ADEA State Update

An Update on Dental Regulations - February 2018

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DiceHHS Delays Implementation of the Common Rule

On Jan. 22, the U.S. Department of Health and Human Services (HHS) issued an Interim Final Rule to delay implementation of the revised Federal Policy for the Protection of Human Subjects (“the Common Rule”) for six months. Specifically, the interim final rule delays the effective date and general compliance date of the 2018 requirements from Jan. 19, 2018, to July 19, 2018. Comments are due by March 19, 2018.

On Jan. 19, 2017, HHS and 15 other federal departments and agencies released the final revisions to the Common Rule. The regulations, in place since 1991, govern federally supported research involving human subjects. Changes to the regulations include the following: mandate that a single Institutional Review Board (IRB) reviews and approves all multi-site research; mandate an extension of the Common Rule to all clinical trials conducted at a U.S. institution that receives federal funding regardless of the funding source; and require new approaches to the informed consent process, such as the publication of informed consent documents. 

Duggan Dental