A Limited Data Set may be used only if the covered entity providing the data and the recipient of the data first enter into a Data Use Agreement. The investigator, the holder of the PHI, and their respective institutions, must sign Data Use Agreements, either for access to a Limited Data Set or for the release of a Limited Data Set. At IU, the Office of Research Administration, Research Compliance will assist with the completion of these agreements. These agreements must, among other things, establish the permitted uses and disclosures of the information included in the Limited Data Set and must provide that the recipient of the Limited Data Set will not identify the information or use it to contact individuals
As with research conducted pursuant to an authorization, disclosure(s) of PHI that are part of a Limited Data Set need not be tracked for purposes of providing an accounting to an individual.
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