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New Year, New Federal Regulations: FY2025 Updates from NIH

wooden blocks spelling 2025 

Fiscal year 2025 is officially under way, which means new guidelines and forms packages! Here is a summary of what you need to prepare for in 2025. Contact your research administration team through ROAR for questions.

NIH Review Criteria Simplified

Review criteria have been updated on many NIH research grant applications – including F awards. The previous five criteria (Significance, Investigators, Innovation, Approach, and Environment) have been revised into three key questions to assess the technical merit of proposed projects — two will receive numerical scores and one will be evaluated for sufficiency. These changes impact how an application is reviewed; they do not change how the application is developed.    

 

New Biosketch and eRA Commons ID Regulations 

In May 2025, NIH will implement new regulations for biosketches as part of the NIH-NSF efforts to use Common Forms among federal institutions. After May 2025, those creating biosketches will be required to use SCIENcv and ORCID ID connection in NIH and NSF grant system profiles. The Office of Sponsored Research offers FAQ and links to instruction guides to use SCIENcv and ORCID. Applicants/Recipients are encouraged to start preparing for this change by becoming familiar with SciENcv and establishing ORCID IDs and linking them to the eRA Commons profiles of individuals required to submit a Biographical Sketch as this will be required once the Common Forms go into effect. 

 

Know Your Options for Data Management and Sharing Plans – Now Required on RPPRs 

NIH is also requiring more reporting in progress reports on Data Management and Sharing Plans as of October 1, 2024. Sponsored Research provides templates and tips for proposals. These plans are written during the proposal phase and are meant to be implemented during the life of the project. DMS Plans cover data sharing including uploading information into federal databases, as well as archiving and de-identification costs and practices. 

NIH provides guidance on costs related to data management and sharing as well as budget justification instructions. The Council on Government Relations also provides a quick-reference sheet for determining costs. Allowable costs may be included in NIH budget requests for: 

  • Curating data 
  • Developing supporting documentation 
  • Formatting data according to accepted community standards, or for transmission to and storage at a selected repository for long-term preservation and access 
  • De-identifying data 
  • Preparing metadata to foster discoverability, interpretation, and reuse 
  • Local data management considerations, such as unique and specialized information infrastructure necessary to provide local management and preservation (for example, before deposit into an established repository). 
  • Preserving and sharing data through established repositories, such as data deposit fees. 
  • If the Data Management & Sharing (DMS) plan proposes deposition to multiple repositories, costs associated with each proposed repository may be included. 

 Northwestern IT provides a one-stop-shop for resources on writing a Data Management and Sharing Plan, choosing storage, and data reuse for future projects. They also provide a library of planning tools, guides, archiving and IT services for your data 

Changes to DMS plans on federal awards is now an approval request within annual RPPRs. For awards for which the NIH DMS Policy applies, recipients will be asked: 

  • Whether data has been generated to date and what type of data it is; 
  • Whether data has been shared for use by others; 
  • If data has been shared, in what repository and under what unique digital identifiers; 
  • If data has NOT been shared, what is the status of data sharing (e.g. being prepared for submission, submitted to repository, not yet expected to be shared); and 
  • If data has not been generated and/or shared as outlined in an approved DMS Plan, what corrective actions have or will be taken to comply with the approved Plan. 

In addition, if significant changes to the DMS Plan are anticipated in the next year, recipients will be asked to describe those changes and provide a revised DMS Plan for approval. 

 

New Guidelines for K Award Applicant Referees 

K Award applicants should pay attention to the updated guidelines on how letters of reference can be submitted by referees. These letters are not submitted by the department with the rest of the proposal packet. Read more here on how to write and submit letters of reference. 

 

BESH Trials To Be Added to ClinicalTrials.gov 

After September 2025, NIH Basic Experimental Study with Humans (BESH) applications will need to register in ClinicalTrials.gov and report summary results information. Funding announcements will specify how to fill out the Human Subjects section of applications, as well.  

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