Research

• April 29: To align with the FDA’s reduction of animal testing, the National Institutes of Health (NIH) announced a new initiative to expand human-based science while reducing animal use in research.
• April 10: The U.S. Food and Drug Administration (FDA) announced a plan to phase out animal testing in the development of monoclonal antibody therapies and other drugs. The FDA’s animal testing requirement will be reduced, refined, or potentially replaced using a range of approaches, including AI-based computational models of toxicity and cell lines and organoid toxicity testing in a laboratory setting (so-called New Approach Methodologies or NAMs data).

• May 1: The NIH issued a Guide Noticeupdating their policies and practices utilizing foreign subawards. Under the new policy, awards will not be issued if the project includes a subaward to a foreign entity. The NIH also will not accept prior approval requests to add a new foreign component or subaward to an ongoing project. Awards with a foreign subaward may be eligible for renegotiation and rebudgeting if the work can be performed domestically. If a project is no longer viable without the foreign subaward, the NIH will work with the recipient to negotiate a bilateral termination of the project, taking into consideration any need to support patient safety and/or animal welfare.
  
  The policy, which began May 1, will remain in effect until the details of the new foreign collaboration award structure are released. The new award structure is expected to be implemented no later than September 30, 2025, prior to Fiscal Year 2026.
  
  At this time, the policy update does not apply to commercial contracts.

• March 25: New awards are currently being issued using the previously approved negotiated indirect cost rates, except for awards under which F&A costs are reimbursed at a fixed rate.
• March 5: A federal judge issued a nationwide preliminary injunction, temporarily blocking implementation of a 15 percent cap on NIH F&A costs.
• Feb. 21: Preliminary injunction issued.
• Feb. 10: Temporary restraining order issued, preventing the NIH from enacting the new rate.
• Feb. 10: A lawsuit was filed by 22 state attorney generals against the Department of Health and Human Services (DHHS) and the NIH, seeking injunctive relief from the NIH and requesting that the rate cut be halted.
• Feb. 7: The NIH issued a notice announcing implementation of a standard 15 percent F&A rate, effective Feb. 7, 2025.

• May 5: A lawsuit was filed contesting the cutting of F&A reimbursement rates for NSF grants and cooperative agreements.
• May 2: The NSF issued a policy notice announcing implementation of a standard 15 percent F&A rate, effective May 5, 2025.

• April 4: Maryland joined a lawsuit challenging the administration’s unreasonable and intentional delays in reviewing NIH grant applications, as well as its termination of hundreds of already-issued grants. Read more.
• Feb. 10: In response to claims that federal agencies were continuing to improperly freeze federal funds, a federal judge in Rhode Island reinforced the temporary restraining order (TRO) and ordered the administration to immediately restore frozen funding.
• Jan. 31: A federal judge in Rhode Island granted a TROblocking the administration from freezing federal loans, grants, and other financial assistance under awards and obligations to provide federal financial assistance to the States.

• May 9: The NIH published a notice clarifying which applications will be reviewed under the simplified review framework for August and October 2025 Councils. For a detailed list of impacted activity codes, please review the notice on the NIH website.
• May 7: The NIHupdated its process for No-Cost Extensions (NCE). NCE requests must now be submitted as a prior approval request and all requests will be reviewed for alignment with current NIH mission and agency priorities.
• April 21: The NIH Notice of Civil Rights and Conditions of Award was issued, requiring recipients of federal awards to promise not to advance or promote programs that violate federal antidiscrimination laws. UMB’s existing policies ensure compliance with all Federal and State laws and aims to prevent and address discrimination.
• March 25: The March issue of the NIH’s Extramural Nexus newsletter provided several important updates including: a link to their new Implementation of New Initiatives and Policies page, which provides information on recent and upcoming changes that impact applications and grants administration; guidance on how to effectively prepare NIH research project grant applications; and the reviewer guidance for the simplified review framework. Additionally, the NIH website indicates that Federal Register Notices for meetings, including scientific review groups and study sections, are ongoing and Federal Register Notices for National Advisory Councils and Boards have resumed. 
• March 6: The NIH announced plans to centralize peer review of all applications for grants, cooperative agreements and research and development contracts within the agency’s Center for Scientific Review in an effort to reduce spending and improve efficiency of the review process.

• Feb. 26: An executive order was issued requiring federal agencies, in consultation with the Department of Government Efficiency (DOGE), to immediately review all existing contracts and grants considered discretionary. Reviews were to be completed within 30 days. The order further allows, where appropriate and consistent with applicable law, for the termination or modification (including through renegotiation) of such covered contracts and grants. In addition, agencies are now prevented from signing new contracts or modifying existing contracts without consultation with DOGE.

Beginning on Jan. 21, external communications and some operations were paused across a number of federal agencies. This included the White House Office of Management and Budget (OMB) freezing spending on all federal loans and grants. This action was intended to provide time to review federal funding and ensure spending aligns with current executive branch priorities. Because federal funding is appropriated by Congress (the legislative branch), lawsuits have been filed challenging the legality of the executive branch to issue such a directive.

• Feb. 4: The Department of Health and Human Services issued internal guidance and procedures allowing certain external communications, travel, and grant reviews to resume.
• Jan. 29: OMB rescinded its memo, but continued to pause certain federal financial assistance.
• Jan. 28: A federal judge in the District of Columbia issued a temporary stay on the OMB memo, pausing implementation with respect to the disbursement of Federal funds under all open awards.
• Jan. 27: The OMB issued a memo directing federal agencies to temporarily pause all activities related to federal financial assistance or that may be implicated by recent executive orders.
• Jan. 21: The Department of Health and Human Services (DHHS) issued a memo pausing public communications and suspending all work-related travel and grant reviews for all DHHS agencies.

No, unless you have received a stop work order, you should not stop working on any sponsored awards. Please continue preparing and submitting proposals according to the published agency deadlines.

If you receive a stop work order, suspension notice, or equivalent directive from an authorized official of a Sponsor — either a United States Government (USG) Sponsor or Pass-Through-Entity (PTE) — send it immediately by email to Jill Frankenfield, MSL, MS, associate vice president, Sponsored Programs Administration, and Laura Scarantino, MSF, CPA, assistant vice president, Office of Sponsored Projects Accounting and Compliance, copying your department chair and school dean. They will, with guidance from the Office of University Counsel, review the contents, determine its applicability, and provide guidance on how to proceed.

Please note that some stop work orders, suspension notices, or equivalent communications are currently subject to federal injunction orders and may not be legally applicable at this time.  

If you are provided guidance that your project is subject to a stop work order, suspension notice, or equivalent directive that has not been enjoined by an injunction, no work should be charged against the grant until official notification lifting the order has been received from an authorized official or until you receive further clarification from Jill Frankenfield or Laura Scarantino.

The cost of any work performed during the effective period of a stop work order or a suspension order that is not subject to the injunction referenced above may not be paid by the Sponsor.

During a stop work or suspension, recipients are expected to maintain operational readiness to resume work if and when the order is lifted. Deliverables in the contract/agreement may or may not be negotiable upon resumption of the award. It is therefore important to approach contingency planning, bridge funding, project de-scoping, and budget realignment carefully to ensure the ability to resume implementation immediately if approved.

Note: Only USG Contract Officers, Agreement Officers, and PTE Authorized Organizational Representatives have binding contract authority. Communications and instructions from a Contracting Officer’s Technical Representative, or other USG or PTE technical or program office representative, are not binding. 

If UMB Is the Institutional Review Board (IRB) of Record:

If you receive a stop work order, suspension notice, or equivalent directive from an authorized official of a Sponsor, immediately notify the IRB in addition to forwarding the stop work or suspension notice to Jill Frankenfield and Laura Scarantino, as described above. 

You must notify the IRB by utilizing the Reportable New Information pathway in CICERO; select #9 “Suspension or termination of the research by the sponsor or the investigator."

Include the following information: 

• attach the written stop work order, suspension, or equivalent directive 
• the number and status of participants 
• the overall status of the research project
• the potential impact on the rights, welfare, and safety of participants resulting from the stop work, suspension, or equivalent directive
• the potential impact on the collection of study data and overall study integrity

All stop work orders, suspensions, or equivalent directives will be reviewed by a fully convened panel of the IRB for review.

If an External IRB Serves as the IRB of Record:

If you receive a stop work order, suspension notice, or equivalent directive from an authorized official of a Sponsor, immediately notify the IRB in addition to forwarding the stop work or suspension notice to Jill Frankenfield and Laura Scarantino, as described above.

You must notify the IRB by utilizing the Reportable New Information pathway in CICERO; select #14 “Determination...Suspension or termination at UMB (External IRB studies ONLY)”

Include the following information: 

• attach the written stop work order, suspension, or equivalent directive
• the number and status of participants 
• the overall status of the research project
• potential impact on the rights, welfare, and safety of participants resulting from the stop work, suspension, or equivalent directive
• potential impact on the collection of study data and overall study integrity

All stop work orders, suspensions, or equivalent directives will be reviewed by a fully convened panel of the IRB for review.

If you receive a stop work order, suspension notice, or equivalent directive from an authorized official of a Sponsor, immediately notify the Institutional Animal Care and Use Committee (IACUC) in addition to Jill Frankenfield and Laura Scarantino, as described above, utilizing the following mechanisms:

For paper protocols, submit via email at iacuc@umaryland.edu and include the following information: 

• IACUC number
• number of animals on study and being maintained in animal facilities
• overall status of the research project
• potential impact on study data and overall study integrity
• potential impact on the animals

For CICERO protocols, submit via the system utilizing the following pathway:

• Open your protocol
• Click the button “Contact IACUC Staff” found in the left navigation menu
• Enter text as described above
• Attach the stop work order, suspension notice, or equivalent directive
• Click “OK” to submit

If you have questions or concerns regarding the care and disposition of your animals, contact the Office of Animal Welfare Assurance at iacuc@umaryland.edu.

All stop work orders, suspensions, or equivalent directives will be reviewed by a fully convened panel of the IACUC for review.

Discuss the matter with your chair or dean. You may wish to review II-1.00(C) - UMB Policy on Extending the Deadline for Tenure Review for Parenthood or Extraordinary Circumstances.