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Include the following on your IRB application for your DHS research data request. If you are filing an amendment to an existing IRB application, use this as a guide.
1. In Section 6.1, check “USC HSC Locations” and “LAC+USC Associated Locations.”
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2. In Section 6.a.1 check the specific DHS facilities that are applicable to your research study. This checkbox triggers the DHS research Oversight Board (ROB) research categorization process. To learn more about this process, click here.
3. In Section 6a.4, select “Yes” to indicate that this research will potentially benefit DHS patients in the future.
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4. In Section 9.1 Methods and Procedures, check one of the “Secondary Analysis” options that is most relevant to your research. Checking one of these boxes triggers the activation of Section 13, also needed for your IRB application.
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5. In Section 13.1, indicate “Yes” or “No” if you will be including DHS patients who are deceased. This must also be indicated in your patient cohort inclusion/exclusion criteria.
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7. In Section 13.2.1, check "Yes" for use of the Clinical Data Warehouse (CDW) at LA County. This answer will trigger Section 42.
8. Indicate if you intend to contact DHS patients using the information provided by the Informatics and Analytics core for study recruitment purposes. In your study protocol in Section 5.2, in your own words, generally state you will be working with the DHS Informatics and Analytics to extract the data variables listed in sections 13.2 & 13.3 which will be sourced from the DHS Data Warehouse or DHS i2b2.
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Indicate which variables you plan to obtain by working with the Informatics Team and or i2b2.
Indicate which variables you plan to abstract by conducting further chart review.
Indicate if you intend to contact DHS patients using the information provided by the Informatics and Analytics core for study recruitment purposes.
9. In Section 13.4 Methods and Procedures, indicate if any identifying patient private health information (PHI) is requested.
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12. In Section 42, select which Clinical Data Warehouse(s) you will request research data from.
13. In your the research study protocol in Section 5.2, specify in the Methods and Procedures section , specify a plan how the DHS Investigator(s) will take responsibility for all DHS data storage, transfer, and management. PHI files will must be kept within the DHS Intranet, encrypted, password-protected, and behind DHS firewalls. (check section 24.5.1 B). Include how data management/transfer will be handled (i.e. de-identifying DHS PHI before external data transfer). Be sure to enable track changes if making these protocol changes to your IRB.
Identified datasets will only be released to study personnel with proper DHS credentials, named and approved for viewing identifiable data as named reflected in your IRB. All provisioned datasets will be destroyed upon completion of the research study. Please indicate that the Informatics and Analytics Core will receive any incoming data and deliver the requested research data via one of the two following methods.
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15. In Section 42.3, indicate if you plan to contact people whose data will be obtained from the CDW. Ensure that your contact methods and management of patient DHS PHI are clearly stated in your study protocol in Section 135.2.
16. Once you have received an IRB letter of approval in iStar with an ROB categorization score, aka DHS Level of Support (ranges from 1-5), you are ready to submit a data request to the DHS Informatics and Analytics Core.
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