Part I Overview Information


Department of Health and Human Services

Participating Organizations
National Institute of Health (NIH) (http://www.nih.gov)

Components of Participating Organizations
National Heart, Lung, and Blood Institute (NHLBI) (http://www.nhlbi.nih.gov)

Title: NHLBI Research Career Development Programs in Emergency Medicine Research (K12)

Announcement Type

New

Update: The following update relating to this announcement has been issued:

Request for Applications (RFA) Number: RFA- HL-11-011

NOTICE: Applications submitted in response to this Funding Opportunity Announcement (FOA) for Federal assistance must be submitted electronically through Grants.gov (http://www.grants.gov) using the SF 424 Research and Related (R&R) forms and the SF 424 (R&R) Application Guide.

APPLICATIONS MAY NOT BE SUBMITTED IN PAPER FORMAT.

This FOA must be read in conjunction with the application guidelines included with this announcement in Grants.gov/Apply for Grants (hereafter called Grants.gov/Apply).

A registration process is necessary before submission and applicants are highly encouraged to start the process at least four (4) weeks prior to the grant submission date. See Section IV.

Catalog of Federal Domestic Assistance Number(s)
93.837, 93.838, 93.839

Key Dates
Release/Posted Date: July 16, 2010
Opening Date:  August 6, 2010 (Earliest date an application may be submitted to Grants.gov)
Letters of Intent Receipt Date(s): September 7, 2010
NOTE: On-time submission requires that applications be successfully submitted to Grants.gov no later than 5:00 p.m. local time (of the applicant institution/organization).
Application Due Date(s): October 7, 2010
Peer Review Date(s): March-April 2011 
Council Review Date(s): May 2011
Earliest Anticipated Start Date(s): July 1, 2011
Additional Information to Be Available Date (Activation Date): Not Applicable
Expiration/Closing Date: October 8, 2010

Due Dates for E.O. 12372

Not Applicable.

Additional Overview Content

Executive Summary

Table of Contents


Part I Overview Information

Part II Full Text of Announcement

Section I. Funding Opportunity Description
1. Institutional Research Career Development Program Objectives

Section II. Award Information
1. Mechanism of Support
2. Funds Available

Section III. Eligibility Information
1. Eligible Applicants

    A. Eligible Institutions
    B. Eligible Individuals
2. Cost Sharing or Matching
3. Other - Special Eligibility Criteria

Section IV. Application and Submission Information
1. Request Application Information
2. Content and Form of Application Submission
3. Submission Dates and Times
    A. Submission, Review, and Anticipated Start Dates
          1. Letter of Intent
    B. Submitting an Application to the NIH
    C. Application Processing
4. Intergovernmental Review
5. Funding Restrictions
6. Other Submission Requirements

Section V. Application Review Information
1. Criteria
2. Review and Selection Process 
3. Anticipated Announcement and Award Dates

Section VI. Award Administration Information
1. Award Notices
2. Administrative and National Policy Requirements
3. Reporting

Section VII. Agency Contact(s)
1. Scientific/Research Contact(s)

2. Peer Review Contact(s)
3. Financial/Grants Management Contact(s)

Section VIII. Other Information - Required Federal Citations

Part II - Full Text of Announcement


Section I. Funding Opportunity Description


1. Institutional Career Development Program Objectives

This funding opportunity announcement (FOA) solicits applications from applicant organizations that propose creative and innovative institutional research career development programs in emergency medicine, a mission area of the National Heart, Lung, and Blood Institute (NHLBI).  The NIH K12 grant mechanism is a specialized mechanism designed to foster the development of biomedical, behavioral, and clinical researchers through creative and innovative institutional career development programs. The overall goal of the NHLBI’s Research Career Development programs is to ensure that highly trained scientists will be available in adequate numbers and in appropriate scientific areas to address the Nation’s biomedical, behavioral, and clinical research needs.

The NIH encourages all proposed programs to foster the participation of individuals from diverse backgrounds.  Of particular interest is the recruitment and retention of persons from backgrounds underrepresented in biomedical and behavioral research, such as individuals from racial and ethnic groups, individuals from disadvantaged backgrounds, and individuals with disabilities.

The proposed institutional research career development program may complement other ongoing research training and career development programs at the applicant institution, but the proposed career development experiences must be distinct from those career development programs currently receiving federal support.

Purpose:

The goal of this funding opportunity announcement (FOA) issued by the National Heart, Lung, and Blood Institute (NHLBI), National Institutes of Health, is to increase the number and skills of emergency medicine investigators through a mentored research and career development program.  The program provides supervised research training to assist junior faculty in their transition into productive physician- scientists in areas related to emergency medicine.

The intent of this program is to fund up to five awards for five years each, using the NIH Mentored Clinical Scientist Development Program (K12) mechanism.  Training will require an integrated multidisciplinary team approach with effective collaboration among researchers and clinicians.  Scholars entering the programs are to receive two or three years of focused research training to become clinician-investigators in emergency medicine. Scholars are required to obtain an MS in clinical research or equivalent two-year research degree.  Program length is two or three years.  Program directors must create research milestones for Scholars both within and following K12 training. Scholars are expected to transition from K12 training to individual career development awards (K awards) or independent NIH research funding.

Background:

Emergency medicine has developed as a distinct subspecialty over the past 30 years, however, the number of federally funded emergency medicine investigators remains low.  At the same time, newly emerging scientific areas such as rapid imaging, biomarkers, pharmacology, and cellular immunology have potential application to the emergency-based management of acute cardiopulmonary and hematologic disorders.  Many advances in the basic science of cardiopulmonary and hematologic diseases await translation into clinical research.  Without an adequate number of clinical scientists trained in emergency medicine research, new science and bio-technologies will not be translated into clinical research.

In 2005, a report of the American College of Emergency Physicians (ACEP) Research Committee noted that emergency medicine residency programs had grown rapidly, from 1 program in 1970 to 132 in 2005. In 2005, there were 3909 emergency medicine residents enrolled in clinical training nationally.  However, the number of federally funded emergency medicine investigators remains low, with only 87 federally funded (NIH, CDC, AHRQ) investigators in 2005 (ACEP Research Committee, 2005).  Barriers to  emergency medicine research include a limited number of adequately trained investigators, poorly defined professional research tracks, limited interdisciplinary collaboration, and limited funding streams. 

Program Description:

Programs will provide comprehensive research training to evaluate innovative approaches for diagnosis and clinical management of patients with severe, acute manifestations of cardiovascular, pulmonary, and hematologic diseases, and severe trauma in emergency settings.  Programs must have formal ties to emergency medicine and/or trauma programs to ensure adequate access to patient populations and settings required to conduct this research.  Multiple ED/trauma settings may be required to meet programmatic needs.

Programs must include a graduate level clinical research curriculum that includes didactic courses;  Scholar-initiated, independent research projects; courses in ethical conduct of clinical research;  institutional review board training and apprenticeship; training in clinical trial oversight, data safety and monitoring;  data management and security;  scientific writing, grant writing, and scientific presentations; and leadership training.  Didactic courses should include epidemiology, health services research, biostatistics, medical decision-making, and other courses that are determined to be important by the Scholars and their mentors for research career development.  Programs must lead to a Master of Science in clinical research or an equivalent degree.

Each Scholar is to be mentored during the program, by a multidisciplinary research team based on the research and clinical focus of the Scholar’s research. Each Scholar must have a primary research mentor, an academic mentor, as well as other scientists/methodologists who can contribute to the Scholars research development.  Programs are encouraged to track the research and career development of their scholars post-program.

Research career development is key to success, and program directors must specify how Scholars will advance in their research training following the K12 program.  Program directors must indicate when and how Scholars will be transitioned to mentored career development grants (K23) or to the role of Principal Investigator on NIH research grants. 

Scholars research projects may be experimental or observational.  Observational research may only be pursued if it will lead to hypothesis generation and primary data for future competitive studies.  Examples of research topics that Scholars might pursue in their research project include, but are not limited to, diagnosis and management of:

Mentors: Mentors will interact closely with the Scholar, and should have research expertise and experience relevant to the proposed career development program. Mentors must be committed to continue their involvement throughout the total period of the Scholar’s career development under this award. Describe the roles and responsibilities of program mentors.

Multidisciplinary research mentoring teams are required to support the research and clinical focus of the Scholar’s research and career development.  Each Scholar must have a primary research mentor, an academic mentor, as well as other scientists/methodologists who can contribute to the Scholar’s research development.

 Plans for Scholar mentoring and frequency of mentoring need to be provided.

Metrics of Scholar progress should be established to help guide mentors in establishing milestones for Scholar success.

Plans for measuring the mentors contribution to Scholars should be ongoing.

Advisory Committee: An advisory committee is encouraged to provide input, guidance, and oversight of the program. Describe the membership (including background relevant to the program) and responsibilities of the advisory committee.

See Section VIII, Other Information - Required Federal Citations, for policies related to this announcement.

Section II. Award Information


1. Mechanism of Support

This FOA will use the NIH Institutional Research Career Development (K12) award mechanism.  The PDs/PIs (if multiple PD/PI option is used) will be solely responsible for planning, directing, and executing the proposed institutional career development program. 

This FOA uses “just-in-time” information concepts (see SF424 (R&R) Application Guide). It also uses the non-modular budget format.  Applicants must complete and submit detailed categorical budget requests using the SF24 Research and Related (R&R) Budget Component found in the application package for this FOA.

2. Funds Available

Because the nature and scope of the proposed institutional career development program will vary from application to application, it is anticipated that the size and duration of each award will also vary. Although the financial plans of the NHLBI provide support for this program, awards pursuant to this funding opportunity are contingent upon the availability of funds and the submission of a sufficient number of meritorious applications.

The total project period for an application submitted in response to this funding opportunity may not exceed five years. Although the size of award may vary with the scope of the institutional research career development program proposed, it is expected that applications will stay within the following direct cost thresholds: Year 1: $200,000, Year 2: $500,000, Year 3: $1,000,000, Year 4: $1,150,000, and Year 5: $1,000,000.

Facilities and Administrative (F&A) costs requested by primary consortium participants, if applicable, are not included in the direct cost limitation.  See NOT-OD-05-004.  

All awards are subject to the availability of funds. The estimated amount of funds available for support of programs awarded as a result of this announcement is $1,080,000 for fiscal year 2011.  NHLBI intends to commit approximately $20.79 million in total costs over a five-year period to fund up to five new grants in response to this FOA.  Future year amounts will depend on annual appropriations.

Allowable Costs

Allowable costs must be consistent with NIH policy and be reasonable, allocable, well documented and fully justified for the institutional career development program proposed in the application. Grant funds may not be used to supplant funds otherwise available at the applicant institution.  Note that instructions for completing the budget information in the SF 424 (R&R) application, using the Research & Related (R&R) budget, are included in Section IV, “Selecting the Appropriate Budget Component.”

Applicants must request costs to cover the following items: a) consultant costs to fund the support an External Advisory Committee consisting of three senior scientists to annually review program and Scholar progress, and b) travel to attend the annual K12 meeting in Bethesda MD.   

Applicants may request Program start-up costs to cover the following items: (a)  costs of program recruitment activities, (b) website development, (c)  program director travel to disseminate the K12 program availability, and (d) recruitment of external advisory committee members.

Personnel: Individuals designing, directing, and implementing the career development program may request salary and fringe benefits appropriate for the person-months devoted to the program.  Salaries requested may not exceed the levels commensurate with the institution's policy for similar positions and may not exceed the Congressionally mandated cap. If mentoring interactions and other activities with Scholars are considered a regular part of an individual's academic duties, then mentoring and other interactions with Scholars are non-reimbursable from grant funds. Limited program-related administrative and clerical salary costs associated distinctly with the program that are not normally provided by the applicant organization may be direct charges to the grant only when specifically identified and justified.  These expenses must be itemized in Sections A and B, as appropriate, of the R&R Budget.

Program Administration Costs: If applicable and justified, the costs of a research administrator and/or program assistant with responsibilities directly associated with the institutional career development program can be requested, and salaries must be commensurate with institutional policy for similar positions, and specifically identified and justified. When applicable, this expense must be itemized in Section A or B, as appropriate.

Other Program-Related Expenses: Consultant costs, equipment, supplies, travel for key persons, and other program-related expenses must be justified as specifically required by the proposed program and must not duplicate items generally available for similar programs at the applicant institution. These expenses must be itemized in Sections C, D, and F, as appropriate.

Scholar Costs: Scholars are those individuals who benefit from the proposed activities and experiences involved in the career development program. Scholar costs must be justified as specifically required for the proposed career development program and based on institutional policies for salaries paid to individuals in similar positions, regardless of the source of funds. These expenses must be itemized in Section B (scholar salaries) and F (other program-related expenses) as appropriate.

K12 awardee stipend levels at the NHLBI are capped at $75,000 for 75% effort excepting fringe and Scholar health insurance. Scholar costs per year should not exceed the following: $30,000 for tuition and associated texts, $25,000 for research costs; and $2,000 for travel to the annual K12 meeting in Bethesda Maryland and scientific meeting attendance.

Note: Each applicant should not propose more than 6 trainees in a 3- year period and Scholars enter the program in years 2, 3, and 4 of the award. No new candidates shall begin after year 4 unless prior approval from the NHLBI Grants Officer is obtained in accordance with the NIH Grants Policy Statement.

Items that may NOT be supported with K12 funds include: Salaries for support of ancillary personnel, i.e., mentors, secretarial, and administrative assistance, etc.

Facilities and Administrative (F&A) Costs: F&A costs for the applicant organization and consortium participants will be reimbursed at eight percent of modified total direct costs (excluding tuition, fees, and equipment).  

NIH Grants Policy: 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.

Section III. Eligibility Information


1. Eligible Applicants

1.A. Eligible Institutions

The following institutions/organizations are eligible to apply:

Some institutions provide unique opportunities for access to students and faculty from diverse backgrounds.  These institutions can assist NIH in its efforts to recruit the most talented researchers from all groups; to improve the quality of the educational and training environment; to balance and broaden the perspective in setting research priorities; to improve the ability to recruit subjects from diverse backgrounds into clinical research protocols; and to improve the Nation’s capacity to address and eliminate health disparities.  Accordingly, NIH strongly encourages applications from the following institutions:  Historically Black Colleges and Universities (HBCUs), Tribally Controlled Colleges and Universities (TCCUs), Hispanic-Serving Institutions, and Alaska Native and Native Hawaiian Serving Institutions.

Foreign institutions are not eligible to apply in response to this FOA.  However, collaboration with foreign institutions may be allowable with proper justification.

In many cases, it is anticipated that the proposed institutional research career development program will complement other ongoing research training and career development programs occurring at the applicant institution, and that a substantial number of program faculty will have active research projects in which participants may gain relevant experiences consistent with their research interests and goals.

Institutions with existing K12 or other training programs must explain what distinguishes this program from the others, how their programs will synergize with one another, if applicable, and clarify that the pool of faculty, potential scholars, and resources is robust enough to support additional programs.

If multiple sites are involved in the institutional career development program, the applicant institution must be the primary site for the program.  The need for and use of multiple sites must be justified.   

1.B. Eligible Individuals

Any individual with the skills, knowledge, and resources necessary to carry out the proposed career development program as the PD/PI is invited to work with his/her institution to develop an application for support. Individuals from diverse backgrounds underrepresented in biomedical science and behavioral research, including individuals from racial and ethnic groups as well as individuals with disabilities or disadvantaged backgrounds are always encouraged to apply for NIH support. 

The PD/PI should be an established investigator in the scientific area in which the application is targeted who is capable of providing both administrative and scientific leadership to the development and implementation of the proposed institutional research career development program

Eligible Principal Investigators are clinician-scientists who are established clinical investigators in EM research with strong leadership capabilities and with substantial research mentoring and research training experience.

The PD/PI will be expected to monitor and assess the program and submit all documents and reports as required. (See Section VI.3. “Reporting.”)

More than one PD/PI (i.e., multiple PDs/PIs) may be designated on the application for projects that require a “team science” approach and therefore clearly do not fit the single-PD/PI model. Additional information on the implementation plans and policies and procedures to formally allow more than one PD/PI on individual research projects is available at http://grants.nih.gov/grants/multi_pi. All PDs/PIs must be registered in the NIH electronic Research Administration (eRA) Commons prior to the submission of the application (see http://era.nih.gov/ElectronicReceipt/preparing.htm for instructions).

The decision of whether to apply for a grant with a single PD/PI or multiple PDs/PIs grant is the responsibility of the investigators and applicant organizations and should be determined by the scientific goals of the project. Applications for grants with multiple PDs/PIs will require additional information, as outlined in the instructions below. When considering the multiple PD/PI option, please be aware that the structure and governance of the PD/PI leadership team as well as the knowledge, skills and experience of the individual PDs/PIs will be factored into the assessment of the overall scientific merit of the application.  Multiple PDs/PIs on a project share the authority and responsibility for leading and directing the project intellectually and logistically. Each PD/PI is responsible and accountable to the grantee organization or, as appropriate, to a collaborating organization for the proper conduct of the project or program, including the submission of required reports. For further information on multiple PDs/PIs, please see http://grants.nih.gov/grants/multi_pi.

For background information on the Multiple PD/PI initiative, see http://grants.nih.gov/grants/multi_pi/index.htm.

2. Cost Sharing or Matching

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

3. Other - Special Eligibility Criteria

Sponsoring Institution: The sponsoring institution must assure support for the proposed institutional career development program. Appropriate institutional commitment to the program includes the provision of adequate staff, facilities, and relevant resources that can contribute to the planned program. Applicant institutions must also guarantee the required protected time for the Scholars selected for support. The application must include a letter explaining the institutional commitment to the proposed institutional research career development program (see Section IV.6, item 14).

Scholars: Individuals to be supported by the institutional career development program must be at the career level for which the planned program is intended. Scholars are expected to devote a minimum of nine person-months (75% of full-time professional effort) during the appointment on the K12 award.

Scholar Citizenship and Residency Requirement: Only U.S. citizens or non-citizen nationals, or individuals lawfully admitted for permanent residence who have a currently valid Permanent Resident Card (USCIS Form I-551) or some other verification of legal admission as a permanent resident prior to admission into the K12 program, are eligible for scholar support from this program.  Non-citizen nationals, although not U.S. citizens, owe permanent allegiance to the U.S.  They are usually persons born in lands that are not states but are under U.S. sovereignty, jurisdiction, or administration.  Individuals on temporary or student visas are not eligible.

Number of Applications: An eligible institution may submit only one application in response to this FOA.

Resubmissions: Resubmission applications are not permitted in response to this FOA. 

Renewals: Renewal applications are not allowed for this institutional research career development (K12) program.

Section IV. Application and Submission Information


To download a SF424 (R&R) Application Package and SF424 (R&R) Application Guide for completing the SF424 (R&R) forms for this FOA, use the “Apply for Grant Electronically” button in this FOA or link to http://www.grants.gov/Apply/ and follow the directions provided on that Web site.

Registration:

Appropriate registrations with Grants.gov and eRA Commons must be completed on or before the due date in order to successfully submit an applicationSeveral of the steps of the registration process could take four weeks or more. Therefore, applicants should immediately check with their business official to determine whether their organization/institution is already registered with both Grants.gov and the Commons. All registrations must be complete by the submission deadline for the application to be considered “on-time” (see 3.C.1 for more information about on-time submission).

A one-time registration is required for institutions/organizations at both:

PDs/PIs should work with their institutions/organizations to make sure they are registered in the eRA Commons.

Several additional separate actions are required before an applicant institution/organization can submit an electronic application, as follows:

1.  Organizational/Institutional Registration in Grants.gov/Get Registered

2.  Organizational/Institutional Registration in the eRA Commons

3.  Project Director/Principal Investigator (PD/PI) Registration in the NIH eRA Commons: Refer to the NIH eRA Commons System (COM) Users Guide.

Both the PDs/PI(s) and AOR/SO need separate accounts in the NIH eRA Commons since both are authorized to view the application image.

Note: The registration process is not sequential.  Applicants should begin the registration processes for both Grants.gov and eRA Commons as soon as their organization has obtained a DUNS number.  Only one DUNS number is required and the same DUNS number must be referenced when completing Grants.gov registration, eRA Commons registration and the SF424 (R&R) forms.

1. Request Application Information

Applicants must download the SF424 (R&R) application forms and the SF424 (R&R) Application Guide for this FOA through Grants.gov/Apply.

Note: Only the forms package directly attached to a specific FOA can be used. You will not be able to use any other SF424 (R&R) forms (e.g., sample forms, forms from another FOA), although some of the "Attachment" files may be useable for more than one FOA.

For further assistance, contact GrantsInfo -- Telephone 301-435-0714, Email: GrantsInfo@nih.gov.

Telecommunications for the hearing impaired: TTY: (301) 451-5936

2. Content and Form of Application Submission

Prepare all applications using the SF424 (R&R) application forms for this FOA through Grants.gov/Apply and in accordance with the SF424 (R&R) Application Guide (http://grants.nih.gov/grants/funding/424/index.htm).

The SF424 (R&R) Application Guide is critical to submitting a complete and accurate application to NIH. Some fields within the SF424 (R&R) application components, although not marked as mandatory, are required by NIH (e.g., the “Credential” log-in field of the “Research & Related Senior/Key Person Profile” component must contain the PD/PI’s assigned eRA Commons User ID). Agency-specific instructions for such fields are clearly identified in the Application Guide. For additional information, see “Frequently Asked Questions – Application Guide, Electronic Submission of Grant Applications.”

The SF424 (R&R) application has several components. Some components are required, others are optional. The forms package associated with this FOA in Grants.gov/APPLY includes all applicable components, required and optional. A completed application in response to this FOA includes the data in the following components:

Required Components:
SF424 (R&R) (Cover component)
Research & Related Project/Performance Site Locations
Research & Related Other Project Information
Research & Related Senior/Key Person
PHS398 Cover Page Supplement
PHS398 Research Training Program Plan Component (for Institutional Research Career Development Program)
PHS398 Checklist
SF 424 Research & Related Budget (R&R)

Optional Components:
PHS398 Cover Letter
Research and Related Subaward Budget Attachment(s) Form

Applications with Multiple PDs/PIs

When multiple PDs/PIs are proposed, NIH requires one PD/PI to be designated as the "Contact” PI, who will be responsible for all communication between the PDs/PIs and the NIH, for assembling the application materials outlined below, and for coordinating progress reports for the project. The contact PD/PI must meet all eligibility requirements for PD/PI status in the same way as other PDs/PIs, but has no other special roles or responsibilities within the project team beyond those mentioned above.

Information for the Contact PD/PI should be entered on the SF424(R&R) Cover component. All other PDs/PIs should be listed in the Research & Related Senior/Key Person component and assigned the project role of “PD/PI.” Please remember that all PDs/PIs must be registered in the eRA Commons prior to application submission. The Commons ID of each PD/PI must be included in the “Credential” field of the Research & Related Senior/Key Person component. Failure to include this data field will cause the application to be rejected.

Multiple PD/PI Leadership Plan: For applications designating multiple PDs/PIs, the research training program plan section, Multiple PD/PI Leadership Plan, must be included. A rationale for choosing a multiple PD/PI approach should be described.  The governance and organizational structure of the leadership team and the research project should be described, and should include communication plans, process for making decisions on scientific direction, and procedures for resolving conflicts. The roles and administrative, technical, and scientific responsibilities for the project or program should be delineated for the PDs/PIs and other collaborators.  A single Contact PD/PI must be designated for the purpose of communicating with the NIH, although other individuals may contact the NIH on behalf of the Contact PD/PI when necessary.

If budget allocation is planned, the distribution of resources to specific components of the program or the individual PDs/PIs should be delineated in the Leadership Plan.  In the event of an award, the requested allocations may be reflected in a footnote on the Notice of Award.

Applications Involving a Single Institution

When all PDs/PIs are within a single institution, follow the instructions contained in the SF424 (R&R) Application Guide.

Application Involving Multiple Institutions

When multiple institutions are involved, one institution must be designated as the prime institution, and funding for the other institutions(s) must be requested via a subcontract to be administered by the prime institution.  When submitting a detailed budget, the prime institution should submit its budget using the Research & Related Budget component.  All other institutions should have their individual budgets attached separately to the Research & Related Budget Sub-award Budget Attachments(s) Form.  See Section 4.8 of the SF424 (R&R) Application Guide for further instruction regarding the use of the sub-award budget form.

Evaluation Plan

The application must describe an evaluation plan to review and determine the quality and effectiveness of the career development program.  This should include plans to obtain feedback from current and former Scholars to help identify weaknesses in the program and to provide suggestions for program improvements, as well as plans for assessing Scholars’ career development and progression, including publications, and subsequent positions.  Evaluation results should be included the Final Progress Report.

3. Submission Dates and Times

See Section IV.3.A for details.

3.A. Application Due, Review and Anticipated Start Dates
Opening Date: August 6, 2010 (Earliest date an application may be submitted to Grants.gov)
Letters of Intent Receipt Date(s): September 7, 2010
Application Due Date(s): October 7, 2010
Peer Review Date(s): March-April 2011 
Council Review Date(s): May 2011
Earliest Anticipated Start Date(s): July 1, 2011

3.A.1. Letter of Intent

Prospective applicants are asked to submit a letter of intent that includes the following information:

Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review.

The letter of intent is to be sent by the date listed in Section IV.3.A.

The letter of intent should be sent to:

Director, Office of Scientific Review   
Division of Extramural Research Activities
National Heart, Lung, and Blood Institute
6701 Rockledge Drive, Room 7214 
Bethesda, MD 20892-7924 (Express Mail Zip: 20817)
Telephone: (301) 435-0270
Fax: (301) 480-0730
Email: nhlbichiefreviewbranch@nhlbi.nih.gov

3.B. Submitting an Application Electronically to the NIH

To submit an application in response to this FOA, applicants should access this FOA via http://www.grants.gov/Apply and follow steps 1-4. Note:  Applications must only be submitted electronically.  PAPER APPLICATIONS WILL NOT BE ACCEPTED.  All attachments must be provided to NIH in PDF format, filenames must be included with no spaces or special characters, and a .pdf extension must be used.

In order to expedite the review, applicants are requested to notify the NHLBI Referral Office by email nhlbichiefreviewbranch@nhlbi.nih.gov when the application has been submitted.  Please include the FOA number and title, PD/PI name, and title of the application.
 
3.C. Application Processing

3.C.1. Submitting On-Time

Applications may be submitted on or after the opening date and must be successfully received by Grants.gov no later than 5:00 p.m. local time (of the applicant institution/organization) on the application due date(s). (See Section IV.3.A. for all dates.) If an application is not submitted by the due date(s) and time, the application may be delayed in the review process or not reviewed.

All applications must meet the following criteria to be considered “on-time”:

Please visit http://era.nih.gov/electronicReceipt/app_help.htm for detailed information on what to do if Grants.gov or eRA system issues threaten your ability to submit on time.

Submission to Grants.gov is not the last step – applicants must follow their application through to the eRA Commons to check for errors and warnings and view their assembled application!

3.C.2. Two Day Window to Correct eRA Identified Errors/Warnings

IMPORTANT NOTE! NIH has eliminated the error correction window for due dates of January 25, 2011 and beyond. As of January 25, all corrections must be complete by the due date for an application to be considered on-time. See NOT-OD-10-123.

Once an application package has been successfully submitted through Grants.gov, NIH provides applicants a two day error correction window to correct any eRA identified errors or warnings before a final assembled application is created in the eRA Commons.  The standard error correction window is two (2) business days, beginning the day after the submission deadline and excluding weekends and standard federal holidays.  All errors must be corrected to successfully complete the submission process.  Warnings will not prevent the application from completing the submission process.

Please note that the following caveats apply:

3.C.3. Viewing an Application in the eRA Commons

Once any eRA identified errors have been addressed and the assembled application has been created in the eRA Commons, the PD/PI and the Authorized Organization Representative/Signing Official (AOR/SO) have two weekdays (Monday – Friday, excluding Federal holidays) to view the assembled application before it automatically moves forward to NIH for further processing.

Upon receipt, application will be evaluated for completeness by the CSR and responsiveness by the IC.  Incomplete and/or non-responsive applications will not be reviewed.


There will be an acknowledgement of receipt of applications from Grants.gov and the Commons. The submitting AOR/SO receives the Grants.gov acknowledgments. The AOR/SO and the PI receive Commons acknowledgments. Information related to the assignment of an application to a Scientific Review Group is also in the Commons.

Note: Since email can be unreliable, it is the responsibility of the applicant to check periodically on the application status in the Commons.

The NIH will not accept any application in response to this funding opportunity that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application. However, when a previously unfunded application, originally submitted as an investigator-initiated application, is to be submitted in response to a funding opportunity, it is to be prepared as a NEW application. That is, the application for the funding opportunity must not include an “Introduction” describing the changes and improvements made, and the text must not be marked to indicate the changes from the previous unfunded version of the application.

4. Intergovernmental Review

This initiative is not subject to intergovernmental review.

5. Funding Restrictions

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

Pre-Award Costs are allowable. A grantee may, at its own risk and without NIH prior approval, incur obligations and expenditures to cover costs up to 90 days before the beginning date of the initial budget period of a new award if such costs: are necessary to conduct the project, and would be allowable under the grant, if awarded, without NIH prior approval. If specific expenditures would otherwise require prior approval, the grantee must obtain NIH approval before incurring the cost. NIH prior approval is required for any costs to be incurred more than 90 days before the beginning date of the initial budget period of a new award.

The incurrence of pre-award costs in anticipation of a competing or non-competing award imposes no obligation on NIH either to make the award or to increase the amount of the approved budget if an award is made for less than the amount anticipated and is inadequate to cover the pre-award costs incurred. NIH expects the grantee to be fully aware that pre-award costs result in borrowing against future support and that such borrowing must not impair the grantee's ability to accomplish the project objectives in the approved time frame or in any way adversely affect the conduct of the project. See the NIH Grants Policy Statement.

6. Other Submission Requirements

The K12 clinical research agenda must focus on acute, life-threatening cardiopulmonary and hematologic disorders and severe trauma with cardiopulmonary compromise.

Programs must have formal ties to emergency medicine and/or trauma programs and centers so as to ensure adequate access to patient populations and settings required to conduct research.  Multiple ED/trauma settings may be required to meet programmatic needs. Documentation should be included in “2. Research Training Program Plan Attachments:”, item 14 “letters of support”.  

Provide detailed descriptions of each clinical setting in which research will be conducted.   Provide statistics about patient volume per site/year and the admissions rate from the ED/site/year.  If affiliated with a specialized regional triage system for care for trauma or cardiac patients, specify the affiliation and site ranking. Include in “RESEARCH & RELATED Other Project Information; item 10. Facilities & Other Resources” of the SF424 application package.  

If the program will focus on a specific subset of ED patients (i.e., patients with acute asthma, severe trauma, acute, or life-threatening pediatric bleeding disorders); describe the number of patients per setting that are seen annually in the ED that meet those specific diagnostic criteria. Documentation should be included in “RESEARCH & RELATED Other Project Information”, item 12.

The budget is calculated to provide funding support for 13 training years whereby 4-6 Scholars may receive two or three years of research training from each K12 program. Scholars may matriculate from the K12 Program after two years of training only if subsequent research training funds (K23 or other career development award) have been secured. K12 Program Directors will meet annually with NHLBI program staff to review progress and share common training issues.   Starting in year 02, and for the duration of the grant, all Scholars will attend and participate in the NHLBI-K12 Emergency Medicine PI/PD meetings.

PD/PI Credential (e.g., Agency Login)

The NIH requires the PD(s)/PI(s) to fill in his/her Commons User ID in the “PROFILE – Project Director/Principal Investigator” section, “Credential” log-in field of the “Research & Related Senior/Key Person Profile” component.

Organizational DUNS

The applicant organization must include its DUNS number in its Organization Profile in the eRA Commons. This DUNS number must match the DUNS number provided at CCR registration with Grants.gov. For additional information, see “Frequently Asked Questions – Application Guide, Electronic Submission of Grant Applications.”

PHS 398 Research Training Program Plan Component Sections

Page limitations of the Research Career Development Program Plan (uploaded using the PHS398 Research Training Program Plan) component must be followed as outlined in the SF424 (R&R) Application Guide, Section 8, Supplemental Instructions for the Institutional NRSA Application.

All application instructions outlined in the SF424 (R&R) Application Guide are to be followed, with the following requirements for K12 applications:

Item 1. Introduction to Application: (for Resubmission or Revision only): N/A.7.

Item 2. Background: Provide the rationale for the proposed program, relevant background history, and the need for the career development program proposed. Indicate how the proposed program will foster the research careers of selected individuals.  Summarize the research career development activities of the major participating unit(s) and department(s) represented in the proposed program. Include the names and roles of participating faculty members planned to contribute to the program.

Item 3. Program Plan: Include the following sections: Program Administration, Program Faculty, Proposed Career Development Program, Program Evaluation, Candidates/Scholars, and Institutional Environment and Commitment to the Program.

·         Program Administration (component of Item 3): Describe the acknowledged strengths, leadership and administrative skills, and scientific expertise of the PD/PI. Include active research and the planned strategy to be used to oversee and monitor the program.  For applications with multiple PDs/PI(s), address the Leadership Plan and how the combined knowledge, skills and experience of the individual PDs/PIs will enhance the likelihood of success of the program.  When a Program Administrator position is planned, a description of the scientific expertise, leadership, and administrative capabilities essential to coordinate a program for developing investigators must be included in the application.

Program Faculty (Component of Item 3): The PD/PI should describe past research training activities/experiences including those of mentors documenting the success of former Scholars in seeking further career development and the establishment of independent productive scientific careers.  Describe the complementary expertise and experiences of the proposed mentors for the Scholars. Include active research and other Scholarly activities in which the mentors are engaged, as well as track records of mentoring and training. 

Proposed Career Development Program (Component of Item 3): Provide an overview of the proposed program: Describe the immediate and long-term objectives of the program, including strategies and career development activities that will be used to ensure that the objectives of the FOA are met.  Include information about planned courses, curricula, seminars, workshops, or tutorials which will be incorporated into the career development program and mentored research experiences and activities. Institutions with existing K12 or other institutional career development training programs must explain what distinguishes this proposal from the others, how the programs will synergize, if applicable, and make it clear that the faculty, potential Scholars, and resources are robust enough to support additional programs.  The description should include planned strategies to be used to ensure that the objectives are met.  The PD/PI should also describe past research career development activities/experiences including those of mentors, documenting the success of former Scholars in establishing independent productive scientific careers. 

Program Evaluation (Component of Item 3): Describe an evaluation plan to review and determine the effectiveness of the program.  This should include plans to obtain feedback from current and former Scholars to help identify weaknesses and to provide suggestions for program improvements, as well as plans for assessing Scholars’ career development and progression including degree completion (if applicable), publications, and subsequent positions.  Evaluation results should be included as part of the Final Progress Report.

Candidates/Scholars (Component of Item 3): The Emergency Medicine K12 program’s goal is to recruit a wide variety of clinician Scholars to build a strong emergency medicine research workforce. Physicians who have completed residencies or fellowships in clinical specialties other than emergency medicine (such as trauma surgery, pediatrics, hematology, internal medicine) or with interests in emergency medicine research are also eligible to become K12 scholars.  In addition to physicians in training, clinician-scientists are eligible candidates including clinicians with PhDs or equivalent research training (such as nurses or pharmacists) who have demonstrated interests in emergency medicine research.

Describe in general terms the pool of potential candidates including information about the types of prior clinical and research training and career level required for the program. Do not name prospective Scholars. Describe the criteria to be used for candidate evaluation in the selection of Scholars. Describe plans to recruit candidates, including those from economically, socially, or culturally disadvantaged backgrounds, individuals with disabilities or from racial or ethnic groups that are currently underrepresented in biomedical, behavioral, or clinical sciences and explain how these plans will be implemented. Provide brief summaries of career development plans that the Program will employ. The application should contain a description of how the career development plan will be tailored to the needs of the prospective Scholar candidates, taking into account their past experiences and competences, and should distinguish the plan from fellowship training.  The appointment of Scholars should be documented by a Statement of Appointment Form (Form 2271) and submitted to the funding IC.

Institutional Environment and Commitment to the Program (Component of Item 3): The sponsoring institution must have well-established research programs, highly qualified faculty mentors, and be the site for the institutional program.  Describe the research infrastructure, facilities, etc., that are available and accessible to this Program. This includes the existence of funded laboratories and research space and activities that will meet and sustain the needs of the Program. Provide information establishing the commitment of the applicant institution; the Project Director/Principal Investigator (PD/PI); the Research Administrator, if any; and the faculty mentors who will provide developmental experiences that will lead to independence in biomedical, behavioral, and/or clinical research relevant to the mission of the National Heart, Lung, and Blood Institute. The application must include a statement from the applicant institution describing the commitment to the planned program. The institution must assure that essential time will be allowed for the PDs/PIs, other faculty and mentors, and the required protected time for Scholars (9 person-months, equivalent to 75%) selected for the program.

Item 4. Recruitment and Retention Plan to Enhance Diversity: The NIH recognizes a unique and compelling need to promote diversity in the biomedical, behavioral, clinical and social sciences workforce.  The NIH expects efforts to diversify the workforce to lead to the recruitment of the most talented researchers from all groups; to improve the quality of the educational and training environment; to balance and broaden the perspective in setting research priorities; to improve the ability to recruit subjects from diverse backgrounds into clinical research protocols; and to improve the Nation’s capacity to address and eliminate health disparities.

Accordingly the NIH continues to encourage institutions to diversify their student and faculty populations and thus to increase the participation of individuals currently underrepresented in the biomedical, clinical, behavioral, and social sciences such as:  individuals from underrepresented racial and ethnic groups, individuals with disabilities, and individuals from socially, culturally, economically, or educationally disadvantaged backgrounds that have inhibited their ability to pursue a career in health-related research.  Institutions are encouraged to identify candidates who will increase diversity on a national or institutional basis.  The NIH is particularly interested in encouraging the recruitment and retention of the following classes of candidates:  

A.    Individuals from racial and ethnic groups that have been shown by the National Science Foundation to be underrepresented in health-related sciences on a national basis (see data at http://www.nsf.gov/statistics/showpub.cfm?TopID=2&SubID=27 and the report Women, Minorities, and Persons with Disabilities in Science and Engineering, 2007, p. 262). The following racial and ethnic groups have been shown to be underrepresented in biomedical research: African Americans, Hispanic Americas, Native Americans, Alaska Natives, Hawaiian Natives, and natives of the US Pacific Islands.  In addition, it is recognized that under-representation can vary from setting to setting and individuals from racial or ethnic groups that can be convincingly demonstrated to be underrepresented by the grantee institution should be encouraged to participate in this program.

B.    Individuals with disabilities, who are defined as those with a physical or mental impairment that substantially limits one or more major life activities.

C.    Individuals from disadvantaged backgrounds who are defined as:

1.     Individuals who come from a family with an annual income below established low-income thresholds.  These thresholds are based on family size, published by the U.S. Bureau of the Census; adjusted annually for changes in the Consumer Price Index; and adjusted by the Secretary for use in all health professions programs.  The Secretary periodically publishes these income levels at HHS - Poverty Guidelines, Research, and Measurement. For individuals from low income backgrounds, the institution must be able to demonstrate that such candidates have qualified for Federal disadvantaged assistance or they have received any of the following student loans:  Health Professional Student Loans (HPSL), Loans for Disadvantaged Student Program, or they have received scholarships from the U.S. Department of Health and Human Services under the Scholarship for Individuals with Exceptional Financial Need.

2.     Individuals who come from a social, cultural, or educational environment such as that found in certain rural or inner-city environments that have demonstrably and recently directly inhibited the individual from obtaining the knowledge, skills, and abilities necessary to develop and participate in a research career. 

Recruitment and retention plans related to a disadvantaged background (C1 and C2) are most applicable to high school and perhaps undergraduate candidates, but would be more difficult to justify for individuals beyond that level of achievement.  Under extraordinary circumstances the PHS may, at its discretion, consider an individual beyond the undergraduate level to be from a disadvantaged background.  Such decisions will be made on a case-by-case basis, based on appropriate documentation.

Competing continuation and non-competing applications must include a detailed account of experiences in recruiting individuals from underrepresented groups during the previous funding period. Information must be included on successful and unsuccessful recruitment strategies including aggregate information on the distribution of:

For those Scholars who were enrolled in the career development program, the report should include information about the duration of research career development and whether those Scholars finished their training in good standing.

This Program Announcement requires all applicants to submit a Recruitment and Retention plan to Enhance Diversity (see SF424, Section 8.7. Research Training Program Plan Components, Item 4, Recruitment and Retention to Enhance Diversity).  Additional information on the required Recruitment and Retention Plan to Enhance Diversity is available at Frequently Asked Questions Recruitment and Retention Plan to Enhance Diversity (Diversity FAQs).

Item 5. Instruction in the Responsible Conduct of Research: For detailed guidance on Instruction in Responsible Conduct of Research, please refer to NOT-OD-10-019.  Every Scholar supported by this training grant must receive instruction in the responsible conduct of research. Describe the plan to provide Scholars with such instruction. The plan must address five components: format; subject matter; faculty participation; duration of instruction; and frequency of instruction. 

Applications lacking a plan for instruction in the responsible conduct of research will be considered incomplete and will not be reviewed.

Item 6. Progress Report): N/A. Renewal applications are not allowed for this FOA.

Item 9. Select Agent Research: If participating faculty proposed in the career development program are conducting or plan to conduct research involving select agents in which Scholars may participate, follow the instructions in SF424, Section 5.5, and include information in PHS398 Research Training Program Plan, Item 9, Select Agent Research.

Item 10. Multiple PD/PI Leadership Plan: If multiple PD/PIs are proposed, explain in the Program Plan your rationale for how this will facilitate program administration.

Item 14. Letters of Support:  Provide the sponsoring institution’s letter of commitment and support (see Section III.3.)

Item 15. Appendix: Applicants must follow the specific instructions on Appendix materials as described in the SF424 (R&R) Application Guide
(See http://grants.nih.gov/grants/funding/424/index.htm). Do not use the Appendix to circumvent the page limitations of the Research Career Development Plan component. An application that does not comply with the required page limitations may be delayed in the review process.

SF424 R&R Cover Component

Project/Performance Site Locations Component

Indicate where the career development program described in the Research and Career Development Plans will be conducted. Include collaborating sites, if appropriate.

If multiple sites are involved in the institutional career development program, the applicant institution must be the primary site for the program.  A justification must be included for sites other than the applicant institution in the program narrative.   

Research and Related (R&R) Other Project Information Component

Item 7. Project Summary/Abstract: (Do not exceed 1 page): Provide an abstract of the entire application, including the long-term goals and objectives of the program, key elements of the career development plan, and brief descriptions of planned research projects. Include the rationale and design of the program, the planned duration and projected number of Scholars, including their levels (i.e., predoctoral, postdoctoral, faculty).

Item 8. Project Narrative: Using no more than two or three sentences, describe the relevance of this institutional career development program to public health.  In this section, use plain language that can be understood by a general, lay audience.

Item 9. Bibliography & References Cited: This item should be used only to cite reference supporting the need, rationale, and approach for the institutional career development program described in the PHS 398 Research Training Program Plan.  Note that the Literature Cited section is captured in this section (unlike the placement in the PHS 398).  Do not include lists of publications of project directors, mentors and Scholars in this section, as this information will be included in the biosketches.

Item 10. Facilities & Other Resources: Describe in an attachment the institutional environment, including the facilities, laboratories, participating departments, computer services, and any other resources to be used in the development and implementation of the proposed program.

Item 12. Other Attachments:

Advisory Committee (when applicable): A plan must be provided for the appointment of an Advisory Committee to monitor the progress of the Scholars. Composition, responsibilities, frequency of meetings, and other relevant information should be included. Describe the composition of the Advisory Committee, identifying the role and the desired expertise of members. A plan for Advisory Committee approval and selection of Scholars should be included. Describe how the Advisory Committee will function in providing oversight of the development, implementation, and evaluation of recruitment strategies, the recruitment and retention of candidates, and the evaluation of the overall effectiveness of the career development program. Note that Advisory Committee members do not need to be named in the application, particularly if they include individuals from outside the institution.

Resource Sharing Plan(s): NIH considers the sharing of unique research resources developed through NIH-sponsored research an important means to enhance the value of, and advance research. When resources have been developed with NIH funds and the associated research findings published or provided to NIH, it is important that they be made readily available for research purposes to qualified individuals within the scientific community. If the final data/resources are not amenable to sharing, this must be explained in Resource Sharing section of the application. See http://grants.nih.gov/grants/policy/data_sharing/data_sharing_faqs.htm.

Data Sharing Plan: Not Applicable.

Sharing Model Organisms:. Not Applicable.

Genome-Wide Association Studies (GWAS): Not Applicable.

Senior/Key Person Profile(s) Component

The PD/PI: The PD/PI must be registered in the eRA Commons and be assigned the PI role within the Commons. Follow the instructions in Part I.2 which provides information regarding required registration in the eRA Commons.

Key Personnel must include the PD/PI (or multiple PDs/PIs) as well as any other key persons involved in developing, implementing, directing, monitoring, evaluating, etc., who are integral to and have key roles in the proposed institutional research career development program.

See Section 4.5 of the Grants.gov Application Guide SF424 (R&R).

Complete the Profile for the PD/PI according to instructions in Section 4.5 of the Grants.gov Application Guide SF424 (R&R).

Multiple-Program Directors may be proposed only if the FOA to which you are responding indicated the multiple PD/PIs will be accepted. If multiple PD/PIs are proposed, explain in the Program Plan your rationale for how this will facilitate program administration.  If your application involves Multiple PD/PIs, follow the directions in Section 4.5 to designate the Contact PI and to assign the PD/PI role to other Senior/Key Persons.  Additionally, the application must include a Multi-PD/PI Leadership Plan.

Complete the Profiles for Other Senior/Key Persons according to instructions in Section 4.5 of the Grants.gov Application Guide SF424 (R&R)

The PD/PI, applicable faculty and any other individuals whose contributions are critical to the development, management and execution of the Institutional Career Development Program Plan in a substantive, measurable way (whether or not salaries are reimbursed) should be identified as Senior/Key Persons. These would include the multiple PDs/PIs, if applicable, and other program staff.  Since these efforts are not project related research endeavors, they should not be identified in Other Support information.

Other Personnel: See “R&R Budget Component Research & Related Budget,” Item “B” below.

Budget Component

Institutional Research Career Development Program applications will use the non-modular budget format (Research & Related Budget component) and "Just-in-Time" concepts.  See Sections II and Section IV for budgetary guidance.  Instructions for completing the R&R Budget Component are provided below. Information regarding allowable costs is provided in the specific FOA. The R&R Budget component includes three separate data entry screens (1) Sections A and B; (2) Sections C through E; and (3) Sections F through K.  Applicants must complete a separate detailed budget for each year of support requested.

R&R Budget Component Research & Related Budget: Complete for each budget period requested.

A.    Senior/Key Person: complete for all senior/key persons associated with the institutional career development   program.  The PD/PI (or multiple PDs/PIs) must be included.

B.    Other Personnel: complete for all other personnel (including clerical and program administrative staff) associated with the institutional career development program. Include the salary costs proposed for the planned Scholars, identifying as the Project Role “Scholar.”

C.    Equipment: self-explanatory.

D.    Travel: include any travel funds requested for senior/key persons and other personnel (i.e., those persons identified in Sections A. and B.) associated with the program.

E.    Participant/Trainee Support Costs: Do not complete this budget category (does not apply to K12 programs).

F.    Other Direct Costs: Include the funds requested for research development costs allowed for the Scholars in the program, using lines 8-10 (when necessary), and itemize as appropriate and allowed for institutional career development program.

G.    Indirect Costs: Indirect costs are reimbursed at 8% of modified total direct costs (exclusive of tuition and fees and expenditures for equipment) rather than on the basis of a negotiated rate agreement.

K.    Budget Justification: provide a detailed justification for each category for which funds are requested.  For Section F, itemize each category of support costs per Scholar and justify. Provide an explanation for all Scholar research and development costs in the Budget Justification.  

Although many of the sections of this application are separate PDF attachments, page limitations referenced in the instructions and/or funding opportunity announcement must still be followed. Agency validations will include checks for page limits (and use of appropriate font). Some accommodation will be made for sections that, when combined, must fit within a specified limitation.

Text attachments should be generated using word processing software and then converted to PDF using PDF generating software. Avoid scanning text attachments to convert to PDF since that causes problems for the agency handling the application. In addition, be sure to save files with descriptive file names.

When attaching a PDF document to the actual forms, please note you are attaching an actual document, not just pointing to the location of an externally stored document. Therefore, if you revise the document after it has been attached, you must delete the previous attachment and then reattach the revised document to the application form. Use the “View Attachment” button to determine if the correct version has been attached.

Section V. Application Review Information


1. Criteria 

Only the review criteria described below will be considered in the review process.

2. Review and Selection Process

The mission of the NIH is to support science in pursuit of knowledge about the biology and behavior of living systems and to apply that knowledge to extend healthy life and reduce the burdens of illness and disability.  As part of this mission, applications submitted to the NIH for grants or cooperative agreements to support biomedical and behavioral research are evaluated for scientific and technical merit through the NIH peer review system.

Review Process

Applications that are complete and responsive to this FOA will be evaluated for scientific and technical merit by an appropriate peer review group convened by the NHLBI and in accordance with NIH peer review procedures (http://grants1.nih.gov/grants/peer/), using the review criteria stated below.

As part of the initial merit review, all applications will:

The goals of NIH-supported research training, education, and career development programs are to help ensure that a diverse pool of highly trained scientists is available in adequate numbers and in appropriate scientific areas to address the Nation’s biomedical, behavioral, and clinical research needs.

The NIH K12 grant mechanism is a specialized mechanism designed to foster the development of biomedical, behavioral, and clinical researchers through creative and innovative institutional career development programs.

Overall Impact: Reviewers will provide an overall impact/priority score to reflect their assessment of the likelihood for the institutional research career development  program to exert a sustained, powerful influence on the activities involved, in consideration of the following five scored review criteria, and additional review criteria (as applicable for the proposed program).

Scored Review Criteria: Reviewers will consider each of the five review criteria below to determine scientific merit.  Each will be given a separate score.  An application does not need to be strong in all categories to be judged likely to have a major scientific impact.  For example, a project that by its nature is not innovative may be essential to advance a field.

Career Development Program Plan and Environment:

Program Director(s)/Principal Investigator(s) (PD/PIs):

Mentors:

Candidates/Scholars:

Training Record:

Additional Review Criteria

As applicable for the program proposed, reviewers will consider the following additional items in the determination of scientific merit, 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.

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.

Biohazards: Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.

Vertebrate Animals:  Not applicable.

Biohazards: Not applicable.

Resubmission Applications:  Resubmissions are not allowed for this FOA.

Renewal Applications:  Renewals are not allowed for this FOA.

Additional Review Considerations  

As applicable for the program proposed, reviewers will address 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.

Recruitment and Retention Plan to Enhance Diversity: Peer reviewers will separately evaluate the diversity recruitment and retention plan after the overall score has been determined.  Reviewers will examine the strategies to be used in the recruitment and retention of individuals from underrepresented racial and ethnic groups, individuals with disabilities, and individuals from disadvantaged backgrounds. 

Training in the Responsible Conduct of Research: Reviewers will evaluate plans for instruction in responsible conduct of research as well as the past record of instruction in responsible conduct of research, where applicable.  Reviewers will specifically address five Instructional Components, Format, Subject Matter, Faculty Participation, Duration and Frequency, taking into account the characteristics of institutional programs, detailed in NOT-OD-10-019.  Plans and past record will be rated as ACCEPTABLE or UNACCEPTABLE.  Applications with unacceptable plans will not be funded until the applicant provides an acceptable, revised plan.

Select Agents 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:

When relevant, reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable:

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 institutional career development program and the number of proposed Scholars.  

Selection Process

Applications submitted in response to this funding opportunity will compete for available funds with all other recommended applications. The following will be considered in making funding decisions:

3. Anticipated Announcement and Award Dates

July 1, 2011

Section VI. Award Administration Information


1. Award Notices

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 NIH eRA Commons

If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant. For details, applicants may refer to the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General.

Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the Notice of Award (NoA) are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs. See Section IV.5., “Funding Restrictions.”       

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant 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 NHLBI to the grantee business official. 

2. Administrative and National Policy Requirements

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General  and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities

Termination of Award: When a grantee institution plans to terminate an award, program and grants management staff at the NIH funding component must be notified in writing as soon as possible.

Change of Institution: The institutional career development program may not be transferred from one institution to another.

Change of Program: Awards are made for a specific program under the guidance and leadership of a particular PD/PI.  A change in any of these parameters requires prior approval by the responsible program officer in the NIH funding component.  A rationale must be provided for any proposed changes in the aims of the original, peer-reviewed program.  If the new program does not satisfy this requirement, the award will be terminated.

Change of PD/PI: If change of the PD/PI is necessary, support of the award is not automatic but may be continued with prior written approval by the NIH funding component, provided that the following conditions are met.  The current PD/PI or the grantee institution must submit a written request for the change, signed by the appropriate institutional business official, to the responsible program officer of the NIH funding component that describes the reasons for the change.  The Biographical Sketch of the proposed PD/PI, including a complete listing of active research grant support, must be provided.  The information in the request must establish that the goals of the original peer-reviewed institutional career development program will remain unchanged under the direction of the new PD/PI and that the new PD/PI has the appropriate research and administrative expertise to lead the program.  This request must be submitted sufficiently in advance of the requested effective date to allow the necessary time for review. 

3. Reporting

Complete applications with detailed budgets and progress reports are required annually.

When multiple years are involved, awardees will be required to submit the Non-Competing Grant Progress Report (PHS 2590) annually and financial statements as required in the NIH Grants Policy Statement

The Progress Report should provide information on the development and implementation of the proposed career development program (including training and education in the responsible conduct of research), any modifications to the career development program as originally proposed, details about the applicant pool and the participating Scholars including their career level(s), gender, and racial/ethnic backgrounds (if applicable), updates on the evaluation of the program, and a list of any publications and/or other materials arising from the program.

This report should provide information about changes in the Program, a summary of any ongoing evaluation results, a summary report from the Program Advisory Committee (including information about newly selected candidates, if applicable), and a description of the research and career progress of each candidate. An overview of each Scholar's research accomplishments and goals for the coming year should be clearly stated. These Annual Progress Reports will be closely monitored by NIH staff to ensure that the grant is achieving the goals of the program and to confirm that the institution is continuing to meet its goal of recruiting promising investigators, and facilitating their career development

Examples:

Progress reports should provide metrics of Scholar success annually including completion of coursework and degree programs, as well as scientific presentations, and peer reviewed publications.

Add Information Here

3.A. Additional Reporting Requirements

Financial Status Report (FSR): An annual FSR is required and must be submitted within 90 days of the end of each budget period.  Continuation support will not be provided until the required form is submitted and accepted.

Evaluation: In carrying out its stewardship of human resource-related programs, the NIH may request information essential to an assessment of the effectiveness of this program.  Accordingly, award recipients are hereby notified that they may be contacted after completion of this award for periodic updates on various aspects of program development, implementation, and other information helpful in evaluating the impact of this program.

Publication and Sharing of Research Results: Investigators are encouraged to submit reports of their findings for publication to the journals of their choice.  For each publication that results from this award, NIH support should be acknowledged by a footnote in language similar to the following: “This project was supported by NIH grant number ________.  Its contents are solely the responsibility of the authors and do not necessarily represent the official views of the NIH.”

Failure by the grantee institution to submit the required forms in a timely, complete, and accurate manner may result in an expenditure disallowance or a delay in any continuation funding for the award.  Forms may be found on the NIH Website at http://grants.nih.gov/grants/forms.htm.

Final Reports: A final Progress Report and Financial Status Report are required when an award is terminated.  Evaluation results should be included as part of the Final Progress Report.

Scholar Selection Requirements: The institution must submit a completed Statement of Appointment (PHS Form 2271) for each Scholar selected or returning to the K12 program.  This form must be submitted to the awarding IC at or before the start of each Scholar’s appointment or re-appointment.   When applicable, a notarized statement verifying possession of permanent residency documentation must be submitted with the Statement of Appointment (PHS Form 2271).  Forms may be found on the NIH Website at http://grants.nih.gov/grants/forms.htm

If registered in the NIH eRA Commons, grantees may submit the PHS 2271 data electronically using the xTrain system.  More information on xTrain is available at https://commons.era.nih.gov/commons/.

Section VII. Agency Contacts


We encourage your inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants. Inquiries may fall into three areas: scientific/research, peer review, and financial or grants management issues:

1. Scientific/Research Contacts:

Jane D. Scott, ScD, MSN.
Division of Cardiovascular Sciences
National Heart, Lung, and Blood Institute
Rockledge 2, Room 8210
6701 Rockledge Drive
Bethesda, MD 20892-7940

Telephone: (301) 435-0535
Fax: 301-480-1454
Email: scottj2@nhlbi.nih.gov

2. Peer Review Contacts:

Director, Office of Scientific Review   
Division of Extramural Research Activities
National Heart, Lung, and Blood Institute
6701 Rockledge Drive, Room 7214 
Bethesda, MD 20892-7924 (Express Mail Zip: 20817)
Telephone: (301) 435-0270
Fax: (301) 480-0730
Email: nhlbichiefreviewbranch@nhlbi.nih.gov

3. Financial or Grants Management Contacts:

Denise Payne
Office of Grants Management
National Heart, Lung, and Blood Institute
6701 Rockledge Drive, Room 7160
Bethesda, MD 20892-7926
Telephone: (301) 435-9529
Fax: (301) 451-5462
Email: denisepayne@nhlbi.nih.gov

Section VIII. Other Information


Required Federal Citations

Use of Animals in Research:
Recipients of PHS support for activities involving live, vertebrate animals must comply with PHS Policy on Humane Care and Use of Laboratory Animals (http://grants.nih.gov/grants/olaw/references/PHSPolicyLabAnimals.pdf) as mandated by the Health Research Extension Act of 1985 (http://grants.nih.gov/grants/olaw/references/hrea1985.htm), and the USDA Animal Welfare Regulations (http://www.nal.usda.gov/awic/legislat/usdaleg1.htm) as applicable.

Human Subjects Protection:
Federal regulations (45 CFR 46) require that applications and proposals involving human subjects must be evaluated with reference to the risks to the subjects, the adequacy of protection against these risks, the potential benefits of the research to the subjects and others, and the importance of the knowledge gained or to be gained (http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm).

Data and Safety Monitoring Plan:
Data and safety monitoring is required for all types of clinical trials, including physiologic toxicity and dose-finding studies (Phase I); efficacy studies (Phase II); efficacy, effectiveness and comparative trials (Phase III). Monitoring should be commensurate with risk. The establishment of data and safety monitoring boards (DSMBs) is required for multi-site clinical trials involving interventions that entail potential risks to the participants (“NIH Policy for Data and Safety Monitoring,” NIH Guide for Grants and Contracts, http://grants.nih.gov/grants/guide/notice-files/not98-084.html).

Sharing Research Data:
Investigators submitting an NIH application seeking $500,000 or more in direct costs in any single year are expected to include a plan for data sharing or state why this is not possible (http://grants.nih.gov/grants/policy/data_sharing). Investigators should seek guidance from their institutions, on issues related to institutional policies and local institutional review board (IRB) rules, as well as local, state and federal laws and regulations, including the Privacy Rule.

Policy for Genome-Wide Association Studies (GWAS):
NIH is interested in advancing genome-wide association studies (GWAS) to identify common genetic factors that influence health and disease through a centralized GWAS data repository. For the purposes of this policy, a genome-wide association study is defined as any study of genetic variation across the entire human genome that is designed to identify genetic associations with observable traits (such as blood pressure or weight), or the presence or absence of a disease or condition. All applications, regardless of the amount requested, proposing a genome-wide association study are expected to provide a plan for submission of GWAS data to the NIH-designated GWAS data repository, or provide an appropriate explanation why submission to the repository is not possible. Data repository management (submission and access) is governed by the Policy for Sharing of Data Obtained in NIH Supported or Conducted Genome-Wide Association Studies, NIH Guide NOT-OD-07-088. For additional information, see http://grants.nih.gov/grants/gwas/.

Sharing of Model Organisms:
NIH is committed to support efforts that encourage sharing of important research resources including the sharing of model organisms for biomedical research (see http://grants.nih.gov/grants/policy/model_organism/index.htm). At the same time the NIH recognizes the rights of grantees and contractors to elect and retain title to subject inventions developed with Federal funding pursuant to the Bayh-Dole Act (see the NIH Grants Policy Statement. Beginning October 1, 2004, all investigators submitting an NIH application or contract proposal are expected to include in the application/proposal a description of a specific plan for sharing and distributing unique model organism research resources generated using NIH funding or state why such sharing is restricted or not possible. This will permit other researchers to benefit from the resources developed with public funding. The inclusion of a model organism sharing plan is not subject to a cost threshold in any year and is expected to be included in all applications where the development of model organisms is anticipated.

Access to Research Data through the Freedom of Information Act:
The Office of Management and Budget (OMB) Circular A-110 has been revised to provide access to research data through the Freedom of Information Act (FOIA) under some circumstances. Data that are: (1) first produced in a project that is supported in whole or in part with Federal funds; and (2) cited publicly and officially by a Federal agency in support of an action that has the force and effect of law (i.e., a regulation) may be accessed through FOIA. It is important for applicants to understand the basic scope of this amendment. NIH has provided guidance at http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm. Applicants may wish to place data collected under this funding opportunity in a public archive, which can provide protections for the data and manage the distribution for an indefinite period of time. If so, the application should include a description of the archiving plan in the study design and include information about this in the budget justification section of the application. In addition, applicants should think about how to structure informed consent statements and other human subjects procedures given the potential for wider use of data collected under this award.

Inclusion of Women And Minorities in Clinical Research:
It is the policy of the NIH that women and members of minority groups and their sub-populations must be included in all NIH-supported clinical research projects unless a clear and compelling justification is provided indicating that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All investigators proposing clinical research should read the "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research” (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html); a complete copy of the updated Guidelines is available at http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm. The amended policy incorporates: the use of an NIH definition of clinical research; updated racial and ethnic categories in compliance with the new OMB standards; clarification of language governing NIH-defined Phase III clinical trials consistent with the SF424 (R&R) application; and updated roles and responsibilities of NIH staff and the extramural community. The policy continues to require for all NIH-defined Phase III clinical trials that: (a) all applications or proposals and/or protocols must provide a description of plans to conduct analyses, as appropriate, to address differences by sex/gender and/or racial/ethnic groups, including subgroups if applicable; and (b) investigators must report annual accrual and progress in conducting analyses, as appropriate, by sex/gender and/or racial/ethnic group differences.

Inclusion of Children as Participants in Clinical Research:
The NIH maintains a policy that children (i.e., individuals under the age of 21) must be included in all clinical research, conducted or supported by the NIH, unless there are scientific and ethical reasons not to include them.

All investigators proposing research involving human subjects should read the "NIH Policy and Guidelines" on the inclusion of children as participants in research involving human subjects (http://grants.nih.gov/grants/funding/children/children.htm).

Required Education on the Protection of Human Subject Participants:
NIH policy requires education on the protection of human subject participants for all investigators submitting NIH applications for research involving human subjects and individuals designated as key personnel. The policy is available at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.

Human Embryonic Stem Cells (hESC):
Criteria for Federal funding of research on hESCs can be found at http://stemcells.nih.gov/index.asp and at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-09-116 .html. Only research using hESC lines that are registered in the NIH Human Embryonic Stem Cell Registry will be eligible for Federal funding (http://escr.nih.gov/). It is the responsibility of the applicant to provide in the project description and elsewhere in the application as appropriate, the official NIH identifier(s) for the hESC line(s) to be used in the proposed research.

NIH Public Access Policy Requirement:
In accordance with the NIH Public Access Policy, investigators funded by the NIH must submit or have submitted for them to the National Library of Medicine’s PubMed Central (see http://www.pubmedcentral.nih.gov/), an electronic version of their final, peer-reviewed manuscripts upon acceptance for publication, to be made publicly available no later than 12 months after the official date of publication. The NIH Public Access Policy is available at (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-033.html). For more information, see the Public Access webpage at http://publicaccess.nih.gov/.

Standards for Privacy of Individually Identifiable Health Information:
The Department of Health and Human Services (HHS) issued final modification to the "Standards for Privacy of Individually Identifiable Health Information," the "Privacy Rule," on August 14, 2002. The Privacy Rule is a federal regulation under the Health Insurance Portability and Accountability Act (HIPAA) of 1996 that governs the protection of individually identifiable health information, and is administered and enforced by the HHS Office for Civil Rights (OCR).

Decisions about applicability and implementation of the Privacy Rule reside with the researcher and his/her institution. The OCR website (http://www.hhs.gov/ocr/) provides information on the Privacy Rule, including a complete Regulation Text and a set of decision tools on "Am I a covered entity?" Information on the impact of the HIPAA Privacy Rule on NIH processes involving the review, funding, and progress monitoring of grants, cooperative agreements, and research contracts can be found at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html.

URLs in NIH Grant Applications or Appendices:
All applications and proposals for NIH funding must be self-contained within specified page limitations. For publications listed in the appendix and/or Progress report, Internet addresses (URLs) or PubMed Central (PMC) submission identification numbers must be used for publicly accessible on-line journal articles. Publicly accessible on-line journal articles or PMC articles/manuscripts accepted for publication that are directly relevant to the project may be included only as URLs or PMC submission identification numbers accompanying the full reference in either the Bibliography & References Cited section, the Progress Report Publication List section, or the Biographical Sketch section of the NIH grant application. A URL or PMC submission identification number citation may be repeated in each of these sections as appropriate. There is no limit to the number of URLs or PMC submission identification numbers that can be cited.

Healthy People 2010:
The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2010," a PHS-led national activity for setting priority areas. This FOA is related to one or more of the priority areas. Potential applicants may obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople.

Authority and Regulations:
This program is described in the Catalog of Federal Domestic Assistance at http://www.cfda.gov/ and is not subject to the intergovernmental review requirements of Executive Order 12372. 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. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

The PHS strongly encourages all grant recipients to provide a smoke-free workplace and discourage the use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care, or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people.

Loan Repayment Programs:
NIH encourages applications for educational loan repayment from qualified health professionals who have made a commitment to pursue a research career involving clinical, pediatric, contraception, infertility, and health disparities related areas. The LRP is an important component of NIH's efforts to recruit and retain the next generation of researchers by providing the means for developing a research career unfettered by the burden of student loan debt. Note that an NIH grant is not required for eligibility and concurrent career award and LRP applications are encouraged. The periods of career award and LRP award may overlap providing the LRP recipient with the required commitment of time and effort, as LRP awardees must commit at least 50% of their time (at least 20 hours per week based on a 40-hour week) for two years to the research. For further information, please see: http://www.lrp.nih.gov/.


Weekly TOC for this Announcement
NIH Funding Opportunities and Notices


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