Announcement

The revised Common Rule requires that for any clinical trial conducted or supported by a Common Rule department or agency, one consent form be posted on a publicly available federal website within a specific time frame. The consent form must have been used in enrolling participants in order to satisfy this new provision. No obligations to post such consent forms apply before January 21, 2019. At this time two publicly available federal websites that will satisfy the consent form posting requirement, as required by the revised Common Rule, have been identified: ClinicalTrials.gov and a docket folder on Regulations.gov (Docket ID: HHS-OPHS-2018-0021). HHS and other Common Rule departments and agencies are developing instructions and other materials providing more information to the regulated community about this posting requirement.

Posted

Aug 15, 2018

Comment period

Aug 15, 2018 – Jan 1, 2100

Agency

HHS

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