Date Posted: 3/22/2023
Expiration Date: 5/10/2023
Submitted to Registrar for publication:
YES
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The periodic review decision filed on 2/17/23 for the Regulations to Assure the Protection of Participants in Human Research [12 VAC 35 ? 180] is changed from 'amend' to 'retain.' At this link you can see the excerpt below that the last action initiated on 10/10/2018 was after the final rule was published. Therefore, the revision is reposted with the decision to retain with a corresponding revised EIA. You can see that change here.
The Federal Policy for the Protection of Human Subjects (also known as the "Common Rule" and codified for HHS at 45 CFR part 46, subpart A) was originally promulgated in 1991 and amended in 2005. This version of the Common Rule is referred to as the "pre-2018 Common Rule" or “pre-2018 Requirements - PDF”. You can find the pre-2018 Common Rule by reviewing subpart A of 45 CFR part 46 - PDF as published in the 2016 edition of the Code of Federal Regulations (CFR).A comprehensive revision to the Common Rule was published in the Federal Register on January 19, 2017 (82 FR 7149).
The revised Common Rule has been amended twice, in an interim final rule published on January 22, 2018 (83 FR 2885), and in a final rule published on June 19, 2018 (83 FR 28497). The revised Common Rule is referred to as the “2018 Requirements."
