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Informed Consent › Proposed Rules › Department of Health and Human Services (HHS)

Hogan Lovells

FDA and OHRP publish draft guidance on facilitating understanding in informed consent

Hogan Lovells on

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...more

Health Care Compliance Association (HCCA)

FDA Consolidates, Revises Informed Consent Guidance; 2018 Common Rule Not Addressed

Health Care Compliance Association (HCCA) on

Nearly nine years to the day the Food and Drug Administration (FDA) issued a draft “information sheet” on informed consent, the agency published a 66-page final guidance document on the topic—marking the first time since 1998...more

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