Delays Implementation of the Common Rule
On Jan. 22, the U.S.
Department of Health and Human Services (HHS) issued an Interim
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.
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