Page Comparison

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 mark yes for HSC Facilities.Image Added
   
   
   

2. In section 6.A. please check the 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. Image Added

4. 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.Image Added

5. In section 13.2, upload a Data Collection Form which includes all of the variables you will need for the research.

   1. 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.
6. If applicable, please also include a PDF of your i2b2 print query report. Please review the how-to "Print Query" article for further instruction.
   In section 13.2.1, please check "Yes" for use of the Clinical Data Warehouse (CDW). This is the technical environment research data is sourced from by the Informatics and Analytic core.
   Image Added

7. In section 13.3, in your own words, generally state you will be working with the DHS Informatics and Analytics core for the variables indicated (see step X) which will be sourced from the DHS Data Warehouse or DHS i2b2.

8. In section 13.3, write out your data request's inclusion/exclusion criteria.

   
   
   1. Indicate which variables you plan to obtain by working with the Informatics Team and or i2b2.
   2. Indicate which variables you plan to abstract by conducting further chart review.
   3. Please Indicate if you intend to contact patients using the information provided by the Informatics and Analytics core for study recruitment purposes.
      
      
9. In section 13.4 Methods and Procedures, please indicate if any identifying patient information is requested. 
   1. ADDRESS1  
   2. ADDRESS2
   3. Admit Date
   4. City  
   5. Discharge Date  
   6. Encounter Number  
   7. MRN  
   8. Name  
   9. Phone  
   10. State  
   11. Zip
       
       
10. Please make sure to check off the respective county facilities in section 6a.1 of your IRB application to trigger the Research Oversight Board research categorization process.
    
    
11. In section 24.3, indicate if you will or will not require a HIPAA Waiver of  Consent. If yes, please include the “Waiver of Informed Consent” language.
    
    
12. Include a plan for 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 data via one of the two following methods 
    1. DHS Shared Drive
    2. /wiki/spaces/FAQS/pages/700481643
       
       
13.  In section 42 indicate which PHI  elements you intend to obtain using the Clinical Data Warehouse.

...