National Institutes of Health (NIH)
Funding Opportunity Title
Paul B. Beeson Clinical Scientist Development Award in Aging (K08)
K08 Clinical Investigator Award (CIA)
Reissue of RFA-AG-11-008
Funding Opportunity Announcement (FOA) Number
RFA-AG-12-004, Paul B. Beeson Patient-Oriented Research Career Development Award in Aging (K23)
Catalog of Federal Domestic Assistance (CFDA) Number(s)
The National Institute on Aging (NIA), and the National Institute of Neurological Disorders and Stroke (NINDS), working in part with funds contributed by the John A. Hartford Foundation (http://www.jhartfound.org/) and The American Federation for Aging Research (http://afar.org/), are pursuing this initiative to encourage and assist the development of future leaders in the field of aging by supporting clinically trained (primarily physician) faculty members early in their careers to gain additional research training and to establish independent programs in aging research.
August 1, 2011
Open Date (Earliest Submission Date)
September 27, 2011
Letter of Intent Due Date
Application Due Date(s)
(New Date October 28, 2011 per NOT-OD-12-008), Original Date October 27, 2011, by 5:00 PM local time of applicant organization.
AIDS Application Due Date(s)
Scientific Merit Review
February - March 2012
Advisory Council Review
Earliest Start Date(s)
(New Date October 29, 2011 per NOT-OD-12-008), Original Date October 28, 2011
Due Dates for E.O. 12372
Required Application Instructions
It is critical that applicants follow the instructions in the SF 424 (R&R) Application Guide, especially Supplemental Instructions to the SF424 (R&R) for Preparing an Individual Research Career Development Award (CDA) Application (“K” Series) 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.
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
The overall goal of the NIH Research Career Development program is to help ensure that a diverse pool of highly trained scientists are available in appropriate scientific disciplines to address the Nation's biomedical, behavioral, and clinical research needs. More information about Career programs may be found at the NIH Extramural Training Mechanisms website.
1. Research Career Objectives
The National Institute on Aging (NIA), and the National Institute of Neurological Disorders and Stroke (NINDS), working in part with funds contributed by the John A. Hartford Foundation (http://www.jhartfound.org/), and The American Federation for Aging Research (http://afar.org/), are pursuing this initiative to sustain and promote the research careers of clinically trained individuals who are pursuing research careers in aging. The numbers of physicians and other clinically trained individuals who are committing to and sustaining independent research careers in the biomedical sciences remain inadequate to address the opportunities for translational research, interdisciplinary collaboration, and groundbreaking basic research being generated by advances in genetics, biomedical engineering, and other life sciences. Within the field of aging research the small numbers of individuals receiving training in geriatrics, and the smaller numbers pursuing research on aging remain inadequate to address the burgeoning needs of the rapidly growing older population. These needs require a substantial investment in current and future faculty who will devote their careers to advancing knowledge of effective prevention and management of illness and disabilities, and to inspire successive generations to do the same.
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. Dr. Beeson died in August 2006 at the age of 97.
The aims of the Paul B. Beeson Career Development Awards in Aging (BCDA) program are:
The broad fields of research appropriate for this K08 announcement include work in the basic sciences including animal models of aging or the use of secondary data analyses where there is apparent clinical relevance. Other examples include but are not limited to:
Additional information on research programs supported by the NIA can be found at http://www.nia.nih.gov/ResearchInformation/. The BCDA program particularly includes additional support for clinically trained scientists who wish to pursue careers dedicated to basic research on Alzheimer’s disease and other neurodegenerative diseases, formerly supported by the Alzheimer’s Disease Clinical Scientist Development Award announcement. Up to three additional awards each year will be dedicated to investigators planning careers in neuroscience related to aging and neurodegenerative disease. Overall the program will foster the independent research careers of clinically trained investigators whose research will enhance overall health and quality of life of Americans, particularly older people.
The objective of the NIH Mentored Clinical Scientist Research Career Development Award (K08) program is to provide salary and research support for a sustained period of “protected time” (3-5 years) to support didactic study and/or mentored research for individuals with clinical doctoral degrees (e.g., M.D., D.D.S., D.M.D., D.O., D.C., O.D., N.D., D.V.M., Pharm.D., or Ph.D. in clinical disciplines). The K08 provides support for an intensive, mentored research career development experience in biomedical or behavioral research, including translational research. For the purpose of this award, translational research is defined as application of basic research discoveries toward the diagnosis, management, and prevention of human disease. Individuals with a clinical doctoral degree interested in pursuing a career in patient-oriented research should refer to the companion RFA AG-004 the Paul B. Beeson Patient-Oriented Research Career Development Award in Aging (K23).
The K08 award may be used by candidates with different levels of prior research training and at different stages in their career development. For example, a candidate with limited experience in a given field of research may use an award to support a career development experience that includes a designated period of didactic training followed by a period of closely supervised research experience. A candidate with previous research experience and training may not require extensive additional didactic preparation, and may use an award to support a career development experience that focuses on an intensive, supervised research experience.
K08 Candidates must hold a doctoral degree, and must commit a minimum of 9 person-months (75% of full-time professional effort) conducting research and relevant career development activities during the period of the award. The sponsoring institution must demonstrate a commitment to provide the environment, resources and the protected time required for the candidate to perform the activities included in the proposed research and career development.
The BCDA provides support to clinically trained faculty members in strong research environments to enable them to gain skills and experience in clinically relevant aging research and to establish an independent program of research in these fields. If you are such a faculty member and wish to apply for this program you must identify a mentor or mentors. These individuals should be senior researchers in aging, and/or geriatrics who agree to commit time to supervising and guiding you during the period of the award.
The BCDA is intended to provide individual candidates with the resources and time to establish themselves as independent and funded investigators whose research focuses on clinically relevant topics in aging. It is targeted primarily at individuals who have had some 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. As a career development award it will allow the candidate time to expand his/her research training as well as pursue activities consistent with the expectation of future leadership in the candidate’s chosen field. These activities may include symposia, workshops or other activities in which the candidate has played a leading role in enhancing her/his fields’ academic medical/health and research accomplishments and visibility. The candidates’ career development plan should reflect a detailed strategy to advance both the research training and leadership goals of the BCDA. All principal investigators and their primary mentors should commit to attending one of the annual Beeson meetings as a condition of accepting a BCDA. Annual meetings are a valuable forum for scientific and professional networking opportunities for current Beeson awardees, Beeson alumni and mentors. (You should budget funds for your individual travel to and from the meeting, the location of which will vary from year to year.)
Relatively junior candidates (who have not yet received initial research support) may apply if they have shown clear evidence of early leadership potential through academic honors and awards and early research accomplishment. The career development plan should be tailored to the candidate’s particular career goals, current level of experience, and the environment (including mentors) in which the candidate’s career development will take place. Junior candidates with limited prior research training and research experience and more advanced candidates who are changing or expanding research areas will more likely need longer periods of support on the BCDA, and more didactic coursework and guided research experiences than those with more research training and experience in their proposed field of study. More advanced candidates who are now expanding their prior research efforts within their chosen field of study and transitioning to full independence should clearly state their specific career goals and how these goals will be realized through the proposed program of career development under this award. For all candidates, it is particularly important to show those career development activities that are essential to advance to independence, that complement the research planned, and that could not be accomplished through research support alone. Similarly it is important to show that the mentoring available through this award will clearly benefit the candidate’s emergence as a leading researcher in his/her chosen field.
To accommodate these differences in prior experience or intended direction the initial BCDA award may be from three to five years. In addition, clinically trained candidates with limited research experience are eligible for an up to two year renewal (formerly competing continuation) of the BCDA as described under Funds Available (Section II). Candidates who have a research doctorate earned prior to receiving the BCDA are not eligible for this renewal. The candidate’s program must be tailored to his/her individual needs and ensure that the candidate will gain the experience, knowledge and skills necessary to carry out high quality clinically relevant aging research. The candidate and the selected mentor(s) are jointly responsible for the preparation of the plan for this program.
The candidate may devote the remainder of his/her effort to activities that are consistent with the purpose of the award and which allow him/her to develop the necessary experience, knowledge and skills to become an independent researcher in a clinically relevant field of aging. The BCDA program allows support for the candidate’s salary, fringe benefits, and research/research development expenses to be used for research and training.
The proposed training and research must focus on research on aging, or the aged. The candidate’s research project may be in the basic sciences, use animal models, or employ primary or secondary data analysis. The full range of research methods appropriate to completing the proposed investigation is encouraged provided that the application makes clear the clinical relevance of the proposed work. The BCDA program also now includes funding for up to three additional positions formerly allocated to the NIA Alzheimer’s Disease Clinical Scientist Development Award program and therefore encourages additional applications addressing innovative approaches to neuroscience research that would have relevance to brain aging, Alzheimer’s disease and other neurodegenerative diseases.
Mentor(s): The candidate must name a primary mentor, who together with the candidate is responsible for the planning, direction, and execution of the program. Mentor(s) will also be responsible for providing an annual evaluation of the candidate's progress (as required) in the awardees' annual progress report. The mentor should be an accomplished investigator in the proposed research area and have a track record of success in training independent investigators. The candidate may also nominate co-mentors as appropriate to the goals of the program. It is important that research expertise in the fields of aging and an appropriate funding history of support for aging research be well-represented among the mentors. Where feasible, women, minority individuals and individuals with disabilities should be involved as mentors to serve as role models.
Primary mentors should commit to attending one of the annual Beeson meetings with the awardee as a condition of accepting a BCDA. Annual meetings are a valuable forum for scientific and professional networking opportunities for current Beeson awardees, Beeson alumni and mentors. (You should budget funds for your individual travel to and from the meeting, the location of which will vary from year to year.). The sponsoring applicant institution must have a well-established research and clinical career development program with an emphasis or specialty in geriatrics, or other topical areas within aging research. It must have faculty qualified in aging research to serve as mentors. The institution must demonstrate a commitment to the candidate’s development as a productive, independent investigator in aging-related research. Such commitment may be expressed in terms of the expected distribution of resources (for example, an independent laboratory) as the candidate progresses through the BCDA.
See Section VIII, Other Information -
Required Federal Citations, for policies related to this
The OER Glossary and the SF 424 (R&R) Application Guide provide details on these application types.
Funds Available and Anticipated Number of Awards
The National Institute on Aging, and the National Institute of Neurological Disorders and Stroke intend (in combination) to commit approximately $1 million in FY 2012 to support 5 to 7 awards. The number of awards is contingent upon NIH appropriations, and the submission of a sufficient number of meritorious applications.
The John A. Hartford Foundation and the American Federation for Aging Research (AFAR) have agreed to contribute to this initiative by providing supplemental awards to increase the number of candidates funded and/or by making independent awards and by sponsoring an annual meeting of the funded investigators and primary mentors. NIA, and NINDS strongly encourage you to share your application with these foundations and to share the results of peer review with them. You may send your application to the American Federation for Aging Research (AFAR) at the address below. AFAR will share it with the other listed foundation:
American Federation for Aging Research
Award budgets are composed of salary and other program-related expenses, as described below. Applicants may seek up to $200,000 (direct costs) per year. Direct costs requested across all years may be no more than $600,000 for three year awards; $700,000 for four year awards; and $800,000 for five year awards.
Award Project Period
Awards will be made for three, four or five years. (Note considerations in Part II, Section I, 2. Program, above.)
Applicants may seek up to $200,000 (direct costs) per year. Direct costs requested across all years may be no more than $600,000 for three year awards; $700,000 for four year awards; and $800,000 for five year awards.
The total salary requested must be based on a full-time
staff appointment. The salary must be consistent both with the established
salary structure at the institution and with salaries actually provided by
the institution from its own funds to other staff members of equivalent
qualifications, rank, and responsibilities in the department concerned.
Other Program-Related Expenses
NIH will contribute up to $200,000 per
year towards the award. Candidates may propose a budget
appropriate to the research and related needs (e.g.,
travel to one of the annual Beeson meetings) within this
Indirect Costs (also known as Facilities & Administrative [F&A] Costs) are reimbursed at 8% of modified total direct costs.
NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made in response to this FOA.
Higher Education Institutions
The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:
Nonprofits Other Than Institutions of Higher Education
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.
Applicant organizations must complete the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. Applicants must have a valid Dun and Bradstreet Universal Numbering System (DUNS) number in order to begin each of the following registrations.
All Program Directors/Principal Investigators (PD/PIs) must also work with their institutional officials to register with the eRA Commons or ensure their existing eRA Commons account is affiliated with the eRA Commons account of the applicant organization.
All registrations must be completed by the application due date. Applicant organizations are strongly encouraged to start the registration process at least four (4) weeks prior to the application due date.
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 Principal Investigators are not
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), or for non-U.S. citizen/permanent residents, requirements are described below.
Former PD/PIs on NIH research project (R01), program project (P01), center grants, FIRST Awards (R29), sub-projects of program project (P01) or center grants, other career development awards (K–awards), or the equivalent are not eligible. Former PD/PIs of an NIH Small Grant (R03), Exploratory/Developmental Grant (R21), Dissertation Awards (R36), or SBIR/STTR (R41, R42, R43, R44) remain eligible.
Candidates for this award must have a clinical doctoral degree. Such degrees include but are not limited to the M.D., D.O., D.D.S., D.M.D., O.D., D.C., Pharm.D., N.D. (Doctor of Naturopathy), D.V.M. Individuals with the Ph.D. or other doctoral degree in clinical disciplines such as clinical psychology, nursing, clinical genetics, speech-language pathology, audiology or rehabilitation are also eligible. Individuals holding the Ph.D. in a non-clinical discipline who are certified to perform clinical duties should contact the NIA or NINDS concerning their eligibility for a K08 award.
This FOA does not require cost sharing as defined in the NIH Grants Policy Statement.
Applicant organizations may submit more than one application, provided that each application is scientifically distinct.
NIH will not accept any application that is essentially the
same as one already reviewed. An individual may not have two or more competing
NIH career development applications pending review concurrently.
Resubmissions: Resubmissions will be accepted for applications submitted in response to the prior Beeson solicitations RFA-AG-10-010 Paul B. Beeson Clinical Scientist Development Award in Aging (K08) and RFA-AG-11-008 Paul B. Beeson Clinical Scientist Development Award in Aging (K08) but unfunded. Resubmission applications may be submitted, according to the NIH Policy on Resubmission Applications from the SF 424 (R&R) Application Guide.
Renewals: Generally renewal awards are not allowed. See Part 2, Section I.2 where a special exception is described. Also awards are not transferable from one PI/PD to another.
Resubmission applications may be submitted, according to the NIH Policy on Resubmission Applications from the SF 424 (R&R) Application Guide.
Special Requirements: A K08 awardee cannot hold the BCDA concurrently with another NIH career development award or similar award. The awardee must terminate that other award in order to receive the BCDA. Normally support from the prior career development award and support from the BCDA should total no more than five years. Generally principal investigators can have 5 years of CDA support in aggregate through a combination of K12 KL2 and independent K support. Requests for time beyond five years of total career award support must be justified by indicating changes in circumstances, such as a change of institution, or a change in research direction that requires additional mentoring or initial appointment to an institutional career award (K12 or KL2) at a junior level.
Candidates may submit research project grant (RPG)
applications concurrently with the K application. However, any concurrent RPG
application may not duplicate the provisions of the career award application. K
award recipients are encouraged to obtain funding from NIH or other Federal
sources either as a PI on a competing research grant award or cooperative
agreement, or as project leader on a competing multi-project award as described
This award requires the recipient to devote a minimum of 9 person-months (75 % of full-time professional effort) to conducting health-related research. The remaining effort may be devoted to clinical, teaching, or other research pursuits and activities consistent with the objectives of the award. For information regarding NIH policy on determining full-time professional effort for career awards, see NOT-OD-04-056. At the time of award, the candidate must have a “full-time” appointment at the academic institution that is the applicant institution. 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. Under certain circumstances, an awardee may submit a written request to the awarding component requesting a reduction in minimum required percent effort, which will be considered on a case-by-case basis. Details on this policy are provided in NOT-OD-09-036.
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. The mentor, or a member of the mentoring team,
should have a successful track record of mentoring. 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
principal mentor who will coordinate the candidate’s research. The candidate
must work with the mentor(s) in preparing the application.
The mentor(s) should describe the career development plan for the candidate (coordinated with the candidate’s research strategy). The mentor and any co-mentors are also expected to provide an assessment of the candidate’s qualifications and potential for a research career. The research environment and the availability and quality of needed research facilities and research resources (e.g., equipment, laboratory space, computer time, available research support, etc.) must also be described. The description should include items such as classes, seminars, and opportunities for interaction with other groups and scientists. Training in career skills, e.g. grant-writing and making effective presentations, is strongly encouraged.
Applicants must download the SF424 (R&R) application package associated with this funding opportunity using the “Apply for Grant Electronically” button in this FOA or following the directions provided at Grants.gov.
It is critical that applicants follow the 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.
The forms package associated with this FOA includes all applicable components, mandatory and optional. Please note that some components marked optional in the application package are required for submission of applications for this FOA. Follow the instructions in the SF 424 (R&R) Application Guide to ensure you complete all appropriate “optional” components.
All page limitations described in the SF424 (R&R) Application Guide and the Table of Page Limits must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions:
Project Summary/Abstract (Component of the Other Project Information Component)
This attachment must be uploaded via the Other Project Information Component, and must include a description of your current research and the research you propose to continue in the independent phase.
All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions:
Candidate’s Background (Component of Candidate Information)
Career Goals and Objectives (Component of Candidate Information)
Career Development/Training Activities During Award Period (Component of Candidate Information)
Training in the Responsible Conduct of Research
Individuals are required to comply with the instructions for Training in the Responsible Conduct of Research as provided in Chapter 7 of the SF424 (R&R) Application Guide.
Statements by Mentor, Co-mentor(s), Consultants, Contributors (Component of Statements of Support)
Description of Institutional Environment (Component of Environment and Institutional Commitment to the Candidate)
Institutional Commitment to the Candidate’s Research Career Development (Component of Environment and Institutional Commitment to the Candidate)
Research Strategy (Component of Research Plan)
Do not use the appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide
Candidates must carefully follow the SF424 (R&R) Application Guide, including the time period for when letters of reference will be accepted. Applications lacking the appropriate required reference letters will not be reviewed (more details in the Notice). 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.
Part I. Overview Information contains information about Key Dates. Applicants are encouraged to submit in
advance of the deadline to ensure they have time to make any application
corrections that might be necessary for successful submission.
Organizations must submit applications via 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.
Applicants are responsible for viewing their application 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.
This initiative is not subject to intergovernmental review.
All NIH awards are subject to the terms and conditions, cost
principles, and other considerations described in the NIH Grants Policy
Pre-award costs are allowable only as described in the NIH Grants Policy Statement.
Applications must be submitted electronically following the
instructions described in the SF 424 (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.
All PD/PIs must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF 424(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 Central Contractor Registration (CCR). 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 by the Center for Scientific Review and responsiveness by components of participating organizations, NIH. Applications that are incomplete and/or nonresponsive will not be reviewed.
In order to expedite review, applicants are requested to notify the NIA Referral Office by email at VemuriR@mail.nih.gov when the application has been submitted. Please include the FOA number and title, PD/PI name, and title of the application.
Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-10-115.
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
Reviewers should provide their assessment of the likelihood for the candidate to maintain a strong research program, taking into consideration the criteria below in determining the overall impact/priority score.
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.
Career Development Plan/ Career Goals & Objectives/ Plan to Provide Mentoring
Mentor(s), Co-Mentor(s), Consultant(s), Collaborator(s)
Environment & Institutional Commitment to the Candidate
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/priority score, but will not give separate scores for these items.
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 Human Subjects Protection and Inclusion Guidelines.
Inclusion of Women, Minorities, and Children
When the proposed project involves clinical research, the committee will evaluate the proposed plans for inclusion of minorities and members of both genders, as well as the inclusion of children. For additional information on review of the Inclusion section, please refer to the Human Subjects Protection and Inclusion Guidelines.
The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following five points: 1) proposed use of the animals, and species, strains, ages, sex, and numbers to be used; 2) justifications for the use of animals and for the appropriateness of the species and numbers proposed; 3) adequacy of veterinary care; 4) procedures for limiting discomfort, distress, pain and injury to that which is unavoidable in the conduct of scientifically sound research including the use of analgesic, anesthetic, and tranquilizing drugs and/or comfortable restraining devices; and 5) methods of euthanasia and reason for selection if not consistent with the AVMA Guidelines on Euthanasia. 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.
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.
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/priority score.
Training in the Responsible Conduct of Research
Taking into account the circumstances of the candidate, including level of experience, the reviewers will address the following questions. Does the plan satisfactorily address the format of instruction, e.g. lectures, coursework, and/or real-time discussion groups? Do plans include a sufficiently broad selection of subject matter, such as conflict of interest, authorship, data management, human subjects and animal use, laboratory safety? Do the plans adequately describe the role of the sponsor/mentor or other faculty involvement in the candidate’s instruction? Does the plan meet the minimum requirements for RCR, i.e., eight contact hours of instruction 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.
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) Genome Wide Association Studies (GWAS).
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.
Applications will be evaluated for scientific and technical
merit by (an) appropriate Scientific Review Group (convened by NIA, in
accordance with NIH peer
review policy and procedures, using the stated review
criteria. Review assignments will be shown in the eRA Commons.
As part of the scientific peer review, all applications:
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 NIA and NINDS Advisory Councils. The following will be considered in making funding decisions:
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
Information regarding the disposition of applications is available in the NIH Grants Policy Statement.
If the application is under consideration for funding, NIH
will request "just-in-time" information from the applicant as
described in the NIH Grants
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 the DUNS, CCR Registration, and Transparency Act requirements as noted on the Award Conditions and Information for NIH Grants website.
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.
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. Accordingly, recipients are hereby notified that they 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.
When multiple years are involved, awardees will be required to submit the Non-Competing Continuation Grant Progress Report (PHS 2590) annually and financial statements as required in the NIH Grants Policy Statement. The Additional Instructions for Preparing Continuation Career Development Award (CDA) Progress Reports, must be followed. The Mentor’s Report must include an annual evaluation statement of the candidate’s progress.
A final progress report, 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.
We encourage inquiries concerning this funding opportunity
and welcome the opportunity to answer questions from potential applicants.
GrantsInfo (Questions regarding application instructions and
process, finding NIH grant resources)
eRA Commons Help Desk (Questions regarding eRA Commons
registration, tracking application status, post submission issues)
Phone: 301-402-7469 or 866-504-9552 (Toll Free)
Chyren Hunter, Ph.D
National Institute on Aging (NIA)
Stephen Korn, Ph.D.
National Institute on Neurological Disorders and Stroke (NINDS)
Telephone: (301) 496-4188
Ramesh Vemuri, Ph.D., Chief
National Institute on Aging (NIA)
Telephone: (301) 496-9666
Ms. Lesa McQueen
National Institutes on Aging (NIA)
Telephone: (301) 496-1472
National Institute on Neurological Disorders and Stroke (NINDS)
Telephone: (301) 496-6506
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.
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 Parts 74 and 92.
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