MINORITY INSTITUTIONAL RESEARCH TRAINING PROGRAM (T32)

RELEASE DATE:  April 13, 2004

RFA Number:  RFA-HL-04-027 (Reissued as RFA-HL-08-017)

( See Notice NOT-OD-07-043 Extension of 
Several NRSA Training (T), NRSA Fellowship (F), and Career Development (K) expiration dates.

(Dates changed, see NOT-HL-05-111)

EXPIRATION DATE: January 3, 2008

Department of Health and Human Services (DHHS)

PARTICIPATING ORGANIZATION: 
National Institutes of Health (NIH)
 (http://www.nih.gov/)

COMPONENT OF PARTICIPATING ORGANIZATION: 
National Heart, Lung, and Blood Institute (NHLBI)
 (http://www.nhlbi.nih.gov/)

CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBERS: 93.233, 93.837, 93.838, 93.839

LETTER OF INTENT RECEIPT DATE((Dates changed, see NOT-HL-05-111):   May 22, 2004; May 21, 2005; May 20, 2006
APPLICATION RECEIPT DATE:  June 23, 2004; June 22, 2005; June 21, 2006  

THIS RFA CONTAINS THE FOLLOWING INFORMATION

o Purpose of this RFA
o Research Objectives
o Mechanism(s) of Support
o Funds Available
o Eligible Institutions
o Eligible Principal Investigators
o Special Requirements
o Where to Send Inquiries
o Letter of Intent
o Submitting an Application
o Peer Review Process
o Review Criteria
o Receipt and Review Schedule
o Award Criteria
o Required Federal Citations

PURPOSE OF THIS RFA

This RFA is a continuation of the program formerly named “NHLBI Minority Institutional 
Research Training Program” (RFA-HL-03-013).

The NHLBI’s Minority Institutional Research Training Program is a Ruth L. Kirschstein 
National Research Service Award Program intended to support training of graduate and 
health professional students and individuals in postdoctoral training at minority 
schools having the potential to develop meritorious training programs in 
cardiovascular, pulmonary, hematologic, and sleep disorders.  Graduate and health 
professional students and individuals in postdoctoral training in minority schools need 
further opportunities to develop biomedical and behavioral research skills. The NHLBI 
Minority Institutional Research Training Program is designed to attract students in 
their developmental stages; to increase their awareness of cardiovascular, pulmonary, 
hematologic, and sleep disorders research; and to encourage them to pursue research 
career opportunities in these areas.

RESEARCH 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 graduate 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 women, and individuals from disadvantaged 
backgrounds (including racial and ethnic minorities) 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.

MECHANISM OF SUPPORT

This RFA will use the National Institutes of Health (NIH) Ruth L. Kirschstein 
Institutional National Research Service Award (NSRA) mechanism (T32).  As an applicant 
you will be solely responsible for planning, directing, and executing the proposed 
project.  See the SUPPLEMENTARY INSTRUCTIONS section for additional information.  An 
unsuccessful application to this RFA for one receipt date may be submitted as an 
amended application on subsequent receipt dates for this RFA.  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.  The anticipated award date for 
the first receipt date is April 1, 2005; for the second is April 1, 2006; and for the 
third is April 1, 2007.

FUNDS AVAILABLE

The estimated annual funds (total costs) available for the first year of support for 
the program is expected to be $250,000.  The actual amount may vary annually, depending 
on the response to the RFA and availability of funds. The total project period for an 
application submitted in response to this RFA may not exceed five years.  Two new 
awards are anticipated each year. 

Facilities and Administrative Costs will be awarded based on 8% of total direct costs 
exclusive of tuition, and fees.

Loan Repayment Program (LRP):  Awardees under this program may be eligible to apply for 
the NIH Extramural Loan Repayment Program.  Information regarding the eligibility 
requirements and benefits of the program may be obtained through the LRP website at 
http://www.lrp.nih.gov/

ELIGIBLE INSTITUTIONS    

The Institution must be a domestic college or university with student enrollment drawn 
substantially from minority ethnic groups (including African Americans/Blacks, 
Hispanics, American Indians, Alaska Natives, and non-Asian Pacific Islanders).  It must 
have the ongoing staff and facilities required for the proposed program.  The program 
director at the minority institution will be responsible for the selection and 
appointment of students and the overall direction of the program. Racial/ethnic 
minority individuals, women, and persons with disabilities are encouraged to apply as 
program directors.  Foreign institutions are not eligible to apply. 

ELIGIBLE PRINCIPAL INVESTIGATORS/PROGRAM DIRECTORS

Any individual with the skills, knowledge, and resources necessary to carry out the 
proposed research training program is invited to work with their 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 
programs.  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.

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 both advisor and mentor 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. 

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, graduate 
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.

Providing research opportunities for individuals from disadvantaged backgrounds, 
including racial and ethnic minorities, and who are underrepresented in biomedical and 
behavioral research, will significantly contribute to a diverse research workforce in 
the future.

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.  Predoctoral trainees appointed to the grant may receive support 
for up to five years. Postdoctoral trainees appointed to the grant may receive support 
for up to three years.  

Provisions Of The Award

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.

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 graduate 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://www.nih.gov/sigs/bioethics for resources and information on this topic.

Budget

Funds may be requested for:

(A) Stipends - The current stipend level for graduate 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, Fees, and Health Insurance - The combined cost of tuition, fees, and 
health insurance (either self-only or family as appropriate) will be offset at the 
following rate: 100% of all costs up to $3,000 and 60% of costs above $3,000 per 
trainee.  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/archive/grants/policy/nihgps_2001/part_iib_4.htm#_Toc504812072.

(C) Trainee Travel Costs - The institution may request funds to cover the costs of 
trainees’ travel, including attendance at scientific meetings, that are necessary to 
the individual's training. The maximum allowable per student per year is $1,400.  

(D) Training-Related Expenses - Institutional costs of $2,200 a year per predoctoral 
trainee and $3,850 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.  

(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 and fees.

(F) Short-Term Training - Applicants who wish to include a request for short-term 
research training positions should identify short-term positions separately within the 
"stipends" and "training related expenses" categories on the budget page.  Under 
"stipends," short-term positions should be listed in the "other" category.  Tuition, 
fees, health insurance, and trainee travel, and other expenses are to be included in 
"training related expenses."  Within each section of the program plan, a separate 
description of the short-term training should be included. The applicant should address 
the relationship of the proposed short-term training to the regular research training 
and provide assurance that the short-term program will not detract from the regular 
program.  Applicants must observe the 25-page limit on the narrative section.

Payback Agreement - As specified in the NIH Revitalization Act of 1993, NRSA recipients 
incur a service payback obligation only during their first 12 months of postdoctoral 
support.  Additionally, the NIH Revitalization Act of 1993 specifies that the second 
and subsequent years of postdoctoral NRSA training will serve to pay back a 
postdoctoral service payback obligation.  Accordingly, the following guidelines apply:

o Predoctoral trainees are not required to sign the payback agreement and do not incur 
a service payback obligation.

o Postdoctoral trainees in the first 12 months of postdoctoral NRSA support must sign 
the payback agreement form (PHS form 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.

o Postdoctoral trainees in the 13th and subsequent months of NRSA postdoctoral support 
are not required to sign the payback agreement form and will not incur a service 
payback obligation.

o The 13th and subsequent months of postdoctoral NRSA support are considered acceptable 
payback service for prior postdoctoral support. For example, postdoctoral trainees who 
continue under that award for 2 years have fulfilled the obligation incurred during the 
first 12 months of support by the end of the second year.  Simple guidelines for 
completing the payback requirement are available at 
http://www.nhlbi.nih.gov/funding/policies/t32/payback.htm .  Service payback 
obligations can also be paid back by conducting health-related research or teaching 
averaging more than 20 hours per week of a full work year after terminating NRSA 
support.

o Recipients with service obligations must begin to provide service on a continuous 
basis within two years of termination of 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.

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

o For individuals who fail to fulfill their obligation through service, the United 
States is entitled to recover the total amount of 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.

o Under certain conditions, the Secretary, U.S. Department of Health and Human Services 
(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.

o Officials at the awardee institution have the responsibility of explaining the terms 
of the payback requirements to all prospective training candidates 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 relationship of the positions available and the 
training provided must also be discussed along with the applicability of these 
positions to any outstanding service payback obligation.

A Statement of Appointment form (PHS 2271, rev. 5/01) must be submitted at the start of 
each trainee appointment and reappointment.  This form is available at the following 
URL address:  http://grants.nih.gov/training/phs2271.pdf.  Postdoctoral individuals 
supported under this program are required to sign an NRSA Payback Agreement and all 
appointed trainees are required to submit an NRSA Termination Notice.  

WHERE TO SEND INQUIRIES

We encourage inquiries concerning this RFA and welcome the opportunity to answer 
questions from potential applicants.  Inquiries may fall into three areas:  
programmatic, review, and financial or grants management issues:

o Direct your questions about programmatic issues to:

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

o Direct your questions about review issues to:

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

o Direct your questions about financial or grants management matters to:

Beckie Chamberlin
Grants Management Specialist
National Heart, Lung, and Blood Institute
6701 Rockledge Drive, Room 7144, MSC 7926
Bethesda, Maryland 20892-7926
Telephone:  (301) 435-0174
FAX: (301) 480-1948
Email: chamberr@nhlbi.nih.gov

LETTER OF INTENT

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

o Descriptive title of the proposed research
o Name, address, and telephone number of the Principal Investigator
o Names of other key personnel
o Participating institutions
o Number and title of this RFA 

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 NHLBI 
staff to estimate the potential review workload and plan the review.

The letter of intent is to be sent by the date listed at the beginning of this document 
to the Chief of Review at the address listed under WHERE TO SEND INQUIRIES.

SUBMITTING AN APPLICATION

Applications must be prepared using the PHS 398 research grant application instructions 
and forms (rev. 5/2001).  Applications must have a DUN and Bradstreet (D&B) Data 
Universal Numbering System (DUNS) number as the Universal Identifier when applying for 
Federal grants or cooperative agreements.  The DUNS number can be obtained by calling 
(866) 705-5711 or through the web site at http://www.dunandbradstreet.com/.  The DUNS 
number should be entered on line 11 of the face page of the PHS 398 form.  The PHS 398 
document is available at http://grants.nih.gov/grants/funding/phs398/phs398.html in an 
interactive format.  Refer to section V. Institutional National Research Service Award. 
 For further assistance contact GrantsInfo, Telephone (301) 435-0714, Email:  
GrantsInfo@nih.gov.

SUPPLEMENTARY INSTRUCTIONS

NHLBI’s Minority Institutional Research Training Program (T32) applicants may use the 
“Suggested Tabular Formats for Required Data for the Ruth L. Kirschstein Institutional 
National Research Service Award (T32) located at URL:  
http://www.nhlbi.nih.gov/funding/policies/t32/index.htm.  For Competing Continuation 
applications in addition to Tables VIII, IX, and X, provide a table giving a brief 
summary of the research conducted by each trainee supported during the period covered.

While not required, these specific formats will facilitate peer review and may also be 
useful framework for the narrative sections.  These tables should be included in the 
main application (will not be counted toward the page limitation) rather than in the 
Appendix.

USING THE RFA LABEL:  The RFA label available in the PHS 398 (rev. 5/2001) application 
form must be affixed to the bottom of the face page of the application.  Type the RFA 
number on the label.  Failure to use this label could result in delayed processing of 
the application such that it may not reach the review committee in time for review.  In 
addition, the RFA title and number must be typed on line 2 of the face page of the 
application form and the YES box must be marked.  The RFA label is also available at:  
http://grants.nih.gov/grants/funding/phs398/labels.pdf.

SENDING AN APPLICATION TO THE NIH:  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            
Bethesda, MD 20817 (for express/courier service)

All grant applications submitted to the Center for Scientific Review (CSR) must come 
via United States Postal Service or a recognized delivery/courier service.  Individuals 
may not personally deliver packages to the building on Rockledge Drive.  For further 
information please see 
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-012.html.

At the time of submission, two additional copies of the application and all five 
collated sets of the appendix material must be sent to the Chief of Review at the 
address listed under WHERE TO SEND INQUIRIES.  

APPLICATION PROCESSING:  Applications must be received on or before the application 
receipt date listed in the heading of this RFA.  If an application is received after 
that date, it will be returned to the applicant without review. 

Although there is no immediate acknowledgement of the receipt of an application, 
applicants are generally notified of the review and funding assignment within 8 weeks.

The Center for Scientific Review (CSR) will not accept any application in response to 
this RFA that is essentially the same as one currently pending initial review, unless 
the applicant withdraws the pending application.  Acceptance of a revised application 
in response to this RFA automatically withdraws the prior version, since two versions 
of the same application cannot be simultaneously pending. Before a revised application 
can be submitted, the principal investigator must have received the summary statement 
from the previous review. There must be substantial changes in the content of the 
application. The application must include an Introduction of not more than three pages 
that summarizes the substantial additions, deletions, and changes. The Introduction 
must also include responses to the criticisms and issues raised in the summary 
statement. The changes in the Research Plan must be clearly marked by appropriate 
bracketing, indenting, or changing of typography, unless the changes are so extensive 
as to include most of the text. This exception should be explained in the Introduction. 
Do not underline or shade changes. The Preliminary Studies/Progress Report section 
should incorporate any work done since the prior version was submitted.

PEER REVIEW PROCESS

Upon receipt, applications will be reviewed for completeness by the CSR and 
responsiveness by the NHLBI.  Incomplete and/or non-responsive applications will be 
returned to the applicant without further consideration. 

Applications that are complete and responsive to the RFA will be evaluated for 
scientific and technical merit by a Special Emphasis Panel convened by the Division of 
Extramural Affairs, NHLBI, in accordance with the review criteria stated below.  As 
part of the initial merit review, all applications will:

o Undergo a process in which only those applications deemed to have the highest 
scientific merit, generally the top half of the applications under review, will be 
discussed and assigned a priority score
o Receive a written critique 
o Receive a second level review by the National Heart, Lung, and Blood Advisory 
Council.

REVIEW CRITERIA

The following criteria will be considered in the evaluation of the proposed NHLBI 
Minority Institutional Research Training Program:

(1) Program Design:  Design of the proposed training program;

(2) Program Director and Faculty of Minority School:   Qualifications, dedication, 
commitment, and previous training record of the program director and all participating 
faculty, particularly with regard to prior experience with similar programs;

(3) Research Center:  Adequacy of the cooperative arrangements between the minority 
institution and the collaborating research center; commitment of the relevant faculty 
at the collaborating Research Center to the training program;

(4) Recruitment and Retention Plans for Trainees:  Recruitment and selection plans for 
trainees, and the availability of high quality candidates; methods for retaining 
promising students in the program and methods for tracking students;

(5) Environment:  Adequacy of facilities, environment, and resources for the proposed 
research training, both at the minority institution and the collaborating research 
center;

(6) Program Evaluation:  Procedures for evaluation of the effectiveness of the program 
and impact of the program on the trainees involved.

ADDITIONAL REVIEW CRITERIA: In addition to the above criteria, your application will 
also be reviewed with respect to the following:

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 criteria included in the section on Federal Citations, below).

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.  Plans for the 
recruitment and retention of subjects will also be evaluated.  (See Inclusion Criteria 
in the sections on Federal Citations, below).

CARE AND USE OF VERTEBRATE ANIMALS IN RESEARCH:  If vertebrate animals are to be used 
in the project, the five items described under Section f of the PHS 398 research grant 
application instructions (rev. 5/2001) will be assessed.

o BUDGET:  The reasonableness of the proposed budget and the requested period of 
support in relation to the proposed research.

Training in the Responsible Conduct of Research (RCR):  Every predoctoral and 
postdoctoral NRSA trainee supported by an institutional research training grant must 
receive instruction in RCR.  (For more information on this provision, see the NIH Guide 
for Grants and Contracts, Volume 21, Number 43, November 27, 1992, see 
http://grants.nih.gov/grants/guide/notice-files/not92-236.html.)  Applications must 
include a description of a program to provide formal or informal instruction in 
scientific integrity or RCR. 

Program reports on the type of RCR instruction provided, topics covered, and other 
relevant information, such as attendance by trainees and faculty participation, must be 
included in future competing continuation and noncompeting applications.  The NIH 
encourages institutions to provide instruction in RCR to all graduate students, 
postdoctorates, and research staff regardless of their source of support.

NIH initial review groups will assess the applicant’s RCR plans on the basis of the 
appropriateness of topics, format, amount and nature of faculty participation, and the 
frequency and duration of instruction.

The RCR plan will be discussed after the overall determination of merit, so that 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.  Staff within the NIH 
awarding component will judge the acceptability of the revised plan.  

Following initial review, the NHLBI Advisory Council provides a second level of review. 
The Council will consider the assessment of the scientific and educational merit of the 
research training grant application as well as the plan for instruction in RCR. 

RECEIPT AND REVIEW SCHEDULE

Letter of Intent Receipt Date:  May 22, 2004; May 21, 2005; May 20, 2006
Application Receipt Date:  June 23, 2004; June 22, 2005; June 21, 2006
Peer Review Date:  October/November 2004; October/November 2005; October/November 2006
Council Review:  January 2005; January 2006; January 2007
Earliest Anticipated Start Date:  April 1, 2005; April 1, 2006; April 1, 2007

AWARD CRITERIA

Criteria that will be used to make award decisions include:

o Scientific and training merit (as determined by peer review)
o Availability of funds
o Programmatic priorities.

REQUIRED FEDERAL CITATIONS

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:  NIH Policy for Data and Safety Monitoring, NIH Guide 
for Grants and Contracts, June 12, 1998:  
http://grants.nih.gov/grants/guide/notice-files/not98-084.html. 

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 - Amended, October, 
2001," published in the NIH Guide for Grants and Contracts on October 9, 2001 
(http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html); 
a complete copy of the updated Guidelines are 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 RESEARCH INVOLVING HUMAN SUBJECTS: The NIH 
maintains a policy that children (i.e., individuals under the age of 21) must be 
included in all human subjects 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 that is available at 
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 proposals for research involving human subjects.  You will 
find this policy announcement in the NIH Guide for Grants and Contracts Announcement, 
dated June 5, 2000, 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 (see 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.

PUBLIC 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 public 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 RFA 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.

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. Unless otherwise 
specified in an NIH solicitation, Internet addresses (URLs) should not be used to provide 
information necessary to 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 RFA 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 No. 93.233, 93.837, 93.838, and 93.839 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 administered under NIH grants policies 
described at http://grants.nih.gov/grants/policy/policy.htm and under Federal 
Regulations 42 CFR 66.

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.


Weekly TOC for this Announcement
NIH Funding Opportunities and Notices


H H S Department of Health
and Human Services

 
  N I H National Institutes of Health (NIH)
9000 Rockville Pike
Bethesda, Maryland 20892