Emergo Group Blog US FDA Clarifies Human Subject Requirements for Clinical Investigations

EMERGO SUMMARY OF KEY POINTS: New US FDA guidance clarifies compliance requirements for clinical trial sponsors, investigators and IRBs whose studies fall under both agency and Department of Health and Human Services (HHS) requirements. The guidance focuses on differences in human subject protection requirements between HHS and FDA clinical investigation regulations. FDA is currently updating its clinical regulations to better align with HHS requirements regarding human subject safety and informed consent issues.