center Library, the Department of Clinical Sciences and the Department of Purchasing.

Effective January 1, 2011, the Software Core is providing additional assistance to users in acquiring the following three listed software packages.

1) The license for MATLAB is now available at no charge for affiliated clients on designated library computers: there are two at each of the library locations. For purchase options, please visit the Software Core website.

2) The Software Core will assist users in purchasing statistical software packages SPS or SASS from Biostatistics a division of Clinical Sciences. These items also are available at no charge for use at the Southwestern Library.

3) The Software Core will assist users in purchasing Adobe Creative Suite 5 Design Standard through the department of Purchasing for a discounted price.

For more information about these software suites or to suggest software packages to be supported and licensed, please send requests via e-mail to Thomas Spencer with Academic Information Systems.

Website: http://www.utsouthwestern.edu/utsw/home/utsw/home/home/research/corefacilities/researchsoftware/index.html

Manager of Operations
Office of Academic Information Systems
UT Southwestern Medical Center at Dallas
Ph: 214-645-7143
Fax: 214.645-7376
Web: http://www.utsouthwestern.edu/eResearch
Help: http://eresearchtraining.swmed.edu/

***Please distribute to any members of your study team or other colleagues that may not be subscribed to the IRB Listserv***

I am writing to clarify the University policy on the sharing of passwords to electronic systems including the UTSW eIRB. It has come to our attention that some Principal Investigators are sharing their UTSW User ID and password with their staff for the purpose of performing functions in eIRB that are designated as actions to be performed only by the PI.

This is a violation of University Information Security policy (# 200-2), University Acceptable Use policy (# 200-22), and the University Password User Management policy (# 200-7), which collectively state, "Users are responsible for keeping their User IDs and passwords confidential and are prohibited from sharing their User IDs and passwords with anyone."

Additionally, a recently approved directive, the Electronic Signature Policy (#200-29) considers electronic signatures produced by communications and transactions initiated by a UT Southwestern-issued user account, to the extent authorized for that account, to be legally binding as the equivalent of a handwritten signature.

This activity also violates the Information Systems User Responsibilities Policy (#200-13), which implicitly states:

* Users shall not log onto a workstation using another person's User ID nor shall the User permit another person to log on with his or her User ID.

The Information Security Group maintains these policies at the below listed web address: http://www8.utsouthwestern.edu:8080/utsw/cda/dept225060/files/554797.html

Going forward, any instance in which it is determined that a workforce member has used another person's ID and password to login will be considered an information security incident. This will result in disciplinary actions (up to and including termination) for both the person using another's ID, as well as the person who gave his or her ID and password to another to use.

If you have any questions regarding this communication, please contact me directly.

Robert Myles, CISSP, CISM
AVP Information Security & CISO
UT Southwestern Medical Center at Dallas
5323 Harry Hines Blvd., MC: 8595
Dallas, Texas 75390
214-633-1234
Robert.Myles@utsouthwestern.edu
www.utsouthwestern.edu

Diane Sheppard, R.N.
Director, Research Protections
U.T. Southwestern Medical Center
214-645-8245 (office)
214-645-6426 (fax)
diane.sheppard@utsouthwestern.edu

Dear Research Community:

I am writing to clarify that Statement of Financial Interest (SFI) forms must be submitted by
*all* members of a study team listed on an IRB protocol application. This requirement also
applies to new study team members added via a modification request form

The IRB will hold final approval of new and continuing reviews (and modifications to add new study team members) until SFI forms for all investigators and study personnel are submitted to the COI office.

To avoid a delay or lapse in IRB approval, all investigators and research personnel are strongly encouraged to submit SFI forms now.

The SFI form may be completed via the web by going to https://sws001.swmed.edu
/coi/disclosure.

Those unable to log in to iAim may download a PDF version (http://www.utsouthwestern.edu/vgn/images/portal/cit_56417/57/11/585540Statement_of_Financial_Interests_-_rev_4-10.pdf) and send it to the COI Office at Mail Code 8574 or fax 214-645-9248.

Please feel free to contact Sheria Oswalt, COI Program Coordinator, at (214) 648-5398 or sheria.oswalt@utsouthwestern.edu should you have questions about this communication.

Please do not reply directly to this Listserv message.

Thank you,

Diane Sheppard, R.N.
Manager, Institutional Review Board
214-648-5486

Dear Research Community:

I am writing to clarify our procedures for review of researchers' financial interests prior to approval of human research protocols (or addition of new study personnel to an existing protocol via a modification).

In the past, we only required submission of Statement of Financial Interest (SFI) forms by faculty members and by key personnel on IRB protocols.

Now, we require submission of SFI forms from all faculty members and *all* other members of a study team listed on an IRB protocol application. This is because any member of a study team could affect the design, conduct or reporting of research. To protect your science and our research participants, it is our duty to review all personal financial interests that could have even the appearance of influencing the decisions of study team members.

The SFI form may be completed via the web by going to https://sws001.swmed.edu/coi/disclosure. Those unable to log in to iAim may download a PDF version (http://www.utsouthwestern.edu/vgn/images/portal/cit_56417/57/11/585540Statement_of_Financial_Interests_-_rev_4-10.pdf) and send it to the COI Office at Mail Code 8574 or fax 214-645-9248.

Please feel free to contact Sheria Oswalt, COI Program Coordinator, at (214) 648-5398 or sheria.oswalt <@t> utsouthwestern.edu should you have questions about this communication.

Thank you for your cooperation.

Suzanne Rivera
*********************************
Suzanne M. Rivera, Ph.D., M.S.W.
Vice President for Research Administration
Assistant Professor of Clinical Sciences
UT Southwestern Medical Center
5323 Harry Hines Boulevard
Dallas, TX 75390-9003
Tel (214) 648-0455
Fax (214) 648-2119
suzanne.rivera <@t> utsouthwestern.edu

________________________________

UT Southwestern Medical Center
The future of medicine, today.

Dear Investigators and Research Personnel,

As you likely are aware, any clinical trial in which a sponsor, a third-party payer (e.g., Medicare, Medicaid, managed care plan, etc.), or a patient may be billed for an item or service provided as part of the clinical trial must include a coverage analysis. A coverage analysis is a systematic and formal review of clinical trial documents and payer policies to: (1) identify the study-specific items and services that will be provided as part of the trial; and (2) identify the appropriate source of payment (i.e., sponsor, payer/patient, etc.) for each study-related item or service. Accurately billing for clinical trial-related items and services is critical for establishing and maintaining an effective and appropriate clinical research operation.

Performing a formal coverage analysis for clinical trials has been a requirement for some time. The consequences for not performing an accurate coverage analysis include significant criminal and/or civil penalties for the involved researchers and the university. Over the past several years, notable universities have entered into large settlements with the federal government as a result of billing errors related to clinical research. Cornell University's Weill Medical College ($4.38 million), the University of Alabama at Birmingham ($3.39 million), and Rush University Medical Center ($1 million) are just a few examples of settlements resulting from a failure to conduct coverage analyses properly.

Fortunately, UT Southwestern has had an aggressive billing compliance program in place for some time. To help you to better respond to billing complexities related to clinical trials, we have done a great deal of work this year to enhance our existing clinical trials billing compliance program. As part of this effort, new systems (e.g., Velos, eIRB), new tools (e.g., standardized coverage analysis forms), and new resources are now available or will be available soon. During the next several weeks, the University's Compliance Office will be forwarding additional information to you about these new and/or enhanced systems, tools, resources and requirements.

In the meantime, please do not hesitate to contact me (86108) or Dr. Doug Arrington (86034) if you have any questions about coverage analysis, or about any of the other information included in this memorandum.

Dieter A. Lehnortt
Assistant Vice President/Institutional Compliance Officer

________________________________

UT Southwestern Medical Center
The future of medicine, today.

The following message is distributed via the IRB Listserv at the request of the Simmons Comprehensive Cancer Center, Clinical Research Office. Please do not reply directly to this message.

Please note that when proposing human research involving cancer-related populations, it is necessary to submit your study to the study-appropriate Simmons Cancer Center's Disease Oriented Team (DOT) and the Protocol Review and Monitoring Committee (PRMC) prior to IRB review. To do so, you are required to complete PRMC forms 10.A and 10.B (see attached) in addition to eIRB submission. Once this has been done, the PRMC Coordinator will assist you with getting your study reviewed by both the DOT and PRMC as both committees use the same forms.

A cancer-related study is defined as a study that involves: 1) cancer patients or their relatives; 2) cancer prevention; or 3) epidemiologic, imaging or biological marker studies related to cancer risk factors, cancer incidence, prevalence or mortality, or early detection of cancer. This includes IRB exempt and expedited research studies on existing cancer-related samples.

While we are currently working on making the PRMC process electronic, investigators are currently required to complete the two paper PRMC forms (10.A and 10.B) in addition to the online eIRB application. These may be submitted concurrently. More information and the PRMC documents can be found attached to this email, at: http://www.utsouthwestern.edu:8080/utsw/cda/dept227763/files/452740.html or by contacting the PRMC Coordinator at the Simmons Cancer Center Clinical Research Office (CRO) at 214.648.7097.

Please contact me or the PRMC Coordinator if you have questions or need assistance.

Lynn A. Baker, M.B.A.
Assistant Director, Clinical Research Office
UT Southwestern Medical Center
Simmons Comprehensive Cancer Center
5323 Harry Hines Blvd.
Dallas, Texas 75390
Phone: (214) 648-7034

With the new eIRB system in place, please keep in mind that investigators are still required to submit ERGO NR3 forms for research studies to be conducted at Parkland, Children's Medical Center, University Hospitals and/or UT Southwestern Ambulatory Services Clinics. Submission of the NR3 form (in addition to IRB approval) is necessary to obtain performance site permission.

The NR3 form is under review. We hope to incorporate most of the information captured in the NR3 into the existing Velos and eIRB systems, thereby reducing the total number of questions investigators must answer.

We have already begun the streamlining effort by eliminating the need for duplicating attachments. As performance site approvers now have access to the eIRB submission, supporting documents uploaded to eIRB, do *not* need to be uploaded to the NR3 as well.

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 announce new guidance on Adverse Event Reporting now available on the IRB website. The guidance describes which types of adverse events are required to be reported to the IRB and indicates the timeline for reporting. The guidance also includes reference charts and decision trees to print and use as quick reference tools. You may access the guidance directly at: http://www8.utsouthwestern.edu/utsw/cda/dept27777/files/68311.html

The adverse event reporting requirements are effective immediately. All investigators and research personnel are strongly encouraged to review the guidance to ensure an understanding of the new reporting requirements.

Note: For those who attended the February Research Matters presentation on Adverse Events Reporting, there has been one minor change in the criteria for reporting local, serious adverse events. As you will see from the posted guidance; all local, serious adverse events are reportable to the IRB.

Also, please forward this message to others on your team who may not be subscribed to the IRB Listserv.

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

August 19, 2009

Dear Investigators and Research Personnel,

This is a reminder that human research studies proposed to occur at one or more of our affiliated performance sites requires site approval before any research-related activities may begin at the site. Site approval involves a resource utilization review and verification of privileges, among other considerations. UT Southwestern IRB approval does not constitute site approval.

Site approval is requested via the ERGO NR3 form, which can be accessed at: http://ergo.utsouthwestern.edu. The NR3 form is used for site approval at:

Children's Medical Center Dallas,
Parkland Health and Hospital Systems,
UT Southwestern University Hospitals, and
UT Southwestern Ambulatory Facilities.

If you should have any questions about obtaining site approval, please contact me directly at diane.sheppard@utsouthwestern.edu. Please do not reply directly to this message.

January 30, 2009

Dear Investigators and Research Personnel,

The IRB and the Department of Clinical Sciences are pleased to announce new guidance on Data Safety Monitoring Plans (DSMPs). DSMPs are meant to assure that each clinical investigation has a system for appropriate oversight and monitoring. This oversight protects research participants and the integrity of study data.

A DSMP should be tailored to the nature, size, and complexity of the protocol; the expected risks of the research; and the subject population being studied. The DSMP can be as simple as the investigator annually submitting his/her safety and AE information to the IRB or as complex as having a Data and Safety Monitoring Board. Typically, a DSMP is a written plan included as part of the study protocol, or if preferred, as a separate document submitted as an addendum to the protocol.

Many research protocols already include a DSMP (e.g. Cooperative Group Trials, and many FDA regulated studies). If not, the new DSMP guidance is intended to assist investigators to prepare plans as part of their IRB protocol submissions.

The direct link to the DSMP guidance and template instructions is:

http://www8.utsouthwestern.edu/vgn/images/portal/cit_56417/14/24/514274DSMP_Guidance_rev_smr.doc

Please do not reply to this Listserv e-mail. If you have questions or need additional information, please contact me directly at: diane.sheppard@utsouthwestern.edu or 214-648-5486.

December 20, 2007

Dear Investigators,

The National Institutes of Health (NIH) has issued a policy for the sharing of de-identified genotype and phenotype data obtained in NIH supported genome-wide association studies (GWAS).

The NIH has given us a basic definition of a GWAS, namely, "... any study of genetic variation across the entire human genome that is designed to identify genetic associations with observable traits (such as blood pressure or weight), or the presence or absence of a disease or condition."

It is likely that new RFPs will contain language that dictates adherence to this policy. Current grantees should contact their NIH program officers to determine if their work is subject to the GWAS policy.

This policy requires the implementation of new institutional policies and procedures related to IRB review of the investigator's plans for data submission, the adequacy of the informed consent process and documents through which the data was obtained, and the consideration of risks to research subjects.

We need to understand how this policy will affect UT Southwestern and we'd like to allow investigators conducting GWAS to be involved in the implementation process. Please reply to me directly at diane.sheppard@utsouthwestern.edu if you are currently conducting, or are planning to conduct, studies affected by this policy. Also, please indicate if you would be interested in participating in a working group to provide input and guidance to the IRB.

More information about the NIH GWAS policy is available at: http://grants.nih.gov/grants/gwas/index.htm

Please do not reply directly to this message.

December 17, 2007

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, althoughthe 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/.

November 12, 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.

Please do not reply to this message.

November 10, 2006

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. Researchperformed 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

If you have any comments, concerns or questions please contact Diane Sheppard at diane.sheppard@utsouthwestern.edu.