EPA Issues Final Rule Delaying Compliance Date for Human Subjects Policy by Six Months; Institutions May Utilize Three Burden-Reducing Provisions during the Delay
On June 19, 2018, 16 federal agencies, including the U.S. Environmental Protection Agency (EPA), issued a final rule delaying until January 21, 2019, the general compliance date for 2017 revisions to the policy governing studies with human subjects that are sponsored or utilized for regulatory purposes by the federal government (83 Fed. Reg. 28497). These revisions to the human testing policy were adopted on January 19, 2017, in a final rule (82 Fed. Reg. 7149) that amended and expanded the “Common Rule” governing human testing originally promulgated in 1991. The 2017 revisions to the human testing policy were originally scheduled to take effect on January 19, 2018, but the agencies published an interim final rule on January 22, 2018, that delayed the effective date for the new policy until July 19, 2018. Thereafter, on April 20, 2018, the same 16 agencies published a proposed rule (83 Fed. Reg. 17595) to delay the general compliance date for an additional six-month period, and to allow regulated entities to implement certain burden-reducing provisions during this interim period.
The rule delaying the effective date of the 2017 revisions for an additional six months takes effect on July 19, 2018. In the period between July 19, 2018, and January 21, 2019, regulated entities must continue to comply with the requirements of the human testing policy as it was in effect prior to the 2017 revisions. Notwithstanding this general rule, affected institutions will be permitted (but not required) to implement, for certain research, three burden-reducing provisions. Those three provisions are:
- The revised definition of “research,” which deems certain activities not to be research covered by the Common Rule;
- The elimination of the requirement for annual continuing review with respect to certain categories of research; and
- The elimination of the requirement that institutional review boards (IRB) review grant applications or other funding proposals related to the research.
The principal purposes of the additional delay in implementation of the 2017 revisions to the human testing Common Rule are to allow more time for affected institutions to prepare for compliance and for the federal agencies that have adopted the new policy to issue further guidance. The final rule states that the agencies do not expect that any additional delay in the implementation of the policy will be needed.