The United States Department of Health and Human Services (“HHS”) recently submitted a final rule to delay the implementation of the revisions to the Federal Policy for the Protection of Human Subjects (the “Common Rule”). HHS and the other Common Rule agencies published the long-awaited Final Rule revising the Common Rule on January 19, 2017 (the “Final Rule”), during the last days of the Obama Administration. While the implementation date for the bulk of the revisions made by the Final Rule is currently set for January 19, 2018, for some time there has been talk about delaying the implementation date. In fact, a separate proposed rule was submitted last October to delay by a year the implementation date of many of the changes made by the Final Rule.
HHS’s final rule delaying implementation was submitted to the Office of Management and Budget (“OMB”) for review on January 4, 2018. Although the text of the final rule is not yet publicly available, its title indicates that it would delay the implementation of the revisions to the Common Rule for an unspecified period of time. It is highly unlikely that the OMB will finish its review of the rule before the January 19 implementation date, and there probably will be a period after that date before HHS’ January 4 final rule delaying the implementation date goes into effect. During any such interim period, HHS and the other Common Rule agencies may not enforce the changes made by the Final Rule. The implementation date may be delayed by a year or possibly longer.
Whenever implementation is required—whether it is sooner or later—we renew our recommendation that institutional review boards and entities that are engaged in research efforts subject to the Common Rule continue to evaluate and update their policies and standard operating procedures to comply with the Final Rule once the changes do go into effect.