NPRM Symposium: Helpful Resources to Understand What the NPRM Proposes to Change

For those trying to make sense of the NPRM, the Academic and Clinical Research Group at Verrill Dana has issued two very helpful resources: 

  1. A redline of HHS’s current Common Rule regulations at 45 C.F.R Part 46, Subpart A against the proposed regulations in the NPRM.
  2. Several decision charts walking through the following issues: 
  • the scope of covered human subject research and clinical trials,
  • the key definitions of “human subject” and “research,”
  • the exclusions (and conditions for exclusion) from the proposed regulations, and
  • the exemptions (and associated requirements) from the proposed regulations.

For those interested, the firm’s full client advisories on the NPRM are available here

[Posted with Verrill Dana’s permission]

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