Funding Agency Stop Work Orders: Sample IRB Guidelines for Investigators. View Now
Skip to main content

Reg Roundup 1.4: More Human Subjects and Research Oversight Announcements and Initiatives in the Pipeline

Posted on by

Several rulemakings and policy efforts that could change how human subjects research is reviewed and overseen are in the pipeline but have not yet been published. The FDA items below come from the Unified Agenda, so treat the target dates as forecasts rather than commitments. Knowing what is coming gives your institution time to plan, even when the timing is uncertain.

News You May Have Missed

FDA’s rule to add new IND exemptions to 21 CFR part 312 is in its final stages. This final rule would exempt certain clinical trials of lawfully marketed conventional foods (including dietary supplements) and cosmetics from FDA’s IND requirements.  An NPRM detailing the proposal and justification for it was originally published in 2022.  FDA listed in the Unified Agenda that the target publication window for this final rule was July 2026, which has already passed.  Unified Agenda entry; 2022 NPRM.

FDA intends to reopen its IRB regulations to build in Phase 1 flexibilities. A separate rulemaking would amend both 21 CFR Part 56 (the IRB regulations) and Part 312 (the IND regulations) together, building risk-based flexibilities into Phase 1 clinical trial review.  This is another Operation TrialBlazer initiative aiming to shorten the path from drug identification to first-in-human trials.  Unified Agenda entry

A broader overhaul of sponsor and investigator responsibilities under Part 312 is also in the pipeline, aimed at enhancing clinical trial quality, safeguarding participant rights and safety, aligning with global regulatory standards, and promoting trials that are representative of the populations a drug is intended for. This would touch sponsor and investigator obligations across essentially all FDA-regulated clinical trials.  The NPRM publication target is December 2026. Unified Agenda entry

Pediatric research has its own pending rulemaking. FDA is proposing new requirements for submitting initial pediatric study plans for new drug and biologics license applications, implementing pediatric study plan provisions of the FD&C Act and the Secretary’s authority to grant exemptions from those requirements. Unified Agenda entry

FDA’s rule governing electronic records and signatures is due for its own revision. FDA is planning to modernize 21 CFR Part 11, which sets the standards for how electronic records and signatures can satisfy recordkeeping and signature requirements found in other FDA regulations (referred to as predicate rules).  Part 11, as this regulation is affectionately called, causes significant challenges and headaches for people in clinical trial operations.  We are very curious about the ultimate scope of this rulemaking effort. Unified Agenda entry

NIH paused new studies in its HIV clinical trial networks. Reporting indicates that NIH told its four HIV clinical trial networks (ACTG, HPTN, HVTN, and IMPAACT) to hold off on new studies that could not finish before current funding ends in November 2027, because the renewal funding announcements, which were expected in late summer, are under review at HHS. Ongoing trials and enrolled participants are not affected. AVAC Global Health Watch | Medical Daily

 

We want your feedback!

How did we do?  Too much? Wanted more? Are there items on which you’d like for us to publish a deep-dive?  Let us know on LinkedIn or provide your feedback here.

How to read a Reg Roundup:

Inaugural Edition of Reg Roundup: