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Reg Roundup 1.3: Hot Items (so far!) from Fall 2026

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The summer items in Reg Roundup 1.2 set the direction, and fall has brought more activity along the same lines. This installment covers NIH’s plan to rewrite its Policy for Data and Safety Monitoring, FDA’s new Rare Disease Framework Initiative, and the HHS and ARPA-H SURPASS program to redesign how clinical trials are run. Each is at an early stage, so we focus on what is known so far and what to watch for next.

News You May Have Missed

NIH is preparing to rewrite its 1998 Policy for Data and Safety Monitoring. A “Draft Policy Update to the NIH Policy for Data and Safety Monitoring” request for information has been under White House review since September 29, 2026 (RIN 0925-ZA25). At a May 2026 webinar, NIH raised monitoring tiered to study risk, required components of monitoring plans, new templates, and a key scoping question: whether the policy should cover all clinical research or all human subjects research, including observational, behavioral, and implementation studies. Because IRBs must find that research plans make adequate provision for monitoring data to ensure participant safety (45 CFR 46.111(a)(6)), a broader NIH policy would show up quickly in IRB review checklists and HRPP procedures. The “draft policy update” title suggests NIH will publish proposed policy text rather than just questions. OIRA detail | NIH webinar page

FDA launched a Rare Disease Framework Initiative aimed at a “fit-for-purpose” approach to rare disease drug and biologic development. A white paper released October 14, 2026 lays out six guiding principles: more predictable decisions, the patient voice built in at defined milestones, more use of outside disease experts, shared training and resources, risk-based review of manufacturing and pre-approval inspections, and novel statistical methods. FDA says it may revise existing regulations or add new provisions to build these evidence standards into rare disease review, and it plans a systematic review of guidance on endpoints, statistical approaches, trial design, patient engagement, and post-approval obligations. The white paper does not address IRBs or informed consent. A hybrid public meeting hosted by the Reagan-Udall Foundation is set for October 28, with a Federal Register request for information to follow. FDA press release | White paper | Public meeting 

HHS and ARPA-H followed TrialBlazer with SURPASS, a multi-year program to redesign how clinical trials are run. Announced September 30, 2026, SURPASS (Simulation-augmented, Real-time Platform Adaptive Seamless Trials) funds work on “phaseless” adaptive trial designs, continuous real-time analysis of accumulating trial data, and AI-driven trial operations. Three companion efforts come with it: STACK, to make research-naive sites trial-ready through reusable agreements and shared tools; COMMONS, a national research data resource built on a “privacy-by-design” consent architecture; and CINCH, for patient-contributed real-world data. The announcement does not address IRB review, but reusable site agreements, broad-consent-style data resources, and continuously adapting protocols all raise questions IRBs and HRPPs will need to answer. HHS press release

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