2025 Federal Changes

We have been made aware that there is a hold on submissions to the Federal Register, where public notices of upcoming meetings — including NIH study sections — are required by law to be posted. We are also aware that some study sections have been cancelled. We are monitoring the situation and will provide more detail when available. Read more on thetransmitter.org.

To align with new administration guidance:

• Do not evaluate, score or factor into final scoring the Diversity Plan section. 
• Reviewers must evaluate as usual the scientific justification for Inclusion of Women, Minorities and Individuals Across the Lifespan in applications with human subjects (excluding research that qualifies for Exemption 4).
• Reviewers must evaluate as usual SABV (sex as a biological variable) in vertebrate animal and human studies.

Consistent with the Executive Order (EO) entitled Defending Women from Gender Ideology Extremism and Restoring Biological Truth to the Federal Government (Defending Women), the U.S. Department of Justice’s National Institute of Justice (NIJ) is providing the following instruction and procedures and is seeking award information on or related to surveys, forms, or other data collection tools that ask about “gender” or “gender identity.” 

Instruction. If an award-funded project includes a survey, form, or data collection tool that asks about “gender” or “gender identity,” it must instead ask about “sex,” with only two available responses: “male” and “female.” A “choose not to disclose” response is not permitted. All questions about “gender identity” must be removed. Therefore:

• If the project’s survey/form/data collection tool is under development or will be under development later in the project timeline:
  • Ensure that the question complies with the above Instruction.
• If the project’s survey/form/data collection tool has been developed, but has not yet been administered:
  • If it has been reviewed and approved by the Institutional Review Board (IRB) but not by NIJ’s Human Subjects Privacy (HSP) team, change the question(s) to be in compliance with the above instruction before submitting the package to NIJ for HSP review.
    • This may require resubmission for review and modification approval by the IRB.
  • If it has not yet been approved by the IRB, change the question(s) to comply with the above Instruction before submitting the package for IRB and NIJ HSP review.
• If the project’s survey/form/data collection tool has been developed, approved, and administered:
  • If administration is ongoing, pause administration and change the question(s) to comply with the above Instruction.
    • This may require resubmission for review and modification approval by the IRB.
  • Submit the updated package to NIJ for HSP review and approval. Administration of the survey/form/data collection may resume only upon the award recipient’s receipt of notice of NIJ approval.

Your timely compliance is appreciated. Failure to comply with this directive may affect the award.

A federal judge in Boston ordered a nationwide temporary pause on plans by the National Institutes of Health to substantially slash indirect cost reimbursements for research to universities, medical centers, and other grant recipients. Read more on statnews.com.

The National Institutes of Health (NIH) issued guidance on Feb. 7 regarding cuts to federal research grants. Specifically, the NIH announced it would cap the rate for what are known as “indirect costs” to 15% for all existing and new NIH contract awards. On Feb. 10, litigation was filed by multiple states challenging this decision.

If this policy change is enacted, it will impact the way we do research at the University of Kentucky. It will cost UK tens of millions of dollars annually and will hit our local and state economies. More important than any numbers, though, it will impact the work we do to advance the health of Kentucky in those areas most critical to our future — including cancer, heart disease, Alzheimer’s and substance use disorder.

How the university is responding:

• Our government relations team is meeting with our congressional delegation and others to communicate how fundamentally important and serious this issue is to our community and all those we serve through discovery and healing.
• Our cabinet, deans and other leaders are meeting regularly to confer on this and other issues to ensure we remain careful and prudent stewards of our resources — that we are moving thoughtfully to protect what we do and the future of our research enterprise.
• We will comply with all federal and state laws and policies. That is our responsibility. At the same time, we will forcefully advocate for what we do and our vital mission to advance this state. This includes advocating for the restoration of these critical research dollars.
• We will continue to keep you informed of important updates.
• See President's message: Potential Impact of Federal Research Cuts

We typically extend NIH awards using the "Extension" option in eRA Commons. The extension option is currently not available. We checked several awards that should be eligible for an extension and the extension option wasn’t available. eRA Commons confirmed that further guidance is pending. In the meantime, we need to submit No-Cost Extension (NCE) requests directly to the NIH Grants Management Specialist (GMS). Please work with CGS and OSPA post-award staff to submit NCE requests via this new mechanism.

The National Institutes of Health (NIH) resumed some study sections to review grant applications. An NIH internal notice announced that as of Monday, Feb. 3 advisory councils are now permitted to hold closed sessions to discuss and approve funding for research projects, but not open sessions involving public presentations or discussions. See STAT article.

Unless you have received a notice to suspend activities for a specific award from a sponsor, you can continue your research activities.

The NIH is the largest funder of health research in America. In the past five years the University of Kentucky — as a major health research and clinical institution — received an annual average of $159 million in NIH awards (grants and contracts).

Those awards fund basic science research into the diseases and illnesses that most impact Kentucky: cancer, diabetes, heart disease, children’s health, aging-related illness, opioid use disorder and many others.

Awards have two major components. There are direct costs — dollars directly associated with the scientific research in question.

And there are indirect costs — what are often called Facilities and Administration or F&A. Those are dollars associated with the award to pay for items that make that research possible. That could be the construction and outfitting of a lab, research equipment, utilities such as ventilation, heat and lighting, associated technology and graduate students who work in the lab setting.

That indirect cost or rate is negotiated for a period of time between an institution — like UK — and the NIH. Those rates range from 20% of the cost of a grant to 54%, depending upon the research being conducted and the terms of the award.

For example, a $1 million grant with a 37% indirect rate would mean that $1 million directly funds research; $370,000 ultimately goes to the university to allocate to pay those support costs, like facilities, equipment, technology and personnel. The structure for how those dollars can be used is very prescribed.

Cutting the rate to 15% — what the NIH has described as a benchmark for what private foundations that award grants provide — would cut tens of millions of dollars in essential support services to scientists and clinicians who are asking the most important questions about the biggest health challenges Kentucky faces. This one change, if enacted for the next 12 months, would represent a cut of at least $40 million to the University and its critical research efforts on behalf of the health of our state.  

Too, the comparison between a private foundation providing a grant around research in education policy, for example, simply does not involve the same cost or cost structure as a basic science grant that could include building and lab space and all the supports that go along with that infrastructure. The complicated discovery and research our investigators perform cost more than the research often funded by private foundations.

The Council on Government Relations (COGR) has many resources on their website.

• F&A Costs of Research one-pager
• Costs of Federally Sponsored Research infographic