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Nonrulemaking
HHS
Open for Comments
HHS-OPHS-2018-0021
Clinical Trial Informed Consent Form Posting (sec. 116(h) of the revised Common Rule)
Documents
1
Comments
189
Description
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.
Key Dates
Comment Period OpensAug 15, 2018
Comment Period ClosesJan 1, 2100
Documents
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Other |
Comment Statistics
Total Comments
189
Data from Regulations.gov