IRB Frequently Asked Questions for THCIC Inpatient, Outpatient and Emergency Room Data

Contents

1. How soon can the data be released once the application is complete and approved by the IRB?
2. How much does it cost?
3. What data years and variables are available?
4. Where are the IRB forms?
5. Where do I send the IRB forms?
6. Who can I speak with if I have a question on the IRB forms?
7. When will I know if my IRB application was approved?
8. What are the tips to avoid mistakes commonly made on THCIC IRB applications?

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1. How soon can the data be released once the application is complete and approved by the IRB?
   Approximately one week after payment is received.
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2. How much does it cost?
   Base charge is $30 pervariable per data quarter or $120 per variable per data year. Depending on therequirements for the IRB proposal additional charges may be applied and for: Linking to or with another dataset; Sub setting the data (for example,only a subset of the state data is allowed or needed for the proposal); or the IRBproposal requests future data in that is not available at the time of approvalor wants quarterly releases of the data.
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3. What data years and variables are available?
   • Inpatient; see form at thcic/hospitals/RDF_IP_OrderForm.pdf
   • Outpatient; see form at thcic/hospitals/RDF_OP_OrderForm.pdf
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4. Where are the IRB forms?
   http://www.dshs.state.tx.us/irb/applirb.shtm
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5. Where do I send the IRB forms?
   See instruction page at: 
   • Inpatient: /thcic/hospitals/inpatientresearchfile.shtm
   • Outpatient: /thcic/Texas-Outpatient-Research-Data-File-(OP-RDF)/
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6. Who can I speak with if I have a question on the IRB forms?
   DSHS IRB Administrator - 512-776-2202
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7. When will I know if my IRB application was approved?
   You will receive an email from the IRB Administrator.
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8. What are the tips to avoid mistakes commonly made on THCIC IRB applications?
   • Fully address and answer each question asked on the IRB forms
   • If data partners are listed, please provide their role in the IRB proposal and whether they will be accessing the data
   • Request only data necessary for proposed project, asking for “all data available” may require further action
   • Provide lists of personnel that access the data for analysis and who has access to disks or the data on the network
   • Provide detailed responses on how data will be securely stored. For example, where the data will be stored (disks, flash drives, network system, standalone computers or laptops) and the protection mechanisms on those devices
   • Provide detailed responses on how patients and physician identities are to protected when data are accessed, and for any presentations of the data
   • Provide detailed responses on how data are to be destroyed once data project is complete. For example: hard drive shredding, data erasure, overwriting, physical destruction
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