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

Reg Roundup 1.5: Animal Research Policy Updates + Additional Items Worth Your Attention

Posted on by

This final installment starts with animal research, where FDA’s move away from animal testing and new NIH requests for input could affect IACUC and Assurance practices. It then turns to additional items worth your attention, including comment opportunities on NIH’s plan to share study results with participants, an FDA request for information on early-phase ibogaine trials, and a revised Certificate of Confidentiality information collection. Several of these have comment deadlines in the coming weeks, so we note dates wherever we have them. Shorter items are grouped by agency under Honorable mention at the end.

Animal Research

FDA finalized a rule reducing reliance on animal testing. The rule replaces “animal test” and “animal study” language throughout FDA’s regulations with broader “nonclinical test” and “nonclinical study” terminology, confirming that non-animal methods, including human cell cultures, organs-on-chips, and computer or in silico models, can satisfy nonclinical safety testing requirements ahead of human trials. FDA simultaneously launched a database of 25 examples of New Approach Methodologies already in use. This did not eliminate animal studies or lower evidence standards, but it does change how sponsors and IRBs think about IND-enabling nonclinical testing ahead of first-in-human trials. FDA press release

NIH’s Office of Laboratory Animal Welfare is asking whether it should require institutions to report their annual live vertebrate animal numbers, the same way they already report facility square footage, average daily inventory, and USDA pain and distress categories in their Animal Welfare Assurance filings. The RFI specifically seeks input on current tracking methods, feasibility, implementation timelines, resource needs, and burden, for species not already covered by USDA Animal Welfare Act reporting, and any resulting annual reports would be made publicly available online. This is a meaningful potential change to IACUC and Assurance recordkeeping. Comments are due December 21, 2026. NIH Guide notice

NIH’s National Institute of Environmental Health Sciences announced a November 4 to 5 meeting of the Scientific Advisory Committee on Alternative Toxicological Methods (SACATM), the federally chartered body that advises NIEHS and the Interagency Coordinating Committee on the Validation of Alternative Methods on non-animal toxicological testing approaches. This is the advisory infrastructure behind the same non-animal testing methods FDA’s rule above addresses, and public comment registration is open through October 23. Federal Register notice

Also Worth Your Attention

NIH wants to start sharing study results directly with the people who participated in them. NIH is proposing a new policy under which researchers would share summary-level results of clinical studies with those participants.  NIH is asking for public comment on how to promote and enable this practice across the research community. Comments are due October 26, 2026. Federal Register notice

FDA laid out what it expects early-phase ibogaine trials to look like, and it is asking IRBs and others to weigh in. Ahead of federally funded trials through ARPA-H and NIDA, FDA published a request for information describing the design it is considering for first trials of ibogaine, a Schedule I drug with serious cardiac risk, in adults with opioid use disorder or PTSD: capped single doses with stepwise escalation, inpatient cardiac monitoring for at least 36 hours, detailed exclusion criteria, 12-month cognitive follow-up, and an independent data safety monitoring board with specified expertise. FDA asks directly what informed consent must say to convey “serious, potentially life-threatening risks” and what IRBs and DSMBs should consider. This is close to a template protocol for a high-risk psychedelic trial, and a rare chance for IRBs to comment on review expectations before protocols arrive. Comments are due November 20, 2026 (docket FDA-2026-N-10429). Federal Register notice | FDA press release

NIH is consulting Tribal Nations on two All of Us changes and a new Tribal Data Sovereignty Policy. One All of Us proposal would add a tier of sensitive participant data that requires mandatory IRB review before researchers can access it, a new access control for NIH’s largest cohort that other NIH data resources may copy. A second would include self-identified American Indian and Alaska Native participants in a large-scale biospecimen analysis effort, raising consent-scope and group-harm questions for previously collected samples. The Tribal Data Sovereignty Policy, still under development, would govern how NIH funding announcements, grant mechanisms, and research activities recognize Tribal sovereignty over data generated by, about, and within Tribal communities, which could add Tribal approval or data-governance terms to NIH awards that HRPPs will need to coordinate with. Consultations were held October 19 and 20; written comments from Tribes are due November 20, 2026. Federal Register notice

NIH updates its “Basic Experimental Studies with Humans” (BESH) definition. NIH’s BESH definition changes mean certain studies are no longer automatically classified as clinical trials, which changes which registration and reporting rules apply.  OHRP issued guidance on how this NIH update affects the revised Common Rule’s informed consent posting requirement (45 CFR 46.116(h)) on August 10, 2026. NOT-OD-26-067 | NOT-OD-26-032[LH3] 

ORI released new guidance documents under the 2024 research misconduct rule. Released September 29, 2026, the documents cover conflicts of interest, institutional committees, and the roles of Research Integrity Officers and Institutional Officials under the updated 42 CFR Part 93, and ORI reorganized its guidance webpage to make them easier to find. ORI guidance documents

A new information collection public comment period suggests NIH’s Certificate of Confidentiality (CoC) system might be modified. The electronic application system researchers use to obtain a discretionary CoC from NIH went down around April 30, 2025 when its prior OMB approval expired. NIH did not submit the paperwork to reinstate the collection until July 8, 2025; OMB did not approve the reinstatement until August 20, 2025, leaving the system unavailable for roughly three and a half months in between. That reinstated approval is valid through August 31, 2028. NIH submitting a new “information collection” package now, years ahead of that expiration, suggests that NIH is proposing to change some aspect of the system itself (likely something minor, but we will be able to discern more once the OIRA submission page is updated). Also of interest: In calendar year 2025, NIH saw 518 discretionary CoC submissions; in calendar year 2024 NIH received 865 discretionary CoC submissions.  We will keep an eye on whether this is a one-off decrease or a consistent trend. Comments are due November 13, 2026 (60 days after the September 14 publication). Federal Register notice

CMS proposed the RAPID pathway, a new accelerated Medicare coverage route for innovative medical technologies, relevant to any device or diagnostic research program aimed at Medicare coverage. The comment period closed October 13, 2026. Device manufacturers asked whether non-significant risk device studies, which are overseen by IRBs without an IDE application to FDA, could qualify, which would put more of the pathway’s protocol requirements in front of IRBs. Federal Register notice

Honorable mention

FDA

  • FDA opened a 60-day comment period on renewing OMB control number 0910-0130, the collection underlying its core Protection of Human Subjects and Institutional Review Boards regulations, covering informed consent documentation under 21 CFR Part 50, IRB operations and recordkeeping under 21 CFR Part 56, and Certificate of Confidentiality requests. This OMB control number dates back to 1980; its current approval was granted December 26, 2023, and runs through December 31, 2026.  This reads as a routine renewal ahead of that expiration rather than an indication that a change is being contemplated. We will know more once the record is updated on reginfo.gov. Comments are due November 30, 2026. Federal Register notice
  • FDA is surveying providers on barriers to enrolling pregnant patients in pregnancy exposure registries, aiming to improve enrollment in these voluntary observational studies that track medication safety during pregnancy. Federal Register notice
  • FDA finalized FAQ guidance on developing cellular and gene therapy products, spanning regulatory, CMC, and clinical questions in CGT product development. Federal Register notice
  • FDA sought public input on advancing botanical drug product development, relevant to anyone advising sponsors on that clinical development pathway. FDA press release
  • FDA sent OMB a revision of its expanded access collection (Form FDA 3926), the form treating physicians use to request single-patient access to an investigational drug. It adds a “planned date of treatment initiation” field. The one public comment urged FDA to use expanded access submissions as a data source, which would blur the line between treatment and research that IRBs rely on. Federal Register notice

NIH

  • NIH extended its modified peer review triage practices through January 2027, continuing the enhanced triage procedures adopted to manage a grant-application backlog. NOT-OD-26-114
  • NICHD opened a comment period on its DASH data and specimen repository, the Eunice Kennedy Shriver Data and Specimen Hub used for secondary research data sharing. Federal Register notice
  • NIAID proposed a reorganization of its Division of Clinical Research, worth watching for anyone with active NIAID-funded engagements since it could shift which office handles a given clinical research review. Federal Register notice
  • HHS opened an NIH clinic for observational research on people reporting health problems after vaccination. HHS has not yet released a protocol, enrollment criteria, or information about IRB review. HHS press release
  • NIH is operating under a continuing resolution through December 11, 2026. Non-competing awards may be issued below previously committed levels, and implementation of the revised Uniform Guidance is on hold until then. NOT-OD-26-131

Other HHS

  • OMB’s rescission package proposed cutting $27.7 million from HHS’s Agency for Healthcare Research and Quality (AHRQ), naming specific research topics as examples of work it considers wasteful or duplicative. Federal Register notice
  • CMS sought OMB reinstatement of an information collection associated with its Coverage with Evidence Development program, the mechanism CMS uses to condition Medicare coverage of certain items and services on patient participation in an approved clinical study. Federal Register notice
  • OCR’s FAQ on Part 2 substance use disorder confidentiality requirements and Medicaid cleared White House review and was released September 29, 2026. It explains when Part 2 permits state Medicaid agencies to use substance use disorder records to verify that an applicant or beneficiary qualifies for an exclusion from Medicaid community engagement requirements. OIRA detail | OCR FAQ | HHS press release
  • HRSA revised the OPTN data system collection, the forms transplant centers and organ procurement organizations use to report donor and recipient data to the Organ Procurement and Transplantation Network, including moving death-referral reporting to a separate Ventilated Patient Form. Federal Register notice

Other Fed

  • NSF sought reinstatement of its National Training, Education, and Workforce Survey, a statistical survey of the STEM training and workforce pipeline. Federal Register notice

 

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: