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IRB Issues and Archival Data: From Data Deposit to Data Use

Presenter 1
Amy Pienta

IRB issues as they relate to archival data are quite wide-ranging. This presentation will describe the importance of understanding the IRB process with respect to archiving and use of secondary research data. IRB often provide oversight of data archiving plans and informed consent statements may prohibit public archiving of data. ICPSR will present examples of informed consents that should and should not be used when a researcher intends to provide long-term access to data through a data archive. With respect to use of secondary data, some IRBs in the U.S. recognize publicly archived data as being exempt from IRB review when secondary analysis is proposed. The University of Michigan recently instituted a process of adding public-use data to a list of pre-approved data that do not need IRB-clearance prior to analysis. These examples will be discussed in this presentation.

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