NICHD INSTITUTIONAL TRAINING FOR PEDIATRICIANS

Release Date:  May 16, 2002

RFA:  HD-02-019

National Institute of Child Health and Human Development (NICHD) 
 (http://www.nichd.nih.gov) 

Letter of Intent Receipt Date:  July 17, 2002

Application Receipt Date:  August 16, 2002
 
THIS RFA CONTAINS THE FOLLOWING INFORMATION

o Purpose of this RFA
o Program Objectives
o Mechanism of Support 
o Funds Available
o Eligible Institutions
o Eligible Training Program Directors
o Eligible Trainees
o Special Program Considerations
o Stipend Supplementation, Compensation, and Other Income 
o Service Payback
o Trainee Reporting Requirements
o Leave 
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

The National Institute of Child Health and Human Development (NICHD) invites 
applications for Institutional National Research Service Awards (NRSA) to 
establish programs of postdoctoral pediatrics research training in basic 
science or clinical research.  The NICHD will award these Institutional 
Training Grants to eligible institutions to develop or enhance research 
training opportunities for individuals, selected by the institution, who are 
training for careers in pediatrics research.  The purpose of this NRSA 
program is to help ensure that a diverse and highly trained workforce of 
pediatricians is available to assume leadership roles related to the Nation's 
biomedical and behavioral research agenda in areas of child health.  This 
initiative responds to language in The Children's Health Act of 2000 
recommending support for the expansion or initiation of programs to train new 
investigators in pediatrics. 

The Institutional Training Grant is a mechanism for the postdoctoral training 
of physicians who may have extensive clinical training, but limited research 
experience.  Such individuals would benefit from a period during which there 
is protection from clinical and teaching responsibilities for further 
development of knowledge and skills.  The goal is to provide an environment 
in which trainees can acquire the skills necessary to carry out scientific 
investigation.  This environment should provide the time, expertise, and 
guidance to enable trainees to gain critical knowledge of an area of 
research.  For those embarking on basic science research, courses in 
molecular biology techniques should be an integral part of the training and 
may be a part of a research degree program.  For those interested in clinical 
research, courses in epidemiology, ethics, and biostatistics should be an 
integral part of the training.  In addition, trainees should develop skills 
in writing and should be instructed in the preparation of manuscripts and 
grant applications.  Research training positions should last at least nine 
months and must not exceed three years.  In most cases, postdoctoral trainees 
should agree to engage in at least two years of research, research training, 
or comparable activities beginning at the time of appointment because the 
duration of training has been shown to be strongly correlated with successful 
post-training research activity.

PROGRAM OBJECTIVES

Background

The NICHD Institutional Training Grant for Pediatricians provides pediatric 
research institutions with the funds to recruit and train qualified physician 
investigators.  The primary objective of the program is to promote the 
development of a diverse and highly trained workforce of pediatrician 
scientists to assume leadership roles related to the Nation's biomedical and 
behavioral research efforts in the area of child health.  Established 
investigators will serve as mentors for physicians who are within the 
training period described in this RFA.  There is currently a shortage of such 
training opportunities for pediatricians who intend to pursue research 
careers.  The U.S. Congress has noted the absence of such training 
opportunities and has, in the Children's Health Act of 2000, recommended that 
the NICHD support the expansion of existing programs or initiation of new 
programs to train new investigators in pediatrics.  The ultimate objective of 
this program is to produce a well-qualified cadre of academic pediatricians 
who will be capable of successfully competing for NIH support.  Training 
Grant Program Directors, therefore, should limit appointments to individuals 
who are committed to a career in research and plan to remain on the training 
grant or in some other type of research training experience for a minimum of 
two years.  It is anticipated that many of the trainees will be encouraged to 
pursue further training in basic science or clinical research via individual 
research career development awards (K-series mechanisms).  During the review 
of applications, peer reviewers will examine the training record of the 
department to determine the average duration of training appointments for 
trainees and whether there is a record of transition to independent support 
mechanisms.

Scope of Training

Institutional research training grants (T32) are a desirable mechanism for 
the postdoctoral training of physicians who may have extensive clinical 
training, but have limited research experience.  For such individuals, the 
training may be a part of a research degree program.  Master's level 
coursework in, but not limited to, areas such as epidemiology and clinical 
trials methodology may be an integral part of the program.  Established 
investigators from basic science departments may be included as mentors to 
supply expertise and resources, provided the emphasis remains on research 
that has some relevance to clinical pediatrics and is consistent with the 
goals of the program.  Applications should describe the basic science 
department's contribution to the research training experience.  Although 
mentors from collaborating departments may provide expertise and resources, 
the emphasis should remain on research relevant to child health.  
Multidisciplinary studies are encouraged although the research of the 
applicant department may focus on a single theme. 

The training program will provide each trainee with two years of full-time 
postdoctoral research training, including didactic instruction, mentoring, 
and supervised research experience.  Plans must be presented for each trainee 
to be guided by a qualified mentor.  The mentor should be recognized as an 
accomplished investigator and have a track record of success in training 
independent investigators.  The training program may be integrated into the 
last year of a residency program in pediatrics or integrated into a 
fellowship program in a subspecialty area of pediatrics.   

The application should provide details about how a curriculum will be 
developed and what it will include.  Appropriate topics to be addressed 
include, but are not limited to, human subjects protection, research ethics, 
clinical trial methodologies, biostatistics, genetics, cellular and molecular 
biology, and state-of-the-art laboratory technologies such as genomics, 
proteomics, and bioinformatics.
 
MECHANISM OF SUPPORT
 
This RFA will use the NIH Institutional Training Grant (T32) award mechanism.  
As an applicant, you will be solely responsible for planning, directing, and 
executing the proposed project.  Future unsolicited, competing continuation 
applications based on this project will compete with all investigator-
initiated applications and will be reviewed according to the customary peer 
review procedures.  The anticipated award date is May 2003. 

FUNDS AVAILABLE

The NICHD intends to commit approximately $1.2 million in total costs [Direct 
plus Facilities and Administrative (F&A) costs] in FY 2003 to fund up to six 
new institutional training grants in response to this RFA.  In general, at 
least three, and no more than five, postdoctoral trainees per year may be 
proposed for training.  Smaller departments may request two trainees for the 
first year of the grant.  New trainee appointments can be made by the 
department as those originally appointed complete their training.  Each 
trainee may receive two years of support with a possibility of extending for 
a third year.  Although the financial plans of the NICHD provide support for 
this program, awards pursuant to this RFA are contingent upon the 
availability of funds and the receipt of a sufficient number of meritorious 
applications.  At this time, it is not known if this RFA will be reissued.

ELIGIBILE INSTITUTIONS

Only domestic, non-profit, private or public institutions may apply for 
grants to support research training programs.  The applicant institution must 
have a strong research program in the area(s)proposed for research training 
and must have the requisite staff and facilities to carry out the proposed 
program.  

ELIGIBLE TRAINING PROGRAM DIRECTORS

Training programs with a focus on subspecialty areas generally considered to 
have inadequate numbers of trainees (such as pediatric endocrinology) are 
encouraged to apply.  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.  Trainees appointed to the 
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 in 
pediatrics.  The applicant must have access to a training environment with 
ongoing basic or clinical research and/or clinical trials, preferably 
including several subspecialty areas of pediatrics.  The applicant 
organization may be a professional organization that will serve as a 
coordinating center for a training program implemented through collaborations 
with qualified academic pediatric departments.  

The Principal Investigator must be the Chairperson of the Department of 
Pediatrics or the Chief of the Pediatric Service.  When the applicant is a 
professional organization, the Principal Investigator is the key person 
directing the organization or an individual in charge of research 
development.  The Program Director may be the department head or another 
individual in the Department of Pediatrics involved in residency or 
fellowship training.  

ELIGIBLE TRAINEES

Positions on NRSA institutional grants may not be used for study leading to 
the M.D., D.D.S., or other clinical, health-professional degrees except when 
those studies are a part of a formal combined research degree program, such 
as the M.D./Ph.D.  It is permissible and encouraged for clinicians to engage 
in NRSA-supported full-time, postdoctoral research when that experience is 
creditable toward certification by a clinical specialty or subspecialty 
board.  Pediatric residents may interrupt their studies to engage in an 
extended period of full-time research training before completing their 
clinical training.  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 appointed under this program must hold, as of the beginning date 
of the NRSA appointment, an M.D. or D.O. degree from an accredited domestic 
or foreign institution and have completed, or be within one year of 
completing, postgraduate clinical training in pediatrics in an ABP-approved 
residency program.  To be appointed to a training position supported by an 
NRSA research training grant, an individual must be a citizen or noncitizen 
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).  Noncitizen 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.  

SPECIAL PROGRAM CONSIDERATIONS

The primary objective of the NRSA program is to prepare qualified individuals 
for careers that significantly impact the Nation's research agenda.  Within 
the framework of the program's longstanding commitment to excellence and 
projected need for investigators in particular areas of research, attention 
must be given to recruiting individuals from racial or ethnic groups 
underrepresented in the biomedical and behavioral sciences.  The following 
groups have been identified as underrepresented in biomedical and behavioral 
research nationally: African Americans, Hispanic Americans, Native Americans, 
Alaskan Natives, and Pacific Islanders. Use of the term "minority" in this 
announcement will refer to these groups.

Other considerations relate to the duration of training and the transition of 
trainees to individual support mechanisms.  Studies have shown that the 
length of the appointment to a training grant for postdoctoral trainees with 
health-professional degrees strongly correlates with subsequent application 
for and receipt of independent NIH research support.  Training grant program 
directors, therefore, should limit appointments to individuals who are 
committed to a career in research and plan to remain on the training grant or 
in some other type of research experience for a minimum of 2 years.  It has 
also been shown that individuals who have been supported by an individual 
postdoctoral fellowship are more likely to subsequently apply for and receive 
NIH research support than are individuals who have received support only from 
a research training grant.  Therefore, program directors should encourage 
postdoctoral trainees who have proceeded beyond the didactic part of their 
training to apply for individual postdoctoral fellowships or mentored career 
development awards (K awards).  During the review of training grants 
applications, peer reviewers will examine the training record to determine 
the average duration of training appointments for health-professional 
postdoctoral trainees and whether there is a record of transition to 
individual support mechanisms.

Past studies have shown that health professional trainees, who train in 
combined programs with post-doctoral researchers with an intensive research 
background, are more likely to apply for and receive research grant support.  
Programs located in clinical departments that focus on research training for 
individuals with an M.D. or other health-professional degrees should consider 
developing ties to basic science departments or modifying their program to 
include individuals with research doctoral degrees when such changes are 
consistent with the goals of the program.  Applications should describe the 
basic science department's contribution to the research training experience 
and also indicate if both health professional trainees and trainees with 
research doctorates are included in the training program.

Individual Training Plans

Plans also must be presented for the means by which individual trainee needs 
and goals will be developed and addressed.  Plans for ongoing program 
evaluation and mechanisms to improve course content, mentoring, and 
supervised research experiences must be included.  Trainees should have a 
period of research training and career development consistent with his or her 
previous research and clinical experience.  For a trainee with limited 
experience in a given field of research, a phased program, including a period 
of didactic training followed by a period of mentored research experience, 
may be the most effective means of attaining independence.  A trainee with 
previous research experience and training may not require extensive 
additional didactic preparation, and a shorter program that focuses on 
mentored research experience may be most appropriate.  The didactic and 
research components of both phases must develop new knowledge and research 
skills in scientific areas relevant to the career goals of the trainee.

ALLOWABLE COSTS 

Stipends:  National Research Service Awards provide funds, in the form of 
stipends, to physician trainees.  A stipend is provided as a subsistence 
allowance to help trainees defray living expenses during the research 
training experience.  It is not provided as a condition of employment with 
either the Federal Government or the awardee institution.  Stipends must be 
paid to all trainees at the levels approved by the Secretary of the 
Department of Health and Human Services.  Stipend levels are adjusted 
occasionally, and current stipend levels are available on the NIH website at: 
http://grants.nih.gov/training/nrsa.htm. 

The current annual stipend for postdoctoral trainees is determined by the 
number of FULL years of relevant postdoctoral experience at the time of 
appointment.  Relevant experience may include research experience (including 
industrial), teaching, internship, residency, clinical duties, or other time 
spent in full-time studies in a health-related field following the date of 
the qualifying doctoral degree.  Stipend levels for Fiscal Year 2003 and 
beyond may change.  Consult the NIH website above for the future 
announcements of stipend levels.  Postdoctoral stipends for awards made with 
FY 2002 funds are as follows:

Years of Postdoctoral Experience                    Annual Amount  
                            
            0                                           $ 31,092
            1                                           $ 32,820
            2                                           $ 38,712
            3                                           $ 40,692
            4                                           $ 42,648
            5                                           $ 44,616
            6                                           $ 46,584
            7 or more                                   $ 48,852

Tuition, Fees, and Health Insurance:  The NIH will offset the combined cost 
of tuition, fees, and health insurance (either self-only or family, as 
appropriate) at the following rate:  100 percent of all costs up to $3,000 
and 60 percent of costs above $3,000.  Costs associated with tuition, fees, 
and health insurance are allowable only if they are required for all 
individuals in a similar research training status at the institution 
regardless of the source of support.  A full description of the tuition 
policy is contained within the NRSA Policy Guidelines on the NIH website at:  
http://grants.nih.gov/training/nrsaguidelines/nrsa_toc.htm.  

Other Trainee Costs:  Trainee travel, including attendance at scientific 
meetings that the institution determines to be necessary to the individual's 
research training, is an allowable trainee expense.  In addition, support for 
travel to a research training experience away from the institution may be 
permitted.  Research training experiences away from the parent institution 
must be justified and should consider the type of opportunities for training 
available, the manner in which these opportunities differ from and complement 
those offered at the parent institution, and the relationship of the proposed 
experience to the trainee's career stage and goals.  This type of research 
training requires prior approval from the NICHD.  Letters requesting such 
training may be submitted to the NICHD at any time during the award period.  
Under exceptional circumstances, which may include providing accommodations 
for a trainee with disabilities, it is possible to request institutional 
costs above the standard rate.  Requests for additional trainee costs must be 
explained in detail and carefully justified in the application.  Consultation 
with NICHD program staff in advance of such requests is strongly advised.

Training Related Expenses:  Institutional costs of $3850 per 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. 
 
Facilities and Administrative Costs:  A Facilities and Administrative (F & A) 
allowance (indirect cost allowance) based on eight percent of total allowable 
direct costs (this excludes amounts for tuition, fees, health insurance, and 
equipment) may be requested.  See NRSA Policy Guidelines on the NIH Website 
at: http://grants.nih.gov/training/nrsaguidelines/nrsa_toc.htm. 

STIPEND SUPPLEMENTATION, COMPENSATION, AND OTHER INCOME 

No departure from the established stipend schedule may be negotiated by the 
institution with the trainee.  For postdoctoral trainees, the stipend for 
each additional full year of research training support is the next level in 
the stipend structure and does not change in the middle of an appointment.  
The grantee institution is allowed to provide funds to an individual in 
addition to the stipends paid by the NIH.  Such additional amounts may be 
either 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.

For complete information on Stipend Supplementation, Compensation, 
Educational Loans, G.I. Bill, Concurrent Awards, and Tax Liability, see the 
current announcement for NRSA Institutional Research Training Grants (T32), 
available on the Internet at 
http://grants.nih.gov/grants/guide/pa-files/PA-00-103.html.

SERVICE PAYBACK 

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.  The applicable
guidelines for the payback provision are presented in the current 
Institutional Research Training Grant announcement at 
http://grants.nih.gov/grants/guide/pa-files/PA-00-103.html.

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 at the 
beginning of the appointment period.  Additionally, a completed Payback 
Agreement (PHS Form 6031) must be submitted for each trainee in their first 
12 months of postdoctoral support. Within 30 days of the end of the total 
support period for each trainee, the institution must submit a Termination 
Notice (PHS Form 416-7).  Failure 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.

LEAVE

In general, trainees may receive stipends during the normal periods of 
vacation and holidays observed by individuals in comparable training 
positions at the grantee 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 
grant funds for leave not taken.  Individuals requiring periods of time away 
from their research training experience longer than specified here must seek 
approval from the NICHD for an unpaid leave of absence.  At the beginning of 
a leave of absence, the trainee must submit a Termination Notice (PHS Form 
416-7) and upon return from the leave of absence, the trainee must be 
formally reappointed to the grant by submitting an updated Statement of 
Appointment (PHS Form 2271).  Trainees within the first 12 months of 
postdoctoral support must also submit a Payback Agreement (PHS Form 6031) 
upon return from a leave of absence.

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:  scientific/research, peer review, and financial or grants management 
issues:

o Direct your questions about scientific/research issues to:

Karen K. Winer, M.D.
Endocrinology, Nutrition and Growth Branch
National Institute of Child Health and Human Development
6100 Executive Boulevard, Suite 4B11, MSC 7510
Bethesda, MD  20892-7510
Telephone:  (301) 435-6877
FAX:  (301) 480-9791 
Email:  winerk@mail.nih.gov  

o Direct your questions about peer review issues to:

Robert H. Stretch, Ph.D.
Acting Director, Division of Scientific Review
National Institute of Child Health and Human Development
6100 Executive Blvd., Room 5B01, MSC 7510
Bethesda, MD 20892-7510
Rockville, MD 20852  (for express/courier service)
Telephone:  (301)496-1485 
FAX: (301)402-4104  
Email:  stretchr@mail.nih.gov 

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

Mary E. Daley
Grants Management Branch
National Institute of Child Health and Human Development
6100 Executive Boulevard, Suite 8A17, MSC 7510
Bethesda, MD  20892-7510
Telephone:  (301) 496-1305
FAX:  (301) 402-0915
Email:  daleym@nih.gov
 
LETTER OF INTENT

Prospective applicants are asked to submit a letter of intent that includes a 
descriptive title of the proposed program, the name, address, and telephone 
number of the Principal Investigator, the identities of other key personnel 
and participating institutions, and the 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 NICHD 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.  The letter of intent should be sent to:

Karen K. Winer, M.D.
Endocrinology, Nutrition and Growth Branch
National Institute of Child Health and Human Development
6100 Executive Boulevard, Suite 4B11, MSC 7510
Bethesda, MD  20892-7510
Telephone:  (301) 435-6877
FAX:  (301) 480-9791 
Email:  winerk@mail.nih.gov

SUBMITTING AN APPLICATION

Applications must be prepared using the PHS 398 research grant application 
instructions and forms (rev. 5/2001).  The PHS 398 is available at 
http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive 
format.  For further assistance contact GrantsInfo, Telephone (301) 435-0714, 
Email: GrantsInfo@nih.gov.
 
SUPPLEMENTAL INSTRUCTIONS:  The special instructions for Institutional 
National Research Service Awards (T32) presented in the PHS 398 must be 
followed, including all components and page limits.  Applicants may request 
up to five years of support through the T32 mechanism.  The applicant should 
justify the number of full-time postdoctoral training positions requested.  
Tuition, fees, health insurance, and trainee travel, and other expenses are 
to be included in "training related expenses."

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/label-bk.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)
 
At the time of submission, two additional copies of the application must be 
sent to:

Robert H. Stretch, Ph.D.
Acting Director, Division of Scientific Review
National Institute of Child Health and Human Development
6100 Executive Blvd., Room 5B01, MSC 7510
Bethesda, MD 20892-7510
Rockville, MD 20852  (for express/courier service)
 
APPLICATION PROCESSING:  Applications must be received by 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.
 
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.  The 
CSR will not accept any application that is essentially the same as one 
already reviewed.  This does not preclude the submission of substantial 
revisions of applications already reviewed, but such applications must 
include an Introduction addressing the previous critique.

PEER REVIEW PROCESS   

Upon receipt, applications will be reviewed for completeness by the CSR and 
for responsiveness to this RFA by NICHD.  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 an appropriate peer review group 
convened by the NICHD in accordance with the review criteria stated below.  
As part of the initial merit review, all applications will:

o Receive a written critique
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 second level review by the National Advisory Child Health and 
Human Development Council. 

REVIEW CRITERIA

o  Past research training record of both the program and the designated 
preceptors as determined by the success of former trainees in seeking further 
career development and in establishing productive scientific careers.  
Evidence of further career development can include receipt of fellowships, 
career development 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, 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.

o  Objectives, design, and direction of the research training program and 
plans for implementation.

o  Caliber of well-funded, established investigators who can act as mentors 
to the trainees.  The ongoing research at the institution should not be 
narrowly defined and should encompass several subspecialty areas of 
pediatrics.  In addition, areas of expertise may include molecular biology 
techniques, biostatistics, epidemiology, and clinical trials. 

o  The institutional training environment, including institutional commitment 
to the program, quality of the facilities, availability of appropriate 
courses, and availability of research support.  

o  Recruitment and selection plans for trainees and the availability of a 
pool of high quality candidates. 

o  The probability that this training experience will contribute notably to 
the scientific development of trainees.

o  Likelihood that the postdoctoral trainees will continue their research 
training or other research activities for at least two years.  Record of the 
research training program (or similar programs at the institution) in 
retaining health-professional postdoctoral trainees in research training or 
other research activities.

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

o PROTECTIONS:  The adequacy of the proposed protection for humans, animals, 
or the environment, to the extent they may be adversely affected by the 
project proposed in the application.

o INCLUSION:  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 
included in the section on Federal Citations, below)

o BUDGET:  The reasonableness of the proposed budget and the requested period 
of support.

OTHER REVIEW CONSIDERATIONS

(1)  Minority Recruitment Plan

The plan will be discussed after the overall determination of merit.  The 
review panel's evaluation will not be a factor in the determination of the 
priority score, but will be included in an administrative note in the summary 
statement.  If the minority recruitment plan or if the record of recruitment 
and retention of minorities is judged to be unacceptable, funding will be 
withheld until a revised plan that addresses the deficiencies is received.  
NICHD staff, with guidance from the National Advisory Child Health and Human 
Development Council, will determine whether amended plans are acceptable.

(2)  Plans for Training in the Responsible Conduct of Research

The 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.  NICHD staff will judge the 
acceptability of the revised plan.  

The National Advisory Child Health and Human Development Council will 
consider, in addition to the reviewers' assessment of the scientific and 
educational merit of the application, the comments on the recruitment of 
individuals from under-represented minority groups into the research training 
program and the plan for instruction in the responsible conduct of research.

RECEIPT AND REVIEW SCHEDULE

Letter of Intent Receipt Date: July 17, 2002
Application Receipt Date:  August 16, 2002
Peer Review Date:  October/November 2002 
Council Review:  January 2003
Earliest Anticipated Start Date:  May 1, 2003

AWARD CRITERIA

Criteria that will be used to make award decisions include:

o Responsiveness to the purpose of this RFA;

o Quality of the proposed training program, as determined by peer review;

o Availability of funds.

REQUIRED FEDERAL CITATIONS 

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 AMENDMENT "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 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 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. This policy applies to all initial (Type 1) applications submitted for 
receipt dates after October 1, 1998.

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://grants.nih.gov/grants/stem_cells.htm 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 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.

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. 93.865, Research for Mothers and Children, 
and is not subject to the intergovernmental review requirements of Executive 
Order 12372 or Health Systems Agency review.  Awards are administered under 
NIH grants policies described at http://grants.nih.gov/grants/policy/policy.htm.
NRSA Institutional Research Training Grants are made under the authority of 
Section 487 of the Public Health Service Act as amended (42 USC 288).  Title 42 
of the Code of Federal Regulations, Part 66, is applicable to this program.  

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.

Return to Volume Index

Return to NIH Guide Main Index

	Office of Extramural Research (OER)			National Institutes of Health (NIH) 9000 Rockville Pike Bethesda, Maryland 20892			Department of Health and Human Services (HHS)
Note: For help accessing PDF, RTF, MS Word, Excel, PowerPoint, RealPlayer, Video or Flash files, see Help Downloading Files.