This Funding Opportunity Announcement (FOA) is developed as a Common Fund initiative (http://commonfund.nih) through the NIH Office of the NIH Director, Office of Strategic Coordination (http://dpcpsi.nih.gov/osc). All NIH Institutes and Centers participate in Common Fund initiatives. Grants management of the awards will be administered by the National Institute of Dental and Craniofacial Research (http://www.nidcr.nih.gov/) on behalf of the NIH.
Funding Opportunity Title
NIH Director's Early Independence Award (DP5 - Clinical Trial Optional)
Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.
Scientific Merit Review
Advisory Council Review
Earliest Start Date
Due Dates for E.O. 12372
Required Application Instructions
It is critical that applicants follow the instructions in the Research (R) Instructions in the SF424 (R&R) Application Guide, except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.
There are several options available to submit your application through Grants.gov to NIH and
Department of Health and Human Services partners. You must use one of these submission
options to access the application forms for this opportunity.
Use the NIH ASSIST system to prepare, submit and track your application online.
Use an institutional system-to-system (S2S) solution to prepare and submit your application
to Grants.gov and eRA Commons to track your
application. Check with your institutional officials regarding availability.
Use Grants.gov Workspace to prepare and submit your application and eRA Commons to track your application.
The NIH Director's Early Independence Award provides an opportunity for exceptional junior scientists to accelerate their entry into an independent research career by forgoing the traditional post-doctoral training period. Though most newly graduated doctoral-level researchers would benefit from post-doctoral training, a small number of outstanding junior investigators would benefit from skipping such training and launching essentially directly into an independent research career. For those select junior investigators who already have established a record of scientific innovation and research productivity and who have demonstrated unusual scientific vision and maturity, typical post-doctoral training would unnecessarily delay their entry into independent research. Also, importantly, the NIH Director’s Early Independence Award provides an opportunity for institutions to invigorate their research programs by bringing in the fresh scientific perspectives of the awardees that they host.
To be eligible, the investigator, at the time of application, must have received the most recent doctoral degree or completed clinical training within the previous fifteen months or expect to do so within the following twelve months. To be consistent with the updated NIH definition of Early Stage Investigators, eligible clinical training includes clinical residency and clinical fellowship. For full eligibility requirements, see Section III. Eligibility Information. By the end of the award period, the Early Independence Award investigator is expected to be competitive for continued funding of his/her research program through other NIH funding activities and for a permanent research-oriented position.
The NIH recognizes a compelling need to promote diversity in the biomedical, behavioral, clinical and social sciences research workforce. The NIH expects its efforts towards diversifying the workforce to lead to the recruitment of the most talented researchers from all groups; to improve the quality of the educational and training environment; to balance and broaden the perspective in setting research priorities; to improve the ability to recruit subjects from diverse backgrounds into clinical research protocols; and to improve the Nation's capacity to address and eliminate health disparities. Applicant institutions are always encouraged to consider talented researchers from diverse backgrounds underrepresented in biomedical research, including underrepresented racial and ethnic groups, persons with disabilities, and women for participation in all NIH-funded research opportunities.
The NIH Director's Early Independence Award is part of the High-Risk, High-Reward Research program funded through the NIH Common Fund. All Common Fund initiatives invite investigators to develop bold, innovative, and often risky approaches to address major problems that are especially daunting or to seize new opportunities that offer the potential for rapid progress.
The NIH Common Fund intends to commit approximately $4,000,000 to support approximately 10 awards in FY 2019, contingent upon availability of funds and receipt of a sufficient number of meritorious applications. Future year amounts will depend on annual appropriations and satisfactory progress.
Awards will be for up to $250,000 in direct costs per year, plus applicable Facilities and Administrative (F&A) costs.
Award Project Period
The project period is limited to five years.
NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made from this FOA.
Section III. Eligibility Information
1. Eligible Applicants
Higher Education Institutions
Public/State Controlled Institutions of Higher Education
Private Institutions of Higher Education
The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:
Historically Black Colleges and Universities (HBCUs)
Tribally Controlled Colleges and Universities (TCCUs)
Alaska Native and Native Hawaiian Serving Institutions
Asian American Native American Pacific Islander Serving Institutions (AANAPISIs)
Nonprofits Other Than Institutions of Higher Education
Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education)
Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education)
For-Profit Organizations (Other than Small Businesses)
City or Township Governments
Special District Governments
Indian/Native American Tribal Governments (Federally Recognized)
Indian/Native American Tribal Governments (Other than Federally Recognized)
Eligible Agencies of the Federal Government - including the NIH Intramural Research Program
U.S. Territory or Possession
Independent School Districts
Public Housing Authorities/Indian Housing Authorities
Native American Tribal Organizations (other than Federally recognized tribal governments)
Faith-based or Community-based Organizations
Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply
Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.
Foreign components, as defined in the NIH Grants Policy Statement, are allowed.
Applicant organizations must complete and maintain the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. The NIH Policy on Late Submission of Grant Applications states that failure to complete registrations in advance of a due date is not a valid reason for a late submission.
Dun and Bradstreet Universal Numbering System (DUNS) - All registrations require that applicants be issued a DUNS number. After obtaining a DUNS number, applicants can begin both SAM and eRA Commons registrations. The same DUNS number must be used for all registrations, as well as on the grant application.
System for Award Management (SAM) (formerly CCR) – Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.
eRA Commons - Applicants must have an active DUNS number and SAM registration in order to complete the eRA Commons registration. Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
Grants.gov – Applicants must have an active DUNS number and SAM registration in order to complete the Grants.gov registration.
Program Directors/Principal Investigators (PD(s)/PI(s))
All PD(s)/PI(s) must have an eRA Commons account. PD(s)/PI(s) should work with their organizational officials to either create a new account or to affiliate their existing account with the applicant organization in eRA Commons. If the PD/PI is also the organizational Signing Official, they must have two distinct eRA Commons accounts, one for each role. Obtaining an eRA Commons account can take up to 2 weeks.
Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.
Only single PD/PI applications are allowed. Applications with multiple PDs/PIs will not be accepted. Only the PD/PI may be listed as a Senior/Key Person and provide a Biographical Sketch.
There is no citizenship requirement for PDs/PIs. For applications submitted on behalf of non-U.S. citizens with temporary U.S. visas, visa status must allow the PD/PI to conduct the proposed research at the applicant institution. The applicant institution is responsible for determining and documenting that PD's/PI's visa will allow the PD/PI to remain in the U.S. for the duration of the award.
Time window for eligibility: Given the focus on early research independence, the receipt date of the terminal doctoral degree or end of post-graduate clinical training of the PD/PI must be between June 1, 2017 and September 30, 2019. The degree receipt date is that which appears on the official transcript for the degree. The end of post-graduate clinical training includes residency and fellowship periods. At the time of application, the PD/PI must not have served as a post-doctoral fellow following a previous (not the most recent) doctoral degree for more than twelve months.
At the time of award, either 1) the Early Independence investigator must have received a PhD, MD, DO, DC, DDS, DVM, OD, DPM, ScD, EngD, Dr PH, DNSc, ND (Doctor of Naturopathy), PharmD, DSW, PsyD, or equivalent doctoral degree from an accredited domestic or foreign institution (it is the responsibility of the sponsoring institution to determine if a foreign doctoral degree is equivalent), or 2) an authorized official of the degree-granting or training institution must certify that all degree requirements have been met and that the receipt date of the degree (as will appear on the transcript) will be before September 30, 2019; in addition, an authorized official of the host institution must certify that the PD/PI will be eligible to conduct independent research at the institution at the time of the project start date.
Level of effort: Individuals must commit at least 9.6 person-months each year (i.e., 80% effort of a 12-month appointment) during the first two years of the project period to research supported by the Early Independence Award. In the final three years of the project period, awardees may reduce effort toward the Early Independence Award project, but the total effort towards independent research in general must remain at least 9.6 person-months each year (i.e., 80% effort of a 12-month appointment).
Research independence at time of application: Individuals are eligible only if they, at the time of application submission, do not have research independence. Lack of research independence is defined functionally rather than by position title. Eligible individuals must have all the following characteristics:
The PD/PI's current research agenda is set through concurrence with mentors.
The PD/PI's research is funded primarily through support to other investigators (mentored fellowships such as NIH F31 or F32 Fellowships or NSF Graduate Research Fellowships do not preclude eligibility).
The PD/PI does not have any space assigned directly by the institution for the conduct of his/her research.
The PD/PI, according to institutional policy, cannot apply for an NIH R01 grant without special waiver or exemption from the institution.
Though the PD/PI must not be functionally independent at the time of application submission, s/he may become functionally independent prior to time of award and still retain eligibility for the award.
Prospective PDs/PIs should contact appropriate institutional leaders to seek an appointment in an independent research position. Alternatively, institutions may actively recruit eligible junior scientists to apply for support through this program. In either event, the institution will be expected to provide substantial support for the junior scientist as detailed below. To foster independence, it may behoove PDs/PIs to be hosted by institutions other than the ones at which they trained.
Each institution, as defined by having a unique DUNS number or NIH IPF number, may submit only up to two applications to this FOA.
The NIH will not accept duplicate or highly overlapping applications under review at the same time. This means that the NIH will not accept:
A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission (A1) application.
A resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application.
An application that has substantial overlap with another application pending appeal of initial peer review (see NOT-OD-11-101)
Section IV. Application and Submission Information
1. Requesting an Application Package
Buttons to access the online ASSIST system or to download application forms are available in Part 1 of this FOA. See your administrative office for instructions if you plan to use an institutional system-to-system solution.
Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review.
By the date listed in Part 1. Overview Information, prospective applicants are asked to submit a letter of intent that includes the following information:
Descriptive title of proposed activity
Name(s), address(es), and telephone number(s) of the PD(s)/PI(s)
Names of other key personnel
Number and title of this funding opportunity
The letter of intent should be sent to:
Ravi Basavappa, Ph.D.
Office of Strategic Coordination
Office of the Director
6001 Executive Boulevard, Room 8180C
Rockville, MD 20854
All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed
Instructions for Application Submission
The following section supplements the instructions found in the SF424 (R&R) Application Guide and should be used for preparing an application to this FOA.
All instructions in the SF424 (R&R) Application Guide must be followed. Cover Letter Attachment: The cover letter must include the names of those writing letters of reference for the PD/PI.
SF424(R&R) Project/Performance Site Locations
All instructions in the SF424 (R&R) Application Guide must be followed.
SF424(R&R) Other Project Information
All instructions in the SF424 (R&R) Application Guide must be followed. Facilities & Other Resources: Applicant institution officials must address each of the following items below. Use appropriate subheadings in the response. No page limits apply; responses should be concise, yet complete.
During the award period, the Early Independence investigator must be scientifically independent 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 Early Independence investigator will be appointed and how the PD/PI's independence will be ensured during the course of the award.
Describe plans for maintaining protected time for the Early Independence investigator so that s/he will be able to devote at least 9.6 person-months every year (i.e., 80% effort of a 12-month appointment) to conducting independent research during the project period, with at least the first two years being devoted entirely to the Early Independence Award project. Clinicians should be permitted to perform clinical duties to the extent necessary to maintain credentials.
Describe the process and criteria used to select the PD/PI.
Describe the institutional organizational structure within which the Early Independence PD/PI's position will be administered (school, department, etc.), and explain how this administrative structure will best meet the goal of supporting the success of the Early Independence PD/PI. Include details of responsibilities for integrating the Early Independence investigator and his/her scientific project into the institutional culture and the faculty community. Describe the management of problematic situations as well as institutional expectations related to the retention or transfer of the PD/PI at the end of the funding period.
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 a U.S. institution.
Institutional resources commitment:
Describe details of the laboratory space to be provided to the Early Independence investigator, including physical structure and space layout along with the availability of support staff.
Describe other administrative and support functions that will be available to the Early Independence investigator (for example, human resources, supply and equipment ordering systems, administrative assistance, etc.).
Describe the institutional financial commitment to the Early Independence investigator. 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 Early Independence investigator 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. Particularly if the Early Independence investigator is staying at the same institution at which s/he trained, indicate how independence from degree/fellowship mentors will be established and maintained.
Describe plans for integrating the Early Independence investigator into institutional scientific and administrative activities at the institution. Describe the scientific collaborative activities (attendance at faculty meetings, laboratory meetings, participation in institutional scientific retreats, etc.) and career development resources (courses in laboratory management and grant writing, etc.) that will be available to ensure the Early Independence investigator is successful.
Describe the mentoring structure, including membership , meeting frequency, and meeting format. Though the Early Independence investigator must be scientifically independent, it is important that senior colleagues are available as resources and periodically meet with the awardee.
The primary goal for an Early Independence investigator is to establish an independent scientific research program. However, if an Early Independence investigator has an interest in (limited) teaching, describe what opportunities will be available.
Describe expectations and opportunities for the Early Independence investigator to establish a record of independent funding by submitting and accepting grants from sources other than the Early Independence Award.
SF424(R&R) Senior/Key Person Profile
All instructions in the SF424 (R&R) Application Guide must be followed.
Only the PD/PI may be listed as a Senior/Key person and provide a Biographical Sketch.
All instructions in the SF424 (R&R) Application Guide must be followed.
R&R Subaward Budget
All instructions in the SF424 (R&R) Application Guide must be followed.
PHS 398 Cover Page Supplement
All instructions in the SF424 (R&R) Application Guide must be followed.
PHS 398 Research Plan
All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions: Specific Aims:
The specific aims page 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 you are introducing into this research area?
Institutional Support: How will the institutional support, including the assurance of research independence, facilitate the accomplishment of your research objectives?
Early Independence Rationale: How will your scientific and technical background, research accomplishments, leadership/mentorship attributes, and scientific vision be leveraged to accomplish the research objectives?
Research Strategy: Organize the Research Strategy using the instructions provided below. Start each section of the document with the appropriate section heading.
1. Rationale for omitting or abbreviating typical post-doc 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?
2. 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. Also, describe any arrangements you may have made to assume an independent research position that would begin prior to award.
3. 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?
4. 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)
5. 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?
6. 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? Why did you choose this particular challenge to begin your independent research career?
7. 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 if provided 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 FOA. Collaborative elements of the research may also be described here.
8. Innovation: What are the particularly innovative aspects of your proposed research?
9. Relationship to previous work: How is the proposed research related to your research as a student? How does it differ? How will this be accomplished independently from your previous mentors?
10. Timeline: 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. Include a statement committing at least 9.6 person-months every year (i.e., 80% effort of a 12-month appointment) to independent research during the project period, with at least the first two years being devoted entirely to the Early Independence Award project.
Letters of Support: Consultants should provide letters of support that concisely describe their commitment to the research project and the role they will play in conducting the research.
Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide.
The following modifications also apply:
Only limited Appendix materials are allowed. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.
PHS Human Subjects and Clinical Trials Information
When involving NIH-defined human subjects research, clinical research, and/or clinical trials (and when applicable, clinical trials research experience) follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions:
If you answered “Yes” to the question “Are Human Subjects Involved?” on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or Delayed Onset Study record.
Study Record: PHS Human Subjects and Clinical Trials Information
All instructions in the SF424 (R&R) Application Guide must be followed with the following additional instructions:
Delayed Onset Study
All instructions in the SF424 (R&R) Application Guide must be followed.
3. Unique Entity Identifier and System for Award Management (SAM)
See Part 1. Section III.1 for information regarding the requirement for obtaining a unique entity identifier and for completing and maintaining active registrations in System for Award Management (SAM), NATO Commercial and Government Entity (NCAGE) Code (if applicable), eRA Commons, and Grants.gov
4. Submission Dates and Times
Part I. Overview Information contains information about Key Dates and times. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission. When a submission date falls on a weekend or Federal holiday, the application deadline is automatically extended to the next business day.
Organizations must submit applications to Grants.gov (the online portal to find and apply for grants across all Federal agencies). Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants administration. NIH and Grants.gov systems check the application against many of the application instructions upon submission. Errors must be corrected and a changed/corrected application must be submitted to Grants.gov on or before the application due date and time. If a Changed/Corrected application is submitted after the deadline, the application will be considered late. Applications that miss the due date and time are subjected to the NIH Policy on Late Application Submission.
Applicants are responsible for viewing their application before the due date in the eRA Commons to ensure accurate and successful submission.
Information on the submission process and a definition of on-time submission are provided in the SF424 (R&R) Application Guide.
Applications must be submitted electronically following the instructions described in the SF424 (R&R) Application Guide. Paper applications will not be accepted.
Applicants must complete all required registrations before the application due date. Section III. Eligibility Information contains information about registration.
For assistance with your electronic application or for more information on the electronic submission process, visit Applying Electronically. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Guidelines for Applicants Experiencing System Issues. For assistance with application submission, contact the Application Submission Contacts in Section VII.
All PD(s)/PI(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF424(R&R) Application Package. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH. See Section III of this FOA for information on registration requirements.
The applicant organization must ensure that the DUNS number it provides on the application is the same number used in the organization’s profile in the eRA Commons and for the System for Award Management. Additional information may be found in the SF424 (R&R) Application Guide.
See more tips for avoiding common errors.
Upon receipt, applications will be evaluated for completeness and compliance with application instructions by the Center for Scientific Review and responsiveness by components of participating organizations, NIH. Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed.
Applications Involving the NIH Intramural Research Program
Requests by NIH intramural scientists will be limited to the incremental costs required for participation. As such, these requests will not include any salary and related fringe benefits for career, career conditional or other Federal employees (civilian or uniformed service) with permanent appointments under existing position ceilings or any costs related to administrative or facilities support (equivalent to Facilities and Administrative or F&A costs). Allowable costs may include salary for staff to be specifically hired under a temporary appointment for the project, consultant costs, equipment, supplies, travel, and other items typically listed under Other Expenses. Applicants should indicate the number of person-months devoted to the project, even if no funds are requested for salary and fringe benefits.
If selected, funding will be provided by the NIH Common Fund or supporting Institutes/Centers through the NIH Intramural Program. NIH intramural scientists will participate in this program as PD/PIs in accordance with the Terms and Conditions provided in this FOA. Intellectual property will be managed in accord with established policy of the NIH in compliance with Executive Order 10096, as amended, 45 CFR Part 7; patent rights for inventions developed in NIH facilities are NIH property unless NIH waives its rights.
Should an extramural application include collaboration with an intramural scientist, no funds for the support of the intramural scientist may be requested in the application. If funds for the intramural scientist are to be requested, a separate request must be submitted with the constraints described above. The combined direct costs of the extramural and intramural components cannot exceed $250,000 per year.
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 three letters have been submitted prior to the submission deadline. Applicants are encouraged to check the status of their letters in their Commons accounts.
Letters may be submitted beginning August 27, 2018, and must be submitted no later than 5:00 p.m. (local time) September 27, 2018.
Referees will need the following information to submit a letter:
Funding Opportunity Number (FOA) for this announcement: RFA-RM-18-010;
The applicant’s Commons User Name (Note: Referees do not need to be registered in the Commons and do not need their own Commons User Name – only the Commons User Name of the applicant is required);
The applicant’s first and last name (note – the name must match exactly the applicant’s name in the Commons);
Letters of reference are confidential. Applicants will not have access to the letters. Confirmed receipt of letters of reference will be sent via email to both the applicant and the referee. The confirmation sent to the applicant will include the referee’s name and the date and time the letter was submitted. The confirmation sent to the referee will include the referee and applicant’s names, a confirmation number, and the date and time the letter was submitted.
Note: Since email can be unreliable, it is the applicant’s responsibility to check the status of his/her letters of reference periodically in the Commons.
Instructions to Referees:
Letters must be submitted electronically using the letter submission URL above – paper copies or emails will not be accepted.
The applicant's name should be placed at the top of the letter. Although signatures are not required, the letter must include a signature block with the referee’s full name, title, institution, and contact information.
In two pages or less, describe the applicant's qualities that support the applicant’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.
Note: The letter submission page can be accessed without signing into the Commons, and referees do not need to be registered in the Commons. Referees must provide the applicant’s Commons User Name (User ID) and the other information below:
Referee Information (the individual providing the letter of reference):
Referee’s First and Last Name (Required)
Referee’s Middle Initial (MI) (Not Required)
Referee’s Email Address (Required)
Referee’s Institution/Affiliation (Required)
Referee’s Department (Required)
Applicant Information (applicants must send this information to their referees):
Applicant’s Commons User Name (User ID), (Required) (Important – this must be the applicant’s, not the referee’s, Commons User Name (User ID). The letter will not be linked to the appropriate application if the Applicant’s User Name is not entered here.)
Applicant’s Last Name (Required). (Note: must match exactly the applicant’s name in Commons)
Funding Opportunity Number (FOA) of this announcement: RM-18-010 (Required)
Confirmation Number (Required only when resubmitting a letter, that is, when submitting a revised or changed/corrected letter for the current FOA)
Email confirmations will be sent to both the applicant and the referee following submission of the letter. The email confirmation will include a Confirmation Number that will be required only when submitting a revised or changed/corrected letter. Please print the confirmation email for your records.
Applicants are required to follow the instructions for post-submission materials, as described in the policy. Any instructions provided here are in addition to the instructions in the policy.
Section V. Application Review Information
Only the review criteria described below will be considered in the review process. As part of the NIH mission, all applications submitted to the NIH in support of biomedical and behavioral research are evaluated for scientific and technical merit through the NIH peer review system.
For this particular announcement, note the following:
The NIH Director's Early Independence Awards are designed to accelerate the entry of exceptional junior investigators into positions of independent research by providing support to individuals whose terminal doctoral degree receipt date or end of post-graduate clinical training is between June 1, 2017 and September 30, 2019, thereby omitting the traditional post-doctoral training period. Accordingly, though all review criteria described below will be used, the emphases will be on the qualities of the investigator and on the environment provided by the host institution. Substantial preliminary data are not expected; rather, the approach should be made compelling primarily by the logic of the arguments presented.
Informed by the comments provided by Mail Reviewers, a subset of applications will be selected by the Review Panel (excluding Mail Reviewers) for further consideration. The PDs/PIs of these applications will be invited for an in-person interview by the Review Panel. The same review criteria will be used by the Review Panel as was used by the Mail Reviewers.
In addition, for applications involving clinical trials:
A proposed Clinical Trial application may include study design, methods, and intervention that are not by themselves innovative but address important questions or unmet needs. Additionally, the results of the clinical trial may indicate that further clinical development of the intervention is unwarranted or lead to new avenues of scientific investigation.
Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the project proposed).
Scored Review Criteria
Reviewers will consider each of the review criteria below in the determination of scientific merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.
Does the project address an important problem or a critical barrier to progress in the field? Is there a strong scientific premise for the project? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?
Are the scientific rationale and need for a clinical trial to test the proposed hypothesis or intervention well supported by preliminary data (if provided), clinical and/or preclinical studies, or information in the literature or knowledge of biological mechanisms? For trials focusing on clinical or public health endpoints, is this clinical trial necessary for testing the safety, efficacy or effectiveness of an intervention that could lead to a change in clinical practice, community behaviors or health care policy? For trials focusing on mechanistic, behavioral, physiological, biochemical, or other biomedical endpoints, is this trial needed to advance scientific understanding?
Is the PD's/PI?s self-appraisal/ rationale for early independence convincing? Is the investigator well suited to the project? Has the investigator demonstrated appropriate experience, training, and skills to conduct highly innovative research? Has the investigator demonstrated the leadership, mentorship, and management abilities necessary to successfully conduct completely independent research? Do the letters of reference indicate that the investigator is ready to embark upon an independent research career?
Is the Early Independence investigator at a juncture in his/her career at which the Early Independence Award would substantially accelerate establishment of his/her independent research career? Would the Early Independence investigator's scientific productivity and long-term career benefit from this acceleration?
In addition, for applications involving clinical trials
With regard to the proposed leadership for the project, does the PD/PI? has the expertise, experience, and ability to organize, manage and implement the proposed clinical trial and meet milestones and timelines? Does s/he has appropriate expertise in study coordination, data management and statistics? For a multicenter trial, is the organizational structure appropriate and does the application identify a core of potential center investigators and staffing for a coordinating center?
Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?
In addition, for applications involving clinical trials
Does the design/research plan include innovative elements, as appropriate, that enhance its sensitivity, potential for information or potential to advance scientific knowledge or clinical practice?
Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Has the investigator presented strategies to ensure a robust and unbiased approach, as appropriate for the work proposed? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed? Has the investigator presented adequate plans to address relevant biological variables, such as sex, for studies in vertebrate animals or human subjects?
Is the logic of the approach compelling even though substantial preliminary data are not present? Is the scope of the project appropriate for someone who, though highly qualified, is still establishing an independent research program?
If the project involves human subjects and/or NIH-defined clinical research, are the plans to address 1) the protection of human subjects from research risks, and 2) inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion or exclusion of children, justified in terms of the scientific goals and research strategy proposed?
In addition, for applications involving clinical trials
Does the application adequately address the following, if applicable?
Is the study design justified and appropriate to address primary and secondary outcome variable(s)/endpoints that will be clear, informative and relevant to the hypothesis being tested? Is the scientific rationale/premise of the study based on previously well-designed preclinical and/or clinical research? Given the methods used to assign participants and deliver interventions, is the study design adequately powered to answer the research question(s), test the proposed hypothesis/hypotheses, and provide interpretable results? Is the trial appropriately designed to conduct the research efficiently? Are the study populations (size, gender, age, demographic group), proposed intervention arms/dose, and duration of the trial, appropriate and well justified?
Are potential ethical issues adequately addressed? Is the process for obtaining informed consent or assent appropriate? Is the eligible population available? Are the plans for recruitment outreach, enrollment, retention, handling dropouts, missed visits, and losses to follow-up appropriate to ensure robust data collection? Are the planned recruitment timelines feasible and is the plan to monitor accrual adequate? Has the need for randomization (or not), masking (if appropriate), controls, and inclusion/exclusion criteria been addressed? Are differences addressed, if applicable, in the intervention effect due to sex/gender and race/ethnicity?
Are the plans to standardize, assure quality of, and monitor adherence to, the trial protocol and data collection or distribution guidelines appropriate? Is there a plan to obtain required study agent(s)? Does the application propose to use existing available resources, as applicable?
Data Management and Statistical Analysis
Are planned analyses and statistical approach appropriate for the proposed study design and methods used to assign participants and deliver interventions? Are the procedures for data management and quality control of data adequate at clinical site(s) or at center laboratories, as applicable? Have the methods for standardization of procedures for data management to assess the effect of the intervention and quality control been addressed? Is there a plan to complete data analysis within the proposed period of the award?
Will the scientific environment contribute to the probability of success of the Early Independence investigator? Will the situation of the Early Independence investigator provide sufficient separation from previous mentors to promote true intellectual independence? Are the plans for institutional support, equipment, staffing, and other physical resources available to the Early Independence investigator adequate? Will the research activities within the institution help foster the development for the Early Independence investigator? Will the Early Independence investigator benefit from unique features of the scientific environment and collaborative arrangements? Is there evidence that the Early Independence investigator will have the necessary institutional commitment to conduct full-time, independent research for the duration of this award at the level of effort required? Will the Early Independence investigator be given appropriate access to facilities and resources? Are shared institutional resources being made available to the Early Independence investigator? Are the plans for appointing and integrating the Early Independence investigator into the institutional scientific culture adequate and appropriate? Will the research activities and resources provided to the Early Independence investigator assist in the development and strengthening of his/her career? Are the strategies for addressing potential problems adequate? Are benchmarks for the success of the Early Independence investigator presented? Are the proposed plans and criteria to monitor the long-term success of the select Early Independence investigator adequate? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?
In addition, for applications involving clinical trials
If proposed, are the administrative, data coordinating, enrollment and laboratory/testing centers, appropriate for the trial proposed?
Does the application adequately address the capability and ability to conduct the trial at the proposed site(s) or centers? Are the plans to add or drop enrollment centers, as needed, appropriate?
If international site(s) is/are proposed, does the application adequately address the complexity of executing the clinical trial?
If multi-sites/centers, is there evidence of the ability of the individual site or center to: (1) enroll the proposed numbers; (2) adhere to the protocol; (3) collect and transmit data in an accurate and timely fashion; and, (4) operate within the proposed organizational structure?
Additional Review Criteria
As applicable for the project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact score, but will not give separate scores for these items.
Specific to applications proposing clinical trials
Is the study timeline described in detail, taking into account start-up activities, the anticipated rate of enrollment, and planned follow-up assessment? Is the projected timeline feasible and well justified? Does the project incorporate efficiencies and utilize existing resources (e.g., CTSAs, practice-based research networks, electronic medical records, administrative database, or patient registries) to increase the efficiency of participant enrollment and data collection, as appropriate?
Are potential challenges and corresponding solutions discussed (e.g., strategies that can be implemented in the event of enrollment shortfalls)?
Protections for Human Subjects
For research that involves human subjects but does not involve one of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.
For research that involves human subjects and meets the criteria for one or more of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Guidelines for the Review of Human Subjects.
Inclusion of Women, Minorities, and Children
When the proposed project involves human subjects and/or NIH-defined clinical research, the committee will evaluate the proposed plans for the inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion (or exclusion) of children to determine if it is justified in terms of the scientific goals and research strategy proposed. For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research.
The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following criteria: (1) description of proposed procedures involving animals, including species, strains, ages, sex, and total number to be used; (2) justifications for the use of animals versus alternative models and for the appropriateness of the species proposed; (3) interventions to minimize discomfort, distress, pain and injury; and (4) justification for euthanasia method if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals. Reviewers will assess the use of chimpanzees as they would any other application proposing the use of vertebrate animals. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.
Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.
Additional Review Considerations
As applicable for the project proposed, reviewers will consider each of the following items, but will not give scores for these items, and should not consider them in providing an overall impact score.
Applications from Foreign Organizations
Select Agent Research
Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).
Authentication of Key Biological and/or Chemical Resources:
For projects involving key biological and/or chemical resources, reviewers will comment on the brief plans proposed for identifying and ensuring the validity of those resources.
Budget and Period of Support
Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.
2. Review and Selection Process
Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by Center for Scientific Review, in accordance with NIH peer review policy and procedures, using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.
May undergo a selection process in which only those applications deemed to have the highest scientific and technical merit will be discussed and assigned an overall impact score.
Will receive a written critique.
Appeals of initial peer review will not be accepted for applications submitted in response to this FOA.
Applications will be assigned to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications submitted in response to this FOA. Following initial peer review, recommended applications will receive a second level of review by the Council of Councils. The following will be considered in making funding decisions:
Scientific and technical merit of the proposed project as determined by scientific peer review.
Availability of funds.
Relevance of the proposed project to program priorities, including:
The potential for the PD/PI to lead a vigorous independent research program.
Unusually cross-cutting or underrepresented science.
Scientific balance in the portfolio of the Early Independence Award-supported research.
3. Anticipated Announcement and Award Dates
After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons. Refer to Part 1 for dates for peer review, advisory council review, and earliest start date.
Information regarding the disposition of applications is available in the NIH Grants Policy Statement.
Section VI. Award Administration Information
1. Award Notices
If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant as described in the NIH Grants Policy Statement.
A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. The NoA signed by the grants management officer is the authorizing document and will be sent via email to the grantee’s business official.
Awardees must comply with any funding restrictions described in Section IV.5. Funding Restrictions. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.
Any application awarded in response to this FOA will be subject to terms and conditions found on the Award Conditions and Information for NIH Grants website. This includes any recent legislation and policy applicable to awards that is highlighted on this website.
Individual awards are based on the application submitted to, and as approved by, the NIH and are subject to the IC-specific terms and conditions identified in the NoA.
ClinicalTrials.gov: If an award provides for one or more clinical trials, by law (Title VIII, Section 801 of Public Law 110-85), the "responsible party" must register and submit results information for certain "applicable clinical trials" on the ClinicalTrials.gov Protocol Registration and Results System Information Website (https://register.clinicaltrials.gov). NIH expects registration of all trials whether required under the law or not. For more information, see http://grants.nih.gov/ClinicalTrials_fdaaa/.
Institutional Review Board or Independent Ethics Committee Approval: Grantee institutions must ensure that the application as well as all protocols are reviewed by their IRB or IEC. To help ensure the safety of participants enrolled in NIH-funded studies, the awardee must provide NIH copies of documents related to all major changes in the status of ongoing protocols.
Data and Safety Monitoring Requirements: The NIH policy for data and safety monitoring requires oversight and monitoring of all NIH-conducted or -supported human biomedical and behavioral intervention studies (clinical trials) to ensure the safety of participants and the validity and integrity of the data. Further information concerning these requirements is found at http://grants.nih.gov/grants/policy/hs/data_safety.htm and in the application instructions (SF424 (R&R) and PHS 398).
Investigational New Drug or Investigational Device Exemption Requirements: Consistent with federal regulations, clinical research projects involving the use of investigational therapeutics, vaccines, or other medical interventions (including licensed products and devices for a purpose other than that for which they were licensed) in humans under a research protocol must be performed under a Food and Drug Administration (FDA) investigational new drug (IND) or investigational device exemption (IDE).
2. Administrative and National Policy Requirements
All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities. More information is provided at Award Conditions and Information for NIH Grants.
Recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights law. This means that recipients of HHS funds must ensure equal access to their programs without regard to a person’s race, color, national origin, disability, age and, in some circumstances, sex and religion. This includes ensuring your programs are accessible to persons with limited English proficiency. HHS recognizes that research projects are often limited in scope for many reasons that are nondiscriminatory, such as the principal investigator’s scientific interest, funding limitations, recruitment requirements, and other considerations. Thus, criteria in research protocols that target or exclude certain populations are warranted where nondiscriminatory justifications establish that such criteria are appropriate with respect to the health or safety of the subjects, the scientific study design, or the purpose of the research.
In accordance with the statutory provisions contained in Section 872 of the Duncan Hunter National Defense Authorization Act of Fiscal Year 2009 (Public Law 110-417), NIH awards will be subject to the Federal Awardee Performance and Integrity Information System (FAPIIS) requirements. FAPIIS requires Federal award making officials to review and consider information about an applicant in the designated integrity and performance system (currently FAPIIS) prior to making an award. An applicant, at its option, may review information in the designated integrity and performance systems accessible through FAPIIS and comment on any information about itself that a Federal agency previously entered and is currently in FAPIIS. The Federal awarding agency will consider any comments by the applicant, in addition to other information in FAPIIS, in making a judgement about the applicant’s integrity, business ethics, and record of performance under Federal awards when completing the review of risk posed by applicants as described in 45 CFR Part 75.205 “Federal awarding agency review of risk posed by applicants.” This provision will apply to all NIH grants and cooperative agreements except fellowships.
For additional guidance regarding how the provisions apply to NIH grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this FOA. HHS provides general guidance to recipients of FFA on meeting their legal obligation to take reasonable steps to provide meaningful access to their programs by persons with limited English proficiency. Please see http://www.hhs.gov/ocr/civilrights/resources/laws/revisedlep.html. The HHS Office for Civil Rights also provides guidance on complying with civil rights laws enforced by HHS. Please see http://www.hhs.gov/ocr/civilrights/understanding/section1557/index.html; and http://www.hhs.gov/ocr/civilrights/understanding/index.html. Recipients of FFA also have specific legal obligations for serving qualified individuals with disabilities. Please see http://www.hhs.gov/ocr/civilrights/understanding/disability/index.html. Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at http://www.hhs.gov/ocr/office/about/rgn-hqaddresses.html or call 1-800-368-1019 or TDD 1-800-537-7697. Also note it is an HHS Departmental goal to ensure access to quality, culturally competent care, including long-term services and supports, for vulnerable populations. For further guidance on providing culturally and linguistically appropriate services, recipients should review the National Standards for Culturally and Linguistically Appropriate Services in Health and Health Care at http://minorityhealth.hhs.gov/omh/browse.aspx?lvl=2&lvlid=53.
Cooperative Agreement Terms and Conditions of Award
A final RPPR, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH Grants Policy Statement.
The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for awardees of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later. All awardees of applicable NIH grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000. See the NIH Grants Policy Statement for additional information on this reporting requirement.
In accordance with the regulatory requirements provided at 45 CFR 75.113 and Appendix XII to 45 CFR Part 75, recipients that have currently active Federal grants, cooperative agreements, and procurement contracts from all Federal awarding agencies with a cumulative total value greater than $10,000,000 for any period of time during the period of performance of a Federal award, must report and maintain the currency of information reported in the System for Award Management (SAM) about civil, criminal, and administrative proceedings in connection with the award or performance of a Federal award that reached final disposition within the most recent five-year period. The recipient must also make semiannual disclosures regarding such proceedings. Proceedings information will be made publicly available in the designated integrity and performance system (currently FAPIIS). This is a statutory requirement under section 872 of Public Law 110-417, as amended (41 U.S.C. 2313). As required by section 3010 of Public Law 111-212, all information posted in the designated integrity and performance system on or after April 15, 2011, except past performance reviews required for Federal procurement contracts, will be publicly available. Full reporting requirements and procedures are found in Appendix XII to 45 CFR Part 75 – Award Term and Conditions for Recipient Integrity and Performance Matters.
Section VII. Agency Contacts
We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.
Application Submission Contacts
eRA Service Desk (Questions regarding ASSIST, eRA Commons registration, submitting and tracking an application, documenting system problems that threaten submission by the due date, post submission issues)
Finding Help Online: http://grants.nih.gov/support/ (preferred method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)