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.
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2. In section 6.A. please check the specific county 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. Methods and Procedures, please check one of the secondary analysis options, that most apply to your research. Checking one of these boxes triggers the activation of section 13, also needed for your application.
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9. In section 42 indicate which Clinical Data Warehouse you will be requesting data from.
10. In your methods Methods and procedures Procedures section, please include specify a plan how the DHS Investigator will take responsibility for all DHS data storage, transfer, and management. Please indicate that all data files will be encrypted, password-protected, and will only be accessed/reside behind DHS firewalls (check section 24.5.1 B). Data will only be released to individuals 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 methods.
11. In section 42.2, please indicate which variables from the CDW you will require.
12. In section 42.3 please indicate if you plan to contact people whose data will be obtained from the CDW.
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