Full Text HD-95-004


NIH GUIDE, Volume 23, Number 22, June 10, 1994

RFA:  HD-95-004

P.T. 34

  Behavioral/Social Studies/Service 
  Data Management/Analysis+ 

National Institute of Child Health and Human Development

Application Receipt Date: September 13, 1994


The National Institute of Child Health and Human Development (NICHD)
invites applications for a cooperative agreement to participate as
the Data Acquisition and Analysis Center (DAAC) in support of
planning and conducting research on the contexts of development and
developmental outcomes of children who are participating in Phase II
of the NICHD Study of Early Child Care (SECC).  The NICHD has an
active interest in the support of research on the development of
children who have been placed in child care arrangements during their
infancy.  In 1988, NICHD issued a Request for Applications (RFA) for
a cooperative agreement titled "Effects of non-parental infant day
care on child development."  The data collection for the study that
ensued will terminate at the end of 1994 and NICHD intends to extend
this cooperative agreement for an additional five years for the
purpose of follow-up studies of the same cohort of children.  The
requested follow-up will include (a) observational and test data
collection at two time periods between the ages of three and seven
and (b) telephone and/or mail data collection in the periods between
the face-to-face data collection periods.

This RFA is for the Data Acquisition and Analysis Center for the
second phase of the study, starting in the beginning of 1995 and to
be continued for a period of five years.

The Data Acquisition and Analysis Center (DAAC) for Phase II of the
NICHD Study of Early Child Care (SECC) will provide leadership and
consultation in the execution, close-out and analysis of the Phase II
study.  It will ensure that the results of the study and its
subprotocols are of the highest scientific integrity and meet
rigorous statistical standards.  The Data Acquisition and Analysis
Center will be functionally independent of all research sites,
although it could be physically located in one of the participating


The Public Health Service (PHS) is committed to achieving the health
promotion and disease prevention objectives of "Healthy People 2000,"
a PHS-led national activity for setting priority areas.  This RFA,
Data Acquisition and Analysis Center for Behavioral Research, is
related to the health of children and their families.  It is also
related to the Minority Health Initiative of the National Institutes
of Health.  Potential applicants may obtain a copy of "Healthy People
2000" (Full Report:  Stock No. 017-001-00474-0) or "Healthy People
2000" (Summary Report:  Stock No. 017-001-00473-1) through the
superintendent of Documents, Government Printing Office, Washington,
DC 20402-9325 (telephone 202-783-3238).


Applications may be submitted by domestic for-profit and non-profit
organizations, public and private, such as universities, colleges,
units of State and local governments, and eligible agencies of the
Federal government.  Applications from minority]y and women
investigators are encouraged.  Evidence of existing research
capabilities for multi-site studies must be demonstrated.


The mechanism used to support this research is the Cooperative
Agreement (U01), 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 NICHD staff's involvement in the research and by NICHD staff
working jointly with the award recipient in a partner role.  It is,
however, understood that NICHD staff is not to assume direction,
prime responsibility, or a dominant role in the research activity.
Specifically, in the case of the NICHD SECC, the study will continue
to be conducted as a collaboration among awardees at the data
collection sites, the awardee at the DAAC and the NICHD scientific
program staff.  Details of the responsibilities, relationships and
governance of the DAAC to be funded under the cooperative agreement
are discussed later in this document under the section "Terms and
Conditions of Award."

The total requested project period for an application submitted in
response to the present RFA may not exceed five years.  The
anticipated start date is April 1995.

At this time, the NICHD has not determined whether or how this
solicitation will be continued beyond the present RFA.


It is anticipated that one award will be made for a data acquisition
and analysis center for Phase II of the NICHD SECC.  The estimated
total cost for the first year is $ 750,000.  Although this program is
provided for in the financial plans of NICHD, the award of grants
pursuant to this RFA is contingent on the scientific and technical
merit of the application and on the availability of funds for this


Research Goals and Scope

The specific goal of the requested follow-up is to continue to
investigate the contexts of development and their impact on the same
developmental domains investigated in the first phase of the study
(the study of the children from one through 36 months of age).
Therefore, applicants for the DAAC need to present a plan for data
acquisition, monitoring, reduction and analysis for a follow-up study
that is comprehensive, describing the environments of child
development and tapping the social, emotional, cognitive, linguistic,
academic and health aspects of the development of children.  The
applicants will need to demonstrate expertise in handling all aspects
of (a) observational and test data collection at two time periods
between the ages of three and seven and (b) telephone and/or mail
data collection in the periods between the face-to-face data
collection periods.

In addition, applicants need to spell out their plan for creating a
data set that is compatible with that developed by the DAAC involved
in Phase I of the study.  This is important because the data sets
from Phase I and Phase II of the study will need to be merged to
allow analyses across the different age periods.


The Director of the DAAC for the second phase of the SECC will join
the Steering Committee in designing the specific research protocols.
She or he will participate in the development of operation manuals to
guide the implementation of the study in the ten research sites.
During the implementation of the study, the data center will provide
feedback regarding the data collected and interim analyses as guided
by the steering committee.

The DAAC must have expertise in research design as well as in
statistical methods appropriate for multi-site longitudinal research
designed primarily by developmental psychologists using
questionnaires, interviews, observations and tests as methods of data
collection.  The DAAC will serve as a centralized information
management system for collecting, editing, storing and analyzing
data.  It will be responsible for ensuring data integrity, accuracy,
and accessibility to the investigators of the study.  It will be
responsible for the timely production of operation manuals detailing
the study.  It will maintain strict independence from the other sites
participating in the cooperative agreement and will compile, as
needed, progress reports of ongoing components of the study.
Examples of additional functions of the DAAC are:

o  Develop methods for data and videotape storage that are compatible
with those used in Phase I of the NICHD SECC;

o  Finalize manuals describing protocols developed by the Steering

o  Contribute to the development of mechanisms for standardizing data
collection from all sites and implement quality control procedures;

o  Enter data into computerized data sets;

o  Develop plans for appropriate statistical analyses;

o  Provide the Steering Committee with reports on data;

o  Create public use data sets.

To promote the development of a collaborative program and to
facilitate the work of the DAAC, the DAAC director and select staff
members need to meet face-to-face with subcommittees of the Steering
Committee and with the full Steering Committee on a regular basis.
At such meetings, the DAAC Director will contribute to the planning
of the study, to the monitoring of its execution, and to the making
of decisions pertaining to data acquisition and analysis.

The applicant should specify the number of meetings that are required
in order to effectively conduct the business of Phase II of the SECC.

Terms and Conditions

I. The primary responsibilities of the DAAC are to:

o  Collaborate with the awardees of the NICHD SECC in the way
prescribed below.

o  Contribute to deliberations of the Steering Committee and serve as
a voting member of the Steering Committee.

o  Provide assistance in the development of research protocols.

o  Participate in the design of data collection instruments and

o  Prepare the final forms for data collection instruments and
produce the final versions of the manuals.

o  Provide consultation and assistance in the implementation of the
studies planned by the steering committee.

o  Monitor the sites to ensure standardization of procedures and
integrity of the data.

o  Design and implement efficient research data management systems.

o  Provide easy to use data archives with appropriate documentation
of procedures, problems, and analyses performed.

o  Assemble, check for quality, and document all the data collected
at the collaborating sites in line with the objectives set by the
Steering Committee.

o  Carry out data reduction and analysis in line with requests from
the Steering Committee or its subcommittees.

o  Present the Steering Committee with results based on Steering
Committee or subcommittee requests.

o  Assist the Steering Committee in the publication and dissemination
of results.

II.  Scientific Program Staff Involvement

The NICHD scientific project coordinator will be a Health Scientist
Administrator from the Human Learning and Behavior Branch, Center for
Research for Mothers and Children.  The NICHD scientific project
coordinator will:

o  Participate in the development of protocols for specific aspects
of the study.

o  Participate in the monitoring of the progress of ongoing studies,
including field data collection, standardization of methods across
study sites, adherence to protocol and quality control procedures.

o  Participate in data analysis, interpretation, and publication of
study results.

The NICHD reserves the right to terminate or curtail the DAAC in the
event of substantial shortfall in data acquisition, quality control,
data analysis or other major breach of the responsibilities of the

III.  Collaborative Responsibilities

o  Steering Committee.  The principal investigators from the awardee
institutions, the Director of the DAAC, the NICHD scientific project
coordinator and an independent chairperson constitute the Steering
Committee for Phase II of the NICHD SECC.  This Steering Committee is
the "corporate" principal investigator for the study and it plans and
oversees all the scientific work associated with the NICHD SECC.
Members of the Steering Committee collaborate with the other awardees
who are members and with NICHD scientific project coordinator.  They
contribute to the development of the various research protocols that
make up the comprehensive protocol of the SECC.  They design and
prepare data collection instruments and manuals.  They contribute to
plans for data reduction, data analyses and paper writing based on
the results of the study.

The DAAC will be required to implement the data acquisition and
analysis plans developed and/or approved by the Steering Committee.

o  Subcommittees.  Subcommittees will be established by the Steering
Committee, as it deems appropriate.  The NICHD scientific project
coordinator will serve on subcommittees as deemed necessary and

o  For the duration of the cooperative agreement, the combined,
common data set is managed by the DAAC. For the duration of the
cooperative agreement, the Steering Committee coordinates the
publication related activities of the investigators and the DAAC.

IV.  Arbitration Procedures

When agreement between the awardee and the NICHD staff cannot be
reached on scientific/programmatic issues that may arise after the
award, an arbitration panel will be formed.  The panel will consist
of one person selected by the principal investigators of the study,
one person selected by the NICHD staff and a third selected by these
two individuals.  The decision of the arbitration panel, by majority
vote, will be binding.

This special arbitration procedure in no way affects the awardee's
right to appeal an adverse action that is otherwise appealable in
accordance with the PHS regulations at 42 CFR Part 50, Subpart D and
HHS regulation at 45 CFR Part 16.



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 is 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) which have
been in effect since 1990.  The new policy contains some new
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 9, 1994 (FR 59 11146-11151), and reprinted
in the NIH GUIDE FOR GRANTS AND CONTRACTS of March 18, 1994, Volume
23, Number 11.

Investigators may obtain copies from the above sources or from the
program staff listed below.  Program staff may also provide
additional relevant information concerning the policy.

Since the cohort for the study is already in place, the applicant is
advised to build in procedures to safeguard against selective
attrition of gender or racial/ethnic groups.  Such procedures need to
be reported in the application.


The research grant application form PHS 398 (rev. 9/91) is to be used
in applying for the award.  This form is available at most
institutional offices of sponsored research; from the Office of
Grants Information, Division of Research Grants, National Institutes
of Health, 5333 Westbard Avenue, Room 449, Bethesda, MD 20982,
telephone (301) 584-7248; and from the NICHD scientific project
coordinator listed under INQUIRIES.

Additional Information

Information about the NICHD SECC Phase I, about the plans made by the
Steering Committee for Phase II, and about characteristics of the
data set for Phase I of the study will be provided by NICHD staff at
an open meeting to be held in Bethesda Maryland on June 17, 1994.
All interested applicants are invited to attend at their own cost.
Details about the meeting will be provided by the scientific project
coordinator listed under INQUIRIES.

To permit evaluation of the merits of an application (peer review)
information is needed on the following topics:

Professional staff available:

Description of the current staffing, including the proposed principal
investigator and co-principal investigator(s).  The DAAC should
include staff with background in statistics and developmental
psychology.  Expertise in demography, sociology and economics would
be helpful.  A demonstration of staff experience and capability to
develop research protocols is critical.  Information about training
and experience of relevant staff, especially in large scale,
multi-site studies in the social sciences would be required.

Documentation should be provided showing that the personnel involved
in data management and data processing aspects of the project have
experience in 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.

Expertise in research methodology:

The staff of the proposed DAAC must demonstrate expertise in the
design of surveys, cohort studies, multi-site studies and in-depth
research in developmental psychology.  Applicants must provide a
description of their experience in designing such studies with
special emphasis on the statistical expertise required, as well as
examples of past or current projects requiring such expertise.

The applicants must document their understanding of basic elements
required for a DAAC.  This should include an understanding of
computer logistics, programming, coding, data processing, file
building, file and program documentation, and file maintenance.

The applicants must demonstrate their 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 research protocols, design and pretesting of
questionnaires and other research instruments.  An indication of
expertise in coordinating the training of staff in the use of these
protocols and questionnaires and expertise in ensuring quality
control of data collection across several sites would be most useful.

The applicants must demonstrate their ability to design and implement
efficient Research Data Management Systems.  The applicant should
describe methodology to prepare study manuals of operation, keep
track of data, provide ready accessibility of data at any point in
the study, maintain current documentation, and maintain backups of
all data entered.

Since this competition is for a DAAC for the second phase of the
NICHD SECC, the applicants must demonstrate their willingness to work
with the data acquisition and analysis centers that have worked on
the first phase of the study.

Resources and environment:

The application should include descriptions of:

o  Facilities and equipment. The facilities and equipment available,
including computer hardware and software for use by the project.

o  Support systems and services. Support systems and services which
are currently provided by the applicant's organization.

o  Data systems available.  Current data systems controlled by the
applicant or available to the applicant for use in connection with

The RFA label available in the PHS 398 (rev. 9/91) application form
must be affixed to the bottom of the face page of the application.
Failure to use this label could result in delayed processing of the
application such that it may not reach the review committee in time
for review.  In addition, the RFA title and number must be typed on
line 2a of the face page of the application form and the YES box must
be marked.

The applicant must submit a signed, typewritten original of the
application, including the checklist, and three signed photocopies in
one package to:

Division of Research Grants
National Institutes of Health
Westwood Building, Room 240
Bethesda, MD  20892**

At the time of submission, two copies of the application must be sent
under separate cover to:

Susan Streufert, Ph.D.
Division of Scientific Review
National Institute of Child Health and Human Development
6100 Executive Boulevard, Room 5E03
Bethesda, MD  20892


Review Method

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, a
process (triage) may be used by the initial review group in which
applications will be determined to be competitive or non-competitive
based on their scientific merit relative to other applications
received in response to the RFA.  Applications judged to be
competitive will be discussed and be assigned a priority score.
Applications determined to be non-competitive will be withdrawn from
further consideration and the Principal Investigator and the official
signing for the applicant organization will be notified.

In addition to standard criteria used in NIH peer review for the
evaluation of scientific and technical merit, special additional
evaluation criteria for the application are as follows:

o  Experience with large, multi-site behavioral science studies;

o  Expertise in statistics, developmental psychology and related
disciplines (demography, sociology, behavioral pediatrics);

o  Demonstrated ability to finalize protocols, questionnaires and
other research instruments;

o  Demonstrated ability to serve as data center in multi-site
collaborative investigations including quality control and training

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  Facilities and equipment available;

o  Staffing, including the ability to draw on backup resources when
demand increases.


The anticipated award date is April 1, 1995.  Applications
recommended by the NICHD Advisory Council will be considered for
award based upon (a) scientific and technical merit; (b) sufficient
compatibility of features that promise to enhance collaboration; and
(c) availability of funds.

Application Receipt Date:          September 13, 1994
Review by NICHD Advisory Council:  January 31, 1995
Anticipated Award Date:            April 1, 1995


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

Direct inquiries regarding programmatic issues to:

Sarah L. Friedman, Ph.D.
Center for Research for Mothers and Children
National Institute of Child Health and Human Development
Building 61E, Room 4B05
Bethesda, MD  20892
Telephone:  (301) 496-6591
FAX:  (301) 402-2085
Bitnet:  SF2@NIHCU

Direct inquiries regarding fiscal matters to:

Mary Ellen Colvin
Office Of Grants and Contracts
National Institute of Child Health and Human Development
Building 61E, Room 8A17
Bethesda, MD  20892
Telephone:  (301) 496-1303
FAX:  (301) 402-0915
Bitnet:  QMI@NIHCU


This program is described in the Catalog of Federal Domestic
Assistance No. 93.865.  Awards are made under the authorization of
the Public Health Services Act, Title IV, Part A (Public Law 78-410,
as amended by Public Law 99-158, 42 USC 241 and 285) and administered
under PHS grants policies and Federal Regulations 42 CFR 52 and 45
CFR Part 74 and 92.  This program is not subject to the
intergovernmental review requirements of Executive Order 12372 or
Health Systems Agency review.

The Public Health Service (PHS) strongly encourages all grant
recipients to provide a smoke-free workplace and promote the non-use
of all tobacco products.  This is consistent with the PHS mission to
protect and advance the physical and mental health of the American


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