SACHRP Advises FDA to Adjust Informed Consent Waivers to Reflect HHS Rules

The Secretary’s Advisory Committee on Human Research Protections is recommending that the FDA revise its informed consent waivers for cluster randomized trials to mirror HHS rules.

Such a change would allow for minimal risk research to be conducted when specific criteria are met.

The requested changes are intended to aid IRBs, investigators and institutions that must consider when consent is necessary for CRTs. Last week, the committee said that both the FDA and OHRP should issue guidance on informed consent in CRTs.