Include the following on your IRB application for your DHS research request. If you are filing an amendment to an existing IRB application, use this as a guide.
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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, indicate “Yes.”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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Please differentiate between data elements you plan to abstract from the chart and data that will be obtained using the Informatics Core team and or tools such as i2b2. If applicable, please also include a PDF of your i2b2 print query report. Please review the how-to "Print Query" article for further instruction
7. In section Section 13.2.1, check "Yes" for use of the Clinical Data Warehouse (CDW) at LA County.
8. Indicate if you intend to contact DHS patients using the information provided by the Informatics and Analytics core for study recruitment purposes.
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10. In Section 24.3, indicate if you will or will not require a HIPAA Waiver of Consentof Consent.
Please note that if DHS patient data will leave DHS premises for transfer or further analysis (i.e. entering PHI into REDCap in a Keck environment), you may need a Full HIPAA Waiver.
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11. In Section 36.1, indicate that you will be using a “Partial Waiver.” Then, for Section 36.2, select “Both” that you will be obtaining both authorization from participant, in addition to a Full Waiver.
**With a partial waiver, you may have access to DHS PHI for study recruitment purposes. However, once the participant agrees to participate, they must ALSO consent to sign the full HIPAA authorization in order for you to use/retain any of the data accessed from the Partial Waiver.
**The Full Waiver is also needed if patient data will be obtained from the CDW at DHS.
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12. In Section 42, indicate select which Clinical Data Warehouse(s) you will request research data from.
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13. In your Methods and Procedures section, specify a plan how the DHS Investigator will take responsibility for all DHS data storage, transfer, and management. PHI files will 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).
Identified data datasets will only be released to study personnel with proper DHS credentials, named and approved for viewing identifiable data as named 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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16. Once you have received an IRB approval letter of approval 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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