Rapidly Approaching Compliance Date for Single IRB

The January 20, 2020 compliance date for the single IRB requirement for cooperative research at §46.114(b) of the revised Common Rule is only a few short days away.  While it is HRP’s understanding that OHRP intends to issue guidance about this provision, that...

NEWS FLASH: FDA Proposed Rule – Waivers of Consent

On November 13th, the FDA announced a proposed rule to amend its regulations to allow for waivers and alterations of consent for certain minimal risk research. Comments on the proposed rule will be accepted through January 14. 2019 via regulations.gov or in writing...