Compliance and regulatory

FDA’s July 2026 Unified Agenda lists a dozen new proposed rules on clinical trials, Phase 1 IND, DTC ads, and CRL disclosure beyond the IND pilot.

HHS OIG is asking whether the Anti-Kickback Statute needs a new safe harbor for paying clinical trial participants. Comments on the RFI are due August 24, 2026.

Advances in Psychology has paid $100/review since 2022; NIH may reward journals that pay reviewers ~$50/hr and publish their comments.

Chile’s ANID is extending its 2022 Open Access Policy across every instrument it funds in 2026, backed by a new EspacioCiencia repository service and renewed InES Ciencia Abierta capacity funding. Here’s what the mandate actually requires.

FDA shipped Elsa 4.0 and the HALO data platform in May 2026 — an internal AI upgrade, not a sponsor-facing one. Here is what changed and what did not.

EMA’s draft guidance on running clinical trials during public health emergencies closed for comment April 30, 2026. Finalisation is still pending.

FDA’s April 2026 RFI sought input on an AI-enabled early-phase trials pilot. Comment window closed June 29, 2026 — here’s what it covered.

EO 14332 (Aug. 7, 2025) directs new termination-for-convenience rights, F&A-cost preferences, and DEI-linked terms for discretionary federal grants.

FDA eased CMC expectations for cell and gene therapy BLAs on Jan 11, 2026 — finalized in May, extended to genome editing in June.

NSF’s own FY2027 budget request confirms its Office of Inspector General has cut roughly 22 positions (24%) since January 2025, lost its investigative-scientist staff, and now refers research-misconduct allegations to grantee institutions instead of investigating them directly — following the departures of Inspector General Allison Lerner and Deputy IG Ken Chason.

The EU’s proposed Biotech Act (Commission proposal adopted 16 December 2025, not yet enacted) would revise Clinical Trials Regulation Article 93 to align it with GDPR, naming sponsors and investigators as data controllers and permitting cross-trial data reuse — here is what is actually proposed, what the EDPB-EDPS flagged as unresolved, and what remains to be decided.

A June 2026 House Science subcommittee hearing examined FCA grant-fraud enforcement, spotlighting undisclosed foreign affiliations as a growing DOJ target.

On Feb 27, 2026, the EU Commission issued its first Research Security Monitor plus a Council Recommendation on science diplomacy, adopted May 29, 2026.

Northwestern paid $2.3M under HHS-OIG’s Civil Monetary Penalties Law after self-disclosing a Feinberg researcher’s falsified NIH grant data.

Texas HB 127 (not SB 1565) sets an August 2026 research-security certification deadline for Texas public university boards.

In April 2025, NEH terminated more than 1,400 grants worth over $100 million; a federal judge has since ruled the mass termination unconstitutional. Starting June 30, 2026, NEH began asking each affected recipient to formally reconfirm, via a Reinstatement Assurances Form, that they still want the award back.

GAO: 5 top research-funding agencies havent assessed whether security screening risks discriminating against Chinese and Asian-descent scientists.

The House-passed DETERRENT Act would cut the Section 117 foreign-gift threshold to $50,000. A 26-group coalition pushed the stalled Senate bill in May 2026.

BIOSECURE Act became law Dec 18, 2025 (NDAA Sec. 851), restricting federal contracts and grants tied to designated biotechnology companies of concern.

The EU’s February 2026 Research Security Monitor and forthcoming Centre of Expertise add EU-wide policy coordination beyond Horizon Europe grant screening.

Argentina’s INPI Resolution 38/2026 simplifies technology transfer agreement registration under Law 22,426, easing tax-relevant filings for global licensors.

Nigeria’s Federal Executive Council approved the National Intellectual Property Policy and Strategy (NIPPS) on November 6, 2025, and the government launched implementation on December 17, 2025. Here is what the framework actually changes for university IP commercialization and technology transfer offices.

EO 14411 (June 22, 2026) tightens research-security and export-control coordination for quantum research. What it means for QIST funding and tech transfer.

Danish researcher Poul Thorsen was extradited from Germany after 15 years as a fugitive and arraigned on 22 federal wire fraud/money laundering counts.

Wolters Kluwer retracted nine transplant papers in July 2026 over unresolved organ-sourcing ethics tied to a 2019 scoping review.

Dana-Farber paid $15M in Dec. 2025 to settle a DOJ False Claims Act suit over manipulated images in NIH-funded papers, and what it means for grant compliance.

The SAFE Research Act would have cut federal funding over ‘hostile foreign entity’ ties. University pushback got it struck from the FY2026 NDAA.

HHS’s Simpler.Grants.gov initiative has shipped a new default search, account and submission-tracking tools, and a public API through 2025-2026 — but full application submission and a legacy Grants.gov retirement date are not yet confirmed. Here’s what’s actually changed for applicants.

University of Melbourne has opened a formal probe into education researcher John Hattie over alleged plagiarism and fabricated AI-style citations.

Commerce cut, then restored, foreign access to Anthropic’s Fable 5/Mythos 5 over a jailbreak claim — what it means for research-security compliance.

The Netherlands fully revised its National Knowledge Security Guideline on 9 July 2026, updating the threat assessment and adding a risk-indicator appendix.

Senate Judiciary July 14, 2026 hearing on PERA (S.1546) weighed patent eligibility for diagnostics and AI — key stakes for university tech transfer.

MOST Order No. 24 lists 68 categories of research misconduct across six actor types, part of China’s push to hold institutions accountable.

The EDPB’s draft Guidelines 1/2026, published 15 April 2026, set out a six-factor test for “scientific research” under GDPR and detail Article 89 safeguards, legal bases, and a restrictive line on data-subject-right derogations. Consultation closed 25 June 2026; the text is not yet final.

China’s Ministry of Science and Technology has ordered universities to investigate retracted papers for misconduct and warned of penalties for looking away.

Canada’s PRCR ran a Feb 17-Apr 17, 2026 consultation proposing to remove any statute of limitations on research misconduct allegations, alongside new rules on anonymous complaints, post-departure accountability, and retaliatory-allegation protections. The comment period has closed; no revised Framework has been published yet.

Commerce opened a Bayh-Dole march-in proceeding against Harvard’s patents in Aug. 2025 — the first agency-initiated test of march-in rights.

FDA’s Commissioner’s National Priority Voucher (CNPV) pilot promises a one-to-two-month review for drugs meeting national health priorities. Here’s how it differs from statutory Priority Review Vouchers, who has received one, and where the program stands as of FDA’s 2026 public hearing.

Since October 1, 2025, applicants for commercial patent licenses on NIH-owned (intramural) inventions must submit an access plan addressing affordability, availability, acceptability, and sustainability. It does not apply to university-owned inventions from NIH-funded (extramural) research — here’s what tech-transfer offices need to know about scope, requirements, and the effective date.

Health Canada’s draft Clinical Trials Regulations and its April 2026 ICH E6(R3) adoption mark Canada’s biggest trial-oversight overhaul in decades.

FDA’s June 22, 2026 revised draft guidance clarifies when a single adequate and well-controlled trial plus confirmatory evidence can satisfy the substantial-evidence-of-effectiveness standard for drug and biologic approval, narrowing the traditional two-trial default. Comments are open through September 22, 2026.

FDA published draft guidance Jan. 12, 2026 setting expectations for Bayesian primary-analysis designs in drug/biologic trials. Comments closed March 13, 2026.

CMS and FDA launched RAPID on April 23, 2026, targeting Medicare coverage within 60-90 days of FDA authorization for breakthrough devices, pausing TCET for new candidates.

A D.D.C. court granted summary judgment for HHS on Dec. 12, 2025, upholding ORI’s misconduct findings and 3-year debarment of researcher Ivana Frech.

FDA’s final guidance sets trial-design rules for psychedelic drug studies, addressing functional unblinding and abuse-potential testing.

On July 14, 2026, FDA finalized guidances on generic topical corticosteroid bioequivalence testing and formal FDA meetings for OTC monograph drug sponsors.

COPE’s new Code of Conduct for members is live, replacing the retired 2024 Core Practices, with a 12-month transition before adherence is mandatory.

South Korea’s National Research Foundation found no research misconduct in Changwon National University president Park Min-won’s papers, closing a three-year plagiarism and duplicate-publication review.

China’s National Health Commission disclosed 28 sanctioned misconduct cases spanning data fabrication, paper trading, and guest authorship.

OMB’s proposed grants rewrite would give political appointees final sign-off and recast peer review as advisory. Comments closed at 340,000+.

CMS’s CY2027 fee schedule proposal narrows, not bans, third-party RPM/RTM billing. Here is the real mechanism, the OIG data behind it, and what it means for clinical trial billing compliance.

AHRQ has issued near-identical “non-award” letters ending continuation funding for dozens of active grants, citing portfolio prioritization. HHS says these are not terminations; grantees and advocacy groups disagree, a distinction with real consequences for appeal rights and sponsored-programs planning.

UKCORI co-lead Miles Padgett told the UK Reproducibility Network conference the committee has no operations planned beyond 2027, and sketched a scenario for a new centralised UK research-integrity body — not yet a confirmed policy.

A Tufts historian’s award-winning book failed an external peer review. The AHA rescinded her prize; she’s no longer at Tufts and disputes the findings.

Rutgers University is investigating whether payments its own units made to Dean Jacqueline Mattis’s writing-retreat company, Easton’s Nook, violate New Jersey conflict-of-interest law. Reported totals range $145K-$155K over about nine years; the probe is ongoing.

Nobel laureate Thomas Südhof told Lindau 2026 that publishing is unregulated, dismissed COPE as self-serving, and urged a government “FDA for journals.”

A March 2026 ORI finding against former Mount Sinai postdoc Chen-Yeh “George” Ke — for falsified images in a draft manuscript and NIH progress reports — prompted independent image-forensics sleuthing of his broader publication record. That work surfaced an unrelated duplicated image in a 2019 Science Signaling paper, which the journal retracted in July 2026 after finding further discrepancies.

FDA reopened comment on its master protocol draft guidance in June 2026, adding new basket-trial recommendations. Comments are open through August 24, 2026.

ORI’s final rule revising 42 CFR Part 93 took effect Jan 1, 2025 and applies to allegations received on or after Jan 1, 2026. Here’s exactly what changed.

NSF 26-022 bars NSF-funded collaboration with entities on seven federal restricted-party lists, starting FY2027. Here’s what it does and doesn’t cover.

OMB’s May 2026 proposed rule would bar federal grant funds from collaboration with “covered foreign countries.” Here’s what the rule’s text actually says, why the widely-cited “17 countries” figure isn’t a real OMB list, and how this differs from the CHIPS Act’s countries-of-concern list.

COGR’s June 2026 meeting included a GAO briefing flagging research security as a top oversight area. What’s confirmed, and what it means for research admins.

GAO-26-107738 (May 2026) found 2 of 9 agencies lacked a public-access policy, reuse-rights gaps at NSF/USDA, and costs it warns could reach $1B/year.

Executive Order 14292 (May 2025) paused federal funding for dangerous gain-of-function research and set OSTP deadlines for oversight rules, now overdue.

A March 2026 law-firm alert warns the fundamental research exclusion is quietly narrowing for universities. No BIS or Federal Register rule change was found to confirm that framing — here’s what’s actually enacted (NSPM-33, Section 117, the BIOSECURE Act) versus what’s still just a warning.

FDA’s proposed Expedited IND Pilot Program would speed first-in-human trials via Qualified Research Institutions; comments now due Aug. 24, 2026.

ARC’s updated Open Access Policy took effect 1 July 2026: immediate OA for articles, a 12-month window for books, and new Indigenous research provisions.

NIH’s 15% indirect-cost cap is dead: the First Circuit upheld the injunction against it in January 2026, and DOJ let its Supreme Court appeal deadline lapse in April 2026 without filing. Congress has separately blocked equivalent caps at NIH, DOE, and NSF through appropriations riders. The remaining risk isn’t litigation — it’s the annual budget-request cycle.

FDA has initiated two proof-of-concept real-time clinical trials and opened an RFI on a broader RTCT pilot program. Final selection criteria are expected in July 2026, with pilot selections completed in August 2026.

OMB’s proposed rewrite of the Uniform Guidance (2 CFR 200) closed for comment July 13, 2026. What it would change, and its status toward an Oct. 1 target.

The ARC’s updated Generative AI policy took effect 28 April 2026, setting rules for applicants, assessors, and research offices.

US university budget cuts and layoffs have continued into summer 2026, with new rounds at Johns Hopkins, the University of Minnesota, The New School, and others. Some are explicitly tied to NIH, NSF, and USAID funding disruption; others are driven mainly by enrollment or state-funding pressure. Here’s what’s documented, institution by institution.

CIHR, NSERC, and SSHRC’s revised Tri-Agency Guide on Financial Administration takes effect April 1, 2026. The key change: a new Buy-Canadian purchasing expectation for grant-funded spend, plus a tighter rule on consulting fees paid to grant-team-affiliated entities.

Hachette, Cengage, Elsevier, and Scott Turow sued Google in SDNY, alleging Gemini trained on Google Books, Play Books, and Scholar without authorization.

NSF’s PAPPG 26-200 supplement (eff. Dec. 8, 2025) revised SBIR pitch rules, funding caps, equipment thresholds, and research-security requirements.

ED’s Feb. 23, 2026 pact with State adds national-security review to Section 117 foreign-gift oversight. Thresholds and deadlines are unchanged.

NIH triaged applications into discussion tiers to clear its shutdown backlog; a related funding-criteria shift drew reported political-influence concerns.

Federal agencies now require ORCID as a digital persistent identifier; universities are setting their own 2026 linkage deadlines ahead of enforcement.

NIH’s Common Forms leniency period ended May 8, 2026: eRA now blocks SciENcv biosketch/support submissions with unlinked ORCID or eRA Commons.

NIH’s May 2026 notice explains when AI use in funded research crosses into research misconduct, and what enforcement follows.

The US Office of Research Integrity’s 2026 case summaries include a 15-year debarment of former Rice University professor Ariel Fernandez for fabricating data across 12 published papers — one of ORI’s longest debarment periods on record. Alongside two other 2026 cases, it shows an active federal misconduct-enforcement pipeline continuing to work through cases under the current, recently revised 42 CFR Part 93 framework.

NSPM-33’s $50M research security program deadline isn’t one fixed July 2026 date — it’s agency-specific. Plus DoD’s Jan. 2026 memo, explained.

DHS’s new rule ends open-ended F-1/J-1 admission, capping it at up to 4 years and requiring a separate USCIS extension filing, effective Sept. 15, 2026.

ClinicalTrials.gov is retiring the Classic Protocol Registration and Results System (PRS) in stages through 2026 and 2027, moving every sponsor and registrant onto the Modernized PRS. Here is the confirmed timeline, from the July 2026 cutoff on new records to the Fall 2026 submission deadline, and what to do before each one.

Where Harvard’s federal research funding fight stands in 2026, and why the appeal’s jurisdictional question matters for every funded institution.

Federal judge Rita Lin has repeatedly ordered NSF and NIH to restore suspended UCLA grants via preliminary injunction in an ongoing UC faculty lawsuit — roughly $81M (NSF, Aug 2025) and $500M/500 grants (NIH plus DOD/DOT/HHS, Sept 2025). As of July 2026 the case is still open toward a final ruling, with a hearing set for October 20, 2026. Here is what “restored” by preliminary injunction means operationally for a research office — and why it is not the same as a resolved dispute.

A 2026 status map of Accord implementation: HELP/HECS reform now law, university funding mid-transition, ATEC on its own legislative track.

The 2022 Nelson Memo required every federal funder, not just NIH, to adopt zero-embargo public access by Dec. 2025 — here’s where agencies stand in 2026.

The FY2026 Labor-HHS appropriations report directs HHS to process grant disbursements within 5 business days, with exceptions. What NIH awardees should know.

UKRI’s 22 June 2026 FAQ update clarifies Horizon Europe Guarantee compliance and block grants, part of a 2026-2030 Open Access Monitor plan.

Congress rejected NIH’s 27-to-8 institute consolidation in FY2026 funding, but administrative restructuring continues. Here’s the current status.

Where 2026 litigation over SEVIS record terminations and visa revocations stands, and what it means for international researchers.

The 2025 H-1B $100,000 fee hits new petitions requiring consular processing, including at universities. Litigation is ongoing — current status inside.

NSF’s indirect cost cap attempt was blocked and Congress has barred new rate changes. Grant terminations tied to DEI/environmental-justice criteria are being litigated on two separate tracks with different outcomes so far, and NSF’s budget remains under pressure. Here is the current, still-moving status as of mid-2026.

NIH terminated its Minority Biomedical Research Support Program and froze diversity supplements in 2025 – what was cut, and where litigation stands now.

Congress rejected Trump’s proposed 40% NIH cut in FY2026, funding NIH at $48.7B — but grant terminations and indirect-cost fights still reshaped awards.

NSF Notice 149 makes research-security training, MFTRP, and Confucius Institute certifications mandatory for proposals, effective Dec. 2, 2025.

ACM is creating its first director of research integrity role to clear a case backlog, joining Springer Nature and Elsevier in treating misconduct investigation as a dedicated, professionalized function rather than a volunteer committee job.

NIH’s April 2026 notice NOT-OD-26-072 reinstates the $25,000 subaward cap and 10% de minimis rate, rescinding 2025 flexibilities — a separate action from the litigated 15% cost cap.

What the EU AI Act actually requires of research administrators, where the exemptions sit, and the practical compliance checklist for institutions in 2026.