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The Office of Management and Budget has noted in its Unified Agenda that the single IRB final rule is expected to be issued in May 2025, but this date is not guaranteed and is subject to change. Although sponsors, investigators, and institutions may have already implemented changes in processes and standard operating procedures (SOPs) in advance of the rule’s finalization, some may wonder why the rulemaking process takes so long and why the timing of implementation is so unpredictable.
Rulemaking is a complex process outlined under the Administrative Procedures Act (5 USC §553 (1946)). The Act requires that a Notice of Proposed Rulemaking (NPRM) be published in the Federal Register to allow for public comments unless the agency issuing the rule finds the notice and public comments to be impracticable, unnecessary, or not in the public’s interest.
Public comments generally close 60 days after publication of the Federal Register notice. FDA staff then review the comments and decide if points raised in the comments require modification of the proposed rule. Any revisions require consensus among the stakeholders involved in the rule writing. In addition to this, many internal agency and interagency steps occur from the time rule making is initiated until a final rule is published, further lengthening the timeline.
At the FDA, many offices can be involved in the process of rulemaking or in modifying a draft rule. Changes made by one office may require re-review by another office, depending on the significance of the change, to ensure agreement. Once the language is agreed upon, a formal clearance process takes place that may include additional offices. Agency priorities may slow the process. The immediate public health issues resulting from the COVID-19 pandemic are one example of a situation that directed agency resources away from more routine processes and may have delayed the work on the proposed rule.
Interagency review occurs after the FDA finishes its review. Although the additional agencies may not be disclosed, for the single IRB rule, review by the Department of Health and Human Services (HHS), as well as the Office of Human Research Protections (OHRP), will certainly need to take place given the impact on the existing regulations on cooperative research under the Common Rule.
Once the rule is finalized, the FDA will likely allow a grace period for implementation, but whether a grace period is allowed and/or the length of any grace period is not stipulated in the NPRM.
Consequences of Not Being Prepared
Once the rule is finalized, the FDA is likely to allow a grace period for implementation, although the specifics are not guaranteed in the NPRM. Below are the possible consequences for sponsors, institutions, and investigators who are not ready when the final rule goes into effect:
Operational Disruptions: Institutions that have not yet adopted changes in SOPs and processes may face significant operational disruptions. The need for rapid implementation of new procedures could overwhelm administrative and operational capacities, leading to delays in research activities and potentially impacting ongoing studies.
Regulatory Non-compliance: Failure to comply with the new single IRB mandate could result in regulatory non-compliance. This could lead to warnings, fines, or other penalties from regulatory bodies. Non-compliance might also jeopardize funding and sponsorships as adherence to regulatory guidelines is often a pre-requisite for financial support.
Loss of Credibility and Trust: Non-compliance with the single IRB rule can damage an institution’s or investigator’s credibility. It may lead to a loss of trust among stakeholders, including funding bodies, collaborators, and study participants. Maintaining compliance with regulatory requirements is essential for preserving the integrity and reputation of research entities.
Legal Implications: Institutions and sponsors that fail to comply may face legal consequences. Non-compliance can lead to lawsuits or legal actions, particularly if the failure to implement changes results in harm or risk to study participants. Legal battles can be costly and time-consuming, further straining resources and tarnishing reputations.
Sponsors, institutions, and investigators that have yet to implement changes in processes to conform with the single IRB mandate should consider making those changes now in order to be ready when the final rule goes into effect.
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