Frequently Asked Questions

The National Institutes of Health (NIH) has announced a major structural change for all NIH-funded research involving foreign subawards, effective May 1, 2025. Under the new policy, foreign subawards can no longer be issued under prime recipient awards. Instead, there is a temporary pause while NIH is creating a new structure for subprojects with an anticipated release date of September of this year.

Going forward, including the upcoming Cycle II deadlines (including June 5th):

• Foreign subawards are no longer allowed. NIH will not issue new, renewal, or non-competing continuation awards that include subawards to foreign entities.
  
• Prior approval requests to add new foreign subawards to existing projects will no longer be considered.
  
• Current awards with foreign subawards will be restructured or renegotiated to remove the foreign subrecipient, or if not possible the award will be terminated.
  
• This policy applies immediately, including to proposals currently in development.
  

Please review all planned foreign collaborations now. Proposals that do not comply with the new structure may be administratively withdrawn or denied funding. OGC pre-award will return any proposals that have foreign subawards.

If you believe your proposals are impacted by this change, please contact the Office of Grants and Contracts using the CU Anschutz Federal Transition Inquiry Form.

Last updated May 12, 2025.

 

National Institutes of Health (NIH) Standard Terms of Award include the provision for grantees to extend the final budget period of a previously approved project period one time for a period of 1 to 12 months, without additional NIH funds, and without prior approval. 

This request for a No-Cost Extension (NCE) must be made before the project period ends. Typically, the NCE request triggers an automated email notification to the grants management specialist (GMS), and no further action is required by the recipient. 

As of May 7, 2025, NIH temporarily disabled the No-Cost Extension functionality in eRA Commons so that NIH staff can review all existing grants and cooperative agreements to allow the NIH to review the activities of the grant and consistency with funding priorities.

All new requests for NCEs must be submitted as prior approval requests in eRA Commons for NIH review and approval. Given that the Office of Grants and Contracts (OGC) will need to provide documentation and work with the GMS directly, please allow at least 60 days lead time before the end date as this new review process takes place.

If you have an outstanding NCE request in place with OGC, we will contact you for more information and to request the documents needed for the request. Please reach out to us via the CU Anschutz Federal Transition Inquiry Form with any grant-specific questions related to this change.

Last updated May 12, 2025. 

The National Institutes of Health (NIH) released a Notice of Civil Rights Term and Condition of Award that modifies the current terms and conditions for all NIH grants, cooperative agreements and other transaction (OT) awards effective April 21, 2025.

The notice applies to domestic recipients of new, renewal, supplement or continuation awards issued on or after April 21, 2025.

The notice states that by accepting NIH grant awards, recipients are certifying that they do not and will not during the term of the financial assistance award, operate any programs that advance or promote DEI, DEIA or discriminatory equity ideology in violation of Federal anti-discrimination laws or engage in a discriminatory prohibited boycott. (Refer to notice for definitions.) Violations of Federal anti-discriminatory laws or engagement in a prohibited boycott could result in NIH terminating financial assistance awards and recovering funds.

Compliance with this condition of award will be addressed through institutional assurance and will not require individual grant or PI certification.

Last updated May 6, 2025.

As our usual practice, the Principal Investigator or unit is fiscally responsible for pre-award spending if the award is not received. Please keep this in mind if you plan any pre-award spending.

Last updated April 23, 2025

We are seeing delays in receiving some non-competing continuations while others are being issued on time. It is variable, and the Office of Grants and Contracts has not observed specific trends within one agency over another.

Last updated April 23, 2025

While noting the current flux across agencies, institutes and centers of the HHS, such as the Agency for Healthcare Research and Quality (AHRQ) and Centers for Disease Control and Prevention (CDC), we still encourage researchers to submit grant applications; however, please consider the sponsors’ areas of interest, noting that these may change.

Many sponsors do seem to be accepting applications despite reported staff changes.  Principal Investigators are encouraged to contact their specific program officer or manager directly, as this will likely be the most direct way to assess the situation with a specific grant mechanism.

Last updated April 23, 2025

Researchers have reported that in some instances, the requirements of fulfilling their federal research grants, including required sections, may conflict with Executive Orders (e.g., on DEI) issued by the new Administration.

At this time, we believe researchers should complete all required sections of their federally funded grants, including those that pertain to DEI, if this is a requirement of grant submission.

Please closely monitor grant requirements prior to submitting, as they may change due to conflicting requirements between the federal funder and the Executive Orders.

Also, consider including language to indicate that you are following the requirements of the grant and will adapt your work as needed to comply with any confirmed or final federal requirements communicated by the federal funder.

Last updated March 18, 2025.

Funding applications to the National Institutes of Health (NIH) are reviewed in study sections (i.e., Scientific Review Groups or SRGs). Review Branches (RBs) are clusters of study sections based on scientific discipline. With the federal government transition, the status of the scheduling of study sections has been unclear, as typically scheduled meetings have either been occurring inconsistently or not at all.

On March 6, 2025, 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 (CSR). This centralization would eliminate study sections within 23 NIH Institutes and Centers (IC) that currently review 22% of NIH grant applications.

NIH’s proposal is under review with implementation pending external review. This includes review by HHS and the Office of Management and Budget, providing Congress with a 15-day notification period (until March 22), and issuing a Federal Register notice.

Last updated March 18, 2025.

The Office of Grants and Contracts has received responses from a few NIH agencies that they are holding the issuance of new Diversity Supplements currently, and it is unclear if this mechanism will be available in the future. We will continue to follow up on the status. We have not received additional formal guidance on the status of Diversity Supplements that are active and awarded; however, we have noted some instances of non-extension in the new budget year. Please carefully read NIH communications regarding diversity supplements and share these communications with the campus federal transition team.

Last updated April 9, 2025.

You should continue to work on your grants and funded research unless you have received specific instructions to stop from a federal sponsor. Please use caution when looking at long-term investments such as expensive equipment, as guidance may change in the coming weeks or months. If you are unsure, please submit an inquiry to our campus federal transition team through this online form, and our team will follow up with you.

Last updated February 7, 2025.

If you receive any attestation request, a grant-specific questionnaire or any other direct request  from a federal sponsor, including but not limited to any attestation regarding DEI, gender ideology or gender affirming care, these inquiries are considered legal terms and conditions and require an institutional authority (AOR Authorized Organization Representative) to attest and submit on behalf of the University. This is typically done at the time of submission by the Office of Grants and Contracts. 

If you receive an email from the NIH with a request for you to sign an attestation or other document related to your proposal and/or award, please submit it to us via our online form as soon as possible and do not respond to NIH. We will work with NIH to provide the campus attestation as required by NIH policy.

Last updated March 18, 2025.

Please submit an inquiry through this online form, and our team will be in touch.

Last updated February 7, 2025.

Given the current environment, it is important for the success of this biobank to limit multiple requests to potential participants that currently have approved sample collection protocols for non-COVID-19 studies. Unless formally exempted, one should not be specifically collecting COVID-19 samples.

There is an established COVID-19 Prioritization Committee.  If you are ready to submit to the HSR portal, the committee will receive your application through that mechanism. 

A main goal for the COVID-19 Biobank is to make data on specimens and subject to be available to the wider research community in as quickly and efficiently a manner as possible. Updates will be made once a data platform is functional and accessible to researchers.

Due to the nature of the majority of samples being retrieved from clinically discarded specimens, it is not possible to determine what will be available for researchers at this time. We will update applicants to the COVID-19 Steering and Allocation Advisory Committee who have been approved for research when samples are available.

Sample Types that should become available from the COVID-19 Biobank:

1. Serum
2. Plasma/EDTA
3. Plasma/heparin
4. PBMC
5. BAL (bronchoalveolar lavage)
6. Nasal/oral swab
7. FFPE tissue
8. Citrated plasma
9. CSF
10. Isolates (DNA/RNA)
11. Urine
12. Stool
13. Cord Blood and Placenta

For general COVID-19 Biobank Specimen Repository inquiries contact Matthew.Steinbeiss@cuanschutz.edu

Please consult the COVID-19 Biobank Application Timeline for information.