Common Rule delayed 6 months or more following lack of guidance, other challenges

By Melissa Fassbender contact

- Last updated on GMT

(Image: Getty/BrianAJackson)
(Image: Getty/BrianAJackson)

Related tags: Clinical trial, Regulation

Revisions to the Federal Policy for the Protection of Human Subjects has been delayed six months, possibly more, as regulators cite the rule’s complexity, lack of guidance, and other challenges.

Earlier this month, a Final Rule was proposed​ that would have delayed implementation of the revisions to the Federal Policy for the Protection of Human Subjects​, or the Common Rule.

WIRB-Copernicus Group Vice President, IRB Compliance David Borasky MPH, CIP, told us the proposed delay came as a surprise to many in the institutional review board (IRB) community.

The new requirements were scheduled to become effective on January 19, 2018; however, an Interim Final Rule has now delayed the effective date and general compliance date of the requirements to July 19, 2018.

According to the document, the “limited implementation delay​” provides “additional time to regulated entities for the preparations necessary to implement the 2018 Requirements​.”

Now IRBs, institutions and researchers wait to see if the delay is extended beyond six months, and whether or not OHRP ​[Office for Human Research Protections] provides any guidance on how to comply with the new rule​,” said Borasky, noting that for the next six months, it’s business as usual.

However, the Interim Final Rule suggests a longer delay will be considered, ​citing the final rule’s “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​.”

According to the document, federal departments and agencies are currently developing a proposed rule to further delay the requirement’s implementation.

It is expected that such a proposal would go through a rule-making process that provides time for comment, and perhaps allows some aspects of the rule to go forward​,” explained Borasky.

Now what?

The preparation that sponsors and contract research organizations (CROs) need to make depends on a few variables, said Borasky.

The first is whether or not there is federal funding involved, because the regulations that are changing only apply to research that is funded by a federal department or agency that has signed on to the Common Rule​,” he explained.

FDA regulations are not changing currently, so no change is necessary in order to maintain FDA compliance.

However, Borasky said the other potential barrier would be if a sponsor or CRO wants to use a site that has decided to apply these changes regardless of funding. In which case additional informed consent requirements would need to be taken into consideration, he said.

The OHRP is seeking comments​ until 11:59 pm Eastern Standard Time on March 19, 2018.

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