LIMITED DATA SETS

 

Applicability

The study team will need to complete a not-regulated application through eResearch, including Sections 25-1 and 25-4. The Privacy Board will consider the following representations:

  • The data set excludes specified direct identifiers of the individual, relatives, employers, and/or household members of the individuals.
  • The data use agreement establishes the permitted uses and disclosures and limits who can use or receive the data.
  • The recipient has affirmed the following:
    • The data set will be used or disclosed only for the research project described in this application.
    • The data set will be used or disclosed consistent with the IRB‐approved protocol or as required by law.
    • Appropriate safeguards will be used to prevent use or disclosure of limited data set information other than as provided in the application and IRB approval.
    • Any use or disclosure not permitted under the IRB‐approved protocol will be promptly reported to the Compliance Office.
    • No attempts will be made to re‐identify or contact individuals whose information is included in the data set.

 

Data Use Agreement Templates

 

 

 

 

 

 

 

 

 

 

 

 

 

Process Flowchart

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Update Approved by IRBMED Chairs and Director: October 14, 2011
Website Updated: October 17, 2011