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