Please include the following information on your new IRB application. If you are filing an amendment to an existing IRB application, please use this as a guide for the information you need to include. However, the iStar fields possibly will not match.
1. In Section 6.1, ensure to check “yes” for HSC Facilities and LAC+USC Associated Locations.
2. In Section 6.A. 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.
3. 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, also needed for your IRB application.
4. 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.
5. 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
6. In section 13.2.1, check "Yes" for use of the Clinical Data Warehouse (CDW).
7. Indicate if you intend to contact patients using the information provided by the Informatics and Analytics core for study recruitment purposes. In Section 13.3, in your own words, generally state you will be working with the DHS Informatics and Analytics to extract the data variables listed in sections 13.2 & 13.3 which will be sourced from the DHS Data Warehouse or DHS i2b2.
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.
8. 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
8. In Section 24.3, 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. With both a partial waiver, you may have access to PHI for study recruitment purposes. However, once the participant agrees to participate, they must ALSO consent to sign the full authorization in order for you to use/retain any of the data accessed from the partial waiver.
9. In Section 36.1, indicate that you will be using a Partial Waiver. Then, for Section 36.2, answer “Both” that you will be obtaining both authorization from participant and a Full Waiver.
9. In Section 42, indicate which Clinical Data Warehouse(s) you will be requesting research data from.
10. In your Methods and Procedures section, specify a plan how the DHS Investigator will take responsibility for all DHS data storage, transfer, and management. Patient PHI files will be kept within the DHS Intranet, encrypted, password-protected, and behind DHS firewalls. (check section 24.5.1 B). Include how data management and transfer will be handled (i.e. de-identifying all DHS PHI before external data transfer).
Identified data will only be released to study personnel with proper DHS credentials, named and approved for viewing identifiable data as named in your IRB. All provisioned datasets will be destroyed upon completion of the research study. Please indicate that the Informatics and Analytics Core will receive any incoming data and deliver the requested research data via one of the two following methods.
11. In section 42.2, please indicate which variables from the CDW you will require.
12. 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 patient PHI are clearly stated in Section 13.
Once you have received an IRB approval letter of approval 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.