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In your study protocol in Question 5.2, in your own words, state in the Methods and Procedures section (using track edit changes) that you will be working with the DHS Informatics and Analytics Core to extract the data variables listed, which will be sourced from the DHS Clinical Data Warehouse or DHS i2b2. Specify that the DHS Investigator(s) will take responsibility for all DHS data management, storage, transfer, and management. PHI files must be only kept within to IRB-approved study personnel with proper DHS credentials, kept within the DHS Intranet, encrypted, password-protected, and behind DHS firewalls. Be sure to enable track changes if making these protocol changes to your IRB.  Be specific in how DHS PHI will be handled behind County firewalls/DHS Intranet by only IRB-approved DHS study personnel. Provide further details on how the PI will handle DHS data management (i.e. on a password-protected Keck laptop) and if applicable, data transfer (i.e. de-identified data to REDCap)
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In Question 6.1, check “USC HSC Locations” and “LAC+USC Associated Locations.”  |
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In Question 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.  |
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Please list all research personnel with DHS credentials, along with their DHS Employee IDs, aka their County C or E number. Please note that the DHS Investigator(s) should be the primary recipient of data.  |
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In Question 6a.4, select “Yes” to indicate that this research will potentially benefit DHS patients in the future. Mark the following questions in this section that best reflect your research study.  |
Section 9 Methods and Procedures
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In Question 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.  |
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If you are using the CDW at DHS for recruitment purposes, indicate that you will be requesting a “Partial Waiver of HIPAA”. In Question 36.2, select “Obtaining HIPAA authorization from participant” if you are using or accessing the medical records to conduct the study. If you are using the CDW at DHS for patient medical records review only, then you should indicate in Question 36.1, “None of the above” and in Question 36.2, “Full “Full Waiver of HIPAA”. In Question 36.2, select “Obtaining HIPAA authorization from participant” if you are using or accessing the medical records to conduct the study.  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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Indicate if you plan to contact people whose data will be obtained from the CDW. Ensure that your contact methods and management of DHS PHI are clearly stated in your study protocol in Section 5.2. For more information on templates for contacting study participants, please see the following iStar link: Click iStar Link here  |
Section 45 Study Locations
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Select “USC HSC - Health Sciences Associated Locations” and “Los Angeles General Medical Center Locations”  |
Section 45b Los Angeles General Medical Center Locations
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In Question 45b.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.  |
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Please list all research personnel with DHS credentials, along with their DHS Employee IDs, aka their County C or E number. Please note that the DHS Investigator(s) should be the primary recipient of data.  |
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Select“Yes” to indicate that this research will potentially benefit DHS patients in the future. Mark the following questions in this section that best reflect your research study.  |
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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