An official website of the United States government
Disclaimer:
The information in these pages are meant to provide general guidance. Instructions and procedures outlined in the funding opportunity, SF424 Application Guide , and NIH Grants Policy Statement take precedence over any information provided and should be referred to for complete and comprehensive directions.
Learn more about applying for and managing an Early Independence Award . This guide contains information on:
- Pre-Application Steps
- Application
- Letters of Reference
- Application Submission
- Sample Applications
- Post-Submission Materials
- Review Process
- Pre-Award Activities
- Site Visits
More questions? Contact us at EarlyIndependence@od.nih.gov .
SF424 (R&R) Application Guide
The SF424 (R&R) Application Guide provides comprehensive guidance on how to submit applications to NIH, the Centers for Disease Control and Prevention, the Food and Drug Administration, and the Agency for Healthcare Research and Quality.
Use latest version of the SF424 (R&R) Application Guide, and follow the Research (R) instructions.
The funding opportunity provides all the information needed to successfully assemble your application and will tell you when to refer to the SF424 (R&R) Application Guide for more detailed instructions. It will also tell you when to deviate from the SF424 (R&R) Application Guide. Instructions in the funding opportunity supersede instructions from the SF424 (R&R) Application Guide. Failure to comply with the instructions and requirements outlined in the funding opportunity may result in your application being administratively withdrawn for non-compliance.
Eligibility
As outstanding research is conducted at a broad spectrum of institutions, applications from the full range of eligible institutions (including institutions that may be less research-intensive and from all domestic geographic locations) are encouraged to apply. Applications in any area within the biomedical sciences are welcome; topics may involve basic, translational, or clinical research. The primary requirements are that the research be highly innovative and have the potential for unusually broad impact.
Before you try to apply to the Early Independence Award, make sure you are eligible. The Early Independence Award has strict eligibility requirements that must be met.
Steps to Determine Your Eligibility
NIH seeks 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 Early Independence Award welcomes any area within the biomedical sciences; topics may involve basic, translational, or clinical research. The primary requirements are that the research be highly innovative and have the potential for unusually broad impact.
The award provides an opportunity for exceptional junior scientists to accelerate their entry into an independent research career by skipping the traditional postdoctoral training period. The Early Independence Award is an R01-equivalent research grant that will support an independent research project at an institution that will provide the applicant with an independent research position.
Applicants should be newly graduated investigators with a record of scientific innovation and research productivity. They should demonstrate unusual scientific vision and maturity and not need post-doctoral training to develop further skills and knowledge.
Any eligible individual with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director/Principal Investigator (PD/PI) is invited to work with his/her institution to develop an application for support. NIH recognizes the need to foster a diverse research workforce across the nation and encourages applications from diverse PI/PDs, applicant institutions, and research areas relevant to the broad mission of NIH.
You must have completed or will complete an advanced terminal research degree (typically a PhD) sometime between May 1, 2025, and September 30, 2027, as stated on your transcript. For clinicians, you must have completed or will complete your clinical training (which includes residency and fellowship periods) sometime between May 1, 2025, and September 30, 2027.
You cannot have served as a postdoctoral fellow for 12 months or more after a previous, non-terminal doctoral degree (this is only relevant if you have or will have multiple doctoral degrees). This does not include serving as a postdoctoral fellow after your terminal research degree or completion of clinical training. Another way of thinking about it is you cannot have served as a postdoctoral fellow for 12 months or more before May 1, 2025.
You must be in a non-independent research position at the time your application is submitted, meaning all the following are true: (1) Your current research agenda is set through concurrence with mentors. (2) Your research is funded primarily through support to other investigators (mentored fellowships do not count). (3) You do not have any research space assigned directly to you by your institution. (4) Based on institutional policy, you cannot apply for an NIH R01 grant without a special waiver or exemption. While you must be in a non-independent research position at the time your application is submitted, you may become functionally independent after you submit your application and retain eligibility.
The Early Independence Award is a research project grant and R01 equivalent, not a training or mentorship grant. You must develop a research project around a topic of relevance to the NIH mission . Your approach should reflect careful deliberation of strengths and weaknesses and display independence from your previous mentor's work. Preliminary data are not required but will be evaluated if included.
You are welcome to view previously funded Early Independence Award research to get a sense of the scope and framing of successful proposals, but keep in mind that NIH is always looking to expand its portfolio of supported research. If your area of research is underrepresented or has not yet been funded, it does not mean it is not welcome or wanted for the Early Independence Award. NIH welcomes all topics relevant to the NIH mission and encourages unique and diverse topics to apply to the Early Independence Award. Increasing scientific diversity is a programmatic priority.
If you are submitting other NIH applications besides the Early Independence Award, note that multiple applications with essentially the same content and scope are not allowed under review at the same time per NIH policy . An application cannot be submitted before the summary statement of an earlier, overlapping application has been issued.
NIH makes awards to institutions, not directly to individuals. An applicant must have an institution submit the application on their behalf. NIH does not match potential applicants to host institutions. The institution must guarantee an independent research position for the applicant if awarded and is expected to provide substantial support.
There is a two-application limit per institution (as defined by Unique Entity Identifier) per competition. This is to ensure awardees have the proper institutional support needed to succeed. Institutions often have an internal selection process for selecting candidates, so potential candidates should work with their institution and follow its process to ensure their application is one of the two allowed.
Only U.S.-based institutions are allowed to apply, but there is no U.S. citizenship requirement for the applicant. Only single PD/PI applications are allowed.
The project period for an Early Independence Award is five years. For years 1 and 2, you must commit at least 9.6 person-months to your Early Independence Award project. For years 3-5, you do not need to focus exclusively on the Early Independence Award project but must still commit at least 9.6 person-months towards independent research in general.
The Early Independence Award is a research project grant and R01 equivalent, not a training or mentorship grant. You must develop a research project around a topic of relevance to the NIH mission . Your approach should reflect careful deliberation of strengths and weaknesses and display independence from your previous mentor's work. Preliminary data are not required but will be evaluated if included.
You are welcome to view previously funded Early Independence Award research to get a sense of the scope and framing of successful proposals, but keep in mind that NIH is always looking to expand its portfolio of supported research. If your area of research is underrepresented or has not yet been funded, it does not mean it is not welcome or wanted for the Early Independence Award. NIH welcomes all topics relevant to the NIH mission and encourages unique and diverse topics to apply to the Early Independence Award. Increasing scientific diversity is a programmatic priority.
If you are submitting other NIH applications besides the Early Independence Award, note that multiple applications with essentially the same content and scope are not allowed under review at the same time per NIH policy . An application cannot be submitted before the summary statement of an earlier, overlapping application has been issued.
If you still have questions about your eligibility, check out the Frequently Asked Questions section and past Q&A webinars . You can also contact NIH staff at EarlyIndependence@od.nih.gov .
Application Process
This section provides steps and information needed to prepare an Early Independence Award application for submission and includes samples of past Early Independence Award applications. The guidance found here is not detailed, but it is specific to the Early Independence Award. For more detailed guidance on each step, go to the NIH Grants & Funding Application Guide website .
The application process includes:
1. PRE-APPLICATION STEPS
Before you can submit an application, you need to make sure you have all the necessary registrations and accounts. Work closely with your institution's business office to get registered and to determine its internal procedure for submitting an application to NIH.
Step 1: Ensure Applicant Institution Is Registered
Applicant institutions must complete and maintain the following registrations to apply and receive awards. Registration can take six weeks or more, so institutions should begin the registration process as soon as possible.
- System for Award Management (SAM) – Institutions must complete and maintain an active registration, which requires an annual renewal that may take as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code. A Unique Entity Identifier (UEI) is issued as part of the SAM.gov registration process. The same UEI must be used for all registrations, as well as on the grant application.
- eRA Commons – Institutions must have an active unique organization identifier to register. To submit an application, a Signing Official (SO) and Program Director/Principal Investigator (PD/PI) account must be designated.
- Grants.gov – Institutions must have an active SAM registration to complete registration.
Step 2: Ensure Applicant Is Registered
The PD/PI must have an eRA Commons account. The PD/PI should work with his/her institutional officials to either create a new account or to affiliate their existing account with the applicant institution in eRA Commons. Obtaining an eRA Commons account can take up to two weeks.
Step 3: Request an Application Package
The application forms package must be accessed through one of the following systems:
- Application Submission System & Interface for Submission Tracking (ASSIST) – ASSIST is used to prepare and submit applications electronically to NIH and other Public Health Service agencies.
- Grants.gov Workspace – Workspace is the standard way for organizations or individuals to apply for federal grants in Grants.gov.
- Institutional System-to-System – See your institution’s administrative office for instructions if you plan to use an institutional system-to-system solution.
Step 4 (Optional): Submit a Letter of Intent
Potential applicants are requested (but not required) to submit a letter of intent. Letters of Intent are non-binding and are not entered into the review of subsequent applications. The information in the letter is used by NIH staff to estimate the potential review workload and plan the review.
The letter of intent should include only the following information:
- Descriptive title of proposed activity
- Name, address, and telephone number of the PD/PI
- Names of other key personnel
- Participating institution(s)
- Number and title of the funding opportunity
Letters of intent can be emailed to earlyindependence@od.nih.gov by the date listed in the funding opportunity.
1. PRE-APPLICATION STEPS
Before you can submit an application, you need to make sure you have all the necessary registrations and accounts. Work closely with your institution's business office to get registered and to determine its internal procedure for submitting an application to NIH.
Step 1: Ensure Applicant Institution Is Registered
Applicant institutions must complete and maintain the following registrations to apply and receive awards. Registration can take six weeks or more, so institutions should begin the registration process as soon as possible.
- System for Award Management (SAM) – Institutions must complete and maintain an active registration, which requires an annual renewal that may take as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code. A Unique Entity Identifier (UEI) is issued as part of the SAM.gov registration process. The same UEI must be used for all registrations, as well as on the grant application.
- eRA Commons – Institutions must have an active unique organization identifier to register. To submit an application, a Signing Official (SO) and Program Director/Principal Investigator (PD/PI) account must be designated.
- Grants.gov – Institutions must have an active SAM registration to complete registration.
Step 2: Ensure Applicant Is Registered
The PD/PI must have an eRA Commons account. The PD/PI should work with his/her institutional officials to either create a new account or to affiliate their existing account with the applicant institution in eRA Commons. Obtaining an eRA Commons account can take up to two weeks.
Step 3: Request an Application Package
The application forms package must be accessed through one of the following systems:
- Application Submission System & Interface for Submission Tracking (ASSIST) – ASSIST is used to prepare and submit applications electronically to NIH and other Public Health Service agencies.
- Grants.gov Workspace – Workspace is the standard way for organizations or individuals to apply for federal grants in Grants.gov.
- Institutional System-to-System – See your institution’s administrative office for instructions if you plan to use an institutional system-to-system solution.
Step 4 (Optional): Submit a Letter of Intent
Potential applicants are requested (but not required) to submit a letter of intent. Letters of Intent are non-binding and are not entered into the review of subsequent applications. The information in the letter is used by NIH staff to estimate the potential review workload and plan the review.
The letter of intent should include only the following information:
- Descriptive title of proposed activity
- Name, address, and telephone number of the PD/PI
- Names of other key personnel
- Participating institution(s)
- Number and title of the funding opportunity
Letters of intent can be emailed to earlyindependence@od.nih.gov by the date listed in the funding opportunity.
2. APPLICATION
Follow the Instructions
It is critical that applicants follow the Research Instructions in the SF424 (R&R) Application Guide except where instructed in the funding opportunity to do otherwise. When the funding opportunity provides instructions that differ from the SF424 (R&R) Application Guide, the instructions given in the funding opportunity take precedence and should be followed.
All attachments should be formatted according to NIH format standards .
Adherence to the application requirements is mandatory and strictly enforced. Applications that are out of compliance with these instructions may not be accepted for review.
The PD/PI (Program Director/Principal Investigator) mentioned in the instructions refers to the Early Independence Award candidate.
Required Forms
Refer to the funding opportunity and SF424 (R&R) Application Guide for complete instructions.
1. SF424 (R&R) Form
Follow all instructions in the SF424 (R&R) Application Guide .
Agency Routing Identifier
Enter Science Area Designations in the Agency Routing Identifier (in Field 4b). Using the list below, designate the most appropriate scientific area for the proposal. An optional secondary scientific area may also be designated.
1 CB - Chemical Biology
2 CTR - Clinical and Translational Research
3 IDI - Infectious Diseases and Immunology
4 IE - Instrumentation and Engineering
5 MCB - Molecular and Cellular Biology
6 NS - Neuroscience
7 HIB - High-Throughput and Integrative Biology
8 BCB - Bioinformatics and Computational Biology
For each area, enter the one-digit code and abbreviation (e.g., 1 BSS). If selecting two science areas, enter the primary area first followed by a semicolon, then add the secondary area (e.g., 1 BSS; 7 NS).
The areas of science listed above are very broad and frequently overlap. Choose the primary (and optional secondary) science area that is most appropriate for your proposed project. The scientific areas are used solely as an aid to assign panel reviewers, who are chosen for their breadth of knowledge and expertise and will be able to review a broad range of applications. Science area designations do not affect an application’s funding potential, and application requirements and instructions are identical for all science areas. All applications are reviewed in the same time period, with the same review criteria, and compete for a single source of dedicated funds.
Note: The science area designations (two one-digit codes with abbreviations) must also be included at the beginning of the Research Strategy essay.
2. PHS 398 Cover Page Supplement Form
Follow all instructions in the SF424 (R&R) Application Guide .
3. R&R Other Project Information Form
Follow all instructions in the SF424 (R&R) Application Guide with additional instructions outlined in the funding opportunity.
Facilities & Other Resources
The Facilities & Other Resources section is a critical component of the application and should be given due attention. Try to avoid boilerplate language that isn't tailored to the candidate or their needs. It may also be helpful to provide context for what resources and support are being offered. Are they standard for the institution or the field? Let reviewers know why what is being offered meets the candidate's needs and how it fits with other institutional hires and the field.
Applicant institution officials must address all the items listed in the funding opportunity for the Facilities & Other Resources section, including detailing the PD/PI’s independent research position, outlining institutional resources provided to the PD/PI, and describing the institution’s career development plan for the PD/PI. The commitment of institutional resources to the PD/PI is a major review consideration and should be suitably addressed in this section.
Responses must use the corresponding subheadings and numbering. There is no page limit.
Candidate Selection Process
Describe the process and criteria used to select the PD/PI.
Position Details
During the award period, the PD/PI must be scientifically and administratively independent. The appointment need not be permanent or tenure-track and may be contingent upon receipt of the Early Independence Award. Describe in detail the position to which the PD/PI will be appointed and how independence will be ensured during the award.
- What is the title of the position?
- Is the position permanent or tenure-track?
- Is the position contingent upon receipt of the Early Independence Award?
- Describe the position in detail.
- How will the PD/PI's independence be ensured during the award?
- Describe plans for maintaining protected time for the PD/PI so that they can commit at least 9.6 person-months of effort to the Early Independence Award project each year in years 1-2 of the project period. In years 3-5, the PD/PI may reduce their effort towards the Early Independence Award project but must commit at least 9.6 person-months towards general independent research each year. Clinicians should be permitted to perform clinical duties to the extent necessary to maintain credentials.
- Describe the organizational structure where the PD/PI's position will be administered (e.g., school, department, etc.).
- Explain how this administrative structure will best meet the goal of supporting the success of the PD/PI. Include details of responsibilities for integrating the PD/PI and their scientific project into the institutional culture and the faculty community.
- Describe PD/PI access to potential lab personnel, such as access to postdoctoral fellows, graduate students, undergraduates, or technicians.
- Describe management plans for potential problematic situations.
- Describe institutional expectations related to the retention or transfer of the PD/PI at the end of the funding period.
- Affirm that the PD/PI will be able to conduct independent research by the project start date.
- Affirm that the institution will initiate the PD/PI appointment into the independent research position by the project start date.
Institutional Resources Commitment
- If the candidate is not a U.S. citizen or permanent resident, the sponsoring institution must include information about the candidate's visa status and assurance that the candidate's visa provides sufficient time to complete the award at the U.S. institution.
- Describe details of the laboratory space to be provided to the PD/PI, including physical structure and space layout.
- Describe support staff and systems available to the PD/PI, including (but not limited to) human resources, supply and equipment ordering systems, and administrative assistance.
- Describe the institutional financial commitment to the PD/PI. Matching funds are not required; however, an appropriate level of institutional support is expected. Institutional commitment to the development of the PD/PI as a successful and independent research scientist will be given considerable attention during the review and selection process.
- If the PD/PI already has a commitment of funding for independent research (such as through another independent research program or institutional start-up funds), describe how the Early Independence Award will affect the other funding.
Institutional Career Development Commitment
- Describe plans for assuring scientific independence. If the PD/PI is staying at the same institution at which they trained, indicate how independence from degree/fellowship mentors will be established and maintained.
- Describe plans for integrating the PD/PI into scientific and administrative activities at the institution. Describe the scientific collaborative activities (e.g., attendance at faculty meetings, laboratory meetings, participation in institutional scientific retreats, etc.) and career development resources (e.g., courses in laboratory management and grant writing, etc.) that will be available to ensure the PD/PI is successful.
- Describe the mentoring structure and include membership, meeting frequency, and meeting format. Though the PD/PI must be scientifically independent, it is important that senior colleagues are available as resources and periodically meet with the PD/PI.
- The primary goal for the PD/PI is to establish an independent scientific research program. However, if the PD/PI has an interest in (limited) teaching, describe what opportunities will be available.
- Describe expectations and opportunities for the PD/PI to establish a record of independent funding from sources other than the Early Independence Award.
Other Tips
- For more help on human subjects, visit the NIH Grants & Funding website .
- Foreign components are defined as the performance of any significant scientific element or segment of a project outside of the United States, either by the recipient or by a researcher employed by a foreign organization, whether or not grant funds are expended. It is crucial that you disclose all foreign components, which include foreign collaborations that will result in co-authorship. See the definition of Foreign Components for more details.
- A Project Summary/Abstract must be included. There is a limit of 30 lines of text.
- A Project Narrative must be included. There is a limit of three sentences.
4. Project/Performance Site Location(s)
Follow all instructions in the SF424 (R&R) Application Guide .
5. R&R Senior/Key Person Profile Form
Follow all instructions in the SF424 (R&R) Application Guide , but only the PD/PI’s biosketch is allowed. Inclusion of other personnel or collaborator biosketches anywhere in the application will result in your application being administratively withdrawn.
6. PHS 398 Modular Budget Form
Follow all instructions in the SF424 (R&R) Application Guide . Awards will be for up to $250,000 in direct costs per year, plus applicable Facilities and Administrative (F&A) costs.
7. PHS 398 Research Plan Form
Follow all instructions in the SF424 (R&R) Application Guide with additional instructions in the funding opportunity.
Specific Aims
The specific aims page has a one-page limit and must contain three sections with the following headings: "Research Objectives," "Institutional Support," and "Early Independence Rationale." These three sections should contain the information described below.
Research Objectives
- State your research topic and overall approach.
- Why is this area of research significant?
- If you have an overarching hypothesis, what is it?
- What impact will your research have if successful?
- What are the major conceptual or technical innovations your are introducing into this research area?
Institutional Support
How will the institutional support (including the assurance of research independence) help you accomplish your research objectives?
Early Independence Rationale
How will the institutional support (including the assurance of research independence) help you accomplish your research objectives?
Research Strategy
The Research Strategy essay must be organized by the ten headings listed below and effectively respond to the listed questions. The essay is the major component of the application. Your job is to convince the reviewers that (1) you are ready for independent research, (2) you have the resources and support needed to succeed, and (3) you have a significant research topic and innovative approach to addressing it. Make reviewers feel confident that you are ready and prepared to begin your independent research career and are a risk worth taking. The essay is limited to twelve pages. Remember to include your project's Science Area designations (1-digit code and abbreviation for the primary and optional secondary designations) at the top of your essay.
- Rationale for omitting or abbreviating the typical post-doctoral phase:
- Why would omitting or abbreviating the typical post-doctoral fellowship benefit your long-term scientific career?
- What is driving your desire to pursue an independent research career at an earlier than usual stage?
- Evidence of transition to an independent position:
- Provide evidence using all the characteristics described in Section III.1. Eligible Individuals (Program Director/Principal Investigator) that at the time of application submission, you do not have research independence.
- Describe any arrangements you may have made to assume an independent research position that would begin prior to award.
- Personal/career development plan:
- What particular strengths and weaknesses do you have for launching a productive independent research career?
- How would you use this award period to build on your strengths and address your weaknesses?
- How would receipt of this award accelerate your establishment of an independent research career (especially if you already have made an agreement for a functionally independent position)?
- What will your planned career path be if an Early Independence Award is not provided?
- Evidence of training ability and leadership:
- What activities have prepared you to lead a laboratory, train laboratory staff, and perhaps mentor students and post-doctoral fellows? (Note this information may reference but should not duplicate information submitted on the Biosketch.)
- Host institution interactions:
- What arrangements have you made with your host institution to provide you with the support and feedback necessary to establish your research program while maintaining your intellectual independence?
- How will you try to integrate yourself as an active member in your institution's scientific community?
- Research challenge:
- What is the scientific challenge that you wish to address in your research?
- What is the premise of the project, including strengths and weaknesses of prevailing theories?
- Why is this challenge significant to the biomedical/behavioral research community?
- What is the expected impact of your research on this challenge?
- Why did you choose this particular challenge to begin your independent research career?
- Approach:
- What is your experimental approach in addressing your research challenge? The description of the approach should convey that you have thought deeply about your project, identified the major potential pitfalls, and considered alternative approaches.
- Address relevant biological variables, such as sex, for studies in vertebrate animals or human subjects.
- Preliminary data are not required but may be included. If included, they will be evaluated in the review process. You may wish to indicate prominently that substantial preliminary data are not being provided per the guidance in the funding opportunity.
- Describe any collaborative elements of the research.
- Innovation:
- What are the particularly innovative aspects of your proposed research?
- Relationship to previous work:
- How is the proposed research related to your research as a student/trainee?
- How does the work differ?
- How will the work be accomplished independently from your previous mentors?
- Timeline:
- Affirm that you will be ready and able to conduct independent research by the project start date.
- What is the timeline for accomplishing intermediate steps in your award period? This should include steps in establishing a functioning laboratory, meeting career development objectives, as well as achieving your scientific objectives.
- State that you will commit at least 9.6 person-months of effort toward you Early Independence Award project each year in years 1-2. In years 3-5, you may reduce effort towards the Early Independence Award project but must commit at least 9.6 person-months towards general independent research each year.
Letters of Support
Collaborators and consultants should provide letters of support describing their commitment to the research project and their role in the research. Biosketches from collaborators and consultants are not allowed, and their inclusion anywhere in the application will result in your application being administratively withdrawn.
Other Plan(s)
All applicants planning research (funded or conducted in whole or in part by NIH) that results in the generation of scientific data are required to comply with the instructions for the Data Management and Sharing Plan . All applications, regardless of the amount of Direct Costs requested for any one year, must address a Data Management and Sharing Plan.
8. PHS Human Subjects and Clinical Trials Information
Follow all instructions in the SF424 (R&R) Application Guide .
9. PHS Assignment Request Form
Follow all instructions in the SF424 (R&R) Application Guide , but do not request an assignment to a particular review panel (integrated review group) or awarding component (NIH Institute or Center). All applications are automatically received as "Office of the Director" applications and reviewed by a single Special Emphasis Panel convened by the Center for Scientific Review.
List the names and affiliations of significant collaborators so the Scientific Review Officer knows who is in conflict with the application and should not review it. If you wish to exclude additional individuals from reviewing your application, list their names, institutional affiliations, and the reasons why they should not serve as reviewers. NIH will consider this request but is not obligated to accept it.
2. APPLICATION
Follow the Instructions
It is critical that applicants follow the Research Instructions in the SF424 (R&R) Application Guide except where instructed in the funding opportunity to do otherwise. When the funding opportunity provides instructions that differ from the SF424 (R&R) Application Guide, the instructions given in the funding opportunity take precedence and should be followed.
All attachments should be formatted according to NIH format standards .
Adherence to the application requirements is mandatory and strictly enforced. Applications that are out of compliance with these instructions may not be accepted for review.
The PD/PI (Program Director/Principal Investigator) mentioned in the instructions refers to the Early Independence Award candidate.
Required Forms
Refer to the funding opportunity and SF424 (R&R) Application Guide for complete instructions.
1. SF424 (R&R) Form
Follow all instructions in the SF424 (R&R) Application Guide .
Agency Routing Identifier
Enter Science Area Designations in the Agency Routing Identifier (in Field 4b). Using the list below, designate the most appropriate scientific area for the proposal. An optional secondary scientific area may also be designated.
1 CB - Chemical Biology
2 CTR - Clinical and Translational Research
3 IDI - Infectious Diseases and Immunology
4 IE - Instrumentation and Engineering
5 MCB - Molecular and Cellular Biology
6 NS - Neuroscience
7 HIB - High-Throughput and Integrative Biology
8 BCB - Bioinformatics and Computational Biology
For each area, enter the one-digit code and abbreviation (e.g., 1 BSS). If selecting two science areas, enter the primary area first followed by a semicolon, then add the secondary area (e.g., 1 BSS; 7 NS).
The areas of science listed above are very broad and frequently overlap. Choose the primary (and optional secondary) science area that is most appropriate for your proposed project. The scientific areas are used solely as an aid to assign panel reviewers, who are chosen for their breadth of knowledge and expertise and will be able to review a broad range of applications. Science area designations do not affect an application’s funding potential, and application requirements and instructions are identical for all science areas. All applications are reviewed in the same time period, with the same review criteria, and compete for a single source of dedicated funds.
Note: The science area designations (two one-digit codes with abbreviations) must also be included at the beginning of the Research Strategy essay.
2. PHS 398 Cover Page Supplement Form
Follow all instructions in the SF424 (R&R) Application Guide .
3. R&R Other Project Information Form
Follow all instructions in the SF424 (R&R) Application Guide with additional instructions outlined in the funding opportunity.
Facilities & Other Resources
The Facilities & Other Resources section is a critical component of the application and should be given due attention. Try to avoid boilerplate language that isn't tailored to the candidate or their needs. It may also be helpful to provide context for what resources and support are being offered. Are they standard for the institution or the field? Let reviewers know why what is being offered meets the candidate's needs and how it fits with other institutional hires and the field.
Applicant institution officials must address all the items listed in the funding opportunity for the Facilities & Other Resources section, including detailing the PD/PI’s independent research position, outlining institutional resources provided to the PD/PI, and describing the institution’s career development plan for the PD/PI. The commitment of institutional resources to the PD/PI is a major review consideration and should be suitably addressed in this section.
Responses must use the corresponding subheadings and numbering. There is no page limit.
Candidate Selection Process
Describe the process and criteria used to select the PD/PI.
Position Details
During the award period, the PD/PI must be scientifically and administratively independent. The appointment need not be permanent or tenure-track and may be contingent upon receipt of the Early Independence Award. Describe in detail the position to which the PD/PI will be appointed and how independence will be ensured during the award.
- What is the title of the position?
- Is the position permanent or tenure-track?
- Is the position contingent upon receipt of the Early Independence Award?
- Describe the position in detail.
- How will the PD/PI's independence be ensured during the award?
- Describe plans for maintaining protected time for the PD/PI so that they can commit at least 9.6 person-months of effort to the Early Independence Award project each year in years 1-2 of the project period. In years 3-5, the PD/PI may reduce their effort towards the Early Independence Award project but must commit at least 9.6 person-months towards general independent research each year. Clinicians should be permitted to perform clinical duties to the extent necessary to maintain credentials.
- Describe the organizational structure where the PD/PI's position will be administered (e.g., school, department, etc.).
- Explain how this administrative structure will best meet the goal of supporting the success of the PD/PI. Include details of responsibilities for integrating the PD/PI and their scientific project into the institutional culture and the faculty community.
- Describe PD/PI access to potential lab personnel, such as access to postdoctoral fellows, graduate students, undergraduates, or technicians.
- Describe management plans for potential problematic situations.
- Describe institutional expectations related to the retention or transfer of the PD/PI at the end of the funding period.
- Affirm that the PD/PI will be able to conduct independent research by the project start date.
- Affirm that the institution will initiate the PD/PI appointment into the independent research position by the project start date.
Institutional Resources Commitment
- If the candidate is not a U.S. citizen or permanent resident, the sponsoring institution must include information about the candidate's visa status and assurance that the candidate's visa provides sufficient time to complete the award at the U.S. institution.
- Describe details of the laboratory space to be provided to the PD/PI, including physical structure and space layout.
- Describe support staff and systems available to the PD/PI, including (but not limited to) human resources, supply and equipment ordering systems, and administrative assistance.
- Describe the institutional financial commitment to the PD/PI. Matching funds are not required; however, an appropriate level of institutional support is expected. Institutional commitment to the development of the PD/PI as a successful and independent research scientist will be given considerable attention during the review and selection process.
- If the PD/PI already has a commitment of funding for independent research (such as through another independent research program or institutional start-up funds), describe how the Early Independence Award will affect the other funding.
Institutional Career Development Commitment
- Describe plans for assuring scientific independence. If the PD/PI is staying at the same institution at which they trained, indicate how independence from degree/fellowship mentors will be established and maintained.
- Describe plans for integrating the PD/PI into scientific and administrative activities at the institution. Describe the scientific collaborative activities (e.g., attendance at faculty meetings, laboratory meetings, participation in institutional scientific retreats, etc.) and career development resources (e.g., courses in laboratory management and grant writing, etc.) that will be available to ensure the PD/PI is successful.
- Describe the mentoring structure and include membership, meeting frequency, and meeting format. Though the PD/PI must be scientifically independent, it is important that senior colleagues are available as resources and periodically meet with the PD/PI.
- The primary goal for the PD/PI is to establish an independent scientific research program. However, if the PD/PI has an interest in (limited) teaching, describe what opportunities will be available.
- Describe expectations and opportunities for the PD/PI to establish a record of independent funding from sources other than the Early Independence Award.
Other Tips
- For more help on human subjects, visit the NIH Grants & Funding website .
- Foreign components are defined as the performance of any significant scientific element or segment of a project outside of the United States, either by the recipient or by a researcher employed by a foreign organization, whether or not grant funds are expended. It is crucial that you disclose all foreign components, which include foreign collaborations that will result in co-authorship. See the definition of Foreign Components for more details.
- A Project Summary/Abstract must be included. There is a limit of 30 lines of text.
- A Project Narrative must be included. There is a limit of three sentences.
4. Project/Performance Site Location(s)
Follow all instructions in the SF424 (R&R) Application Guide .
5. R&R Senior/Key Person Profile Form
Follow all instructions in the SF424 (R&R) Application Guide , but only the PD/PI’s biosketch is allowed. Inclusion of other personnel or collaborator biosketches anywhere in the application will result in your application being administratively withdrawn.
6. PHS 398 Modular Budget Form
Follow all instructions in the SF424 (R&R) Application Guide . Awards will be for up to $250,000 in direct costs per year, plus applicable Facilities and Administrative (F&A) costs.
7. PHS 398 Research Plan Form
Follow all instructions in the SF424 (R&R) Application Guide with additional instructions in the funding opportunity.
Specific Aims
The specific aims page has a one-page limit and must contain three sections with the following headings: "Research Objectives," "Institutional Support," and "Early Independence Rationale." These three sections should contain the information described below.
Research Objectives
- State your research topic and overall approach.
- Why is this area of research significant?
- If you have an overarching hypothesis, what is it?
- What impact will your research have if successful?
- What are the major conceptual or technical innovations your are introducing into this research area?
Institutional Support
How will the institutional support (including the assurance of research independence) help you accomplish your research objectives?
Early Independence Rationale
How will the institutional support (including the assurance of research independence) help you accomplish your research objectives?
Research Strategy
The Research Strategy essay must be organized by the ten headings listed below and effectively respond to the listed questions. The essay is the major component of the application. Your job is to convince the reviewers that (1) you are ready for independent research, (2) you have the resources and support needed to succeed, and (3) you have a significant research topic and innovative approach to addressing it. Make reviewers feel confident that you are ready and prepared to begin your independent research career and are a risk worth taking. The essay is limited to twelve pages. Remember to include your project's Science Area designations (1-digit code and abbreviation for the primary and optional secondary designations) at the top of your essay.
- Rationale for omitting or abbreviating the typical post-doctoral phase:
- Why would omitting or abbreviating the typical post-doctoral fellowship benefit your long-term scientific career?
- What is driving your desire to pursue an independent research career at an earlier than usual stage?
- Evidence of transition to an independent position:
- Provide evidence using all the characteristics described in Section III.1. Eligible Individuals (Program Director/Principal Investigator) that at the time of application submission, you do not have research independence.
- Describe any arrangements you may have made to assume an independent research position that would begin prior to award.
- Personal/career development plan:
- What particular strengths and weaknesses do you have for launching a productive independent research career?
- How would you use this award period to build on your strengths and address your weaknesses?
- How would receipt of this award accelerate your establishment of an independent research career (especially if you already have made an agreement for a functionally independent position)?
- What will your planned career path be if an Early Independence Award is not provided?
- Evidence of training ability and leadership:
- What activities have prepared you to lead a laboratory, train laboratory staff, and perhaps mentor students and post-doctoral fellows? (Note this information may reference but should not duplicate information submitted on the Biosketch.)
- Host institution interactions:
- What arrangements have you made with your host institution to provide you with the support and feedback necessary to establish your research program while maintaining your intellectual independence?
- How will you try to integrate yourself as an active member in your institution's scientific community?
- Research challenge:
- What is the scientific challenge that you wish to address in your research?
- What is the premise of the project, including strengths and weaknesses of prevailing theories?
- Why is this challenge significant to the biomedical/behavioral research community?
- What is the expected impact of your research on this challenge?
- Why did you choose this particular challenge to begin your independent research career?
- Approach:
- What is your experimental approach in addressing your research challenge? The description of the approach should convey that you have thought deeply about your project, identified the major potential pitfalls, and considered alternative approaches.
- Address relevant biological variables, such as sex, for studies in vertebrate animals or human subjects.
- Preliminary data are not required but may be included. If included, they will be evaluated in the review process. You may wish to indicate prominently that substantial preliminary data are not being provided per the guidance in the funding opportunity.
- Describe any collaborative elements of the research.
- Innovation:
- What are the particularly innovative aspects of your proposed research?
- Relationship to previous work:
- How is the proposed research related to your research as a student/trainee?
- How does the work differ?
- How will the work be accomplished independently from your previous mentors?
- Timeline:
- Affirm that you will be ready and able to conduct independent research by the project start date.
- What is the timeline for accomplishing intermediate steps in your award period? This should include steps in establishing a functioning laboratory, meeting career development objectives, as well as achieving your scientific objectives.
- State that you will commit at least 9.6 person-months of effort toward you Early Independence Award project each year in years 1-2. In years 3-5, you may reduce effort towards the Early Independence Award project but must commit at least 9.6 person-months towards general independent research each year.
Letters of Support
Collaborators and consultants should provide letters of support describing their commitment to the research project and their role in the research. Biosketches from collaborators and consultants are not allowed, and their inclusion anywhere in the application will result in your application being administratively withdrawn.
Other Plan(s)
All applicants planning research (funded or conducted in whole or in part by NIH) that results in the generation of scientific data are required to comply with the instructions for the Data Management and Sharing Plan . All applications, regardless of the amount of Direct Costs requested for any one year, must address a Data Management and Sharing Plan.
8. PHS Human Subjects and Clinical Trials Information
Follow all instructions in the SF424 (R&R) Application Guide .
9. PHS Assignment Request Form
Follow all instructions in the SF424 (R&R) Application Guide , but do not request an assignment to a particular review panel (integrated review group) or awarding component (NIH Institute or Center). All applications are automatically received as "Office of the Director" applications and reviewed by a single Special Emphasis Panel convened by the Center for Scientific Review.
List the names and affiliations of significant collaborators so the Scientific Review Officer knows who is in conflict with the application and should not review it. If you wish to exclude additional individuals from reviewing your application, list their names, institutional affiliations, and the reasons why they should not serve as reviewers. NIH will consider this request but is not obligated to accept it.
3. LETTERS OF REFERENCE
Letters of reference are an important element of the Early Independence Award application. Applicants must arrange to have at least three and no more than five letters of reference submitted on their behalf.
Applications that are missing letters of reference will be considered incomplete and will not be reviewed. Late letters will not be accepted. Applicants are responsible for monitoring the submission of letters to ensure that at least three letters have been submitted prior to the submission deadline. Applicants are encouraged to check the status of their letters in their eRA Commons account.
Letters of Reference Vs. Letters of Support
Letters of reference differ from letters of support. Letters of reference are typically from scientists or others who know the applicant well and are qualified to evaluate the merit of the project proposal and the applicant’s qualifications to fulfill the proposed project.
Letters of support typically come from outside individuals or organizations whose cooperation, assistance, or guidance is needed to successfully complete a project. The letter of support affirms the person or entity’s commitment to assist in the project.
Both letters of support and letters of recommendation are needed for the Early Independence Award application. Letters of support are attached to the application by the candidate, but letters of reference are submitted to NIH directly by the referee and are never seen by the candidate.
Referee Selection
It is best to select referees who can speak to your scientific expertise, leadership experience, and management skills and address how you are qualified to conduct successful independent research. It may not be best to choose referees based primarily on their official position, such as your departmental chair or institutional dean.
Instructions
For Applicants
- Arrange to have at least three and no more than five letters.
- Letters must be submitted by 5:00 P.M. (local time of referee) on the application due date (late letters will not be accepted).
- Letters must be submitted electronically through eRA Commons (paper copies will not be accepted). Note: The referee does not need an eRA Commons account to submit a reference letter for an applicant, but the applicant must have a valid eRA Commons account.
- Provide the referee with the following information:
- Your eRA Commons user ID
- Your last name as is listed in eRA Commons
- Funding opportunity number (e.g., RFA-RM-24-005)
- URL to the eRA Commons:
https://public.era.nih.gov/commonsplus/public/reference/submitReferenceLetter.era - URL to eRA help on submitting reference letters:
https://www.era.nih.gov/erahelp/commons/Commons/Ref_Ltr.htm
- You will not have access to the letters.
- An email confirmation will be sent to you when a letter is submitted.
- Check the status of your letters on eRA Commons periodically, and remind referees to submit their letters on time.
For Referees
- Letter must be submitted by 5:00 P.M. (local time of referee) on the application due date (late letters will not be accepted).
- Letter must be submitted electronically through eRA Commons (paper copies will not be accepted). Note: The referee does not need an eRA Commons account to submit a reference letter for an applicant, but the applicant must have a valid eRA Commons account.
- Letter must include the following information:
- PD/PI's name on top of letter
- Signature block with your full name, title, institution, and contact information
- In two pages or less, describe the PD/PI's qualities that support the PD/PI's claim to possess the scientific, leadership, mentorship, and management skills necessary to conduct successful, completely independent research. When possible, give specific examples that illustrate these qualities.
Submit letter through eRA Commons (you do not need to be registered or logged on to eRA Commons to submit a letter).
- Provide your first and last name, email address, institution/affiliation, and department.
- You will need the applicant's eRA Commons user name, applicant's last name, funding opportunity number (e.g., RFA-RM-24-005), and confirmation number (if submitting a revised Letter).
- An email confirmation will be sent to you when the letter is submitted.
3. LETTERS OF REFERENCE
Letters of reference are an important element of the Early Independence Award application. Applicants must arrange to have at least three and no more than five letters of reference submitted on their behalf.
Applications that are missing letters of reference will be considered incomplete and will not be reviewed. Late letters will not be accepted. Applicants are responsible for monitoring the submission of letters to ensure that at least three letters have been submitted prior to the submission deadline. Applicants are encouraged to check the status of their letters in their eRA Commons account.
Letters of Reference Vs. Letters of Support
Letters of reference differ from letters of support. Letters of reference are typically from scientists or others who know the applicant well and are qualified to evaluate the merit of the project proposal and the applicant’s qualifications to fulfill the proposed project.
Letters of support typically come from outside individuals or organizations whose cooperation, assistance, or guidance is needed to successfully complete a project. The letter of support affirms the person or entity’s commitment to assist in the project.
Both letters of support and letters of recommendation are needed for the Early Independence Award application. Letters of support are attached to the application by the candidate, but letters of reference are submitted to NIH directly by the referee and are never seen by the candidate.
Referee Selection
It is best to select referees who can speak to your scientific expertise, leadership experience, and management skills and address how you are qualified to conduct successful independent research. It may not be best to choose referees based primarily on their official position, such as your departmental chair or institutional dean.
Instructions
For Applicants
- Arrange to have at least three and no more than five letters.
- Letters must be submitted by 5:00 P.M. (local time of referee) on the application due date (late letters will not be accepted).
- Letters must be submitted electronically through eRA Commons (paper copies will not be accepted). Note: The referee does not need an eRA Commons account to submit a reference letter for an applicant, but the applicant must have a valid eRA Commons account.
- Provide the referee with the following information:
- Your eRA Commons user ID
- Your last name as is listed in eRA Commons
- Funding opportunity number (e.g., RFA-RM-24-005)
- URL to the eRA Commons:
https://public.era.nih.gov/commonsplus/public/reference/submitReferenceLetter.era - URL to eRA help on submitting reference letters:
https://www.era.nih.gov/erahelp/commons/Commons/Ref_Ltr.htm
- You will not have access to the letters.
- An email confirmation will be sent to you when a letter is submitted.
- Check the status of your letters on eRA Commons periodically, and remind referees to submit their letters on time.
For Referees
- Letter must be submitted by 5:00 P.M. (local time of referee) on the application due date (late letters will not be accepted).
- Letter must be submitted electronically through eRA Commons (paper copies will not be accepted). Note: The referee does not need an eRA Commons account to submit a reference letter for an applicant, but the applicant must have a valid eRA Commons account.
- Letter must include the following information:
- PD/PI's name on top of letter
- Signature block with your full name, title, institution, and contact information
- In two pages or less, describe the PD/PI's qualities that support the PD/PI's claim to possess the scientific, leadership, mentorship, and management skills necessary to conduct successful, completely independent research. When possible, give specific examples that illustrate these qualities.
Submit letter through eRA Commons (you do not need to be registered or logged on to eRA Commons to submit a letter).
- Provide your first and last name, email address, institution/affiliation, and department.
- You will need the applicant's eRA Commons user name, applicant's last name, funding opportunity number (e.g., RFA-RM-24-005), and confirmation number (if submitting a revised Letter).
- An email confirmation will be sent to you when the letter is submitted.
4. APPLICATION SUBMISSION
NIH expects that applications be submitted on time, which means the application is submitted error free no later than 5:00 PM local (applicant institution) time on the application due date. There is no deadline extension to correct for errors in the application, so all errors must be corrected by the submission deadline.
Institutions often have their own internal deadlines, so be sure to check when your institution needs your application.
About Submitting
Electronic submission of your application is required. Your institution may submit using the NIH Application Submission System and Interface for Submission Tracking (ASSIST) , Grants.gov Workspace , or an institutional system-to-system. If your institution uses a proprietary application system, keep in mind that the system may have its own forms, layouts, or special fields.
Regardless of the application method, all applications pass through Grants.gov for a timestamp and validation checks. To be on time, Grants.gov must successfully timestamp your application by 5:00 PM of your institution's local time on the receipt date listed in the funding opportunity.
Submitting your application may not be straightforward, so be sure to learn more about the process and work with your institution’s business office. If you encounter any problems, contact the NIH Service Desk immediately. They will document the date and time you contacted them, which is helpful in case there are delays in resolving the issue and there are downstream effects.
For technical support and information, use the following links:
- Avoiding Common Errors
- Annotated SF424 Grant Application Forms for field-by-field tips on avoiding common application mistakes
- eRA Training
- NIH Service Desk
- Grants.gov Support
Late Applications
As stated in the funding opportunity, late applications will not be accepted.
4. APPLICATION SUBMISSION
NIH expects that applications be submitted on time, which means the application is submitted error free no later than 5:00 PM local (applicant institution) time on the application due date. There is no deadline extension to correct for errors in the application, so all errors must be corrected by the submission deadline.
Institutions often have their own internal deadlines, so be sure to check when your institution needs your application.
About Submitting
Electronic submission of your application is required. Your institution may submit using the NIH Application Submission System and Interface for Submission Tracking (ASSIST) , Grants.gov Workspace , or an institutional system-to-system. If your institution uses a proprietary application system, keep in mind that the system may have its own forms, layouts, or special fields.
Regardless of the application method, all applications pass through Grants.gov for a timestamp and validation checks. To be on time, Grants.gov must successfully timestamp your application by 5:00 PM of your institution's local time on the receipt date listed in the funding opportunity.
Submitting your application may not be straightforward, so be sure to learn more about the process and work with your institution’s business office. If you encounter any problems, contact the NIH Service Desk immediately. They will document the date and time you contacted them, which is helpful in case there are delays in resolving the issue and there are downstream effects.
For technical support and information, use the following links:
- Avoiding Common Errors
- Annotated SF424 Grant Application Forms for field-by-field tips on avoiding common application mistakes
- eRA Training
- NIH Service Desk
- Grants.gov Support
Late Applications
As stated in the funding opportunity, late applications will not be accepted.
Sample Applications
Always follow the funding opportunity and SF424 Application Guide's instructions for application format. Time has passed since these grantees applied, and the samples may not reflect the latest format or instructions.
The text of these applications is copyrighted. You may use it only for nonprofit educational purposes provided the document remains unchanged and the PI, the grantee organization, and NIH are credited.
Note on Section 508 Conformance and Accessibility: We have reformatted these samples to improve accessibility for people with disabilities and users of assistive technology. If you have trouble accessing the content, please contact NIH staff at EarlyIndependence@od.nih.gov .
| Competition Year | PI Name | Institution Name | Title |
|---|---|---|---|
| 2020 | BAXTER, SALLY LIU | UNIVERSITY OF CALIFORNIA, SAN DIEGO | |
| 2019 | SCHLEIDER, JESSICA LEE | STATE UNIVERSITY NEW YORK STONY BROOK | Harnessing Network Science to Personalize Scalable Interventions for Adolescent Depression |
Thank you to the PIs and institutions for allowing us to post their Early Independence Award applications. We appreciate their assistance and willingness to share.
After Submission
There's still more to do after you push the submit button. Learn more about what happens after your application is submitted, including information on:
POST-SUBMISSION MATERIALS
Post-submission materials are those submitted after submission of the grant application but prior to initial peer review. They are not intended to correct oversights or errors discovered after submission of the application, but rather allow applicants the opportunity to respond to unforeseen events. See NOT-OD-19-083 for more details.
Deadlines
Post-submission materials must be received by the Scientific Review Officer (SRO) no later than 30 calendar days prior to the peer review meeting. Post-submission materials will not be accepted after this time.
Authorized Organization Representative Concurrence
Post-submission materials require concurrence from the Authorized Organization Representative (AOR) of the applicant organization. Although the post-submission materials may originate from the PD/PI, the AOR must send the materials directly to the SRO or must send their concurrence to the PD/PI who will forward the materials and concurrence to the SRO. A communication from the PD/PI only or with a "cc" to the AOR will not be accepted.
Format Instructions
All post-submission materials (other than citations and videos) must conform to NIH policies on font size, margins, and paper size as referenced in the application instructions. Any specified formats and page limits in the application instructions apply.
Post-submission materials (other than citations and videos) can only be submitted as a PDF attachment. The SRO is responsible for uploading acceptable materials into the official electronic grant file maintained in the eRA Commons. The PD/PI can check his/her application via the Commons to see these materials in the section titled "Additions for Review". This procedure provides the information to reviewers in a secure manner.
Some Allowable Post-Submission Materials
- Citations of Issued Patents
- Adjustments resulting from natural disasters (e.g., loss of an animal colony)
- Adjustments resulting from change of institution [e.g., Program Director/Principal Investigator (PD/PI) moves to another university]
- News of professional promotion or positive tenure decision for any PD/PI
- Approval by the NIH Stem Cell Registry of a human embryonic cell line(s) after submission of the application
- Videos, within defined limits, that demonstrate devices and experimental data with a temporal element, which refers to the need to show how something functions or occurs over time, or demonstrates movement or change. Applicants must follow the directions in NOT-OD-12-141 for submitting videos to accompany grant applications.
- News of an article accepted for publication since submission of the application, which must include only:
- List of authors and institutional affiliations
- Title of the article
- Journal or citation (if available)
POST-SUBMISSION MATERIALS
Post-submission materials are those submitted after submission of the grant application but prior to initial peer review. They are not intended to correct oversights or errors discovered after submission of the application, but rather allow applicants the opportunity to respond to unforeseen events. See NOT-OD-19-083 for more details.
Deadlines
Post-submission materials must be received by the Scientific Review Officer (SRO) no later than 30 calendar days prior to the peer review meeting. Post-submission materials will not be accepted after this time.
Authorized Organization Representative Concurrence
Post-submission materials require concurrence from the Authorized Organization Representative (AOR) of the applicant organization. Although the post-submission materials may originate from the PD/PI, the AOR must send the materials directly to the SRO or must send their concurrence to the PD/PI who will forward the materials and concurrence to the SRO. A communication from the PD/PI only or with a "cc" to the AOR will not be accepted.
Format Instructions
All post-submission materials (other than citations and videos) must conform to NIH policies on font size, margins, and paper size as referenced in the application instructions. Any specified formats and page limits in the application instructions apply.
Post-submission materials (other than citations and videos) can only be submitted as a PDF attachment. The SRO is responsible for uploading acceptable materials into the official electronic grant file maintained in the eRA Commons. The PD/PI can check his/her application via the Commons to see these materials in the section titled "Additions for Review". This procedure provides the information to reviewers in a secure manner.
Some Allowable Post-Submission Materials
- Citations of Issued Patents
- Adjustments resulting from natural disasters (e.g., loss of an animal colony)
- Adjustments resulting from change of institution [e.g., Program Director/Principal Investigator (PD/PI) moves to another university]
- News of professional promotion or positive tenure decision for any PD/PI
- Approval by the NIH Stem Cell Registry of a human embryonic cell line(s) after submission of the application
- Videos, within defined limits, that demonstrate devices and experimental data with a temporal element, which refers to the need to show how something functions or occurs over time, or demonstrates movement or change. Applicants must follow the directions in NOT-OD-12-141 for submitting videos to accompany grant applications.
- News of an article accepted for publication since submission of the application, which must include only:
- List of authors and institutional affiliations
- Title of the article
- Journal or citation (if available)
REVIEW PROCESS
NIH seeks the highest level of ethical standards for peer review. NIH policy is intended to promote a bias-free process that evaluates grant applications in a fair, equitable, and timely manner. Peer review is conducted at two levels as mandated by statute and federal regulation. All review criteria and considerations are specified in the funding opportunity.
The first level of review for the Early Independence Award is conducted in two phases in a Special Emphasis Panel convened to review all Early Independence Award applications. The process is overseen by a Scientific Review Officer (SRO) from the NIH Center for Scientific Review (CSR). All applications are automatically sent to the Special Emphasis Panel, and panel members change from year to year.
The second level of review is performed by the NIH Office of the Director’s national advisory council called the Council of Councils . The council is composed of both scientific and public representatives chosen for their expertise, interest, or activity in matters related to health and disease. Applications must receive approval at both levels of review to be eligible for funding.
Below is a diagram of the Early Independence Award review process. Each aspect is discussed in more detail below.
Role of the Scientific Review Officer
The Scientific Review Officer (SRO) is responsible for ensuring that each application receives an objective and fair initial peer review, and that all applicable laws, regulations, and policies are followed. The duties of the SRO include:
- Analyzing the content of each application and checking for completeness
- Documenting and managing conflicts of interest
- Recruiting qualified reviewers based on scientific and technical qualifications and other considerations, including
- Authority in their scientific field
- Dedication to high quality, fair, and objective reviews
- Ability to work collegially in a group setting
- Experience in research grant review
- Balanced representation
- Assigning applications to reviewers for critique preparation and assignment of individual criterion scores
- Attending and overseeing administrative and regulatory aspects of peer review meetings
- Preparing summary statements for all applications reviewed
The SRO is the point of contact for all review-related questions and issues, including post-submission materials.
First Level of Review
The Early Independence Award differs from traditional NIH reviews in that the first level of review occurs in two phases by two separate groups of reviewers with different perspectives. Applications are reviewed by topic experts ("mail" reviewers) in Phase I and by a broad thinking editorial panel in Phase II.
The Early Independence Award is designed to accelerate the entry of promising newly-graduated investigators into positions of independent research by providing support to individuals who have recently completed their terminal doctoral degree or post-graduate clinical training and are ready to skip the traditional post-doctoral training period. Accordingly, the review emphases will be on the qualities of the investigator and on the environment provided by the host institution.
All standard NIH review criteria are used to evaluate applications (some are listed below), but emphases will be on the qualities of the investigator and on the environment provided by the host institution.
- Significance of the problem
- Qualifications of the investigator
- Innovation of the approach
- Strength of the approach
- Environmental support and resources
Full review criteria are listed in the funding opportunity.
Phase I
Phase I is conducted by topic experts (also called "mail" reviewers), who submit independent assessments electronically and do not discuss the applications with other reviewers. Phase I reviewers are assigned based on the application’s subject area (aided by the applicant's Science Area designations in the "Agency Routing Identifier" field) and are assigned based on close matching of their expertise to the application topic. Each application will have three assigned topic experts, who will provide comments and scores.
Phase II
Phase II is conducted by an editorial panel composed of scientists from an array of scientific backgrounds that captures a wide breadth of scientific expertise, experiences, and perspectives. Each application is assigned to three panel members and is not matched to the panelist member’s area of expertise. Panel members are tasked with reviewing the proposal from a broad viewpoint with the aid of the comments from the topic experts and identifying a subset of applications for panel discussion. Typically, half of applications are chosen for discussion. Panel members provide preliminary scores and lead a panel discussion of their assigned applications. Following the panel discussion, the applications are scored by the whole panel. The panel discussion is captured by the SRO and is summarized in the Summary Statement.
Scoring & Summary Statement
Each panel member privately scores each discussed application. A raw score of 1 is the best, while 9 is the worst. The SRO collects and averages all the panel scores and multiplies the resulting number by 10 to yield an overall impact score. A discussed application can have an overall impact score of 10 (best) to 90 (worst). The panel has access to the full range of scores to provide discrimination among applications within this select subset.
After the meeting, all discussed applications will receive an overall impact score within three business days through the PD/PI's eRA Commons account. The overall impact score indicates the reviewers' judgment of the qualifications of the investigator, the institutional support, and the innovativeness of the approach. There is a correlation between a strong impact score and funding, but there is no strict cutoff or pay line for funding. And because applications are responding to a Request for Applications (RFA), the scores are not percentiled, which makes their interpretation difficult. NIH staff cannot disclose where an impact score falls relative to other application scores.
A Summary Statement prepared by the SRO will be available within 30 days of the review through the PD/PI's eRA Commons account. The Summary Statement of discussed applications includes critiques from the assigned editorial panel members and a brief summary of the panel discussion. Applications that are considered "not discussed" are given a Summary Statement with critiques form the topic expert reviewers but no comments from the editorial panel. The information provided in the Summary Statement is valuable and provides critical feedback. However, it is not intended to be an exhaustive critique and will not contain every point reviewers found to be problematic.
After Receiving the Summary Statement
If you have any questions about your Summary Statement, you should reach out to the scientific contact for the Early Independence Award (listed in the funding opportunity). The scientific contact attends the review and may be able to provide more insight into the panel discussion and help clarify some of the comments. You can also ask about the probability of funding and get advice on what to do if your application is outside of the likely pay range. Contacting NIH staff to “sell” your application or to express differences in scientific opinion related to the reviewers’ comments will not affect the likelihood of funding.
It is best to contact NIH staff by email to schedule a time for a phone call. That gives staff time to read your Summary Statement and review any notes. And be patient. They receive numerous inquiries and may not be able to respond to yours immediately.
PD/PIs of discussed applications are given an opportunity to submit an optional two-page response to their Summary Statement. The response should address issues and concerns brought up by reviewers and reinforce the strengths of the application. The response will not be seen by reviewers and is not a part of the review. The response remains an internal NIH document used only by NIH staff during funding deliberations. The scientific contact will reach out to eligible applicants directly with more information on the response and the deadline.
Second Level of Review
The Council of Councils performs the second level of review for the Early Independence Award and assesses the first level of review for fairness and uniformity in the application of review criteria. It is meant to ensure the initial review was conducted with the appropriate expertise, procedures, and without conflicts of interest. The Council of Councils is not tasked with reviewing the applications for scientific or technical merit and is not asked to provide recommendations on which particular applications should be funded. The Council of Councils votes en bloc for concurrence with the first level review recommendations. Applications must receive approval from the council to be eligible for funding.
REVIEW PROCESS
NIH seeks the highest level of ethical standards for peer review. NIH policy is intended to promote a bias-free process that evaluates grant applications in a fair, equitable, and timely manner. Peer review is conducted at two levels as mandated by statute and federal regulation. All review criteria and considerations are specified in the funding opportunity.
The first level of review for the Early Independence Award is conducted in two phases in a Special Emphasis Panel convened to review all Early Independence Award applications. The process is overseen by a Scientific Review Officer (SRO) from the NIH Center for Scientific Review (CSR). All applications are automatically sent to the Special Emphasis Panel, and panel members change from year to year.
The second level of review is performed by the NIH Office of the Director’s national advisory council called the Council of Councils . The council is composed of both scientific and public representatives chosen for their expertise, interest, or activity in matters related to health and disease. Applications must receive approval at both levels of review to be eligible for funding.
Below is a diagram of the Early Independence Award review process. Each aspect is discussed in more detail below.
Role of the Scientific Review Officer
The Scientific Review Officer (SRO) is responsible for ensuring that each application receives an objective and fair initial peer review, and that all applicable laws, regulations, and policies are followed. The duties of the SRO include:
- Analyzing the content of each application and checking for completeness
- Documenting and managing conflicts of interest
- Recruiting qualified reviewers based on scientific and technical qualifications and other considerations, including
- Authority in their scientific field
- Dedication to high quality, fair, and objective reviews
- Ability to work collegially in a group setting
- Experience in research grant review
- Balanced representation
- Assigning applications to reviewers for critique preparation and assignment of individual criterion scores
- Attending and overseeing administrative and regulatory aspects of peer review meetings
- Preparing summary statements for all applications reviewed
The SRO is the point of contact for all review-related questions and issues, including post-submission materials.
First Level of Review
The Early Independence Award differs from traditional NIH reviews in that the first level of review occurs in two phases by two separate groups of reviewers with different perspectives. Applications are reviewed by topic experts ("mail" reviewers) in Phase I and by a broad thinking editorial panel in Phase II.
The Early Independence Award is designed to accelerate the entry of promising newly-graduated investigators into positions of independent research by providing support to individuals who have recently completed their terminal doctoral degree or post-graduate clinical training and are ready to skip the traditional post-doctoral training period. Accordingly, the review emphases will be on the qualities of the investigator and on the environment provided by the host institution.
All standard NIH review criteria are used to evaluate applications (some are listed below), but emphases will be on the qualities of the investigator and on the environment provided by the host institution.
- Significance of the problem
- Qualifications of the investigator
- Innovation of the approach
- Strength of the approach
- Environmental support and resources
Full review criteria are listed in the funding opportunity.
Phase I
Phase I is conducted by topic experts (also called "mail" reviewers), who submit independent assessments electronically and do not discuss the applications with other reviewers. Phase I reviewers are assigned based on the application’s subject area (aided by the applicant's Science Area designations in the "Agency Routing Identifier" field) and are assigned based on close matching of their expertise to the application topic. Each application will have three assigned topic experts, who will provide comments and scores.
Phase II
Phase II is conducted by an editorial panel composed of scientists from an array of scientific backgrounds that captures a wide breadth of scientific expertise, experiences, and perspectives. Each application is assigned to three panel members and is not matched to the panelist member’s area of expertise. Panel members are tasked with reviewing the proposal from a broad viewpoint with the aid of the comments from the topic experts and identifying a subset of applications for panel discussion. Typically, half of applications are chosen for discussion. Panel members provide preliminary scores and lead a panel discussion of their assigned applications. Following the panel discussion, the applications are scored by the whole panel. The panel discussion is captured by the SRO and is summarized in the Summary Statement.
Scoring & Summary Statement
Each panel member privately scores each discussed application. A raw score of 1 is the best, while 9 is the worst. The SRO collects and averages all the panel scores and multiplies the resulting number by 10 to yield an overall impact score. A discussed application can have an overall impact score of 10 (best) to 90 (worst). The panel has access to the full range of scores to provide discrimination among applications within this select subset.
After the meeting, all discussed applications will receive an overall impact score within three business days through the PD/PI's eRA Commons account. The overall impact score indicates the reviewers' judgment of the qualifications of the investigator, the institutional support, and the innovativeness of the approach. There is a correlation between a strong impact score and funding, but there is no strict cutoff or pay line for funding. And because applications are responding to a Request for Applications (RFA), the scores are not percentiled, which makes their interpretation difficult. NIH staff cannot disclose where an impact score falls relative to other application scores.
A Summary Statement prepared by the SRO will be available within 30 days of the review through the PD/PI's eRA Commons account. The Summary Statement of discussed applications includes critiques from the assigned editorial panel members and a brief summary of the panel discussion. Applications that are considered "not discussed" are given a Summary Statement with critiques form the topic expert reviewers but no comments from the editorial panel. The information provided in the Summary Statement is valuable and provides critical feedback. However, it is not intended to be an exhaustive critique and will not contain every point reviewers found to be problematic.
After Receiving the Summary Statement
If you have any questions about your Summary Statement, you should reach out to the scientific contact for the Early Independence Award (listed in the funding opportunity). The scientific contact attends the review and may be able to provide more insight into the panel discussion and help clarify some of the comments. You can also ask about the probability of funding and get advice on what to do if your application is outside of the likely pay range. Contacting NIH staff to “sell” your application or to express differences in scientific opinion related to the reviewers’ comments will not affect the likelihood of funding.
It is best to contact NIH staff by email to schedule a time for a phone call. That gives staff time to read your Summary Statement and review any notes. And be patient. They receive numerous inquiries and may not be able to respond to yours immediately.
PD/PIs of discussed applications are given an opportunity to submit an optional two-page response to their Summary Statement. The response should address issues and concerns brought up by reviewers and reinforce the strengths of the application. The response will not be seen by reviewers and is not a part of the review. The response remains an internal NIH document used only by NIH staff during funding deliberations. The scientific contact will reach out to eligible applicants directly with more information on the response and the deadline.
Second Level of Review
The Council of Councils performs the second level of review for the Early Independence Award and assesses the first level of review for fairness and uniformity in the application of review criteria. It is meant to ensure the initial review was conducted with the appropriate expertise, procedures, and without conflicts of interest. The Council of Councils is not tasked with reviewing the applications for scientific or technical merit and is not asked to provide recommendations on which particular applications should be funded. The Council of Councils votes en bloc for concurrence with the first level review recommendations. Applications must receive approval from the council to be eligible for funding.
PRE-AWARD ACTIVITIES
Roles & Responsibilities
Timely and effective communication between the grantee and NIH staff is critical throughout pre-award, award, and post award processes. At this stage the following people will work closely together:
NIH Staff
- Grants Management Officer (GMO) : The GMO signs the Notice of Award (NoA) and is the NIH official who is responsible for the business management and other non-programmatic aspects of the award. GMOs ensure that laws, regulations, and administrative policies are followed. The GMO will be from the National Institute of Dental and Craniofacial Research (NIDCR), which provides grant management support for the Early Independence Award.
- Grants Management Specialist (GMS) : The GMS works with the GMO on the day-to-day management of the grant. The name and contact information of the GMS assigned to a particular grant appears on the NoA. The GMS will be from NIDCR, which provides grant management support for the Early Independence Award.
- Program Official (PO) : The PO is responsible for the programmatic, scientific, and/or technical aspects of assigned applications and grants. The PO coordinates with grants management on post-award administration.
Grantee Participants
- Authorized Organizational Representative (AOR) : The AOR, also known as Signing Official (SO) in the eRA Commons, is the designated representative of the grantee organization in matters related to the award and its administration. Their signature certifies that the applicant organization will comply and is accountable for all assurances and certifications referenced in the application. This individual's signature further certifies that the applicant organization will be accountable both for the appropriate use of funds awarded and for the performance of the grant-supported project or activities resulting from the application.
- Program Director/ Principal Investigator (PD/PI) : The PD/PI is the individual designated by the applicant organization to have the appropriate level of authority and responsibility to direct the project or program supported by the award. For the Early Independence Award, this individual is the award candidate. The PD/PI is responsible and accountable to the grantee organization for the proper conduct of the project or program, including the submission of all required reports.
The PD/PI is the core member of the grantee team responsible for ensuring compliance with the financial and administrative aspects of the award. The PD/PI works closely within the grantee organization to create and maintain necessary documentation, such as technical and administrative reports, preparing justifications, appropriately acknowledging federal support of research findings in publications, announcements, news programs, and other media, and ensuring compliance with other federal and organizational requirements.
NIH encourages the PD/PI to maintain contact with the NIH program officer with respect to the scientific aspects of the project and the grants management officer concerning the business and administrative aspects of the award.
Just-in-Time Request
Some important time-sensitive information isn’t included in your application. Instead, you prepare it separately and send it in before awarding in a process called Just-in-Time (JIT) .
After initial peer review, NIH sends an automatic email requesting JIT information for applications within a competitive funding range. The notification is NOT a Notice of Award, nor should it be construed as an indicator of possible award.
Requested JIT information includes:
- Other support
- Certification of Institutional Review Board (IRB) approval
- Certification of Institutional Animal Care and Use Committee (IACUC) approval
- Human subjects training certification for all key personnel
JIT information must be submitted for NIH review and evaluation prior to making an award. This information may be submitted via the Just-In-Time function within eRA Commons . If you have questions about the JIT process, contact the grants management specialist assigned to your grant.
Funding Deliberations
Following review of all applicable information, the NIH Office of the Director and the High-Risk, High-Reward Research program working group (composed of NIH staff from nearly every NIH institute and center) will determine whether an award will be made.
The score given to an application during the initial peer review process is an important factor and best indicator of likely funding but is not the sole factor used in making funding decisions. The following are considered in making funding decisions:
- Scientific and technical merit of the proposed project as determined by scientific peer review with consideration of the PD/PI’s optional summary statement response
- Availability of funds
- Relevance of programmatic priorities, including:
- The potential for the investigator to lead groundbreaking and broadly impactful research, despite its inherent risks
- Unusually cross-cutting science
- Scientific balance in the portfolio of Early Independence Award-supported research
- Potential to invigorate exceptionally innovative and impactful science broadly across the nation
- Conformance to clinical trial research policies
The NIH Office of the Director funds the majority of awards. However, other NIH institutes and centers are invited to fund Early Independence Award applications that they deem meritorious and that fit within their mission and priorities. The NIH Office of the Director does not play a role in the funding deliberations of other institutes and centers, but the process is managed by the institute/center’s member of the High-Risk, High-Reward Research program working group.
Pre-Award Negotiation
The pre-award process involves significant communication between the NIH and the applicant organization and includes negotiation if significant adjustments are required prior to award. Some of the issues NIH staff will be considering during award negotiations include:
- Initial peer review recommendations: Peer reviewers may recommend changes to the Specific Aims. These recommendations are provided in the Summary Statement. Under these circumstances, NIH staff will include these recommendations in consideration of a potential award.
- Overlap: Program and grants management staff will review the other support information to ensure there is no overlap with already funded projects (e.g., support, commitment, or budgetary).
- Level of effort: Program and grants management staff will ensure sufficient levels of effort are committed to support the approved project.
- Facilities and Administrative (F&A) Costs: Grants management staff will utilize the negotiated F&A costs (also known as indirect costs) for each grant. More information on the reimbursement of F&A costs can be found in the NIH Grants Policy Statement .
Notice of Award
You may receive communications from NIH staff regarding the intent to make an award, but nothing is official until you receive the Notice of Award (NoA).
The NoA is the legal document issued to notify the grantee institution that an award has been made and that funds are now available for the project. The NoA includes the terms and conditions of the award, your project's start and end dates, and how much money you will receive for current and future years. It also provides contact information for the assigned program officer and grants management specialist. It is important that you read and understand your NoA.
NoAs are issued annually for each budget period and are contingent upon annual assessment of research progress and the availability of funds.
PRE-AWARD ACTIVITIES
Roles & Responsibilities
Timely and effective communication between the grantee and NIH staff is critical throughout pre-award, award, and post award processes. At this stage the following people will work closely together:
NIH Staff
- Grants Management Officer (GMO) : The GMO signs the Notice of Award (NoA) and is the NIH official who is responsible for the business management and other non-programmatic aspects of the award. GMOs ensure that laws, regulations, and administrative policies are followed. The GMO will be from the National Institute of Dental and Craniofacial Research (NIDCR), which provides grant management support for the Early Independence Award.
- Grants Management Specialist (GMS) : The GMS works with the GMO on the day-to-day management of the grant. The name and contact information of the GMS assigned to a particular grant appears on the NoA. The GMS will be from NIDCR, which provides grant management support for the Early Independence Award.
- Program Official (PO) : The PO is responsible for the programmatic, scientific, and/or technical aspects of assigned applications and grants. The PO coordinates with grants management on post-award administration.
Grantee Participants
- Authorized Organizational Representative (AOR) : The AOR, also known as Signing Official (SO) in the eRA Commons, is the designated representative of the grantee organization in matters related to the award and its administration. Their signature certifies that the applicant organization will comply and is accountable for all assurances and certifications referenced in the application. This individual's signature further certifies that the applicant organization will be accountable both for the appropriate use of funds awarded and for the performance of the grant-supported project or activities resulting from the application.
- Program Director/ Principal Investigator (PD/PI) : The PD/PI is the individual designated by the applicant organization to have the appropriate level of authority and responsibility to direct the project or program supported by the award. For the Early Independence Award, this individual is the award candidate. The PD/PI is responsible and accountable to the grantee organization for the proper conduct of the project or program, including the submission of all required reports.
The PD/PI is the core member of the grantee team responsible for ensuring compliance with the financial and administrative aspects of the award. The PD/PI works closely within the grantee organization to create and maintain necessary documentation, such as technical and administrative reports, preparing justifications, appropriately acknowledging federal support of research findings in publications, announcements, news programs, and other media, and ensuring compliance with other federal and organizational requirements.
NIH encourages the PD/PI to maintain contact with the NIH program officer with respect to the scientific aspects of the project and the grants management officer concerning the business and administrative aspects of the award.
Just-in-Time Request
Some important time-sensitive information isn’t included in your application. Instead, you prepare it separately and send it in before awarding in a process called Just-in-Time (JIT) .
After initial peer review, NIH sends an automatic email requesting JIT information for applications within a competitive funding range. The notification is NOT a Notice of Award, nor should it be construed as an indicator of possible award.
Requested JIT information includes:
- Other support
- Certification of Institutional Review Board (IRB) approval
- Certification of Institutional Animal Care and Use Committee (IACUC) approval
- Human subjects training certification for all key personnel
JIT information must be submitted for NIH review and evaluation prior to making an award. This information may be submitted via the Just-In-Time function within eRA Commons . If you have questions about the JIT process, contact the grants management specialist assigned to your grant.
Funding Deliberations
Following review of all applicable information, the NIH Office of the Director and the High-Risk, High-Reward Research program working group (composed of NIH staff from nearly every NIH institute and center) will determine whether an award will be made.
The score given to an application during the initial peer review process is an important factor and best indicator of likely funding but is not the sole factor used in making funding decisions. The following are considered in making funding decisions:
- Scientific and technical merit of the proposed project as determined by scientific peer review with consideration of the PD/PI’s optional summary statement response
- Availability of funds
- Relevance of programmatic priorities, including:
- The potential for the investigator to lead groundbreaking and broadly impactful research, despite its inherent risks
- Unusually cross-cutting science
- Scientific balance in the portfolio of Early Independence Award-supported research
- Potential to invigorate exceptionally innovative and impactful science broadly across the nation
- Conformance to clinical trial research policies
The NIH Office of the Director funds the majority of awards. However, other NIH institutes and centers are invited to fund Early Independence Award applications that they deem meritorious and that fit within their mission and priorities. The NIH Office of the Director does not play a role in the funding deliberations of other institutes and centers, but the process is managed by the institute/center’s member of the High-Risk, High-Reward Research program working group.
Pre-Award Negotiation
The pre-award process involves significant communication between the NIH and the applicant organization and includes negotiation if significant adjustments are required prior to award. Some of the issues NIH staff will be considering during award negotiations include:
- Initial peer review recommendations: Peer reviewers may recommend changes to the Specific Aims. These recommendations are provided in the Summary Statement. Under these circumstances, NIH staff will include these recommendations in consideration of a potential award.
- Overlap: Program and grants management staff will review the other support information to ensure there is no overlap with already funded projects (e.g., support, commitment, or budgetary).
- Level of effort: Program and grants management staff will ensure sufficient levels of effort are committed to support the approved project.
- Facilities and Administrative (F&A) Costs: Grants management staff will utilize the negotiated F&A costs (also known as indirect costs) for each grant. More information on the reimbursement of F&A costs can be found in the NIH Grants Policy Statement .
Notice of Award
You may receive communications from NIH staff regarding the intent to make an award, but nothing is official until you receive the Notice of Award (NoA).
The NoA is the legal document issued to notify the grantee institution that an award has been made and that funds are now available for the project. The NoA includes the terms and conditions of the award, your project's start and end dates, and how much money you will receive for current and future years. It also provides contact information for the assigned program officer and grants management specialist. It is important that you read and understand your NoA.
NoAs are issued annually for each budget period and are contingent upon annual assessment of research progress and the availability of funds.
Award Management
Learn what to expect after your application is selected for funding.
All applications are received as Office of the Director (OD) applications. The OD funds the majority of awards, but other NIH institutes and center are invited to fund applications that within their mission and they deem meritorious. Regardless of who funds the application, all Early Independence Awards remain in the OD with an OD Program Officer. However, the most scientifically relevant NIH institute or center (as determined by the High-Risk, High-Reward Research program working group) select an "affiliate" Program Officer from that institute or center to provide additional guidance for the awardee. Awardees are strongly encouraged to get to know their "affiliate" Program Officers. They have in-depth knowledge of the science being conducted and can:
- Provide advice on future research and funding strategies
- Help navigate NIH and institute/center administrative channels
- Provide career advice
"Affiliate" Program Officers are asked for their assessment on awardees' annual reports, invited to attend the awardee site visit, and encouraged to attend the annual High-Risk, High-Reward Research Symposium .
Administration
All applications are received as Office of the Director (OD) applications. The OD funds the majority of awards, but other NIH institutes and center are invited to fund applications that within their mission and they deem meritorious. Regardless of who funds the application, all Early Independence Awards remain in the OD with an OD Program Officer. However, the most scientifically relevant NIH institute or center (as determined by the High-Risk, High-Reward Research program working group) select an "affiliate" Program Officer from that institute or center to provide additional guidance for the awardee. Awardees are strongly encouraged to get to know their "affiliate" Program Officers. They have in-depth knowledge of the science being conducted and can:
- Provide advice on future research and funding strategies
- Help navigate NIH and institute/center administrative channels
- Provide career advice
"Affiliate" Program Officers are asked for their assessment on awardees' annual reports, invited to attend the awardee site visit, and encouraged to attend the annual High-Risk, High-Reward Research Symposium .
Notice of Award (NOA)
The Notice of Award (NoA) provides information on the project's start and end dates, terms and conditions of award, and how much money will be received for current and future years. A NoA is issued for every budget period of the award.
You can find the NoA in eRA Commons using the Status module or Notice of Award query. Note that grants management staff may issue a revised NoA to reflect any of the following changes:
- Increase or decrease of funds
- Lifting of a restriction
- Change in budget period
- Carryover or offset
Notice of Award (NOA)
The Notice of Award (NoA) provides information on the project's start and end dates, terms and conditions of award, and how much money will be received for current and future years. A NoA is issued for every budget period of the award.
You can find the NoA in eRA Commons using the Status module or Notice of Award query. Note that grants management staff may issue a revised NoA to reflect any of the following changes:
- Increase or decrease of funds
- Lifting of a restriction
- Change in budget period
- Carryover or offset
Research Performance Progress Report (RPPR)
NIH requires grantees to submit annual Research Performance Progress Reports (RPPR) through eRA Commons . The progress report must be approved by NIH to fund the next budget period. Late, incorrect, or incomplete progress reports will delay awards until all reporting elements are complete.
The RPPR asks grantees about accomplishments towards the goal of the project, plans for the next year of the project, manuscripts and publications produced, personnel who have worked on the project, changes to level of effort of key personnel on the project, actual or planned challenges or delays in the projects and plans for resolving them, significant changes regarding human or animal subjects, inclusion enrollment reports for clinical studies, and more.
The Program Officer reviews each progress report to determine whether funding for the project will continue, and the Grants Management Specialist evaluates the grant's administrative and fiscal status. Both must approve a progress report before an award can be issued.
Research Performance Progress Report (RPPR)
NIH requires grantees to submit annual Research Performance Progress Reports (RPPR) through eRA Commons . The progress report must be approved by NIH to fund the next budget period. Late, incorrect, or incomplete progress reports will delay awards until all reporting elements are complete.
The RPPR asks grantees about accomplishments towards the goal of the project, plans for the next year of the project, manuscripts and publications produced, personnel who have worked on the project, changes to level of effort of key personnel on the project, actual or planned challenges or delays in the projects and plans for resolving them, significant changes regarding human or animal subjects, inclusion enrollment reports for clinical studies, and more.
The Program Officer reviews each progress report to determine whether funding for the project will continue, and the Grants Management Specialist evaluates the grant's administrative and fiscal status. Both must approve a progress report before an award can be issued.
Project or Budget Changes
There may be times when adjustments are needed to your project or budget. Some of the adjustments can be made by the grantee without NIH approval due to “expanded authorities” laws, which gives greater autonomy and flexibility to grantees.
Without NIH approval, you can:
- Extend a project period for up to 12 months without additional funds (called a no-cost extension).
- Carry over unobligated balances from one budget period to the next.
- Transfer work to a third party through a consortium agreement, contract, or other means, as long as you retain a substantive role in the research.
- Make cost-related changes, including rebudgeting of funds, as long as the scope of the research remains the same.
- Spend money up to 90 days before the grant's start date with your institution's permission.
Actions that require NIH preapproval include:
- Taking an action that changes the scope of the approved research.
- Reducing PD/PI effort by 25 percent or more.
- Changing the grantee organization.
- Taking a second no-cost extension of a final budget period.
- Changing the award terms and conditions, or undertaking any activities disapproved or restricted as a term of award.
- Adding, removing, or transferring a foreign subaward or foreign site.
The request must be endorsed by your Authorized Organization Representative and sent to the Grants Management Specialist at least 30 days before your proposed change. Contact your Grants Management Specialist with questions on preapprovals.
Project or Budget Changes
There may be times when adjustments are needed to your project or budget. Some of the adjustments can be made by the grantee without NIH approval due to “expanded authorities” laws, which gives greater autonomy and flexibility to grantees.
Without NIH approval, you can:
- Extend a project period for up to 12 months without additional funds (called a no-cost extension).
- Carry over unobligated balances from one budget period to the next.
- Transfer work to a third party through a consortium agreement, contract, or other means, as long as you retain a substantive role in the research.
- Make cost-related changes, including rebudgeting of funds, as long as the scope of the research remains the same.
- Spend money up to 90 days before the grant's start date with your institution's permission.
Actions that require NIH preapproval include:
- Taking an action that changes the scope of the approved research.
- Reducing PD/PI effort by 25 percent or more.
- Changing the grantee organization.
- Taking a second no-cost extension of a final budget period.
- Changing the award terms and conditions, or undertaking any activities disapproved or restricted as a term of award.
- Adding, removing, or transferring a foreign subaward or foreign site.
The request must be endorsed by your Authorized Organization Representative and sent to the Grants Management Specialist at least 30 days before your proposed change. Contact your Grants Management Specialist with questions on preapprovals.
Change in Scope
There may be times when your research plans need adjustment because of a new research path or a dead end. Talk with your Program Officer about whether it makes sense to modify your research. You will need approval from your Grants Management Specialist to change the scope of your research.
Actions that may change the scope of your research include:
- Changing the Specific Aims
- Shifting the research emphasis from one disease area to another
- Changing any aspects of research involving animals or human subjects
- Using a new technology
- Purchasing equipment that costs more than $25,000
- Rebudgeting funds in or out of a budget category by more than 25 percent of the total costs of the award
For a list of all actions that constitute a change in scope, see Section 8 of the NIH Grants Policy Statement .
Change in Scope
There may be times when your research plans need adjustment because of a new research path or a dead end. Talk with your Program Officer about whether it makes sense to modify your research. You will need approval from your Grants Management Specialist to change the scope of your research.
Actions that may change the scope of your research include:
- Changing the Specific Aims
- Shifting the research emphasis from one disease area to another
- Changing any aspects of research involving animals or human subjects
- Using a new technology
- Purchasing equipment that costs more than $25,000
- Rebudgeting funds in or out of a budget category by more than 25 percent of the total costs of the award
For a list of all actions that constitute a change in scope, see Section 8 of the NIH Grants Policy Statement .
Change of Institution
If you wish to change institutions, you must ask the awarded institution to relinquish the award to your new one. The new institution must be a U.S. domestic institution capable of supporting the research and must fulfill all the requirements in the funding opportunity.
Your new institution must submit a new application in response to the Change of Grantee Organization (Type 7 Parent) announcement . NIH staff will review the application to ensure all the requirements in the funding opportunity are met.
For more information, see:
- NIH Change of Institutions/Relinquishing Statements FAQs
- Section 8 of the NIH Grants Policy Statement
If your institution does not agree to transfer your grant or the new institution cannot meet all the requirements in the funding opportunity, the grant must be terminated.
Change of Institution
If you wish to change institutions, you must ask the awarded institution to relinquish the award to your new one. The new institution must be a U.S. domestic institution capable of supporting the research and must fulfill all the requirements in the funding opportunity.
Your new institution must submit a new application in response to the Change of Grantee Organization (Type 7 Parent) announcement . NIH staff will review the application to ensure all the requirements in the funding opportunity are met.
For more information, see:
- NIH Change of Institutions/Relinquishing Statements FAQs
- Section 8 of the NIH Grants Policy Statement
If your institution does not agree to transfer your grant or the new institution cannot meet all the requirements in the funding opportunity, the grant must be terminated.
The High-Risk, High-Reward Research Symposium is held annually in June in Bethesda, MD. The symposium brings together recipients of the NIH Director's Pioneer, New Innovator, Transformative Research, and Early Independence awards to share their groundbreaking research and discoveries. The symposium is free and open to the public. Symposium attendees enjoy:
- Scientific talks and posters from High-Risk, High-Reward Research program awardees
- Networking with some of the most creative scientists in the U.S.
- Scheduled one-on-one meetings with NIH staff during "Office Hours"
High-Risk, High-Reward Research award recipients are strongly encouraged to attend the symposium annually. Awardee lab members, NIH staff and fellows, and members of the general public are also welcome to attend. NIH does not pay for or make travel arrangements for symposium attendees and presenters.
High-Risk, High-Reward Research Symposium
The High-Risk, High-Reward Research Symposium is held annually in June in Bethesda, MD. The symposium brings together recipients of the NIH Director's Pioneer, New Innovator, Transformative Research, and Early Independence awards to share their groundbreaking research and discoveries. The symposium is free and open to the public. Symposium attendees enjoy:
- Scientific talks and posters from High-Risk, High-Reward Research program awardees
- Networking with some of the most creative scientists in the U.S.
- Scheduled one-on-one meetings with NIH staff during "Office Hours"
High-Risk, High-Reward Research award recipients are strongly encouraged to attend the symposium annually. Awardee lab members, NIH staff and fellows, and members of the general public are also welcome to attend. NIH does not pay for or make travel arrangements for symposium attendees and presenters.
Every Early Independence awardee receives a site visit from NIH staff around the end of the first year of their award. Site visits are used to assess the progress of awardees in establishing an independent research program and to ensure they are receiving the support and resources from their institution as described in their application. Below are common questions regarding site visits.
What are site visits?
Every Early Independence awardee will meet with NIH staff to assess their progress and ensure they are receiving the institutional support and help needed to successfully transition to research independence. At the site visit, NIH staff will come to your institution to meet with you, your colleagues, and institution officials, as well as view facilities and discuss your research and career progress. Awardees will have a chance to ask questions, get advice, and get to know NIH staff.
Are site visits audits?
Site visits are not audits and don't fulfill any statutory requirements. They are used to ensure the awardee is getting the support needed to grow a successful independent research program. It is also a good way to build relationships with NIH staff, get questions answered, and get advice. The site visit is a good time for awardees to bring up any concerns they have about their institution's support or environment; NIH staff can bring those concerns up during their meetings with other faculty and institution officials and work towards a resolution.
When and where will the site visit occur?
Site visits are typically scheduled around the end of the first year of the Early Independence Award (usually between August and December). The site visit may be done virtually or in-person at the awardee's institution. Whether or not a site visit happens virtually or in-person depends on NIH priorities.
How long is the site visit?
Site visits will last for one day during regular business hours.
Who will attend from the NIH?
The Program Officer attends and conducts all site visits. Additionally, each awardee has an "affiliate" Program Officer from the most scientifically relevant NIH Institute or Center. They are there to help advance the awardee's scientific program, offer guidance about transitioning to other sources of NIH support, provide insights into navigating NIH administrative channels, and is a great overall resource. The awardee's affiliate Program Officer is invited to attend the site visit as well, but attendance will depend on their availability.
What happens during the site visit?
NIH staff will gather information on lab infrastructure/physical space, progress on establishing an independent research program, integration into the institutional culture and faculty community, and institutional support. NIH staff will need to do the following activities to get a comprehensive view of the support received:
- Meet with the awardee (must be the first meeting of the day for 1.5 hours)
- View the facilities (5-15 minutes)
- Meet with lab personnel (30 minutes)
- Meet with faculty mentors (30 minutes)
- Meet with non-mentor faculty colleagues (30 minutes)
- Meet with the department/division chair (30 minutes)
- Meet with an institutional representative (30 minutes)
Who should be included in the site visit meetings?
NIH staff will want to meet with people involved in the awardee's research and mentorship to better understand the community and support for the awardee. NIH staff should meet with the following people during the site visit:
- Awardee
- Lab members and personnel
- Faculty mentors helping integrate the awardee into the community
- Non-mentoring faculty members (colleagues not involved in the awardee's research or mentorship) to provide insight into the department and its culture
- Department or division chair to learn more about the department or division and the support it has in place for the awardee
- Institutional representative (such as the dean of research) to learn more about the institution's strategy for supporting early career scientists and their research
The awardee will only be present during their designated meeting, facility tour, and wrap-up meeting. The awardee will not be present in any of the other meetings.
Who schedules the meetings at the institution and sets the site visit agenda?
It is the responsibility of the awardee to schedule the meetings and set the site visit agenda. The NIH Program Officer may request modifications to the agenda to ensure that programmatic needs of the site visit are met. If possible, awardees are asked to schedule and organize a seminar at their institution for a presentation on the High-Risk, High-Reward Research program. Broad dissemination of the seminar at the awardee's institution and other local institutions is appreciated.
What information is needed for the agenda?
The agenda should include the time, activity, meeting link (for virtual meetings), and the name, title, and department/organization of the people NIH staff will meet with. Include location and contact information if NIH staff will be traveling to and from in-person meetings unescorted. Please also remember to leave time for lunch. For in-person visits, a working lunch can be scheduled where NIH staff meet with the awardee and perhaps other High-Risk, High-Reward awardees or potential applicants. Or the time can be left open for NIH staff to find lunch on their own. An
Does the awardee attend all the scheduled meetings during the site visit?
No. The awardee should not attend meetings outside their own scheduled meeting, facility tour, and a wrap-up meeting. NIH staff should meet with the other groups without the awardee present.
Should the awardee update the NIH on his/her research progress during their meeting?
Yes. NIH staff will want an update on the awardee's research progress. This is often done with a presentation.
When does the agenda need to be set by?
A draft of the agenda is asked a month before a virtual site visit and at least three months before an in-person site visit so NIH can get travel approvals. It is understood that agendas may change; send an updated version as soon as possible.
For in-person visits, who makes travel and lodging arrangements for NIH staff?
NIH staff will make all their own travel and lodging arrangements and pay for their own meals and expenses.
When and how will site visit dates be scheduled?
Awardees will receive an email from NIH staff with more information and possible site visit dates in February or March after their award is made. The awardee should discuss suitable dates with those at their institution who will participate in the site visit meetings and select the most convenient date that is available. Awardees should respond quickly to requests to select the site visit date as they are given on a first-come, first-serve basis.
What happens if the awardee changes institutions before a site visit?
If an awardee changes or will be changing institutions before a site visit occurs, the site visit can be delayed until the awardee has had time to establish themselves at the new institution.
Will NIH staff complete an official report on the site visit, and will I receive a copy?
Yes. The Program Officer will complete an official report on the findings of the site visit. Affiliate Program Officers are not required to submit a report. The report is not shared with the awardee or institution, but general findings are disclosed to the awardee during the wrap-up meeting at the end of the site visit.
What happens if issues are identified at the site visit?
The site visit is meant to ensure adequate support is being provided to the awardee so they can succeed in their transition to independence. If issues are identified, NIH staff will discuss them with the awardee and institutional officials. The goal is to bring up concerns early so they can be discussed and resolved before the problems become entrenched and more difficult to correct. Institutions are expected to provide the support outlined in the application. Failure to provide independence and/or support to the awardee may lead to NIH actions, including reduction of funds.
Site Visits
Every Early Independence awardee receives a site visit from NIH staff around the end of the first year of their award. Site visits are used to assess the progress of awardees in establishing an independent research program and to ensure they are receiving the support and resources from their institution as described in their application. Below are common questions regarding site visits.
What are site visits?
Every Early Independence awardee will meet with NIH staff to assess their progress and ensure they are receiving the institutional support and help needed to successfully transition to research independence. At the site visit, NIH staff will come to your institution to meet with you, your colleagues, and institution officials, as well as view facilities and discuss your research and career progress. Awardees will have a chance to ask questions, get advice, and get to know NIH staff.
Are site visits audits?
Site visits are not audits and don't fulfill any statutory requirements. They are used to ensure the awardee is getting the support needed to grow a successful independent research program. It is also a good way to build relationships with NIH staff, get questions answered, and get advice. The site visit is a good time for awardees to bring up any concerns they have about their institution's support or environment; NIH staff can bring those concerns up during their meetings with other faculty and institution officials and work towards a resolution.
When and where will the site visit occur?
Site visits are typically scheduled around the end of the first year of the Early Independence Award (usually between August and December). The site visit may be done virtually or in-person at the awardee's institution. Whether or not a site visit happens virtually or in-person depends on NIH priorities.
How long is the site visit?
Site visits will last for one day during regular business hours.
Who will attend from the NIH?
The Program Officer attends and conducts all site visits. Additionally, each awardee has an "affiliate" Program Officer from the most scientifically relevant NIH Institute or Center. They are there to help advance the awardee's scientific program, offer guidance about transitioning to other sources of NIH support, provide insights into navigating NIH administrative channels, and is a great overall resource. The awardee's affiliate Program Officer is invited to attend the site visit as well, but attendance will depend on their availability.
What happens during the site visit?
NIH staff will gather information on lab infrastructure/physical space, progress on establishing an independent research program, integration into the institutional culture and faculty community, and institutional support. NIH staff will need to do the following activities to get a comprehensive view of the support received:
- Meet with the awardee (must be the first meeting of the day for 1.5 hours)
- View the facilities (5-15 minutes)
- Meet with lab personnel (30 minutes)
- Meet with faculty mentors (30 minutes)
- Meet with non-mentor faculty colleagues (30 minutes)
- Meet with the department/division chair (30 minutes)
- Meet with an institutional representative (30 minutes)
Who should be included in the site visit meetings?
NIH staff will want to meet with people involved in the awardee's research and mentorship to better understand the community and support for the awardee. NIH staff should meet with the following people during the site visit:
- Awardee
- Lab members and personnel
- Faculty mentors helping integrate the awardee into the community
- Non-mentoring faculty members (colleagues not involved in the awardee's research or mentorship) to provide insight into the department and its culture
- Department or division chair to learn more about the department or division and the support it has in place for the awardee
- Institutional representative (such as the dean of research) to learn more about the institution's strategy for supporting early career scientists and their research
The awardee will only be present during their designated meeting, facility tour, and wrap-up meeting. The awardee will not be present in any of the other meetings.
Who schedules the meetings at the institution and sets the site visit agenda?
It is the responsibility of the awardee to schedule the meetings and set the site visit agenda. The NIH Program Officer may request modifications to the agenda to ensure that programmatic needs of the site visit are met. If possible, awardees are asked to schedule and organize a seminar at their institution for a presentation on the High-Risk, High-Reward Research program. Broad dissemination of the seminar at the awardee's institution and other local institutions is appreciated.
What information is needed for the agenda?
The agenda should include the time, activity, meeting link (for virtual meetings), and the name, title, and department/organization of the people NIH staff will meet with. Include location and contact information if NIH staff will be traveling to and from in-person meetings unescorted. Please also remember to leave time for lunch. For in-person visits, a working lunch can be scheduled where NIH staff meet with the awardee and perhaps other High-Risk, High-Reward awardees or potential applicants. Or the time can be left open for NIH staff to find lunch on their own. An
Does the awardee attend all the scheduled meetings during the site visit?
No. The awardee should not attend meetings outside their own scheduled meeting, facility tour, and a wrap-up meeting. NIH staff should meet with the other groups without the awardee present.
Should the awardee update the NIH on his/her research progress during their meeting?
Yes. NIH staff will want an update on the awardee's research progress. This is often done with a presentation.
When does the agenda need to be set by?
A draft of the agenda is asked a month before a virtual site visit and at least three months before an in-person site visit so NIH can get travel approvals. It is understood that agendas may change; send an updated version as soon as possible.
For in-person visits, who makes travel and lodging arrangements for NIH staff?
NIH staff will make all their own travel and lodging arrangements and pay for their own meals and expenses.
When and how will site visit dates be scheduled?
Awardees will receive an email from NIH staff with more information and possible site visit dates in February or March after their award is made. The awardee should discuss suitable dates with those at their institution who will participate in the site visit meetings and select the most convenient date that is available. Awardees should respond quickly to requests to select the site visit date as they are given on a first-come, first-serve basis.
What happens if the awardee changes institutions before a site visit?
If an awardee changes or will be changing institutions before a site visit occurs, the site visit can be delayed until the awardee has had time to establish themselves at the new institution.
Will NIH staff complete an official report on the site visit, and will I receive a copy?
Yes. The Program Officer will complete an official report on the findings of the site visit. Affiliate Program Officers are not required to submit a report. The report is not shared with the awardee or institution, but general findings are disclosed to the awardee during the wrap-up meeting at the end of the site visit.
What happens if issues are identified at the site visit?
The site visit is meant to ensure adequate support is being provided to the awardee so they can succeed in their transition to independence. If issues are identified, NIH staff will discuss them with the awardee and institutional officials. The goal is to bring up concerns early so they can be discussed and resolved before the problems become entrenched and more difficult to correct. Institutions are expected to provide the support outlined in the application. Failure to provide independence and/or support to the awardee may lead to NIH actions, including reduction of funds.
The Common Fund {"robots":"noindex, nofollow"}