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:
- NIH on April 21 released an update to the 2024 NIH Grants Policy Statement of a "new Civil Rights term and condition that modifies the current terms and conditions for all NIH grants, cooperative agreements, and other transaction (OT) awards." HHS similarly on April 16 issued a new grants policy statement, effective immediately and suspending the previous version released in October 2024 (PDF).
- No new funding opportunities have been announced since January 22, 2025 on the NIH Guide for Grants and Contracts.
- 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 April 8, 2025:
- 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.
- 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.
- 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.
- The NIH has updated the webpage Implementation of New Initiatives and Policies. Among the changes as of April 8, 2025:
- Adoption of the Common Form for Biographical Sketch and a new Biographical Sketch Supplement originally scheduled for May 25, 2025, is postponed.
- Significant changes to the updated NIH application form (FORMS-I) have been outlined.
- 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.
- FORMS-I Training data tables 6a, 6b, and 7 have been revised to remove calculations for % underrepresented minorities.
- The NIH has resumed posting policy notices in the NIH Guide for Grants and Contracts (see the "Other Notices" tab) and among updates has announced the recission of the final NIH scientific integrity policy and implementation updates regarding institutional biosafety committees.
NIH Study Sections and Advisory Councils:
- On March 20, the federal register listed the first re-scheduled NIH advisory council meeting since late January. Advisory council meetings scheduled since that time are detailed below. Distinct from study sections, the re-scheduling of such advisory councils marks an important procedural step that allows new grants to be awarded.
- From January through March, the NIH paused communications and cancelled scheduled study sections. Since March 4, approximately 330 study sections managed by the NIH Center for Scientific Review (CSR) have been scheduled to convene throughout the spring. Since March 17, approximately 270 IC-managed study sections have also been announced through the Federal Register.
- 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.
- 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.
Complete List of Advisory Committee Meetings across NIH ICs: As of 4/8/2025
NIH Institutes
- National Cancer Institute (NCI): June 10
- National Eye Institute (NEI): April 21, June 13
- National Heart, Lung, and Blood Institute (NHLBI): April 23, June 11
- National Human Genome Research Institute (NHGRI): April 25
- National Institute on Aging (NIA): April 22, May 14
- National Institute on Alcohol Abuse and Alcoholism (NIAAA): April 17, May 13
- National Institute of Allergy and Infectious Diseases (NIAID): April 24
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS): April 21, June 3
- National Institute of Biomedical Imaging and Bioengineering (NIBIB): June 4
- National Institute of Child Health and Human Development (NICHD): June 9, June 10
- National Institute on Deafness and Other Communication Disorders (NIDCD): May 8, May 9
- National Institute of Dental and Craniofacial Research (NIDCR): April 18, May 28
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): April 24
- National Institute of Drug Abuse (NIDA): May 13
- National Institute of Environmental Health Sciences (NIEHS): April 22, June 5
- National Institute of General Medical Sciences (NIGMS): May 22
- National Institute of Mental Health (NIMH): June 17
- National Institute on Minority Health and Health Disparities (NIMHD): May 5
- National Institute of Neurological Disorders and Stroke (NINDS): April 10, May 14
- National Institute of Nursing Research (NINR): April 23, May 20
- National Library of Medicine: X
- Joint: National Advisory Council on Alcohol Abuse and Alcoholism, National Cancer Advisory Board, and National Advisory Council on Drug Abuse, May 14
NIH Centers
- NIH Clinical Center (CC): X
- Center for Information Technology (CIT): X
- Center for Scientific Review (CSR): X
- Fogarty International Center (FIC): X
- National Center for Advancing Translational Sciences (NCATS): April 17
- National Center for Complementary and Integrative Health (NCCIH): April 8
NIH Grant Cancellations:
- Grant Terminations and Funding: Terminated grants from HHS are being documented in a list from HHS, last updated April 11, as well as in an open-source effort from researchers utilizing the data from HHS and other sources. Some previously paused National Institute of General Medical Sciences (NIGMS) programs and funding mechanisms to recruit recent college graduates and postdocs (IRTA/CTRA) have reopened for applications.
- 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 (confirmed 3/25/25)
- CMS Administrator: Mehmet Oz, MD (confirmed 4/3/25)
- The NIH leadership page has announced several new appointments, including Jon R. Lorsch, PhD, long-time director of NIGMS, as the Acting Deputy Director for Extramural Research, and Matthew J. Memoli, MD, MS, as Principal Deputy Director.
Funding-Related Litigation
- HHS Grant Cancellations: On April 2, the American Public Health Association, with organizations and individuals, filed a lawsuit in the U.S. District Court of Massachusetts against the Trump administration challenging the abrupt cancellation of HHS research grants and the unpublishing of existing funding opportunities. On April 4, sixteen state attorneys general files a similar lawsuit in the same court. Since February, NIH has terminated thousands of research grants involving the LGBTQ+ community, vaccine hesitancy, gender identity, and diversity, equity, and inclusion. The AAMC on April 17 filed an amicus brief (PDF) in this case to underscore the real-world consequences of unlawful terminations of National Institutes of Health (NIH) research grants without warning or meaningful explanation.
- Public Health Grant Funding: On April 4, a federal judge in the U.S. District Court of Rhode Island issued a temporary restraining order halting the Trump administration's $11.4 billion immediate cut in public health research and infrastructure funding including testing, vaccination, and global projects. The lawsuit filed by 23 state attorneys general was filed on April 1 and the resulting TRO only impacts funding made to those states.
- NIH Facilities and Administration (F&A) rates: The Trump administration on April 8 filed a notice of appeal to the United States Court of Appeals for the First Circuit to challenge the permanent injunction in a set of cases seeking to halt the administration's planned cuts to federal reimbursements of F&A costs. To learn more, please see the AAMC's F&A resources page.
- DOE Facilities and Administration (F&A) Rates: A lawsuit was filed on April 14 against the Department of Energy (DOE) in the U.S. District Court for the District of Massachusetts from a coalition of universities and higher education organizations in response to DOE's announcement that it would implement a 15% indirect cost rate for all future grants to institutions of higher education (IHEs). US District Judge Allison Burroughs issued a temporary restraining order (TRO) on April 16, preventing the agency from moving forward with a standard indirect cost rate.
- Funding Freeze: The 1st U.S. Circuit Court of Appeals on March 26 upheld a District Court's ruling preventing the White House Office of Management and Budget from implementing its February 27 funding freeze. On April 4, a federal judge ruled that the administration had violated this court order by halting the disbursement of millions of dollars of FEMA grants.
- 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 regarding enforcement of Executive Orders prohibiting DEI activities, including the termination of grants and contracts. As of April 9, the March 14 stay remains in effect.
Policy Issues the AAMC is Monitoring
- Institutions with active international research programs will likely be impacted by a final rule from the Department 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. DOJ on April 11 issued a compliance guide, FAQs, and an implementation and enforcement policy for the final rule. The AAMC previously responded to both an Advance Notice of Proposed Rulemaking (ANPRM) and Notice of Proposed Rulemaking (NPRM) on this issue.
- 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
- 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.
- 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.
- 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)