or tissue, stating that “human subjects” are not involved when the material “was collected for purposes other than submission to the Repository,” and the “material is submitted to the Repository without any identifiable private data or information.”15 Thus, some biobank research constitutes human subjects research covered by the Common Rule, while other biobank research is what has been called “human non-subjects research” and is not covered by the Common Rule.16,17 Developing appropriate standards for the second type remains a challenge, one that DHHS attempts to address in a recent proposal of possible changes to the Common Rule.2
