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.
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
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.
Several developments from this summer generated enough attention on their own in trade press, law firm alerts, and conference programming that most people in this field will have seen at least a headline about one of them. While you may have read about these piecemeal, seeing these efforts described in one place highlights the volume of initiatives and the speed at which HHS and other federal agencies are moving.
Remember: most of the dates listed in these Unified Agenda entries are aspirational and not set in stone. If you aren’t sure how to read a Unified Agenda entry or a reginfo.gov listing, check out our companion piece walking you through these nuances here.
News You May Have Missed
HHS launched Operation TrialBlazer, a department-wide initiative to speed up and modernize clinical trials; several other items in this roundup are components of it. Announced June 22, 2026, TrialBlazer is a coordinated effort across HHS (including FDA, NIH, the Office of the National Coordinator for Health Information Technology, ARPA-H, and the HHS Office of Inspector General) aimed at reversing the trend of clinical trials moving overseas and restoring U.S. leadership in clinical research. On the FDA side alone, TrialBlazer bundles together: the Expedited IND Pilot Program covered later in this roundup; a new Phase 1 IND Navigator webpage and Phase 1 contact center aimed at smaller sponsors without large regulatory teams; draft guidance on dose selection for first-in-human trials using quantitative systems pharmacology; and a significantly revised draft guidance on what counts as substantial evidence of effectiveness, one that would let a single well-designed pivotal trial plus confirmatory evidence support approval in appropriate cases rather than requiring two independent trials. NIH’s side of TrialBlazer includes support for trials incorporating AI, human cell-based models, and real-world data, NCATS work on personalized CRISPR-based gene editing treatments, and NCI work streamlining cancer trial activation and enrollment. HHS press release | FDA actions page
Updates to the Common Rule (subpart A of 45 CFR part 46) are in active development. OHRP is working on a proposed rule to revise the Common Rule, aiming to “uphold protections for human subjects while reducing burden and ambiguity for investigators, institutional review boards, and research institutions.” The described changes include clarifying terminology, expanding exemptions for low-risk research, and building in flexibility for de minimis protocol review changes. This is currently logged in HHS’s Unified Agenda with a target NPRM date that has already passed (which is common for Unified Agenda dates). As of mid-October, the proposed rule had not yet been sent to OIRA for review. Unified Agenda entry
FDA launched a pilot aimed at speeding first-in-human trial starts, and it is one of the concrete pieces of Operation TrialBlazer described above. The Expedited IND Pilot pairs drug sponsors with “Qualified Research Institutions” and allows rolling review of IND application components rather than requiring a complete submission upfront. Sponsor-QRI pairs must apply jointly by October 30, 2026, with 8 to 10 partnerships expected to be selected, making this directly relevant to any institution positioning itself as a QRI. FDA press release
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.
Not every consequential federal development arrives as a headline. This article opens with four items that may have slipped past you, including a K-award change that does not take effect until 2027 and a new HHS rulemaking on graduate medical education accreditation, and then turns to the growing federal activity on artificial intelligence in research. Several of these items surfaced as blog posts, White House review listings, or Unified Agenda entries rather than formal rules, so we explain what each one is, how much weight it carries, and why it may matter at your institution.
News You May Have Missed
NIH updated requirements for its Career Development (K) Award programs, consolidating K funding opportunities into parent announcements, dropping the data management and sharing plan requirement for K applications, and barring the use of K funds to conduct clinical trials, for institutions with active K-award recipients. A list of current NIH K-award types can be found here. This consequential policy change applies to applications with due dates on or after October 12, 2027, and current K funding opportunities expire by July 13, 2027 (except K00, K12, K43, and K76), so institutions have time to prepare. From what we are hearing, this change will have a disproportionate impact on smaller research programs that have a high proportion of early career investigators relying on this type of award to conduct research. NOT-OD-26-098
FDA published a Transparency Roadmap that reaches clinical research directly, and it arrived as a blog post rather than a formal notice. In an October 2 FDA Voices post, FDA committed to proactively publishing redacted Form 483s and additional inspection reports, and it named bioresearch monitoring (BIMO), the inspection program that covers clinical investigators, sponsors, and IRBs, as an area where the public has asked for more transparency. For IRBs, investigators, and sites, this means BIMO inspection findings could become publicly searchable without a FOIA request, and consent language describing who will see study data may deserve a fresh look. Implementation details are still to come; there is no docket or comment period. FDA Voices post
FDA’s successor to its Diversity Action Plans guidance appears to be on the way, under a new name and with a new focus. On October 6, 2026, FDA sent the White House a document titled “Clinical Trial Enrollment Action Plans to Improve Representation of the U.S. Intended Use Population in Clinical Studies” (RIN 0910-ZD84). The document details are not public, but the title tracks the 2024 Diversity Action Plans draft guidance while reframing “representation” around U.S. patients, consistent with FDA leadership’s stated concern about trials moving overseas. FDORA made these enrollment plans a statutory requirement for pivotal drug trials and most device studies once FDA finalizes guidance, so this document will shape sponsor enrollment plans and, downstream, the recruitment materials, eligibility criteria, and site selection that IRBs review. Unanswered questions: whether it will be issued as draft or final, and whether it keeps any demographic enrollment goals. OIRA detail | 2024 draft guidance (background)
HHS is preparing a rule on graduate medical education (GME) accreditation, and it appears to be a brand-new initiative with no existing home in the Department. The Unified Agenda lists “Reforming Accreditation to Strengthen Graduate Medical Education” (RIN 0991-AC41) as an “Other Significant” proposed rule from the Office of the Secretary, with an NPRM target of February 2027. The abstract says only that it will “address regulations related to HHS Graduate Medical Education (GME) funding and new accrediting bodies,” and no legal authority or CFR citation has been identified yet. The title echoes Executive Order 14279 (April 2025), which directed the Departments of Justice and Education, in consultation with HHS, to investigate discrimination by medical schools and GME entities tied to the LCME and ACGME and to consider ending their federal recognition. Since then, the Department of Education has proposed a broad accreditation overhaul that would make it easier for new accreditors to gain recognition, and Secretary Kennedy has secured voluntary commitments from LCME, ACGME, and others to expand nutrition education. Our read, which is an inference and not something HHS has said, is that the likely lever is Medicare GME payment: 42 CFR 415.152 defines an approved GME program by reference to ACGME and a few other bodies “or other organization determined by the Secretary,” so a rule could open that door to new accreditors and attach conditions. Meanwhile, ACGME separately sought comment through October 22 on a major rewrite of its Common Program Requirements (a 43 percent reduction in requirements, proposed effective July 1, 2028), and the Emergency Medicine Residents’ Association reports that the draft would also loosen some work-hour protections, including cutting required rest after 24-hour call from 14 to 12 hours. ACGME’s stated rationale is burden reduction and does not mention federal action, so any link to the HHS rulemaking is unconfirmed. Academic medical centers that sponsor residency and fellowship programs should watch what HHS asks of accreditors and whether GME funding eligibility shifts away from ACGME accreditation alone. Unified Agenda entry | Executive Order 14279 | HHS announcement | ED proposed rule | ACGME proposal | EMRA summary | 42 CFR 415.152
NIH proposed a substantial modernization of its biosafety oversight framework. A new, comprehensive Biosafety Policy for Research Involving Biohazards would replace the current NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules, a framework that has governed institutional biosafety committee oversight for decades. Comments are due October 19, 2026. Federal Register notice
Federal Moves on AI in Research
Federal agencies are moving on artificial intelligence in research on several fronts at once. FDA is asking for input on how to regulate generative AI-enabled medical devices, NIH is proposing a new office to coordinate its AI policy, and ORI has issued guidance on misconduct allegations that involve generative AI. None of these items creates a new binding requirement for your institution today, but together they show where expectations for the use and oversight of AI in research are headed.
FDA is asking for public feedback on how it should regulate generative AI-enabled medical devices. The discussion paper referenced here is more concrete than the typical early-stage RFI. It proposes a two-axis framework for risk assessment, a competency-based approach to premarket evaluation that combines device benchmarking with clinical confirmation, risk-proportionate postmarket monitoring strategies, and specific considerations for foundation models and agentic AI systems. Acting FDA Commissioner Kyle Diamantas framed the effort as part of a broader push for U.S. leadership in AI development. Comments close October 19, 2026 , on docket FDA-2026-N-7874. CDRH’s fiscal year 2027 guidance agenda lists a generative AI guidance as “under construction,” so the feedback FDA collects here is likely to shape that guidance. CDRH FY2027 guidance agenda | FDA press release
NIH proposed creating an Office of the NIH Chief Artificial Intelligence Officer, the likely future home of NIH policy on AI in funded research. The announcement is quite sparse; it’s unclear what would be under the purview of this office, how it would interact with other federal efforts on policy development here, or how quickly this new office might be launched. Comments are due October 28, 2026. Federal Register notice
ORI provided guidance on AI usage and research misconduct. New ORI guidance addresses how Research Integrity Officers should approach cases where generative AI tools are implicated in fabrication, falsification, or plagiarism allegations. ORI blog post
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.
This guide is general information, not legal advice. Agency practices change, so confirm current requirements before relying on any detail below.
Our Reg Roundup covers a lot of ground in a short space. In a single edition you might see a final rule, a proposed rule that has not been published yet, a draft guidance, a request for public input, and a routine paperwork notice. They all look like “news from the feds,” but they can mean very different things for your institution or organization.
This guide gives you a quick way to evaluate any item in the roundup. For each item, ask five questions:
Guidance. Guidance is the category that most often trips up research compliance teams. The Administrative Procedure Act (APA) lets agencies issue interpretive rules and policy statements, which together are known as guidance, without going through notice and comment, and these documents generally do not carry the force of law (CRS LSB10591). OHRP guidance says so directly: “must” means something is required under 45 CFR part 46, “should” means it is recommended, and an institution may use an alternative approach if it satisfies the regulations (OHRP guidance). That does not make guidance unimportant. It shows you what the agency considers a compliant approach, and it is often the best predictor of how an auditor or inspector will think. It does mean you have more flexibility than many people assume; if your institution differs from published guidance, we recommend that the reasoning be clearly documented.
Information collection notices. These are the most common and least exciting items in any roundup, and the easiest to misread. A notice that an agency wants to renew or change a form is not a change to a regulation. Under the PRA, an agency generally must publish a notice with a 60-day comment period, then submit the collection to the Office of Management and Budget (OMB) and publish a second notice opening a 30-day comment period (Reginfo.gov FAQ). OMB approvals last up to three years, and an agency must seek renewal at least 60 days before the control number expires (44 U.S.C. 3507). So a notice that arrives close to an expiration date usually signals routine renewal. A notice that arrives years ahead of schedule, as we noted for the Certificate of Confidentiality system, suggests the agency wants to change something.
For rules, think of a ladder. The agency typically first lists the action in the Unified Agenda. It then drafts the proposal. If the action is “significant,” the draft goes to the Office of Information and Regulatory Affairs (OIRA) at the White House for review under Executive Order 12866. The proposal is then published in the Federal Register, the public submits comments, and the agency drafts a final rule, which may go back to OIRA before it is published (ICF Reg Map, 2020).
Most of what you see in the roundup sits on one of three rungs:
On the Unified Agenda, not yet at OIRA. The agency says it plans to act, but nothing has been sent for review.
Pending at OIRA. Reginfo.gov shows actions currently under review, but it does not show you the draft (Reginfo.gov FAQ).
Published. The proposal or final rule has appeared in the Federal Register.
Under Executive Order 12866, an agency generally may not publish a significant action until OIRA has completed or waived its review, or the review period has expired (Executive Order 12866, section 8). So if a significant rule has not reached OIRA, publication is generally not imminent. That is why we say in the roundup that the FDA single-IRB final rule is worth watching: once it shows up as received at OIRA, the timeline becomes much easier to estimate.
Not everything at OIRA is a rule. Some items on the “pending White House review” list in our roundup, such as FDA’s planned guidance on clinical trial enrollment action plans, are guidance. Whether guidance goes through White House review has depended on executive orders that have changed across administrations (CRS LSB10591).
Less than you would like. A date next to “NPRM” or “Final Rule” in the Unified Agenda is the agency’s forecast, made when it prepared its entry. It is not a schedule, and it does not mean any clock has started. The agenda itself says that dates are subject to change, that agencies may act earlier or later than listed, and that the agenda creates no legal obligation to follow its schedule (2026 Unified Agenda Introduction).
A few reading tips:
A passed date is normal. The Common Rule entry in our roundup lists a target date that has already passed. Often, this means the work is running late, not that something has been decided.
Check the edition and the stage. Entries reflect the agency’s view when that edition was compiled. “Proposed Rule” and “Final Rule” mean the agency’s next step is that action. “Long-Term” means the agency does not expect action within 12 months (2026 Unified Agenda Introduction).
Look for a legal deadline. If a statute requires action by a certain date, that is a stronger signal of pressure on the agency than the target date, although it still does not guarantee timing.
Treat a month-only date as a month-only date. A date such as “12/00/2026” means the agency predicts the month and year, not the day.
Do not confuse comment deadlines with agenda dates. Comment deadlines, like the October 19 deadline for the FDA generative AI discussion paper, are fixed. Agenda dates are not.
The general rule is that final regulations bind you once they take effect. Proposals, forecasts, discussion papers, and draft policies do not. Guidance generally does not bind your institution, except where it simply repeats a regulatory requirement. Statutes and award terms can bind you even when no regulation changes, so read the actual notice and your award terms. For example, the NIH policies related to funding might go into effect immediately, or, as with the changes to career development (or “K” awards), might go into effect in a future application or funding cycle. Additionally, an agency can announce a change with a future effective date and later decide to implement the policy change immediately (as happened with a component of NIH’s K-award changes).
The agency’s own process offers clues. FDA, for example, generally issues a draft guidance for comment and then finalizes it, although it may implement certain guidance immediately and take comments afterward (FDA, Good Guidance Practices). OHRP follows a similar pattern for documents it labels guidance, but it may issue content-specific FAQs without a draft. A final guidance that skipped public comment still reflects the agency’s current thinking. It just has not been tested by outside input.
After you have sorted an item, assign it to one of four buckets.
Act now. The item is final or already in effect, or a deadline is near.
Comment. Comment periods are one of the few ways to shape an agency’s thinking. Written comments on proposed rules go to the docket on Regulations.gov, and comments on an information collection can be submitted through reginfo.gov during the 30-day period, although comments submitted there cannot be claimed as confidential (Reginfo.gov FAQ).
Prepare. The item is proposed or on the agenda, and your institution would need to change policies, training, or systems if it is finalized.
Watch. The item is early, tentative, or routine. Set a reminder to check reginfo.gov, and keep an eye out for whether it appears at OIRA.
Welcome to HRP’s inaugural “Reg Roundup”! As part of our new educational content initiative, we hope to bring you these roundups regularly. Let us know how often you’d like to see these (monthly? quarterly? more often?).
In this edition of HRP’s Reg Roundup, we summarize some of the most interesting and consequential developments in research policy at the federal level from June through mid-October 2026. A lot has happened, so we will be publishing several articles throughout the week instead of one 5,000-word tome.
Before jumping in, check out our companion article that walks through the titillating (we think anyway…) topic of how informal rulemaking works, how to read a reginfo.gov listing, what the Unified Agenda is (and isn’t), what an “information collection” is (and isn’t), and how you can use all of the information published by the federal government to forecast what policy changes might be coming down the pike and when.
FDA has recently released several updates – including new and updated guidance documents, technical amendments, and policy clarifications – that may be relevant to research oversight committees (such as IRBs and IACUCs), investigators, and research organizations. To help research professionals stay informed, HRP has compiled the following summary highlighting updates released between December 1, 2025 through January 27, 2026, that may affect research oversight, study design, and regulatory responsibilities. In keeping with our focus on Helping Research Professionals, this resource is intended to offer practical context and useful reference points as FDA guidelines continue to evolve.
This draft guidance describes FDA’s current thinking on streamlined, risk-based nonclinical safety programs for monoclonal antibodies, including circumstances where certain animal studies (e.g., repeat-dose or NHP studies) may be reduced, replaced, or omitted when scientifically justified. The guidance emphasizes fit-for-purpose nonclinical packages and alignment with the 3Rs, and may inform IACUC deliberations by reinforcing the need for clear scientific rationale and documentation linking animal use decisions to both scientific objectives and downstream human safety considerations.
Dec 4, 2025
Technical Regulatory Updates: Medical Devices; Quality Management System Regulation Technical Amendments
Makes technical and conforming amendments across multiple device regulations (including 21 CFR 812) to align terminology and cross-references with the amended Quality Management System Regulation (21 CFR 820 – amended in 2024). The amendments are non-substantive and do not change underlying regulatory requirements for device research or IDE conduct.
Note: Changes to part 812 may impact citations and quoted text in SOPs and other materials. References to § 820.30 are replaced with references to § 820.10(c) (or § 820.10(c) is newly inserted) at § 812.1(a) (Scope), § 812.35(a)(3)(iii)(A) (Definition of credible information), and § 812.35(a)(3)(iv)(A) (Notice of IDE change).
Dec 15, 2025
Final Guidance: Enhancing Participation in Clinical Trials — Eligibility Criteria, Enrollment Practices, and Trial Designs
Provides recommendations to improve clinical trial participation and representativeness through scientifically justified eligibility criteria, enrollment practices, and trial designs that better reflect the patients likely to use the product in clinical practice. Encourages minimizing unnecessary exclusions and prospective planning and monitoring to support representative enrollment across clinically relevant patient characteristics.
Diverges from the prior 2022 draft guidance “Enhancing the Diversity of Clinical Trial Populations” by shifting from a primary emphasis on demographic diversity to a broader framework of participation and representativeness, incorporating both demographic and non-demographic characteristics (e.g., comorbidities, organ dysfunction, functional status, and real-world access considerations) to support the generalizability and real-world applicability of trial results.
Dec 16, 2025
Final Guidance: Investigator Responsibilities – Safety Reporting for Investigational Drugs and Devices
Clarifies investigator responsibilities for identifying, evaluating, and reporting safety information in IND and IDE studies, including the relationship between FDA safety reporting requirements and reporting to sponsors and IRBs. Aims to reduce confusion and improve consistency in safety reporting.
Compared to the November 2023 draft guidance, the final guidance more clearly delineates investigator versus sponsor responsibilities (e.g., confirming that investigators are responsible for identifying and reporting safety information to sponsors, while sponsors are responsibe for aggregate safety assessment and FDA expedited reporting), clarifies the distinction between FDA and IRB safety reporting obligations (e.g., recognizing that compliance with IND/IDE safety reporting does not replace local IRB unanticipated problem reporting requirements), and emphasizes that the guidance is intended to clarify existing requirements rather than impose new safety reporting duties on investigators.
Dec 16, 2025
Final Guidance: Sponsor Responsibilities – Safety Reporting Requirements and Safety Assessment for IND and Bioavailability/Bioequivalence Studies
Describes sponsor responsibilities for safety assessment and expedited safety reporting under IND regulations, including evaluation of aggregate safety data and submission of IND safety reports. Clarifies expectations to improve signal detection and reduce over-reporting.
Compared to the November 2023 draft, the final guidance more clearly emphasizes the sponsor’s responsibility for aggregate safety assessment and clinical judgment, explicitly discourages over-reporting of expedited IND safety reports, clarifies proportional application to BA/BE studies, and reinforces that the guidance is intended to clarify existing safety reporting requirements rather than impose new obligations.
Dec 18, 2025
Final Guidance: Use of Real-World Evidence To Support Regulatory Decision-Making for Medical Devices; Guidance for Industry and Food and Drug Administration Staff
Outlines FDA’s expectations for using real-world data and real-world evidence (e.g., registries, EHRs, claims data) to support regulatory decision-making for medical devices, including data relevance, quality, and transparency considerations.
Compared to the September 2017 draft, the final guidance reflects FDA’s increased experience with real-world evidence (RWE), shifting from a conceptual framework to a more operational approach that clarifies how RWE may support specific medical device regulatory decisions while emphasizing data quality, methodological rigor, and proportionality to device risk. The final guidance also provides clearer indications of factors relevant to IRB oversight determinations, including whether RWE involves retrospective or secondary data use, data identifiability, and prospective or interventional activities.
Dec 19, 2025
Final Guidance: Processes and Practices Applicable to Bioresearch Monitoring Inspections; Guidance for Industry
The Dec 2025 final guidance consolidates and modernizes FDA’s description of BIMO inspection processes. Compared to earlier information sheets which are now withdrawn (clinical investigator inspections; IRB inspections), the final guidance is broader in scope (clinical and nonclinical), more explicit about statutory authority and access to records/systems and adds structured “best practices” for communication before, during, and after inspections including concepts tied to remote regulatory assessments (RRAs) and electronic system access.
Dec 29, 2025
Final Guidance: CDER/Office of New Drugs Streamlined Nonclinical Studies and Acceptable New Approach Methodologies (NAMs)
This new resource describes CDER’s current thinking on streamlined nonclinical approaches, including the use of New Approach Methodologies (NAMs), to support drug development while reducing or replacing traditional animal testing where scientifically justified. It outlines drug development contexts in which these approaches may be acceptable based on principles of scientific justification and regulatory decision-making and is intended as a living resource that will be updated over time.
The resource may be informative to IACUCs by highlighting considerations that can help evaluate proposed reductions or alternatives to animal use, particularly where sponsors seek to align nonclinical programs with evolving FDA expectations.
Jan 6, 2026
Final (Updated) Guidance: Clinical Decision Support Software
The final (updated) guidance clarifies FDA’s interpretation of when clinical decision support software functions are excluded from the device definition or subject to oversight, focusing on factors such as user type (e.g., health care professionals vs. patients), transparency of the software logic, and the ability for clinicians to independently review the basis for recommendations.
Jan 6, 2026
Final (Updated) Guidance: General Wellness: Policy for Low Risk Devices
Describes FDA’s enforcement discretion policy for low-risk general wellness products, including fitness trackers and wellness apps, and clarifies the boundary between general wellness functions and regulated medical device claims—important when such tools are used in research or as exploratory endpoints.
The final (updated) guidance clarifies FDA’s enforcement discretion approach for low-risk general wellness products, refining how the FDA distinguishes general wellness functions from regulated medical device claims based on intended use, claims, and risk to users. The update reflects FDA’s experience with the expanded use of modern consumer-facing digital health tools and wearables, providing clearer examples and boundaries to help stakeholders determine when wellness products remain outside of FDA oversight and when their use or claims may trigger oversight, including in research settings or when used to generate exploratory endpoints.
Jan 7, 2026
Draft Guidance: Considerations for the Use of Artificial Intelligence To Support Regulatory Decision-Making for Drug and Biological Products
This draft guidance outlines FDA’s proposed risk-based framework for assessing the credibility of artificial intelligence (AI) models used to generate data supporting regulatory decision-making for drug safety, effectiveness, or quality, based on a defined context of use across the drug lifecycle. The guidance is directed to sponsors and “other interested parties” and excludes AI used solely for discovery or internal operational efficiencies.
Although not directed to IRBs or investigators, the guidance may be indirectly relevant when AI tools are incorporated into clinical research in ways that influence participant risk stratification, safety monitoring, or protocol-driven clinical decisions. In such cases, IRBs and investigators may wish to consider how AI outputs are used within the study, whether appropriate human oversight is maintained, and whether the AI’s context of use affects risk assessment or human subject protections.
Jan 12, 2026
Draft Guidance: Use of Bayesian Methodology in Clinical Trials of Drug and Biological Products
This draft guidance provides recommendations on the appropriate use of Bayesian statistical methods in clinical trials to support regulatory decision-making, including design, evaluation, prior justification, success criteria, and reporting expectations.
While directed to industry, the guidance may prompt IRBs to look more closely at how studies using Bayesian designs describe data and safety monitoring, including interim reviews, stopping criteria, and oversight roles, and to consider how these features may affect ongoing assessments of participant risk and potential benefit as the study progresses.
FDA has recently released several updates – including new and updated guidance documents, technical amendments, and policy clarifications – that may be relevant to research oversight committees (such as IRBs and IACUCs), investigators, and research organizations. To help research professionals stay informed, HRP has compiled the following summary highlighting updates released between December 1, 2025 through January 27, 2026, that may affect research oversight, study design, and regulatory responsibilities. In keeping with our focus on Helping Research Professionals, this resource is intended to offer practical context and useful reference points as FDA guidelines continue to evolve.
Expanding HRP’s Leadership in AI Research Oversight
HRP Consulting Group is pleased to announce that Tamiko Eto has joined the firm, bringing over two decades of leadership experience in human subjects research protections at world-class institutions.
Ms. Eto is widely recognized as a thought leader in the interpretation and development of policies governing AI-enabled research, bridging the gap between rapidly evolving technologies and established regulatory frameworks. Her work focuses on building institutional capacity for AI oversight through rigorous yet pragmatic approaches that enable research innovation while safeguarding the rights and welfare of research participants.
Advancing Responsible Artificial Intelligence in Human Subjects Research
Throughout her career, Ms. Eto has played a pivotal role in advancing responsible AI use in research oversight. She led the creation of the world’s first agentic AI IRB protocol submission and review platforms, setting a new standard for how institutions operationalize AI governance within IRB and compliance processes.
She has also co-developed numerous CITI Program and PRIM&R AI training programs, helping research administrators, IRB professionals, and compliance leaders worldwide build fluency in AI concepts and their ethical and regulatory implications.
National and Global Leadership in AI Ethics and Policy
In addition to her applied work, Ms. Eto actively shapes the future of AI ethics and policy through key advisory and leadership roles. These include serving on the AI Ethics Advisory Board for the Institute of Experiential AI and as a Senior Teaching and Research Fellow with the Center for AI and Digital Policy (CAIDP), among other national and international engagements.
Her leadership reflects a forward-looking vision for research ethics—one that anticipates the challenges posed by emerging AI technologies while ensuring innovation remains grounded in integrity, transparency, and public trust.
Strengthening HRP’s Support for Institutions Navigating AI Innovation
At HRP, Ms. Eto will enhance the firm’s ability to support institutions navigating the ethical, regulatory, and operational challenges associated with AI-enabled research. Her expertise strengthens HRP’s capacity to deliver practical, strategic guidance that aligns innovation with compliance and participant protections.
HRP Consulting Group is delighted to welcome Tamiko Eto to the team.
On December 31, 2025, the USDA released its first unified General Terms & Conditions (unified T&C’) for Federal Awards. The unified T&C are intended to replace the patchwork of USDA agency and office specific T&C, giving agencies 45 calendar days to adopt and implement the unified T&C, with any deviations needing to be approved by the Office of the Chief Financial Officer (OCFO). The 2025 unified T&C applies to all new awards and to significant modifications (as determined by OCFO) to existing awards, to the extent consistent with law.
Executive Order-related Key Terms & Conditions: Among other terms, the unified T&C formalize the agency’s adoption and implementation of various Executive Orders and Secretary’s Memorandums that were issued in 2025, including:
Foreign Ownership, Control or Influence (FOCI) by a Country of Concern (Section 10.7) – Establishes requirement that recipients certify that they are not, and will not, enter into any subawards, contract, or other agreements with any individual or entity that is subject to FOCI by a foreign country of concern or other foreign adversary. [Note: In considering this term, institutions should refer to the definition of “U.S. citizen or entity subject to foreign ownership, control, or influence (FOCI)” at the end of Section 10.0.]
Disclosures (Section 10.8) – Establishes requirements for recipients of awards, and covered individuals working on the award, to complete the Common Forms for Biosketch and for Current and Pending (Other) Support to submit the forms at the time of application and no less than annually.
Malign Foreign Talent Recruitment Program (MFTRP) with 10-year look back (Section 10.9) – Establishes requirement for recipients of awards to certify that they, and any covered individuals working on the award are not participating in, and have not within the past 10 years, any MFTRP on the Common Forms for Biosketch and for Current and Pending (Other) Support and to recertify annually.
Consequences for Violation of Disclosure Requirements (Section 10.10) – Establishes that violations of disclosure requirements may lead to criminal, civil, and/or administrative consequences.
Dual Use Research of Concern (DURC) and Dangerous Gain-of-Function (Section 10.11) – Establishes requirements for:
recipient agreement to ensure that USDA awards do not support any research that USDA will not fund (with three specified examples).
recipients to have an Institutional Biosafety Committee (IBC) or other Institutional Review Entity (IRE) who are responsible for the review of research involving agents covered by the Policy.
registration of Policy-defined select agents or other potential pandemic pathogens with the CDC or USDA
special award conditions when USDA funds research that involves the creation, transfer, or use of potential pandemic pathogens.
recipient establishment of an Institutional Contact for Dual Use Research (ICDUR) to serve as an internal resource and agency liaison.
record-keeping
Section 10.11 goes on to define “Dangerous gain-of-function research”, “Dual use research of concern”, “Institutional Contact for Dual Use Research”, and “Life sciences.”
Civil Rights/Diversity Equity and Inclusion (DEI)/Sex vs Gender Ideology funding restrictions (Sections 12.2, 13.5, and 13.6) – referencing Executive Orders (EOs) and Federal anti-discrimination laws, regulations, and policies that recipients must certify compliance with for the duration of the award.
Compliance with Executive Orders and Other Presidential Actions (Section 13.0) – establishes requirements for the USDA and recipient organizations to comply with EOs and other Presidential Actions, listing 12 specific EOs that are “expressly incorporated” into USDA awards.
Other New or Significantly Modified Terms & Conditions – the unified T&C also incorporates several provisions that were either previously unaddressed or that have been significantly modified from prior award requirements, including:
Conflict of Interest (Section 1.7) – establishes requirements for the disclosure and resolution of any conflict of interest (COI), including organizational COIs, requiring recipients to notify USDA within five calendar days of discovery and submit their proposed approach for resolving the conflict. Section 1.7 further authorizes USDA to review and determine the effectiveness of the recipient’s conflict management approach, prohibits recipients from requesting payment for costs associated with conflicted transactions pending USDA’s determination, and identifies cost disallowance and award termination as potential remedies for failure to disclose. [Note: Unlike the PHS fCOI framework, USDA requirements apply to any COI, including organizational COI, require agency review and approval of the conflict management approach, impose a five-day disclosure timeline, and prohibit payment requests for conflicted transactions pending USDA’s determination.]
Records Retention, Access, and Audit Rights (Sections 5, 8, 9) – clarifies and standardizes USDA’s rights to access, inspect, and audit recipient records, including electronic systems, and clarifies record retention and post-closeout access requirements, representing a more explicit and enforceable framework than many prior USDA agency-specific terms.
Expanded Flow-Down Requirements (Sections 5, 10) – requires recipients to flow down applicable USDA compliance, disclosure, and eligibility requirements to subawards and contracts, not solely financial and audit terms, and to actively monitor compliance, representing a broader and more explicit flow-down obligation than many prior USDA agency-specific requirements.
Award Termination for Cause, Convenience, and Policy Noncompliance (Section 7) – establishes department-wide authority to terminate awards for cause, convenience, or based on risk, integrity, or policy concerns, representing a broader and more explicit enforcement framework than prior agency-specific requirements which were primarily focused on performance issues or financial noncompliance.
Suspension of Payments and Imposition of Special Conditions (Sections 5, 7) – establishes USDA’s authority to suspend payments, impose special conditions, and require corrective actions at any point in an award, not only at renewal or close-out; and requires recipients to maintain effective internal controls and oversight.
Remedies Tied to Disclosure and Information Integrity Failures (Sections 7, 10.10) – connects disclosure failures to termination and other remedies, while prior agency-specific terms often treated disclosure errors as correctable administrative issues.
Subrecipient/Contractor Noncompliance (Sections 5, 7, 10) – establishes prime award recipient responsibility for downstream noncompliance and establishes remedies when prime recipients fail to sufficiently monitor and for ongoing downstream violations.