RESEARCH ON THE SCOPE AND CAUSES OF STILLBIRTH IN THE UNITED STATES  
 
RELEASE DATE:  October 3, 2002 (see amendment NOT-HD-03-008)
 
RFA:  HD-02-025 
 
National Institute of Child Health and Human Development (NICHD) 
 (http://www.nichd.nih.gov/) 

LETTER OF INTENT RECEIPT DATE:  February 13,2003  

APPLICATION RECEIPT DATE:  March 13,2003  
 
THIS RFA CONTAINS THE FOLLOWING INFORMATION

o Purpose of this RFA
o Research Objectives
o Mechanism of Support 
o Funds Available
o Eligible Institutions
o Individuals Eligible to Become Principal Investigators
o Special Requirements 
o Where to Send Inquiries
o Letter of Intent
o Submitting an Application
o Peer Review Process
o Review Criteria
o Receipt and Review Schedule
o Award Criteria
o Required Federal Citations

PURPOSE OF THIS RFA

The purpose of this solicitation is to create a network of clinical research 
sites with central data collection and analysis, which will develop and 
implement common research protocols to study stillbirth (fetal death 20 weeks 
or greater gestation).  According to annual national vital statistics, the 
number of fetal deaths at 20 weeks or greater gestation is similar in 
magnitude to the total number of infant deaths in the U.S.  Despite this 
significant and persistent burden of stillbirths, they have remained largely 
unstudied and, for at least half of all stillbirths, the cause is 
undetermined.  The objective of this RFA is to create a network of 
multidisciplinary investigators to develop research diagnostic protocols as 
well as a body of data on the scope and causes of stillbirths among varied 
populations within the United States, while encouraging community involvement 
to obtain an adequate sampling of rural and urban populations and a diverse 
ethnic/racial makeup.  The information that is obtained will aid in future 
research to improve preventive and therapeutic interventions and to 
understand the pathologic mechanisms leading to fetal death.  

RESEARCH OBJECTIVES

Background

Stillbirths account for a large proportion of perinatal mortality.  According 
to annual national vital statistics, the number of fetal deaths, defined as 
deaths at 20 weeks or more gestation, is similar in magnitude to the total 
number of infant deaths in the U.S.  In 1998, there were 28,371 infant deaths 
and 26,702 fetal deaths.  More than half of these fetal deaths are of 28 
weeks or more gestation and 20 percent, or about 5000 cases, are term 
gestation.  In addition, the cause of about half of all stillbirths is 
undetermined.  

The stillbirth rate has been reduced dramatically since the 1950s with the 
introduction of interventions for gestational diabetes, pre-eclampsia, and Rh 
isoimmunization.  However, while the infant mortality rate declined by about 
32 percent between 1985 and 1998 from 10.6 to 7.2/1000 live births, the 
stillbirth rate declined by only about 14 percent from 7.8 to 6.7 deaths/1000 
live births.  Despite this significant and persistent burden of stillbirths, 
they have remained largely unstudied.

The National Institute of Child Health and Human Development (NICHD) convened 
a workshop on March 26, 2001 with experts in the field to set a national 
agenda for stillbirth research.  Among the identified gaps in knowledge that 
hamper progress in this field, were problems associated with current data on 
stillbirths in the U.S.  These include:  (1) the fetal death report is 
voluntary and under-reporting of stillbirths is as high as 10-15 percent; (2) 
there is variability in the quality and completeness of the fetal death 
certificates including certification of the cause of death; (3) there is no 
standard protocol for postmortem investigation of stillbirths, including 
serologic, toxicologic, and genetic tests; (4) while placental pathology is 
common, fetal autopsy rates are low; and (5) there are few geographic 
population-based, detailed investigations of reproductive and fetal risks 
associated with stillbirth. 

Some of the recent evidence points to the association of repeat fetal deaths 
with the genetic predisposition for thrombophilias (Factor V Leiden mutation) 
and genetic conditions (telomere mutations).  Novel neuropathology findings 
of CNS insults point to specific findings related to fetal death, involving 
central nervous system insults.  Other associations include maternal 
complications (diabetes, hypertension, anemia) and umbilical cord accidents; 
however, the limited ascertainment leads to a bias in the findings, as only a 
small portion have autopsies or tests performed. 

These deaths are devastating to the family.  It is hoped that increased 
knowledge regarding the causes of stillbirths will benefit families who have 
experienced a loss, pregnant women, and their physicians, and may lead to the 
development and evaluation of improved clinical and preventive interventions.

Objectives and Research Approach

Because procedures in case ascertainment and registration of fetal deaths 
vary so widely across the U.S., we do not have a true picture of stillbirths.  
This information is necessary for future studies to elucidate pathogenic 
mechanisms and improve on current preventive and therapeutic strategies.  The 
objective of this RFA is to establish a network of clinical research sites 
with central data collection and analysis to: 

(1)  develop a standard stillbirth postmortem protocol, to include review of 
clinical history, protocols for autopsies and pathologic examinations of the 
fetus and placenta, other postmortem tests to illuminate genetic, maternal, 
and other environmental influences, and 

(2) obtain a geographic population-based determination of the incidence of 
fetal deaths at 20 weeks gestation or greater, their causes, and risk 
factors.  This will involve a geographic population-based study of 
stillbirths enrolled at the time of demise, and a sub-cohort case-control 
study. 
  
Project Organization

This RFA solicits applications for clinical sites to form a network to obtain 
an accurate ascertainment of the stillbirths and understanding of causes. 
This RFA also solicits a Data Coordinating and Analysis Center.  The grantees 
will form a cooperative network in scientific partnership with NICHD to 
conduct a geographic population-based study of stillbirths, which will 
require a highly effective surveillance system and at least 90 percent 
ascertainment.  The catchment for the study will include a diversity of 
populations (urban/rural/different social and racial groups).  The sites will 
employ a standardized protocol for evaluation of the cases. 

Clinical Sites:

With a stillbirth rate estimated at five per 1000, we anticipate a sample 
size of 500 would be an adequate initial sampling.  This would require four 
to seven clinical centers over a five-year period, anticipating the total 
geographic population pool has 100,000 deliveries.  Importantly, the centers 
will be multidisciplinary and have significant community involvement to 
obtain an adequate sampling of rural and urban populations and a diverse 
ethnic/racial makeup.

Data Coordinating and Analysis Center:

The Data Coordinating and Analysis Center (DCAC) will be responsible for 
central data collection, quality control, management and analysis.  The 
analytic plan will be developed by the Steering Committee. 

Steering Committee:

A Steering Committee will be assembled and will consist of the Principal 
Investigators and Co-Principal Investigators of all awarded grants, and NICHD 
staff.  Each site and NICHD will have one vote on the Steering Committee.  
The vote may be divided into shares at the discretion of the participating 
sites and the NICHD.  The Steering Committee will be charged with the task of 
combining multiple perspectives and research agendas across sites into a 
coherent plan of action, to include the development of study protocols and 
the analytic plan.

It is anticipated that protocol development and piloting will take place in 
year one, study implementation and data collection in years two through four, 
and data analysis in years three through five.
  
MECHANISM OF SUPPORT
 
This RFA will use the National Institutes of Health (NIH) Cooperative 
Clinical Research (U10) award mechanism.  This RFA is a one-time 
solicitation.  The anticipated award date is September 26, 2003.  

The NIH U10 is a cooperative agreement award mechanism in which the Principal 
Investigator retains the primary responsibility and dominant role for 
planning, directing, and executing the proposed project, with NIH staff being 
substantially involved as a partner with the Principal Investigator, as 
described under the section "Cooperative Agreement Terms and Conditions of 
Award." 

FUNDS AVAILABLE 
 
The NICHD intends to commit approximately $3 million in Total Costs [Direct 
plus Facilities and Administrative (F & A) costs] in FY 2003 to fund five to 
eight new grants in response to this RFA, one of which will be the DCAC.  An 
applicant may request a project period of up to five years.  An applicant for 
a clinical site may request a base budget (see Budget Preparation, below) for 
direct costs of up to $120,000 for the first year.  An applicant for the Data 
Coordinating and Analysis Center may request a budget (see Budget 
Preparation, below) for direct costs of up to $250,000 for the first year.  
Because the nature and scope of the proposed research will vary from 
application to application, it is anticipated that the size of each award 
will also vary.  Although the financial plans of the NICHD provide support 
for this program, awards pursuant to this RFA are contingent upon the 
availability of funds and the receipt of a sufficient number of meritorious 
applications.  
 
ELIGIBLE INSTITUTIONS
 
You may submit an application if your institution has any of the following 
characteristics:	
o For-profit or non-profit organizations 
o Public or private institutions, such as universities, colleges, hospitals, 
and laboratories 
o Domestic 

Institutions applying to be a Clinical Site are not barred from applying to 
be the Data Coordinating and Analysis Center provided that independence of 
functions is demonstrated.  Therefore, a separate application is required for 
the Data Coordinating and Analysis Center.  An institution may apply to be 
the Data Coordinating and Analysis Center only. 

INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS   

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

SPECIAL REQUIREMENTS 

Clinical Sites

o Minimum Catchment Populations:  Clinical Sites with urban populations 
should have a catchment population with at least 8,000 deliveries per year, 
and those with rural populations at least 3,000 deliveries per year in order 
to apply.  Applicants may propose urban only, rural only, or urban and rural 
geographic areas for case ascertainment.  The applicant must demonstrate that 
a large majority of the population receives prenatal care within the 
catchment.

o Clinical Sites should have experience in multi-center research 
investigations.

o Some, but not necessarily all, of the following expertise should be part of 
the research team:  obstetrics, maternal-fetal medicine/perinatology, 
neonatology, perinatal pathology, genetics, infectious disease/immunology, 
epidemiology, and neuropathology.  

o There also should be a dedicated research nurse and a community outreach 
worker.

o The site should have experience in community outreach to pregnant women and 
in working with community clinics, hospitals, and other organizations that 
provide support to pregnant women.

o The site must have an established perinatal data system, preferably 
computerized, to collect and tabulate perinatal data statistics.

o The investigators should be prepared to meet as a Steering Committee about 
six times in the first year to develop protocols and three times per year 
thereafter.

o The investigators should be prepared to work collaboratively with the NICHD 
and the DCAC to achieve the goals of this solicitation.

o Departmental and institutional commitments to collaborative research 
(including departments of obstetrics, pediatrics, genetics, pathology, etc.) 
should be clearly documented by providing letters to the Principal 
Investigator that should accompany the application.

o The applicant must exhibit a preparedness to pursue capitation of 
particular operational costs of the protocol (see Budget Preparation). 
 
Data Analysis and Coordinating Center

o The applicant must have demonstrated prior experience as a coordinating and 
statistical center in multi-center clinical studies. 

o The Principal Investigator, with other staff, must have appropriate 
biostatistical, computational, data management, and coordination expertise 
and capability.  The applicant must have the ability to assist in designing 
protocols, study manuals, and data collection systems, including distributed 
data entry. 

o The applicant must have experience in developing and maintaining a quality 
control system, and should demonstrate experience in monitoring quality 
assurance of data.

o The applicant must have experience in data monitoring, patient tracking 
systems, and coordination. 

o The DCAC will report quarterly to the NICHD, and to the Steering Committee 
prior to/at each meeting regarding accumulated data and clinical unit 
performance.  The applicant should document the ability to meet such 
reporting deadlines. 

o The investigators should be prepared to meet as a Steering Committee about 
six times in the first year to develop protocols and three times per year 
thereafter. 

o The applicant must be prepared to cooperate with the Clinical Sites and 
NICHD in all design, collection, and analysis functions.

o The applicant must be prepared to assist the NICHD in securing services of 
research sub-specialties to supplement the expertise of members of the 
Steering Committee.

Data Collection and Sharing

o There will be central data collection, management, and analysis for this 
study.  The Data Coordinating and Analysis Center, in collaboration with the 
Steering Committee, will develop and implement plans to create a database 
that is accessible to the public within a year of study completion. 

o Because the data elements and study design will be developed after award, 
the data-sharing plan will not be reviewed at the time of application.  It 
will be reviewed after award by the Advisory Board (see below) and the NICHD, 
before implementation.
 
Cooperative Agreement Terms and Conditions of Award 

Cooperative agreements are assistance mechanisms and are subject to the same 
administrative requirements as grants.  The special Terms and Conditions of 
Award are in addition to, not in lieu of, otherwise applicable OMB 
administrative guidelines, HHS, PHS, and NIH grant regulations, policies, and 
procedures, with particular emphasis on HHS regulations at 42 CFR Part 74 and 
92.  Facilities and Administrative cost (indirect cost) award procedures will 
apply to cooperative agreement awards in the same manner as for grants. 
Business management aspects of these awards will be administered by the NICHD 
Grants Management Branch in accordance with HHS and NIH grant administration 
requirements. 

The cooperative agreement funding mechanism will require collaboration among 
the NICHD Project Scientists and the Principal Investigators of the Clinical 
Sites and the Data Coordinating and Analysis Center.  The NICHD Project 
Scientists will coordinate the activities of the Stillbirth Research 
Collaboration, and will facilitate communication and the exchange of 
information as described below.

1.  The Primary Rights and Responsibilities of the Awardees

All awardees will agree to accept the participatory and cooperative nature of 
the group process.  All awardees are required to submit annual progress 
reports to NICHD, as appropriate, and to provide study and site performance 
information as stipulated by NICHD.

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

o  Identification of priority issues for research.

o  Development and implementation of protocols.

o  Collection and transmission of accurate data in a timely manner.

o  Analysis of data and publication of results.

The DCAC will be responsible for central data collection, quality control, 
management, and analysis.  The DCAC will also be responsible for contracting 
with consultants to the Steering Committee on an as-needed basis.
  
All parties will agree to accept the coordinating role of the group and the 
participatory and cooperative nature of the group process.

Awardees will retain custody of, and primary rights to, their data developed 
under the award, subject to Government rights of access consistent with 
current HHS and NIH policies.

2. NICHD Staff Responsibilities

NICHD Project Scientists:

The role of the NICHD Stillbirth Project Scientists 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 reporting results in the community of investigators and 
health care recipients.

o Assistance in the efficient conduct of the study, 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 Recommend consultants for appointment to the Steering Committee on an as 
needed basis.

NICHD Program Official:

The NICHD will appoint a Stillbirth Program Official, apart from the 
Stillbirth Project Scientist, who will:

o Assure the scientific merit of the study, including the option to withhold 
support of a participating center if technical performance requirements such 
as protocol compliance and enrollment targets are not met.

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

o Perform other duties required for normal program stewardship of grants.

3. Collaborative Responsibilities

The guidance and management of the Stillbirth Research Network will include, 
but not be limited to the following committees whose functions are as 
follows:

Steering Committee:

A Steering Committee will be responsible for protocol development, assisted 
by the Advisory Board and, at times, consultants to the Steering Committee.  
The Steering Committee will have primary responsibility for the conduct of 
protocols and the preparation of publications.  The Steering Committee will 
comprise all Principal Investigators, one representative from the Data 
Center, and two NICHD staff.  Participating NICHD staff will include the 
Pregnancy and Perinatology Branch Stillbirth Project Scientists.  There will 
be only one vote for NICHD staff, which will be shared by the Stillbirth 
Project Scientists.  A nonvoting member of the NICHD Grants Management Branch 
will advise the Steering Committee on administrative and funding matters.  An 
outside chairperson, who is not participating as a Principal Investigator, 
will be selected by the NICHD.

The responsibilities of the Steering Committee are as follows:

o Develop the study protocols to include postmortem protocols for diagnosis, 
protocols for surveillance and case enrollment, and protocols sub-cohort 
case-control study.

o Develop a data management plan, with primary input from the DCAC, to 
include plans for quality assurance and plans for public access to the 
database.

o Monitor surveillance and enrollment upon study initiation. 

o Establish Policies and Procedures that govern its operations, including 
publications. 

o Develop an analytic plan in collaboration with the Data Coordinating and 
Analysis Center.

Advisory Board:

An Advisory Board will advise the Steering Committee in the development of 
research protocols.  The Advisory Board, chosen by the NICHD with the advice 
of the Steering Committee, will comprise individuals with expertise in 
obstetrics, perinatal pathology, biostatistics, epidemiology, perinatology, 
neonatology, and genetics.  The Chairperson of the Steering Committee, the 
Principal Investigator of the Data Coordinating and Analysis Center, and the 
Stillbirth Project Scientists may attend Advisory Board meetings to provide 
information as needed.  Additional members will participate based on the need 
for specific expertise.

Data Safety and Monitoring Committee:

A Data Safety and Monitoring Committee (DSMC) will monitor the safety of 
ongoing study protocols.  This committee will be established by NICHD and 
will represent expertise in ethics, clinical trials/epidemiology, 
perinatology, neonatology, genetics, and pathology.   

4.  Arbitration Procedures

When agreement between an awardee and NICHD staff cannot be reached on 
programmatic and scientific-technical 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, one person selected by the NICHD 
staff, and a third person selected by these two members.  The decision of the 
arbitration panel, by majority vote, will be binding.  These special 
arbitration procedures in no way affect the awardees right to appeal an 
adverse action in accordance with PHS regulations at 42 CFR Part 50, Subpart 
D, and HHS regulations at 45 CFR Part 16. 

WHERE TO SEND INQUIRIES

We encourage inquiries concerning this RFA and welcome the opportunity to 
answer questions from potential applicants.  Inquiries may fall into three 
areas:  scientific/research, peer review, and financial or grants management 
issues:

o Direct your questions about scientific/research issues to:

Marian Willinger, Ph.D.
Pregnancy and Perinatology Branch
National Institute of Child Health and Human Development
6100 Executive Boulevard, Room 4B03, MSC 7510
Bethesda, MD  20892-7510
Telephone:  (301) 435-6896
FAX:  (301) 496-3790
E-mail:  mw75q@nih.gov

o Direct your questions about peer review issues to:

Robert Stretch, Ph.D.
Director, Division of Scientific Review
National Institute of Child Health and Human Development
6100 Executive Boulevard, Room 5B01, MSC 7510
Bethesda MD 20892-7510
Rockville MD 20852 (for express/courier service)
Telephone: (301) 496-1485
FAX: (301) 402-4104
E-mail:  stretchr@mail.nih.gov

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

Christopher P. Myers
Grants Management Branch
National Institute of Child Health and Human Development
6100 Executive Boulevard, Room 8A17H, MSC 7510
Bethesda, MD  20892-7510
Telephone:  (301) 435-6996
FAX:  (301) 402-0915
E-mail:  cm143g@nih.gov 

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

o Descriptive title of the proposed research
o Name, address, and telephone number of the Principal Investigator
o Names of other key personnel 
o Participating institutions
o Number and title of this RFA 

Although a letter of intent is not required, is not binding, and does not 
enter into the review of a subsequent application, the information that it 
contains allows NICHD staff to estimate the potential review workload and 
plan the review.
 
The letter of intent is to be sent by the date listed at the beginning of 
this document.  The letter of intent should be sent to:

Marian Willinger, Ph.D.
Pregnancy and Perinatology Branch
National Institute of Child Health and Human Development
6100 Executive Boulevard, Room 4B03, MSC 7510
Bethesda, MD  20892-7510
Telephone:  (301) 435-6896
FAX:  (301) 496-3790
E-mail:  mw75q@nih.gov

SUBMITTING AN APPLICATION

Applications must be prepared using the PHS 398 research grant application 
instructions and forms (rev. 5/2001).  The PHS 398 is available at 
http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive 
format.  For further assistance contact GrantsInfo, Telephone (301) 710-0267, 
Email: GrantsInfo@nih.gov.
 
SUPPLEMENTAL INSTRUCTIONS:

Clinical Sites

Please provide the following in your application:

(1) Patient population

o Geographic definition of the catchment area proposed for a population-based 
assessment of stillbirths by the applicant organization.

o Documentation of number of deliveries at or later than 20 weeks within the 
catchment geographic population from 1995-1999 to include: (a) each pregnancy 
outcome (fetal death, live birth,) stratified by race/ethnicity; (b) each 
pregnancy outcome stratified by gestational age (20-23 weeks, 24-27 weeks, 
28-31 weeks, 32-36 weeks, 37 plus weeks); (c) proportion receiving prenatal 
care within the catchment stratified by trimester.

o Estimated rates of fetal deaths at or later than 20 weeks per 1000 live 
births plus stillbirths, and rates of fetal autopsy and placental pathology 
from 1995-1999.

o Distribution of causes of fetal deaths at or later than 20 weeks from 1995-
1999. 

(2) Staffing and Procedures

o Descriptions of the staff and programs in place for surveillance of 
deliveries in the catchment area to identify all eligible fetal deaths at or 
later than 20 weeks, and proposals for expansion of services if needed.  This 
includes creative proposals for partnering with community-based organizations 
including health departments.

o Descriptions of staff and subspecialty services, support services and 
laboratories necessary for evaluating and investigating the cause of death. 
Provision should be made for a dedicated research nurse and a community 
outreach worker.

o An enrollment plan to include procedures for approaching the families to 
optimize enrollment, a sample consent form, and procedures for supplying 
grief support to the families.

o Descriptions of recent research productivity by the applicant clinical site 
in previous or present cooperative multicenter studies.  Specifically, 
contributions in key areas such as protocol design, patient recruitment, data 
analysis and interpretation, and publication are important.

o A description of special areas of expertise among your applicant team that 
would benefit this multi-center cooperative study of stillbirth.  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 the research beyond what it might be otherwise.  Capabilities 
in areas such as genetics, placental function, or perinatal pathology are 
examples of relevant strengths that could be included.

o Letters of collaboration from prenatal clinics, community hospitals, and 
medical centers within the catchment area to participate in a geographic 
population-based study of stillbirth.  This includes a commitment for timely 
notification of eligible stillbirths for enrollment into study, utilization 
of a standard postmortem protocol, and availability of medical records for 
abstraction. 

(3) Sample Study

Provide a description of a sample multi-center, geographic population based 
study of stillbirth that meets the objectives of the RFA.  The description 
should include elements of the surveillance system, diagnostic procedures, 
and information to be collected.  It should not be a complete protocol and 
should not exceed five pages.  

The sample research study will serve as a starting point for deliberations 
within the Steering Committee and will enable reviewers to evaluate the 
applicant's ability to identify the critical issues to be addressed in a 
geographic population-based assessment of stillbirth, and to conceptualize a 
multi-center investigation of fetal deaths.  Investigators will not be 
expected to perform these studies at their site.    

(4) Intent to Participate

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

(4) Perinatal Data System 

o A perinatal data system, preferably computerized, to collect and tabulate 
perinatal statistics is desirable.  Applicants must provide a detailed 
description of the variables collected, and the data quality and management 
activities.  The applicant must also 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 study.

(5) Acceptance of Budgetary Mechanism (see also Budget Preparation below)

o Assurance of willingness and ability to cooperate 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.

Data Coordinating and Analysis Center

Please provide the following in your application:

(1) Research Experience

o Description of previous experience in managing multi-center clinical 
research studies. 

o Description of applicant's perception of their role in the study. 

(2) Staffing and Procedures

o Description of staff and computing, data processing, and analytic 
capability. 

o A plan detailing methods of data receipt, quality control, analysis and 
reporting, including communication with clinical and administrative 
personnel.  This plan should be based on the assumption that there will be a 
patient tracking system and a database that will include information from 
medical records and specialized laboratory studies (genetics, pathology, and 
maternal interview. 

(3) Intent to Participate

o There must be a clearly expressed intent to participate in a cooperative 
manner with the Clinical Sites and the NICHD in all aspects of Network 
research as outlined in this RFA.

BUDGET PREPARATION:

The instructions for budget requests provided with the research grant 
application form PHS 398 (rev 5/01) should be followed.  F&A 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 estimates for all years.

Clinical Sites

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

o Principal Investigator/Co-Principal Investigator(s):  up to a total of 30 
percent effort

o Research Nurse Coordinator/outreach worker:  50 percent effort

o Data Entry Clerk:  50 percent effort

o Supplies and Small Equipment (itemized and justified):  Not to Exceed 
$4,500

o Travel (a total of 18 person trips to Bethesda):  as appropriate

o Other costs (itemized and individually justified):  Not to Exceed $2,500

When an application has been reviewed and is being considered for funding, 
the applicant will be required to complete the budgets based on capitation 
funding.  Each Clinical Site will be given base costs (listed above) in 
addition to a flat fee per subject.  When protocol development is near 
completion, a final per-subject rate will be determined, that will include 
costs, which cannot be estimated at this time, such as pathology and 
laboratory tests.
 
After protocol development, the individual member sites will be required to 
project subject enrollment during a specified time frame.  Taking this 
information into account, NICHD will determine the capitation level and make 
an award.  Continuation and level of funding for future years will be based 
on the number of subjects successfully enrolled and completed.  

Future years' budget requests should be limited to base budget costs, with an 
annual increment of base salary not to exceed three percent.  The travel 
should be reduced to 12 person trips per year after the first year, with an 
annual increment not to exceed three percent.  The maximum amount available 
for equipment, supplies, and other costs will not increase.  Federal agencies 
shall use negotiated rates for F&A costs in effect at the time of the initial 
award throughout 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.
   
Data Coordinating and Analysis Center

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

o Principal Investigator/Biostatistician team:  up to 100 percent effort 

o Programmer/Systems Analyst:  50 percent effort 

o Study Coordinator/Administrative Assistant:  50 percent effort

o Travel (a total of 12 person trips to Bethesda):  as appropriate

o Consultants for protocol development and one meeting of the DSMC:  $10,000

o Supplies and small equipment:  $10,000

When an application has been reviewed and is being considered for funding, 
the applicant will be required to complete a budget based on operational 
costs.  The data center will be given base costs (listed above) in addition 
to operational costs.  When protocol development is near completion, 
operational costs will be determined, that will include costs, which cannot 
be estimated at this time, such as data entry and management, quality control 
costs, software, printing and duplication of forms, distribution and storage 
of forms, and service contracts, logistic support to the study, report 
generation, and data analysis.  Taking subject enrollment estimates into 
account, NICHD will determine the level of operational costs and make an 
award.  Continuation and level of funding for future years will be based on 
the number of subjects successfully enrolled and completed.  

Future years' budget requests 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 supplies and other costs not increase.  
Federal agencies shall use negotiated rates for F&A costs in effect at the 
time of the initial award throughout 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.

USING THE RFA LABEL:  The RFA label available in the PHS 398 (rev. 5/2001) 
application form must be affixed to the bottom of the face page of the 
application.  Type the RFA number on the label.  Failure to use this label 
could result in delayed processing of the application such that it may not 
reach the review committee in time for review.  In addition, the RFA title 
and number must be typed on line 2 of the face page of the application form 
and the YES box must be marked. The RFA label is also available at: 
http://grants.nih.gov/grants/funding/phs398/label-bk.pdf.
 
SENDING AN APPLICATION TO THE NIH:  Submit a signed, typewritten original of 
the application, including the Checklist, and three signed, photocopies, in 
one package to:
 
Center for Scientific Review
National Institutes of Health
6701 Rockledge Drive, Room 1040, MSC 7710
Bethesda, MD  20892-7710
Bethesda, MD  20817 (for express/courier service)
 
At the time of submission, two additional copies of the application must be 
sent to:

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

APPLICATION PROCESSING:  Applications must be received by the application 
receipt date listed in the heading of this RFA.  If an application is 
received after that date, it will be returned to the applicant without 
review.
 
The Center for Scientific Review (CSR) will not accept any application in 
response to this RFA that is essentially the same as one currently pending 
initial review, unless the applicant withdraws the pending application.  The 
CSR will not accept any application that is essentially the same as one 
already reviewed.  This does not preclude the submission of substantial 
revisions of applications already reviewed, but such applications must 
include an Introduction addressing the previous critique.

PEER REVIEW PROCESS  
 
Upon receipt, applications will be reviewed for completeness by the CSR and 
responsiveness by the NICHD.  Incomplete and/or non-responsive applications 
will be returned to the applicant without further consideration.

Applications that are complete and responsive to the RFA will be evaluated 
for scientific and technical merit by an appropriate peer review group 
convened by the NICHD in accordance with the review criteria stated below.  
As part of the initial merit review, all applications will:

o Receive a written critique
o Undergo a process in which only those applications deemed to have the 
highest scientific merit, generally the top half of the applications under 
review, will be discussed and assigned a priority score
o Receive a second level review by the National Advisory Child Health and 
Human Development Council  
 
REVIEW CRITERIA

Clinical Sites:

(1) Qualifications, Experience, and Commitment of Key Personnel

o  Scientific, clinical, and administrative abilities and academic 
productivity of the Principal Investigator and other team members;

o  Knowledge and experience in areas relevant to the conduct of collaborative 
clinical research, especially in maternal-fetal medicine.  This should 
include specific experience in research design;

o  Commitment of staff time for the satisfactory conduct of the study;

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

(2) Documentation and Procedures

o  Adequacy of documentation of the patient population as outlined in 
supplemental instructions;

o  Quality of the site's participation in collaborative clinical research;

o  Adequacy of surveillance procedures and enrollment plan and ability to 
carryout the surveillance, enrollment and diagnostic procedures.

o  Willingness to work and cooperate with other sites, the DCAC, and the 
NICHD in the manner summarized in this RFA;

o  Additional research strengths, as presented.

(3) Description of sample study

o  Adequacy of the conceptual framework and design to meet the objectives of 
the RFA.

o  Potential of the proposed study elements to advance knowledge, 
methodology, and/or concepts relating to the scope and causes of fetal death 
in the United States.

(4)Facilities and Management

o  Adequacy of administrative, clinical, and data organizational management 
facilities as described in supplemental instructions; this includes 
documentation of collaborative arrangements to ensure geographic population-
based surveillance and enrollment within the catchment area; 

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

Data Coordinating and Analysis Center:

(1)  Qualifications, Experience, and Commitment of Key Personnel:  Scientific 
and administrative abilities of the Principal Investigator and other team 
members; experience of the Principal Investigator and other key personnel in 
statistical data management, quality control, study coordination, and 
administrative aspects. 

(2)  Protocols and Procedures:  Quality of past performance and proposed 
plans for study coordination, data collection, analysis,  and monitoring. 

(3)  Facilities and Management:  Evidence of satisfactory facilities and 
supporting environment, including space and equipment for work proposed (any 
new equipment requested under this award must be adequately justified); 
evidence of institutional support for participation in a long-term 
collaborative project. 

(4)  Willingness to work cooperatively with other awardees and NICHD in the 
manner summarized in the Cooperative Agreement Terms and Conditions of Award.

ADDITIONAL REVIEW CRITERIA:  In addition to the above criteria, your 
application will also be reviewed with respect to the following:

o PROTECTIONS:  The adequacy of the proposed protection for humans, animals, 
or the environment, to the extent they may be adversely affected by the 
project proposed in the application.

o INCLUSION:  The adequacy of plans to include subjects from both genders, 
all racial and ethnic groups (and subgroups), and children as appropriate for 
the scientific goals of the research.  Plans for the recruitment and 
retention of subjects will also be evaluated. (See Inclusion Criteria 
included in the section on Federal Citations, below.)

o BUDGET:  The reasonableness of the proposed budget in light of the budget 
guidelines listed under "Budget Preparation" and the requested period of 
support in relation to the proposed research.

RECEIPT AND REVIEW SCHEDULE

Letter of Intent Receipt Date:  February 13, 2003
Application Receipt Date:  March 13, 2003
Peer Review Date:  June/July 2003
Council Review:  September 2003
Earliest Anticipated Start Date:  September 2003

AWARD CRITERIA

Criteria that will be used to make award decisions include:

o Scientific merit (as determined by peer review). The combined expertise of 
all sites will play a role in the selection of grants for award.  These 
include but are not limited to community outreach, perinatal pathology, and 
epidemiology.
 
o Availability of funds

o Programmatic priorities to include geographic and subpopulation diversity.  
 
REQUIRED FEDERAL CITATIONS 

INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH:  It is the policy of 
the NIH that women and members of minority groups and their sub-populations 
must be included in all NIH-supported clinical research projects unless a 
clear and compelling justification is provided indicating that inclusion is 
inappropriate with respect to the health of the subjects or the purpose of 
the research. This policy results from the NIH Revitalization Act of 1993 
(Section 492B of Public Law 103-43).

All investigators proposing clinical research should read the AMENDMENT "NIH 
Guidelines for Inclusion of Women and Minorities as Subjects in Clinical 
Research - Amended, October, 2001," published in the NIH Guide for Grants and 
Contracts on October 9, 2001 
(http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html); a complete 
copy of the updated Guidelines is available at 
http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm.
The amended policy incorporates: the use of an NIH definition of clinical 
research; updated racial and ethnic categories in compliance with the new OMB 
standards; clarification of language governing NIH-defined Phase III clinical 
trials consistent with the new PHS Form 398; and updated roles and 
responsibilities of NIH staff and the extramural community.  The policy 
continues to require for all NIH-defined Phase III clinical trials that: a) 
all applications or proposals and/or protocols must provide a description of 
plans to conduct analyses, as appropriate, to address differences by 
sex/gender and/or racial/ethnic groups, including subgroups if applicable; 
and b) investigators must report annual accrual and progress in conducting 
analyses, as appropriate, by sex/gender and/or racial/ethnic group 
differences.

INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS: 
The NIH maintains a policy that children (i.e., individuals under the age of 
21) must be included in all human subjects research, conducted or supported 
by the NIH, unless there are scientific and ethical reasons not to include 
them. This policy applies to all initial (Type 1) applications submitted for 
receipt dates after October 1, 1998.

All investigators proposing research involving human subjects should read the 
"NIH Policy and Guidelines" on the inclusion of children as participants in 
research involving human subjects that is available at 
http://grants.nih.gov/grants/funding/children/children.htm.  

REQUIRED EDUCATION ON THE PROTECTION OF HUMAN SUBJECT PARTICIPANTS:  NIH 
policy requires education on the protection of human subject participants for 
all investigators submitting NIH proposals for research involving human 
subjects.  You will find this policy announcement in the NIH Guide for Grants 
and Contracts Announcement, dated June 5, 2000, at 
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.

PUBLIC ACCESS TO RESEARCH DATA THROUGH THE FREEDOM OF INFORMATION ACT:  The 
Office of Management and Budget (OMB) Circular A-110 has been revised to 
provide public access to research data through the Freedom of Information Act 
(FOIA) under some circumstances.  Data that are (1) first produced in a 
project that is supported in whole or in part with Federal funds and (2) 
cited publicly and officially by a Federal agency in support of an action 
that has the force and effect of law (i.e., a regulation) may be accessed 
through FOIA.  It is important for applicants to understand the basic scope 
of this amendment.  NIH has provided guidance at 
http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm.

Applicants may wish to place data collected under this RFA in a public 
archive, which can provide protections for the data and manage the 
distribution for an indefinite period of time.  If so, the application should 
include a description of the archiving plan in the study design and include 
information about this in the budget justification section of the 
application. In addition, applicants should think about how to structure 
informed consent statements and other human subjects procedures given the 
potential for wider use of data collected under this award.

URLs IN NIH GRANT APPLICATIONS OR APPENDICES:  All applications and proposals 
for NIH funding must be self-contained within specified page limitations. 
Unless otherwise specified in an NIH solicitation, Internet addresses (URLs) 
should not be used to provide information necessary to the review because 
reviewers are under no obligation to view the Internet sites.  Furthermore, 
we caution reviewers that their anonymity may be compromised when they 
directly access an Internet site.

HEALTHY PEOPLE 2010:  The Public Health Service (PHS) is committed to 
achieving the health promotion and disease prevention objectives of "Healthy 
People 2010," a PHS-led national activity for setting priority areas. This 
RFA is related to one or more of the priority areas. Potential applicants may 
obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople.

AUTHORITY AND REGULATIONS:  This program is described in the Catalog of 
Federal Domestic Assistance No. 93.865 and is not subject to the 
intergovernmental review requirements of Executive Order 12372 or Health 
Systems Agency review.  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 described at 
http://grants.nih.gov/grants/policy/policy.htm and under Federal Regulations 
42 CFR 52 and 45 CFR Parts 74 and 92. 

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

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