Common Rule Changes: The Proposal for Excluded Research

Common Rule changes – The proposal for excluded research

One of the major changes outlined in the Notice of Proposed Rule Making (NPRM) is the creation of a new section of the regulations describing activities that would be “excluded” from the requirements of the Common Rule.

This whitepaper summarizes the new excluded categories under the proposed rule, and provides explanations for how each Excluded Category impacts existing Exempt Categories where applicable.

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Download the whitepaper