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National Institutes of Health (NIH) Proposal Toolkit

National Institutes of Health

Begun as a one-room Laboratory of Hygiene in 1887, the National Institutes of Health (NIH) today is one of the world’s foremost medical research centers. An agency of the Department of Health and Human Services, the NIH is the Federal focal point for health research. Its mission is to seek fundamental knowledge about the nature and behavior of living systems and the application of that knowledge to enhance health, lengthen life, and reduce illness and disability.

The goals of the agency are:

  • to foster fundamental creative discoveries, innovative research strategies, and their applications as a basis to advance significantly the Nation’s capacity to protect and improve health;
  • to develop, maintain, and renew scientific human and physical resources that will assure the Nation’s capability to prevent disease;
  • to expand the knowledge base in medical and associated sciences in order to enhance the Nation’s economic well-being and ensure a continued high return on the public investment in research; and
  • to exemplify and promote the highest level of scientific integrity, public accountability, and social responsibility in the conduct of science.

Learn the Basics about funding from NIH:

SF424 Guide: NIH Application Guide

The NIH Application Guide provides application instructions to be used in conjunction with the guidance in the funding opportunity announcement (FOA) to submit grant applications to NIH, the Centers for Disease Control and Prevention, the Food and Drug Administration, and the Agency for Healthcare Research and Quality. The guide is broken into 3 primary sections, each with subsections:

 

Prepare to Apply

 

Write Application

 

Submit Application

 

NIH Resources

NIH Resources

NIH Grants Policy Statement

**Note per the NIH Grants Policy Statement (section 11.2.9.2, Fellowships): “A stipend is provided as a subsistence allowance for Kirschstein-NRSA fellows to help defray living expenses during the research training experience. It is not provided as a condition of employment with either the Federal government or the sponsoring institution.” Please also see NOT-OD-23-111: Reminder NIH Policies for NRSA Stipends, Compensation and Other Income for more information.

Types of Grant Programs

NIH uses activity codes (e.g. R01, R43, etc.) to differentiate the wide variety of research-related programs we support. NIH Institutes and Centers (ICs) may vary in the way they use activity codes; not all ICs accept applications for all types of grant programs or they apply specialized eligibility criteria. Look closely at Funding Opportunity Announcements (FOAs) to determine which ICs participate and the specifics of eligibility. See the comprehensive list for all grant activity codes for descriptions.

The following groupings represent the main types of grant funding we provide:

 

Application Elements

Application Elements

The following elements need to be included in the grant application as appropriate. Unless stated, these elements do not influence the rating (priority score) of the application. However, the reviewers are asked to comment on the adequacy of the information provided for each element. Any concerns the reviewers identify may negatively affect and postpone the granting of an award. 

Bibliography & References Cited Provide a bibliography of any references cited in the Research Plan. Each reference must include the names of all authors (in the same sequence in which they appear in the publication; you can use “et al.” convention in place of listing all authors in a citation), the article and journal title, book title, volume number, page numbers, and year of publication. Make sure that only bibliographic citations are included. Be especially careful to follow scholarly practices in providing citations for source materials relied upon when preparing any section of the application. Visit Bibliography and Appendix from NIAID for information.

Care and Use of Vertebrate Animals in Research If you are planning to use live vertebrate animals in the project, you must adhere to the requirements in the Public Health Service (PHS) Policy on Humane Care and Use of Laboratory Animals (Policy): HTML Version and PDF Version. For an overview of what is required in your application and detailed instructions, see the Vertebrate Animals Section webpage. Additional information can be found at:

Consortium/Contractual Arrangements Explain the programmatic, fiscal, and administrative arrangements to be made between the applicant organization and the consortium organization(s).

Consultants and Collaborators Attach appropriate letters from all consultants and collaborators confirming their roles in the project. For consultants, letters should include rate/charge for consulting services.

Facilities & Other Resources This information is used to assess the capability of the organizational resources available to perform the effort proposed. Identify the facilities to be used (Laboratory, Animal, Computer, Office, Clinical and Other). If appropriate, indicate their capacities, pertinent capabilities, relative proximity and extent of availability to the project. Describe only those resources that are directly applicable to the proposed work.

Inclusion of Women, Minorities and Children in Research Peer reviewers will also assess the adequacy of plans to include subjects from both genders, all racial and ethnic groups (and subgroups), and children, as appropriate, for the scientific goals of the research will be assessed. Plans for the recruitment and retention of subjects will also be evaluated.  Check out the NIH inclusion of women and minorities policy website which has resources such as a decision tree to help you determine which of your studies are subject to NIH’s inclusion policy.

Multiple PD/PI For applications designating multiple PDs/PIs, you must include a leadership plan.

Page Limits Follow the page limits specified for the attachments in your grant application, unless otherwise specified in the FOA.

Protection of Human Subjects from Research Risk Applicants must assure NIH that all human subjects are protected. Reviewers will assess the potential risk to human subjects in proposed research and evaluate what protections are in place to guard against any research-related risk. Awards cannot be made until assurances are on file with the Office for Human Research Protections (OHRP). Decision charts are presented that are helpful in thinking through relevant human subject protections issues. Also see Research Using Human Subjects: Note that even some work with samples qualifies as human subjects research; Research Using Stem Cells: See NIH Stem Cell Information.

Data Management and Resource Sharing Plan In addition to Resource Sharing Plan information, this section includes Data Sharing Plan, when applicable, and Sharing Model Organisms. For more information on data sharing, please see the NIH website at https://sharing.nih.gov/. The Data Management and Sharing Plan page provides a comprehensive source of information.

Select Agents Identify any select agents to be used in the proposed research. Select agents are hazardous biological agents and toxins that HHS or USDA have identified as having the potential to pose a severe threat to public health and safety, to animal and plant health, or to animal and plant products. CDC maintains a list of HHS and USDA Select Agents and Toxins.

Use of Internet Sites NIH instituted a policy that prohibits the use of World Wide Web addresses (URLs) in grant applications in the place of text describing the same material. This is because of the potential for providing a large amount of extra material from a Web site beyond what would fit in the page limit, and thereby giving an unfair advantage to some applicants and a large additional burden for reviewers.

Specific Aims Recommended elements for writing a concise and compelling specific aims page (from Stanford University) provides a detailed description and samples to assist in writing this section. Introduction to the Specific Aims Page, a grant proposal article provides an overview and details on elements within the page.

Letters for Grant Applications  Types of Letters for Grant Applications explains the difference in letters and usage. Also see Reference Letters or Letters of Support: What's the Difference?

PHS Assignment Request Form Use the optional PHS Assignment Request Form to list expertise needed to review your application, exclude reviewers, and request an institute assignment. For investigator-initiated R01, R21, and R03 applications, we also advise you to request assignment to the most appropriate study section of reviewers.In any case, it’s a good idea to consult a program officer to get his or her advice on the appropriate institute and study section assignments. In the absence of a request from you, NIH’s Center for Scientific Review (CSR) will assign your application to an institute and study section. CSR bases assignments on its referral criteria, relying on referral staff and knowledge-based technologies to decide.

 

Budget and Personnel

Budget and Personnel

Learn what you need to address when building a team, identifying your resources, and planning a budget you will submit to reviewers.

 

Submitting an Application

Submitting an Application

Take action to prepare for your application's submission by understanding timelines and due dates, learn how to comply with technical requirements, and learn what to do if your application isn't funded.

 

 

Pre-Award and Award Process

Pre-Award and Award Process

When NIH awards a grant, we are formalizing our partnership with the recipient to ensure compliance with federal laws, regulations and policies. This protects the integrity of the overall scientific endeavor. This page describes what happens between peer review through award for applicants whose applications have been deemed highly meritorious in the scientific peer review process.

 

Applications and Other Samples

Applications and Other Samples

Some useful samples and examples that are part of the grant application from NIH, including sample applications and summary statements, data sharing, and model organism sharing plans.

 

COI Disclosures

COI Disclosures

Standard and Non-Standard COI Disclosures for NIH 

The University of Chicago's Revised Conflict of Interest Policy requires that all individuals with the designation of faculty, or other academic appointment, annually file a Conflict of interest-Conflict of Commitment Disclosure. Furthermore, any individual that is engaged in the design, conduct or reporting of research, or is considered "key personnel" must comply with the policy. This is a university-wide policy and applies regardless of whether the faculty or academic is engaged in research, or receives external research funding, and regardless of whether they have a full time or part time appointment.

When OS or CPS documents are required at proposal stage or Just-in-Time (JIT) stage, the URA Pre-Award Specialist with send an Ancillary Review to the URA COI team to identify any additional items that need to be reported for key personnel. The URA COI team will complete the Ancillary Review and inform the key personnel, Administrative Contact, and URA Pre-Award Specialist about what involvements and activities should be included.

For this process of developing or updating the Other Support (OS) or Current and Pending Support (CPS) documentation for a faculty member, the question arises on where to include outside faculty appointments, ownership in an external business, or other non-standard or unusual circumstances identified by the URA COI team.

For the NIH OS document this can be manually added to the OS document between “In Kind Support" and "Overlap.” Suggested headers include: “Other Involvement”, “Other Activities”, etc.

 

 

NIH Outgoing Foreign Subawards

NIH Outgoing Foreign Subawards

On September 15, 2023, the National Institutes of Health (NIH) released its Final Updated Policy Guidance (NOT-OD-23-182) clarifying its longstanding foreign subaward policy.  This applies to all NIH grants with Outgoing Subawards to foreign institutions.          

As of January 1, 2024, all foreign subrecipients must “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.” Access may be entirely electronic and must include all data that supports the research outcomes reported in the yearly Research Performance Progress Report.

The notice also requires that all existing subaward agreements with foreign subrecipients be revised to include the new requirement by March 1, 2024.  A separate email will be sent to affected Principal Investigators (PIs). 

**Effective January 1, 2024, NIH also expects recipients at proposal stage to submit letters of support from foreign subrecipients indicating their awareness of these requirements and the subrecipients’ willingness to abide by all requirements if an award is issued. We interpret “letter of support” in this policy to mean Letter of Intent (LOI) or Subrecipient Commitment Form, and therefore, we have updated the LOI and Subrecipient Commitment Form with the following language for foreign subrecipients as applicable: 

Since the Prime Awarding Agency is the National Institutes of Health, we, the subrecipient organization, will abide by all requirements of the NIH Final Updated Policy Guidance for Subaward/Consortium Written Agreements (NOT-OD-23-182). We certify that we have the necessary resources, expertise, and facilities to perform the proposed research activities and to comply with the applicable policies and regulations NIH requires that recipients flow down to all Foreign Subrecipients when funding is provided from NIH prime awards.

Please find the updated Subrecipient Commitment Form and LOI templates on our website with this language. The updated templates are to be used for proposals with foreign outgoing subrecipients when NIH is the prime sponsor. More information may also be found here. 

Should you have questions about this requirement at proposal or pre-award stage, please contact Anna Jackson, Director, Pre-Award and Sponsored Development Services at annaj@uchicago.edu.

Information on updates to the policy: