Is IRB review or exemption required for analysis of a data set that contains no identifiers and no means (anywhere) to link specific data with an individual respondent?
Yes, if done for research purposes (i.e. increase generalizable knowledge). If the investigator provides the IRB with details of the method by which data will be recorded without identifiers, and the data are already in existence, exemption category 4 may be appropriate (such situations may also be considered not human subject research in accordance with 45 CFR 46 if the data was collected for non-research purposes). Alternatively, if the data are publicly available, and analysis is limited to existing data, the project may also be eligible for exemption under category 4.
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