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:
https://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:
https://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: https://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
https://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
https://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
https://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive
format. For further assistance contact GrantsInfo, Telephone (301) 710-0267,
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:
https://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 (https://grants.nih.gov/grants/guide/notice-
files/NOT-OD-02-001.html), a complete copy of the updated Guidelines is
available at
https://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
https://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
https://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 https://grants.nih.gov/grants/stem_cells.htm and at
https://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
https://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 https://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.