DATA COORDINATION CENTER FOR THE NIH-DC INITIATIVE TO REDUCE INFANT MORTALITY IN
MINORITY POPULATIONS

Release Date:  January 9, 1998

RFA:  HD-98-003

P.T.

National Institute of Child Health and Human Development
Office of Research on Minority Health

Letter of Intent Receipt Date:  February 2,1998
Application Receipt Date:  March 27, 1998

PURPOSE

The National Institute of Child Health and Human Development (NICHD), in
cooperation with the National Institutes of Health (NIH) Office of Research on
Minority Health (ORMH), invites new and renewal applications from institutions
desiring to participate with the NICHD under a cooperative agreement as the Data
Coordination Center (DCC) in support of an ongoing multi-center research program
designed to investigate topics related to the high infant mortality among
minority populations in Washington, DC.  It is the objective of this initiative
to expedite the development of answers to these problems through a cooperative
research network of participating centers in Washington, DC in cooperation with
the NICHD.  Research topics to be addressed include studies and interventions in
women during pregnancy, infants and young children, as well as non-pregnant women
during the preconception or interconception phase.  Funding will be provided by
ORMH and NICHD.  The current Data Coordinating Center has been the Initiative
Data Center since July 1993 and is supported through August 31, 1998.

Applicants must  be able to provide the services of the Data Coordination Center
(DCC) for the network of research organizations established via a prior Request
for Applications (RFA HD-96-005) including providing management support and
consultation in the design, execution, and analysis for multi-institutional
experimental studies in the field of infant mortality; ensuring that the studies
are of the highest scientific integrity and meet rigorous statistical standards;
providing consultation in epidemiology, statistics, and intervention design
methodology; and providing logistic support for multi-site protocols.  The DCC
will be functionally independent of all research sites, although it could be
physically located at one of them.

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-lead national
activity for setting priority areas.  This Request for Applications (RFA), Data
Coordination Center for the NIH-DC Initiative to Reduce Infant Mortality in
Minority Populations, is related to the priority areas of infant mortality, fetal
deaths, low birth weight, high risk pregnancies and prenatal care.  Potential
applicants may obtain a copy of "Healthy People 2000" (Full Report:  Stock No.
017-001-00474-0 or 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.  Institutions may submit singly or in
partnerships with two or more organizations or groups.  For-profit organizations
interested in applying under this RFA should note that no profit or fees may be
requested under this kind of assistance award. In addition, since there are no
cost principles applicable to for-profit organizations receiving financial
assistance awards, those set forth in Federal Acquisition Regulations in 48 CFR
Part 31.2 will generally be used.  Organizations should have experience in
functioning as a statistical and data coordinating center for multi-center and
community based research, including randomized controlled trials and
observational studies of both a medical and psychosocial 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 the DCC to assist the
community in undertaking this coordinated population-based research effort will
be a cooperative agreement mechanism, the NIH research demonstration cooperative
agreement (U18).

The major difference between a cooperative agreement and a research project 
grant is that there will be substantial NIH scientific and/or programmatic
involvement with the awardee above and beyond the levels required for traditional
program management of grants [Grants Policy Statement, DHHS Publication (OASH)
94-50, 000 (rev. April 1, 1994)].  Details of the responsibility, relationship
and governance of the study to be funded under a cooperative agreement are
discussed later in this document under the Section "Terms of Agreement."

The total project period for an application submitted in response to this RFA may
not exceed five years.  The anticipated award date is September 1998.  At this
time, the NICHD has not determined whether or how the solicitation will be
continued beyond the present RFA.  Awards and level of support depend on receipt
of a sufficient number of applications of high scientific merit.

FUNDS AVAILABLE

It is anticipated that one award for the Data Coordinating Center will be made
with an estimated total cost of  $500,000 (including direct, and facilities and
administrative costs) for the entire program for the first year.  These funds
will be allocated to Phase I:  protocol design and  implementation planning and
Phase II: protocol implementation and participant recruitment.  The actual cost
of each approved protocol will be determined in Phase I  (see budget section for
allowable costs).  This Grant will be co-funded by NICHD and ORMH (Year 01 to be
funded by ORMH).  Although this program is provided for in the financial plans
of the NICHD and the ORMH, the award of a grant pursuant to this RFA is also
contingent on the availability of funds for this purpose.

RESEARCH OBJECTIVES

A.  Background

Infant mortality among blacks continues to be twice as high as among whites.  In
1992, the infant mortality rate among whites in the U.S. was 6.9 per 1000 births
and for blacks 16.8 per 1000 births, and the black-white ratio was 2.4:1.  The
overall infant mortality rate (provisional data) for the U.S. in 1994 was the
lowest ever at 7.9 per 1000 births, but in Washington, DC, it was 20.1 per 1000
births.  Similar disparities among blacks and whites exist for other birth
outcomes related to infant mortality such as low birth weight and preterm
delivery.

Known risk factors of poor perinatal outcome include young maternal age, low
level of maternal education, poverty, inadequate housing, lack of social support,
being unmarried, late or no prenatal care, unintended childbearing, adverse
health behaviors during pregnancy like smoking, drinking and drug abuse, as well
as a number of medical risk factors, including preeclampsia, premature rupture
of the membranes, urinary tract and vaginal infections.

Certain causes of infant deaths occurring post-neonatally, such as infections,
injuries and sudden infant death syndrome, are more common among black infants.

B.  Objectives and Scope

To address these issues among minority populations in Washington, DC, the NICHD
and the ORMH established a cooperative research network among six institutions
in Washington, DC and the NICHD, as well as a Data Coordinating Center in
September 1992.  Recent recompetition has resulted in a revised network of four
primary grantee sites.  The Steering Committee for Phase I of this initiative
identified a number of areas of research interest and coordinated the development
of protocols which have been implemented.  Studies currently being completed
include an intervention to improve parenting skills among high risk mothers
leading to better utilization of preventive health services for their infants,
an adolescent pregnancy prevention school-based program, a study of barriers,
motivators and facilitators to early entry and maintenance of prenatal care, a
baseline study of injuries among infants and young children leading to emergency
room visits in Washington, DC, a study of the determinants of lack of age-
appropriate immunization coverage, and a study of characteristics of health
services in neonatal intensive care units among most hospitals in Washington, DC. 
Information about these studies can be obtained from the NICHD as listed in the
INQUIRIES section of this RFA.

This initiative calls for innovative investigations leading to a better
understanding of the determinants and risk factors of the high rates of infant
mortality and low birth weight among minorities in Washington, DC and development
of interventions leading toward a reduction of those risk factors.  Projects in
Phase II may be population-, clinic- or hospital-based or may deal with selected
population groups. Study populations may be pregnant women, women of childbearing
age, adolescents, or young infants, who reside in Washington, DC at the time of
the investigation.  Potential research topics may cover the development and
testing of health education/health promotion interventions to effect a reduction
in smoking, drinking, drug abuse or other adverse health behaviors during
pregnancy.  Other studies may deal with interventions during the preconceptual
and interconceptual period to increase family planning service utilization and
to reduce the risk of adverse birth outcome among high-risk women.

Examples of types of research that could be conducted under this Cooperative
Agreement include, but are not limited to:

o  The development of effective outreach strategies to enhance participation in
prenatal care.

o  The development of health education/health promotion interventions which are
shown to be effective in this population, directed toward smoking, drinking and
drug abuse, or other behaviors

o  Investigations and interventions aimed at preventing preterm delivery or
intrauterine growth retardation.

Because of the complex nature of the problem of the high infant mortality rate
in Washington, DC involving social, demographic, health care delivery, access and
utilization of health and social services and barriers to them, as well as
medical and clinical problems impinging upon infant survival, the research
approaches to address these problems involve contributions from many different
disciplines, including sociology, behavioral sciences, health education, health
service delivery, clinical obstetrics and pediatrics, nursing, epidemiology and
statistics, and possibly some others.

Examples of possible specific investigations (listed mainly for illustrative
purposes) include:

o  There is an extensive research literature on smoking interventions in women
before and during pregnancy, some of which have been tested in high risk inner
city populations. Based on the currently available knowledge, a smoking
intervention might be developed and tested in this population.

o  Findings from clinical trials which address the prevention of various
obstetrical complications, including preeclampsia, if proven to be beneficial
could be incorporated on a population basis into the content of prenatal care to
test their overall efficacy in an inner city population.

o  The previous cooperative agreement included surveys and observational studies
of barriers, motivators and facilitators of prenatal care, childhood injuries,
and age-appropriate immunizations.  Interventions could be developed  to increase
early entry and adherence to prenatal care schedules, reduce injuries in young
children or increase immunization rates in children under the age of two building
on the results of these Phase I studies.

Although the studies funded under the associated Cooperative Agreement  will
differ in terms of their focus or disciplinary perspective, it is expected that
investigators, through the Steering Committee, will develop common protocols and
quality control procedures and will share the data generated by it.  The selected
protocol(s) will be subject to external scientific review by an uninvolved expert
group, the Scientific Advisory Board, and external community review by the
Community Advisory Board.  The study will proceed into the implementation phase
only with the concurrence of both the awardees and the NICHD.  Factors that will
be considered in choosing projects to be implemented include:  (1) studies that
are feasible to undertake in the proposed research population; (2) financial
resources available to the network; and (3) strategies that are likely to be the
most productive and cost-effective in addressing the research priorities of the
network.

The awardee is expected to cooperate with the multi-disciplinary investigators
at the four grantee sites and at other participating clinical centers and with
the Program Officer, the Program Coordinator, and other participating NICHD staff
in the design and conduct of protocols, analysis of data, and reporting of result
of Initiative research.  Systems for data collection, analysis, coordination, and
quality assurance are essential.  Required data summaries will be provided to the
Steering Committee, NICHD, the Data Safety and Monitoring Committee, and others
as determined by the Steering Committee.  Logistical support will be required.

To provide this support and consultation to the participating organizations, the
DCC will need a staff of epidemiologists, biostatisticians, research assistants,
programmers, data clerks, word processors, trainers, and support staff.  The DCC
will work with the Steering Committee and serve as a technical support
organization to this Committee by implementing the decisions of the Steering
Committee regarding protocol development, protocol execution, data processing,
and analysis.

Minimum requirements for the Data Coordinating Center (DCC) are described below.

General

The Data Coordinating Center must have either their central or a branch office
located in the Washington, DC metropolitan area.  The applicant must demonstrate
prior experience as a Data Coordinating Center in multi-center and community
based studies in prenatal, perinatal, and infant studies during the previous five
years.  The Principal Investigator, and other staff, must have appropriate
expertise and capability in epidemiology, biostatistics, data management, data
analysis, and project management.

Design

The DCC staff must be willing to collaborate with the study investigators in the
development of study protocols including patient eligibility criteria,
randomization and/or stratification techniques, treatment and/or follow-up
schedules, specification of primary and secondary outcomes, sample size
determination, statistical analysis plans and a projected timetable of tasks to
be conducted. The DCC will be expected to provide expert epidemiological advice
in the selection of topics of research and in the development and implementation
of protocols as needed.  Prior to the initiation of a study, the DCC will
collaborate with the study investigators in the development of the data
collection forms and will take the lead on the development of detailed manual of
operation and training manuals.  The DCC will assume principal responsibility for
the design of sampling and/or randomization procedures, specification of the
performance monitoring procedures, and training of the study personnel in the
data processing procedures.  Applicants should provide a description of their
experience in designing these different types of projects with special emphasis
on epidemiological and the statistical expertise required, as well as examples
of past or current projects requiring this expertise.

Execution

The DCC will provide information processing support during the execution of each
study protocol.  The DCC will serve as the repository for clinical and central
laboratory data, and will provide the microcomputer-based remote data entry
system and the mainframe-based centralized data entry, management, and analysis
system.  Throughout the execution of each study the DCC will provide ongoing
training of study personnel with regard to data processing procedures; distribute
updates to study documents; review eligibility and monitor enrollment of study
patients; provide computerized editing of submitted data; assist in the clinical
review of data collected on study patients; monitor and prepare periodic reports
on protocol performance; and conduct interim statistical analysis of emerging
results including patient safety issues.

Analysis

The DCC will apply appropriate statistical methodology to the analysis of data
collected for the studies supported by the Cooperative Agreement  to ensure the
highest scientific and statistical standards.  It will assure expert
epidemiological input in this analysis.  To ensure that all patient outcomes are
properly documented, a final check of each study patient's data record will be
conducted to resolve any outstanding missing or inconsistent data items.  The
applicant must show experience in the conduct statistical analyses for the
presentation of results and  the collaboration with the clinical investigators
in preparing manuscripts for publication.  The DCC will ensure that all relevant
study documents and data are organized and archived for future access.

Logistic Management Support

The DCC will assist in the coordination and execution of all Initiative meetings
and conferences including, but not limited to: scheduling, site selection,
information dissemination, and minutes preparation.  The DCC will provide
logistical support the NICHD program office for such items as: participant
directory, calendar dissemination and project files. The applicant should
describe:  (1) proposed methods to be used to facilitate communications among the
DCC staff, Initiative investigators, and the NICHD staff; (2) proposed staffing
patterns for providing DCC functions from protocol design through analysis (This
should include provisions for adjusting staff time commitments during the life
of the study.); and (3) proposed administrative and management structure that
would support and enhance the operational structure while assuring continuing
attention to cost-efficiency and productivity.

Reporting

The applicant must have the capacity to generate monthly reports on subject
enrollment and progress for several concurrent studies; appropriate reports for
the use of the Data Safety and Monitoring Board meetings; and special reports as
required.

Guidance and Management Structures

It is expected that the first year of this initiative will be devoted to the
prioritization of proposed research projects;  the detailed development of common
protocols, manuals of operation, training manuals, etc.; the finalization of 
implementation plans and time lines; and budget development.  Protocols will be
implemented and evaluated in the following years of the initiative.

The management structure of the NIH-DC Infant Mortality Initiative includes four
committees:  (1)  A Steering Committee, (2) A Scientific Advisory Board, (3) The
Community Advisory Board,  and (4) Data and  Safety Monitoring Board.  The roles
of these committees are defined in the section on Terms and Conditions of this
RFA.

SPECIAL REQUIREMENTS

The NICHD invites applications from the current DCC (competing renewal
application), current members of the NIH-DC Initiative to Reduce Infant Mortality
in Minority Populations in the District of Columbia and from new applicants. 
Applicants must be able to demonstrate relevant research support experience
pertinent to the objectives delineated in this RFA, qualifications of key
personnel, and proven capacity to support recruitment of community, clinic or
hospital based populations for the interventions being considered.  Applicants
must also demonstrate a willingness and ability to participate in a cooperative
program of research and evaluation with other successful applicants.  The
following terms and conditions will be incorporated into the award statement and
provided to the principal investigator(s) as well as the institutional officials
at the time of award.  Minimum requirements for applications are described below
(See Application Procedures and Review Criteria).

The current DCC must describe in general terms a contingency plan to transfer all
DCC functions for Phase I of the NIH-DC Initiative from the incumbent to another
DCC entity which may be successful in the competition for Phase II.  This
contingency plan should address the feasibility of transferring specific DCC
functions at various stages of development, including design, data processing,
and analysis.  All transfers should be completed within six months of award.  The
current DCC must also demonstrate past progress and the ability to meet the Terms
and Conditions of this award.

New applicants must describe in general terms, a contingency plan to accept all
DCC responsibility and functions for Phase I of the NIH-DC Initiative that might
be transferred from the incumbent DCC.  This plan should address the feasibility
of transferring specific DCC functions at various stages of development,
including design, data processing, and analysis.  All transfers should be
completed within six months of award.

Terms and Conditions of Award

These special Terms of Award are in addition to, and not in lieu of, otherwise
applicable OMB administrative guidelines, DHHS Grant Administration Regulations
at 45 CFR Parts 74 and 92, and other DHHS and NIH grant administration policies.

The administrative and  funding instrument used to assist the scientific
community in conducting studies and interventions as part of the NIH-DC Infant
Mortality Initiative will be a cooperative agreement (U18), an þassistanceþ
mechanism (rather than an þacquisitionþ 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 recipientþs 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 staff designated below.

A.  Awardees Rights and Responsibilities

The  tasks or activities in which the DCC will have primary substantial
responsibilities include:  Collaboration with the awardees of the Cooperative
Community-Based Perinatal Studies and Interventions in Minority Populations (RFA
HD-96-005);  Provision of assistance in the development of research protocols for
specific studies, including interventions; Assistance in the design and
preparation of data collection instruments and manuals;  Provision of statistical
advice in the design, analysis and interpretation of projects; Provision of
consultation and assistance in the implementation of the projects selected by the
steering committee;  Training of project staff at the sites in the use of study
instruments to ensure standardization of procedures and integrity of data; 
Design and implementation of efficient Research Data Management Systems; 
Monitoring of data collection, including quality control, and performance of
analyses and interpretation of data; Provision of easy to use data archives with
appropriate documentation of procedures, problems, and analyses performed; 
Presentation of study instruments, manuals, and protocols for final approval by
the Steering Committee;  Aid in the publication and dissemination of results.

In addition, the DCC will provide logistic management support to the awardees of
the Cooperative Community-Based Perinatal Studies and Interventions in Minority
Populations (RFA HD-96-005) and the NICHD.

Awardee of the Cooperative Community-Based Perinatal Studies and Interventions
in Minority Populations (RFA HD-96-005) will retain custody of and have primary
right to their siteþs data developed under their awards, subject to Government
rights of access consistent with current HHS, and NIH policies.  The data
developed under this award will not be disseminated publicly prior to publication
or presentation of study results in a peer reviewed forum.  The awardees of the
Cooperative Community-Based Perinatal Studies and Interventions in Minority
Populations (RFA HD-96-005) will establish  policies and procedures which direct
their collaborative operations, including a publication policy.  These documents
may be amended and supplemented as approved by the Steering Committee.

B.  NICHD Staff Responsibilities

Responsibility for  review and oversight of these cooperative agreements will
reside with the NICHD Program Officer.  This role will include the following:
oversight to assure  the scientific merit of studies, interventions and trials
done under this initiative; assistance in the efficient conduct of studies,
interventions and trials, including ongoing review of progress, possible
redirection of activities to improve performance, and frequent communication with
other members of the Steering Committee; and initiation of a decision to modify
or terminate a study based on the advice of the Data Coordinating Center, the
Data Safety and Monitoring Board, the Community Advisory Board , the Scientific
Advisory Board, and/or the Steering Committee.  The NICHD Program Officer will
have voting membership on the Steering Committee, and its subcommittees.

The NICHD Program Coordinator will provide traditional extramural program
management.  In addition, the Program Coordinator will assist in coordination
across institutions and will serve as Executive Secretary of the Scientific
Advisory Board, the Community Advisory Board, and any Data Safety Monitoring
Boards constituted for clinical trials reporting findings to the Steering
Committee and protocol investigators.  The NICHD Program Coordinator will monitor
the data management and quality assurance systems and evaluate the cost-
effectiveness of the Data Coordinating Center using consultants as appropriate. 
Criteria will include the quality and quantity of participation in collaborative
Initiative research; timeliness of their efforts; data reports prepared for the
Steering Committee and subcommittees; biannual and annual progress reports; and
site visit findings.

NICHD intramural staff may collaborate with awardees in the formulation of
studies, and in the analysis and reporting of results.

Grants Management responsibility: A grants management specialist in the Grants
Management Branch, NICHD will administer the business and financial management
aspects of the award.

The NICHD reserves the right to terminate or curtail a study in the event of
substantial shortfall in participant recruitment, follow-up, data reporting,
quality control, or other major breach of a protocol; a study reaches a major
study endpoint substantially before schedule with persuasive statistical
significance; qualified scientific investigators are not available to participate
in the study; or human subject ethical issues that may dictate a premature
termination.  The NICHD also reserves the right to withhold support from the DCC
if technical performance requirements such as protocol support, data acquisition
and analysis targets, and adequate quality assurance of data are not met.

C.  Collaborative Responsibilities

The management of the NIH-DC Infant Mortality Initiative includes four committees
whose functions are as follows:

(1) A Steering Committee will be responsible for the overall coordination of the
study including: protocol prioritization, finalization, implementation and
conduct of studies, and the preparation of publications.  The Steering Committee
will be composed of the awardee Principal Investigators, the Principal
Investigator from the Data Coordinating Center and the NICHD Program Officer,
each having one vote. The chairperson of the Steering Committee will be an
outside consultant chosen by the NICHD in consultation with the Steering
Committee. The program coordinator, scientific consultant, and a staff member
from the Grants Management Branch will attend Steering Committee meetings.  The
Steering Committee chairperson will chair all meetings of this committee.  The
Steering Committee will meet three to four times per year.

(2) A Scientific Advisory Board will advise the NICHD and the Steering Committee
on the scientific merit and technical soundness of protocols which have been
developed before their implementation.  This advisory board will have expertise
in areas relevant to the research topics of this initiative and will be chosen
by the NICHD in consultation with the Steering Committee.  The NICHD Program
Coordinator will act as executive secretary of this Board and report the findings
to the Steering Committee and Protocol investigators.

(3) The Community Advisory Board will advise the NICHD and the Steering Committee
on issues related to community acceptance and sensitivities, as well as
appropriateness of a given research protocol.  This advisory board will consist
of individuals with a demonstrated knowledge of, and a history of involvement
with, the community and will be chosen by the NICHD in consultation with the
Steering Committee.

(4) Data and  Safety Monitoring Board will be established as needed to monitor
the safety of ongoing interventions or clinical trials and advise on research
design issues, data quality and analysis, and ethical and human subject aspects. 
Members of the Board will represent expertise in ethics, clinical trial design,
and other disciplines relevant to the intervention or trial for which they are
constituted.  The members of the Board will be chosen by the NICHD.  The DCC
prepares confidential reports for the DSMB meetings; The DCC Principal
Investigator participates as an ex-officio member; and the NICHD Program
Coordinator serves as the Executive Secretary.

The collaborative protocols will be approved by the Steering Committee.  Data
will be submitted centrally to the Data Coordinating Center.  The Steering
Committee will define rules regarding access to data and publications.  An
independent Data and Safety Monitoring Board will review progress of clinic
trials at least annually and report to the NICHD.

Awardee of the Cooperative Community-Based Perinatal Studies and Interventions
in Minority Populations (RFA HD-96-005) and the DCC will be required to accept
and implement the common protocol(s) and procedures approved by the Steering
Committee.

D.  Arbitration

Any disagreement that may arise on scientific matters (within the scope of the
award), between award recipients and the NICHD may be brought to arbitration. 
An arbitration panel will be composed of three members -- one person selected by
the principal investigator,  one person selected by the NICHD,  and a third
person selected by the two prior selected members.  The decision of the
arbitration panel, by majority vote, will be binding.  These special Terms of
Award are in addition to, and not in lieu of, otherwise applicable OMB
administrative guidelines, DHHS Grant Administration Regulations at 45 CFR Parts
74 and 92, and other DHHS and NIH grant administration policies.  These special
arbitration procedures described above in no way affect the right of a recipient
of a cooperative agreement assistance mechanism to appeal an adverse
determination in accordance with PHS regulations at 42 CFR Part 50, Subpart D and
DHHS regulations 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," 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 February 2, 1998, a letter of
intent that includes a descriptive title of the 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.

A letter of intent is to be sent to:

Barbara Wingrove, M.P.H.
Division of Epidemiology, Statistics  and Prevention Research
National Institute of Child Health and Human Development
Building 6100, Room 7B07, MSC 7510
Bethesda, MD  20892-7510
Telephone:  (301) 594-1302
FAX:  (301) 480-0649
Email:  Barbara_Wingrove@NIH.GOV

APPLICATION PROCEDURES

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 and from the Division of Extramural Outreach and Information
Resources, National Institutes of Health, 6701 Rockledge Drive, MSC 7910,
Bethesda, MD 20892-7910, telephone (301) 435-0714; email ASKNIH@od.nih.gov.

Budget

In preparing requested budgets, the form pages in the research grant application
form PHS-398 (Revised 05/95) must be used.  Facilities and administrative costs
will be awarded in the same manner as for research project grants.  Allowable
costs and policies governing the research grant 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 yearþs budget for Phase I: Protocol design and implementation planning
will be limited to the following maximum allowances:

Principal Investigator/Senior Biostatistician/Epidemiologist     60% effort
Epidemiologist/Study Design Methodologist                        50% effort
Senior/Research Statistician                                     100% effort
Logistic Support Administrator                                   100% effort
Secretary                                                        50% effort

Supplies and small equipment (itemize and justify) Not to exceed $4500
Travel to Steering Committees based upon four meetings a year lasting one day
each attended by no more than three individuals.
Other expenses (itemize and individually justified) Not to exceed $2500

Budgets for tasks associated with implementation of protocols for years 2 through
5 must be estimated.  Actual annual budgets for subsequent years of the
Initiative of the NIH-DC Initiative to Reduce Infant Mortality in Minority
Populations in the District of Columbia will be based on individual protocols. 
Budgets for  protocols will be based on specific protocol requirements and
availability of funds.  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.

The RFA label available in the PHS-398 application form must be affixed to the
bottom of the face page of the application.  Failure to do this 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 checked.

The signed, typewritten original of the application, including the Checklist, and
three signed exact photocopies should be sent 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:

Susan Streufert, Ph.D.
Division of Scientific Review
National Institute of Child Health and Human Development
6100 Executive Boulevard, Room 5E03A, MSC 7510
Bethesda, MD  20892-7510
Rockville, MD  20852 (for express/courier service)

Applications must be received by March 27, 1998.  If an application is received
after that date, it will be returned to the applicant without review.  The 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 also not accept an 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.

Letter of Intent Receipt Date:  February 2, 1998
Application Receipt Date:       March 18, 1998
NICHD Council Review:           June 1998
Anticipated Award Date:         September 1998

REVIEW CONSIDERATIONS

Upon receipt, applications will be reviewed for completeness by CSR and for
responsiveness by the NICHD.  Incomplete 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 scientific peer review group convened by the NICHD in
accordance with the review criteria stated below.  As part of the initial merit
review, a  process may be used in which applications will be determined to be
competitive or noncompetitive based on their scientific merit relative to other
applications received in response to this RFA.  Applications determined to be
noncompetitive by the scientific review committee will be withdrawn from further
consideration, and the Principal Investigator will receive a summary statement
reflecting the reviewers' evaluation.  Applications judged to be competitive will
be further discussed and assigned a priority score.  They will then receive a
second level review by the National Advisory Child Health and Human Development
Council (NACHHD).

General Considerations

All applications will be judged on the basis of their scientific and technical
merit and the documented ability of the investigators to meet the RESEARCH
OBJECTIVES of the RFA.

Review Criteria

A.  Professional Staff Available

o  Expertise of the proposed staffing, including the proposed Principal
Investigator:  including, as applicable, staff with a background in perinatal and
reproductive epidemiology, retrieval and linkage of data from existing data
sources, biostatistics, data management, and information retrieval.  Review will
focus on expertise, qualifications, experience, commitment and continued
substantial availability of key personnel.

o  Demonstrated staff experience and capability to develop multi-center
collaborative research protocols, particularly in perinatal epidemiology and in
biostatistics.

o  Experience and training of relevant staff in community-based projects and
intervention trials

o  Documented experience and expertise of personnel involved in data management
and data processing aspects of the project in the management of large data sets,
designing and documenting appropriate systems, computer programming, data coding,
on-site and remote data entry, data editing, quality control, file building, file
manipulation, data analysis, and data archiving

o  Organizational and administrative abilities of the Principal Investigator and
other team members

B.  Institutional Capabilities (Research Design and Methods)

While it is critical that key individuals have the expertise described under
"Professional Staff Available" above, it is equally important that the
institution have the demonstrated capabilities that are itemized as follows:

o  Expertise in the design of surveys, case-control studies, cohort studies and
interventions.

o  Documented understanding of the basic elements required for a data
coordinating center:  This should include an understanding of computer logistics,
programming, coding, data processing, file building, file and program
documentation, and file maintenance.

o  Ability to finalize research protocols and questionnaires and to monitor
quality control:  This should include prior and/or current experience relative
to the development of protocols, design and pretesting of questionnaires and
other research instruments, and interaction with multi-disciplinary teams.  An
indication of procedures used for training of staff in the use of these protocols
and questionnaires and quality control of data collection across several sites
would be most useful.

o  Demonstrated ability to design and implement efficient Research Data
Management Systems:  Applicants should describe their methodology for preparing
study manuals of operation, keeping track of data, providing ready accessibility
of data at any point in the study, maintaining current documentation, and
maintaining backups of all data entered.

o  Demonstrated ability in the management of large data sets, designing and
documenting appropriate systems, computer programming, data coding, data entry,
data editing, quality control, file building, file manipulation, data analysis,
and data archiving

o  Demonstrated experience in the use and linkage of data from existing data
sources

C.  Resources and Environment

o  Adequacy of facilities and equipment available, including computer hardware
and software, for use by this project as well as any new equipment requested
under this award.  This should also include  the capacity of personal computers,
work stations, mainframe capability or access (such as access to the IBM
Mainframe maintained by DCRT at NIH), software programs available, and ability
to access remote data entry facilities.

D.  Logistic Support

o  Demonstrated ability to provide logistic support to multi-site research
studies, including scheduling, dissemination of information, meeting
administration, minutes production and information archiving.

E.  Special Strengths Applicant Would Bring to the Initiative

Special research strengths in the field of maternal-child health which would be
relevant to the NIH-DC Initiative to Reduce Infant Mortality in Minority
Populations in the District of Columbia.  This could include specific scientific
capabilities which are relevant and which might be shared or made available to
the initiative and which would extend the scientific productivity of the
research.

F.  Budget

Appropriateness of the proposed budget for the proposed work; evidence of cost-
effectiveness.

G.  Inclusion of Women and Minorities

Appropriateness of plans for compliance with the NIH policy on inclusion of women
and minorities.

The initial review group will also examine the provisions for the protection of
human subjects and the safety of the research environment.

AWARD CRITERIA

Applications recommended by the NICHD Council will be considered for award
principally on scientific and technical merit as determined by initial review. 
Program balance, that is, the scope and variety of research strengths to enable
a successful collaborative program, will be considered.  Availability of funds
may also determine the award made.

INQUIRIES

Written and telephone inquiries concerning this RFA are encouraged.  The
opportunity to clarify any issues or questions from potential applicants is
welcome.

Inquiries regarding programmatic issues may be directed to:

Barbara Wingrove, M.P.H.
Division of Epidemiology, Statistics  and Prevention Research
National Institute of Child Health and Human Development
6100 Building, Room 7B07, MSC 7510
Bethesda, MD  20892-7510
Telephone:  (301) 594-1302
FAX:  (301) 480-0649
Email:  Barbara_Wingrove@NIH.GOV

Inquiries regarding fiscal matters should be made to:

Ms. Mary Ellen Colvin
Grants Management Branch
National Institute of Child Health and Human Development
6100 Building, Room 8A17, MSC 7510
Bethesda, MD  20892-7510
Telephone:  (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.
93.865, Research for Mothers and Children.  The award will be made under the
authority of the Public Health Service Act, Section 301 (42 USC241), and
administered under PHS grant policies and Federal Regulations 42 CFR 52 and 45
CFR Part 74 and 92.  This program is not subject to review under the
intergovernmental review requirements of Executive Order 12372 or Health Systems
Agency review.

The NIH 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 NIH
mission to protect and advance the physical and mental health of the American
people.


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