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 301-710-0267, 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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