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Grant Process Graphic

NIH Requirements  

The following items detail information on common components in NIH applications, including guidelines, templates, and NIH notices and policies to help guide investigators through the grant application process. If you are looking for a component that you do not see reflected here, please contact the CTSI Grants Submission Unit at gsu@mednet.ucla.edu.

This information is provided for general guidance only. Investigators should always refer to the specific Funding Opportunity Announcement (FOA) for any submission-specific information.

Authentication of Key Biological and/or Chemical Resources

This section briefly describes methods to ensure the identity and validity of established key biological and/or chemical resources used in the proposed study. Standard laboratory reagents that are not expected to vary do not need to be included in the plan (examples are buffers and other common biologicals or chemicals).

Plans should be based on accepted practices in the relevant field. Include frequency of authentication and stability over long-term use. Applicants should not include experimental methods or preliminary data. See additional details on authentication requirements in the links below.

Page Limit: None. Recommended 1 page.


Last updated December 8, 2022

Bibliography & References Cited

The Bibliography & References Cited section is required for all NIH applications unless otherwise stated. It should include any and all references cited in your research plan. NIH allows any standard format and suggests that investigators consider using the NLM format. Citations within bibliographies, similar to biosketch citations, must comply with the NIH Public Access Policy.

While there is no required citation style, best practices indicate that you should include authors' names in correct order (NIH allows the use of “et al”), article and journal title, volume number, page numbers, year of publication and PMCID#, if applicable. PMID#s are not required but may be included.

It is important to note that URLs are only allowed when an article is published online (and the URL is therefore part of the official citation), or when a manuscript is publicly available online for free (and that publication does not have a PMCID#).

Note: If citations are included in other components of the grant application, such as the Human Subjects sections, those citations should still be included in the overall bibliography, not embedded within individual documents.

For multi-component center grants, each component (e.g., Overall, Admin Core, Research Projects, and Research/Service Cores) typically will each have their own bibliographies.

PMCID Numbers: NIH requires that you provide PMCID#s for applicable papers (those arising from NIH support) when citing papers that were (co-) authored by the applicant. If a PMCID# is not yet assigned, citing NIHMS numbers or stating “PMC Journal – In Process” is also acceptable.

Page Limit: None.


Last updated March 8, 2022


Biographical sketches (biosketches) are required for all key personnel (and mentors for training awards). This includes all PIs and Co-Investigators but, in some instances, may also include consultants, advisory board members, community members, and patients. Required components for an NIH biosketch include name, eRA Commons user name (for all senior/key personnel), position title, education and training, and the following sections:

  1. Personal Statement (citing up to four publications)
  2. Positions, Scientific Appointments, and Honors (all items should be in reverse chronological order, beginning with most recent)
  3. Contribution to Science (up to five) (citing up to four publications per contribution) 
  4. As of January 25, 2022, Section D should no longer appear on non-fellowship biosketches. Instead, you may highlight research from the past three years in your Personal Statement (Section A). For more information, see this NIH notice

An entire NIH biosketch cannot be more than five pages, with no figures, graphics, or attached files.

As of January 25, 2022, all senior key personnel must have an eRA Commons ID

Biosketches for other agencies, such as PCORI, NSF and DOD, have different requirements. These forms often change with the funding cycle, so be sure to check the funding announcement for details.

Page Limit: 5 pages per biosketch.

Below are some biosketch template examples. However, agencies periodically issue updates. Please refer to the FOA for any change notices.


Non-NIH Biosketch Resources:

Webinar: NIH Biosketch Writing Tips
Learn more about the requirements and recommendations when creating an NIH Biosketch.

Video last updated February 2, 2022. This video contains all updates for biosketches submitted on or after January 25th, 2022.

Clinical Trials

NIH has specific requirements for applications that involve clinical trials. Please visit UCLA CTSI's Resources for NIH's Human Subjects and Clinical Trials Updates for guidance.


  • ResearchGo - a virtual clinical research resource that provides a single portal to a wealth of resources, expertise, and best practices for investigators and research staff to facilitate efficient, compliant and ethical study conduct and management. This website can also help you with locating resources for each stage of the study: the design, set-up, conduct and close-out of a study.

Last updated March 8, 2022

Contacting your NIH Program Officer (PO)

All funding opportunities are assigned at least one program officer (PO), who serves an important role as the main liaison between the NIH and researchers. The PO’s role is to:

  • Act as the primary contact for a grant’s programmatic, scientific, and/or technical components;
  • Provide investigators with scientific guidance (pre-submission and post award); and
  • Oversee post-award issues.

Why should I contact the PO?

Contacting your program officer is required if you are requesting a budget overage (more than $500K direct per year), applying for an R13 conference grant, or if the funding opportunity specifies that you must contact the PO.

However, even if it is not required, it is usually recommended to contact your PO, especially if you are an early stage investigator (ESI). It gives you a valuable opportunity to share your research with the PO and ensure that your proposed project is a good fit for both the funding opportunity and the programmatic goals of the participating institute or center (IC) that would be funding your project. The PO will be your advocate throughout the application and award process.

Where can I find my PO’s name?

Your PO’s name and contact information will usually be located on the funding opportunity, under Section VII. Agency Contacts. If you don’t yet have a funding opportunity identified, check NIH RePORTER for funded projects that are similar to yours. The PO will be listed under the “Details” tab of awarded projects.

When should I contact the PO?

Contact your PO as early as possible in the application process, well before the LOI (letter of intent) deadline, which is usually 30 days before the application is due.

For resubmissions, it’s best to wait until after you have received your summary statement so that you can review it fully with the PO and discuss necessary revisions.

If you are requesting a larger budget, you must contact the PO at least 6 weeks ahead of the deadline.

How should I contact the PO?

After you have thoroughly read the funding opportunity (or your Summary Statement, if applying for resubmission), email the PO (DO NOT CALL) to request a meeting. The PO will let you know what, if any, documents they would like to review before the call (i.e. Specific Aims).

Email example: “My team and I are planning to submit a grant application to the FOA XXX-XX-XXX titled, “TITLE HERE.” Before proceeding, I would like to schedule a brief call with you in order to discuss our application and ensure our proposed project is a programmatic fit with the FOA as well as your IC’s interests. Please let me know when you might be available at your earliest convenience.”

What should I discuss with the PO?

For a first submission, during this meeting, you can confirm that your project aligns with the IC’s mission, interests, and high-priority research areas. You should be prepared to describe your proposed grant application’s specific aims and research design. If the PO determines the application is not a good fit for their IC or the FOA, ask them for additional recommendations.

If this is a resubmission, make sure you have read the summary statement and are prepared to discuss the major critiques and whether the PO recommends a resubmission at this time.

Other talking points:

  • Ask if the PO is willing to review specific aims or a draft outline and provide general advice.
  • Clarify any questions you have about the funding opportunity.
  • Get information on other potential FOAs to apply to.


Last updated March 8, 2022

Cover Letters

Applicants have the option to include a cover letter for internal use only (the letter is not shared with reviewers). The cover letter is used mainly to explain late or corrected applications, budget inconsistencies, agency approval for budget overages, and other very specific information. It should not be used to request specific study sections or reviewers. Some types of applications do not allow cover letters (e.g., Diversity Supplements) so always check the funding opportunity announcement before submitting.

Please see NIH guidelines below for more information on what the cover letter can include.

Page Limit: None. Recommended 1 page.


Last updated December 8, 2022

Data Management and Sharing Plan

The Data and Management Sharing Plan (as of January 25, 2023) should describe the data management, preservation, and sharing of scientific data and accompanying metadata. The new NIH-wide Policy defines scientific data as “the recorded factual material commonly accepted in the scientific community as of sufficient quality to validate and replicate research findings, regardless of whether the data are used to support scholarly publications.” Accordingly, Plans should outline where, when, and how these resources will be shared.

The Data Management and Sharing Plan should also:

  • Briefly describe the expected schedule for data sharing;
  • State format of the final dataset;
  • Provide documentation;
  • Address if analytic tools also will be provided;
  • Address if a data-sharing agreement will be required (if so, provide a brief description of the agreement (including decision criteria); and
  • Describe mode of data sharing.

Your Data Management and Sharing Plan should also be referenced in:

  • Budget, if costs are associated;
  • Budget Justification (no more than two paragraphs--this is the only part of the DMSP that reviewers will see);
  • Background and Significance (especially for large databases); and
  • Human Subjects (for confidentiality assurances)

Sharing methods should be specific to the type of data being produced and can include publishing, researcher efforts, a data enclave or archive, or a mix of these. If intellectual property is anticipated to be developed as a result of the proposed research, investigators should consider patent issues, potential proprietary information, and possible restrictions for privacy laws (HIPAA, etc.).

In all cases, protecting the rights and privacy of human subjects should be a top priority.

Page limit: 2 pages


Last updated December 8, 2022

Facilities & Other Resources

The Facilities & Other Resources (aka. "Resources") section summarizes the overall scientific environment, institutional resources, and commitments relevant to the effective implementation of a project. Applicants should describe how the proposed project will use the facilities and resources available. They should also document how the study as a whole will benefit from laboratories, patient populations, and collaborations. Applicants should consider using a table of contents for the Facilities and Resources document if it is particularly lengthy.

Typically, this document would include categories such as Scientific Environment, Clinics, Laboratories, Animal, Other, Office, and Computers.

If there are multiple study sites, applicants should describe the resources at each. All resources listed must be relevant to the proposed project. Refer to the FOA for specific rules, since they might vary from FOA to FOA.

For Early Stage Investigators (ESIs): ESIs should also consider adding details regarding institutional investment in their success, and logistical and financial support.

Page Limit: None.


Last updated December 8, 2022

Human Subjects

NIH has requirements for applications that involve human subjects (including clinical trials). Visit UCLA CTSI's Resources for NIH's Human Subjects and Clinical Trials Updates for guidance on the NIH application requirements for each type of study that plans to utilize human subjects, specimens, and/or data.

Included on the webpage is a full menu of templates and guidelines for the PHS Human Subjects and Clinical Trials Information Form. Templates and guidelines are organized by type of study:

  • Non-Exempt
  • Exempt
  • Delayed Onset
  • Clinical Trial
  • No Human Subjects

Last updated March 8, 2022

Letters of Intent

NIH Letters of Intent (LOI) tell program officers that a researcher is interested in applying for a particular funding opportunity. They also help funding agencies determine in advance what expertise will be necessary to review an application. This benefits applicants, and because letters of support are typically not binding, information about a proposed study can still be changed after an LOI is sent.

Letters of intent are often not required for an application, and sometimes not allowed (e.g., Parent R01 grants), especially for smaller projects. If letters are allowed, they are typically due 30 days prior to the application due date. Always check the FOA’s “Key Dates” for information, as specific requirements or due dates might be requested for some FOAs.

Most NIH letters of intent require the following:

  • Descriptive title of the proposed research,
  • Name, address, and telephone number of the principal investigator(s),
  • Names of other key personnel,
  • Participating institutions, and
  • The number and title of the funding opportunity.

Please note that LOIs for other agencies, such as NSF, PCORI, TRDRP and DOD, typically have different requirements and may be mandatory.

Page Limit: None. Recommended 1 page.


Last updated March 8, 2022

Letters of Support

Letters of support (LOS) convey enthusiasm for a project and lend credibility to a proposal. These letters demonstrate institutional buy-in and commitment to the project from key institutions, collaborators, consultants, consortium participants, and others.

Multi-component applications must include institutional support letters at many levels and at least one letter from each subaward site, if applicable. Some FOAs may have specific requirements, particularly for Program Project and Center grants and SBIR/STTR applications.

Common types of LOS include:

  • Institutional letters demonstrate interest in and support of the project. These letters can be from a school, department, division, and any affiliated centers or institutes. The signer should sign on behalf of the institution and have the authority and position to do so.
  • CTSA letters are written for projects that involve CTSA interests, resources and/or researchers. They describe the translational nature of the project and should be used if a project leverages resources and/or infrastructure from the site’s CTSA. Request a UCLA CTSI LOS here.
  • Letters from consultants are required for anyone being paid as a consultant on the project’s budget. These letters must detail the proposed amount of effort, the cost, and the scope of work and services being provided.
  • Collaborators typically write letters of support when they are performing significant work for the project but are not key personnel. These letters should describe the collaborator’s expertise and appropriateness for the project.
  • Departmental letters will come from the principal investigators’ department heads and describe how the project’s goals align with the department’s mission. These letters should be signed on behalf of the department.
    • ESIs: Letters for early stage investigators must include a description of departmental support for the ESI, including protected time for research, access to resources, and other means of assistance.
  • Letters of support from advisory boards are used to describe the appropriateness of a board member for a proposed role on the project. They emphasize the board member’s relationship to the principal investigator and project, and they usually include a specific commitment of time/travel. Check the FOA to ensure that advisory board members can be named during the application phase.
  • Community support letters are appropriate for projects with community components or external partnerships with non-traditional research institutions. These letters demonstrate community interest and support.
  • Letters from patient advocates are used when patients are involved in the research strategy. They often include a personal narrative, describe an interest in the project, and detail a commitment of time and travel.
  • When a project includes subaward sites, participants from these sites may provide letters of support that indicate their interest in the project and support for work performed at their institutions. In these letters, it’s important to clarify the role of the signer and his/her relationship to the site lead, as well as any resource commitments being made. These letters can also serve as departmental or institutional letters of support; however, they are typically not signed by key personnel at the site but rather by someone who has the authority to sign on behalf of the institution or department.

All letters of support should be combined into a single PDF before uploading to an application. Always check the funding opportunity for additional requirements. Consider creating a table of contents if there are a substantial amount of letters to include. Typically, if applicants are applying for multi-component projects (e.g., U54s, P01s), LOS can be uploaded together in the Overall component OR individually into each component to which the LOS belongs (or both).

Page Limit: None, but individual letters should typically not be longer than 1.5 pages each.


Last updated March 8, 2022

Multi PI/PD Leadership Plan

If there will be more than 1 lead PI/PD for an NIH application, and this is allowed by the FOA, applicants must include a Multi PI/PD Leadership Plan document. The plan should include the rationale, organizational structure of the team, communication plans, processes for making decisions on scientific direction, procedures for resolving conflicts, roles and responsibilities, and distribution of budgetary resources.

There is usually no limit on the number of PIs, but it should be reasonable and well justified. All PIs should be qualified and share equal responsibility; the governance structure is determined by the applicants. Please note that a Multi PI/PD Plan is not the same as having “Site PIs” at subaward sites.

Page Limit: None. Recommended 1 page.


Last updated March 8, 2022

Other Support

While not currently part of the pre-award application process, the NIH will request during the Just-in-Time procedures for grant applications and/or progress reports that all key personnel proposed on a grant application provide information on active and pending support. This is to ensure there is no scientific, budgetary, or commitment overlap. Called “Other Support,” this document may also be referred to as “current and pending support” or “active and pending support.”

Information collected includes:

  • Project number
  • Contact Principal Investigator
  • Source of support
  • Title of project/subproject*
  • Dates of approved/proposed project
  • Person month
  • $ of Award Period
  • Overlap (scientific, budgetary, and commitment)

The NIH has recently reiterated that Other Support must include all current and pending research support, and all sources of support, even if there is no monetary value (i.e., financial support for lab personnel, provision of materials, in-kind support, etc.). This is especially important for faculty who receive foreign support. Faculty with joint appointments at other institutions must still provide information on all sources of support (specific rules apply for joint VA appointments). For NIH applications, key personnel can exclude the current proposal from being listed.

Effective May 25, 2021, Other Support should be re-organized to separate funded projects from in-kind contributions. There is also be a signature block added for Program Director/Principal Investigator or Other Senior/Key Personnel to certify the accuracy of the information submitted. Each PD/PI or senior/key personnel must electronically sign their respective Other Support form as a PDF prior to submission. For details, please see the NIH notice issued on March 12, 2021.

If you have any questions about completing Other Support documentation, please contact GSU or your department’s fund manager or pre-award manager.

*For multi-component grants, investigators should list the project number, PI, and source of support for the overall award, and for all other sections, should report on the subproject information only.

Please note that agencies such as NSF and DOD also request similar information during the grant application process (Current and Pending Support for NSF and Previous/Current/Pending Support for DOD applications). There are minor differences in reporting requirements, but the overall reporting goals are the same.


Non-NIH Resources:

NSF Current and Pending Support: Unlike NIH Other Support, NSF’s Current and Pending Support is included with the grant application process. It must include the current project, location of project, major goals, annual direct costs, and a separate section for “Submissions planned for near future.”

DOD Previous/Current/Pending Support: Major differences between the NIH and DOD include the following: Previous/Current/Pending Support is included with the grant application process, must report on support over the past 5 years, must include names and addresses of the grant officer, and include program goals and specific aims.

Last updated March 8, 2022

Resource Sharing Plans

Effective January 25, 2023, the Resource Sharing Plan will only be necessary if your project will be sharing model organisms. Any data (including genomic data) will be discussed in the new Data Management Sharing Plan (DMSP). Please see the tab above for more information on the DMSP.

The Sharing Model Organisms section should detail plans for sharing and distributing model organisms, or provide an explanation of why sharing is restricted or not possible. Models may include mammalian, non-mammalian, and genetically modified or mutant organisms (GMOs); do not include human models (cell lines). Model organisms that will be patented must still be made reasonably available and accessible. Material Transfer Agreements (MTAs) are typically the accepted way to share model organisms with other researchers/institutions and are managed by the UCLA Technology Development Group.

Unless otherwise specified in the FOA, multi-component grants can include one combined Resource Sharing Plan for the overall component and one for each individual component.

Page Limit: None, but one page is standard and descriptions should be brief.


Last updated December 8, 2022

Rigor & Transparency

NIH reviewer guidance on rigor and transparency (PDF)

  • Click here (PDF) to access University of Colorado School of Medicine's New NIH Requirements for 2016 Grant Proposals presentation. The presentation addresses:
    • the timeline of recent and upcoming NIH changes for 2016
    • rigor and transparency
    • vertebrate animals
    • a summary of other recent changes
  • Click here (PDF) to access University of Rochester Medical Center CTSI's Rigor, Transparency and Reproducibility presentation. The 2016 presentation addresses:
    • rigor
      • scientific premise
    • reproducibility
      • quality system in your lab
    • transparency
    • robust and unbiased results
      • sex factored into design
    • authentication of key biological and/or chemical resources
      • New attachment

Other Resources: 

The following boilerplate is intended for people who have taken or plan to take the UCLA course, M261 "Responsible Conduct of Research Involving Humans":

As a __(insert)__ trainee, I plan to take a course in the responsible conduct of research. The main UCLA course, entitled “Responsible Conduct of Research Involving Humans” (M261), is a didactic course of 20 hours taught over one quarter with expert faculty members leading discussions in a particular topic area. Students are expected to read course materials and actively participate in classroom discussions of relevant case scenarios. Topics covered include Responsible Conduct of Research, Professionalism and the Ethical Imperatives of Clinical Research, Protection of Research Subjects-- the IRB process, Managing the Practice of Research, Conflicts of Interest, Genetics and Stem Cell Research, Community and International Research, Misconduct, and Conflicts of Interest.

To build upon the above training, I will continue my responsible conduct of research training with my mentor, __(insert)__, while actively conducting my research project. My mentor will meet with me on a __(insert)__ basis and there will be additional collaborative meetings with colleagues to address specific related research topics. Some of those topics will include authorship, sharing of data, and data management.

The UCLA CTSI is strongly committed to upholding the highest ethical and professional standards in research endeavors and ensures all investigators, research staff, and students are educated and remain current in “best practices” in the responsible and ethical conduct of research. The comprehensive mentoring and training activities in this area will thoroughly prepare me to accomplish the proposed research and educational training activities during the period of this award and into the future as I renew such training every four years.

(optional content) Other formats include both on-line and in-person opportunities for education. The CITI training platform for the Responsible Conduct of Research includes both a UCLA-specific RCR course as well as the CITI-provided course. Through an on-line training environment, University constituents self-identify for most of their required research training needs. The UCLA Office of the Human Research Protection Program, the Clinical and Translational Science Institute (CTSI), and the Health System Office of Compliance offer seminar series, covering topics such as “Protecting Encryption Research Data” and “Obtaining and Documenting Informed Consent” to which all trainees are invited.

Last updated March 8, 2022

Vertebrate Animals

The Vertebrate Animals section is required on all NIH applications when the use of any type of vertebrate animal is proposed.

For UCLA-based studies, an introductory paragraph should be included for the UCLA DLAM facilities, along with information on the expertise and availability of veterinary staff. See the provided guidelines on specific requirements in the documents below.

Page Limit: None.


Last updated December 8, 2022

NIH Public Access Policy Requirements

Citing CTSI

All research supported by CTSI resources must cite the CTSI grant. These resources include:

  • Pilot funds
  • Voucher awards
  • Career-development awards (e.g., KL2 and TL1)
  • Cohort-finding tools (i.e., Los Angeles Data Repository, UC ReX)
  • Clinical & Translational Research Centers (formerly GCRCs)
  • Reliance-Review IRB
  • Research cores
  • Consultations:
    • Bioinformatics
    • Biostatistics
    • Community-engaged research
    • Cohort finding
    • Data analysis
    • Data management
    • Ethics
    • Evaluation
    • Health services research
    • Implementation and dissemination
    • Participant recruitment and study management
    • Preclinical development
    • Regulatory services
    • Special populations
    • Study design
    • Trial Innovation Network (i.e., central IRB, recruitment plans)

Last updated March 8, 2022

Grant Citation Language

Any publications or projects completed using UCLA CTSI resources must cite the UCLA CTSI grant and comply with "NIH Public Access Policy" and be submitted to PubMed Central to receive a PMCID assignment.

Citing CTSI: Required Grant Citation Language

Researchers cite grant UL1TR001881 as shown below. K Scholars and TL1 trainees have alternate citations below.

Researchers cite grant UL1TR001881, as follows:
“This research was supported by NIH National Center for Advancing Translational Science (NCATS) UCLA CTSI Grant Number UL1TR001881.”

K scholars cite grant KL2TR001882, as follows:
"This research was supported by NIH National Center for Advancing Translational Science (NCATS) UCLA CTSI Grant Number KL2TR001882."

TL1 trainees cite grant TL1TR001883, as follows:
"This research was supported by NIH National Center for Advancing Translational Science (NCATS) UCLA CTSI Grant Number TL1TR001883."

Note: If the research was supported by more than one grant, please reference all relevant grant numbers.

Last updated March 8, 2022

NIH Public Access Policy


The NIH Public Access Policy requires scientists to submit final peer-reviewed journal manuscripts that arise from NIH funds to PubMed Central upon acceptance for publication. Papers must be accessible to the public on PubMed Central no later than 12 months after publication.

The policy covers any manuscript that meets the following conditions:

  • It was peer-reviewed
  • It was accepted for publication in a journal on or after April 7, 2008
  • It arose from:
    • any direct funding from an NIH grant or cooperative agreement active in FY 2008 or beyond, or
    • any direct funding from an NIH contract signed on or after April 7, 2008, or
    • any direct funding from the NIH Intramural Program

For step-by-step instructions about how to bring your publication into compliance, please go to the NIH site, which covers these topics:

  • Applicability of NIH Public Access Policy
  • Copyright
  • Submitting a paper to PubMed Central (PMC)
  • Including PMCID in citations

Investigators can use My NCBI to check the compliance status of their publications and to initiate the compliance process.

Last updated March 8, 2022


Investigators can use My NCBI to check the compliance status of their publications and to initiate the compliance process.

  • Sign in to My NCBI using the “NIH Login” button.
  • Use your eRA Commons credentials on the subsequent sign-in page.
  • Once signed in, go to the My Bibliography section.

Instructions on how to use My NCBI to manage compliance can be found in the NCBI Help Manual under the heading, Managing Compliance to NIH Public Access Policy.

A My NCBI account can be created with accounts you already have, such as eRA Commons or Google. Go here for instructions.

Last updated March 8, 2022