Pharmaceutical & Life Sciences News

Common Sense to Be Used in Enforcing New Research Rule

July 11, 2018, 8:11 PM

HHS compliance officers won’t use a heavy hand to enforce an overhaul of a major research rule when those changes take effect in January.

Jerry Menikoff, director of the Health and Human Services Office for Human Research Protections, told Bloomberg Law he plans to exercise compliance discretion “to the extent we’re allowed to do so” on the first-ever changes to the human subject protection regulations known as the Common Rule (45 C.F.R. 46).

That should bring relief to academic medical centers, ethics panels known as institutional review boards, and other entities regulated by the Common Rule. The...

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