The Common Rule was revised last year to enhance protection for clinical trial participants. The US Department of Health and Human Services (HHS) and 15 other federal agencies published the final rule to update the regulations which had been in place since 1991.
The updated rule was set to go into effect in 2018.
However, late last week the Office of Management and Budget (OMB) posted a proposed Final Rule titled “Federal Policy for the Protection of Human Subjects: Delay of the Revisions to the Federal Policy for the Protection of Human Subjects.”
OMB is the largest office within the Executive Office of the President of the United States (EOP) and assists the President in meeting policy, budget, management, and regulatory objectives.
The posting came as a surprise to many in the institutional review board (IRB) community, said David Borasky, MPH, CIP, vice president, compliance, WIRB-Copernicus Group and co-chair of SACHRP’s Subpart A Subcommittee, in a statement to Outsourcing-Pharma.com.
“This is notable because it appears as a Final Rule and because there was still a proposed rule titled ‘Federal Policy for the Protection of Human Subjects: Proposed 1-Year Delay of the General Implementation Date While Allowing the Use of Three Burden-Reducing Provisions During the Delay Year’ that had been sitting with OMB for the past three months,” Borasky explained.
Yet, the new rule’s title does not reference burden-reducing provisions, which he said suggests that this would be a delay of the complete rule.
“This could be viewed as a concession on the part of the Office for Human Research Protections (OHRP) that much of the regulated community is ill-prepared to implement the revised Common Rule, and that OHRP has not provided any implementation guidance,” said Borasky, noting that since the revised Common Rule was published in the Federal Register a year ago OHRP “has been virtually silent.”
The exception to this silent has been the HHS Secretary’s Advisory Committee on Human Research Protections (SACHRP), which is advisory to OHRP, explained Borasky.
“In the past year, SACHRP has approved recommendations regarding three aspects of the revised rule – transition provisions, benign behavioral interventions, and broad consent – but SACHRP recommendations are only advisory and none of these recommendations have been translated into official guidance,” Borasky said.
“During the past 12 months, OHRP has remained virtually silent on the status of the rule in every public forum, so with this development the level of clarity regarding the regulations hovers somewhere around pea soup,” he added.
Borasky explained that “the silver lining” to the delay is additional time for OHRP to formalize guidance and for the FDA to begin moving forward with the regulatory harmonization required by 21st Century Cures. “It would also buy additional time for IRBs that have not prepared themselves for the changes,” he said.
“WIRB-Copernicus Group has put significant effort and energy into preparing for compliance with the revised Common Rule,” added Borasky, “and will be ready to operate on the January 19 implementation date regardless of the outcome of the rule making process.”