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Funding

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.

Resources:

Last updated July 31, 2019

Biosketches

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 PIs only), position title, education and training, and the following sections:

  1. Personal Statement (citing up to four publications)
  2. Positions and Honors
  3. Contribution to Science (up to five) (citing up to four publications per contribution)
  4. Additional Information: Research Support and/or Scholastic Performance

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

Please note that 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.

Resources:

Non-NIH Biosketch Resources:


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

Last updated June 1, 2018

Clinical Trials

NIH has new, 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.

Resources:

  • 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 June 1, 2018

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.

Resources:

Last updated June 1, 2018

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.

Resources:

Last updated June 1, 2018

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 June 1, 2018

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.

Resources:

Last updated June 1, 2018

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.

Resources:

Last updated June 1, 2018

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. Additional guidance can be found below and here.

Page Limit: None. Recommended 1 page.

Resources:

Last updated June 1, 2018

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 June 1, 2018

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 UCLA’s 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.

Resources:

Last updated June 1, 2018

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 June 1, 2018

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 June 1, 2018

NIH Public Access Policy

Questions?

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

Click here to see an informational webinar that addresses How the NIH Policy Mandate Affects Researchers.

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

Last updated June 1, 2018

My NCBI

Questions?

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 June 1, 2018