DHS IRB Instructions for iStar

In your study protocol in Section 5.2, in your own words, state in the Methods and Procedures section 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)

• 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.

In Section 6.1, check “USC HSC Locations” and “LAC+USC Associated Locations.”

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.

In Section 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.

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.

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.

In Section 13.2, upload a Data Collection Form which includes all of the variables you will need for the research data request (can be a Word Doc or Excel Sheet).

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.

In Section 13.2.1, check "Yes" for use of the Clinical Data Warehouse (CDW) at LA County.  This answer will trigger Section 42.       
         

In Section 13.4 Methods and Procedures, indicate if any identifying patient private health information (PHI) is requested. 

• ADDRESS1 

• ADDRESS2

• Admit Date

• City 

• Discharge Date 

• Encounter Number 

• Medical Record Number (MRN) 

• Name 

• Phone 

• State

• Zip

If the research study is submitted for exempt review, it will not have iStar section 24.3. If NOT exempt, in Section 24.3, for “Informed consent and waivers” 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.

• DHS Shared Drive

• /wiki/spaces/FAQS/pages/700481643

In Section 36.1, if you are using the CDW at DHS for RECRUITMENT purposes, indicate that you will be requesting a “Partial waiver of HIPAA.”

If you are using the CDW at DHS for medical records review only, then you should indicate in section 36.1, “None of the above” and in section 36.2, “Full waiver of HIPAA”.

Then, for Section 36.2, select “Both” to indicate that you will be obtaining both HIPAA authorization from participant in addition to a Full Waiver (since their PHI will be obtained).

**With a Partial Waiver, you may have access to DHS PHI for study recruitment purposes. However, for recruitment studies, 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.

In Section 42, select which Clinical Data Warehouse(s) you will request research data from.

In Section 42.2, please indicate which PHI variables from the CDW you will require.

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 DHS PHI are clearly stated in your study protocol in Section 5.2.