EXPIRED
National Institutes of Health (NIH)
National Heart, Lung, and Blood Institute (NHLBI)
NHLBI Career Transition Award for Intramural Fellows (K22)
K22 Career Transition Award
Reissue of PAR-14-302
PAR-15-341
None
93.233, 93.837, 93.838, 93.839
The purpose of the NHLBI Career Transition Award (K22) program is to provide highly qualified postdoctoral fellows in the NHLBI Division of Intramural Research the opportunity to transition of their research programs as new investigators to extramural institutions.. To achieve these objectives, the NHLBI Career Transition Award will support two phases of research: a mentored intramural phase (up to two years) and an extramural phase (three years), for a total of five years of combined support. Transition from the intramural phase of support to the extramural phase is not automatic. Approval of the transition will be based on the success of the awardee's research program during the 2-year mentored phase as determined by an NHLBI progress review, which will include an evaluation of a research plan to be carried out at the extramural institution.
September 3, 2015
September 12, 2015
Not Applicable
Standard dates apply, by 5:00 PM local time of applicant organization. All types of non-AIDS applications allowed for this funding opportunity announcement are due on these dates.
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.
Standard AIDS dates apply, by 5:00 PM local time of applicant organization. All types of AIDS and AIDS-related applications allowed for this funding opportunity announcement are due on these dates.
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.
Standard dates apply
Standard dates apply
Standard dates apply
May 8, 2016
Not Applicable
Required Application Instructions
It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide, includingSupplemental 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 is available in appropriate scientific disciplines to address the Nation's biomedical, behavioral, and clinical research needs. In addition to this opportunity, NIH Institutes and Centers (ICs) support a variety of other mentored career development programs designed to foster the transition of new investigators to research independence. These other programs may be more suitable for particular candidates. NIH also supports non-mentored career development programs for independent investigators. More information about Career programs may be found at the NIH Extramural Training Mechanisms website.
The objective of the NHLBI Career Transition Award (K22) program is to enable outstanding postdoctoral individuals to obtain research training experience in the NHLBI Division of Intramural Research and to facilitate their successful transition to an extramural environment as independent researchers. Eligible applicants must agree to be supported by their NHLBI laboratory or branch for the intramural phase of the program.Applicants must contact the NHLBI program staff (Section VII.) for guidance and additional information. Following the intramural phase support, eligible organizations for the extramural phase of the program are listed under Eligible Applicants in Section III.
To achieve these objectives, the NHLBI Career Transition Award will support two phases of research. The award will provide up to two years of support for mentored research training in an NHLBI intramural laboratory followed by three years of support for an independent research project in an extramural institution. It is anticipated that awardees will subsequently apply for and obtain funding for research project grants such as the R01 to support the continuation of their work.
Transition from the intramural phase of support to the extramural phase is not automatic. Approval of the transition will be based on the success of the awardee’s research program during the 2-year mentored phase as determined by an NHLBI progress review, which will include an evaluation of a research plan to be carried out at the extramural institution.
The extramural institution must demonstrate a commitment to the candidate by providing protected research time and space needed to perform the proposed research. Supplemental funds from the extramural institution for equipment and supplies (and if necessary, salary) are strongly encouraged.
Awardees approved to transition to the second phase of support will receive notification of approval in writing from the NHLBI. Information provided by the extramural institution on behalf of the candidate will be required for the NHLBI to process the second phase of the K22.
Acceptance into the NHLBI Career Transition Award Program does not convey any commitment or intent of the NHLBI to consider the awardee for a tenure track position within the NHLBI. The NHLBI Career Transition Award is specifically intended to help develop scientists who will pursue their careers in the extramural biomedical research community. However, the NHLBI K22 awardees are not precluded from applying for available tenure track positions at the NIH. If an awardee obtains an NIH position, phase 2 of the K22 award will not be activated.
NHLBI Division of Intramural Research
The NHLBI Division of Intramural Research conducts clinical research on the normal and pathophysiologic functioning of the cardiac, pulmonary, blood, and endocrine systems and basic research on normal and abnormal cellular behavior at the molecular level. The research activities of the laboratories and branches range from structural organic chemistry to cardiology: http://www.nhlbi.nih.gov/research/intramural/.
Major areas of interest include:
Mechanisms of gene regulation, viral-mediated gene transfer and gene therapy, the molecular basis of lipoprotein dysfunctions and the atherogenic process, the molecular basis of diseases of the alveolar structures of the lung and the design of new therapeutic modalities, the cellular and molecular events underlying ischemic heart disease and myocardial hypertrophy, biochemical events associated with aging and certain pathologic processes, molecular, structural, and developmental aspects of muscle and nonmuscle contractile systems, cell and organelle movement, molecular and cellular processes for the conversion of metabolic energy into useful work, mechanisms of cardiac development, the molecular basis of transmembrane signaling, the pathophysiology of renal function at the cellular and molecular levels, the biochemistry of trace nutrients, enzyme kinetics, metabolic regulation and protein chemistry, molecular immunology and cytokines, hematopoietic stem cell biology and bone marrow transplantation, pathophysiology and treatment of sickle cell disease, pathophysiology of vascular diseases with emphasis on molecular genetic interventions and the role of inflammation, cardiac imaging through ultrasound and magnetic resonance imaging, as well as some aspects of cardiovascular devices, computational biophysics, and mass and optical spectroscopy. Animal medicine and surgery support is provided to both clinical and basic science by full-time NHLBI staff. Candidates needing assistance (e.g, understanding the application process, identifying a mentor) should contact the Office of Education at direducation@nhlbi.nih.gov and submit a curriculum vitae and a brief description of his/her past training, research experience and research interests as well as future research plans. Potential candidates are also urged to visit the web site for the Division of Intramural Research at NHLBI: http://www.nhlbi.nih.gov/research/intramural/
Grant: A support mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity.
New
Resubmission
The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types.
The number of awards is contingent upon NIH appropriations and the submission of a sufficient number of meritorious applications.
Award budgets are composed of salary and other program-related expenses, as described below.
The total period of support is five years (two years intramural, plus three years extramural). Awards are not renewable.
Intramural Phase:
Support during the intramural phase will be based on the candidate's years of postdoctoral experience, commensurate with the NHLBI intramural salary structure and is provided by the candidate's laboratory or branch.
Extramural Phase:
Support for the extramural phase will be provided to the extramural institution and may not exceed three years in duration. The total cost for the extramural phase may not exceed $249,000 per year and $747,000 for the three-year period. This amount includes salary, fringe benefits, research support allowance and applicable facilities and administrative (F&A) costs (see Indirect Costs below).
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.
The sponsoring institution may supplement the NIH salary contribution up to a level that is consistent with the institution's salary scale. However, supplementation may not be from Federal funds unless specifically authorized by the Federal program from which such funds are derived. In no case may PHS funds be used for salary supplementation. Institutional supplementation of salary must not require extra duties or responsibilities that would interfere with the purpose of the career award.
Intramural Phase
Support for the intramural phase is provided by the candidate's NHLBI intramural laboratory or branch. Research expenses including personnel, consultants, equipment, supplies, and travel will be negotiated with the laboratory chief and will depend on the nature and scope of the research.
Extramural Phase
The total cost for the extramural phase may not exceed $249,000 per year and $747,000 for the three-year period. This amount includes salary, fringe benefits, research support and applicable facilities and administrative (F&A) costs (see Indirect Costs below). Allowable research expenses include (1) research expenses, such as supplies, equipment, and technical personnel; (2) travel to research meetings or training; and (3) statistical services, including personnel and computer time.
Salary for mentors, secretarial and administrative assistants, etc. is not allowed.
For the extramural phase, Indirect Costs (also known as Facilities & Administrative [F&A] Costs) are reimbursed at 8% of modified total direct costs. F&A costs requested by consortium participants are included in the total cost limitation.
NIH grant policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made in response to this FOA.
Eligible Applicant Organizations for Phase 1 (mentored, intramural):
For Phase 1, only NHLBI intramural laboratories are eligible to apply on behalf of the intramural candidate.
Eligible Applicant Organizations for Phase 2 (independent, extramural):"
'All institution/organization types listed below are eligible for the independent phase, with the following exception: Eligibility of organizations, other than institutions of higher education, for the independent phase depends on the nature of the appointment, and the ability of the PD/PI to conduct independent research and apply for NIH research (R01 or R01-equivalent) grants.
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
For-Profit Organizations
Governments
Other
Only the NHLBI intramural program is eligible to apply for the mentored phase of this K22 program on behalf of the candidates. They are not eligible to apply for the independent phase.
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
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.
Program Directors/Principal Investigators (PD(s)/PI(s))
All PD(s)/PI(s) must have an eRA Commons account. PD(s)/PI(s) should work with their organizational officials to either create a new account or to affiliate their existing account with the applicant organization in eRA Commons. If the PD/PI is also the organizational Signing Official, they must have two distinct eRA Commons accounts, one for each role. Obtaining an eRA Commons account can take up to 2 weeks.
Any 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
NHLBI postdoctoral fellows are invited to work with their mentors to develop an application for support. Individuals who have been accepted to an intramural NHLBI postdoctoral position may work with their prospective mentors to develop an application for submission after their intramural appointment begins." Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support. Applicants are encouraged to apply relatively early in their intramural appointment. Multiple PDs/PIs are not allowed.
Individuals in NHLBI intramural postdoctoral positions with other titles are eligible if they can demonstrate they are still in a non-independent phase of training. Evidence for non-independence may include:
Conversely, evidence for independence, and therefore lack of eligibility, includes:
Candidates for this award must have earned a terminal clinical or research doctorate (including PhD, MD, DO, DC, ND, DDS, DVM, ScD, DNS, PharmD., or equivalent doctoral degree), or a combined clinical and research doctoral degree. The candidate must have postdoctoral research experience, during which the potential for highly productive basic or clinical research was demonstrated. During the intramural phase of the award, the candidate will spend full time on research. The required research experience must be completed in an intramural NIH laboratory.
To obtain support for the extramural phase, at the time of the award candidates must have a full time formal tenure-track (or equivalent) appointment offer 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 tenure track appointment (or equivalent) requirement at the applicant institution. Candidates with VA appointments should contact the NHLBI staff prior to preparing an application to discuss their eligibility.
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.
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:
Individuals are eligible for a K22 award if they have been, or currently are, the PD/PI of an NIH R03 or R21 grant or a PHS or non-Federal award that duplicates the specific aims or research goals of an R03 or R21 grant. Individuals are NOT eligible to apply if they have pending an application for any other PHS career development award, an NIH institute-specific K22, or a Pathway to Independence Award (K99/R00). Individuals are not eligible to apply if they have been or are currently a PD/PI on an NIH research grant (such as R01, R29, P01) or a subproject leader on a Program Project (P01) or Center Grant (P50), or a non-NIH equivalent to these grants/awards.
Special Requirements
Acceptance into the NHLBI Career Transition Award Program does not convey any commitment or intent of the NHLBI to consider the awardee for a tenure track position within the NHLBI. The NHLBI Career Transition Award is specifically intended to help develop scientists who will pursue their careers in the extramural biomedical research community. However, NHLBI K22 awardees are not precluded from applying for available tenure track positions at the NIH.
Once a candidate is accepted into the NHLBI Career Transition Award Program, the awardee is expected to remain with the NHLBI Intramural Program for at least 12 months, with a maximum of 24 months. Exceptions may be reviewed on a case-by-case basis.
Intramural Phase:
Mentor(s): The candidate must name a primary sponsor/mentor who, together with the applicant, is responsible for the planning, direction, and execution of the program. The mentor must be an investigator at the NHLBI who is recognized as an accomplished investigator in the proposed research area and has a track record of success in training research scientists. Candidates may also nominate co-mentors as appropriate to the goals of the program. Co-mentors may be NIH investigators or may be full-time faculty at an extramural institution. Candidates are encouraged to consider nominating extramural investigators as active members of their mentoring committee or Scientific Advisory Committee.
Extramural Phase:(Provide this information only during the time of transition to Extramural Phase.)
Sponsoring Extramural Institution: To obtain support for the Extramural Phase, the Intramural Phase awardee must have a formal tenure-track (or equivalent) offer at the extramural institution. The institution must demonstrate a commitment to the individual by providing protected research time and space needed to conduct the proposed research.
K22 award recipients are expected to apply for NIH or other independent research grant support during the extramural phase of the award. Recipients may hold concurrent research support and under certain circumstances salary support from the final two years of their K22 award and a competing NIH research project grant when recognized as the PD/PI or subproject Director of the research project grant. See NOT-OD-08-065.
Extramural Phase 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 career development and research training 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. 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 principal mentor should be an NHLBI Intramural 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, 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 should be identified as the principal mentor who will coordinate the candidate’s research. The candidate should work with the mentor(s) in preparing the application.
The mentor should describe the career development plan for the candidate (coordinated with the candidate’s research strategy). The description of the career development plan 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. 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.) should also be described.
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.
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, including Supplemental Grant Application Instructions 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.
All page limitations described in the SF424 (R&R) Application Guide and the Table of Page Limits must be followed.
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.
All instructions in the SF424 (R&R) Application Guide, including Supplemental Instructions to the SF424 (R&R) for Preparing an Individual Research Career Development Award (CDA) Application ( K Series), must be followed.
All instructions in the SF424 (R&R) Application Guide, including Supplemental Instructions to the SF424 (R&R) for Preparing an Individual Research Career Development Award (CDA) Application ( K Series), must be followed.
All instructions in the SF424 (R&R) Application Guide, including Supplemental Instructions to the SF424 (R&R) for Preparing an Individual Research Career Development Award (CDA) Application ( K Series), must be followed, with the following additional instructions:
Project Summary/Abstract
Include a description of your current research and the research you propose to continue in the extramural phase.
All instructions in the SF424 (R&R) Application Guide, including Supplemental Instructions to the SF424 (R&R) for Preparing an Individual Research Career Development Award (CDA) Application ( K Series), must be followed.
All instructions in the SF424 (R&R) Application Guide, including Supplemental Instructions to the SF424 (R&R) for Preparing an Individual Research Career Development Award (CDA) Application ( K Series), must be followed.
All instructions in the SF424 (R&R) Application Guide, including Supplemental Instructions to the SF424 (R&R) for Preparing an Individual Research Career Development Award (CDA) Application ( K Series), must be followed.
All instructions in the SF424 (R&R) Application Guide, including Supplemental Instructions to the SF424 (R&R) for Preparing an Individual Research Career Development Award (CDA) Application ( K Series), must be followed, with the following additional instructions:
All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions:
Candidate s Plan for Career Development/Training Activities During Award Period
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).
The plan must address the five, required instructional components outlined in the NIH policy: 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 instruction; 4) Duration of Instruction - the number of contact hours of instruction, taking into consideration the duration of the program; and 5) Frequency of Instruction instruction must occur during each career stage and at least once every four years. See also NOT-OD-10-019.
Applications lacking a Plan for Instruction in the Responsible Conduct of Research will not be reviewed.
Statements and Letters of Support
All instructions in the SF424 (R&R) Application Guide, including Supplemental Instructions to the SF424 (R&R) for Preparing an Individual Research Career Development Award (CDA) Application ( K Series), must be followed, with the following additional instructions:
Plans and Statements of Mentor and Co-mentor(s)
Letters of Support from Collaborators, Contributors and Consultants
Environmental and Institutional Commitment to the Candidate
All instructions in the SF424 (R&R) Application Guide, including Supplemental Instructions to the SF424 (R&R) for Preparing an Individual Research Career Development Award (CDA) Application ( K Series), must be followed, with the following additional instructions:
Research Plan
All instructions in the SF424 (R&R) Application Guide, including Supplemental Instructions to the SF424 (R&R) for Preparing an Individual Research Career Development Award (CDA) Application ( K Series), must be followed, with the following additional instructions:
Research Strategy
Appendix
Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.
When conducting clinical research, follow all instructions for completing Planned Enrollment Reports as described in the SF424 (R&R) Application Guide.
When conducting clinical research, follow all instructions for completing Cumulative Inclusion Enrollment Report 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 (letters are due by the application due date as described in the NOT-OD-11-079). 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.
See Part I. Section III.1 for information regarding the requirements for obtaining a Dun and Bradstreet Universal Numbering System (DUNS) Number and for completing and maintaining an active System for Award Management (SAM) registration. Part I. Overview Information contains information about Key Dates. 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.
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.
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.
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 Statement.
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 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.
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, NIH. Applications that are incomplete or non-compliant will not be reviewed.
Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-13-030.
Important Update: See NOT-OD-16-012 and NOT-OD-16-006 for updated review language for applications for due dates on or after January 25, 2016.
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.
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.
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 and Objectives/Plan to Provide Mentoring
Mentor(s), Co-Mentor(s), Consultant(s), Collaborator(s)
Intramural Phase
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.
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.
When the proposed project involves human subjects and/or NIH-defined clinical research, the committee will evaluate the proposed plans for the inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion (or exclusion) of children to determine if it is justified in terms of the scientific goals and research strategy proposed. For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research.
The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following 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.
Not Applicable
Not Applicable
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.
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.
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).
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).
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(s) convened by NHLBI, 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:
Applications will be assigned to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications . Following initial peer review, recommended applications will receive a second level of review by the NHLBI Advisory Council. 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 Commons.
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 Policy Statement.
There will not be a formal Notice of Award (NoA) associated with the mentored phase of the K22 award conducted in the NIH intramural program. The NHLBI will transmit to the successful candidate an approval letter that will include the terms and conditions of the NIH intramural K22 award, as well as requirements for the transition to the independent phase of the award.
A formal Notice of Award (NoA) will be provided as part of the extramural phase of the K22 award conducted at a domestic, sponsoring extramural institution/organization. The NoA signed by the grants management officer is the authorizing document. Once all administrative and programmatic issues have been resolved, the NoA will be generated via email notification from the awarding component to the grantee 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.
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.
Transition from the intramural phase to the extramural phase is not automatic. Approval of the transition will be based on the success of the awardee’s research program as determined by annual scientific reviews and by the evaluation of a research and career development plan to be carried out at the institution. Additionally, the sponsoring institution must demonstrate a commitment to the candidate by providing a minimum of nine person-months (75% full time professional effort) protected research time, space and resources needed to conduct the proposed research project, and appropriate scientific mentoring. A plan for career development that will lead to research independence and the ability to successfully compete for research support is essential. The NHLBI will conduct a transition review no later than three months before the end of the intramural phase.
The extramural phase institution will submit an application on behalf of the candidate for the K22 award using the SF424 application forms. These materials should be sent directly to the NHLBI, Office of Grants Management (tm275a@nih.gov). The original application plus one copy (preferably in a PDF format) are to be mailed to the Financial/Grants Management contact person of the NHLBI listed in this FOA. The independent phase application must include the following:
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.
Intramural Phase:
The awardee’s progress will be evaluated on an annual basis by the mentor, Laboratory Chief, and Scientific Director and continued support will be approved by the intramural administrative officer.
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.
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.
We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.
eRA Commons Help Desk (Questions regarding 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
Web ticketing system: https://grants-portal.psc.gov/ContactUs.aspx
Email: support@grants.gov
GrantsInfo (Questions regarding application instructions and
process, finding NIH grant resources)
Email: GrantsInfo@nih.gov (preferred method of contact)
Telephone: 301-710-0267
Intramural programmatic issues:
Herbert M. Geller, Ph.D.
National Heart, Lung, and Blood Institute (NHLBI)
Telephone: 301-451-9440
Email: direducation@nhlbi.nih.gov
Extramural programmatic issues:
Nara Gavini, Ph.D.
National Heart, Lung, and Blood Institute (NHLBI)
Telephone: 301-451-5081
Email: gavininn@nhlbi.nih.gov
Director, Office of Scientific Review
National Heart, Lung, and Blood Institute (NHLBI)
Telephone: 301-435-0270
Email: nhlbichiefreviewbranch@nhlbi.nih.gov
Mr. Tyrone Smith, M.S.
National Heart, Lung, and Blood Institute (NHLBI)
Telephone: 301-435-0141
Email: smithty@nhlbi.nih.gov
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 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.