Common Rule further postponed, burden-reducing provisions allowed during delay period

By Melissa Fassbender contact

- Last updated on GMT

(Image: Getty/mshch)
(Image: Getty/mshch)
The rule designed to increase protection for clinical trial participants was set to go into effect next month, but another delay announced today has pushed this date back an additional six months.

Revisions to the Federal Policy for the Protection of Human Subjects​, or "Common Rule," were published in a final rule on January 19, 2017, and were meant to enhance protection for clinical trial participants.

However, an interim final rule published in January of this year​ delayed the effective date and general compliance date of the requirements to July 19, 2018.

Now​, this date was pushed an additional six months.

The rule, published today in the Federal Register​, delays the general compliance date 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 until January 21, 2019,”​ according to the rule document.

For certain research, institutions will be permitted, though not required, to implement any of three burden-reducing provisions during the delay period.

According to the document, the 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.”

Studies using the provisions must be initiated prior to January 21, 2019.

The potential for the additional delay was suggested in the interim final rule, which cited the “complexity, the absence of needed guidance, and the need to revamp institutional procedures and electronic systems in order to come into compliance with the requirements of the rule.”

The Department of Health and Human Services (HHS) and other federal departments solicited public comment on the interim final rule between January 22, 2018 and March 19, 2018.

According to the agencies, several common themes emerged, including the need to have “as much advance notice as possible about any delay in implementing the 2018 Requirements.”​ The comments also reflected the need for guidance as well as “general support for a delay of the general compliance date, with more limited support for a delay beyond January, 2019.”

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