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If you are here looking for the information about the National Institutes of Health (NIH) U Grants, then the chances are you are already somewhat familiar with the vast structure of 27 different NIH institutes and centers (ICs) and a huge variety of federal funding grants differentiated by activity codes. Every year the NIH invests $31 billion in research and development (R&D) by providing financial assistance to more than 300,000 scientists and researchers. To accomplish this, there is a comprehensive system in place to allow fair opportunities for new, early-stage investigators as well as for senior research scientists to obtain funding awards to conduct researches contributing to collective scientific advancement.

Nonetheless, to set the procedure of any particular award program in motion you must study different research project grants, fellowships, career development awards, and multi-project center grants through all the information – accumulated from the books, research papers/journals, and scientific literature published by credible scientists – available on digital archive of National Library of Medicine (NLM) in numerical form by grant number metadata. (Powell, 2019)

Going through the types, requirements, and purposes of each NIH grant will help you immensely, especially if you are just starting as an individual seeking federal funding or as an institution backed investigator looking to finance projects related to social, behavioral, biomedical, and/or clinical research. This article, however, is focusing on U Grants funding mechanisms in a way that will address your questions and reservations in an easily understood manner.

What is a U Grant?

Every once in a while, you may notice a Funding Opportunity Announcements (FOAs) for a grant award that starts with U, but you don’t come across a lot of readily available information to fully grasp what the U grants are meant for.

U grants, like any other funding grant, are separated by activity codes to represent the structure of funding types, mechanisms, and research support, e.g., U01, U19, U24, or U54. These grants are basically cooperative agreement oriented between the NIH staff and the grantee’s organization. Projects that are multifaceted, area targeted, specified, and discrete in the approach require greater involvement on the part of the award granting institution for coordinated assistance to carry out the research comprising different grants and resources.

So, you must be wondering how the U-grant is any different from the Research Project Grant (R01). The fundamental difference lies in research project activities. While the NIH staff and Program Directors/Principal Investigators (PD/PI) work cooperatively on every project that has been awarded the funding grant, there are some ventures that call for considerably more involvement of the staff in terms of participation, coordination, and training. In grants like R01, the staff remains in the backseat in the sense of both the ownership and responsibility of awardee’s activities despite working jointly with the PD/PI. (Berg et al., 2007)

How to Determine the Cooperative Agreement Requirement

To determine which extramural research program requires staff involvement to the point where cooperative agreement becomes essential for PD/PIs, we have listed down different activities that will exhibit whether or not your project will necessitate cooperative agreement in order to be funded.

Activities that Do Warrant a Cooperative Agreement

Here are a few examples of research project activities that would warrant substantial staff involvement under U mechanism’s cooperative agreement:

  • Making the institutional resources available to every member of the project team
  • Assisting with task administration and technical performance
  • Taking part in committees’ organizations that would work centrally to project activities
  • Active participation at the stage of project design and subsequent development
  • Making sure to coordinate with the principal investigator during all stages of data consolidation from research, collection, analysis, to interpretation
  • Participating in the selection and/or approval process of the data evaluation system
  • Coordinating or providing training of project staff in awardee institutions
  • Supervising the project staff selection as well as providing training to the member selected from the organization of grantee
  • Monitoring every transitional stage of the project for the approval of the following process until the clinical trial
  • Arranging joint publication assignments and co-authoring several papers with the program director

Activities that Do Not Warrant a Cooperative Agreement

These are the examples of research project activities that would suffice normal staff over substantial staff involvement under U mechanism’s cooperative agreement:

  • Ensuring policy implementation and oversight following the NIH’s administrative requirements of federal funding terms and conditions
  • Assisting in selecting and approving the award receiving mechanism beforehand
  • Occasionally visiting the project site to ensure the satisfactory performance of the awardee institution
  • Assessing the project progress at different stages to prevent any inadequacy
  • Assisting only when the PI or PD formally requests it
  • Intervening only when it is deemed inevitable due to certain shortcomings in a project to rectify the process
  • Employing institutional monitoring only for those awardee organizations that were classified as ‘risky’ for any number of inconsequential reasons
  • Conducting the performance evaluation only after the project completion

RFA and FOA – Your Major Sources of U Grant Information

You can only apply for U grants in response to Requests for Applications (RFAs) and FOAs that are periodically updated in compliance with the NIH provisions. RFAs state all the compulsory requirements, such as – the purpose and its scientific scope, division of responsibilities among the staff and the project PD/PI, project activities, type of NIH staff involvement – that must be considered well and good by grant applicants before any other step forward.

As we have established above that the prerequisite, as well as the objective of U grants or cooperative agreements, is to facilitate the complex procedure of collaborating many different grants and resources to ensure the smooth conduct of specified research. So, when you attempt to respond to U funding opportunity, you absolutely must absorb every detail indicating smooth execution of the research project under a cooperative agreement. Contact the scientific official mentioned in the funding opportunity announcement for further understanding of PD/PI roles and responsibilities.

Lastly, go through sections I, IV, V, and VI of Part 2 Full Text of Announcement for FO description, application, submission, and review information, and terms and conditions of the award with due deliberation in order to prevent unintentional violations of specific rules or regulations of the award. In those cases, NIH immediately halts the award and forms a special monitoring body, which usually results in the termination of an award. In some cases, institutes demand an accurate funding track record for faculty engagements. (Schimanski, 2018)

U Grants Application

We have always maintained the significance of writing an impressive application in abidance with the NIH guidelines and policies for any of the huge variety of funding grants, but writing a cooperative agreement application is by far the most meticulous task. Given the complicated nature of U grants, you need to utilize all the available resources to help you understand, prepare, and write your application. Once you are confident about your part of the job – of addressing each and every question, section, guideline aligned formatting, appropriate data, and attachment, make sure to contact relevant officials mentioned in the grant FOA. Having informed opinions and guidance of someone from the NIH representative will eliminate the chance of oversight and errors beforehand. (Arthurs, 2014)

The NIH has several Application Submission Options, but not all of them are applicable to every funding program. It is compulsory for grant applicants to ensure the required method in advance with the NIH authorized official and grantee’s own organization. Once you are done writing your cooperative agreement application, you will proceed to the Electronic Submission Process, as stated in the cooperative agreement FOA. It will take more or less two months to get through five registrations that are mandatory before you will be considered eligible to submit your application electronically using either the ASSIST or Grants.gov portals. To confirm that your application has been received by the NIH, you must check Electronic Research Administration (eRA) commons, which is the NIH’s system that lets you as well as the NIH staff access and track your application.

The Just-in-Time (JIT) procedure is the same for cooperative agreements as it is for the proposals established to have funding potential. JIT allows some features of the application to be addressed and submitted later in the process, particularly after review. These features include other support information (active and pending) for key personnel, certification of International review board (IRB) approval of the project’s proposed use of human subjects; verification of Institutional Animal Care and Use Committee (IACUC), and evidence of compliance with the protection of human research members obligation. When/If you receive a JIT request, you should be able to submit the documents mentioned above within a month of the notice.

You will be notified through e-mail when and/or if JIT information for your application is needed. However, do not mistake this email notification with Notice of Award translating as an indicator of possible funding.

Peer Review for U Grant Applications

For every grant application for the NIH funding grants, the scientific review officer (SRO) forms the review panels comprising highly sought after scientists of their respective fields. These review panels ensure the fair conduct of several sessions to determine the credibility of individual reviews carried out by a primary and secondary reviewer, usually assigned to every proposal submitted to the NIH. (Abdoul et al., 2012)

The Center for Scientific Review (CSR) at the NIH directs the SRO to constitute a special emphasis panel that reviews the applications submitted in response to an RFA by employing the standards and criteria mentioned in the FOA of the U grants. The applications for cooperative agreement are not subjected to the usual scoring method that is common in the peer-review process of other applications due to the research project activities that call for substantial involvement of the NIH staff.

Lastly, keep track of your application through eRA commons, and email for any follow-up requirement.

References

  1. Powell, K. (2019, April 1). Searching by Grant Number: Comparison of Funding Acknowledgments in NIH RePORTER, PubMed, and Web of Science.J Med Libr Assoc, 107(2), 172-178. https://doi.org/10.5195/jmla.2019.554
  2. Berg, K.M., Brown, A.F., Elmore, J.G., Gill, T.M., Wilson, I.B., & Zerzan, J. (2007, November). Demystifying the NIH Grant Application Process. J Gen Intern Med, 22(11), 1587–1595. http://dx.doi.org/10.1007/s11606-007-0301-6
  3. Hendriks, T.C., & Viergevercorresponding, R.F. (2016, February 18). The 10 Largest Public and Philanthropic Funders of Health Research in the World: What They Fund and How They Distribute Their Funds. Health Res Policy Syst, 14, 12. http://dx.doi.org/10.1186/s12961-015-0074-z
  4. Arthurs, O.J. (2014, November 19). Think it Through First: Questions to Consider in Writing a Successful Grant Application. Pediatr Radiol, 44(12), 1507-1511. https://doi.org/1007/s00247-014-3053-6
  5. Abdoul, H., Alberti, C., Amiel, P., Gottot, S., Perrey, C., Tubach, F., & Zaleski, I.D. (2012, September 28). Peer Review of Grant Applications: Criteria Used and Qualitative Study of Reviewer Practices. PLoS One, 7(9), e46054. https://doi.org/10.1371/journal.pone.0046054

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