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·         NIH Final Updated Policy Guidance for Subaward/Consortium Written Agreements

·         Notice Number: NOT-OD-23-182

·         Previous Notice Number: NOT-OD-23-133

·         https://grants.nih.gov/grants/guide/notice-files/NOT-OD-23-182.html

Purpose

·        In response to audits conducted by the HHS Office of the Inspector General (OIG) and by the Government Accountability Office (GAO), NIH published a Notice in the Federal Register (88 FR 36603) on June 5, 2023, outlining its plans to update the NIH Grants Policy Statement, section 15.2, to require that foreign subrecipients provide copies of all lab notebooks, all data, and all documentation that supports the research outcomes as described in the progress report, to the primary recipient no less than once every six months. NIH has received extensive feedback and is issuing this Notice to respond and to issue a final revised Notice.

This notice updates the NIH Grants Policy Statement (NIHGPS), Section 15.2, which outlines the requirements for consortium/subaward agreements on NIH-funded grants. These updates will be incorporated into the GPS in the FY24 publication. This updated guidance is effective October 1, 2023. A Federal Register Notice announcing the updates will be posted in the coming weeks.

Updated Policy Guidance

Effective January 1, 2024, section 15.2 will be updated to include the following clarifications (changes are bold and italicized):

15.2 ADMINISTRATIVE AND OTHER REQUIREMENTS

The following highlights several areas within the consortium relationship that the recipient needs to address with consortium organizations receiving subawards under a grant to ensure compliance with NIH requirements. The requirement for a written agreement addressing these and other areas is specified in this section.  NIH will not support any agreement that does not meet the minimum requirements outlined in the written agreement section below (15.2.1). NIH reserves the right to request copies of the written agreement and relevant supporting documentation as needed, as part of its oversight responsibilities. Failure to provide requested documentation may lead to remedies for noncompliance and potential enforcement actions (see 8.5, Specific award conditions and remedies for noncompliance).

NIH expects recipients to ask potential subrecipients, at the application stage, to submit language in their letters of support indicating their awareness of these requirements and the subrecipient’s willingness to abide by all requirements should an award be issued.

Note that most of these requirements only apply to a recipient’s consortium relationships with sub-recipients. When the relationship is with a vendor that is providing routine goods and services within normal business operations that are ancillary to the operation of the research program, the public policy requirements listed below do not apply. The vendor must also be providing similar goods and services to many different purchasers and provide them in a competitive environment.

15.2.1 Written Agreement

The recipient must enter into a formal written agreement, signed, and agreed to by both parties, with each consortium participant/subrecipient that addresses the negotiated arrangements for meeting the scientific, administrative, financial, and reporting requirements of the grant, including those necessary to ensure compliance with all applicable Federal regulations and policies and facilitate an efficient collaborative venture. If a subrecipient is unwilling to accept the requirements outlined in this section, by signing a written agreement, then an agreement cannot be issued. At a minimum, this agreement must include the following:

Note: All current requirements remain in place, with the addition of:

·        For foreign subrecipients, a provision requiring the foreign subrecipient to provide access to copies of all lab notebooks, all data, and all documentation that supports the research outcomes as described in the progress report, to the primary recipient with a frequency of no less than once per year, in alignment with the timing requirements for Research Performance Progress Report submission. Such access may be entirely electronic.

Please refer to the full Notice for further details as this is only an excerpt of the new requirement. 

Should you have any questions, please contact OSP.

** Originally published in UMBC's Undergraduate Research Group** 

Meet Garrett Hill, a FOUR-TIME URA Scholar! 

Garrett attended Mount Hebron High School in Howard County, where he had the opportunity to participate in the Biotechnology Career Academy at the Applications and Research Laboratory (ARL) program and conduct research at UMBC during his senior year at Hebron. He is a senior Biochemistry and Molecular Biology major, a Meyerhoff Scholar, and conducts research in the Marten lab.

Research Title: Characterization of the PrkA Protein Kinase in Aspergillus nidulans

Describe your project:

My project aims to investigate the way that mold repairs its cell wall after damage and how the cell organizes structures related to this repair. New understandings gained through this research can contribute to how we use fungi to make drugs and enzymes and may even help others to design new antifungal medications.

Who is your mentor for your project? 

I work with Dr. Mark R. Marten in the Department of Chemical, Biochemical, and Environmental Engineering. As a high school senior, I was a part of a program that allowed me to participate in research at neighboring institutions, and I came across Dr. Marten and his lab when searching for research I may be interested in. After meeting and talking about the work done in the lab, something that stood out to me was how Dr. Marten stressed the importance of project ownership. Being the “expert” in the lab on a project gives students a unique level of both responsibility and drive, and this is what drew me to joining his lab.

How did you become interested in this project?

Before starting work on this project, I had assisted some graduate students with their projects, and that’s when I learned that I had an interest in both the molecular genetics and the fluorescence microscopy that we do in our lab. This project seemed to combine both interests, so I decided to choose it when looking for a project of my own.

What has been the hardest part about your research/what was the most unexpected thing about being a researcher? 

Something that really took getting used to was the number of setbacks I faced in my project. I quickly learned that in research, it takes many tries to get something right, and failure became much more familiar to me throughout my journey as an undergraduate researcher.

What has been the most rewarding part?

I am very grateful to have had the opportunity to engage in research at almost every stage a projects life. I started with comprehensive literature reviews, where I then formulated my own hypotheses, and under the guidance of my mentor, I designed experiments to test these hypotheses. I also got experience communicating my science in conferences and presentations, allowing me to get a great view of what research really feels like.

How will you disseminate your research?

I plan to present my research next spring at URCAD and look forward to the prospect of attending conferences to potentially present my work.

What is your advice to other students about getting involved in research?

I think getting involved in research can seem a little daunting at first, so I would recommend that people just take the leap! There is a lot of exciting research being done at UMBC, so I would say to just see what’s out there and if something seems interesting, reach out to the lab to see if you can get involved. Now is the time to experiment and see what you want to do in your career, and there are many mentors here that could help you on that journey.

What are your career goals?

After graduating UMBC, I plan to pursue a PhD in microbiology. The prospect of staying in academia and becoming a mentor for others is exciting to me, but I also look forward to exploring what other career paths I might be able to follow after graduate school.

Read more about UMBC's URA Scholars:

ur.umbc.edu