Full Text HD-97-010
 
DATA COORDINATING CENTER for the COOPERATIVE MULTICENTER NEONATAL
RESEARCH NETWORK
 
NIH GUIDE, Volume 26, Number 23, July 18, 1997
 
RFA:  HD-97-010
 
P.T. 34

Keywords: 
  Data Management/Analysis+ 
  Clinical Trial 

 
National Institute of Child Health and Human Development
 
Letter of Intent Receipt Date:  August 1,1997
Application Receipt Date:  September 19, 1997
 
PURPOSE
 
The National Institute of Child Health and Human Development (NICHD)
is interested in clinical research in neonatal medicine and supports
an ongoing 14-center Neonatal Research Network to do clinical
research to investigate the safety and efficacy of treatment and
management strategies to care for newborn infants, particularly those
of low birth weight. The Network is funded by cooperative agreements
and includes a Data Center which provides statistical expertise, data
management, and analysis for Network trials and studies. The current
Data Center has been the Network Data Center since its inception and
is supported through March 31, 1998.
 
NICHD invites all potential applicants to apply for the cooperative
agreement to participate as the Data Center for the NICHD Neonatal
Research Network.  The successful applicant will be responsible for
completing ongoing trials and studies and initiating new research in
neonatology and perinatology.
 
HEALTHY PEOPLE 2000
 
The Public Health Service (PHS) is committed to achieving the health
promotion and disease prevention objectives of "Healthy People 2000,"
a PHS-led national activity for setting priority areas.  This Request
for Application (RFA), Cooperative Multicenter Neonatal Research
Network, is related to the priority area of low birth weight.
Potential applicants may obtain a copy of "Healthy People 2000" (Full
Report:  Stock No. 017-001-00474-0) or "Healthy People 2000" (Summary
Report:  Stock No. 017-001-00473-1) through the Superintendent of
Documents, Government Printing Office, Washington, DC 20402-9325
(telephone 202-512-1800).
 
ELIGIBILITY REQUIREMENTS
 
Applications may be submitted by domestic organizations, public and
private, such as universities, colleges, hospitals, laboratories,
units of State and local governments, and eligible agencies of the
Federal government.  Racial/ethnic minority individuals, women, and
persons with disabilities are encouraged to apply as Principal
Investigators.  Organizations should have experience in functioning
as a statistical coordinating center for multi-center research,
including randomized controlled trials and observational studies of
both a medical (preferable neonatal and perinatal) and a
psychological nature.  The need for continuous and active
communication among sites and with the NICHD dictates that only U.S.
institutions with a branch or central office in the Washington, DC
metropolitan area are eligible to apply.
 
MECHANISM OF SUPPORT
 
The administrative and funding instrument to be used for this program
will be a cooperative agreement (U01), 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 partnership role.
Details of the responsibilities, relationships and governance of the
study to be funded under cooperative agreements are discussed later
in this document under the section "Terms and Conditions of Award."
 
The total project period for applications submitted in response to
the present RFA may not exceed five years.  The anticipated award
date is April 1, 1998.  NICHD intends that the ongoing Cooperative
Agreements will be recompeted every five years, depending on
available funds.
 
FUNDS AVAILABLE
 
It is anticipated that one award for a Data Center will be made, with
an estimated total cost of $2 million (including direct and
facilities and administrative costs) in the first year.  Although
this program is provided for in the financial plans of the NICHD,
awards pursuant to this RFA are contingent upon the availability of
funds for this purpose.
 
RESEARCH OBJECTIVES
 
A. Backrgound
 
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 their introduction and use.  In a critically-ill infant, an
innovative idea may be tried which, if the infant's condition
improved, may rapidly set a new trend, and become the standard of
care.  Therefore, their 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 and a companion Maternal Fetal Medicine Unit Network in 1986.
The first Network consisted of seven clinical centers; in 1991 the
membership was expanded to 12 and capitation funding of multiple
simultaneous trials and studies was introduced.  In the latest
recompetition (RFA 95-HD-06) two new centers were added.  Among the
areas addressed by the Network are trials of therapies for sepsis,
intraventricular hemorrhage, chronic lung disease, pulmonary
hypertension, and studies of the impact of drug exposure on child and
family outcome, and a standardized follow-up program of extremely low
birth weight (ELBW, < 1000 gms) infants.  In addition, the Network
supports a registry of infants less than 1500 grams at birth.
 
Currently, the Network is participating in three trials (indomethacin
in the prevention of neurologic disability, supplemental oxygen to
prevent retinopathy of prematurity, and vitamin A to prevent lung
disease) and four studies: follow up of ELBW infants, intrauterine
drug exposure and child and family outcome (Maternal Life Style [MLS]
Study), antenatal magnesium sulfate and cerebral palsy, and vitamin A
and retinopathy of prematurity.  Of these, the follow up and the MLS
studies are expected to continue into FY98. Over 8,600 evaluations
have been conducted in the MLS study to date.  New protocols which
are expected to continue into FY98 include a trial of ventilator
management and early steroid treatment.  Additional areas of interest
include all major areas of newborn pathophysiology:  cerebral
function, pulmonary physiology, gastrointestinal function and
nutrition, immunology; the rapid transfer of new technologies to
neonatal medicine, and strategies to reduce the cost and preserve the
quality of neonatal care.
 
B. Objectives and Scope
 
The awardee is expected to cooperate with the clinical investigators
at the 14 Network Clinical Centers, and with the Program Officer and
other participating NICHD staff in the design and conduct of
protocols, analysis of data, and reporting of results of Network
research.  Systems for data collection, analysis, coordination, and
quality assurance are essential.  Required data summaries will be
provided to the Network Steering Committee, the subcommittees, NICHD,
the Data Safety and Monitoring Committee, and others as determined by
the Steering Committee.  Logistical services, including provision of
study drugs, collecting and storing of biological fluids, and other
supplies for the conduct of research may be required.
 
Content of Application
 
The application should have (1) an introduction, either (2a) a
progress report (incumbent Data Center grantee only) or, (2b) a
description of relevant capabilities and experience (other
applicants) and (3a/3b) a research plan for the next competitive
segment.  The progress report/description and the research plan must
incorporate the following minimum requirements:
 
Minimum Requirements for the Data Coordinating Center
 
o  Staff must be prepared to cooperate effectively in all Network
functions with NICHD and the clinical centers.
o  The Data Center must have their central or a branch office located
in the Washington, DC metropolitan area.
 
o  The Data Center must demonstrate prior experience as a data
coordinating center in multicenter studies in
neonatology/perinatology during the previous five years.
 
o  The Principal Investigator, and other staff, must have appropriate
expertise and capability in biostatistics, data management, data
analysis, and project management.
 
o  The Principal Investigator must possess a doctoral degree in an
appropriate field and be willing to be committed to at least 90%
effort on Network activities.
 
o  The Data Center must have the ability to assist in designing
protocols, data collection forms, manuals of operation, and data
collection systems, including distributed data entry.
 
o  The Data Center must have experience in developing and maintaining
data quality control systems.
 
o  The Data Center must have the capacity to generate monthly reports
on subject enrollment for several concurrent studies; quarterly
reports on enrollment and clinical center performance (including
efforts to reallocate study resources); appropriate reports for the
use of the Network Data Safety and Monitoring Committee meetings; and
special reports as required below.
 
o  The Data Center must demonstrate successful experience in
assisting clinical investigators in preparing manuscripts for
publication.
 
o  The Data Center must have experience in arranging logistical
services for multicenter clinical trials, i.e., assuring the
appropriate preparation and delivery of study medications to the
Clinical Centers.
 
o  The Data Center must provide evidence of superior management
capability (a) to estimate appropriate and reasonable resources
needed for individual projects in its role as the Data Center for
multicenter research, (b) to manage those resources efficiently
during the research, (c) to adjust the assigned resources as the work
changes qualitatively and quantitatively during the research, and (d)
to report these resource allocations to NICHD periodically, and (e)
to sub-contract with outside organizations to supplement its own
resources, as needed.
 
(2a) Progress Report (incumbent center  only)
 
o  Describe how the Data Center has cooperated effectively in all
Neonatal Research Network functions with the NICHD and the Clinical
Centers.
 
o  Describe the facility and how it has been used for Neonatal
Network functions.
 
o  Describe how staff strengths in biostatistics, data management,
data analysis, and project management have been used in Neonatal
Network activities.
 
o  Describe the commitment of the Principal Investigator during the
previous grant period.
 
o  Describe changes in staff and staff assignment during the previous
grant period.
 
o  Describe processes used in assisting protocol design, data forms
preparation, manual preparation, and in data collection for the
Network.
 
o  Describe the performance in data quality control for the Network.
 
o  Describe the generation of data and performance reports on Network
Clinical Center activities (include dates of study initiation,
termination, final report distribution).
 
o  Describe contribution to the preparation of manuscripts from
Network studies.
 
o  Describe logistical service arrangements for Network protocols.
 
o  Describe the organizational systems used to assign and adjust
resources to specific protocols of the Network during the previous
grant period.
 
o  Illustrate the calculation of costs of all Data Center work for
the performance of the Dexamethasone trial.
 
(2b) Description of Capabilities and Experience (new applicants only)
 
o  Describe previous successful collaboration in multicenter research
in neonatology/perinatology within the last five years.
 
o  Describe the applicant's facility and how it has been used for
multicenter clinical research.
 
o  Describe how the Data Center staff's strengths in biostatistics,
data management, data analysis, and project management have been used
in multicenter clinical research.
 
o  Describe the extent of commitment of the Data Center Principal
Investigator to this multicenter clinical research.
 
o  Describe the processes used in assisting protocol design, forms
and manual preparation, and in data collection for previous
multicenter clinical research.
 
o  Describe the processes used in data quality control in previous
multicenter clinical research by the Data Center applicant.
 
o  Describe the reports prepared by the applicant on data and
performance of Clinical Centers in previous multicenter clinical
research.
 
o  Summarize the applicant's contributions in preparing manuscripts
from previous multicenter clinical research.
 
o  Describe logistical services arranged by the applicant in support
of multicenter clinical research.
 
o  Describe the organizational systems used by the applicant to
assign and adjust its resources to participate in multicenter
clinical research.
 
o  Illustrate the calculation of costs of the applicant's
contribution to the performance of a specific clinical protocol
conducted in a multicenter setting during the past five years.  The
sample size, quantity of data accumulated and analyzed, and the
number of publications should be specified.
 
(3a) Research Plan for the next competitive segment for the incumbent
applicant.
 
o  Statement of intent to collaborate in a manner consistent with the
terms of the award.
o  Plans and estimated timetables for all ongoing and planned Network
protocols (include the Registry, Magnesium Sulfate, Followup, and
Maternal Lifestyles, Vitamin A, Combined Early Steroids and Gentle
Ventilation, and Erythropoietin) to be completed, the data analyzed,
the results published, and the data archived.
 
o  Plans for staff allocation to meet the demands of the plans and
timetables in above.
 
o  Describe any planned modifications in the Data Center processes to
be used in protocol design, data forms preparation, data collection,
data quality control, report generation, manuscript preparation, and
provision of logical services for the Neonatal Network.
 
o  Propose methods to be used to facilitate communication between
Data Center staff and other components of the Neonatal Network,
including NICHD and the 14 Clinical Centers.
 
o  Describe any planned modifications in the organizational systems
to assign and adjust resource allocation during protocol performance.
This should include any potential for outsourcing to increase
efficiency or to meet short-term needs.
 
o  Describe new procedures to increase operational efficiency and
decrease costs.  Include proposals for an expanded role for Clinical
Center staff (including statisticians) and strategies to achieve
interactive, timely data analysis in collaboration with members of
the Steering Committee, while protecting the integrity of the data
and the quality of the analyses.
 
o  Assume that three new protocols, including two randomized clinical
trials and one observational study, were planned but not yet
implemented by the Network Data Center applicant.  Assume, however,
for this exercise that the three studies plan to generate data on
1500 items and 500 items for the randomized trials, respectively, and
on 300 and 800 items from the observational study during the first
year (assume no actual data collection).  Assume that the proportion
of distributed data entry for the two randomized trials is 90% and
30%, respectively, and 100 and 50% for the observational study.
Using these assumptions, estimate the minimal base costs associated
with providing professional and support staffing, and with the
preparations necessary to receive and process data from the four
studies during the first year.
 
o  Describe the method to be used by the applicant in calculating all
operational costs per protocol and per enrolled patient for all Data
Center functions.
 
o  Describe in general terms a contingency plan to transfer all Data
Center functions for one or more active protocols from the incumbent
to another Data Center entity which may be successful in the
competition.  This contingency plan should address the feasibility of
transferring specific protocols at various stages of development,
including design, enrollment, and analysis.  It is anticipated that
this transfer will be achieved within six months of the award date.
 
(3b) Research Plan for the Next Competitive Segment for Other
(non-incumbent) Applicants
 
o  Describe the applicant's perception of its potential role in the
Neonatal Network.
 
o  Provide a statement of intent to collaborate in a manner
consistent with the terms of award.
 
o  Propose an operational structure for providing and coordinating
all Data Center functions for several Network protocols
simultaneously.  This should include lines of
responsibility/authority for professional staff.
 
o  Describe any modifications in the applicant's current processes
used to provide Data Center functions that may be made if the
applicant were to be selected as the Network Data Center.
 
o  Propose an idealized staffing pattern for providing Data Center
functions from protocol design through analysis. This should include
provisions for adjusting staff time commitments during the life of a
study.
 
o  Propose an administrative and management structure that would
support and enhance the operational structure.
 
o  Propose administrative and management functions that would assure
continuing attention to cost-efficiency and productivity.  This
should include adjustment of resource allocation during protocol
performance and the potential for outsourcing to improve efficiency
or meet short-term needs.
 
o  Propose methods to be used to assure effective communication
between Data Center staff and other components of the Neonatal
Network, including NICHD and the 14 Clinical Centers.
 
o  Describe in general terms, a contingency plan to accept all Data
Center responsibility and functions for one or more ongoing Network
protocol that might be transferred from the incumbent Data Center.
This plan should address the feasibility of protocol transfer at
various stages of development, including design, enrollment, and
analysis.  It is anticipated that this transfer will be achieved
within six months of the award date.
 
o  Assume that three new protocols, including two randomized clinical
trials and one observational study, were planned but not yet
implemented by the Network Data Center applicant.  Assume, however,
for this exercise that the three studies plan to collect data on 1500
items and 500 items for the randomized trials, respectively, and on
300 and 800 items from the observational study during the first year
(assume no actual data collection).  Assume that the proportion of
distributed data entry for the two randomized trials is 90% and 30%,
respectively, and 100 and 50% for the observational study.  Using
these assumptions, estimate the minimal base costs associated with
providing professional and support staffing, and with the
preparations necessary to receive and process data from the four
studies during the first year.
 
o  Describe the method to be used in calculating all operational
costs per protocol and per enrolled patient for all Data Center
functions.
 
C. Reference Material
 
Information about protocols, their manual of operations, and about
characteristics of the data sets of the several studies will be
provided by NICHD staff at an open meeting to be held in Bethesda,
Maryland on August 4, 1997.  All interested applicants are invited to
attend at their own expense.  Details about the meeting will be
provided by the scientific project officer listed under INQUIRIES.
 
Budget Preparation
 
The instructions for budget requests provided with the Research Grant
application form (PHS 398) should be followed.  Indirect costs will
be awarded in the same manner as for research project grants.
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 requests for all
years.
 
Ongoing annual budgets of the Data Center will consist of base costs
(see Appendix I), in addition to protocol-specific capitation fees.
At such time as an application has been favorable recommended and is
being considered for funding, the Data Center will be required to
complete a protocol budget reflecting specific protocol-related costs
to be based on the number of patients to be recruited to the protocol
and the actual time and effort expended.  Capitation awards will be
made before implementation and will be revised based on actual
recruitment and management costs.  Funding for extended analyses will
be limited and must be justified on a protocol-by-protocol basis,
based on actual time required for analyses.  Biostatistical staff
with advanced degrees must be justified.
 
Future years' budgets should be limited to base budget costs, with an
annual increment not to exceed 3%.
 
SPECIAL REQUIREMENTS - Terms of Agreement
 
The NICHD has established the Neonatal Research Network in order to
conduct clinically important research which requires a multicenter
setting.  The Network consists of 14 Clinical Centers who have agreed
to perform common protocols using central data management.  Both the
Clinical Centers and the Data Center are supported by cooperative
agreements, as described below:
 
1.  All components of the Network agree to accept the coordinating
role of the group and the collaborative and participatory nature of
the Network concept.
 
2.  The management of the Neonatal Research Network includes three
committees whose functions are as follows:
 
a. The Steering Committee has primary responsibility for the
selection of topics and the design of protocols for Network research
(within budget constraints).  It is assisted in these functions by
the Advisory Board, external reviewers, and the Data Safety and
Monitoring Committee.  The Steering Committee is also responsible for
conduct of the protocols, analysis and interpretation of data,
prioritization of Data Center efforts,and the timely preparation of
publications. Data ownership resides with the individual Clinical
Centers and the Network Steering Committee.
 
The Steering Committee is composed of an independent Chairperson, a
Principal Investigator from each of the clinical centers, the Data
Center principal investigator, and two NICHD staff.  NICHD staff
include the Director of the Center for Research for Mothers and
Children (CRMC) (non-voting member) and a neonatologist from the
Pregnancy and Perinatology Branch (Neonatal Research Network Program
Official).  The outside chairperson, who is not a principal
investigator, is selected by the NICHD, and participates in planning
Network activities and overseeing the administrative aspects of the
Network in collaboration with the Program Official.  A member of the
Grants Management Branch advises the Steering Committee on funding
matters.
 
b. An Advisory Board advises the NICHD and the Steering Committee in
the identification and prioritization of topics for Network research
and the preparation of publications. The Advisory Board, chosen by
the NICHD is composed of individuals with expertise in clinical
trials, biostatistics, epidemiology, perinatology, and neonatology;
the Chairpersons of the Neonatal and Maternal Fetal Network Steering
Committees; the Program Officials of the Neonatal and Maternal Fetal
Networks and the Director of the CRMC; and the Principal Investigator
of the Data Centers.
 
c. A Data Safety and Monitoring Committee (DSMC) advises NICHD on
research design issues, data quality and analysis, ethical and human
subject aspects, and monitors the safety of ongoing clinical trials.
It is established by NICHD and its membership represents expertise in
clinical trial design and conduct, perinatology, biostatistics,
neonatology, basic science, and ethics.  The Data Center prepares
confidential reports for the DSMC meetings; the Data Center Principal
Investigator participates as an ex-officio member and the Deputy
Director of the Center for Research for Mothers and Children serves
as the Executive Secretary.
 
The Network has established Policies and Procedures that govern its
operations, including a publication policy. These documents are under
periodic review, and may be amended and supplemented at the
discretion of the Steering Committee and NICHD.
 
3.  The Cooperative Agreement funding mechanism is an assistance
mechanism.  The major difference between a Cooperative Agreement and
a research grant is that a Cooperative Agreement specifies
substantial programmatic involvement of NICHD staff above and beyond
the levels required for traditional program management of grants.
The NICHD Neonatal Research Network Program Official will participate
in the following ways:  o Assistance in the identification
ofimportant 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  Collaborate in analysis and reporting of results to the community
of investigators and health care recipients.
 
o  Assurance of the scientific merit of the trials.
 
o  Assistance in the efficient conduct of the trials.
 
o  Monitoring of the data management and quality assurance systems
and evaluation of the cost-effectiveness of the Data Center using
consultants as appropriate.  Criteria will include the quality and
quantity of participation in collaborative Network research;
timeliness of their efforts; data reports prepared for the Steering
Committee and subcommittees; biannual and annual progress reports;
and site visit findings.
 
Programmatic responsibility for oversight of these Cooperative
Agreements will reside with the Chief, Pregnancy and Perinatology
Branch.  This role will include the following:
 
o  Ongoing review of progress to ensure that objectives are being
met; to redirect activities to improve performance and cooperation.
 
o  The option to withhold support of a participating clinical center
if technical performance requirements such as protocol compliance,
enrollment targets, or randomization of subjects are not met.
o  The option to withhold support from the Data Center if technical
performance requirements such as protocol support, data acquisition
and analysis targets, and adequate quality assurance of data are not
met.
 
4.  The responsibilities and authorities of the awardee will be as
follows:
 
o  Collaboration in the development, implementation, and monitoring
of common protocols.
 
o  Data management including preparation of data and safety reports
for the Data Safety and Monitoring Committee and preparation of data
reports for Network subcommittees, centers, and public data files.
 
o  Collaboration in the analysis of data and publication of results
of the Neonatal Research Network studies.
 
The specific terms, conditions, and details of arbitration procedures
pertaining to the scope and nature of the interaction between NICHD
and the participating Neonatal Research Network units and the Data
Coordinating Center will be incorporated into the Notice of Grant
Award.
 
When agreement between the awardee and the NICHD staff cannot be
reached on scientific/programmatic issues that may arise after the
award, an arbitration panel will be formed. The panel will consist of
one person selected by the principal investigators of the study, one
person selected by the NICHD staff and a third selected by these two
individuals.  The decision of the arbitration panel, by majority
vote, will be binding.
 
The special terms of Award of Cooperative Agreement are in addition
to, and not in lieu of, otherwise applicable OMB administrative
guidelines, DHHS grant administration regulations at 45 CFR Part 74
and other DHHS and NIH grant administration policies.  The NICHD
review procedure in no way affects the right of a recipient of a
cooperative agreement to appeal an adverse determination under the
terms of PHS regulations at 42 CFR Part 50, Subpart D, and DHHS
regulations at 45 CFR Part 16.  Business management aspects of these
awards will be administered by the NICHD Grants Management Branch,
NICHD, in accordance with DHHS and NIH grants administration
requirements.
 
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," which have been published in the
Federal Register of March 28, 1994 (FR 59-14508-14513) and the NIH
Guide for Grants and Contracts, Volume 23, Number 11, March 18, 1994.
 
LETTER OF INTENT
 
Prospective applicants are asked to submit, by August 1, 1997, 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 the RFA in response to
which the application may be submitted.  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
the NICHD staff to estimate the potential review workload and avoid
conflict of interest in the review.
 
The letter of intent is to be sent to:
 
Linda L. Wright, M.D.
Center for Research for Mothers & Children
National Institute of Child Health and Human Development
6100 Executive Boulevard, Room 4B03F - MSC 7510
Bethesda, MD 20892-7510
Telephone: 301-496-5575
Fax:  301-496-3790
Email:  lw47i@nih.gov
 
APPLICATION PROCEDURES
 
All applicants must document their ability to meet or exceed the
minimum requirements as set out in the SPECIAL REQUIREMENTS section
as detailed above.  This specifically includes understanding of and
commitment to the cooperative nature of this program.
 
Any competing renewal application should include in the progress
report a description of how the site has met the special cooperative
agreement terms and conditions of the award, including its
interaction with other Network sites and the NICHD Program Officer.
 
The research grant application form PHS 398 (rev.  5/95) is to be
used in applying for these grants.  These forms are available at most
institutional offices of sponsored research; from the Office of
Extramural Outreach and Information Resources, 6701 Rockledge Drive,
MSC 7910, Bethesda, MD 20892; telephone 301-710-0267; e-mail:
asknih@odrock.od.nih.gov; and from the program administrator listed
under INQUIRIES.
 
The RFA label available in the PHS 398 (rev.  5/95) application form
must be affixed to the bottom of the face page of the application.
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, COOPERATIVE
MULTICENTER NEONATAL DATA CENTER RFA HD-97-010, 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:
 
Division of Research Grants
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:
 
Division of Scientific Review
NIH/NICHD
6100 Building/Room 5E03F
6100 Executive Boulevard, MSC 7510
Bethesda, MD 20892-7510
 
Applications must be received by September 5, 1997.  If an
application is received after that date, it will be returned to the
applicant without review.  The Division of Research Grants (DRG) 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 DRG 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.
 
Schedule
 
Letter of Intent Receipt Date:  August 1, 1997
Application Receipt Date:  September 19, 1997
NICHD Council Review:  January 27, 1998
Earliest Award Date:  April 1, 1998
 
REVIEW CONSIDERATIONS
 
Upon receipt, applications will be reviewed for completeness by DRG
and responsiveness by NICHD.  Incomplete applications will be
returned to the applicant without further consideration.  Any
application that does not meet the minimum requirements of this RFA
will be considered unresponsive to the RFA and returned to the
applicant. 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 Division of Scientific
Review, NICHD in accordance with the review criteria stated below.
 
As part of the initial merit review, a process may be used by the
initial review group in which applications will be determined to be
competitive or non-competitive based on their scientific merit
relative to other applications received in response to the RFA.
Applications determined to be non-competitive will be withdrawn from
further consideration and the Principal Investigator and the official
signing for the applicant organization will be notified.  Those
applications that are complete and responsive, will undergo further
scientific merit review.
 
The second level of review will be provided by the National Advisory
Child Health and Human Development Council.
 
Criteria for Review of Applications:
 
1.  Statistical expertise, qualifications, experience, commitment,
and stability of key personnel.
 
o  Scientific, organizational, and administrative abilities of the
Principal Investigator and other team members; knowledge and
experience in areas relevant to the conduct of collaborative clinical
research, especially randomized clinical trials, in neonatal medicine
and development; availability of the resources necessary to perform
as a Data Center.
 
2.  Protocols and Procedures
 
o  Quality of the Data Center's participation in either (1) (current
Network Data Coordinating Center) Network protocols during the
current grant period or (2) (new applicants) multicenter randomized,
clinical trials and studies in the recent past; willingness to work
cooperatively with the awardees and NICHD in the manner summarized in
Terms of Award.
 
3.  Facilities and Management
 
o  Efficient organizational structure; quality of administrative,
clinical, and data organizational management as described in the
minimum requirements; evidence of adequate, cost-effective
facilities, including space and equipment for the work proposed, and
justification for any new equipment requested under this award;
institutional assurance to provide support to the study in such areas
as fiscal administration, personnel management, space allocation,
procurement, planning and budgeting;
 
4.  Budget
 
o  Appropriateness of the proposed budget; evidence of
cost-effectiveness; willingness to accept capitation funding as
outlined above, including an institutional assurance of cooperation
with the policy of capitation of research costs for each individual
protocol.
 
5.  Appropriateness of Plans for Protection of Human and Animal
Subjects and Compliance with NIH Policy on Inclusion of Women and
Minorities.
 
AWARD CRITERIA
 
Applications recommended by the NICHD Council will be considered for
award based primarily on scientific and technical merit.
Programmatic priorities and availability of funds may also determine
the award 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.
NIH/NICHD/CRMC/Pregnancy and Perinatology Branch
Executive Building/Room 4B03F
6100 Executive Boulevard, MSC 7510
Bethesda, MD 20892-7510
Phone: 301-496-5575
Fax: 301-496-3790
Email: lw47i@nih.gov
 
Direct inquiries regarding fiscal matters to:
 
Ms. Mary Ellen Colvin
Grants Management Branch, NIH/NICHD
6100 Building/Room 8A17G
6100 Executive Boulevard MSC 7510
Bethesda, MD 20892-7510
Phone:  301-496-1303
Fax: 301-402-0915
Email:  mc113b@nih.gov
 
AUTHORITY AND REGULATIONS
 
This program is described in the Catalog of Federal Domestic
Assistance No. 93.3, 93.865.  Awards are made under authorization of
the Public Health Service Act, Title IV, Part A (Public Law 78-410,
as amended by Public Law 99-158, 42 USC 241 and 285) and administered
under PHS grants policies and Federal Regulations 42 CFR 52 and 45
CFR Part 74.  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 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.
 
Appendix I:
 
At the time of application, the base budget will be required, and a
description of a method to calculate operational costs will be
required.
 
Base Budget
 
The base budget will be one necessary to design protocols and to
prepare to receive data entered from the three hypothetical
protocols, and in the research plan outlines for incumbent (3a) and
other (3b) applicants, respectively. In addition, other fixed Data
Center costs such as supplies and travel may be included, as outlined
below:
 
Personnel
 
Principal Investigator >90% Senior biostatistical staff 100%
Network coordinator 200% (Liaison between NICHD and Data Center;
facilitates communication between Steering Committee members)
Secretary 100% Registry (GDB)
Statistical staff 25%
Technical staff 25% MLS study
Statistical staff 100%
Technical staff 200% Supplies $ 2,500
 
Computer systems for 14 Clinical Centers
 
o  New distributive data entry systems will be provided to the
Clinical Centers
 
Travel - (site visits) $10,000
 
Capitation budget - (No specific budget requested at time of
application)
 
Operational costs are those costs incurred after the start of patient
enrollment, based on actual time and effort and resource utilization
associated with a specific protocol. They include:
 
o  data entry, management, quality control
 
o  report generation; data analysis, in addition to that provided by
the PI;
 
o  arrangement of logistical services; protocol-specific costs,
including subcontracts, supplies.
 
The methods to calculate these costs will be used as the basis for
individualizing cost recovery for individual protocols.  Agreement
will be reached by discussions between NICHD staff and the successful
applicant.  Periodic adjustment of these reimbursement arrangements
will be made based on actual experience with individual protocols.
 
.

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