An overview of stakeholder comments on proposed revisions to informed consent forms and the posting of informed consent forms within 60 days after closure of enrollment.

On September 28, 2015, the U.S. Department of Health and Human Services (HHS) and 15 other federal agencies issued a notice of proposed rulemaking (NPRM) updating federal policy for the Protection of Human Subjects, more commonly known as the Common Rule. Earlier this month, we summarized stakeholder comments regarding the redefinition of “biospecimen” as a “human subject” and the consent requirements for secondary use of these biospecimens. This update focuses on proposed changes to informed consent forms (ICFs) and the requirement to post ICFs within 60 days after patient enrollment closes.