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    CER Specialized Registry

    2014NAACCRsilver

Texas Cancer Registry Applying for DSHS-IRB Approval

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Applying for DSHS-IRB Approval

1. Email us at Cancerdata, or call us at 1-800-252-8059 to discuss the feasibility and timeline of your proposal.

2. Complete the "Request for Confidential Cancer Registry Data" form and submit for review by the TCR.

a. This review ensures that the DSHS-Institutional Review Board (IRB) is necessary and that the TCR can provide the requested data.

b. A peer-review by the TCR Epidemiology Group is generally completed within three weeks of receipt

c. After review, any suggested changes to the study/data request deemed necessary by the TCR are provided, as well as advisement about whether or not IRB review is necessary to receive the requested data set and/or analyses.

d. If IRB approval is not required, at the end of the 3-week review period, TCR will contact you with a data request number and timeline for when you can expect the data set.

3. If IRB approval is required:

a. Complete TCR-requested revisions to the “Request for Confidential Cancer Registry Data” form. This form and its attachments become part of the IRB application.

b. Complete a first draft of the required IRB #1 forms. For a complete list of what is required, refer to the “Initial Submission” checklist available at the bottom of this web page: http://www.dshs.state.tx.us/irb/applirb.shtm. Forms listed as required on the checklist are available from the same URL. Please make sure you have the most current versions of all forms before submitting, as outdated forms will delay your request.

c. The draft, unsigned IRB packet should be e-mailed to CancerData, for TCR review before final signed originals are submitted.

d. Work with TCR to iteratively revise your IRB application until it meets TCR approval. Note that this part of the process may take a week, a month, or longer, depending on the issues identified and the speed with which they are addressed in the written application.

e. TCR must receive the TCR-approved complete IRB application, signed and initialed by the Principal Investigator, by the 15th of the month in order for the application to be considered at the next month’s IRB meeting (e.g. by September 15th, for October IRB consideration).  

4. The Texas Cancer Registry, Program Contact listed on the DSHS-IRB Application should be:

Leticia Nogueira, Ph.D, MPH
Cancer Epidemiology and Surveillance Branch
Texas Department of State Health Services
1100 West 49th Street
Austin, TX 78756
512-776-3422
Leticia.Nogueira@dshs.state.tx.us

or

Valentina Cisneros, MPH
Cancer Epidemiology and Surveillance Branch
Texas Department of State Health Services
1100 West 49th Street
Austin, TX 78756
512-776-3614
Valentina.Cisneros@dshs.state.tx.us

5. Once TCR has obtained required DSHS signatures on your completed IRB forms, we will send you a PDF of the entire signed application. You must make 16 photocopies of the PDF (collated, double-sided, no staples) and mail them to the address listed above, so that they arrive by the last business day of the month. We will submit the DSHS-IRB packet on your behalf. Applications for which photocopies are received after the deadline will be delayed for IRB consideration for an additional month.

6. On average, time from initial TCR application to IRB approval is about three months.

7. Once DSHS-IRB approval is received, within two weeks the TCR will provide an estimate of the timeline to complete your data request. Factors such as the size and type of request, as well as the number of other data requests and registry projects at that time can affect the timeframe in which we can prepare your data set.

a. Normally files are provided to researchers via the TCR Web Plus server (a secure file transfer server). A week before the file will be ready, researchers must apply for a TCR WebPlus account by following the procedures described at http://www.dshs.state.tx.us/tcr/Web-Plus/Web-Plus.aspx; please allow 3 working days from the time TCR receives the application forms for account creation.

b. Once the researcher has been notified that the file is available on WebPlus, the researcher must download the file within one week. Files are subject to removal after that time.

8. Questions about the request process for protected data can be directed to Cancerdata or:

phone: 512-776-3080 (outside of Texas)
phone: 1-800-252-8059 (in Texas)
fax: 512-776-7681

  

 

Contact TCR

 

Last updated November 21, 2014