Please include the following information on your new IRB application. If you are filing an amendment to an existing IRB application, please use this as a guide for the information you need to include. However, the iStar fields possibly will not match.
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2. In section 6.A. please check the specific county 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 9. Methods and Procedures, please check one of the secondary analysis options, that most apply to your research. Checking one of these boxes triggers the activation of section 13, also needed for your application.
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8. In section 24.3, indicate if you will or will not require a HIPAA Waiver of 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.With a partial waiver, you may have access to PHI for recruitment purposes. However, once the participant agrees to participate, they must sign the full authorization in order for you to use/retain any of the data accessed from the partial waiver.
9. In section 42, indicate which Clinical Data Warehouse you will be requesting data from.
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10. In your Methods and Procedures section, please specify a plan how the DHS Investigator will take responsibility for all DHS data storage, transfer, and management. Please indicate that all data files will be encrypted, password-protected, and will only be accessed/reside behind DHS firewalls (check section 24.5.1 B). Data will only be released to individuals 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.
11. In section 42.2, please indicate which variables from the CDW you will require.
12. In section 42.3 please indicate if you plan to contact people whose data will be obtained from the CDW.
Once you have received IRB approval and a letter of approval with a categorization scre, you are ready to submit a data request to the DHS Informatics and Analytics Core.