As noted above, some biobanks collect their own data and samples, while others rely on primary researchers and collectors at multiple sites to perform collection, with data and/or samples then aggregated in the biobanks. Three variables of importance to our analysis below are: whether the biobank is itself conducting research, the degree and type of de-identification of data and samples in the biobanks, and (related to this) whether biobank research and secondary research by researchers accessing biobank data/samples qualify as research on human subjects under the Common Rule.11 We address these three variables in turn.
