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FDA and OHRP Issue Joint Draft Guidance on Content, Organization, and Presentation of Consent Forms for Research Participants

On March 1, 2024, the U.S. Food and Drug Administration (FDA) and the U.S. Department of Health and Human Services’ (HHS’s) Office for Human Research Protections (OHRP) released a draft guidance titled “Key Information and...more

OHRP Draft Guidance on the Use of Single IRBs: Reminder to Comment by August 30

On July 1, 2022, the Office for Human Research Protections (OHRP) published a draft guidance document for public comment on the “Use of a Single Institutional Review Board for Cooperative Research” (“Draft Guidance”)....more

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