Bill Ferreira

Mar 11, 2024 | lexology.com | Heidi Forster Gertner |Bill Ferreira |Randy Prebula |Yetunde Fadahunsi |Will Tenbarge

As part of its broader efforts to improve the informed consent process for prospective study participants, the U.S. Food and Drug Administration (FDA) and the Office for Human Research Protections (OHRP) in the Department of Health and Human Services (HHS) published new draft guidance on how to present key information at the beginning of an informed consent document.