PRIM&R Public Policy Research Ethics Resources
Staying informed about evolving federal policies is essential for those involved in research oversight and ethics.
This timeline tracks key legislative, regulatory, and policy developments impacting human and animal research protections, bioethics, and public trust in research.
Updated regularly, we highlight proposed bills, agency rulemaking, executive actions, and other government initiatives that shape the research landscape. Whether you’re a researcher, IRB member, or institutional leader, this resource provides real-time insights to help you navigate the shifting policy environment and advocate for ethical research practices.
Federal Public Policy
Stay informed with our Federal Policy Tracker, providing real-time updates on legislative and regulatory changes impacting research ethics and oversight.
Order/Action: ORI — 42 CFR Part 93 Guidance on Generative Artificial IntelligencePublication Date: 8/2026Type: Guidance (ORI)Immediate Effects: ORI issued nonbinding guidance for institutions navigating research misconduct proceedings involving generative AI. The guidance addresses disclosure of AI use, verification of AI-derived results, fabricated citations, plagiarism, evidentiary considerations, and the role of scientific and AI subject-matter expertise in misconduct investigations.Status: Guidance issued; effective August 2026.
Order/Action: FDA/CDER — Establishment of a Quantitative Medicine Innovation Network (QMIN): Scope, Feasibility, and OpportunitiesPublication Date: 8/5/26Type: RFI (FDA)Immediate Effects: CDER's Quantitative Medicine Center of Excellence requested public input on structuring a cross-sector network to advance computational and model-based approaches to drug development, including New Approach Methodologies. The notice lists "reduced animal use" as a candidate success metric but does not address ethical review or validation governance for the network's activities.Status: Comment period closes 11/3/26.Summary for the group
Order/Action: Modification of Certain Terminology in Title 21; Reopening of the Comment PeriodAgency: Food and Drug Administration (FDA), U.S. Department of Health and Human Services (HHS)Publication Date: 8/3/26Type: Federal Register Notice / Reopening of Comment PeriodImmediate Effects: FDA reopened the public comment period on its proposed rule to modify certain terminology throughout Title 21 of the Code of Federal Regulations. The proposal would update terminology used in FDA regulations to reflect current scientific, medical, and policy standards by replacing or revising certain terms used across FDA-regulated products and activities. The reopening provides stakeholders—including regulated industry, researchers, healthcare professionals, and the public—additional time to review and comment on the proposed changes. The notice does not make the terminology changes final or alter existing regulatory requirements at this time.Status: Active—Open for Public Comment. FDA reopened the comment period through September 2, 2026, after receiving requests for additional time. FDA will consider all comments before issuing a final rule.
Order/Action: Statement of Organization, Functions, and Delegations of AuthorityAgency: U.S. Department of Health and Human Services (HHS)Publication Date: 7/29/26Type: Federal Register Notice / Organizational Delegation of AuthorityImmediate Effects: HHS announced revisions to its Statement of Organization, Functions, and Delegations of Authority to reflect changes in the Department's organizational structure and internal authorities. The notice updates the responsibilities and delegated authorities of HHS leadership and operating divisions to improve administrative efficiency and clarify decision-making responsibilities. The changes are organizational in nature and do not establish new regulatory requirements for federally funded research or alter existing compliance obligations for research institutions. However, they identify which HHS officials and offices are responsible for carrying out specific departmental authorities and functions.Status: Effective. The organizational and delegation changes became effective upon publication on July 29, 2026, unless otherwise specified in the notice.
Order/Action: U.S. Government Policy for Stopping High-Risk Life Sciences ResearchAgency: Executive Office of the President / White House Office of Science and Technology Policy (OSTP), in coordination with federal departments and agenciesPublication Date: 7/2026Type: White House PolicyImmediate Effects: The White House issued a government-wide policy establishing a framework to identify, assess, and, when appropriate, prohibit high-risk life sciences research that could reasonably be anticipated to pose significant risks to public health, national security, or public safety. The policy directs federal departments and agencies that fund or conduct life sciences research to implement oversight processes for evaluating research proposals, managing identified risks, and ensuring consistent decision-making across the federal government. Agencies are expected to update their policies and oversight mechanisms to align with the new framework, with implementation coordinated through the Office of Science and Technology Policy (OSTP). The policy replaces previous federal guidance governing research involving pathogens and other high-consequence biological agents.Status: Issued—Implementation Underway. Federal departments and agencies are responsible for implementing the policy, developing agency-specific procedures, and integrating the framework into their research oversight processes in accordance with implementation timelines established by OSTP.
Order/Action: Cancer Clinical Trial Eligibility Criteria: Organ Dysfunction; Draft Guidance for Industry, Institutional Review Boards, and Clinical InvestigatorsAgency: Food and Drug Administration (FDA), U.S. Department of Health and Human Services (HHS)Publication Date: 7/28/26Type: FDA Draft Guidance / Federal Register NoticeImmediate Effects: FDA issued draft guidance recommending that sponsors broaden eligibility criteria for cancer clinical trials involving participants with hepatic, renal, cardiac, pulmonary, or other organ dysfunction when scientifically and clinically appropriate. The guidance encourages sponsors to base eligibility criteria on available clinical and pharmacologic evidence rather than excluding participants with organ impairment by default. FDA notes that unnecessarily restrictive eligibility criteria can limit enrollment, reduce the representativeness of trial populations, and delay access to investigational therapies. The draft guidance provides recommendations for designing studies that safely include participants with varying degrees of organ dysfunction while maintaining participant safety and generating data that better reflects real-world patient populations. The guidance, if finalized, will represent FDA's current thinking and does not establish legally enforceable requirements.Status: Draft Guidance—Open for Public Comment. FDA is accepting public comments on the draft guidance before issuing a final version. Once finalized, the guidance will inform sponsors, institutional review boards (IRBs), and clinical investigators in the design and conduct of cancer clinical trials.
Order/Action: Cancer Clinical Trial Eligibility Criteria: Washout Periods and Concomitant Medications; Guidance for Industry, Institutional Review Boards, and Clinical InvestigatorsAgency: Food and Drug Administration (FDA), U.S. Department of Health and Human Services (HHS)Publication Date: 7/28/26Type: Federal Register Notice / Final GuidanceImmediate Effects: FDA announced the availability of a final guidance recommending approaches for determining appropriate washout periods and managing concomitant medications when establishing eligibility criteria for cancer clinical trials. The guidance encourages sponsors to avoid unnecessarily restrictive requirements that may limit patient participation without improving participant safety or trial integrity. FDA recommends that washout periods and medication restrictions be scientifically justified, risk-based, and tailored to the investigational product and study objectives. The guidance is intended to help sponsors, institutional review boards (IRBs), and clinical investigators design more inclusive cancer clinical trials while maintaining participant safety and data quality. It finalizes draft guidance issued in 2024 and represents FDA's current thinking; it does not establish legally enforceable responsibilities.Status: Final Guidance—Effective. The guidance was announced on July 28, 2026, and is available for immediate use by sponsors, IRBs, and clinical investigators. Comments on FDA guidance documents may be submitted at any time.
Order/Action: Cancer Clinical Trial Eligibility Criteria: Performance Status; Guidance for Industry, Institutional Review Boards, and Clinical InvestigatorsAgency: Food and Drug Administration (FDA), U.S. Department of Health and Human Services (HHS)Publication Date: 7/28/26Type: Federal Register Notice / Final GuidanceImmediate Effects: FDA announced the availability of a final guidance recommending that sponsors consider expanding eligibility criteria in cancer clinical trials to include patients with a broader range of performance status when scientifically and clinically appropriate. The guidance is intended to help sponsors, institutional review boards (IRBs), and clinical investigators design more inclusive trials that better reflect the populations likely to use approved therapies. FDA notes that unnecessarily restrictive eligibility criteria can limit patient access to clinical trials, slow enrollment, and reduce the generalizability of study results. The guidance finalizes a 2024 draft and includes additional recommendations related to trial retention, sample size, and other considerations when including participants with lower performance status. The guidance represents FDA's current thinking and does not establish legally enforceable requirements.Status: Final Guidance—Effective. The guidance was announced on July 28, 2026, and is available for immediate use by sponsors, IRBs, and clinical investigators. Comments on FDA guidance documents may be submitted at any time.
Order/Action: Agency Information Collection Activities; Proposed Collection; Comment Request – Expanded Access to Investigational Drugs for Treatment UseAgency: Food and Drug Administration (FDA), U.S. Department of Health and Human Services (HHS)Publication Date: 7/28/26Type: Federal Register Notice / Information Collection Request (Paperwork Reduction Act)Immediate Effects: FDA is requesting public comment on the proposed extension of the information collection associated with expanded access (compassionate use) to investigational drugs for treatment use. The notice covers the information submitted by physicians, sponsors, and institutional review boards (IRBs) to support requests for patients with serious or immediately life-threatening diseases or conditions to access investigational drugs outside of clinical trials when no satisfactory alternatives are available. The proposal does not change FDA's expanded access regulations or program requirements; rather, it seeks public input on the continuing information collection and associated reporting burden under the Paperwork Reduction Act.Status: Active—Open for Public Comment. Public comments must be submitted by 9/28/2026. FDA will consider comments before seeking Office of Management and Budget (OMB) approval to continue the information collection
Order/Action: Rescinding Portions of the U.S. Department of Health and Human Services Title VI Regulations To Align With the Statutory Text and Conform to Executive Order 14281Agency: Office for Civil Rights (OCR), Office of the Secretary, U.S. Department of Health and Human Services (HHS)Publication Date: 7/24/26Type: Final RuleImmediate Effects: HHS amends its regulations implementing Title VI of the Civil Rights Act of 1964 by removing regulatory provisions that impose or illustrate disparate-impact liability, limiting enforcement to allegations of intentional discrimination based on race, color, or national origin. According to HHS, the changes align the regulations with the statutory text of Title VI, Supreme Court precedent, and Executive Order 14281, while reducing compliance costs and regulatory uncertainty for recipients of HHS funding. The rule also rescinds obsolete Title VI guidance contained in Appendix B to 45 CFR Part 80 and removes related cross-references in other HHS regulations. The Office for Civil Rights will continue to investigate complaints and enforce Title VI where intentional discrimination is alleged.Status: Final Rule—Effective. The rule became effective July 24, 2026, and is now in force.
Order/Action: HHS Request for Comment on the Update to the National Plan to Address Alzheimer's DiseaseAgency: Office of the Assistant Secretary for Planning and Evaluation (ASPE), U.S. Department of Health and Human Services (HHS)Publication Date: 7/24/26Type: Federal Register Notice / Request for Information (RFI)Immediate Effects: HHS is seeking public input to inform an update to the National Plan to Address Alzheimer's Disease, which establishes the federal government's strategy for addressing Alzheimer's disease and related dementias (AD/ADRD). The agency is requesting feedback on research priorities, prevention and risk reduction, early detection and diagnosis, care and support for individuals living with dementia and their caregivers, health equity, and opportunities to improve coordination across federal agencies and external partners. The information collected will help shape future federal policy and strategic priorities through the updated National Plan. No regulatory requirements change as a result of this notice.Status: Closed. The public comment period ended 8/15/2026. HHS will review submitted comments as it develops the updated National Plan to Address Alzheimer's Disease.
Order/Action: U.S. House Passes FDA Modernization Act 3.0Agency: U.S. House of Representatives / U.S. Congress (directing the U.S. Food and Drug Administration)Publication Date: 7/20/26 (House passage); reported 7/22/26Type: Congressional LegislationImmediate Effects: The U.S. House of Representatives passed the FDA Modernization Act 3.0 (H.R. 2821), bipartisan legislation directing FDA to update its regulations to replace outdated references to animal testing with broader nonclinical testing methods, consistent with changes made by the FDA Modernization Act 2.0. The bill does not prohibit animal testing or change the evidentiary standards for drug approval. Instead, it requires FDA to revise its regulations to recognize scientifically valid alternatives—including new approach methodologies (NAMs) such as organ-on-chip systems, computational models, and other human-relevant methods—where appropriate. The legislation is intended to align FDA regulations with existing federal law and support modernization of preclinical testing.Status: Passed the House. As of July 2026, the bill has passed the House of Representatives and must be approved by the Senate before being sent to the President for signature. If enacted, FDA would be required to undertake rulemaking to update its regulations.
Order Action: Agency Information Collection Request; 30-Day Public Comment Request – HHS Registration of an Institutional Review Board (IRB) Form
Agency: Office for Human Research Protections (OHRP), Office of the Assistant Secretary for Health (OASH), U.S. Department of Health and Human Services
Publication Date: 7/20/26
Type: Federal Register Notice / Information Collection Request (Paperwork Reduction Act)Immediate/ Effects: HHS/OHRP proposes revisions to the Institutional Review Board (IRB) Registration Form by eliminating the requirement for IRBs to submit membership roster information during registration. The change aligns the form with the 2018 Common Rule, reduces administrative burden, and maintains existing IRB registration requirements for OHRP and FDA oversight. No regulatory requirements change at this time; HHS is requesting public comment before final approval.
Status: Active—Open for Public Comment. Public comment period ends 8/19/2026.
Order/Action: Agency Information Collection Request; 60-Day Public Comment Request – OHRP Research Complaint Form
Agency: OHRPDate: 7/2/26Type: Federal Register Notice / Information Collection Request (Paperwork Reduction Act)Immediate/ Effects: The Office for Human Research Protections (OHRP) is requesting a three-year extension of OMB No. 0990-0473-60D, the HHS Subpart C Certification Form. The purpose of this form is to provide a simplified, standardized procedure for institutions to submit subpart C research certifications to OHRP in order to obtain authorization to include prisoners in HHS-conducted or supported human subjects research. The form also simplifies the internal process used by OHRP to review and record such certifications, resulting in faster processing while reducing unnecessary and burdensome staff time.Status: Active. Public comment period that ends 08/31/2026
Order/Action: Agency Information Collection Request; 60-Day Public Comment Request – HHS Registration of an Institutional Review Board (IRB) Form
Agency: Office for Human Research Protections (OHRP), Office of the Assistant Secretary for Health (OASH), U.S. Department of Health and Human Services Publication Date: 7/2/26Type: Federal Register Notice / Information Collection Request (Paperwork Reduction Act)Immediate/ Effects: HHS/OHRP initiated public comment on proposed revisions to the Institutional Review Board (IRB) Registration Form. The proposal would eliminate the requirement for IRBs to submit membership roster information during registration, aligning the form with the 2018 Common Rule while reducing administrative burden. This notice begins the Paperwork Reduction Act review process before submission to OMB.Status: Active. Public comment period that ends 08/31/2026
Order/Action: Potential Revisions to the Common Rule (45 CFR Part 46)Agency: Office for Human Research Protections (OHRP), Office of the Assistant Secretary for Health (OASH), U.S. Department of Health and Human Services Publication Date: 7/1/26Type: Intent to File Notice of Proposed Rulemaking (NPRM)Immediate/ Effects: The U.S. Department of Health and Human Services (HHS) has added to its regulatory agenda that could bring significant updates to the Common Rule (45 CFR part 46). According to the agenda, HHS is considering revisions intended to modernize and simplify IRB oversight, reduce unnecessary administrative burden, expand exemptions for certain low-risk research activities, clarify key regulatory terminology, and introduce greater flexibility for the review of minor protocol changes. Status: Upcoming Proposed Rule
Order/Action: Expedited Investigational New Drug (IND) Pilot Program; Request for InformationAgency: U.S. Food and Drug Administration (FDA)Publication Date: 6/24/26Type: Request for Information (RFI)Immediate/ Effects: FDA is seeking public input on a proposed Expedited Investigational New Drug (IND) Pilot Program intended to accelerate the transition from drug discovery to first-in-human clinical trials. The agency is requesting feedback on eligibility criteria, program design, regulatory flexibilities, and scientific approaches that could shorten development timelines while maintaining appropriate protections for research participants and preserving the quality of safety and efficacy evaluations. The RFI signals FDA's interest in exploring new regulatory pathways for innovative therapies and may inform future pilot programs or rulemaking.Status: Comments due August 24, 2026. FDA will review stakeholder feedback to determine whether to establish an Expedited IND Pilot Program or pursue additional regulatory or policy changes. On July 6, 2026, FDA published a correction updating the contact email address; no substantive changes were made to the RFI.
Order/Action: Demonstrating Substantial Evidence of Effectiveness for Human Drug and Biological Products (Revised Draft Guidance)Agency: U.S. Food and Drug Administration (FDA)Publication Date: 6/24/26Type: Revised Draft Guidance for IndustryImmediate/ Effects: This revised draft guidance updates FDA's recommendations for demonstrating substantial evidence of effectiveness to support approval of human drugs and biological products. The guidance emphasizes that, in appropriate circumstances, a single adequate and well-controlled clinical investigation supported by confirmatory evidence may be sufficient to establish effectiveness, rather than relying on the historical expectation of two adequate and well-controlled studies. FDA describes factors it will consider when evaluating this approach, including the design, conduct, analysis, and persuasiveness of the clinical trial; the source and strength of confirmatory evidence; disease-specific considerations such as seriousness, unmet medical need, and prevalence; and whether conducting multiple trials would be ethical or practicable. The guidance also encourages sponsors to discuss development strategies with FDA early in the process, including through pre-IND meetings.Status: Draft Guidance—Open for Public Comment.
Order/Action: Medicare and State Health Care Programs: Fraud and Abuse; Request for Information Regarding the Federal Anti-Kickback Statute and Beneficiary Inducements CMPAgency: U.S. Department of Health and Human Services (HHS), Office of Inspector General (OIG)Publication Date: 6/24/26Type: Request for Information (RFI)Immediate/ Effects: OIG is seeking public input on whether changes are needed to the Federal Anti-Kickback Statute safe harbor regulations or the Beneficiary Inducements Civil Monetary Penalty (CMP) exceptions to better address compensation and other remuneration provided to individuals participating in clinical trials. The agency is requesting feedback on whether current regulations create barriers to participant recruitment, retention, reimbursement, or other support activities, and whether additional regulatory flexibility is needed while continuing to protect against fraud and abuse. The RFI could inform future rulemaking affecting sponsors, research institutions, investigators, and participants involved in clinical research.Status: Open for Public Comment. Comments due August 24, 2026. OIG will review stakeholder feedback to determine whether future revisions to the Anti-Kickback Statute safe harbor regulations or Beneficiary Inducements CMP exceptions are warranted. No regulatory changes have been proposed or adopted at this stage.
Order/Action: Master Protocols for Drug and Biological Product Development (Revised Draft Guidance)Agency: U.S. Food and Drug Administration (FDA)Publication Date: 6/24/26Type: Revised Draft Guidance for IndustryImmediate/ Effects: This revised draft guidance provides FDA's current recommendations on the design, conduct, analysis, and oversight of clinical trials conducted under a master protocol. It defines key trial designs—including master, umbrella, basket, platform, and sub-study designs—and offers recommendations on randomization, control groups, adaptive designs, blinding, statistical considerations, data sharing, safety reporting, and investigational new drug (IND) submissions. The guidance also addresses ethical and operational considerations for informed consent. FDA recommends that the initial informed consent process describe all treatment arms to which a participant could reasonably be randomized. For platform trials, consent documents may require updates as treatment arms are added or removed over time. The guidance also discusses the potential use of post-randomization, drug-specific consent for sub-studies, noting that while this approach may simplify complex trial designs for participants, it may also introduce bias if participants decline enrollment after randomization.Status: Draft Guidance—Open for Public Comment.
Order/Action: FDA Achieves Year 1 Goals in Reducing Animal Testing in Drug Development
Date: 4/20/26
Type: FDA Implementation Update / Progress Report
Immediate Effects: FDA announced that it met key first-year goals under its roadmap to reduce animal testing in preclinical safety studies and released a follow-up report describing progress and next steps. FDA states that this effort is part of broader work to reduce reliance on animal testing and incorporate new approach methodologies into regulatory decision-making where appropriate.
Status: Active
Order/Action: FDA Issues Draft Guidance on Genome Editing Safety Standards to Advance Gene Therapy Development
Date: 4/14/26
Type: Draft Guidance
Immediate Effects: FDA issued draft guidance for sponsors developing human gene therapy products involving genome editing technologies. The guidance provides recommendations on standardized approaches for assessing safety, including the use of next-generation sequencing, and is intended to support regulatory review of these products.
Status: Draft Guidance
Order/Action: Implementation of Changes for Basic Experimental Studies with Humans
Date: 4/6/26
Type: NIH Notice
Immediate Effects: NIH implemented changes to its policy on Basic Experimental Studies with Humans (BESH), stating that for competing applications due on or after 5/25/26, BESH studies will no longer be classified as clinical trials. NIH states that these studies will not be subject to certain clinical trial requirements, such as registration and results reporting in ClinicalTrials.gov, while remaining subject to applicable human subjects protections.
Status: Active; applies to due dates on or after 5/25/26
Order/Action: GOHRP Updates Federalwide Assurance (FWA) Process
Date: 3/26
Type: Administrative and Non-Regulatory Policy Update
Immediate Effects: OHRP implemented updates to the Federalwide Assurance form and electronic submission system to implement burden-reducing provisions from the revised Common Rule and clarify when 45 CFR part 46 applies to HHS-supported or conducted nonexempt human subjects research.
Status: In effect.
Order/Action: FDA Releases Draft Guidance on Alternatives to Animal Testing in Drug Development
Date: 3/18/26
Type: Draft Guidance
Immediate Effects: FDA issued draft guidance to help drug developers validate new approach methodologies for use in place of animal testing in drug development and to support regulatory submissions when scientifically appropriate. The guidance outlines general validation principles and considerations for regulatory use of non-animal methods.
Status: Draft guidance.
Order/Action: ORI Additional Final Rule Guidance Documents Released
Date: 3/5/26 (additional guidance); prior guidance released 12/19/25
Type: Guidance Implementation Updates
Immediate Effects: ORI released additional topic-specific guidance documents to support institutional implementation of the revised Public Health Service research misconduct regulation at 42 CFR Part 93, which took effect 1/1/26.
Status: In effect
Order/Action: Request for Information on Draft NIH Controlled-Access Data Policy and Proposed Revisions to NIH Genomic Data Sharing Policy
Date: 12/17/25
Type: Request for Information
Immediate Effects:
NIH requested public input on a proposed Controlled-Access Data Policy and proposed revisions to the NIH Genomic Data Sharing Policy. The proposal would establish clearer rules for which human participant data should be managed through controlled access and revise genomic data-sharing expectations.
Status: Comment period closed; under NIH review.
Order/Action: FDA Releases Draft Guidance on Reducing Testing on Non-Human Primates for Monoclonal AntibodiesDate: 12/2/25Type: Draft GuidanceImmediate Effects: FDA issued draft guidance identifying product types for which six-month non-human primate toxicity testing may be reduced or eliminated as part of broader efforts to modernize nonclinical drug evaluation and incorporate alternative methods into regulatory decision-making.
Status: Draft guidance
Order/Action: NIH Policy on Enhancing Security Measures for Human Biospecimens
Date: 9/24/25
Type: NIH Policy Notice
Immediate Effects: NIH established a policy governing human clinical and research biospecimens obtained from U.S. persons and supported by NIH funds. The policy applies regardless of identifiability and restricts distribution of covered biospecimens to institutions or parties located in countries of concern, with limited exceptions described by NIH.
Status: In effect
Order/Action: NIH Launches Initiative to Modernize and Strengthen Biosafety OversightDate: 9/9/25Type: NIH Director Policy InitiativeImmediate Effects: NIH announced a Biosafety Modernization Initiative intended to update biosafety policies, practices, and oversight to reflect current research methods and risks and to strengthen oversight frameworks involving institutional biosafety programs.
Status: Active
Order/Action: Updated NIH Processes for Proposed Projects Involving Chimpanzees or Chimpanzee Biomaterials
Date: 7/17/25
Type: NIH Policy Notice
Immediate Effects: NIH updated its administrative process for reviewing proposed projects involving chimpanzees or chimpanzee biomaterials, rescinded the prior reporting system process, confirmed that invasive chimpanzee research remains prohibited, and transferred review responsibilities to OLAW.
Status: In effect
Order/Action: NIH Funding Announcements to Align with NIH Initiative to Prioritize Human-Based Research
Date: 7/10/25
Type: Funding Policy Update
Immediate Effects: NIH announced that new funding opportunities related to animal model systems must also support human-focused approaches and that NIH will no longer issue Notices of Funding Opportunity exclusively supporting animal models.
Status: In effect
Order/Action: FDA and OHRP Issue Joint Guidance on IRB Written Procedures
Date: 7/9/25
Type: Final Guidance
Immediate Effects: FDA and OHRP issued joint final guidance for institutions and institutional review boards on developing and maintaining written procedures. The guidance explains regulatory requirements and includes a checklist intended to support compliance and consistency across human subjects research oversight programs.
Status: In effect
Order/Action: ORI First Phase of Final Rule Guidance Documents Released
Date: 6/23/25
Type: Guidance Implementation Update
Immediate Effects: ORI released the first phase of guidance documents to help Public Health Service-funded institutions prepare for implementation of the revised research misconduct regulation, which took effect 1/1/26.
Status: In effect
Order/Action: NIH Implementation of Executive Order on Improving the Safety and Security of Biological Research
Date: 6/18/25
Type: Implementation Update
Immediate Effects: NIH required awardees to review research portfolios to identify projects meeting the definition of dangerous gain-of-function research and stated that awards could be suspended or terminated as directed under the executive order.
Status: In effect
Order/Action: NIH Strengthens Transparency Measures for Institutional Biosafety Committees
Date: 6/2/25
Type: Biosafety Oversight Policy Update
Immediate Effects: NIH announced that rosters of all active Institutional Biosafety Committees would be posted publicly and that approved IBC meeting minutes must be posted publicly on institutional websites, subject to appropriate redactions.
Status: In effect
Order/Action: OHRP and FDA Seek Comments on Proposed Change to IRB Registration
Date: 5/22/25
Type: Request for Information
Immediate Effects: The Office for Human Research Protections and the Food and Drug Administration are seeking public comment on a proposed change to IRB registration requirements. Specifically, OHRP proposes removing the IRB membership roster from the required registration form to better align with the 2018 Common Rule requirements at 45 CFR 46.103. The agencies anticipate this change will simplify and shorten the registration process. This proposal is submitted under the Paperwork Reduction Act, and OHRP estimates it would save approximately 20 minutes per registration, totaling more than 2,000 hours saved annually across the research community. Comments are due by July 21, 2025.
Status: Active
Order/Action: GAO Assesses Promise and Barriers of Organ-on-a-Chip Technology
Date: 5/21/25
Type: Government Accountability Office (GAO) Report
Immediate Effects: A new GAO technology assessment examines the promise and current limitations of human organ-on-a-chip (OOC) technologies, which use microfluidic devices lined with human cells to model organ functions. The report finds that OOCs may reduce reliance on animal models by offering more human-relevant biological data, but adoption is slowed by limited access to human cells, lack of validation standards, proprietary data restrictions, and unclear regulatory guidance. Although not positioned to replace animal testing entirely, OOCs are increasingly seen as a complementary approach. The GAO outlines six policy options to support ethical and effective integration of this technology, including promoting cell banks, funding validation studies, and clarifying FDA pathways. This report does not introduce new policy but signals a growing federal interest in advancing human-relevant research alternatives.
Status: Active
Order/Action: White House MAHA Commission Releases Report on Children’s Health
Date: 5/21/25
Type: Executive Order Report
Immediate Effects: The Executive Office’s MAHA (Maternal and Adolescent Health Alliance) Commission—established by executive order and convened for a single meeting—released its report on children's health, citing poor diet, environmental chemicals, chronic stress, physical inactivity, and overmedicalization as primary drivers of illness. The report strongly critiques conflicts of interest and corporate influence in the food, chemical, and pharmaceutical industries. A national strategy to address the findings is expected by mid-August. Critics argue the report downplays poverty and other social determinants of health, casts unwarranted doubt on vaccination, and highlights problems like chemical exposure while the administration reduces relevant oversight resources.
Status: Active
Order/Action: GAO Report Recommends Strengthening Federal Oversight of Foreign Talent Recruitment Risks
Date: 5/16/25
Type: Government Accountability Office (GAO) Report
Immediate Effects:
A new Government Accountability Office (GAO) report recommends that the Office of Science and Technology Policy (OSTP) and federal research agencies take additional steps to mitigate risks associated with foreign talent recruitment programs. The report identifies gaps in current disclosure and risk management practices related to researchers’ foreign affiliations and participation in talent programs, especially those sponsored by countries of concern. Although some agencies have implemented disclosure requirements and training, the GAO found inconsistencies and limited enforcement. The report recommends OSTP develop guidance for identifying and mitigating undue foreign influence, and urges the Department of Energy, Department of Defense, and NIH to improve documentation and monitoring.
Status: Active
Order/Action: HHS issues RFI on Regulatory Reform Affecting Research OversightDate: 5/14/25Type: Request for InformationImmediate Effects: The U.S. Department of Health and Human Services issued a request for information (RFI) titled “Ensuring Lawful Regulation and Unleashing Innovation to Make American Lives Better.” The RFI invites public comment on potential deregulatory actions, including those that could impact human subjects research protections. Comments are due by July 14, 2025.
Status: Active
Order/Action: DoD Issues 2025 Policy Update on Fundamental Research Security
Date: 5/09/25
Type: Policy Update
Immediate Effects: The Department of Defense has updated its 2025 Decision Matrix to guide risk-based reviews of fundamental research proposals submitted on or after May 9. The matrix outlines how DoD components should assess potential security risks associated with foreign affiliations and collaborations. Key changes include removing the requirement for institutions to have a policy prohibiting participation in malign foreign talent recruitment programs, though individual researchers are still barred from participating under federal law. The DoD also now prohibits collaborations between U.S. institutions and foreign academic entities or personnel listed under Section 1286 of the fiscal 2019 National Defense Authorization Act, as amended.
Additional updates include eliminating the distinction between “associations” and “affiliations,” clarifying treatment of co-authorships with listed entities, and requiring annual compliance reporting by DoD components. Co-authorship alone is not disqualifying but may require project-specific mitigation. The updates aim to protect the integrity of DoD-funded research while supporting international scientific collaboration. Status: Active
Additional updates include eliminating the distinction between “associations” and “affiliations,” clarifying treatment of co-authorships with listed entities, and requiring annual compliance reporting by DoD components. Co-authorship alone is not disqualifying but may require project-specific mitigation. The updates aim to protect the integrity of DoD-funded research while supporting international scientific collaboration. Status: Active
Order/Action: Update NIH Processes for No-Cost ExtensionsDate: 5/7/25Type: Notice Number NOT-OD-25-110Immediate Effects: National Institutes of Health (NIH) issued Notice Number NOT-OD-25-110, announcing a temporary change to its No-Cost Extension (NCE) process. The automatic NCE feature in eRA Commons has been disabled to allow NIH staff to review all extension requests and ensure they align with the agency's mission and priorities. During this period, all NCE requests must be submitted as prior approval requests through eRA Commons. Requests for activities that do not align with NIH's mission will not be approved.
As of now, NIH has not provided an update on when the automatic NCE feature will be reinstated. Researchers are advised to monitor NIH communications for further information. Status: Active
As of now, NIH has not provided an update on when the automatic NCE feature will be reinstated. Researchers are advised to monitor NIH communications for further information. Status: Active
Order/Action: OHRP releases foundational training on human research protections
Date: 5/05/25
Type: Guidance
Immediate Effects: The Office for Human Research Protections has launched a comprehensive online training program aligned with the revised Common Rule. Designed for IRB professionals and investigators, the training supports institutions in fostering a culture of ethical research through foundational learning.
Status: Active
Order/Action: Indirect Rates for NSF Grants
Date: 5/2/25
Type: NSF Policy Notice
Immediate Effects: Effective May 5, 2025, the National Science Foundation will cap indirect cost rates at 15 percent for all new grants and cooperative agreements awarded to institutions of higher education. The change applies to modified total direct costs and aims to increase transparency, reduce administrative burden and direct more funding to research. The cap will not apply retroactively, and institutions with existing negotiated rates may continue using them for current awards. The policy aligns with federal guidance under 2 CFR 200.414(c).
Status: Active
Order/Action: Certificates of Confidentiality for Research Not Funded by NIH
Date: 5/1/25
Type: Policy Update
Immediate Effects: The National Institutes of Health now allows researchers conducting studies not funded by NIH to request Certificates of Confidentiality, expanding access to privacy protections beyond federally funded projects. These certificates help safeguard identifiable, sensitive information by limiting disclosure, even under legal demands. To be eligible, research must align with the health-related missions of NIH or the Department of Health and Human Services, involve sensitive data, and comply with applicable laws and regulations. Certificates are issued for individual studies, not entire programs, and are generally not granted for research involving criminal activity unless the project is NIH-funded.
Status: Active
Order/Action: NIH Issues New Civil Rights Term and Condition of Award
Date: 4/21/25
Type: Notice Number NOT-OD-25-090
Immediate Effects: Effective April 21, 2025, the National Institutes of Health added a new civil rights term and condition to all domestic grant, cooperative agreement, and other transaction awards. Recipients must certify they do not promote or operate programs advancing diversity, equity and inclusion, or participate in boycotts against Israeli companies or affiliates, if such actions violate federal anti-discrimination laws. Noncompliance may result in award termination and recovery of funds. The policy applies only to U.S.-based institutions and supersedes Section 4.1.2 of the NIH Grants Policy Statement.
Status: Active
Order/Action: National Science Foundation Updated Priorities Related to Broader Impacts
Date: 4/18/25
Type: Policy update
Immediate Effects: The National Science Foundation has updated its funding priorities to align with recent federal directives. While continuing to support discovery-based research and innovation, the agency has ended some awards that do not align with current priorities, including those focused on DEI, environmental justice, and misinformation. Outreach efforts must now be broadly inclusive, and proposals will continue to be evaluated on intellectual merit and broader impacts.
Status: Active
Order/Action: DOE to Reduce Indirect Costs to 15%
Date: 4/11/25
Type: Policy Change
Immediate Effects: The U.S. Department of Energy has announced a policy change to cap indirect cost reimbursements for university research grants at 15 percent, down from an average of more than 30 percent. The department estimates the change will save approximately $405 million annually by reducing spending on administrative and facility-related expenses, allowing more funds to go directly toward research.
A coalition of universities—including MIT, Princeton, Caltech, and the University of Illinois—along with several academic associations, has filed a lawsuit in the U.S. District Court for the District of Massachusetts, arguing the policy is arbitrary and violates federal grant regulations. 4/16/25 A federal judge has issued a temporary restraining order blocking implementation while the court reviews the case. Status: Active
A coalition of universities—including MIT, Princeton, Caltech, and the University of Illinois—along with several academic associations, has filed a lawsuit in the U.S. District Court for the District of Massachusetts, arguing the policy is arbitrary and violates federal grant regulations. 4/16/25 A federal judge has issued a temporary restraining order blocking implementation while the court reviews the case. Status: Active
Order Action: Rescission of the Final Scientific Integrity Policy of the National Institutes of HealthDate: 3/28/25Type: NoticeImmediate Effects: The NIH has announced the rescission of its Final Scientific Integrity Policy (NOT-OD-24-178) to align with broader administrative priorities. The agency affirms its continued commitment to scientific integrity through a range of existing policies, including those related to research misconduct, authorship, protections for human and animal subjects, and data management and sharing. These policies remain in effect. This update pertains solely to the Final Scientific Integrity Policy and does not impact other related policies. Moving forward, the NIH will follow the HHS Scientific Integrity Policy to support ongoing efforts in promoting scientific integrity.
Order Action: HHS Announces Transformation to Make America Healthy Again
Date: 3/27/25
Type: Agency Memo
Immediate Effects: The U.S. Department of Health and Human Services (HHS) announced a major restructuring that reduced its staff by 10,000 full-time employees, in addition to the 10,000 who have already departed under the new administration, for a total reduction of 82,000 to 62,000. The restructuring includes creating a new Administration for a Health America (AHA) that combines offices like OASH, HRSA, and SAMHSA; consolidates 28 HHS divisions down to 15; and halves regional offices from 10 to 5. Some offices, like the CMS and HHS Offices of Minority Health, were eliminated entirely.
Order Action: NIH Common Forms Implementation for Biosketch and Current and Pending (Other) Support
Date: 3/25/25
Type: Implementation Notice
Immediate Effects: NIH will adopt standardized Common Forms for the Biographical Sketch and Current and Pending Support to align with government-wide research disclosure requirements. Originally set for May 2025, implementation has been delayed. Until further notice, applicants should continue using NIH-specific forms. Once in effect, use of SciENcv and ORCID iDs will be required, along with a new supplement to capture NIH-specific information.
Order Action: Consolidation of study sections under Center for Scientific ReviewDate: 3/11/25Type: Agency Policy StatementImmediate Effects: The National Institutes of Health (NIH) has announced plans to centralize the peer review of all grant and research applications within its Center for Scientific Review (CSR). The change aims to improve efficiency, reduce administrative duplication, and save more than $65 million annually. Currently, CSR manages the majority of NIH reviews, while the rest are conducted separately by individual NIH Institutes and Centers. Under the proposal, CSR would oversee all first-level peer reviews, with funding decisions still made by individual Institute directors. The plan is under external review and pending further approval.
Order/Action: HHS: 45 CFR Subtitle A: Policy on Adhering to the Text of the Administrative Procedure Act
Date: 3/3/25
Type: Policy Notice
Immediate Effects: HHS is withdrawing its 1971 "Richardson Waiver" policy, which required the department to use public notice and comment procedures for rules related to agency management, personnel, grants, benefits, contracts, and public property. The Administrative Procedure Act (APA) exempts these matters from such requirements. Effective immediately, HHS will align with the APA, allowing these rules to be issued without formal notice and comment procedures. The department states that this change will streamline administrative processes and enable more responsive rulemaking while maintaining notice and comment procedures where legally required.
Status: Active
Order/Action: Guidance on Agency RIF and Reorganization Plans Requested by Implementing The President’s “Department of Government Efficiency” Workforce Optimization Initiative
Date: 2/26/25
Type: Agency Memo
Immediate Effects: This memorandum provides guidance to federal agencies on implementing a Workforce Optimization Initiative aimed at enhancing efficiency and streamlining operations across the government. It directs agencies to develop Agency Reduction in Force (RIF) and Reorganization Plans (ARRPs) to improve organizational effectiveness and reduce redundancies. Agencies must submit Phase 1 plans by March 13, 2025, focusing on initial adjustments and identifying non-statutorily mandated functions, followed by Phase 2 plans by April 14, 2025, outlining future-state organizational structures. The guidance includes timelines for implementing RIFs, tools for achieving efficiencies (such as hiring freezes, attrition, and organizational restructuring), and requirements for identifying positions deemed essential. Certain positions are excluded from these measures, including those related to national security, military personnel, and positions requiring presidential appointment.
Status: Active
Order/Action: HHS Guidance Document
Date: 2/19/25
Type: Guidance Document from HHS
Immediate Effects: The guidance defines the terms sex, female, male, woman, girl, man, boy, mother and father
Status: Active
Order/Action: Ensuring Accountability for All Agencies
Date: 2/18/25
Type: Executive Order
Immediate Effects: This executive order increases oversight of independent regulatory agencies by requiring them to submit significant regulatory actions to the Office of Information and Regulatory Affairs for review prior to publication. It sets performance standards and management objectives for independent agency heads, directs the Office of Management and Budget (OMB) to review and potentially adjust agency budgets in line with administration priorities, calls for regular consultation between independent agency chairs and White House officials, requires the creation of White House Liaison positions within agencies, and states that legal interpretations from the President and Attorney General guide executive branch employees. The order excludes the Federal Reserve's monetary policy functions but includes its supervision and regulation of financial institutions. For the Department of Health and Human Services (HHS), this could involve increased White House involvement in healthcare regulations, pharmaceutical approvals, and public health initiatives, with potential impacts on the timing and alignment of regulatory processes with administration objectives.
Status: Active
Order/Action: Expanding Access to In Vitro Fertilization
Date: 2/18/25
Type: Executive Order
Immediate Effects: This executive order addresses access to in vitro fertilization (IVF) by focusing on affordability and regulatory considerations. It notes that infertility affects approximately one in seven couples and directs the Assistant to the President for Domestic Policy to develop recommendations within 90 days for protecting IVF access and addressing costs, which currently range from $12,000 to $25,000 per treatment cycle.
Status: Active
Order/Action: Radical Transparency About Wasteful SpendingDate: 2/18/25Type: Executive MemoImmediate Effects: This memorandum directs federal agencies to publicly disclose information on terminated programs, canceled contracts, and discontinued funding obligations. In the context of science and research, this transparency initiative could affect federally funded projects by making information on discontinued initiatives publicly available. It may also influence research funding decisions, project planning, and international scientific collaborations as funding priorities are reviewed.
Status: Active
Order/Action: Keeping Education Accessible and Ending Covid-19 Vaccine Mandates in Schools
Date: 2/15/25
Type: Executive Order
Immediate Effects: This executive order restricts the use of discretionary federal funds for educational institutions that require COVID-19 vaccinations for in-person attendance. It instructs the Secretary of Education to provide guidelines on legal considerations related to parental authority and religious rights in the context of vaccine requirements and calls for a plan to review COVID-19-related school policies within 90 days.
Status: Active
Order/Action: Establishing the President's Make America Healthy Again Commission
Date: 2/13/25
Type: Executive Order
Immediate Effects: The executive order establishes the Make America Healthy Again Commission, chaired by the Secretary of Health and Human Services, to address rising chronic disease rates, with an initial focus on childhood health. Within 100 days, the Commission must submit an assessment on childhood chronic diseases, identifying contributing factors such as diet, environmental exposures, and medical treatments. Within 180 days, it must develop a national strategy to address these issues. Federal agencies are directed to prioritize research on chronic disease prevention, promote healthier food production, ensure transparency in health data, and expand preventive healthcare options.
Status: Active
Order/Action: NIH Indirect Cost Reimbursement Reduction
Date: 2/7/25
Type: Guidance Document to NIH Policy
Immediate Effects: NIH provides federal research grants that include both direct research costs and indirect costs, which include facilities and administrative expenses. Previously, NIH used individually negotiated indirect cost rates for institutions, though regulations allowed for deviations. Under new guidance, NIH is standardizing indirect cost rates to 15% across all grants, replacing the previous system of negotiated rates. This change applies to both new and existing grant awards effective immediately.
Status: 2/10: 22 Attorney Generals filed suit for TRO- granted in 22 states | 2/11: AAMC’s motion for nationwide TRO granted by Federal Judge in Mass hearing on Feb 21 | 2/21: TRO set to expire on 2/24 has been extended until U.S. District Judge can make a final decision on whether to issue an injunction on the proposed change | 3/5: US District Judge issued a nation-wide preliminary injunction on the NIH cost reductions until full arguments of the pending lawsuits are heard.
Order/Action: Pause on Federal Grant Funding
Date: 2/7/25
Type: Guidance Document to NIH Policy
Immediate Effects: Federal agencies instructed to pause new grant funding across research, public health, and social programs. A pause on federal grant funding would cause immediate disruptions to research institutions, potentially forcing them to scale back operations, pause hiring, and interrupt ongoing studies. Universities and labs might face significant budget shortfalls, affecting everything from graduate student support to major research projects. The long-term impact could slow scientific progress as research teams seek alternative funding or leave academia, potentially disrupting the pipeline of scientific discovery across multiple fields.
Status: Rescinded OMB Memo 2/29/25
Order/Action: Protecting Children from Chemical and Surgical Mutilation
Date: 1/28/25
Type: Executive Order
Immediate Effects: This executive order prohibits federal support for gender-related medical care for individuals under 19. The federal funding restrictions may impact clinical research and data collection in this field, potentially affecting ongoing studies and limiting new research on health outcomes and best practices for youth healthcare.
Status: Lawsuits filed by several states and advocacy orgs | 2/13/25 14-day TRO issued by Federal Judge 3/4, the court issued an injunction stopping the administration from implementing the order with respect to funding while the case proceeded. However, the administration nonetheless moved forward with instructing healthcare orgs that they should discontinue care. That led to a 3/7 request from the plaintiffs that the court order the admin to rescind these instructions based on the existing 3/4 decision. The court has not made a decision on that request as of 3/18.
Order/Action: Communication Freeze at Federal Health Agencies Date: 1/21/25 Type: Internal HHS Directive Immediate Effects: Federal health agencies are required to pause public communications and obtain approval from presidential appointees for reports, guidance, and announcements. The administration aims to ensure consistent messaging across agencies. This pause affects CDC publications such as the MMWR and may delay research grant announcements. As a result, healthcare professionals and researchers may experience delays in accessing public health data, while ongoing research projects could face uncertainty due to postponed funding decisions and guidance updates.
Status: Slated to lift 2/1 – status unclear
Order/Action: Ending Radical and Wasteful Government DEI Programs and Preferencing
Date:1/20/25
Type: Executive Order
Immediate Effects: This executive order discontinues all federal DEI programs, including diversity officer positions, equity plans, and related requirements. The OMB, in coordination with the attorney general and the Office of Personnel Management, will oversee implementation within 60 days. The removal of these programs may impact the evaluation and awarding of research grants, potentially leading to changes in funding criteria and reporting requirements across scientific institutions. Research programs, recruitment initiatives, and training efforts focused on diversity in science may need to seek alternative funding sources or restructuring to continue operations.
Status: 3/17, an appeals court lifted an injunction on major parts of the order. The 3-0 decision found that the injunction was too broad and premature. The lower court judge had said that "DEI" was not properly defined and implementation would likely violate free speech rights. However, the appeals court suggested that it was premature to pause the executive order based only on its wording and that the administration should be allowed to act on the order while the case proceeds. One justice noted that the actual implementation may indeed violate the constitution, but that hasn't happened yet.
Order/Action: Defending Women from Gender Ideology Extremism and Restoring Biological Truth to the Federal Government
Date: 1/20/25
Type: Executive Order
Immediate Effects: "On January 29, 2025, the Acting Director of the Office of Personnel Management issued a memo to all government departments and agencies.
The memo directs federal agencies to take actions to discontinue programs using taxpayer funds to promote or reflect gender ideology. Subsequently, over 8,000 webpages and datasets related to LGBTQ+ health, HIV prevention, and other health topics were removed from public access.
On February 5, 2025, it was observed that OHRP replaced the term 'gender' with 'sex' in a section of the Code of Federal Regulations on the Protection of Human Subjects (46.107 IRB Membership), known as the 'Common Rule,' on its website.
Status: 2/1/25: TRO issued by federal judge instructing agencies to restore public access to health-related websites and datasets.
Order/Action: Withdrawing the United States from the World Health Organization
Date: 1/20/25
Type: Executive Order
Immediate Effects: This executive order withdraws the US from the WHO, citing concerns over crisis management, reforms, political influence, and funding. It redirects WHO-related activities to new US personnel and leadership positions.
Status: To take effect in 2026
Order/Action: Regulatory Freeze Pending Review Date: 1/20/25Type: Executive Order Immediate Effects: This executive order pauses pending and existing regulations for review. Unpublished rules will be withdrawn, and unenacted rules will be delayed to allow for stakeholder input. The review process will be overseen by the OMB and presidential appointees, impacting the timeline for rulemaking related to research protections and ethical standards.
Status: Active
Order/Action: NIH Public Access Policy
Date: 12/17/24
Type: Policy Notice
Immediate Effects: Policy to expand access to NIH-funded research results. Applies to all 'author-accepted manuscripts' accepted for publication in a journal on or after December 31, 2025. The policy removes the 12-month embargo period, making manuscripts resulting from NIH funding publicly available upon publication.
Status: Active
Public Policy Resources
Understanding the Terms
Executive Orders
Issued By: Executive Branch
Issued To: Government Officials/Agencies
Authority: Constitution Statute
Notice: Federal Register
OMB Memos
Issued By: Office of Management Budget, Executive Branch
Issued To: Federal Agencies
Authority: Administration Procedure Act
Notice: Whitehouse.gov
Guidance
Issued By: Federal Agency, Executive Branch
Issued To: Federal Agencies, General Public
Authority: Administration Procedure Act
Notice: Federal Register
Internal Agency Directives
Issued By: Federal Agency Executive Branch Issued To: Employees of that federal agencyAuthority: Administration Procedure Act Notice: US General Services Administration Directives Library