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: 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: 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