Full Text HD-96-005
 
COOPERATIVE COMMUNITY BASED PERINATAL STUDIES AND INTERVENTIONS IN
MINORITY POPULATIONS IN THE DISTRICT OF COLUMBIA
 
NIH GUIDE, Volume 25, Number 44, December 20, 1996
 
RFA:  HD-96-005
 
P.T. 34, FF

Keywords: 
  0775013 
  Pregnancy 
  Community/Outreach Programs 

 
National Institute of Child Health and Human Development
Office of Research on Minority Health
 
Letter of Intent Receipt Date:  January 31, 1997
Application Receipt Date:  April 3, 1997
 
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 in 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.
 
Applicants must be able to propose research projects and to
demonstrate relevant research experience pertinent to the objectives
delineated in this RFA, qualifications of key personnel, and proven
capacity to recruit community, clinic or hospital based populations
for the planned interventions.  The applicants must be willing and
able to participate in a cooperative program of research and
evaluation with other successful applicants.  Peer reviewers convened
by the NICHD will evaluate the qualifications and relevant research
experience of the principal investigator and staff to do the proposed
research, and the availability of resources necessary to conduct the
research. It is anticipated that between six and eight organizations
will be involved in this initiative.
 
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), Cooperative Community Based Perinatal
Studies and Interventions 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 profit or non-profit organizations
within the District of Columbia whether public or private, such as
medical schools, universities, colleges, hospitals, laboratories,
community based organizations, or units of local government.
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.
 
Institutions may submit singly or in partnerships with two or more
organizations or groups. Evidence of existing or proposed community
affiliations and research capabilities must be represented regardless
of which organization is submitting as the applicant entity.
 
MECHANISM OF SUPPORT
 
The administrative and funding instrument to be used for this program
to assist the community in undertaking this coordinated
population-based research effort will be a cooperative agreement
mechanism, the research demonstration cooperative agreement (U18).
This cooperative agreement provides "support for testing, by means of
a research design, the effectiveness of the transfer and application
of techniques or interventions derived from a research base for the
control of diseases or disorders, or for the promotion of health.
The project should be capable of making conclusions which are
generally applicable to other sites."
 
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 awardees 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 applications submitted in response to
the present RFA may not exceed five years.  The anticipated award
date is February 1998. At this time the NICHD has not determined
whether or how the solicitation will be continued beyond the present
RFA.
 
Because the nature and scope of the research proposed in response to
this RFA may vary, it is anticipated that the sizes of the awards
will vary also.
 
Awards and level of support depend on receipt of a sufficient number
of applications of high scientific merit.  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.
 
FUNDS AVAILABLE
 
It is anticipated that between 6 and 8 awards for participating
centers will be made with an estimated total cost of  $3,000,000
(including direct, facilities, and administrative cost) for the
entire program for the first year ($1.5 million from NICHD and $1.5
million from ORMH).  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)
 
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.  The Steering Committee for this initiative
identified a number of areas of research interest and coordinated the
development of protocols which have been implemented.  Studies
currently in the field 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.
 
For this RFA, applicants should describe one or more research
hypotheses for consideration by the group of awardees.  We encourage
collaborative efforts by groups, and research topics will be
evaluated independently of resources required for network wide
participation.  Applicants should briefly describe research topics
which:  directly or indirectly address the problem of infant
mortality and morbidity in the District of Columbia, clarify the
relationship between the defined biological or sociological risk
factors and infant mortality and morbidity, could be designed to
address the question being asked, and which clarify the primary
sources of individuals to be studied, accounting for possible
co-interventions and reasonable accrual rates within the time limits
of the initiative and the boundaries of the District of Columbia.
 
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 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
interconceptional 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:
 
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 this RFA 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
representatives of the community, the Community Advisory Board.  The
study will proceed into the implementation phase only with the
concurrence of both the awardees and the NICHD.  Recognition that it
will not be possible to implement all the research projects proposed
for technical review is essential.  Other limiting considerations
will include:  (1) studies that are feasible to undertake in the
proposed research population, (2) the 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 data coordinating center (DCC), which will be
chosen through a separate RFA, will provide management support and
consultation in the design, execution, and analysis for
multi-institutional studies in the field of infant mortality, and
will ensure that the studies are of the highest scientific integrity
and meet rigorous statistical standards.  It will also assume
responsibility for any protocol-related training, monitoring of sites
for accurate and complete data collection, regulatory compliance, and
research subject safeguards. The DCC will be responsible for the
integrity of the scientific databases by editing and entering data,
as well as designing and maintaining the study database(s).  The DCC
will be functionally independent of all research sites, although it
could be physically located at one of them.
 
GUIDANCE AND MANAGEMENT STRUCTURES
 
It is expected that the first year of this initiative will be devoted
to the prioritization of research projects approved during initial
peer review, 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 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 both from current members of the
NIH-DC Initiative to Reduce Infant Mortality in Minority Populations
in the District of Columbia (competing renewal applications) and from
new applicants. Applicants must be able to propose research projects
and to demonstrate relevant research experience pertinent to the
objectives delineated in this RFA, qualifications of key personnel,
and proven capacity to recruit 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, also see review criteria).
 
Terms and Conditions of Award
 
These special Terms of Award are in addition to, and not in lieu of,
otherwise applicable OMB administrative guidelines, HHS Grant
Administration Regulations at 45 CFR Parts 74 and 92, and other HHS,
PHS, and NIH Grant Administration policy statements.
 
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 "assistance" mechanism (rather than an
"acquisition" mechanism) in which substantial NIH scientific and/or
programmatic involvement with the awardee is anticipated during the
performance of the activity.  Under the cooperative agreement, the
NIH purpose is to support and/or stimulate the recipient"s activity
by involvement in, and otherwise working jointly with, the award
recipient in a partner role, but it is not to assume direction, prime
responsibility, or a dominant role in the activity.  Consistent with
this concept, the dominant role and prime responsibility for the
activity resides with the awardee(s) for the project as a whole,
although specific tasks and activities in carrying out the studies
will be shared among the awardees and the NICHD staff designated
below.
 
A.  Awardees Rights and Responsibilities
 
The tasks or activities in which awardees have primary substantial
responsibilities include:  identification of priority issues for
research, research design and protocol development, participant
recruitment and follow- up, collection, quality control, and
transmission of accurate data in a timely manner, analysis and
interpretation of data, preparation of publication of results of
studies, interventions and trials done under this initiative, and
collaboration with other awardees and NICHD scientists.
 
Awardees will retain custody of and have primary right to their
site"s data developed under these awards, subject to Government
rights of access consistent with current HHS, PHS, and NIH policies.
The data developed under these awards will not be disseminated
publicly prior to publication or presentation of study results in a
peer reviewed forum.
 
The awardees 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.  Awardees will be required to accept and
implement the common protocol and procedures 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 for the Scientific Advisory Board, reporting findings to
the Steering Committee and protocol investigators.  Other NICHD
intramural scientific staff may collaborate with awardees in the
studies.
 
The NICHD Scientific Consultant, a staff member of the Epidemiology
Branch of the Division of Epidemiology, Statistics and Prevention
Research (DESPR) will provide scientific and technical assistance to
the awardee investigators. This assistance includes, assistance in
refining methodological issues of protocols, definition of study
populations, analysis plans, and evaluation of study 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 (or an
individual award) 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, an awardee"s nonparticipation in the
committee/group activities, or human subject ethical issues that may
dictate a premature termination.
 
C.  Collaborative Responsibilities
 
The management of the NIH-DC Infant Mortality Initiative includes
four committees:
 
(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 their conduct.  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.
 
Subcommittees will be established by the Steering Committee, as it
deems appropriate, the NICHD Program Officer will serve on the
subcommittees as appropriate.
 
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.
 
Awardees 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, HHS Grant Administration Regulations at 45
CFR Parts 74 and 92, and other HHS, PHS, and NIH Grant Administration
policy statements.  These special arbitration procedures described
above in no way affect the right of a recipient of a cooperative
agreement assistance grant to appeal an adverse determination in
accordance with PHS regulations at 42 CFR Part 50, Subpart D and HHS
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 new policy
results from the NIH Revitalization Act of 1993 (Section 492B of
Public Law 103-43) and supersedes and strengthens the previous
policies (Concerning the Inclusion of Women in Study Populations, and
Concerning the Inclusion of Minorities in Study Populations), which
have been in effect since 1990.  The new policy contains some
provisions that are substantially different from the 1990 policies.
 
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 20, 1994 (FR 59-14508-14513) and reprinted
in the NIH Guide for Grants and Contracts, Volume 23, Number 11,
March 18, 1994.
 
The usual NIH policies concerning research on human subjects also
apply.  All applications for clinical research submitted to the NIH
are required to address these policies.  NIH funding components will
not award grants or cooperative agreements that do not comply with
these policies.
 
Investigators may also obtain copies of the policy from the program
staff listed under INQUIRIES.  Program staff may also provide
additional relevant information concerning the policy.
 
LETTER OF INTENT
 
Prospective applicants are asked to submit by January 31, 1997, 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 and the 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 should be
sent to:
 
Barbara K. Wingrove
Division of Epidemiology, Statistics and Prevention Research
National Institute of Child Health and Human Development
6100 Executive Boulevard, 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 business offices and from the Extramural Outreach and
Information Resources Office, National Institutes of Health, 6701
Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910, telephone (301)
435-0714, email: asknih@odrockm1.od.nih.gov.
 
Budget
 
Facilities and administrative costs will be awarded in the same
manner as for research project grants (R01).  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 year"s budget for Phase I: Protocol design and
implementation planning will be limited to the following maximum
allowances:
 
Principal Investigator:     10 percent effort
Co-principal Investigator:   5 percent effort
Site Coordinator:           50 percent effort
Secretary:                  50 percent 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 per
institution  Other costs (itemize and individually justified) Not to
exceed $2500
 
Budgets for implementation of protocols must include estimated
research project costs for years 2 through 5 at the applicant"s
institution.  Actual annual budgets for subsequent years of the
Initiative of the member institutions of the NIH-DC Initiative to
Reduce Infant Mortality in Minority Populations in the District of
Columbia will be based on individual protocols in which these member
institutions are participating.   Budgets for  protocols will be
based on specific protocol requirements and availability of
funds.Determination of actual cost allocations will be those
requested by the individual protocol group(s) based on the
requirements of the approved protocols and approved by the Steering
Committee.
 
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 exact photocopies must be sent to:
 
DIVISION OF RESEARCH GRANTS
NATIONAL INSTITUTES OF HEALTH
6701 ROCKLEDGE DRIVE, ROOM 1040 - MSC 7710
BETHESDA, MD  20892-7710
BETHESDA, MD  20817 (for express/courier service)
 
At the time of submission, two additional copies of the application
must be sent to:
 
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
Bethesda, MD  20852 (for express/courier service)
 
Applications must be received by April 3, 1997.  If an application is
received after that date, it will be returned to the applicant
without review.  The DRG will not accept any application in response
to this RFA that is essentially the same as one currently pending
initial review, unless the applicant withdraws the pending
application.  The DRG will also not accept an application that is
essentially the same as one already reviewed.
 
Letter of Intent Receipt Date:  January 31, 1997
Application Receipt Date:       April 3, 1997
NICHD Council review:           September 1997
Anticipated Award Date:         February 1998
 
REVIEW CONSIDERATIONS
 
Upon receipt, applications will be reviewed for completeness by DRG
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 triage 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
merit and the documented ability of the investigators to meet the
RESEARCH OBJECTIVES of the RFA.  Although the technical merit of the
application is important, it will not be the sole criterion for
evaluation of the application.  Other considerations, such as access
to populations and qualifications of the project staff, will be part
of the evaluation criteria.
 
Review Criteria
 
A.  Experience with community-based perinatal studies or clinical
trials and protocol development.
 
Quality of the unit"s participation in either an intervention,
clinical trial or study of a cooperative nature in the recent past
(new applicants) or in ongoing protocols during the current grant
support period (current members in the initiative).
 
B.  Qualifications of Applicant
 
Interdisciplinary nature of potentially available scientific
collaborators reflecting several of the disciplines required for
these studies.
 
Knowledge and experience in areas relevant to the conduct of research
relevant to the area of infant mortality and low birth weight in
minority populations, including interventions and clinical trials,
and experience in research design.
 
Commitment of staff for the satisfactory conduct of the study.
 
Willingness to work as part of a cooperative study with other
participating members in the NICHD as outlined in the RFA.
 
C.  Qualifications of Personnel
 
Qualifications, research experience and commitment of the principal
investigator and key personnel, particularly, but not exclusively, in
the area of the proposed research.
 
Scientific, clinical and administrative abilities and academic
productivity of Principal Investigator and other team members.
 
Willingness to work as part of a cooperative study with other
participating members in the NICHD as outlined in the RFA.
 
D.  Available Population
 
Access to populations which may be the target of both research
projects or collaborative relationships in the community addressing
concerns in maternal- child health. Adequacy of plans to include both
genders and minorities and their subgroups as appropriate for the
research.  Plans for the recruitment and retention of subjects will
be evaluated.  The scientific peer  review group will also examine
the provisions for the protection of human  subjects and the safety
of the research environment.
 
E.  Evidence of Collaboration
 
Evidence of collaboration with other institutions, agencies, or
community- based organizations for outreach, case identification, and
participation in clinical trials.  Every collaborative initiative
cited should be accompanied by a letter of commitment specific to the
activity of this RFA.
 
F.  Facilities and management.
 
Availability of the resources necessary to perform the research,
Institutional assurance to provide support to this study in such
areas as fiscal administration, personnel management, space
allocation.  Facilities in which health care and support services are
provided or arranged for, including hours of operation and provision
for off-hour coverage.
 
G.  Data Systems Available
 
Current data systems for populations currently in care, preferably
computerized, including the description of the variables collected
and the data quality and management activities.
 
H.  (Optional) 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.
 
I.  Budget
 
Budgets will be reviewed on the basis of appropriateness for the work
proposed.
 
AWARD CRITERIA
 
Applications recommended by the NICHD Council will be considered for
award principally on scientific and technical merit.  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 awards made.
 
INQUIRIES
 
Written and telephone inquiries concerning this RFA are encouraged in
an 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 Executive Boulevard, 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 may be made to:
 
Ms. Mary Ellen Colvin
Grants Management Branch
National Institute of Child Health and Human Development
6100 Executive Boulevard, Room 8A17, MSC 7510
Bethesda, MD  20892-7510
Telephone:  (301) 496-1303
FAX:  (301) 402-0915
Email:  ColvinM@HD01.NICHD.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 USC 241), 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 PHS strongly encourages all grant and contract recipients to
provide a smoke-free workplace and promote the non-use of all tobacco
products.  In addition, Public Law 103-227, the Pro-Children Act of
1994, prohibits smoking in certain facilities (or in some cases, any
portion of a facility) in which regular or routine education,
library, day care, health care or early childhood development
services are provided to children.  This is consistent with the PHS
mission to protect and advance the physical and mental health of the
American people.
 
.


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NIH Funding Opportunities and Notices


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