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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: 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: Federal judge extended TRO until she makes a final decision on the injunction
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
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: Lawsuits pending
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