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Research Matters

Delay: Federal Policy for the Protection of Human Subjects

Substantial revisions to the federal regulations for the protection of human participants in research (Common Rule) may become effective on July 19, 2018. These changes will apply to all new studies submitted for IRB determination or review on or after July 19, 2018.

The U.S. Department of Health and Human Services (HHS) and 16 other federal departments and agencies are issuing a Final Rule to delay the compliance date for a Federal Policy for the Protection of Human Subjects (also known as the Common Rule) until Jan. 21, 2019. The Final Rule adopts the proposals that were described in the April 2018 NPRM. The exception to this general rule is that institutions will be permitted (but not required) to implement, for certain studies, three burden-reducing provisions of the 2018 Requirements during the delay period (July 19, 2018 through Jan. 20, 2019.)  See the Human Subjects Office website for additional information.