Include the following on your IRB application for your DHS research data request. If you are filing an amendment to an existing IRB application, use this as a guide.
Section 2 Study Personnel
Ensure that all study personnel that will access the data are listed. If they will access identifying patient data (names, dates, MRNs, etc.), select ‘Yes’ under ‘Access Identifiable Data’.
Section 5 Type of Study Review
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.
Section 6 HSC Location(s) and/or Los Angeles General Medical Center Locations
In Question 6.1, check “USC HSC Locations” and “LAC+USC Associated Locations.”
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.
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.
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
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.
Section 13 Methods and Procedures
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.
In Question 13.2.1, check "Yes" for use of the Clinical Data Warehouse (CDW) at LA County. This answer will trigger Section 42.
Section 24 Subject Recruitment and Informed Consent
If you will be using the dataset to contact DHS patients for study recruitment, select ‘Clinical Data Warehouse’:
Please note that if the research study is submitted for Exempt review, it will NOT have iStar Question 24.
Section 35 Is the HIPAA Privacy Rule Applicable?
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.
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.
Section 36 HIPAA Analysis
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 Waiver of HIPAA”.
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.
Section 42 Clinical Data Warehouse
In Question 42, select which Clinical Data Warehouse(s) you will request research data from.
Please indicate which PHI variables from the CDW you will require.
Select all variables that you will be requesting to include in the dataset. Please note that we cannot include identifiers in your dataset that are not indicated here.
A commonly missed item is dates. If you are requesting to include any dates in your dataset (date of birth, admission date, etc), make sure to select ‘All elements (except years) of dates related to an individual’
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
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.