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Defining the ‘human subject’: Federal regulations series part 2 of 5

Part 2 of MESM’s series on proposed federal research regulation amendments and the impacts on commericial sponsors and research organisations.

In this article we examine the rationale behind the NPRM proposals and the detail of the proposed reclassification of biospecimens as a ‘human subject’, irrespective of whether the sample is identifiable or not.

The Common Rule NPRM proposes a very fundamental shift in the definition of ‘human subjects’ and extends the Human Subjects Protection Framework to non-identified biospecimens research, with impacts on biobanking, secondary research and genomic research. In this article you'll find out more detail about what will change and how it will affect research in the United States.

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