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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)

• 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 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.

In Question 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.

If you will be using the dataset to contact DHS patients for study recruitment, select ‘Clinical Data Warehouse’:

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Please note that if the research study is submitted for exempt Exempt review, it will not NOT have iStar Question 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. 

Select ‘Yes’ if you will be requesting to include any of the 18 HIPAA identifiers (listed in Question 35.1) in your dataset. Note that you would only select ‘No’ to this question if you are requesting a fully de-identified dataset.

Please select ‘Yes’ as applicable if your dataset will include HIV data, mental health data, or substance abuse treatment data. Make sure to select ‘Yes’ if your study’s selection criteria has any of this data.

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 patient medical records review only, then you should indicate in Question 36.1, “None of the above” and in Question 36.2, “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.

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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

• If you will be using the dataset to contact and recruit subjects for your study, select ‘Partial Waiver of HIPAA Authorization for screening, recruiting, and identifying participants.

• Otherwise, select ‘None of the Above’ and in section 36.2, “Full waiver of HIPAA”.

Then, for Question 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.

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