Regulatory Updates

Regulatory Updates

  • On November 15, FDA issued a notice of proposed rulemaking (NPRM) titled Institutional Review Board Waiver or Alteration of Informed Consent for Minimal Risk Clinical Investigations. This proposed rule, if finalized, would permit IRBs to waive or alter certain informed consent elements or to waive the requirement to obtain informed consent, under limited conditions, for certain FDA-regulated minimal risk clinical investigations. The proposed rule is a response to certain statutory changes required by the Cures Act, and takes a step toward harmonizing the FDA rules with the Common Rule. The public may submit comments until January 14, 2019.

  • On October 12, 2018, FDA published guidance to clarify the impact of certain provisions of the 2018 Common Rule requirements on FDA-regulated clinical investigations. Clarifications include that:

    • Certain provisions of the 2018 requirements related to informed consent are not inconsistent with FDA’s current policies and guidance; and
    • FDA’s current regulations for expedited review and continuing review must be followed for FDA-regulated studies