The National Institute of Health’s mission is to seek fundamental knowledge about the nature and behavior of living systems and the application of that knowledge to enhance health, lengthen life, and reduce illness and disability. The goals of the agency are as follows:
- to foster fundamental creative discoveries, innovative research strategies, and their applications as a basis for ultimately protecting and improving health;
- to develop, maintain, and renew scientific human and physical resources that will ensure the nation’s capability to prevent disease;
- to expand the knowledge base in medical and associated sciences in order to enhance the nation’s economic well-being and ensure a continued high return on the public investment in research; and
- to exemplify and promote the highest level of scientific integrity, public accountability, and social responsibility in the conduct of science.
In realizing these goals, the NIH provides leadership and direction to programs designed to improve the health of the nation by conducting and supporting research:
- in the causes, diagnosis, prevention, and cure of human diseases;
- in the processes of human growth and development;
- in the biological effects of environmental contaminants;
- in the understanding of mental, addictive and physical disorders; and
- in directing programs for the collection, dissemination, and exchange of information in medicine and health, including the development and support of medical libraries and the training of medical librarians and other health information specialists.
To align with their mission and goals, the NIH is focusing on Ongoing Administrative Burden Reduction Activities to reduce administrative burden and complexity. They will be striving to promote innovation, experimentation and evaluation in funding approaches; promote research integrity; enhance biosafety and laboratory safety; detect and disrupt foreign interference; and to develop a NIH/national strategy for shared research resources. One of the first things they did was to reduce the number of notices of funding opportunity (NOFOs) by 50% relative to Jan. 2025. They also launched Highlighted Topics to replace the use of NOFOs focusing on specific research areas.
Other examples of changes include the following:
Budget changes consist of the end the modular budget “pilot.” Researchers will no longer require detailed budgets in applications for non-complex grants which includes most research project grants. Budget justifications will be still be required so peer reviewers can assess the general reasonableness of the overall request. Certain cases will still request full budgets as just-in-time information.
The Data Management and Sharing Plan will be simplified to 4 yes/no questions with only explanations required for the no answers. The focus will shift from prospectively describing specifics to the general assent to sharing useful scientific data rather since it isn’t always known in advance every data type that will be generated.
This approach allows the NIH to focus on compliance in the cases where grantees won’t share their data.
Basic Experimental Studies in Humans (BESH) is no longer considered to be a clinical trial. BESH projects seek fundamental information about human biology and behavior and do not have clinical outcomes, so they will no longer be considered clinical trials. The NIH re-interpreted definition of clinical trials.
Other Burden Reduction and Simplification Plans
- Replace letters of support with letters of collaboration to align with NSF.
- Combine facilities and equipment sections of applications to align with NSF.
- Simplify to focus only on what is needed for proposed work.
- Simplify and align terminology, including other significant contributor roles.
- Reduce the number of career development (K) activity codes from 26 to 4.
- Explore increased use of just-in-time information.
- Issue a request for information asking the community for input on additional requirements that could be simplified or eliminated.
- National Science and Technology Council working group on administrative burden reduction stays current.
The NIH has a new Strategic Plan.
How Strict Is NIH Peer Review?
NIH peer review is highly structured, standardized, and legally mandated, with strict adherence to fairness, objectivity, and scientific merit. It is governed by the Public Health Service Act (42 U.S.C. 289a and 284a), the Federal Advisory Committee Act, and 42 CFR 52.4, which require two sequential review levels for most grant applications: Initial review is completed by an Institute/Center (IC) Scientific Review Group (SRG) or Institutional Review Group (IRG) for administrative and technical compliance. Scientific merit review is completed by the IC’s National Advisory Council/Board OER.
These requirements ensure that all applications are evaluated consistently and that decisions are based on scientific quality, not personal bias.
The “dual review” process is designed to balance scientific rigor with administrative efficiency. The first level checks that the application meets NIH’s technical and administrative requirements, while the second level assesses the scientific merit of the proposed research Agency for Healthcare Research and Quality. Reviewers must maintain strict confidentiality, avoid conflicts of interest, and not communicate directly with applicants. Review materials are returned or destroyed after meetings, and all proceedings are confidential for life. NIH policies emphasize a fair, equitable, and timely process that strives to eliminate bias. Reviewers are expected to apply the same criteria to all applications, and NIH provides detailed review guidelines for each study section Agency for Healthcare Research and Quality.
Recent operational adjustments were temporarily made (e.g., during the 2025–2026 shutdown backlog) to manage workload, such as grouping applications into “top third,” “middle third,” and “bottom third” for discussion, and simplifying summary statements. These changes aimed to maintain quality while expediting reviews, but did not alter the core standards of the Office of Sponsored Research. While operational adjustments occurred, the underlying framework remained rigorous to protect the integrity of NIH’s funding decisions.
The NIH is Changing their Language
It is important for health equity researchers to know that the NIH is now flagging the term “social determinant” as requiring additional justification under new HHS guidance. The reason for this matters because some well-scoring proposals are starting to be harder to justify, due to the language, for funding even when the science itself is strong. One reason that social determinants of health (SDoH) are described as a single construct, even when the population focus and study design are very different among researchers. To align with how proposals are being evaluated right now, one should describe SDoH by population focus and study focus in ways that advance specificity and clarity and reflect the actual scope and context of the work. How to Adapt: Researchers are advised to break down SDoH by context (distinguish between maternal health research versus chronic disease management); match terminology to the study design (if the research is population-based, community-level, or focused on specific domains (e.g., housing, food security), use that specificity in the proposal).