COOPERATIVE MULTICENTER NEONATAL RESEARCH NETWORK

Release Date:  April 3, 2000

RFA:  HD-00-010 (This RFA has been reissued, see RFA-HD-04-010)

National Institute of Child Health and Human Development

Letter of Intent Receipt Date:  April 21, 2000
Application Receipt Date:       July 11, 2000

PURPOSE

The National Institute of Child Health and Human Development (NICHD) invites 
applications from investigators willing to participate with the NICHD under a 
Cooperative Agreement (U10) in an ongoing multicenter clinical program 
designed to investigate the safety and efficacy of treatment and management 
strategies to care for newborn infants, particularly those related to 
management of low birth weight infants.  The objective of this program is to 
facilitate evaluation of these strategies by establishing a network of 
academic centers that, by rigorous patient evaluation using common protocols, 
can study the required numbers of patients and can provide answers more 
rapidly than individual centers acting alone. 

The NICHD program staff will assist the Principal Investigators of the 
Neonatal Research Network and the Advisory Board in identifying research 
topics of high priority, and in designing and implementing protocols 
appropriate to the evaluation of optimal  management in these areas.

It is anticipated that approximately 14 to 16 clinical centers will be 
involved in the program.

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 Request for 
Applications (RFA), Cooperative Multicenter Neonatal Research Network, is 
related to the priority area of low birth weight.  Potential applicants may 
obtain  “Healthy People 2010” at http://www.health.gov/healthypeople/. 

ELIGIBILITY REQUIREMENTS

Applications may be submitted by domestic non-profit organizations, public 
and private.  Organizations should have academically-oriented divisions of 
neonatal medicine.  The need for continuous and active communication among 
sites dictates that only institutions in the United States are eligible to 
apply.  Racial/ethnic minority individuals, women, and persons with 
disabilities are encouraged to apply as Principal Investigators.

MECHANISM OF SUPPORT

This RFA will use the National Institutes of Health (NIH) cooperative 
clinical research cooperative agreement (U10) award mechanism, an 
“assistance” mechanism (rather than an “acquisition” mechanism) in which 
substantial NIH scientific and/or programmatic involvement with the awardee 
is anticipated during performance of the activity.  Under the cooperative 
agreement, the NIH purpose is to support and stimulate the recipients’ 
activity by involvement in the activity and otherwise working jointly with 
the award recipients in a partner role, but it is not to assume direction, 
prime responsibility, or a dominant role in the activity.  Details of the 
responsibilities, relationships and governance of the study to be funded 
under cooperative agreements are discussed below under “Terms and Conditions 
of Award.”

FUNDS AVAILABLE

NICHD intends to commit approximately $5.1 million in total costs [Direct 
plus Facilities and Administrative (F & A) costs] in FY 2001 to fund 14 to 16 
new and/or competing continuation grants in response to this RFA.  An 
applicant may request a project period of up to five years and a budget for 
direct costs of up to $200,000 per year, excluding F & A costs on consortium 
arrangements.  Because the nature and scope of the research proposed may 
vary, it is anticipated that the size of awards also will vary.  Although the 
financial plans of 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.

RESEARCH OBJECTIVES

Background

Modern neonatology 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 adequate evaluation of 
their safety and efficacy.  Indeed, because of the urgent demands of sick 
infants, care is often based on limited knowledge of new modalities not 
subjected to critical studies prior to introduction and use.  In a critically 
ill infant, an innovative idea may be tried which, if the infant"s condition 
improves, may rapidly set a new trend, and become the standard of care.  
Therefore, the incorporation into the arsenal of therapies frequently is 
based on limited experience, and their efficacy and/or safety have not been 
evaluated scientifically.

In an attempt to respond to the need for well-designed clinical trials in 
neonatal medicine, NICHD established a Neonatal Research Network in 1986.  
Seven university units were selected from among respondents to an RFA.  The 
Network Steering Committee, which consists of representatives from each 
Clinical Center, NICHD staff, and data center staff, evaluated several 
controversial issues for study.  It then selected certain priority areas in 
which to develop protocols for randomized clinical trials.  Protocols on the 
prevention of sepsis, intraventricular hemorrhage, pulmonary hypertension, 
surfactant administration, and outcome and resource requirements for very low 
birthweight (VLBW) infants were initiated.  In addition, the Network 
established a generic data base of infants less than 1500 grams at birth. 

During the second grant period of the Neonatal Research Network (1991-1996), 
clinical trials were initiated on the prevention or treatment of chronic lung 
disease (CLD), intraventricular hemorrhage, retinopathy of prematurity, and 
persistent pulmonary hypertension.  Studies of VLBW maturity and postnatal 
growth, the sequelae of the fetal drug exposure, and a standardized follow-up 
program also were initiated.

During the third Neonatal Research Network funding period (1996 – 2001), 
intraventricular hemorrhage, retinopathy of prematurity, the treatment of 
persistent pulmonary hypertension, parenteral glutamine, indomethacin, 
erythropoieten, inhaled nitric oxide, postnatal steroids, ventilation 
management strategies, and outcome at follow-up were addressed.

Objectives and Scope

There are a number of controversial issues in neonatology that might be 
clarified by multicenter collaborative research.  Funded Principal 
Investigators will cooperate with the NICHD Program Coordinator in 
identifying research topics of high priority and in designing protocols 
appropriate to the evaluation of superior, or even optimal management in 
these areas.  The participating Neonatal Research Network members will be 
designated as “Clinical Centers” which will recruit, assess and treat 
subjects under the supervision of the respective Clinical Center Principal 
Investigator.  The data center, which is funded under a separate RFA, will 
have primary responsibility for data management and analysis for Network 
research in collaboration with the Steering Committee.

The NICHD expects that the ongoing trials dealing with hypothermia for 
asphyxiated babies, benchmarking to reduce chronic lung disease, and the 
follow-up program will continue into the new grant period in existing 
centers.  New protocols may be developed before the start of the 
continuation.  Centers that join the Network in the next award period 
(beginning April 1, 2001) may participate in the protocols ongoing at that 
time.

The NICHD intends to enable the Network to initiate new protocols within the 
first year of the next award period.  The topics of these protocols will be 
decided cooperatively by the Steering Committee with advice from the Advisory 
Board.  Areas of interest include all major areas of newborn pathophysiology:  
cerebral function, pulmonary physiology, gastrointestinal function and 
nutrition, immunology, etc.  Also of interest are evaluation of drugs in the 
newborn, the rapid transfer of new technologies to neonatal medicine, 
strategies to reduce the cost and preserve the quality of neonatal care, and 
long-term outcome.

Guidance and Management Structures

The management of the Neonatal Research Network includes three committees as 
described below under Terms and Conditions of Award/Collaborative 
Responsibilities.

In addition, the Network has established Policies and Procedures that govern 
its operations, including publications.  These documents are under periodic 
review, and may be amended and supplemented at the discretion of the Steering 
Committee and the NICHD.

SPECIAL REQUIREMENTS

The NICHD invites applications both from current members of the Neonatal 
Research Network (competing renewal applications) and from prospective 
members (new applications).  Minimum requirements for applicants are as 
follows (see APPLICATION PROCEDURES/Application Instructions, below, for 
detailed application instructions):

Applicant Clinical Centers must have at least 500 admissions per year 
currently in the unit.  No more than 30 percent of admissions should be 
outborn.  Large perinatal centers will be given preference over combined 
services composed of a small inborn unit and a transfer/tertiary care 
service.

An established neonatal follow-up program with experience in following 
patients and a designated facility must be in place.

The applicant must have an established neonatal/perinatal data system, 
preferably computerized, to collect and tabulate statistics.

A research nurse must be designated for the full-time nurse coordinator 
position.

To provide peer reviewers and NICHD an idea of the capabilities of 
investigators, all applicants must submit a “concept” protocol, briefly (two 
to three pages) summarizing a project that the applicant might submit to the 
Network for possible implementation at all Network centers.  

The departmental and institutional commitments to collaborative neonatal 
research should be clearly documented by providing letters to the Principal 
Investigator, and by citing evidence of past support.

Terms and Conditions of Award

The following Terms and Conditions of Award are in addition to, and not in 
lieu of, otherwise applicable OMB administrative guidelines, HHS grant 
administration regulations in 45 CFR Parts 74 and 92 and other HHS, PHS and 
NIH grant administration policies.

The administrative and funding instrument used for this program will be the 
cooperative agreement (U10), an “assistance” mechanism (rather than an 
“acquisition” mechanism) in which substantial NIH scientific and/or 
programmatic involvement with the awardee is anticipated during the 
performance of the activity.  Under the cooperative agreement, the NIH 
purpose is to support and/or stimulate the recipient"s activity by 
involvement in and otherwise working jointly with the award recipient in a 
partner role, but it is not to assume direction, prime responsibility, or a 
dominant role in the activity.  Consistent with this concept, the dominant 
role and prime responsibility for the activity resides with the awardee(s) 
for the project as a whole, although specific tasks and activities in 
carrying out the studies will be shared among the awardees and the  NICHD 
Program Coordinator, as described in these terms and conditions.   (The 
substantial programmatic involvement by the NICHD Program Coordinator is 
above and beyond the levels required for traditional program management and 
stewardship of awards.)
1.  Awardee Rights and Responsibilities

The responsibilities and authorities of the awardees will be as follows:

o  Identification of priority issues for research.
o  Development and implementation of common protocols.
o  Collection and transmission of accurate data in a timely manner.
o  Analysis of data and publication of results of the Neonatal Research 
Network studies.

All parties will agree to accept the coordinating role of the group and the 
participatory and cooperative nature of the group process.

The individual members will be required to project patient enrollment for a 
specific protocol during a specified time frame, continuation and level of 
funding will be based on actual recruitment.

The Neonatal Research Network will retain custody of and have primary rights 
to the data developed under these awards, subject to Government rights of 
access consistent with current HHS, PHS and NIH policies.

2.  NICHD Staff Responsibilities

Traditional program management/stewardship responsibility for review and 
oversight of the cooperative agreement award will reside with the Neonatal 
Research Network Program Official. This role will include the following:

o  Assurance of the scientific merit of the trials, including the option to 
withhold support of a participating center if technical performance 
requirements such as protocol compliance, enrollment targets, or 
randomization of subjects are not met.

o  Initiation of a decision to modify or terminate a study based on the 
advice of the data center, Data Safety and Monitoring Committee, and Advisory 
Committee with the mutual consent of the Steering Committee.

The role of the participating NICHD Neonatal Research Network Program 
Coordinator will be to aid the awardees and the Steering Committee in the 
following ways:

o  Assistance in the identification of important areas of study.
o  Assistance in the development of study protocols.
o  Assistance in the development and review of capitation-based budgets, 
including the identification of study costs and special institutional needs.
o  Assistance in the review and evaluation of each stage of the program 
before subsequent stages are started, in conjunction with the Steering 
Committee and the Advisory Board.
o  Assistance in the efficient conduct of the trials, including ongoing 
review of progress, possible redirection of activities to improve performance 
and cooperation, and frequent communication with other members of the 
Steering Committee.
o  Participation on the Steering Committee and all active subcommittees.
o  Assistance in reporting results in the community of investigators and 
health care recipients.
 
3.  Collaborative Responsibilities

The management of the Neonatal Research Network includes three committees 
whose functions are as follows:

o  A Steering Committee will be responsible for protocol development, 
assisted by the Advisory Board and the Data Safety and Monitoring Committee.  
The Steering Committee will have primary responsibility for the conduct of 
protocols and the preparation of publications.  The Steering Committee will 
be composed of all Principal Investigators, one representative from the data 
center, and one NICHD staff member, a neonatologist from the Pregnancy and 
Perinatology Branch (the Neonatal Research Network Program Coordinator).  The 
Neonatal Research Network Program Coordinator will be the only voting NICHD 
staff member of the Steering Committee.  A member of the NICHD Grants 
Management Branch advises the Steering Committee on funding matters.  An 
outside chairperson, who is not participating as a Principal Investigator, 
will be selected by the NICHD.

o  An Advisory Board will advise the Steering Committee in the identification 
and prioritization of topics for Network research.  The Advisory Board, 
chosen by the NICHD with the advice of the Steering Committee, will be 
composed of individuals with expertise in clinical trials, biostatistics, 
epidemiology, perinatology, and neonatology, the Chairperson of the Steering 
Committee, the data center Principal Investigator, the Director of the NICHD 
Center for Research on Mothers and Children (CRMC), and the Neonatal Research 
Network Program Coordinator.  Additional members will participate based on 
the need for specific expertise.

o  A Data Safety and Monitoring Committee (DSMC) will monitor the safety of 
ongoing clinical trials and advise on their conduct.  The DSMC will be 
established by NICHD and will represent expertise in clinical trial design 
and conduct, perinatology, neonatology, basic science, and ethics.

In addition, the Network has established Policies and Procedures that govern 
its operations, including publications.  These documents are under periodic 
review, and may be amended and supplemented at the discretion of the Steering 
Committee.

4.  Arbitration

Any disagreement that may arise on scientific/programmatic matters (within 
the scope of the award), between award recipients and the NICHD may be 
brought to arbitration.  An arbitration panel will be constituted, consisting 
of three members:  one selected by the Steering Committee (with the NICHD 
member not voting) or by the individual awardee in the event of an individual 
disagreement, a second member selected by NICHD, and the third member 
selected by the two previously selected members. This special arbitration 
procedure in no way affects the awardee’s right to appeal an adverse action 
that is otherwise appealable in accordance with the PHS regulations at 42 CFR 
Part 50, Subpart D, and HHS regulation at 45 CFR Part 16.

INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN
SUBJECTS

It is the policy of the NIH that women and members of minority groups and 
their subpopulations must be included in all NIH-supported biomedical and 
behavioral research projects involving human subjects, unless a clear and 
compelling rationale and justification are provided 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 research involving human subjects should read the 
‘NIH Guidelines For Inclusion of Women and Minorities as Subjects in Clinical 
Research,” published in the Federal Register of March 28, 1994 (FR 59-14508-
14513) and in the NIH Guide for Grants and Contracts, Volume 23, Number 11, 
March 18, 1994, and available at: 
http://grants.nih.gov/grants/guide/notice-files/not94-100.html .

INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS

It is the policy of NIH 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,” published in the NIH Guide for Grants and 
Contracts, March 6, 1998, and available at:   
http://grants.nih.gov/grants/guide/notice-files/not98-024.html.

Investigators also may obtain copies of the policy from the program staff 
listed under INQUIRIES.  

LETTER OF INTENT

Prospective applicants are asked to submit a letter of intent that includes a 
descriptive title of the proposed research, 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 to Dr. Linda L. Wright at the address 
listed under INQUIRIES, below, by April 21, 2000.

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.  Reviewers are cautioned that their anonymity may 
be compromised when they directly access an Internet site.

APPLICATION PROCEDURES

The research grant application form PHS 398 (rev. 4/98) is to be used in 
applying for these grants.  These forms are available at most institutional 
offices of sponsored research, on the Internet at 
http://grants.nih.gov/grants/funding/phs398/phs398.html, and from the 
Division of Extramural Outreach and Information Resources, National 
Institutes of Health, 6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-
7910, telephone 301-435-0714, E-mail: Grantsinfo@nih.gov.

Application Instructions 

The NICHD invites applications both from current members of the Neonatal 
Research Network (competing renewal applications) and from prospective 
members (new applications).  Instructions accompanying the PHS 398 (rev. 
4/98) are to be followed in completing these applications.  Applications 
should address the following items:

A.  Requirements for Applicants

1.  Academic Productivity

Provide evidence of recent research productivity by the applicant Clinical 
Center in previous or present clinical trials, especially of a cooperative, 
multicenter nature.  Specifically, contributions in key areas such as 
protocol design, patient recruitment, data analysis and interpretation, and 
publication are important.

Applicants who are current Neonatal Research Network members should describe 
their participation in Network research during the current competitive 
segment in detail, i.e., GDB infants per year, number of patients who were 
recruited to each study, and subcommittee memberships and chairmanships.

New applicants should describe their recent participation in at least one 
randomized clinical trial and one observational study, preferably of a 
multicenter nature, providing similar information to that requested from 
current Network members.

2.  Neonatology Staffing

Participants must be based in a level III neonatal intensive care unit that 
admits both inborn and outborn patients.  Physician staffing of the Clinical 
Center should include at least four full-time board-certified neonatologists.  
Provide complete descriptions of their training and qualifications in both 
clinical care and research, and their previous and current involvement in 
clinical research.  Specifically, the academic status and academic career 
development pathways should be described.  The approximate percentage time 
protected for research by the academic department should be specified.  The 
Principal Investigator should be a practicing neonatologist, his/her 
clinical, academic, administrative, and research commitments should be 
described in detail.

3.  Available Population

Applicant Clinical Centers must have at least 500 admissions per year 
currently in the unit.  No more than 30 percent of admissions should be 
outborn.  Large perinatal centers will be given preference over combined 
services composed of a small inborn unit and a transfer/tertiary care 
service.

Applicants that have numbers of births near the minimum or have experienced a 
recent decline in annual admissions should describe this decline and document 
efforts to maintain access to an adequate number of neonatal patients for 
research purposes.

The patient population served by the Clinical Center should be characterized 
by demographics, obstetric parameters, and payment status.  Indications 
should be given of the proportions of various subgroups, including 
minorities, that have been eligible and actually have been randomized in 
previous or current clinical trials (see also section on Inclusion of Women 
and Minorities).

4.  Maternal Fetal Medicine Unit

The Clinical Center should be located in an institution with a perinatal 
program that delivers high-risk pregnancies and has one or more 
perinatologists active in clinical research on staff.  A history of 
cooperation between neonatology and obstetrics towards excellence in clinical 
care, maintenance of a data base, and research productivity should be 
documented.  An obstetrician at the institution who has interest and 
experience in clinical research and is willing to participate in the Neonatal 
Research Network should be designated.  Such individual(s) must commit to 
serve as a consultant and possible collaborator in Network research.  The 
academic status and career development pathways of such individual(s) must be 
described.

A description of the organization and service load of the Maternal Fetal 
Medicine Units at the institution, including its research activities, must be 
included.  If the institution submits applications in response to both the 
Maternal Fetal Medicine Unit RFA (HD-00-009) and the Neonatal Research 
Networks RFA, the applicant must describe how the two research programs will 
be integrated.

5.  Facilities and Clinical Capabilities

The applicant Clinical Center should have a full range of pediatric 
subspecialists, state-of-the-art facilities and clinical capabilities, and 
excellent support staff.  The applicant Clinical Center should include a 
detailed description of facilities, equipment, and clinical capabilities, 
pediatric subspecialists and support staff, specialty clinics, laboratory 
facilities, and imaging capabilities.  The availability of an institutional 
research pharmacy and respiratory therapy program capable of supporting 
clinical research also should be documented.

An established neonatal follow-up program with experience in following 
patients and a designated facility must be in place.  The professional staff 
should include a developmental pediatrician or neonatologist with similar 
expertise.  Specialists available to consult should include pediatric 
neurology, ophthalmology, orthopedics, surgery, physical and/or occupational 
therapy, nutrition, and social services.  A system of ongoing follow-up data 
collection must be documented including the population followed, compliance 
rates, schedule of follow-up visits, funding sources, as well as established 
policies and procedures for conducting clinical research in these facilities.  
A Biographical Sketch of the individual responsible for the Network Follow-Up 
study and a letter of support from the director of the follow-up program 
should be included.

All applicants, both new and competing renewals, also are invited to describe 
briefly any special research strengths that may be relevant to Network 
research.  Such strengths would represent state-of-the-art scientific 
capabilities that might be shared or made available to the Network, to expand 
the scientific productivity of Network research.  For example, an ongoing 
specialized registry or capabilities in areas such as PET scanning, prenatal 
diagnosis, molecular biology, and clinical pharmacology represent some of the 
relevant strengths that could be included.

Special administrative strengths also may be described.  For example, both 
competing continuation and new applications may present the availability of 
potentially collaborating neonatal units in medical centers with which 
affiliations have been developed by the applicant institution for clinical 
research.  The requirements described above must be met by such affiliated 
institutions.  Centers that propose to combine institutions or multiple sites 
must justify the proposed organization and provide a detailed logistical plan 
for cost-effective management.

Applicants from institutions that have a General Clinical Research Center 
(GCRC) funded by the NIH National Center for Research Resources may wish to 
identify the GCRC or other funded perinatal research centers as resources for 
conducting the proposed research.  If so, a letter of agreement that 
identifies the level of support from either the GCRC program director or 
Principal Investigator should be included with the application.

A description of whether, and how, policies and procedures may have been 
modified to support neonatal clinical research in the past must be provided.

6.  Perinatal Data System

The Clinical Center must have an established neonatal/perinatal data system, 
preferably computerized, to collect and tabulate statistics. Applicants must 
provide a detailed description of the variables collected and the data 
quality and management activities.  The applicant also should illustrate how 
the system has been used recently to plan and perform clinical research.  All 
successful applicants must be willing to provide complete, accurate, and 
timely data to the Neonatal Research Network registry.

7.  Research Nurse Staffing

A research nurse must be designated for the full-time nurse coordinator 
position.  Also, additional research nursing staff should be available.  
Provide descriptions of these individuals’ training, experience, and 
involvement in clinical research.

8.  Proposed Protocol Concept (all applicants)

To provide peer reviewers and NICHD an idea of the capabilities of 
investigators, all applicants must submit a “concept” protocol, briefly (two 
to three pages) summarizing a project that the applicant might submit to the 
Network for possible implementation at all Network centers.  The proposed 
“concept” will serve as an indicator of the applicant"s ability to 
participate in the development and design of cooperative protocols in the 
Network and reflect the problems and population available in the Network.  
The “concept” may not actually be performed by the Network, although it is 
anticipated that funded Neonatal Research Network centers will be invited to 
submit the “concepts” included in their applications to the Network Steering 
Committee for consideration.

For purposes of this RFA only, the protocol “concept” should address ONE of 
the following topics:  nutrition in the less than 1kg neonate, prevention of 
CLD, improvement in neurologic outcome, or prevention/treatment of sepsis 
in the VLBW neonate.

The “concept” should also demonstrate use of the applicant"s perinatal data 
system to estimate numbers of available patients eligible for the protocol at 
his/her institution.  The “concept” should address relevant ethical issues 
and the appropriate inclusion of minorities as subjects.

9.  Intent to Participate

There must be a clearly expressed intent to participate in a cooperative 
manner with other Neonatal Research Network Clinical Centers, the NICHD, and 
the data center, in all aspects of Network research as outlined in this RFA.

10.  Departmental and Institutional Commitments

The departmental and institutional commitments to collaborative 
neonatal/perinatal research and to prioritization of Network research should 
be clearly documented by providing letters to the Principal Investigator, and 
by citing evidence of past support.  This institutional assurance to provide 
support should address areas such as fiscal administration, personnel 
management, space allocation, procurement, planning, equipment, and 
budgeting.

11.  Acceptance of Budgetary Mechanism

Assurance of cooperation with the policy of capitation of research costs for 
each individual protocol, in addition to a base budget, should be provided 
from the department and from the institutional office of sponsored research 
programs.

B.  Budget Preparation

The instructions for budget requests provided with the research grant 
application form PHS 398 (rev. 4/98) should be followed.  F & A costs will be 
awarded in the same manner as for research project grants (R01).  Budgets 
will be reviewed on the basis of appropriateness for the work proposed.  
Allowable costs and policies governing the research grants programs of the 
NIH will prevail.  In planning the budget section of the application each 
applicant should submit budget estimates for all years.

The first-year budget at the time of application will be limited to a BASE 
BUDGET with maximum allowances as follows:

Principal Investigator:  10 percent effort
Research Nurse Coordinator:  100 percent effort
Data Entry Clerk:  50 percent effort
Supplies and Small Equipment (itemized and justified):  Not to Exceed $4,500
Travel:  (a total of 10 trips to Bethesda per Network team) as appropriate
Other costs (itemized and individually justified):  Not to Exceed $2,500

When an application has been favorably recommended and is being considered 
for funding, the applicant will be required to complete protocol budgets for 
those studies underway within the Network.  These budgets will consist of 
specific protocol-related costs and will be capitated on the anticipated 
number of subjects to be enrolled in the study at the applicant Clinical 
Center.

Ongoing annual budgets of Neonatal Research Network members will be based on 
individual protocols, which will be funded through a capitation system.  Each 
Clinical Center will be given base costs (listed above), in addition to a 
flat fee per patient successfully enrolled and completed. For centers with 
GCRC funding, applicable capitation funds will be reduced relative to the 
amount of GCRC support.  The Principal Investigator will be required to 
project patient enrollment for a specific protocol during a specified time 
frame, continuation and level of funding will be based on actual recruitment.

Future years’ budgets should be limited to base budget costs, with an annual 
increment of base salary and travel costs not to exceed three percent (the 
maximum amount available for equipment and supplies will not increase).  
Federal agencies shall use the negotiated rates for facilities and 
administrative (F&A) costs in effect at the time of the initial award 
throughout the each competitive segment of the project.  Award levels for 
sponsored agreements may not be adjusted in future years as a result of 
changes in negotiated rates. 

Submission Instructions

The RFA label available in the PHS 398 (rev. 4/98) application form must be 
stapled to the bottom of the face page of the application and must display 
the RFA number HD-00-010.  A sample RFA label is available at 
http://grants.nih.gov/grants/funding/phs398/label-bk.pdf.  Please note this 
is in the pdf format.  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.

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 should be 
sent to:

L. R. Stanford, Ph.D.
Director, Division of Scientific Review
National Institute of Child Health and Human Development
6100 Executive Boulevard, Room 5E03, MSC 7510
Bethesda, MD  20892-7510
Rockville, MD 20852 (for express/courier service)
Telephone:  301-496-1485

Applications must be received by July 11, 2000.  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.

REVIEW CONSIDERATIONS

Upon receipt, applications will be reviewed for completeness by CSR and for 
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 receive a written 
critique and may undergo a process in which only those applications deemed to 
have the highest scientific merit will be discussed, assigned a priority 
score, and receive a second level review by the National Advisory Child 
Health and Human Development Council.

Review Criteria

o  Criteria for Evaluation of Concept Protocol

The goals of NIH-supported research are to advance our understanding of 
biological systems, improve the control of disease, and enhance health.  In 
their written comments, reviewers will be asked to discuss the following 
aspects of the application in order to judge the likelihood that the proposed 
research will have a substantial impact on the pursuit of these goals.  Each 
of these criteria will be addressed and considered in assigning the overall 
score, weighting them as appropriate for each application.  Note that the 
application does not need to be strong in all categories to be judged likely 
to have major scientific impact and thus deserve a high priority score.  For 
example, an investigator may propose to carry out important work that by its 
nature is not innovative, but is essential to move a field forward.

(1) Significance:  Does this study address an important problem?  If the aims 
of the application are achieved, how will scientific knowledge be advanced?  
What will be the effect of these studies on the concepts or methods that 
drive this field?

(2) Approach:  Are the conceptual framework, design, methods, and analyses 
adequately developed, well-integrated, and appropriate to the aims of the 
project?  Does the applicant acknowledge potential problem areas and consider 
alternative tactics?

(3) Innovation:  Does the project employ novel concepts, approaches or 
methods?  Are the aims original and innovative?  Does the project challenge 
existing paradigms or develop new methodologies or technologies?

(4) Investigator:  Is the investigator appropriately trained and well suited 
to carry out this work?  Is the work proposed appropriate to the experience 
level of the Principal Investigator and other researchers (if any)?

(5) Environment:  Does the scientific environment in which the work will be 
done contribute to the probability of success?  Do the proposed experiments 
take advantage of unique features of the scientific environment or employ 
useful collaborative arrangements?  Is there evidence of institutional 
support?

o  Criteria for Evaluation of Overall Application

(1)  Qualifications, experience, and commitment of key personnel:

Scientific, clinical, and administrative abilities and academic productivity 
of the Principal Investigator, the follow-up staff, and other team members,

Knowledge and experience in areas relevant to the conduct of collaborative 
clinical research, especially randomized clinical trials, in neonatal 
medicine.  This should include specific experience in research design,

Commitment of staff time for the satisfactory conduct of the study,

Experience and qualifications of team members who would be responsible for 
data quality and management activities.

(2)  Protocols and Procedures:

Quality of the Clinical Center"s participation in either (a) (current Network 
members) Network protocols during the current grant period or (b) (new 
applicants) a randomized, clinical trial in the recent past,

Willingness to work and cooperate with other Neonatal Research Network units 
and the NICHD in the manner summarized in this RFA,

Optional research strengths, as presented.

(3)  Facilities and Management:

Adequacy of administrative, clinical, and data organizational management 
facilities as described in the minimum requirements,

Institutional assurance to provide support to the study in such areas as 
fiscal administration, personnel management, space allocation, procurement, 
planning, equipment and budgeting,

Optional administrative strengths, such as affiliations with other research 
units.

In addition to the above criteria, in accordance with NIH policy, all 
applications also will be reviewed with respect to the following:

o The adequacy of plans to include both genders, minorities and their 
subgroups, and children as appropriate for the scientific goals of the 
research.  Plans for the recruitment and retention of subjects also will be 
evaluated.

o The reasonableness of the proposed budget and duration in relation to the 
proposed research.

o 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.

SCHEDULE

Letter of Intent Receipt Date:    April 21, 2000
Application Receipt Date:         July 11, 2000
Peer Review Date:                 October 2000
Council Review:                   January 2001
Earliest Anticipated Award Date:  April 1, 2001

AWARD CRITERIA

Applications recommended by the National Advisory Child Health and Human 
Development Council will be considered for award based primarily on 
scientific and technical merit, as determined by peer review.  Program 
balance, that is, the scope and variety of research strengths to enable a 
successful collaborative program, will be considered.  Final selection of 
Clinical Centers for funding may be based partly in the need for diversity in 
the study population.  Availability of funds may also determine the awards 
made.

INQUIRIES

Inquiries concerning this RFA are encouraged.  The opportunity to clarify any 
issues or questions from potential applicants is welcome. 

Direct inquiries regarding programmatic issues to:

Linda L. Wright, M.D.
Pregnancy and Perinatology Branch
Center for Research for Mothers and Children
National Institute of Child Health and Human Development
6100 Executive Boulevard, Room 4B03F, MSC 7510
Bethesda, MD  20892-7510
Telephone:  (301) 402-0830
FAX:  (301) 496-3790
E-mail:  WrightL@mail.nih.gov 

Direct inquiries regarding fiscal matters to:

Ms. Joy Knipple
Grants Management Branch 
National Institute of Child Health and Human Development
6100 Executive Boulevard, Room 8A17E, MSC 7510
Bethesda, MD  20892-7510
Telephone:  (301) 402-4165
FAX:  (301) 402-0915
E-mail:  jk173r@nih.gov 

AUTHORITY AND REGULATIONS

This program is described in the Catalog of Federal Domestic Assistance No. 
93.865.  Awards are made under authorization of Sections 301 and 405 of the 
Public Health Service Act, as amended (42 USC 241 and 284) and administered 
under NIH grants policies and Federal Regulations 42 CFR 52 and 45 CFR Parts 
74 and 92.  This program is not subject to the intergovernmental review 
requirements of Executive Order 12372 or Health Systems Agency review.

The PHS strongly encourages all grant and contract recipients to provide a 
smoke-free workplace and promote the non-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 routing 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.



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