June 25, 2018
In a widely expected move, HHS issued a final rule to once again delay implementation of the revised Common Rule on the protection of human subjects in clinical trials until Jan. 21, 2019, and to permit an exception from the existing federal policy for three burden-reducing provisions during the delay period.
The new federal policy was originally scheduled to go into effect on Jan. 19, 2018, but was delayed for six months through a controversial January 17 interim final rule—a last-minute move that caused considerable confusion in the regulated industry.
In the 142-page final rule, HHS acknowledged that the “rollout created administrative burdens for institutions, as many had changed IT systems, training programs and other operational tasks and then had to hastily undo these changes.”
HHS proposed the delay until 2019 in an Apr. 20 notice of proposed rulemaking and called for stakeholder comments on allowing the three burden-reducing provisions for regulated entities.
The three burden-reducing provisions center on the definition of “research,” which deems certain activities not to be research, the elimination of annual continuing review of certain categories of research and the elimination of the requirement that institutional review boards review grant applications related to the research.
The three burden-reducing provisions can only be implemented during the delay period for studies begun prior to Jan. 19, 2019. Any study that implements the three provisions during the delay period must, beginning on Jan. 21, 2019, comply with all of the 2018 Common Rule requirements for the balance of the study.
Comments on the interim final rule included objections to the short time between closing of the comment period on the Apr. 20 proposal and the July 19 implementation date, arguing the timing meant any further delay would create similar chaos and confusion.
Other comments suggested the general compliance dates for the 2018 requirements should coincide with FDA amendments to its human subjects protection regulations to ensure there is no window where FDA regulations are not aligned with those of other Common Rule agencies and departments.
In response to these comments, HHS said the FDA is “currently working to harmonize its human subjects regulations with the 2018 Requirements, to the extent permitted by FDA’s statutory authority and mandate. We do not believe it is necessary to further delay the 2018 Requirements’ general compliance date as a result of a separate rulemaking effort.”
“I don’t think anyone is surprised by the additional delay. The Interim Final Rule issued in January was clear that OHRP was going to ask for the additional delay because they needed time to develop guidance for IRBs implementing the revised Common Rule,” said David Borasky, vice president of Institutional Review Board (IRB) compliance at WIRB-Copernicus Group. “I also found it interesting that almost half of the comments received by OHRP advocated letting institutions begin implementing the entire revised rule immediately. I think that there is a large minority of people who are tired of the rulemaking process, which has gone on for several years now.”
–By Zack Budryk