PEDIATRIC CRITICAL CARE SCIENTIST DEVELOPMENT PROGRAM

RELEASE DATE:  May 28, 2003

RFA: HD-03-015 - (Reissued as RFA-HD-08-022)

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

CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER(S):  93.929

LETTER OF INTENT RECEIPT DATE:  September 17, 2003

APPLICATION RECEIPT DATE:  October 16, 2003

THIS RFA CONTAINS THE FOLLOWING INFORMATION

o Purpose of this RFA
o Research Objectives
o Mechanism of Support
o Funds Available
o Eligible Institutions
o Individuals Eligible to Become 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

The National Institute of Child Health and Human Development (NICHD) issues 
this initiative in order to support a program of career development awards in 
pediatric critical care through the Pediatric Critical Care Scientist 
Development Program (PCCSDP) intended to develop resources to speed the 
transfer of knowledge gained through studies in basic science to clinical 
applications that improve the acute care and long-term outcomes for children 
with serious illness and injury.  The PCCSDP will support research career 
development of pediatric intensivists who have recently completed 
subspecialty training, and who are commencing basic and/or clinical research 
relevant to improving outcomes, decreasing morbidity, and minimizing 
disability in children who are survivors of pediatric critical care.  The 
goals of this initiative are to expand the cadre of investigators trained to 
advance research in pediatric critical care and to support educational 
institutions in their ability to stimulate novel research.  The intent of the 
initiative is to stimulate pediatric critical care research in the basic and 
clinical sciences that will improve long-term outcomes in children who 
sustain critical illness and/or injury.  

RESEARCH OBJECTIVES

Background

Several convergent developments in critical care medicine, as well as in the 
larger medical, scientific, and national communities, underlie the decision 
to develop and maintain special support of pediatric critical care career 
development and research at the junior faculty level.  One of the most 
pressing is that clinical expertise in this rapidly evolving specialty is in 
such short supply, while the demand for intensivists to supervise the care of 
hospitalized patients, both in and out of the pediatric intensive care unit, 
is presently burgeoning.  Recently publicized studies, as well as the 
interest of the business community, have heightened the benefits for patients 
of the intensivist-led model.  As the clinical, educational, and 
administrative agenda increases in critical care, time for fully trained 
intensivists to devote to research is in ever-shorter supply.
  
Modern pediatric critical care medicine has introduced a number of principles 
of management and innovative methodologies without rigorous use of the 
controlled observation necessary for their objective evaluation.  A major 
problem has been the balance between assuring prompt implementation of new 
technologies, procedures, treatments, and drugs, and evaluation of their 
safety, efficacy, and cost/risk/benefit ratios.  Indeed, because of the 
urgent demands of critically ill children, care is based on limited knowledge 
of new modalities not subjected to critical studies prior to introduction and 
use.  In a critically ill child, for example, an innovative idea may be 
tried, which, if the patient's condition improves, may rapidly start a new 
trend and become the standard of care, expected and demanded by families of 
critically ill children and the professionals caring for them.  As a result, 
incorporation into the arsenal of critical care therapies may be based on 
limited experience, with efficacy and/or safety partially evaluated 
scientifically due to the pressured operational clinical milieu that 
surrounds pediatric critical care practice.  In addition, careful descriptive 
studies of the pathophysiology of critical illness in special needs children 
as related to long-term outcome remain minimal, but urgently needed.

Earlier attempts to address this need by the community of critical care 
investigators, while productive of smaller studies, have not resulted in the 
level of scientific knowledge that should underlie the emergence of a dynamic 
new specialty and optimize outcomes for children who are critically ill.  
Research that will improve long-term outcomes is the focus of this 
initiative.  It is expected that Principal Investigators and Mentors 
supported by this initiative will emphasize long-term outcomes, and 
reductions in morbidity and disability, during research training.  As well, 
support that directs the attention of pediatric intensivists at the junior 
faculty level toward rigorous research is vital to progress in pediatric 
critical care medicine as an emerging specialty. 

Recent discoveries across a broad range of basic science research areas have 
greatly expanded the options for the critically ill child.  Crucial advances 
in understanding of the molecular biology underlying organ system failure 
offer the possibility of manipulating otherwise poorly controlled processes, 
including inflammation, cell and organ death, and regeneration of tissues and 
functional organ system capacity.  Modalities of mechanical ventilation, non-
invasive ventilation, circulatory support, and extracorporeal life support 
have extended therapeutic options to patients previously thought to be beyond 
the reach of state-of-the-art therapy.  The use of less invasive techniques 
in neurosurgery, general, and vascular surgery, as well as implementation of 
newer techniques of respiratory and circulatory support, have been central to 
the radical changes in morbidity and the declines in mortality achievable 
with state-of-the-art pediatric critical care medicine.  As a result, 
children in higher risk groups who are victims of critical illness or injury, 
and those who might benefit from surgical interventions once not feasible, 
are benefiting from critical care in increasing number.

More often, in the present context of pediatric critical care, children with 
complex illnesses, combinations of medical, surgical, and traumatic 
processes, are surviving to discharge from multidisciplinary critical care 
units.  As mortality from critical illness and injury declines, survival of 
patients with disabling residuals of the critical pathology increases, and 
chronic medical conditions become more common.  In children, it is well known 
that such conditions make the risk of subsequent critical illness greater.  
Relatively few studies are available that might quantitate this risk and the 
impact of the increasing numbers of medically fragile children on families, 
schools, pediatric practice, and health care costs.  Measuring the efficacy 
of critical care practice by morbidity, while essential in the early years of 
the specialty, is no longer practical.

Support of pediatric critical care research must depend on basic and clinical 
science derived by intensivists in order to form the foundation of pediatric 
critical care practice.  The subspecialty has evolved rapidly in the clinical 
arena as described above, and the clinical services and leadership provided 
are in great demand.  The current pediatric literature provides documentation 
that one half (45-55 percent) of emergency admissions to pediatric intensive 
care units (PICUs) occur in children with known special needs.  When one 
considers the admission of children for postoperative critical care following 
elective surgical procedures, the percentage of children in the pediatric 
intensive care units with special needs is much higher.  

Program Scope

Only applications that address the following will be considered responsive to 
this solicitation:

o  Developing guidelines for training, didactic interactions, career 
development, and the responsible conduct of research.

o  Developing and promoting a network of established faculty with a record of 
research support and productivity, who could serve as potential mentors and 
secondary resources for trainees.  

o  Assuring that first consideration be given to candidates whose research 
interests will lead to expanded knowledge that ultimately will improve 
outcomes and quality of life for children with potential and present 
disability.

o  Negotiating and coordinating with participating institutions and 
departments to ensure that trainees get appropriate research support, non-
clinical time commitments, and opportunities for advancement.

o  Recruiting, selecting, and placing those individuals who would most 
benefit from participation in this program and are most likely to develop 
independent careers in research.

o  Providing special opportunities for research presentations and 
professional advancement, and career counseling and networking.

o  Enhancing the involvement of individuals from underrepresented minority 
groups or those returning to research careers after family obligations and, 
whenever possible, enabling persons with disabilities as trainees, mentors, 
and other resource positions.

o  Providing a periodic evaluation of the PCCRSD program as a whole.

MECHANISM OF SUPPORT

This RFA will use the NIH Mentored Research Scientist Development Program 
(K12) award mechanism.  As an applicant you will be solely responsible for 
planning, directing, and executing the proposed project.  The anticipated 
award date is July 01, 2004.  

FUNDS AVAILABLE

The NICHD intends to commit approximately $400,000 in total costs [Direct 
plus Facilities and Administrative (F & A) costs] in FY 2004 and 
approximately $800,000 in FY 2005   2008 to support up to one new grant in 
response to this RFA.  An applicant may request a project period of up to 
five years and a budget for total costs of up to $400,000 in Year 01 and 
$800,000 per year in Years 02 - 05.  Facilities and Administrative costs on 
K12 awards are limited to eight percent of modified total direct costs.
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. 

The National Institute of Neurological Disorders and Stroke (NINDS) 
recognizes the importance of supporting the career development of pediatric 
intensivists.  While not a participant in this RFA, the NINDS will consider 
supporting individuals appointed to an NICHD-funded PCCSDP Program.  
Individuals considered for such career development support by NINDS include, 
but are not limited to, pediatric neurology or neurosurgery junior faculty 
who are conducting basic and/or clinical research in pediatric neurotrauma.

ELIGIBLE INSTITUTIONS

You may submit an application if your institution has any of the following 
characteristics: 

o For-profit or non-profit organizations 
o Public or private institutions, such as universities, colleges, hospitals, 
and laboratories 
o Units of State and local governments 
o Eligible agencies of the Federal government  
o Faith-based or community-based organizations 
o Domestic  

Institutions outside the United States are not eligible for this award.

INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS

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

Candidates must be citizens of the United States or permanent, legal 
residents of the United States.

SPECIAL REQUIREMENTS

COMPONENTS OF A K12 PEDIATRIC CRITICAL CARE SCIENTIST DEVELOPMENT AWARD:

The K12 award provides five years of funding to the applicant organization to 
support a national training program.  The Program Director, in consultation 
with the Advisory Committee, shall define the application process, review 
candidates, make appointments to qualified individuals, and monitor progress.  
For each candidate, the four- to five-year career development program 
consists of two phases.  In Phase I, the candidate receives two to three 
years of intense training in a basic or clinical science discipline with an 
established mentor scientist at the mentor's institution.  In conjunction 
with the mentor, the candidate develops a research and career development 
plan, which will be reviewed annually by the PCCSD program.  Phase II begins 
with the transition to independent investigator status.  The PCCSD program 
will assist with placement in a sponsoring PCCM (or related) department, and 
continue to monitor progress and provide support as necessary.  During Phase 
II (generally two to three years), individuals should be supported by 
independent research grants, departmental funds, and possibly even clinical 
duties - but not directly from the K12 grant.  It is expected that the PCCM 
departments associated with this PCCSD program will make a strong commitment 
to supporting individuals as they reach Phase II, including faculty positions 
and the provision of protected research time.

A.  Principal Investigator

The Principal Investigator of the PCCSD should possess the scientific 
expertise, leadership, and administrative capabilities required to coordinate 
and supervise a national, multidisciplinary research-training program.  The 
Principal Investigator is responsible for appointing the Program Director and 
members of the Advisory Committee (see below) and uses their recommendations 
to determine the appropriate allotment of funds for research and career 
development.  The Principal Investigator may not receive salary or fringe 
benefit support from the grant for this role per se, but may receive 
financial support for additional roles in the PCCSD program (e.g., Program 
Director). 

B.  Program Director and Administrative Staff

The Program Director has responsibility for the day-to-day administration of 
the PCCSD, and may receive up to 10 percent support from the K12 grant.  The 
Principal Investigator also may serve in the role of Program Director, and 
can receive appropriate remuneration for this role.  The Program Director 
must be a physician and senior faculty member who is knowledgeable about 
pediatric critical care research, has a record of success in laboratory 
and/or clinical investigation, and demonstrated skill in career development. 
The Program Director may be assisted by a grant-supported part-time 
secretary.  In addition, limited funds may be provided for a well-qualified 
recruitment officer to enhance participation in the program by women, members 
of minority groups that are underrepresented in biomedical research, and 
individuals with disabilities.  

C.  Advisory Committee

The Advisory Committee, chaired by the Principal Investigator, is a select 
group of scientists and clinicians who have interests and expertise in 
pediatric critical care research.  They also may be potential PCCSD mentors.  
The Committee may involve advocates of the rehabilitation community, as 
appropriate.  The Advisory Committee evaluates all applicants to the program, 
monitors progress of current trainees, and provides direct feedback to 
individuals as appropriate.  

D.  Mentors

Mentors shall be tenured faculty (or their equivalent) who have an 
established record of research productivity and grant support (preferably 
from the NIH) in areas of basic and translational research relevant to 
pediatric critical care medicine.  Generally, they will be researchers and 
clinicians from allied fields, whose particular expertise is needed to 
support certain career research goals.  Linkages to other departments should 
be encouraged, as they enhance the power of this career development program 
and pediatric critical care rehabilitation research, in general.  Although 
mentors must demonstrate a commitment to the PCCSD program and potential 
trainees, they cannot receive salary, fringe benefits, or research support 
for this role from the K12 grant.  However, provisions are made to support 
the research activities of particular PCCSD trainees within their 
laboratories, as described below.  Mentors may be added to the roster of the 
program as appropriate, with NCMRR staff approval.

It is expected that institutions that support PCCSD trainees in Phase I make 
a strong commitment to supporting these candidates in Phase II when they seek 
positions as independent investigators.

E. PCCSD Candidates

As part of its recruitment efforts, the PCCSD program should make every 
effort to broadly advertise training opportunities and provide information on 
prospective mentors.  The program is required to seek out qualified women, 
individuals from underrepresented minorities, and persons with physical 
disabilities.  PCCSD candidates should be physicians who have completed 
clinical training and are no more than five years beyond fellowship training 
when they enter the program.  An individual who has previously served as 
Principal Investigator of an NIH research grant (R01, R03, R21, P01), 
mentored career development award (K series), subproject of program project 
(P01) or contract (N01) may not be considered for training in this program.  

Candidates must be U.S. citizens or noncitizen nationals, or must have been 
lawfully admitted for permanent residence and possess an Alien Registration 
Receipt Card (I-151 or I-551) or some other verification of legal admission 
as a permanent resident.  Noncitizen nationals, although not U.S. citizens, 
owe permanent allegiance to the U.S.  They are usually born in lands that are 
not states but are under U.S. sovereignty, jurisdiction, or administration.  
Individuals on temporary or student visas are not eligible.

Prospective trainees should be encouraged to contact potential mentors prior 
to formally applying to the PCCSD program.  Although remaining at the 
institution of their fellowship is a possibility for trainees under this 
award, academic diversity through research training and clinical practice at 
a different institution should be strongly encouraged.  When possible, the 
program should support career development in those areas of research that 
would have the most impact on the emerging field of pediatric critical care 
medicine.  

Candidates must make a commitment to the PCCSD program for four to five 
years, spanning both Phase I and Phase II training.  Upon entering the 
program, trainees should develop, in conjunction with their primary mentor, a 
long-range research and career development plan.  During Phase I, at least 75 
percent of the trainee's time must be devoted to basic research activities 
supported by the PCCSD program.  Provided they are making appropriate 
progress as judged by the Advisory Committee, trainees may be renewed 
annually for up to three years of total Phase I support.  Toward the end of 
the second year, trainees should be strongly encouraged to seek outside grant 
support as they transition to independent researcher positions in sponsoring 
PCCM institutions.  Phase II trainees will remain associated with the PCCSD 
program for another two to three years, submit yearly progress reports, and 
attend PCCSD meetings.  However, they should develop independent and stable 
means of research support outside the K12 grant.  It is expected that their 
departments provide at least 50 percent - and preferably 75 percent - 
protected time for research activities during this period.  Total training 
under the PCCSD program may not exceed five years.   

During Phase I or II, trainees may engage in brief research activities at 
another institution if it is directly related to the purpose of the award.  
Periods of leave from the program for greater than two months, whether for 
professional or personal reasons, require prior written approval from NICHD.

In carrying out its stewardship of human resource-related programs, the NIH 
may begin requesting information essential to an assessment of the 
effectiveness of this program.  Accordingly, awardee institutions are hereby 
notified that PCCSD trainees may be contacted after the completion of their 
career development experiences for periodic updates on various aspects of 
their employment history, publications, support from research grants or 
contracts, honors and awards, professional activities, and other information 
helpful in evaluating the impact of the program.

SPECIAL BUDGETARY REQUIREMENTS:

A composite budget and individual budgets for the Administrative Core and the 
total trainee costs should be provided.  

o  Administrative Core:  The Administrative Core may include salaries and 
support for a Program Director (up to 10 percent time and effort), a part-
time secretary, and a recruiting officer (up to 10 percent time and effort).  
It may also include funds for services specific to the administration of this 
program and not typically covered by institutional overhead charges (e.g., 
supplies, duplicating equipment, telephone, or maintenance contracts for 
equipment).  Travel of Principal Investigator and Program Director to annual 
PCCSD meetings may also be included.  The Administrative Core may include 
modest expenses for members of the Advisory Committee.

o  Trainee Expenses:  As indicated above, funds for prospective trainees 
should be provided on a separate budget, with indication of the number of 
positions requested and to what extent these funds will be used for salaries. 
Individual trainees are eligible for up to $75,000 per year in salary, in 
addition to fringe benefits, consistent with their institution's salary 
scale; this may not be supplemented with other Federal funds unless 
specifically authorized by that Federal program.  For each trainee, up to 
$10,000 in additional funds may be budgeted each year to defray the costs of 
materials, supplies, technical assistance, and miscellaneous expenses 
generated by the trainee's research in the laboratories of the established 
investigators who serve as mentors.  In specific cases, grant funds may also 
be used for tuition, fees, and books related to career development.  Up to 
$3,500 per trainee in travel funds may be budgeted to attend annual PCCSD 
functions and other professional meetings.  Total awards to individual 
trainees need not be equal across these different budget categories.  Salary 
and research expenses are not appropriate for Phase II trainees; however, the 
K12 grant may provide travel funds to allow them to attend annual PCCSD 
meetings.

Facilities and administrative costs on K12 awards are limited to eight 
percent of modified total direct costs. 

Items that may NOT be supported with K12 grant funds include:

1.  Direct support of the mentors' laboratories beyond those expenses 
directly attributable to the trainee's project;

2.  Salary and support for central institutional administrative personnel 
(e.g., budget officers, grant assistants, and building maintenance 
personnel), which are usually paid from institutional overhead charges;

3.  Salary and support for administrative activities such as institutional 
public relations or health and educational services;

4.  Travel of the Principal Investigator, the Program Director, or other 
established investigators to scientific meetings beyond those associated with 
the administration of the PCCSD program;

5.  Patient care costs such as inpatient bed days or outpatient visits, 
except for clinical laboratory analyses essential for the trainees' research;

6.  Alterations and renovations.

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:  

Carol Nicholson, M.D., M.S.
Pediatric Critical Care and Rehabilitation Research Program
National Institute of Child Health and Human Development
6100 Executive Boulevard, Room 2A03, MSC 7510
Bethesda, MD  20892-7510
Telephone:  (301) 435-6843
FAX:  (301) 402-0832
Email:  [email protected] 

o Direct your questions about peer review issues to:  

Robert Stretch, Ph.D.
Director, Division of Scientific Review
National Institute of Child Health and Human Development
6100 Executive Boulevard, Room 5B01, MSC 7510
Bethesda, MD  20892-7510
Telephone:  (301) 496-1485
FAX:  (301) 402-4104
Email:  [email protected] 

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

Kathy Hancock
Acting Chief, Grants Management Branch
National Institute of Child Health and Human Development
6100 Executive Boulevard, Room 8A17, MSC 7510
Bethesda, MD  20892-7510
Telephone:  (301) 496-5482
FAX:  (301) 402-0915
Email:  [email protected] 

LETTER OF INTENT

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

o Descriptive title of the proposed program 
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 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:  

Carol Nicholson, M.D., M.S.
Pediatric Critical Care and Rehabilitation Research Program
National Institute of Child Health and Human Development
6100 Executive Boulevard, Room 2A03, MSC 7510
Bethesda, MD  20892-7510
Telephone:  (301) 435-6843
FAX:  (301) 402-0832
Email:  [email protected] 

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) 710-0267, 
Email: [email protected].
 
SUPPLEMENTAL INSTRUCTIONS:

Budget Instructions

The application should include DETAILED BUDGET FOR THE INITIAL BUDGET PERIOD 
(page 4), COMPOSITE BUDGET FOR THE ENTIRE PROPOSED PERIOD OF SUPPORT (page 
5), and appropriate justifications in narrative form.  As described above, 
the administrative core may include Personnel, Supplies, Travel Expenses (for 
the Principal Investigator and Program Director to annual PCCSD meetings), 
and Other Expenses.  Funds for prospective trainees should be listed on a 
separate budget page with indication of the number of positions.  Facilities 
and administrative costs on K12 awards are limited to eight percent of 
modified total direct costs.  

Biographical Sketches

A biographical sketch is required for all key personnel to assess each 
individual's qualifications for their specific role in the program, as well 
as to evaluate the overall qualifications of the training network.  Include 
information on current research projects and those completed during the last 
three years.  For Advisory Board nominees, include a brief justification for 
their role in the PCCSD program.  For proposed mentors, provide a paragraph 
on the relevance of their research to pediatric critical care medicine.  No 
more than four pages may be used for each person.  

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 Stretch, Ph.D.
Director, Division of Scientific Review
National Institute of Child Health and Human Development
6100 Executive Boulevard, Room 5B01, MSC 7510
Bethesda, MD  20892-7510
Rockville, MD 20852 (for express/courier service)

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 eight 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.  
However, when a previously unfunded application, originally submitted as an 
investigator-initiated application, is to be submitted in response to an RFA, 
it is to be prepared as a NEW application.  That is, the application for the 
RFA must not include an Introduction describing the changes and improvements 
made, and the text must not be marked to indicate the changes.  While the 
investigator may still benefit from the previous review, the RFA application 
is not to state explicitly how.

PEER REVIEW PROCESS

Upon receipt, applications will be reviewed for completeness by the CSR and 
responsiveness by the 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

The goals of NIH-supported research are to advance our understanding of 
biological systems, improve the control of disease, and enhance health.  In 
the written comments, reviewers will be asked to discuss the following 
aspects of your application in order to judge the likelihood that the 
proposed program will have a substantial impact on the pursuit of these 
goals:

(1)  Probable impact of the PCCSD program on the development of well-
qualified medical PCCM investigators, advancement of pediatric critical care 
research, and the application of basic research developments to significant 
clinical problems.

(2)  Commitment of a broadly based and productive network of established 
investigators to the goals of the PCCSD program, especially in research areas 
relevant to current NICHD interests and programmatic needs. 

(3)  Institutional commitment of the applicant organization and potential 
training sites, as demonstrated by salary support, equipment, core laboratory 
support, or other contributions to the success of the program.

(4)  Evidence for the availability of a pool of prospective trainees, who 
could benefit from participation in this program and are likely to develop 
into productive independent researchers. 
 
(5)  Novel mechanisms for recruiting candidates, especially qualified 
individuals from under-represented minority groups, and for connecting them 
with potential mentors.

(6)  Evidence of a sound and equitable system for evaluating candidates and 
monitoring their research progress and career development.

(7)  Availability of potential faculty positions at participating PCCM 
institutions for investigators trained in this PCCSD program, and strong 
evidence of institutional commitment to these individuals as they become 
independent investigators.

(8)  Quality of the proposed training in the responsible and ethical conduct 
of research.

ADDITIONAL REVIEW CRITERIA:  In addition to the above criteria, the following 
items will be considered in the determination of scientific merit and the 
priority score:

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

ADDITIONAL CONSIDERATIONS 

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

RECEIPT AND REVIEW SCHEDULE

Letter of Intent Receipt Date:    September 17, 2003
Application Receipt Date:         October 16, 2003
Peer Review Date:                 March 2004
Council Review:                   June 2004
Earliest Anticipated Start Date:  July 01, 2004

AWARD CRITERIA

Criteria that will be used to make award decisions include: 

o Scientific 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 

MONITORING PLAN AND DATA SAFETY AND MONITORING BOARD:  Research components 
involving Phase I and II clinical trials must include provisions for 
assessment of patient eligibility and status, rigorous data management, 
quality assurance, and auditing procedures.  In addition, it is NIH policy 
that all clinical trials require data and safety monitoring, with the method 
and degree of monitoring being commensurate with the risks (NIH Policy for 
Data Safety and 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 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.

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). Those who must comply with the Privacy Rule (classified 
under the Rule as "covered entities") must do so by April 14, 2003  (with the 
exception of small health plans which have an extra year to comply).  

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 at http://www.cfda.gov/ and is not subject to the 
intergovernmental review requirements of Executive Order 12372 or Health 
Systems Agency review.  Awards are made under the authorization of Sections 
301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) 
and under Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92.  All 
awards are subject to the terms and conditions, cost principles, and other 
considerations described in the NIH Grants Policy Statement.  The NIH Grants 
Policy Statement can be found at 
http://grants.nih.gov/grants/policy/policy.htm.

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

Weekly TOC for this Announcement
NIH Funding Opportunities and Notices

			Department of Health and Human Services (HHS)
NIH... Turning Discovery Into Health®