The Department of Health and Human Services (HHS) and other federal departments and agencies on Monday announced a six-month delay to the federal policy on the protection of human subjects, which is better known as the “Common Rule.”
The 142-page final rule unveiled Monday adopts proposals from a 20 April notice of proposed rulemaking, thus delaying the general compliance date for 2018 requirements for an additional six-month period, until 21 January 2019.
In addition to the final rule, HHS also explained some of the comments and said 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).”
The rule clarifies that the three burden-reducing provisions of the 2018 requirements can only be implemented during the delay period for studies initiated prior to 21 January 2019 that will transition to compliance with the revised Common Rule.
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 burden reducing provisions must comply with all other pre-2018 requirements during the delay period, the rule says.
As far as comments, the rule notes several commenters described what they categorized as “chaos that ensued when the interim final rule was put on public display 48 hours before the original effective date."
The rulemaking said it acknowledges that “the timing of the interim final rule was not ideal and led to frustration.”
A small subset of comments also suggested additional revisions to the Common Rule, the final rule says.
“For example, one commenter discussed the inclusion of a provision that would permit parents to decline certain procedures on behalf of their children,” the rule said.
In response, the rule said that this comment “listed several clinical procedures done in the routine course of medical care. Such activities are outside of the scope of the Common Rule, and thus are outside of the scope of this rulemaking.”
Federal Policy for the Protection of Human Subjects: Six Month Delay of the General Compliance Date of Revisions While Allowing the Use of Three Burden-Reducing Provisions during the Delay Period