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
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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’.  Image Added |
Section 5 Type of Study Review
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| title | Question 5.2 Full Protocol |
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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.
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| title | Question 6.1 Study Locations Section |
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In Question 6.1, check “USC HSC Locations” and “LAC+USC Associated Locations.”  Image Removed |
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| title | Question 6.a.1 HSC Location(s) and/or Los Angeles General Medical Center 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.  Image Removed |
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| title | Question 6a.4 Los Angeles General Medical Center Studies |
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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.  Image Removed |
Section 9
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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.  |
Section 13 Methods and Procedures
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| title | Question 13.1 Methods and Procedures - Collection of Data/Specimens |
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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.  |
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| title | Question 13.2 Methods and Procedures - Collection of Data/Specimens |
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In Question 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. |
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| title | Question 13.2.1 Methods and Procedures - Collection of Data/Specimens |
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In Question 13.2.1, check "Yes" for use of the Clinical Data Warehouse (CDW) at LA County. This answer will trigger Section 42.
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| title | Question 13.4 Methods and Procedures - Collection of Data/Specimens |
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In Question 13.4 Methods and Procedures, indicate if any identifying patient private health information (PHI) is requested. |
Section 24 Subject Recruitment and Informed Consent
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| title | Question 24.3 Informed consent and waivers |
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If you will be using the dataset to contact DHS patients for study recruitment, select ‘Clinical Data Warehouse’:  Image AddedPlease 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. |
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Section 35 Is the HIPAA Privacy Rule Applicable?
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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.  Image Added |
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| title | Question 36 HIPAA Analysis |
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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.
In Question 36.1, if |
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.  Image Added |
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| title | Questions 35.4 to 35.6 |
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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.  Image Added |
Section 36 HIPAA Analysis
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| title | Question 36.1 - 36.2 |
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If you are using the CDW at DHS for RECRUITMENT recruitment purposes, indicate that you will be requesting a “Partial waiver Waiver of HIPAAHIPAA”.” 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 section Question 36.2, “Full waiver “Full Waiver of HIPAA”. Then, for In Question 36.2, select “Both” to indicate that you will be obtaining both “Obtaining 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.  Image Removed |
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participant” if you are using or accessing the medical records to conduct the study. Image AddedPlease 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
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| title | Question 42 Clinical Data Warehouse.1 |
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In Question 42, select which Clinical Data Warehouse(s) you will request research data from.  |
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| title | Question 42.2 Clinical Data Warehouse |
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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. | Info |
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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’ |
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| title | Question 42.3 Clinical Data Warehouse |
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| In Question 42.3, indicate |
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”  Image Added |
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.  Image Added |
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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.  Image Added |
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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.  Image Added |
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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