By Lyle Dennis, Cavarocchi – Ruscio – Dennis Associates, Consultants to AASLD
In early 2017, multiple federal departments and agencies revised the federal policy governing the Protection of Human Subjects (often referred to as the “Common Rule”), which each department and agency adopted. The revised Common Rule was scheduled to become effective in early 2018, with general compliance required on that date. However, with an interim final rule issued two days before the effective date, federal departments and agencies delayed the effective date and the general compliance date for the revised Common Rule for a six-month period, until July 19, 2018. The revised Common Rule, including technical amendments made by the January 22, 2018 interim final rule, is referred to as the “2018 Requirements.”
On April 20 of this year, the federal departments and agencies involved published a notice of proposed rulemaking (NPRM) proposing and seeking comments as to whether the general compliance date for the 2018 Requirements should be delayed for an additional six-month period. The NPRM also proposed and sought comments on whether to allow regulated entities to implement certain burden-reducing provisions of the 2018 Requirements in specified circumstances the continued delay period.
Through this final rule published this week, the agencies have adopted the proposals described in the April 20, 2018 NPRM. This rule delays the general compliance date for the 2018 Requirements for an additional six-month period, until January 21, 2019. As a result of this delay, regulated entities will be required, with an exception, to continue to comply with the requirements of the pre-2018 version of the Federal Policy for the Protection of Human Subjects (the “pre-2018 Requirements”) until January 21, 2019.
The one exception to this general rule is that institutions will be permitted (but not required) to implement, for certain research, three burden-reducing provisions of the 2018 Requirements during the delay period (July 19, 2018, through January 20, 2019). 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 (IRBs) review grant applications or other funding proposals related to the research. Institutions taking advantage of the three burden-reducing provisions must comply with all other pre-2018 Requirements during the delay period. The three burden-reducing provisions of the 2018 Requirements can only be implemented during the delay period with respect to studies initiated prior to January 21, 2019 that will transition to compliance with the revised Common Rule. Any study that implements these three burden-reducing provisions during the delay period must, beginning on January 21, 2019, comply with all of the 2018 Requirements for the balance of the study’s duration.
The full text of the rule can be found here.