Does a research project using leftover blood samples require it to be classified as human subjects research if identifiable medical records are reviewed?

The classification of a research project as human subjects research hinges on whether the research involves identifiable private information about individuals. In the case of using leftover blood samples, if the research includes the review of identifiable medical records, it pertains to information that can be traced back to specific individuals. This means the research can potentially affect the privacy and rights of those individuals.

When identifiable information is used, it implicates ethical considerations and regulations designed to protect human subjects. The ethical frameworks, such as those outlined in the Common Rule and by institutional review boards, are in place to safeguard individuals' rights when their personal information is involved in research. Therefore, because the review of identifiable medical records connects the research activity directly to individuals, it necessitates the application of human subject protections.

The other options do not align with these considerations, as they suggest scenarios that do not adequately address the need for protection when identifiable data, in this case, medical records, are involved in the research.