Science Policy Hub
The AAMC engages frequently with federal agencies on policies and regulations that impact the funding, conduct, and oversight of medical research at academic medical centers.
On this page:
Issues We're Watching
This section contains information on ongoing policy/regulation development, as well as forthcoming implementation deadlines. For additional in-depth coverage of policy topics, please refer to Science Policy Issues in the left-hand navigation.
Federal Grant Funding Updates
Funding Information from NIH:
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A new page, NIH Grants and Funding Information Status, describes changes to "NIH grants and funding policies and processes...as NIH aligns with new agency priorities." Among the updates as of March 26, 2025:
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Posting of new funding opportunities and policy guidance is currently on hold.
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NIH is accepting applications for active funding opportunities. Some funding opportunities have been closed and others have been updated to align with agency priorities. Applicants must carefully reread funding opportunities for any changes prior to submission and adjust their applications accordingly.
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NIH institutes and centers are issuing awards for competing, non-competing continuation, and administrative supplements using previously approved negotiated indirect cost rates, except for awards under which F&A costs are reimbursed at a fixed rate.
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The ability to generate the Trainee Diversity Report is no longer available to recipients, in addition to many other application requirements around diversity which have been modified.
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The NIH has updated the webpage Implementation of New Initiatives and Policies. Among the changes as of March 26, 2025:
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Adoption of the Common Form for Biographical Sketch and a new Biographical Sketch Supplement originally scheduled for May 25, 2025, is postponed.
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Significant changes to the updated NIH application form (FORMS-I) have been outlined.
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For institutional training grants, Recruitment Plans to Enhance Diversity are no longer required and those included in applications under review will not be evaluated or considered in funding decisions.
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FORMS-I Training data tables 6a, 6b, and 7 have been revised to remove calculations for % underrepresented minorities.
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NIH Study Sections and Advisory Councils:
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On March 20, the federal register listed the first re-scheduled NIH advisory council meeting since late January. Since then, several advisory council meetings have been scheduled across various ICs. Distinct from study sections, the re-scheduling of such advisory councils marks an important procedural step that allows new grants to be awarded.
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From January through March, the NIH paused communications and cancelled scheduled study sections. Since March 4, approximately 200 study sections managed by the NIH Center for Scientific Review (CSR) have been scheduled to convene throughout April and May, and since March 17 nearly 200 IC-managed study sections have also been announced through the Federal Register.
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These postings follow an announcement by the NIH that all first-level study sections will be managed by the CSR in the future, although the implementation date of this change has not been announced.
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The NIH Office of the Director has announced a convening of the NIH Council of Councils (CoC) on April 21. Note that this is the first CoC held during this administration, as the Feb. 6-7 meeting was cancelled. The CoC advises the NIH Director on matters related to the policies and activities of the Division of Program Coordination, Planning, and Strategic Initiatives.
NIH Grant Cancellations:
- The NIH has continued the cancellation of active grants that fund studies on a wide range of scientific research areas, as documented in a list of hundreds of terminated grants HHS is compiling and updating periodically. Reports suggest that nearly 1000 additional U.S. and international grants were in jeopardy or were terminated after March 20, the latest date included on the most recent HHS grant termination list.
- The cancelled grants include those focused on LGBTQ+ individuals, diversity, equity, and inclusion (DEI) research, and vaccine hesitancy, areas targeted by the Administration's Executive Orders.
Scientific Leadership and Federal Workforce:
- HHS Secretary: Robert F. Kennedy, Jr. (confirmed 2/13/25)
- NIH Director: Jay Bhattacharya, MD, PhD (confirmed 3/25/25)
- FDA Commissioner: Martin Makary, MD, MPH (confirmed 3/25/25)
- CDC Director: Susan Monarez, PhD (Currently Acting CDC Director, nominated by President Trump on 3/24/25)
- OSTP Director: Michael Kratsios (Senate committee voted to advance 3/12/25)
Funding-Related Litigation
- NIH Facilities and Administration (F&A) rates: An AAMC-led lawsuit resulted in a March 5 preliminary injunction against a proposed standard F&A reimbursement rate of 15% across all NIH grants and all institutions. To learn more, please see the AAMC's F&A resources page.
- Federal Grant Funding Freeze: On March 6, Judge John McConnell, Jr. of the U.S. District Court for the District of Rhode Island issued a preliminary injunction against the freezing of allocated funds, which impacts millions of dollars in federal grand funding.
- DEI Executive Orders: On March 14, the U.S. Court of Appeals for the Fourth Circuit granted the federal government's request to stay, pending appeal, a nationwide preliminary injunction issued by the U.S. District Court for the District of Maryland with regard to enforcement of Executive Orders prohibiting DEI activities, including the termination of grants and contracts.
Policy Issues the AAMC is Monitoring
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Institutions with active international research programs will likely be impacted by a final rule from the Depart of Justice (DOJ) limiting access to Americans' "bulk sensitive personal data" and government-related data by "countries of concern." As a result of the proposed rule's inclusion of genomic and other -omics data under a risk framework intended to address other data types such as geolocation and financial data, the rule will likely impact foundational research and other scientific collaborations, even with exceptions for data shared in open repositories and as a requirement of a federal grant or contract. The AAMC previously responded to both an Advance Notice of Proposed Rulemaking (ANPRM) and Notice of Proposed Rulemaking (NPRM) on this issue. More information and resources are forthcoming.
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The AAMC continues to closely monitor federal efforts to standardize research security requirements led by the White House Office of Science and Technology Policy and the National Science Foundation (refer to the research security resource page for more information). The association anticipates additional opportunities for public comment in 2025 and is actively soliciting feedback from institutions on their research security programs.
Forthcoming Implementation Deadlines
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The National Institutes of Health (NIH) is implementing multiple changes that will impact the preparation and peer review of most grant applications submitted to the agency due on or after Jan. 25, 2025.
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The US Government Policy for Oversight of Dual Use Research of Concern and Pathogens with Enhanced Pandemic Potential will go into effect on May 6, 2025. Institutions should think about how to identify relevant projects at the institution and engage their IRB and IBC prior to the implementation date. Refer to the implementation guidance and recently released FAQ for more information. NIH has also released an implementation notice outlining changes for researchers and institutions.
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The Department of Health and Human Services (HHS) issued a final rule revising the regulations governing Public Health Service Policies on Research Misconduct, which must be implemented through new institutional policies and procedures by Jan. 1, 2026. For more information, visit the HHS Office of Research Integrity.
Recent Developments
- The HHS Office for Human Research Protections has announced the publication of a final rule amending HHS regulations for the protection of human subjects at 45 CFR part 46 ("The Common Rule.") This final rule, which is effective upon publication, includes no substantive amendments, though institutions may choose to update their materials accordingly.
Take Action
This section contains engagement opportunities the AAMC has identified as important for the academic medical research enterprise. If you have questions about any of the items in this section, please reach out to us at researchpolicy@aamc.org.
Register for the April 9 Biomedical Reseach Community Call
On April 9 at 12:00 PM EDT we will be convening the community for a third webinar to provide you with an opportunity to hear from AAMC Chief Scientific Officer Elena Fuentes-Afflick, MD, MPH and Senior Director for Science Policy Heather Pierce, JD, MPH. This call for the AAMC biomedical research community will provide information about the current status and leadership of federal agencies that fund or oversee biomedical research. This call will also provide the opportunity for the AAMC to learn how these recent changes are impacting biomedical research at AAMC-member institutions. Please note that you must be part of an AAMC-member institution or an AAMC Affinity Group to join this call. Please register here.
AAMC Seeks Examples on the Impact of Executive Actions on Academic Medicine
The White House's recent executive orders and actions affecting federally funded grants, programs, and activities may have significant implications for AAMC-member institutions and our faculty, researchers, learners, and trainees. The AAMC is collecting detailed examples of how these actions are impacting your research, education, clinical care, and overall institutional operations. Your responses will help us advocate on behalf of academic medicine by providing policymakers with concrete evidence of the challenges these changes present. You can submit your examples here, or if you would prefer to speak to an AAMC staff member, please email researchpolicy@aamc.org.
Share AAMC Abstract with Your Colleagues
We invite you to help expand the reach of AAMC Abstract by sharing this link with your colleagues, societies, trainees and postdoctoral students, research administrators, or anyone interested in the creation or implementation of research policy. Anyone from this sector can subscribe to AAMC Abstract.
Recent AAMC Comments
Refer to the AAMC’s most recent letters below or access the full list of comments submitted on medical research. For more on the latest legislative and regulatory activities affecting academic medicine, check out AAMC Washington Highlights.
AAMC urges NIH to expand data collection and strengthen partnerships in its Strategic Plan for Disability Health Research.
- March 12, 2025
AAMC submits comments to the NIH on the use of persistent identifiers and metadata to increase the transparency of research.
- Feb. 20, 2025
The AAMC submitted comments to the DOJ on proposed restrictions to the sharing and transfer of bulk sensitive personal data, including human genomic data.
- Nov. 29, 2024
Learn About the Comment Process
Public Engagement in the Federal Rulemaking Process
Federal agencies solicit feedback on proposed regulations, policies, and other programmatic activities through the "notice and comment" process, where draft documents are made available to the public for response. Typically, these notices are posted in the Federal Register, on the agency websites, or in official notices such as the NIH Guide for Grants and Contracts. Agencies may also use email listservs or social medial to reach broader audiences. The public typically has 30-60 days to provide written comments in response to the agency, who may also hold public meetings or listening sessions. Submitted responses to proposed regulations are typically placed in an online docket and can be accessed by the public. After the comment period ends, the agency reviews and considers the feedback submitted and generally concludes the process by publishing a final regulation, policy, or programmatic decision in the Federal Register or other official agency channels. Once a regulation is issued as a final rule it becomes "effective" meaning that the regulated community must come into compliance with its requirements.
How the AAMC Develops Science Policy Comment Letters
Comment letters are one essential step in the AAMC's efforts to inform the development of federal agency initiatives. The science policy team begins with a thorough review of proposed regulations, policies, or agency actions that affect the biomedical research mission in academic medicine. We identify comment opportunities where AAMC expertise can meaningfully add to agency deliberations and which could impact AAMC members' interests across the spectrum of research from fundamental discovery to clinical trials and population health research, particularly in areas of research conduct, training, grants, policy, and oversight. Engaging the AAMC constituent community is also a key part of this process. To gather input, we host community calls, conduct surveys, and maintain open lines of communication with key collaborators, including AAMC affinity groups and other organizations. Final comment letters are published on this webpage under Recent AAMC Comments and featured in AAMC Abstract and Washington Highlights, weekly newsletters for the AAMC community.
Are you aware of a comment opportunity that isn't mentioned on this page and want to know if AAMC will be responding? Reach out to us at researchpolicy@aamc.org.
Making Your Voice Heard at FDA
The Insider's Guide to Effective Commenting on NIH Policies
Brookings: How to Effectively Comment on Regulations (PDF)