Department of Health and Human Services
Part 1. Overview Information
Participating Organization(s)

National Institutes of Health (NIH)

Components of Participating Organizations

National Institute on Aging (NIA)

Funding Opportunity Title

Paul B. Beeson Emerging Leaders Career Development Award in Aging (K76 Independent Clinical Trial Required)

Activity Code

K76 Emerging Leaders Career Development Award

Announcement Type

Reissue of RFA-AG-18-006

Related Notices

None

Funding Opportunity Announcement (FOA) Number

RFA-AG-19-018

 

Companion Funding Opportunity

RFA-AG-19-017, K76 Emerging Leaders Career Development Award

Catalog of Federal Domestic Assistance (CFDA) Number(s)

93.866    

 

Funding Opportunity Purpose

This Funding Opportunity Announcement (FOA) invites early-stage physician and other health professional investigators with a commitment to aging and/or aging-related diseases to apply for this award to advance their research and leadership skills in their specialty and in the broader field of aging and geriatrics research.

The National Institute on Aging is pursuing this initiative to recruit early-stage investigators who have begun to establish research programs and who, through this award, will be ready to assume leadership roles in their field of expertise and will be poised to change theory, practice and health outcomes related to the health of older individuals. Unlike other mentored K awards, candidates for this award must have received competitively awarded research support as a PD/PI at the faculty level or have otherwise leveraged faculty-level research support to develop an independent line of research. They must show evidence of leadership in the clinical or research domain.

This Funding Opportunity Announcement (FOA) is designed specifically for applicants proposing to serve as the lead investigator of an independent clinical trial, a clinical trial feasibility study, or an ancillary clinical trial, as part of their research and career development. Applicants not planning an independent clinical trial, or proposing to gain research experience in a clinical trial led by another investigator, must apply to the companion FOA (RFA-AG-19-017).    

Key Dates
Posted Date

June 8, 2018

Open Date (Earliest Submission Date)

September 24, 2018

 

Letter of Intent Due Date(s)

Not Applicable

Application Due Date(s)

October 24, 2018, by 5:00 PM local time of applicant organization. All types of non-AIDS applications allowed for this funding opportunity announcement are due on this date.

No late applications will be accepted for this Funding Opportunity Announcement.

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.

AIDS Application Due Date(s)

Not Applicable

Scientific Merit Review

January/February 2019

Advisory Council Review

May 2019

Earliest Start Date

July 2019

Expiration Date

October 25, 2018

Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

It is critical that applicants follow the Career Development (K) 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.

  1. Use the NIH ASSIST system to prepare, submit and track your application online.
  2. 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.

  3. Use Grants.gov Workspace to prepare and submit your application and eRA Commons to track your application.
  4. Table of Contents

    Part 1. Overview Information
    Part 2. Full Text of the Announcement

    Section I. Funding Opportunity Description
    Section II. Award Information
    Section III. Eligibility Information
    Section IV. Application and Submission Information
    Section V. Application Review Information
    Section VI. Award Administration Information
    Section VII. Agency Contacts
    Section VIII. Other Information

     


    Part 2. Full Text of Announcement
    Section I. Funding Opportunity Description

    The overall goal of the NIH Research Career Development program is to help ensure that a diverse pool of highly trained scientists is available in appropriate scientific disciplines to address the Nation's biomedical, behavioral, and clinical research needs. NIH Institutes and Centers (ICs) support a variety of mentored and non-mentored career development award programs designed to foster the transition of new investigators to research independence and to support established investigators in achieving specific objectives. Candidates should review the different career development (K) award programs to determine the best program to support their goals. More information about Career programs may be found at the NIH Extramural Training Mechanisms website.

    The objective of the NIH Emerging Leaders Career Development Award (K76) is to help develop a cadre of emerging scientists prepared to take an active leadership role in transformative change that will lead to improved research or healthcare outcomes. This program supports basic or clinically trained faculty members who seek additional research, professional career and leadership skills essential for assuming a leadership role in an increasingly global biomedical workforce. NIH Emerging Leaders are early-stage investigators (https://grants.nih.gov/policy/early-investigators/index.htm) conducting research who have shown early signs of leadership and who will use this award to further develop the tools, skills and resources to have a significant impact as leaders in their field of expertise. These skills will prepare them to assume academic leadership roles and independent careers in an emerging discipline within their professional specialty. Emerging leaders demonstrate a commitment to increase the visibility and overall research support and academic capacity within their educational, medical/health or research community. Their scientific expertise will be in demand as reviewers, educators and policy makers.

    Within the field of aging research the small numbers of individuals skilled in geriatrics and the smaller numbers pursuing research on aging are inadequate to address the burgeoning needs of the rapidly growing older population. A key goal of this initiative therefore is to foster the careers of emerging clinical investigators who possess the skills and fortitude necessary for academic leadership in aging and geriatrics. Unlike other mentored K award programs, this initiative will recruit investigators who have had competitively awarded research support at the faculty level and who have shown early signs of leadership in their field of expertise. Although early-stage investigators, through their efforts, these individuals are well poised to change theory, practice and health outcomes related to the health of older individuals. Emerging leaders will use this award to capitalize on current opportunities in clinical and translational research or groundbreaking basic research in aging and geriatrics to advance an emerging discipline or effect changes in practice within their professional specialty.

    The program is named after Dr. Paul B. Beeson who profoundly influenced the career paths of many physicians, including several who now form the core leadership in geriatric medicine. Dr. Beeson was Chairman of Medicine at Emory and Yale Medical Schools, Nuffield Professor at Oxford University and Professor and distinguished VA Physician at the University of Washington. He chaired the first Institute of Medicine study on "Aging and Medical Education" in 1978. His leadership as an editor of the Cecil Textbook of Medicine greatly influenced medical education. From his research and patient care base, he grew increasingly interested in the process of aging, and this interest led to a commitment that included his editorship of the Journal of the American Geriatrics Society.

    The aims of the Paul B. Beeson Emerging Leaders Career Development Award in Aging program are:

    To provide support for career development and to advance the leadership skills of medical and surgical specialists conducting clinically relevant basic, translational or clinical, and Patient-Oriented Research (POR) in disciplines relevant to aging and geriatrics.

    To deepen the commitment of research institutions to promote transformative academic research and leadership in aging and geriatric medicine by linking mentors to emerging scientists with a commitment to future leadership in aging research and policy.

    NIA welcomes applications in all of the fields of aging research from basic science, through diseases and disabling conditions of aging, to topics of the social consequences of an aging society and topics in between. A particular priority of NIA at the moment is research on Alzheimer's disease (AD) and on Alzheimer's-related dementias (ADRD).

    Program

    The objective of the NIH Emerging Leaders Career Development Award is to provide salary and research support for a sustained period of "protected time" (3-5 years) for career development and to advance the leadership skills of physican-investigators and other health-professionally trained investigators. These investigators conduct research in basic, translational or clinical, and Patient-Oriented Research (POR) in disciplines relevant to aging and geriatrics.

    The award is intended to prepare early-stage investigators for academic research leadership as well as mentoring in their scientific research area of interest. The focus is on building a cadre of investigators and leaders to advance knowledge and skills in a new field, a new methodology, or a new approach, both through their own research and, through their leadership, in the broader community of their specialty.

    This career development award allows candidates to expand their research area of interest and pursue activities consistent with the expectation of future leadership in the candidate's chosen field. Candidates must identify mentors who are senior researchers in aging and/or age-related diseases and conditions, and who agree to commit time to supervising and guiding the candidate during the period of the award. A part of that commitment is the intent to advance the candidate both as a researcher and as an emerging leader in the field.

    This initiative is targeted primarily at individuals who have had prior training in research coursework, methods, and resources related to aging and who have received initial funding for research such as through Small Grant support from NIH, through similar support from other federal agencies, or through foundation funding. The award(s) should have been competitively awarded to the candidate at the faculty level. Individuals who have leveraged faculty-level research development support to advance and develop an independent line of research and who can provide evidence that they possess the attributes of committed and skilled leaders in their respective fields are also welcome to apply.

    Prior evidence of leadership can be in either clinical duties or in research activities that illustrate keen engagement and commitment to moving their respective field forward. Examples include: organizing seminar series, conferences or symposia at a national meeting, organizing workshops, or other activities where the candidate has played a leading role in enhancing her/his fields' academic medical/health and research accomplishments and visibility.

    The proposed career development and research should focus on aging or the aged. For this FOA, the candidate's project may be in any of a broad range of basic, translational or patient-oriented research areas relevant to aging. The full range of research methods appropriate to completing the proposed investigation is encouraged. We expect that scholars will contribute significantly to the research and scientific literature associated with the field of aging research.

    Annual meetings are a valuable forum for scientific and professional networking opportunities for current Beeson awardees, Beeson alumni and mentors. A central part of the award is an annual meeting for Beeson scholars and their mentors. The meeting sparks collaborations and exposes scholars to a wide range of exciting science on aging.

    NIH defines a clinical trial as "A research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes." (NOT-OD-15-015).

    NIH not only supports trials of safety and efficacy, it also supports mechanistic exploratory studies that meet the definition of a clinical trial and are designed to explore or understand a biological or behavioral process, the pathophysiology of a disease, or the mechanism of action of an intervention.  These studies may focus on basic and/or translational discovery research in healthy human subjects and in human subjects who are affected by the pathophysiology of diseases and disorders.  By addressing basic questions and concepts in biology, behavior, and pathophysiology, these studies may provide insight into understanding human diseases and disorders along with potential treatments or preventive strategies.  NIH also supports biomarker studies that meet the definition of a clinical trial and that may provide information about physiological function, target engagement of novel therapeutics, and/or the impact of therapeutics on treatment response.  NIH thus supports studies that meet the definition of clinical trials (as noted above) but do not seek to establish safety, clinical efficacy, effectiveness, clinical management, and/or implementation of preventive, therapeutic, and services interventions. 

    Note: This Funding Opportunity Announcement (FOA) is designed specifically for applicants proposing to serve as the lead investigator of an independent clinical trial, a clinical trial feasibility study, or an ancillary clinical trial, as part of their research and career development. Applicants not planning an independent clinical trial, or proposing to gain research experience in a clinical trial led by another investigator, must apply to companion FOA (RFA-AG-19-017).

    See Section VIII. Other Information for award authorities and regulations.

    Section II. Award Information
    Funding Instrument

    Grant: A support mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity.

    Application Types Allowed

    New
    Resubmission of applications to RFA-AG-18-006

    The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types.

    Clinical Trial?

    Required: Only accepting applications that propose an independent clinical trial(s)

    Need help determining whether you are doing a clinical trial?

    Funds Available and Anticipated Number of Awards

    NIA intends to commit $2 million in FY 2019 to fund an estimate of 7 to 10 awards for this RFA and its companion. Future year amounts will depend on annual appropriations.

    Award Budget

    Award budgets are composed of salary and other program-related expenses, as described below and are limited to $225,000 in direct costs in any year. 

    Award Project Period

    The total project period may not exceed 5 years.

     

    Other Award Budget Information
    Salary

    NIH will contribute up to the legislative limit per year toward the salary of the career award recipient. Further guidance on budgeting for career development salaries is provided in the SF424 (R&R) Application Guide. Salary must be within the overall direct cost limit of $225,000 (see also NOT-OD-17-094).

    The total NIH contribution to salary, however, may not exceed the legislatively mandated salary cap.  See: http://grants.nih.gov/grants/policy/salcap_summary.htm.

    Other Program-Related Expenses

    NIH will contribute support up to the overall direct cost limit per year toward the research development costs of the award recipient, which must be justified and consistent with the stage of development of the candidate and the proportion of time to be spent in research or career development activities.

    Salary for mentors, secretarial and administrative assistants, etc. is not allowed. It is expected that awardees will use a portion of their research development funds to cover the costs of traveling to an annual domestic meeting for Beeson scholars.

    Indirect Costs

    Indirect Costs (also known as Facilities & Administrative [F&A] Costs) are reimbursed at 8% of modified total direct costs.

    NIH grant 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
    Eligible Organizations

    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:

    • Hispanic-serving Institutions
    • 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

    • Small Businesses
    • For-Profit Organizations (Other than Small Businesses)

    Governments

    • State Governments
    • County Governments
    • 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
    • U.S. Territory or Possession

    Other

    • 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
    • Regional Organizations

     

    Foreign Institutions

    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 not allowed.

    Required Registrations

    Applicant Organizations

    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.
    • NATO Commercial and Government Entity (NCAGE) Code – Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM. 
    • 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.

    Eligible Individuals (Program Director/Principal Investigator)

    Any candidate 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 mentor and 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. Multiple PDs/PIs are not allowed.

    By the time of award, the individual must be a citizen or a non-citizen national of the United States or have been lawfully admitted for permanent residence (i.e., possess a currently valid Permanent Resident Card USCIS Form I-551, or other legal verification of such status).

    Candidates for the K76 award must retain their early-stage investigator status at the time of award. Candidates must have a research or clinical doctoral degree, including, but not limited to PhD, MD, DO, DDS, DMD, OD, DC, PharmD, ND (Doctor of Naturopathy), and DVM.

    2. Cost Sharing

    This FOA does not require cost sharing as defined in the NIH Grants Policy Statement.

    3. Additional Information on Eligibility
    Number of Applications

    Applicant organizations may submit more than one application, provided that each application is scientifically distinct, and each is from a different candidate.

    The NIH will not accept duplicate or highly overlapping applications under review at the same time. An individual may not have two or more competing NIH career development applications pending review concurrently. In addition, 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).

    Candidates may submit research project grant (RPG) applications concurrently with the K application. However, any concurrent RPG application may not have substantial scientific and/or budgetary overlap with the career award application. K award recipients are encouraged to obtain funding from NIH or other Federal sources either as a PD/PI on a competing research grant award or cooperative agreement, or as project leader on a competing multi-project award as described in NOT-OD-08-065.

    Level of Effort

    At the time of award, the candidate must have a "full-time" appointment at the academic institution. Candidates are required to commit a minimum of 75% of full-time professional effort (i.e., a minimum of 9 person-months) to their program of career development during the mentored phase. Candidates may engage in other duties as part of the remaining 25% of their full-time professional effort not covered by this award, as long as such duties do not interfere with or detract from the proposed career development program.

    Candidates who have VA appointments may not consider part of the VA effort toward satisfying the full time requirement at the applicant institution. Candidates with VA appointments should contact the staff person in the relevant Institute or Center prior to preparing an application to discuss their eligibility.

     After the receipt of the award, adjustments to the required level of effort may be made in certain circumstances.  See NOT-OD-09-036 for more details.  

    Mentor(s)

    Before submitting the application, the candidate must identify a mentor who will supervise the proposed career development and research experience. The mentor should be an active investigator in the area of the proposed research and be committed both to the career development of the candidate and to the direct supervision of the candidate's research. The mentor must document the availability of sufficient research support and facilities for high-quality research. Candidates are encouraged to identify more than one mentor, i.e., a mentoring team, if this is deemed advantageous for providing expert advice in all aspects of the research career development program. In such cases, one individual must be identified as the primary mentor who will coordinate the candidate's research. The candidate must work with the mentor(s) in preparing the application. The mentor, or a member of the mentoring team, should have a successful track record of mentoring individuals at the candidate's career stage. Where feasible, women, individuals from diverse racial and ethnic groups, and individuals with disabilities should be involved as mentors to serve as role models.

    The mentor(s) or mentoring team must demonstrate appropriate expertise, experience, and ability to guide the applicant in the organization, management and implementation of the proposed research and clinical trial.

    Peer Reviewed Research Support

    Candidates for the K76 award are expected to hold or have had prior competitively awarded research support as a PD/PI at the faculty level or have leveraged faculty-level research development support to advance and develop an independent line of research.

    Institutional Environment

    The applicant institution must have a strong, well-established record of research and career development activities and faculty qualified to serve as mentors in biomedical, behavioral, or clinical research.

    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.

    2. Content and Form of Application Submission

    It is critical that applicants follow the Career Development (K) Instructions in the SF424 (R&R) Application Guide, except where instructed in this funding opportunity announcement to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

    For information on Application Submission and Receipt, visit Frequently Asked Questions – Application Guide, Electronic Submission of Grant Applications.

    Page Limitations

    All page limitations described in the SF424 (R&R) Application Guide and the Table of Page Limits must be followed.

    Instructions for Application Submission

    The following section supplements the instructions found in the SF 424 (R&R) Application Guide and should be used for preparing an application to this FOA.

    SF424(R&R) Cover

    All instructions in the SF424 (R&R) Application Guide must be followed.   

    SF424(R&R) Project/Performance Site Locations

    All instructions in the SF424 (R&R) Application Guide must be followed.   

    Other Project Information

    All instructions in the SF424 (R&R) Application Guide must be followed.

    SF424(R&R) Senior/Key Person Profile Expanded

    All instructions in the SF424 (R&R) Application Guide must be followed. 

    R&R Budget

    All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions: Include funds in the budget to travel to an annual domestic meeting for Beeson scholars.

    PHS 398 Cover Page Supplement

    All instructions in the SF424 (R&R) Application Guide must be followed.

    PHS 398 Career Development Award Supplemental Form

    The PHS 398 Career Development Award Supplemental Form is comprised of the following sections:

    Candidate

    Research Plan

    Other Candidate Information

    Mentor, Co-Mentor, Consultant, Collaborators

    Environment & Institutional Commitment to the Candidate

    Other Research Plan Sections

    Appendix

    All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions:

    Candidate Section

    All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions:

    Candidate Information and Goals for Career Development

     Candidate's Background

    • Describe the candidate's commitment to a health-related research career with a focus on aging, including Alzheimer's disease and its related dementias, and other geriatric conditions. Describe all the candidate's professional responsibilities in the grantee institution and elsewhere and describe their relationship to the proposed activities on the career award. This description can reference but should not duplicate information from the biosketch.
    • Describe prior training and how it relates to the objectives and long-term career plans of the candidate. Where a candidate is requesting more than five years of combined mentored career award support with earlier years obtained from other awards (such as K12s, KL2s, or K23s) and the additional years obtained from the Beeson award, the extra time beyond five years should be clearly justified.
    • Describe the candidate's research efforts to this point in his/her research career, including any publications, prior research interests and experience.
    • Provide evidence of the candidate's potential to develop into an independent investigator focused on aging research.
    • Describe the candidate's background as an emerging leader: How the candidate has (a) prior or current competititve external funding for research at the faculty level; (b) lead-author, peer-reviewed publications; and (c) current leadership experience either in clinical duties or in research activities. This description can reference but should not duplicate information from the biosketch.
    • Provide evidence that the candidate has an area of research where she/he intends to show future leadership in promulgating research and research findings on aging to a professional community or to the general public.
    • If applicable, describe the candidate's prior clinical trials research efforts, research interests and experience.

    Career Goals and Objectives

    • Describe a systematic plan that: (1) shows a logical progression from prior research and training experiences to the research, career development, and leadership activities that will occur during the career award period and following the award; (2) justifies the need for further career development to become an independent investigator and emerging leader; and (3) uses the relevant research and educational resources of the institution.
    • Describe the candidate's immediate, near-term, and long-range career development goals.
    • The candidate must demonstrate they have received training or will participate in courses such as: data management, epidemiology, study design (including statistics), hypothesis development, drug development, etc., as well as the legal and ethical issues associated with research on human subjects and clinical trials.

    Candidate's Plan for Career Development/Training Activities During Award Period

    • The candidate and the mentor are jointly responsible for the preparation of the career development plan. A career development timeline is often helpful. The mentor and any co-mentor may form a mentoring team to assist with the development of a program of study or to monitor the candidate's progress through the career development program.
    • Describe a career development plan that will contribute substantially to the continued scientific development, productivity and leadership potential of the candidate.
    • Show how the career development plan is integrated with both leadership goals and research goals.

    Research Plan Section

    All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions:

    Research Strategy

    • Provide a sound research project with a primary focus on aging (including aging-related diseases and conditions) that is consistent with the candidate's level of research development and objectives of his/her career development plan. The research description should demonstrate the quality of the candidate's research thus far and also the novelty, significance, creativity and approach, as well as the ability of the candidate to carry out the research.
    • The application must also describe the relationship between the mentor's research and the candidate's proposed research plan and the benefits of that relationship including how the candidate's project will lead to an independent line of research. For disciplines such as large epidemiological studies requiring team-based approaches, explain how the research will enhance the candidate's expertise to have a major role in designing and leading future projects.
    • Applicants proposing a clinical trial, ancillary or feasibility study should describe the planned analyses and statistical approach and how the expected analytical approach is suited to the available resources, proposed study design, scope of the project, and methods used to assign trial participants and deliver interventions.
    • If proposing an ancillary clinical trial, provide a brief description of its relationship to the larger clinical trial.
    • If proposing a feasibility study, to begin to address a clinical question, provide justification why this is warranted and how it will contribute to the overall goals of the research project including planning and preliminary data for future, larger scale clinical trials.
    • Describe the proposed timelines for the proposed clinical trial, feasibility or ancillary study, including any potential challenges and solutions (e.g., enrollment shortfalls or inability to attribute causal inference to the results of an intervention when performing a small feasibility study).
    • Describe how the proposed clinical trial or ancillary study will test the safety, efficacy or effectiveness of an intervention that could lead to a change in clinical practice, community behaviors or health care policy (This would not apply to a feasibility study).
    •  

    Training in the Responsible Conduct of Research

    • All applications must include a plan to fulfill NIH requirements for instruction in the Responsible Conduct of Research (RCR). See SF424 (R&R) Application Guide for instructions.

    Mentor, Co-Mentor, Consultant, Collaborators Section

    All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions:

    Plans and Statements of Mentor and Co-mentor(s)

    • The candidate must name a primary mentor who, together with the candidate, is responsible for the planning, directing, monitoring, and executing the proposed program. The candidate may also nominate co-mentors as appropriate to the goals of the program. 
    • The mentor should be recognized as an accomplished investigator in the proposed research area and have a track record of success in training and placing independent investigators. Experience and leadership in aging research (including age-related dieases and conditions) is important in the mentor or mentoring team.
    • The mentor should have sufficient independent research support to cover the costs of the proposed research project in excess of the allowable costs of this award.
    • The application must include a statement from the mentor providing: 1) information on his/her research qualifications and previous experience as a research supervisor; 2) a plan that describes the nature of the supervision and mentoring that will occur during the proposed award period; 3) a plan for career progression for the candidate to move from the mentored stage of his/her career to independent research investigator status during the project period of the award; and 4) a plan for monitoring the candidate's research, publications, and progression towards independence.
    • Similar information must be provided by any co-mentor.  If more than one co-mentor is proposed, the respective areas of expertise and responsibility of each should be described.  Co-mentors should clearly describe how they will coordinate the mentoring of the candidate. If any co-mentor is not located at the sponsoring institution, a statement should be provided describing the mechanism(s) and frequency of communication with the candidate, including the frequency of face-to-face meetings.
    • The mentor must agree to provide annual evaluations of the candidate's progress as required in the annual progress report.
    • The mentor or mentoring team must provide evidence of expertise, experience, and ability to guide the applicant in the organization, management and implementation of the proposed clinical trial, ancillary or feasibility study and help him/her to meet timelines.

    Letters of Support from Collaborators, Contributors and Consultants

    • Signed statements must be provided by all collaborators and/or consultants confirming their participation in the project and describing their specific roles. Collaborators and consultants do not need to provide their biographical sketches unless also listed as senior/key personnel. However, information should be provided clearly documenting the appropriate expertise in the proposed areas of consulting/collaboration.
    • Advisory committee members (if applicable): Signed statements must be provided by each member of the proposed advisory committee.  These statements should confirm their participation, describe their specific roles, and document the expertise they will contribute.  Unless also listed as senior/key personnel, these individuals do not need to provide their biographical sketches.

    Environmental and Institutional Commitment to the Candidate

    All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions:

    Description of Institutional Environment

    • The sponsoring institution must document a strong, well-established research and career development program related to the candidate's area of interest, including a high-quality research environment with key faculty members and other investigators capable of productive collaboration with the candidate.
    • Describe how the institutional research environment is particularly suited for the development of the candidate's research career and the pursuit of the proposed research plan.
    • Describe the resources and facilities that will be available to the candidate, including any clinical trial-related resources, such as specialized administrative, data coordinating, enrollment, and laboratory/testing support.  If applicable, include a description of the resources and facilities available at international sites.

    Institutional Commitment to the Candidate's Research Career Development

    • The sponsoring institution must provide a statement of commitment to the candidate's development into a productive, independent investigator and to meeting the requirements of this award. It should be clear that the institutional commitment to the candidate is not contingent upon receipt of this career award.
    • Provide assurances that the candidate will be able to devote the required effort to activities under this award.The remaining effort should be devoted to activities related to the development of the candidate's career as an independent scientist.
    • Provide assurances that the candidate will have access to appropriate office and laboratory space, equipment, and other resources and facilities (including access to clinical and/or other research populations) to carry out the proposed research plan.
    • Provide assurance that appropriate time and support will be available for any proposed mentor(s) and/or other staff consistent with the career development plan.

    Candidates who will be using resources associated with a Clinical and Translational Science Award (CTSA) during the course of their career development award should include a letter of agreement from the CTSA PD/PI as part of their application.

    Appendix

    Limited items are allowed in the Appendix.  Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide; any instructions provided here are in addition to the SF424 (R&R) Application Guide instructions.

    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 a 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.

    Delayed Onset Study

    All instructions in the SF424 (R&R) Application Guide must be followed. 

    PHS Assignment Request Form

    All instructions in the SF424 (R&R) Application Guide must be followed. 

    Reference Letters

    Candidates must carefully follow the SF424 (R&R) Application Guide, including the time period for when reference letters will be accepted. Applications lacking the appropriate required reference letters will not be reviewed. This is a separate process from submitting an application electronically. Reference letters are submitted directly through the eRA Commons Submit Referee Information link and not through Grants.gov.

    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) using ASSIST or other electronic submission systems. 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.

    5. Intergovernmental Review (E.O. 12372)

    This initiative is not subject to intergovernmental review.

    6. Funding Restrictions

    All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

    Pre-award costs are allowable only as described in the NIH Grants Policy Statement.

    7. Other Submission Requirements and Information

    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.

    Important reminders:

    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.

    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 (SAM). 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.

    In order to expedite review, applicants are requested to notify the NIA Referral Office by email at ramesh.vemuri@nih.gov when the application has been submitted. Please include the FOA number and title, PD/PI name, and title of the application.  

    Post Submission Materials

    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
    1. Criteria

    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.

    Overall Impact

    Reviewers should provide their assessment of the likelihood that the proposed career development and research plan will enhance the candidate's potential for a productive, independent scientific research career in a health-related field, taking into consideration the criteria below in determining the overall impact score.

    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.

    The reviewers will consider that the clinical trial may include study design, methods, and intervention that are not by themselves innovative, but address important questions or unmet needs. Reviewers should also consider the scope of the clinical trial relative to the available resources, including the possibility that research support provided through K awards may be sufficient to support only small feasibility studies.

    Candidate

    • Does the backgrouind of the candidate reveal potential to become an outstanding independent investigator prepared to take an active leadership role in transformative change leading to improved health-care outcomes focused on aging, and age-related diseases and conditions?
    • Are the candidate's interactions with senior and junior scientists and trainees indicative of his/her ability to lead in their chosen field?
    • Is the candidate's academic, clinical (if relevant), and research record of high quality?
    • Is there likelihood that the award will contribute substantially to the academic and research career development of the candidate?
    • Do the reference letters on behalf of the candidate express the potential and commitment to the planned academic career program and the likelihood that the program will meet the candidate's career goals?
    • If the candidate is seeking more than five years (combined) of career development support are the additional years beyond five justified?
    • Does the candidate have the potential to organize, manage, and implement the proposed clinical trial, feasibility or ancillary study? 
    • Does the candidate have training (or plans to receive training) in data management and statistics including those relevant to clinical trials?

    Career Development Plan/Career Goals and Objectives/Plan to Provide Mentoring

    • What is the likelihood that the plan will contribute substantially to the scientific development of the candidate and lead to scientific independence?
    • Are the candidate's prior training and research experience appropriate for this award?
    • Are the content, scope, phasing, and duration of the career development plan appropriate when considered in the context of prior training/research experience and the stated training and research objectives for achieving research independence?
    • Are there adequate plans for monitoring and evaluating the candidate's research and career development progress?
    • Is the proposed plan to enhance leadership skills of the candidate of high quality?
    • Is the time requested appropriate to the career development plan?
    • Does the career development plan offer appropriate guidance in aging and/or age-related diseases and conditions?
    • Are appropriate timelines planned for the candidate's progress?
    • Is there a satisfactory and appropriate relationship of the research plan to the career development goals and the candidate's previous experience?

    Research Plan

    • Is there a strong scientific premise for the project?
    • Has the candidate presented strategies to ensure a robust and unbiased approach, as appropriate for the work proposed?
    • Has the candidate presented adequate plans to address relevant biological variables, such as sex, for studies in vertebrate animals or human subjects?
    • Are the proposed research question, design, and methodology of significant scientific and technical merit?
    • Is the research plan relevant to the candidate's research career objectives?
    • Is the research plan appropriate to the candidate's stage of research development and as a vehicle for developing the research skills described in the career development plan?
    • Is the plan for coupling the research with other planned activities, appropriate and adequate for providing the experience, knowledge, and skills necessary to achieve the objectives of the award?
    • Are the scientific rationale and need for a clinical trial, feasibility or ancillary study well supported by preliminary data, clinical and/or preclinical studies, or information in the literature or knowledge of biological mechanisms?
    • If proposing a small feasibility study, is the study warranted and will it contribute to planning and preliminary data needed for design of future larger scale clinical trials?
    • Is the clinical trial or ancillary study necessary for testing the safety, efficacy or effectiveness of an intervention, or in the case of a feasibility study necessary to establish feasibility of future clinical trial?
    • Is the study design justified and relevant to the clinical, biological, and statistical hypothesis(es) being tested?
    • Are the plans to standardize, assure quality of, and monitor adherence to, the protocol and data collection or distribution guidelines appropriate?
    • Are planned analyses and statistical approach appropriate for the proposed study design and methods used to assign participants and deliver interventions, if interventions are delivered?
    • For trials focusing on mechanistic, behavioral, physiological, biochemical, or other biomedical endpoints, is this trial needed to advance scientific understanding?

    Mentor(s), Co-Mentor(s), Consultant(s), Collaborator(s)

    • Are the qualifications of the mentor(s) in the area of the proposed research appropriate?
    • Does the mentor(s) adequately address the candidate's potential and his/her strengths and areas needing improvement?
    • Is there adequate description of the quality and extent of the mentor's proposed role in providing guidance and advice to the candidate?
    • Is the mentor's description of the elements of the research career development activities, including formal course work adequate?
    • Is there evidence of the mentor's, consultant's, and/or collaborator's previous experience in fostering the development of independent investigators?
    • Is there evidence of the mentor's current research productivity and peer-reviewed support?
    • Is active/pending support for the proposed research project appropriate and adequate?
    • Are there adequate plans for monitoring and evaluating the career development awardee's progress toward independence and advancing leadership skills?
    • Are the qualifications of the mentor(s) including current and pending research support, prior research experience, and mentoring track record appropriate and adequate for guiding the candidate in meeting the goals of the Development Award?
    • How appropriate is the expertise in aging and/or age-related diseases and conditions among the mentors and consultants?
    • Does the mentor or mentoring team have the expertise, experience, and ability to guide the applicant in the organization, management and implementation of the proposed clinical trial, ancillary, or feasibility study and help him/her to meet timelines?

    Environment & Institutional Commitment to the Candidate

    • Does the sponsoring institution clearly commit to ensuring that a minimum of 9 person-months (75% of the candidate's full-time professional effort) will be devoted directly to the research and career development activities described in the application, with the remaining percent effort being devoted to an appropriate balance of research, teaching, administrative, and clinical responsibilities?
    • Are the research facilities, resources and training opportunities, including faculty capable of productive collaboration with the candidate adequate and appropriate?
    • Is there assurance that the institution intends the candidate to be an integral part of its research program as an independent investigator?
    • Are the quality and relevance of the environment for continuing the scientific and professional development of the candidate and for others pursuing research appropriate and adequate?
    • 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 feasibility or ancillary study at the proposed site(s) or centers? If applicable, are there 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?
    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.

    Study Timeline for 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.

    Vertebrate Animals

    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.

    Biohazards

    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.

    Resubmissions

    For Resubmissions, the committee will evaluate the application as now presented, taking into consideration the responses to comments from the previous scientific review group and changes made to the project.

    Renewals

    Not Applicable

    Revisions

    Not Applicable

    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.

    Training in the Responsible Conduct of Research

    All applications for support under this FOA must include a plan to fulfill NIH requirements for instruction in the Responsible Conduct of Research (RCR).  Taking into account the level of experience of the applicant, including any prior instruction or participation in RCR as appropriate for the applicant's career stage, the reviewers will evaluate the adequacy of the proposed RCR training in relation to the following five required components: 1) Format - the required format of instruction, i.e., face-to-face lectures, coursework, and/or real-time discussion groups (a plan with only on-line instruction is not acceptable); 2) Subject Matter - the breadth of subject matter, e.g., conflict of interest, authorship, data management, human subjects and animal use, laboratory safety, research misconduct, research ethics; 3) Faculty Participation - the role of the mentor(s) and other faculty involvement in the fellow's instruction; 4) Duration of Instruction - the number of contact hours of instruction (at least eight contact hours are required); and 5) Frequency of Instruction –instruction must occur during each career stage and at least once every four years.  Plans and past record will be rated as ACCEPTABLE or UNACCEPTABLE, and the summary statement will provide the consensus of the review committee. See also: NOT-OD-10-019.

    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).

    Resource Sharing Plans

    Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: (1) Data Sharing Plan; (2) Sharing Model Organisms; and (3)  Genomic Data Sharing Plan (GDS).

    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), 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.

    As part of the scientific peer review, all applications:

    • May undergo a selection process in which only those applications deemed to have the highest scientific and technical merit (generally the top half of applications under review) will be discussed and assigned an overall impact score.
    • Will receive a written critique.

    Appeals for 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 National Advisory Council on Aging. 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.
    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. 

    Specific to applications proposing clinical trials, ancillary or feasibility studies

    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, or an ancillary clinical trial. By law (Title VIII, Section 801 of Public Law 110-85), the lead investigator 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. More specifically, for K Awards, visit the Research Career Development ("K") Awardees section of the NIH Grants Policy Statement.

    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.

    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 https://www.hhs.gov/civil-rights/for-individuals/special-topics/limited-english-proficiency/index.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 https://www.hhs.gov/civil-rights/for-providers/laws-regulations-guidance/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 https://www.hhs.gov/ocr/about-us/contact-us/index.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.

    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.

    3. Reporting

    When multiple years are involved, awardees will be required to submit the Research Performance Progress Report (RPPR) annually and financial statements as required in the NIH Grants Policy Statement. The Supplemental Instructions for Individual Career Development (K) RPPRs must be followed. The Mentor's Report must include an annual evaluation statement of the candidate's progress.

    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.

    4. Evaluation

    In carrying out its stewardship of human resource-related programs, the NIH may request information essential to an assessment of the effectiveness of this program from databases and from participants themselves. Participants may be contacted after the completion of this award for periodic updates on various aspects of their employment history, publications, support from research grants or contracts, honors and awards, professional activities, and other information helpful in evaluating the impact of the program.

    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)

    Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading forms and application packages)
    Contact Center Telephone: 800-518-4726
    Email: support@grants.gov

    GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
    Email: GrantsInfo@nih.gov (preferred method of contact)
    Telephone: 301-945-7573

    Scientific/Research Contact(s)

    Robin A. Barr, D.Phil.
    National Institute on Aging (NIA)
    Telephone: 301-402-7715
    Email: BarrR@mail.nih.gov

    Peer Review Contact(s)

    Alexander Parsadanian, Ph.D.
    National Institute on Aging (NIA)
    Telephone: 301-496-9666
    Email: ParsadanianA@mail.nih.gov

    Financial/Grants Management Contact(s)

    Lesa McQueen, M.Sc.
    National Institute on Aging (NIA)
    Telephone: 301-496-1472
    Email: McQueenL@mail.nih.gov

    Section VIII. Other Information

    Recently issued trans-NIH policy notices may affect your application submission. A full list of policy notices published by NIH is provided in the NIH Guide for Grants and Contracts. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

    Authority and Regulations

    Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Part 75.  

     

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