Institutional Review Board Application Process THCIC Program Hospital

Institutional Review Board Application Process THCIC Program • • • Hospital Discharge Data Outpatient Surgical / Radiological Procedures Emergency Department Events November 28, 2017

Research Data Available for Research Two type of data files are available for health related research: 1. Research Data File (RDF) 2. Public Use Data File (PUDF) Select the data file that best benefits your research needs. 2

Public Use Data File PUDF • No DSHS IRB approval required • PUDF released within days of payment • Inpatient PUDF has about 290 variables • Outpatient PUDF has about 260 variables • Some variable masking or suppression (partial or complete ZIP codes, patient race and ethnicity) Order the PUDF at: http: //www. dshs. state. tx. us/thcic/hospitals/Inpatientpudf. shtm http: //www. dshs. state. tx. us/thcic/Outpatient. Facilities/Outpatient. PUDF. shtm 3

Research Data File RDF • RDF requires DSHS IRB approval. • The approval process and data release can take several months. • RDF has over 300 variables available. • Cost is based on the number of variables and data years selected. • Justification for each selected variable must be provided. • IRB application must be detailed and clear. • Dates, data years, and data variables must match throughout all forms. • RDF Data must be destroyed by the project end date or must be renewed through the DSHS program and DSHS IRB by the project end date. 4

Research Data RDF or PUDF Datasets The following datasets are available through the THCIC program for both RDF and PUDF include: Inpatient Data - Administrative Hospital Inpatient Discharge Claims Data Outpatient Data - Administrative Hospital and Ambulatory Surgery Center Outpatient Claims Data. includes only those patients which received and one or more invasive surgical or radiological/imaging procedures. ED Data - Administrative hospital based Emergency Department visit data. 5

Research Data RDF vs PUDF “What is the difference between the RDF and PUDF? ” • The RDF requires DSHS IRB approval; the PUDF does not. • The RDF may take months to release the data; the PUDF data files are released within days of receipt of payment. • The RDF variables are selected individually for what is needed for your specific IRB approved research project; the PUDF variables are all included. • There are more RDF variables available than what is available in the PUDF. For example: The DSHS IRB approved RDF can have date of birth, service dates, unsuppressed ZIP codes or patient race and ethnicity codes. The RDF may contain Census Block or Census Block Groups. 6

Getting Started Before contacting the THCIC program regarding your research data request. The applicants should review and be familiar with the following documents: • THCIC (Inpatient, Outpatient or ED) Data Order Form(s) • THCIC Inpatient User Manual or Outpatient Data Dictionary or ED Manual (when available) • DSHS IRB Forms This will make the communications much more effective and efficient. 7

RDF Program Inpatient Order Forms and User Manuals Download the Program Order Form(s) and review the User Manual/Data Dictionary Inpatient Order Form and User Manual are posted at: http: //www. dshs. texas. gov/thcic/hospitals/RDF_IP_Order. Form. pdf • User Manual 1999 -2003 http: //www. dshs. texas. gov/thcic/publications/hospitals/IP_RDF_Data. Di ctionary 1999_2003. pdf • User Manual 2004 -3 Qtr 2015 http: //www. dshs. texas. gov/thcic/publications/hospitals/IP_RDF_Data. Di ctionary 2004_Present. pdf • User Manual 4 Qtr 2015 -Present http: //www. dshs. texas. gov/thcic/publications/hospitals/IP_RDF_Data. Di ctionary. Q 42015. pdf 8

RDF Program Order Forms Outpatient Data Dictionaries Download the Program Order Form(s) and review the User Manual/Data Dictionary Outpatient / ED Order Form and Data Dictionary are posted at: http: //www. dshs. texas. gov/thcic/hospitals/RDF_OP_Order. Form. pdf • Data Dictionary 2010 - 3 Qtr 2015 http: //www. dshs. texas. gov/thcic/publications/hospitals/OP_RDF_Diction ary. pdf • Data Dictionary 4 Qtr 2015 -Present http: //www. dshs. texas. gov/thcic/publications/hospitals/OP_RDF_Diction ary. Q 42015. pdf 9

DSHS IRB Checklist and Forms DSHS IRB Application forms are located at: http: //www. dshs. texas. gov /irb/applirb. shtm Review the “Checklist” section for the type of application forms and select the most appropriate form for your situation. All new request will use the “Initial Submission Form” 10

DSHS IRB Required Training All Persons accessing the data must take the required course: Human Participant Protection Education and submit their certificate with the application. Contact the THCIC program to discuss your research study 11

Draft Application Email DRAFT application packet to the THCIC Program Application packet includes: • Completed IRB forms. • Human Participant Protection Education Certificate(s). • Completed THCIC Order Form(s). • Initial and sign all forms. • Scan all forms into one PDF file. • Email PDF file to the THCIC program at: thcichelp@dshs. texas. gov • Include the in Email Subject line the following: “Draft IRB – (Name of Principal Investigator)”. 12

Program Response on Draft Application THCIC staff will review the draft application and respond to the Principal Investigator listed on the IRB application by email within 5 to 10 business days. The THCIC staff responses are to provide feedback to the Principal Investigator on areas where the application needs more information or clarity, if needed. 13

Submit Finalized Application Packet • Principal Investigator finalizes their DSHS IRB application packet and returns to THCIC staff. • Print out one original packet (single-sided) and one copy (single-sided) of the application packet. • Mail both packets (one original packet and one (1) copy) to: Regular mail: Texas Department of State Health Services Center for Health Statistics, THCIC Program P. O. Box 149347, MC 1898 Austin, Texas 78714 -9347 Overnight mail: Texas Department of State Health Services Center for Health Statistics, THCIC Program 1100 W. 49 th Street, MC 1898 Austin, Texas 78756 -3199 14

THCIC IRB Application Process The following DSHS programs must review and preapprove the finalized IRB application packet prior to its delivery to the IRB Committee for placement on the meeting calendar. This pre-approval process take about two (2) weeks. • DSHS THCIC program • DSHS Office of General Counsel (OGC) • DSHS Assistant Deputy Commissioner 15

THCIC IRB Application Process If any of the programs disapprove the application, the THCIC staff will notify the Principal Investigator of the contributing issues. The Principal Investigator may submit another updated finalized application packet with the modifications. It must include one original and one copy of the complete application packet. 16

THCIC IRB Application Process Once the application packet is pre-approved by the three review areas, the packet is delivered by THCIC staff to the DSHS IRB Administrator for placement on DSHS IRB Committee’s meeting calendar. A pre-approved application packet must be delivered by the THCIC staff to the IRB Committee approximately three (3) weeks prior to a scheduled IRB Committee meeting. This requires submission by the Principal Investigator to THCIC staff five (5) weeks prior to the meeting The IRB Committee meets the third Thursday of each month. (There are generally no DSHS IRB meetings scheduled for the month of August) http: //www. dshs. texas. gov/irb/applirb. shtm 17

THCIC IRB Application Process If your application is approved by the DSHS IRB Committee, it is forwarded to the DSHS Executive Steering Committee (ESC) for final approval. Note: This is Applicable for “first-time new submissions”. Upon final decision by the IRB Committee or ESC, the DSHS IRB Administrator will email the Principal Investigator, as well as the THCIC program, whether the application is approved/disapproved. This may take about two or three weeks after the IRB Committee meeting before the Principal Investigator receives the email determination notice. 18

Receiving the Data Once THCIC staff receives the approval notice from the DSHS IRB Administrator, THCIC staff will email the Principal Investigator a billing invoice. When the payment is received by the DSHS Accounting Office and THCIC are notified of the deposit, THCIC staff will begin building the DSHS IRB approved research dataset for your project. The research dataset will be mailed to the Principal Investigator approximately 5 to 7 business days after the payment is received. This time may be longer for datasets that are multiple years, or for additional processes to provide the approved dataset. 19

Questions? • Contact the THCIC Program at 512 -776 -7261 or thcichelp@dshs. texas. gov Data questions • IRB FAQs at http: //www. dshs. texas. gov/thcic/IRBFAQs. aspx • Contact the IRB Administrator at 512 -776 -2202 IRB form or required training questions 20