Part I Overview Information


Department of Health and Human Services

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

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

Title: Minority Institutional Research Training Program (T32)

Announcement Type
This is a reissue of RFA-HL-04-027.

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

Request For Applications (RFA) Number: RFA-HL-08-017

Catalog of Federal Domestic Assistance Number(s)
93.233, 93.837, 93.838, 93.839

Key Dates
Release Date: June 12, 2008
Letters of Intent Receipt Date: July 15, 2008
Application Receipt Date: August 15, 2008
Peer Review Date(s): October/November 2008
Council Review Date: January 2009
Earliest Anticipated Start Date: April 1, 2009   
Additional Information To Be Available Date (Url Activation Date): Not Applicable
Expiration Date: August 16, 2008

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. Research Training Objectives

Section II. Award Information
1. Mechanism(s) 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. Address to Request Application Information
2. Content and Form of Application Submission
3. Submission Dates and Times
    A. Receipt, Review and Anticipated Start Dates
         1. Letter of Intent
    B. Sending an Application to the NIH
    C. Application Processing
   D.  Application Assignment
4. Intergovernmental Review
5. Funding Restrictions
6. Other Submission Requirements and Information

Section V. Application Review Information
1. Criteria
2. Review and Selection Process
    A. Additional Review Criteria
    B. Additional Review Considerations
    C. Resource Sharing Plan(s)
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. Research Training Objectives
 
Through the Minority Institutional Research Training Program, research training grant awards are made in cardiovascular, pulmonary, hematologic, and sleep disorders research to minority schools to enable qualified predoctoral and health professional students and individuals in postdoctoral training to participate in research programs.  It is expected to attract students in their developmental stages, increase their awareness of these diseases, and to encourage them to pursue career opportunities in research related to the mission of the National Heart, Lung, and Blood Institute (NHLBI).

Trainee appointments will be determined by the institution and carried out in a manner that will include the recruitment of racial and ethnic minorities, individuals from disadvantaged backgrounds, individuals with disabilities, and women into heart, lung, blood, and sleep disorders scientific research areas.

NHLBI encourages research training and career development crossing disciplinary boundaries (examples; biophysics, biostatistics, bioinformatics, bioengineering) to develop a new interdisciplinary workforce.

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

Section II. Award Information


1. Mechanism of Support

This funding opportunity will use the National Institutes of Health (NIH) Ruth L. Kirschstein Institutional National Research Service Award (NSRA) (T32) award mechanism(s). The Project Director/Principal Investigator (PD/PI) will be solely responsible for planning, directing, and executing the proposed project.

This FOA uses “Just-in-Time” information concepts. It also uses non-modular budget formats described in the PHS 398 application instructions (see http://grants.nih.gov/grants/funding/phs398/phs398.html). 

2. Funds Available

The estimated amount of funds available for support of two projects awarded as a result of this announcement is $250,000 for fiscal year 2009. Future year amounts will depend on annual appropriations.

See the SUPPLEMENTARY INSTRUCTIONS section for additional information. 

Funds will be provided on an annual basis to develop and maintain a stable research training experience for qualified students.  Successful applicants may compete for subsequent awards of up to five years duration upon completion of the initial grant period. Funding beyond the first year of the grant is contingent upon satisfactory progress during the preceding year and availability of funds.

Because the nature and scope of the proposed research training 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 IC(s) provide support for this program, awards pursuant to this funding opportunity are contingent upon the availability of funds and the receipt of a sufficient number of meritorious applications.

Allowable Costs:

(A) Stipends - The current stipend level for predoctoral and health professional student trainees at all levels of experience is $20,772.  Current stipend levels for

postdoctoral trainees are available at http://grants.nih.gov/training/nrsa.htm.

(B) Tuition and Fees - The combined cost of tuition and fees will be offset at the

following rate for predoctoral trainees: an amount equal to 60% of the level requested by the applicant institution, up to $16,000 per year, will be provided. If the program supports formally combined dual-degree training (e.g., M.D.-Ph.D, D.D.S.-Ph.D.), the amount provided per trainee will be up to $21,000 per year.  For postdoctoral trainees, an amount equal to 60% of the level requested by the applicant institution, up to $4,500 per year, will be provided. If the program supports postdoctoral individuals in formal degree-granting training, the amount provided per trainee enrolled in a degree-granting program will be up to $16,000 per year. Costs associated with tuition and fees are allowable only if they are

required for specific courses in support of the research training experience supported by the training grant.  A full description of the tuition policy is contained within the NRSA Policy Guidelines on the NIH website at:  http://grants.nih.gov/training/nrsa.htm#policy.

(C) Trainee Travel Costs - If requested by the grantee, the NHLBI awarding office may provide grant funds to cover the costs of trainee travel, including attendance at scientific meetings, which the organization determines is necessary to the individual’s training.  Funds may not be expended to cover the costs of travel between the trainee’s place of residence and the training institution, except that the grantee organization may authorize a one-way travel allowance in an individual case of extreme hardship. The maximum allowable per student per year is $1,400.

In addition, support for travel to a research training experience away from the grantee organization may be permitted.  Research training experiences away from the parent organization must be justified on the basis of the type of opportunities for training available, the opportunities offered that are different from those at the parent organization, and the relationship of the proposed experience to the trainee’s career stage and career goals.  This type of research training and applicable costs requires prior approval of the NHLBI awarding office.  Letters requesting such training may be submitted to the NHLBI awarding office at any time during the appointment period.

(D) Training-Related Expenses (includes Health Insurance) - Institutional costs of $4,200 a year per predoctoral trainee and $7,850 a year per postdoctoral trainee may be requested to defray the costs of other research training related expenses, such as staff salaries, consultant costs, equipment, research supplies and staff travel, and health insurance.  

(E)  Facilities and Administrative Costs - The Notice of Grant Award will provide facilities and administrative costs based on 8% of total direct costs, exclusive of tuition, fees and equipment.

(F) Stipend Supplementation, Compensation, and Other Income – The grantee institution is allowed to provide funds to an individual in addition to the stipends paid by the NIH.  Such additional amounts either may be in the form of augmented stipends (supplementation) or in the form of compensation, such as salary or tuition remission for services such as teaching or serving as a laboratory assistant, provided the conditions described below are met.  Under no circumstances may the conditions of stipend supplementation or the services provided for compensation interfere with, detract from, or prolong the trainee's approved NRSA training program.

Grantees may supplement stipends from non-Federal funds provided the supplementation is without obligation to the trainee.  An organization can determine what amount of stipend supplementation, if any, will be provided according to its own formally established policies governing stipend support.  These policies must be consistently applied to all individuals in a similar training status regardless of the source of funds.  Federal funds may not be used for stipend supplementation unless specifically authorized under the terms of the program from which funds are derived.  An individual may use Federal educational loan funds or VA benefits when permitted by those programs.  Under no circumstances may PHS funds be used for supplementation.

Compensation:  Funds characterized as compensation may be paid to trainees only when there is an employer-employee relationship, the payments are for services rendered, and the situation otherwise meets all of the conditions and policies in the NIH Grants Policy Statement.  Additionally, compensation must be in accordance with organizational policies consistently applied to both federally and non-federally supported activities and must be supported by acceptable accounting records that reflect the employer-employee relationship.  An institution may provide additional funds to a trainee in the form of compensation (as salary and/or tuition remission) for services performed outside of the responsibilities of the full-time NRSA-supported training such as teaching or serving as a research assistant.  A trainee may receive compensation for services as a research assistant or in some other position on a Federal research grant, including a DHHS research grant.  However, compensated services should occur on a limited, part-time basis apart from the normal full-time research training activities. In addition, compensation may not be paid from a research grant that supports the same research that is part of the trainee’s planned training experience as approved in the institutional training grant application.   Training Program Directors must approve all instances of employment on research grants to verify that the circumstances will not detract from or prolong the approved training program.

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.

Educational Loans or G.I. Bill:  An individual may make use of Federal educational loan funds and assistance under the Veterans Readjustment Benefits Act (G.I. Bill).  Such funds are not considered supplementation or compensation.  Postdoctoral trainees in their first and third years of training may also be eligible to participate in the NIH Extramural Loan Repayment Program.  Information about this program is available at: http://www.lrp.nih.gov/.

Section III. Eligibility Information


1. Eligible Applicants

1.A. Eligible Institutions

The following organizations/institutions are eligible to apply:

The applicant institution must have a strong and high quality research program in the area(s) proposed for research training and must have the requisite staff and facilities on site to conduct the proposed research training program. 

Foreign institutions are not eligible to apply.

The Institution must be a domestic college or university with student enrollment drawn substantially from minority racial and ethnic groups (such as African Americans/Blacks, Hispanics, American Indians, Alaska Natives, and non-Asian Pacific Islanders) currently underrepresented in biomedical and behavioral research. Ongoing staff and facilities must be available for the proposed program.

1.B. Eligible Individuals

Any individual with the skills, knowledge, and resources necessary to carry out the proposed research training program as the PD/PI is invited to work with his/her institution to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.

The research training program director at the institution will be responsible for the selection and appointment of trainees to the NRSA research training grant and for the overall direction, management, and administration of the program, program evaluation, and the submission of all required forms in a timely manner.

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

Applicants may not submit more than one application.

Resubmission applications are not permitted in response to this FOA.   

Renewal applications are permitted in response to this FOA.     

SPECIAL REQUIREMENTS

Research Center

The minority institution must identify and collaborate with a research center (medical school or comparable institution) that has strong, well-established cardiovascular, pulmonary, hematologic, or sleep disorders research and research training programs. 

Cooperation and collaboration between institutions is needed to provide each trainee with a mentor who is recognized as an accomplished investigator in cardiovascular, pulmonary, hematologic or sleep disorders research and who will assist the advisor at the minority institution with the trainee's development and research plan.  Plans for summer training as well as academic year training should be developed by the student and advisor at the trainee's home institution in collaboration with the mentor at the research center.  It is expected that the mentor(s) will guide the trainee through the initial training period and continue this interaction throughout the award. The development of strong mentoring relationships is essential to the success of the trainees and the program.

The minority institution will identify and complete arrangements with an established cardiovascular, pulmonary, hematologic, or sleep disorders research center(s) before submitting an application.  Arrangements between the participating institutions for the recruitment of trainees and joint selection of trainers for the provision of training, and for ongoing cooperation and collaboration between the institutions in the implementation of the program, should be clearly outlined in the application.

A written commitment to the training plan signed by the intended faculty mentors at the research center, the department(s) involved and countersigned by both institutional officials, must be part of the application.  The trainee and his or her faculty advisor at the minority institution will jointly select a faculty mentor at the research center.

Trainees

Trainees appointed to the training program must have the opportunity to carry out supervised biomedical or behavioral research with the primary objective of developing or extending their research skills and knowledge in preparation for a research career.

A trainee must be a citizen or non-citizen national of the United States or must have been lawfully admitted for permanent residence (i.e., in possession of a currently

valid Alien Registration Receipt Card I-551, or some other legal verification of such status).  Non-citizen nationals are generally persons born in outlying possessions of the United States (e.g., American Samoa and Swains Island).  Individuals on temporary or student visas are not eligible.

Individuals who hold doctoral degrees who are pursuing a second doctoral degree are generally to be considered postdoctoral trainees.

Trainees must be in one of the following categories:

(A) Predoctoral Trainees.  Predoctoral trainees must have received a baccalaureate degree by the beginning date of their NRSA appointment, and must be training at the postbaccalaureate level and enrolled in a program leading to a Ph.D. in science or in an equivalent research doctoral degree program.  Health professional students, predoctoral students in the quantitative sciences, or individuals in postgraduate clinical training who wish to interrupt their studies for a year or more to engage in full-time research training before completing their formal training programs are also eligible.

(B) Postdoctoral Trainees.  Postdoctoral trainees must have received, as of the beginning date of the NRSA appointment, a Ph.D., M.D., D.D.S., or comparable doctoral degree from an accredited domestic or foreign institution.  Eligible doctoral degrees include, but are not limited to, the following:  D.M.D., D.C., D.O., D.V.M., O.D., D.P.M., Sc.D., Eng. D., Dr. P. H., D.N.Sc., Pharm.D., N.D. (Doctor of Naturopathy), D.S.W., and Psy.D.  Documentation by an authorized official of the degree-granting institution certifying all degree requirements have been met prior to the beginning date of training is acceptable.

(C) Short-Term Health Professional Trainees.  To be eligible for short-term predoctoral research training positions, students must be enrolled and in good standing and must have completed at least one quarter in a program leading to a clinical doctorate or a masters or doctorate in a quantitative science such as physics, mathematics, or engineering prior to participating in the program.  Individuals already matriculated in a formal research degree program in the health sciences, or those holding a research doctorate or master’s degree or a combined health-professional/research doctorate normally are not eligible for short-term training positions.  Within schools of pharmacy, only individuals who are candidates for the Pharm.D. degree are eligible for short-term positions.

Positions on NRSA institutional grants may not be used for study leading to the M.D., D.D.S., or other clinical, health-professional training except when those studies are a part of a formal combined research degree program, such as the M.D./Ph.D.  Similarly, trainees may not accept NRSA support for clinical training that is a part of residency training leading to clinical certification in a medical or dental specialty or subspecialty.  It is permissible and encouraged, however, for clinicians to engage in

NRSA supported full-time, postdoctoral research training even when that experience is creditable toward certification by a clinical specialty or subspecialty board. 

Trainees are required to pursue their research training on a full-time basis, devoting at least 40 hours per week to the program.  Within the 40 hours per week training period, research trainees who are also training as clinicians must devote their time to the proposed research training and must confine clinical duties to those that are an integral part of the research training experience.

The trainees may be appointed for 9-12 months at any time during the course of the budget period.  Students must be enrolled on a full-time basis.  A strong interest in a cardiovascular, pulmonary, hematologic, or sleep disorder research career must be evident.  Short-term training positions for health professional students are allowed under this program.  No individual trainee may receive more than 5 years of aggregate NRSA support at the predoctoral level or 3 years of support at the postdoctoral level, including any combination of support from institutional training and individual fellowship awards.  Any exception to the maximum period of support requires a waiver from the NIH awarding office based on a review of the written justification from the individual trainee, and endorsed by the Program Director and the sponsoring grantee institution.  Trainees seeking additional support are strongly advised to consult with the NIH awarding office.

Section IV. Application and Submission Information


1. Address to Request Application Information

The PHS 398 application instructions are available at http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. Applicants must use the currently approved version of the PHS 398. 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

Applications must be prepared using the most current PHS 398 research grant application instructions and forms. Applications must have a D&B Data Universal Numbering System (DUNS) number as the universal identifier when applying for Federal grants or cooperative agreements. The D&B number can be obtained by calling (866) 705-5711 or through the web site at http://www.dnb.com/us/. The D&B number should be entered on line 11 of the face page of the PHS 398 form.

The title and number of this funding opportunity must be typed in item (box) 2 only of the face page of the application form, and the YES box must be checked.

The PHS 398 document is available at http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. Refer to Part I. 8. Instructions for Preparing an Institutional Research Training Application Including Ruth L. Kirschstein-NRSA Applications.

All individuals designated as PD/PI must be registered in the eRA Commons and must be assigned the PD/PI role in that system (other roles such as SO or IAR will not give the PD/PI the appropriate access to the application records). Each PD/PI must include their respective eRA Commons ID in the eRA Commons User Name field.

Additional information is available in the PHS 398 grant application instructions.

3. Submission Dates and Times

Applications must be received on or before the receipt date described below (Section IV.3.A). Submission times N/A.

3.A. Receipt, Review and Anticipated Start Dates
Letter of Intent Receipt Date: July 15, 2008
Application Receipt Date: August 15, 2008
Peer Review Date(s): October/November 2008
Council Review Date: January 2009
Earliest Anticipated Start Date: April 1, 2009

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:

Chief, Review Branch 
Division of Extramural Research Activities
National Heart, Lung, and Blood Institute
6701 Rockledge Drive, MSC 7924 
Two Rockledge Center, Room 7214
Bethesda, MD 20892-7924 (for express mail: Bethesda, MD 20817)
Telephone: (301) 435-0270
FAX: (301) 480-0730 
Email: nhlbichiefreviewbranch@nhlbi.nih.gov

3.B. Sending an Application to the NIH

Applications must be prepared using the forms found in the PHS 398 instructions for preparing a research grant application. Submit a signed, typewritten original of the application, including the checklist, and three signed photocopies in one package to:

Center for Scientific Review
National Institutes of Health
6701 Rockledge Drive, Room 1040, MSC 7710
Bethesda, MD 20892-7710 (U.S. Postal Service Express or regular mail)
Bethesda, MD 20817 (for express/courier service; non-USPS service)

Personal deliveries of applications are no longer permitted (see http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-040.html).

At the time of submission, two additional copies of the application and all copies of the appendix material must be sent to:

Chief, Review Branch
Division of Extramural Research Activities
National Heart, Lung, and Blood Institute
6701 Rockledge Drive, MSC 7924
Two Rockledge Center, Room 7214
Bethesda, MD 20892-7924 (for express mail: Bethesda, MD 20817)
Telephone: (301) 435-0270
FAX: (301) 480-0730
Email: nhlbichiefreviewbranch@nhlbi.nih.gov

3.C. Application Processing

Applications must be received on or before the application receipt date) described above (Section IV.3.A.). If an application is received after that date, the application may be delayed in the review process or not reviewed.  Upon receipt, applications will be evaluated for completeness by the CSR and for responsiveness by the reviewing Institute Incomplete and/or non-responsive applications will not be reviewed.

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.

Resubmission applications are not permitted in response to this FOA.  However, when a previously unfunded application, originally submitted as an investigator-initiated application, is to be submitted in response to an FOA, it is to be prepared as a NEW application.  That is, the application for the FOA 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.

Information on the status of an application should be checked by the Principal Investigator in the eRA Commons at: https://commons.era.nih.gov/commons/.

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. The Grants Policy Statement can be found at NIH Grants Policy Statement.

Pre-award costs are not allowable charges for either stipends or tuition on institutional training grants since stipends and tuition costs may not be charged to the grant before the trainee appointment is actually made.  However, the policies governing the pre-award cost authority for the expenditure of the other funds provided in a training grant are those permitted in the NIH Grants Policy Statement as follows:

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 or renewal award if such costs: 1) are necessary to conduct the project, and 2) 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 or renewal 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 NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part6.htm.)

The National Research Service Award (NRSA) policies apply to this program.   Awards are contingent upon availability of funds.  Furthermore, the duration of the award and the number of funded training positions may be less than the levels recommended by the peer review group, based on programmatic and budgetary considerations.

Funds for continuation support beyond the initial year are determined by the success as described in the annual progress report, the timely submission of required forms, and the availability of funds for continuation programs.

Concurrent awards:  An NRSA appointment may not be held concurrently with another federally sponsored fellowship, traineeship, or similar Federal award that provides a stipend or otherwise duplicates provisions of the NRSA.

Taxability of Stipends: Internal Revenue Code Section 117 applies to the tax treatment of all scholarships and fellowships. The Tax Reform Act of 1986, Public Law 99-154, impacts on the tax liability of all individuals supported under the NRSA program.  Under that section, non-degree candidates are now required to report as gross income all stipends and any monies paid on their behalf for course tuition and fees required for attendance.  Degree candidates may exclude from gross income (for tax purposes) any amount used for tuition and related expenses such as fees, books, supplies, and equipment required for courses of instruction at a qualified educational organization.

The IRS and Treasury Department released regulations in January 2005 (Revenue Procedure 2005-11) clarifying the student exception to the FICA (Social Security and Medicare) taxes for students employed by a school, college, or university where the student is pursuing a course of study.  Our understanding is that these final regulations do not apply to or impact Kirschstein-NRSA programs or awards. An NRSA stipend is provided by the NIH as a subsistence allowance for Kirschstein-NRSA fellows and trainees to help defray living expenses during the research training experience.  NRSA recipients are not considered employees of the Federal government or the grantee institution for purposes of the award. We must note that NIH takes no position on the status of a particular taxpayer, nor does it have the authority to dispense tax advice.  The interpretation and implementation of the tax laws are the domain of the IRS.

Individuals should consult their local IRS office about the applicability of the tax laws to their situation and for information on their tax obligations.

Service Payback: As specified in the NIH Revitalization Act of 1993, Kirschstein-NRSA recipients incur a service payback obligation for the first 12 months of postdoctoral support.  Additionally, the Act specifies that the second year of postdoctoral Kirschstein-NRSA training support will serve to pay back a postdoctoral service payback obligation.  (See Section VI.2. Administrative and National Policy Requirements for further details.)

6. Other Submission Requirements and Information

Research Training Program:  The program should plan to provide didactic training as well as laboratory or clinical research experience.  This should include a plan for determining trainee experience and needs and monitoring progress to accomplish desired goals.  The program should develop trainee skills in understanding research, applying their critical abilities to conduct research, identify problems in the process of conducting research, raise questions and propose solutions to resolving problems.  Trainees should be prepared to utilize their research findings as they pursue future research.  Programs should provide all NRSA trainees with additional professional development skills and career guidance including instruction and training in grant writing in order to apply successfully for future career development and independent research support.  All postdoctoral NRSA trainees should also be provided with instruction in laboratory and project management.

Program Director:  The Program Director must possess the scientific background and leadership and administrative capabilities required to coordinate, supervise, and direct the proposed research training program.  The Program Director will be responsible for the selection and appointment of trainees to the approved research training program, and for the overall direction, management, administration, and evaluation of the program.  Program Directors must provide potential trainees information associated with NRSA programs and submit all required trainee forms in a timely manner.

Past Training Record:  This should describe the past research training record of the program, the Program Director, and designated preceptors/mentors.  The information should describe the success of former trainees of the designated preceptors/mentors in seeking further career development and in establishing productive scientific careers.  Evidence can include successful completion of programs, further career advancement of former trainees such as receipt of fellowships, careers awards, further training appointments and similar accomplishments.  Evidence of a productive scientific career can include a record of successful competition for research grants, receipt of special honors or awards, a record of publications, receipt of patents, promotion to scientific positions, and any other accepted measures of success consistent with the nature and duration of the training period.  

Trainee Appointments:   All trainees are required to pursue their research training full time, normally defined as 40 hours per week, or as specified by the sponsoring institution in accordance with its own policies.  Appointments are normally made in 12-month increments, and no trainee may be appointed for less than 9 months during the initial period of appointment, except with prior approval of the NIH awarding unit, or when trainees are appointed to approved, short-term training positions.

No individual trainee may receive more than 5 years of aggregate NRSA support at the predoctoral level or 3 years of support at the postdoctoral level, including any combination of support from institutional training and individual fellowship awards.  Any exception to the maximum period of support requires a waiver from the NIH awarding office based on a review of the written justification from the individual trainee, and endorsed by the Program Director and the sponsoring grantee institution.  Trainees seeking additional support are strongly advised to consult with the NIH awarding office.

Research Environment/resources:  The applicant institution must have a strong and high-quality research program in the area(s) proposed for research training and must have the requisite staff and facilities to carry out the proposed program.

Institutional Commitment:  The applicant institution should include information that documents a commitment to the proposed research training program’s goals, and provide assurance that the institution intends the program to be an integral part of its research and research training endeavor.  The application should include a description of support (financial or otherwise) to be provided to the program, which could include, for example, space, shared laboratory facilities and equipment, funds for curriculum development, release time for the Program Director and participating faculty, support for additional trainees in the program, or any other creative ways to improve and enhance the growth of the research training program.

Program Evaluation Plan: Procedures for annual evaluation of the program should include plans to measure the impact of the program on the individual students and plans to measure the trainees’ progress.  The evaluation procedures should also describe plans to monitor the future career course of individual trainees, to evaluate the effectiveness of the overall program, and assess the impact of the training program on the institution.  It should also include plans for assessing the effectiveness of the mentoring relationship and the training plan.

Recruitment Plan:  Applicants must submit a recruitment plan for recruiting trainees from both outside and inside their sponsoring institutions.  The application should describe any recruitment and outreach plan to increase the depth and diversity of the applicant pool including those underrepresented in the current scientific research workforce in the area of the proposed research training.

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 http://www.nsf.gov/statistics/showpub.cfm?TopID=2&SubID=27)  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 http://aspe.hhs.gov/poverty/index.shtml. 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 are most applicable to high school and perhaps undergraduate candidates, but would be more difficult to justify for individuals beyond that level of achievement.

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

Peer reviewers will separately evaluate the recruitment and retention plan to enhance diversity after the overall score has been determined.  Reviewers will examine the strategies to be used in the recruitment and retention of individuals from underrepresented groups.  The review panel’s evaluation will be included in an administrative note in the summary statement.  If the recruitment and retention plan to enhance diversity is judged to be unacceptable, funding will be withheld until a revised plan (and report) that addresses the deficiencies is received.  Staff within the NIH awarding component, with guidance from the appropriate national advisory committee or council as needed, will determine whether amended plans and reports submitted after the initial review are acceptable.

This FOA requires all applicants to submit a recruitment and retention plan to enhance diversity.  If an application is received without a plan, the application will be considered incomplete and will not be reviewed.

Training in the Responsible Conduct of Research (RCR)

The application must include a description of plans to provide instruction in the responsible conduct of research.  Applications without plans for instruction in the responsible conduct of research will be considered incomplete and will be returned to the applicant without review.  Although the NIH does not establish specific curricula or formal requirements, all programs are encouraged to consider instruction in the following areas:  conflict of interest, responsible authorship, policies for handling misconduct, data management, data sharing, and policies regarding the use of human and animal subjects.  Within the context of training in scientific integrity, it is also beneficial to discuss the relationship and the specific responsibilities of the institution and the predoctoral students or postdoctorates appointed to the program.  Plans for RCR training must describe the proposed subject matter, format, frequency and duration of instruction. The rationale for the proposed plan of instruction must be provided.  No award will be made if an application lacks this component. See the NIH website http://bioethics.od.nih.gov/ for resources and information on this topic.

Appendix Materials

All paper PHS 398 applications must provide appendix material on CDs only. Include five identical CDs in the same package with the application..  (See http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-031.html.)

Do not use the Appendix to circumvent the page limitations of the Research Plan component. An application that does not observe the required page limitations may be delayed in the review process.

Plan for Sharing Research Data

Not applicable.

Resource Sharing Plan(s)

The following resource sharing policies do not apply to this FOA:

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

Applications that are complete and responsive to the FOA will be evaluated for scientific and technical merit by an appropriate peer review group convened by 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 scientific peer review, all applications will:

The following will be considered in making funding decisions:

The goals of NIH-supported research training are to help ensure that a diverse pool of highly trained scientists is available in adequate numbers and in appropriate research areas to address the Nation’s biomedical, behavioral, and clinical research needs. The scientific review group will address and consider each of these criteria in assigning the application’s overall score, weighting them as appropriate for each application.  Reviewers will first determine the quality of the proposed research training program and then consider whether the requested number of trainee positions is appropriate for the program.

NHLBI research training applications are evaluated using the following criteria:

Training Program:  Are the objectives, design and direction of the proposed research training program appropriate?  Does the proposed program provide suitable training for the levels of trainees being proposed and the area of science to be supported by the program?  Is the quality of proposed course contents and training experience appropriate for all levels of trainees to be included in the program?   Are inter- and multi-disciplinary and inter-professional research training opportunities or novel concepts, approaches, methodologies, or technologies appropriately utilized?

Program Director and Faculty of Minority School:  Are the qualifications, dedication, and previous student recruitment record of the Principal Investigator and all participating faculty, particularly with regard to prior experience with similar programs, appropriate for the students needs?

Past Training Record:  Is the past research training record of the program, the Program Director, and designated preceptors/mentors appropriate?  How successful are former trainees in seeking further career development and in establishing productive scientific careers?  Is there evidence of successful completion of programs, receipt of subsequent fellowships and/or career awards, further training appointments, and similar accomplishments?  Is there evidence of a productive scientific career, such as a record of successful competition for research grants, receipt of special honors or award, a record of publications, receipt of patents, promotion to scientific positions, and any other measure of success consistent with the nature and duration of the training received.  What is the track record of proposed mentors in similar research training programs? Is there a record in retaining health-professional postdoctorates (i.e., individuals with the M.D., D.O, D.D.S. D.N.Sc., etc.) for at least 2 years in research training or other research activities, if appropriate?

Institutional Training Environment, Commitment, and Resources:  Is the quality of the research environment for the proposed research training program appropriate?  Is the level of institutional commitment, quality of available facilities, courses, research and research training support suitable?  Is the proposed program to be an integral component of the applicant institution’s overall research program/mission?  Are the facilities, environment, and resources for the proposed research training, both at the minority institution and collaborating research center adequate and appropriate?

Recruitment and Retention Plans for Trainees: Are the recruitment and selection plans for students adequately developed and appropriate and is there an availability of high-quality candidates?  In addition, are there adequate methods for retaining promising students in the program and methods for tracking students? 

Program Evaluation: Are there adequate procedures for evaluating the effectiveness and impact of the program on the students involved?

Research Center: Are the cooperative arrangements between the minority institution and the collaborating research center and the commitment of the relevant faculty at the collaborating research center to the training program adequate?

2.A. Additional Review Criteria:

In addition to the above criteria, the following items will continue to be considered in the determination of scientific merit and the rating:

Protection of Human Subjects from Research Risk: The involvement of human subjects and protections from research risk relating to their participation in the proposed research will be assessed (see the Research Plan section on Human Subjects in the PHS 398 instructions).

Inclusion of Women, Minorities and Children in Research: The adequacy of plans to include subjects from both genders, all racial and ethnic groups (and subgroups), and children as appropriate for the scientific goals of the research will be assessed. Plans for the recruitment and retention of subjects will also be evaluated (see the Research Plan section on Human Subjects in the PHS 398 instructions).

Care and Use of Vertebrate Animals in Research: If vertebrate animals are to be used in the project, the five points described in the Vertebrate Animals section of the Research Plan will be assessed.

Biohazards: If materials or procedures are proposed that are potentially hazardous to research personnel and/or the environment, determine if the proposed protection is adequate.

2.B. Additional Review Considerations

Budget: The reasonableness of the proposed budget and the requested period of support in relation to the proposed research. The priority score should not be affected by the evaluation of the budget.

Training in the Responsible Conduct of Research: Peer reviewers will assess the applicant's plans for training in the responsible conduct of research on the basis of the appropriateness of topics, format, amount and nature of faculty participation, and the frequency and duration of instruction.

The plan will be discussed after the overall determination of merit, and the review panel's evaluation of the plan will not be a factor in the determination of the priority score. Plans will be judged as acceptable or unacceptable. The acceptability of the plan will be described in an administrative note on the summary statement. Regardless of the priority score, applications with unacceptable plans will not be funded until the applicant provides a revised, acceptable plan. Program staff will judge the acceptability of the revised plan.

Diversity Recruitment and Retention Plan: The NIH recognizes a unique and compelling need to promote diversity in the biomedical, behavioral, clinical and social sciences research 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.

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 socially, culturally, economically, or educationally disadvantaged backgrounds.  The review panel’s evaluation will be included in an administrative note in the summary statement.  If the diversity recruitment and retention plan is judged to be unacceptable, funding will be withheld until a revised plan (and report) that addresses the deficiencies is received.  Staff within the NHLBI, with guidance from the appropriate national advisory committee or council, will determine whether amended plans and reports submitted after the initial review are acceptable.

2.C. Sharing Research Data

Not applicable.

2.D. Resource Sharing Plan(s)   

The following resource sharing policies do not apply to this FOA:

3. Anticipated Announcement and Award Dates

Not Applicable

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 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.

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 awarding component to the grantee business official (designated in item 12 on the Application Face Page). If a grantee is not email enabled, a hard copy of the Notice of Award will be mailed to the business official.

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

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 (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part4.htm) and Part II Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_part9.htm).

Special Administrative Requirements associated with NRSA programs:

Leave Policies:  In general, trainees may receive stipends during the normal periods of vacation and holidays observed by individuals in comparable training positions at the sponsoring institution. For the purpose of these awards, however, the period between the spring and fall semesters is considered to be an active time of research and research training and is not considered to be a vacation or holiday.  Trainees may receive stipends for up to 15 calendar days of sick leave per year.  Sick leave may be used for the medical conditions related to pregnancy and childbirth.  Trainees may also receive stipends for up to 30 calendar days of parental leave per year for the adoption or the birth of a child when those in comparable training positions at the grantee institution have access to paid leave for this purpose and the use of parental leave is approved by the program director.  A period of terminal leave is not permitted, and payment may not be made from traineeship funds for leave not taken. Trainees requiring periods of time away from their research training experience longer than specified here must seek approval from the NIH awarding component for an unpaid leave of absence.  Trainees supported by academic institutions should refer to the NIH Institutional NRSA training grant guidelines at: http://grants1.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part11.htm for further guidance regarding vacations and requested leave. 

Part-time Training:  While NRSA trainees are required to pursue research training full time, normally defined as 40 hours per week, or as specified by the sponsoring institution in accordance with its own policies, under unusual and pressing personal circumstances, a Program Director may submit a written request to the awarding component to change a trainee appointment to less than full-time.  Such requests will be considered on a case-by-case basis and must be approved by the awarding Institute in advance for each budget period.  The nature of the circumstances requiring part-time training might include medical conditions, disability, or pressing personal or family situations such as child or elder care.  Permission for part-time training will not be approved to accommodate other sources of funding, job opportunities, clinical practice, clinical training, or for other responsibilities associated with the trainee’s position at the institution.  In each case, the Program Director must submit a written request countersigned by the trainee and an appropriate institutional business official that includes documentation supporting the need for part-time training.  The written request also must include an estimate of the expected duration of the period of part-time training, an assurance that the trainee intends to return to full-time training when that becomes possible, and an assurance that the trainee intends to complete the research training program.  In no case will it be permissible for the trainee to be engaged in NRSA supported research training for less than 50% effort.  Individuals who must reduce their commitment to less than 50% effort must take a leave-of-absence from NRSA training grant support.  The stipend will be pro-rated in the grant award during the period of any approved part-time training.  Part-time training may affect the rate of accrual or repayment of the service obligation for postdoctoral trainees. 

Carryover of Unobligated Balances: Most of the NIH funding components require prior written approval for carryover of funds from one budget period to the next.  When required, such requests must include compelling justification including the status of trainee appointments to the program.  If not stated on the Notice of Award, the Program Director should contact the applicable IC’s Grants Management contact to determine the funding IC’s carryover policy.

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

Change of Institution: Awards are made to a specific institution for a specific research training program and the training program may not be transferred from one institution to another.  Trainees seeking to change institutions must terminate their current appointment using the Termination Notice (form PHS 416-7, Rev. 10/05), located at http://grants.nih.gov/grants/forms.htm#training.

Change of Training Program Director: If change of a Training Program Director (TPD) 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 TPD or the grantee institution has submitted a written request for the change, countersigned by the appropriate institutional business official, to program and grants management staff at the NIH funding component describing the reasons for the change.  The Biographical Sketch of the proposed TPD, including a complete listing of active research grant support, must be provided.  The information in the request must establish that the specific aims of the original peer-reviewed program will remain unchanged under the direction of the new TPD and that the new TPD has the appropriate research training and administrative expertise to lead the training program.  This request must be submitted sufficiently in advance of the requested effective date to allow the necessary time for review.

Change of Program:   A rationale must be provided for any proposed changes in the aims of the original, peer-reviewed program.  Any change requires prior approval by program staff of the NIH funding component. If the new program does not satisfy this requirement, the award will be terminated.  

Service Payback Provisions:  As specified in the NIH Revitalization Act of 1993, Kirschstein-NRSA recipients incur a service payback obligation for the first 12 months of postdoctoral support.  Additionally, the Act specifies that the second year of postdoctoral Kirschstein-NRSA training will serve to pay back a postdoctoral service payback obligation. Accordingly, the following guidelines apply:

Postdoctoral trainees in the first 12 months of postdoctoral Kirschstein-NRSA support must sign the Payback Agreement Form (PHS 6031) before initiating an appointment.  Postdoctoral trainees in their first 12 months of support will incur a period of service payback obligation equal to the period of support.

Postdoctoral trainees in the 13th and subsequent months of NRSA postdoctoral support are not required to sign the payment agreement form and will not incur a service payback obligation for this period of support.  In addition, the 13th and subsequent months of postdoctoral Kirschstein-NRSA support are considered acceptable payback service for prior postdoctoral support.  For example, postdoctoral trainees who continue under that award for two years have fulfilled the obligation incurred during the first 12 months of support by the end of the second year. 

Service payback obligations can also be paid back after termination of Kirschstein-NRSA support by conducting health-related research or teaching averaging at least 20 hours per week of a full work year.  Payback service may be conducted in an academic, governmental, commercial, or nonacademic environment, in the United States or in a foreign country.  Examples of acceptable payback service include research associateships/assistantships, postdoctoral research fellowships, and college or high school science teaching positions.  Examples of unacceptable payback service include clinical practice and administrative responsibilities not directly related to scientific research.  Recipients with service obligations must begin to provide acceptable payback service on a continuous basis within two years of termination of Kirschstein-NRSA support.  The period for undertaking payback service may be delayed for such reasons as temporary disability, completion of residency requirements, or completion of the requirements for a graduate degree.  Requests for an extension must be made in writing to the NIH specifying the need for additional time and the length of the required extension.

Recipients of Kirschstein-NRSA support are responsible for informing the NIH of changes in status or address.

For individuals who fail to fulfill their obligation through service, the United States is entitled to recover the total amount of Kirschstein-NRSA funds paid to the individual for the obligated period plus interest at a rate determined by the Secretary of the Treasury.  Financial payback must be completed within three years beginning on the date the United States becomes entitled to recover such amount.  Under certain conditions, the Secretary, DHHS (or those delegated this authority), may extend the period for starting service or repayment, permit breaks in service, or in rare cases in which service or financial repayment would constitute an extreme hardship, may waive or suspend the payback obligation of an individual.  Detailed information on the accrual and repayment of the Kirschstein-NRSA service payback obligation and waivers is available at: http://grants1.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part11.htm

Officials at the grantee institution have the responsibility of explaining the terms of the payback requirements to all prospective trainees before appointment to the training grant.  Additionally, all trainees recruited into the training program must be provided with information related to the career options that might be available when they complete the program.  The suitability of such career options as methods to satisfy the NRSA service payback obligation must be discussed. 

3. Reporting

Awardees will be required to submit the PHS Non-Competing Grant Progress Report, Form 2590 annually (http://grants.nih.gov/grants/funding/2590/2590.htm) and annual financial statements as required in the NIH Grants Policy Statement.  The NRSA program is not subject to SNAP.

The NRSA instructions for the non-competing grant progress report (starting on page 19, Form 2590) should be followed. Note that a substitute budget page and a summary of trainee page are to be included in the request for continuation support. The non-competing budget page should list the names and levels of those trainees who are continuing in the research training program.  Information on each trainee should also be included in the narrative portion of the progress report as described in the PHS Form 2590 instructions.

An evaluation and tracking report as described in Section IV.6. of this announcement should be included annually as part of the Progress Report. 

Additional information that should be included in the annual progress report in concert with the PHS 2590 instructions:

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.

Trainee Reporting Requirements:  The institution must submit a completed Statement of Appointment (PHS Form 2271) for each trainee appointed or reappointed to the training grant.  This form must be completed at the beginning of the initial appointment and annually thereafter.  Additionally, a completed Payback Agreement Form (PHS 6031, Rev. 10/05) must be submitted for each postdoctoral trainee in his or her first 12 months of support.  No funds may be provided until such documents are submitted and accepted by the funding Institute.

Within 30 days of the end of the total support period for each trainee, the institution must submit a Termination Notice (PHS 416-7, Rev. 10/05) to the NIH.  If the trainee has a payback obligation, he or she must notify the NIH of any change in address and submit Annual Payback Activities Certification Forms (PHS 6031-1, Rev. 10/05) until the payback service obligation is satisfied.  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.

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, recipients are hereby notified that they may be contacted after the completion of this award for periodic updates on various aspects of their employment history, publications, support from research grants or contracts, honors and awards, professional activities, and other information helpful in evaluating the impact of the research training program.

Publication and Sharing of Research Results:   NIH supports the practical application and sharing of outcomes of funded research.  Therefore, trainees should make the results and accomplishments of their Kirschstein-NRSA research training activities available to the research community and to the public at large.  The grantee organization should assist trainees in these activities, including the further development of discoveries and inventions for furthering research and benefiting the public.  No restrictions should be placed on the publication of results in a timely manner.

Trainees are encouraged to submit reports of their findings for publication to the journals of their choice.  For each publication that results from a trainee’s research, NIH support should be acknowledged by a footnote in language similar to the following: “This investigation was supported by the National Institutes of Health under Ruth L. Kirschstein National Research Service Award (number).    Its contents are solely the responsibility of the authors and do not necessarily represent the official views of the NIH.”  In addition, federal funding must be acknowledged as provided in “Public Policy Requirements and Objectives-Availability of Information-Acknowledgment of Federal Funding.”

Inventions:  Traineeships made primarily for educational purposes are exempted from the PHS invention requirements and thus invention reporting is not required for institutional training grants. 

Copyrights:  Except as otherwise provided in the terms and conditions of the award, the recipient is free to arrange for copyright without approval when publications, data, or other copyrightable works are developed in the course of work under a PHS grant-supported project or activity. Any such copyrighted or copyrightable works shall be subject to a royalty-free, nonexclusive, and irrevocable license to the Government to reproduce, publish, or otherwise use them, and to authorize others to do so for Federal Government purposes.

Final Reports:  A final Progress Report and Financial Status Report are required at the end of the grant project period or upon relinquishment of an award.  Note that an evaluation and tracking report is required as part of the Final Progress Report.

Human Embryonic Stem Cells (hESC):  Only approved hESC lines listed on the NIH Human Embryonic Stem Cell Registry http://stemcells.nih.gov/registry/ may be used for research training activities. The abstract of the application must provide the registry identifying numbers of the HESC lines to be used.

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:

Sandra Colombini Hatch, M.D.
Division of Lung Diseases (responding for all NHLBI programmatic Divisions)
National Heart, Lung, and Blood Institute
Two Rockledge Center, Suite 10162, MSC 7952
6701 Rockledge Drive
Bethesda, MD 20892-7952
Telephone: (301) 435-0222  
FAX: 301-480-3557
Email:
hatchs@nhlbi.nih.gov

2. Peer Review Contacts:

Chief, Review Branch 
Division of Extramural Research Activities
National Heart, Lung, and Blood Institute
Two Rockledge Center, Room 7214
6701 Rockledge Drive, MSC 7924
Bethesda, MD 20892-7924 or Bethesda, MD 20817 (for express mail)
Telephone: (301) 435-0270
FAX: (301) 480-0730
Email:  nhlbichiefreviewbranch@nhlbi.nih.gov

3. Financial or Grants Management Contacts:

Ms. Beckie Chamberlin
Division of Extramural Research Activities
National Heart, Lung, and Blood Institute
Two Rockledge Center, Room 7146, MSC 7926
6701 Rockledge Drive
Bethesda, MD 208922-7926 or Bethesda, MD 20817 (for express mail)
Telephone: (301) 435-0183
FAX: (301) 451-5462
Email: chamberr@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 (45CFR46) 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).

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 new PHS Form 398; 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-02-005.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. Applications that do not provide this information will be returned without review.

NIH Public Access Policy Requirement:
In accordance with the NIH Public Access Policy (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-033.html) investigators must submit or have submitted for them their final, peer-reviewed manuscripts that arise from NIH funds and are accepted for publication as of April 7, 2008 to PubMed Central (http://www.pubmedcentral.nih.gov/), to be made publicly available no later than 12 months after publication. As of May 27, 2008, investigators must include the PubMed Central reference number when citing an article in NIH applications, proposals, and progress reports that fall under the policy, and was authored or co-authored by the investigator or arose from the investigator’s NIH award.  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 (DHHS) 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 DHHS 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) must be used for publicly accessible on-line journal articles.  Unless otherwise specified in this solicitation, Internet addresses (URLs) should not be used to provide any other information necessary for the review because reviewers are under no obligation to view the Internet sites. Furthermore, we caution reviewers that their anonymity may be compromised when they directly access an Internet site.

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 or Health Systems Agency review. Awards are made under the authorization of Section 487 of the Public Health Service Act as amended (42 USC 288) and under Federal Regulations 42 CFR 66. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement. The NIH Grants Policy Statement can be found at http://grants.nih.gov/grants/policy/policy.htm.

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.


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NIH Funding Opportunities and Notices


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