Full Text HD-94-013

PERINATAL EMPHASIS RESEARCH CENTERS

NIH GUIDE, Volume 23, Number 1, January 7, 1994

RFA:  HD-94-013

P.T. 04

Keywords: 
  0755013 
  Biomedical Research, Multidiscipl 
  Infants 
  Pregnancy 


National Institute of Child Health and Human Development

Letter of Intent Receipt Date:  February 7, 1994
Application Receipt Date:  May 24, 1994

PURPOSE

The National Institute of Child Health and Human Development (NICHD)
invites applications from current members of the Perinatal Emphasis
Research Centers (PERC) program (competitive continuation
applications) and from prospective members (new applications) with
the objective of encouraging investigators to develop
multidisciplinary research efforts that will advance knowledge about
diseases and disorders of pregnancy and infancy and special issues
relevant to rural populations.  These grants are for the support of
hypothesis-testing research efforts; they are not intended to support
service or demonstration projects.  PERCs are organized around
problem/need themes and are established where research can be
coordinated with existing programs of health care to ensure the rapid
assimilation of new scientific knowledge into health care delivery.
Active PERCs are addressing issues in high-risk pregnancies
(diabetes, hypertension), prevention of prematurity, fetal hypoxia,
intrauterine growth retardation, and infant sleep physiology.  PERC
centers work closely with the NICHD in participating in the center
network and in carrying out its objectives in a manner consistent
with NICHD goals and missions.

HEALTHY PEOPLE 2000

The Public Health Service (PHS) is committed to achieving the health
promotion and disease prevention objectives of "Healthy People 2000,"
a PHS-led national activity for setting priority areas.  This Request
for Applications (RFA), Perinatal Emphasis Research Centers, is
related to the priority area of maternal and infant 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).

ELIGIBILITY REQUIREMENTS

The need for continuous and active communication among centers
mandates that only institutions in the United States will be eligible
for participation.  Domestic, non-profit organizations and
institutions are eligible to apply.  Applications from minority
individuals and women are encouraged.  As stated in the NICHD Center
Guidelines, the NICHD will not support more than one NICHD center
grant (P50) in a given department or specialty unit.

MECHANISM OF SUPPORT

Grants will be awarded using the NIH specialized research center
grant (P50) mechanism.  Review of applications and management of
grants will be subject to applicable policies for NIH research center
P50 grants.  The P50 is an institutional award, made in the name of a
Principal Investigator, and awarded competitively.  It provides
support for both research projects and the core services used by
those projects.  It is expected that up to two awards will be made as
the result of this announcement (one award in the area of
perinatology and one in the area of rural maternal-infant health).
The number of grants to be awarded is contingent upon receipt of a
sufficient number of meritorious applications.  Awards will be made
initially for a five-year period with an option for renewal following
competitive review.

FUNDS AVAILABLE

Although the program is included and provided for in the financial
plans for FY 1994, award of PERC grants is contingent upon ultimate
allocation of appropriated funds for this purpose.  Awards will not
exceed $500,000 for direct costs for the first year for new
applications, plus up to four percent of current award for
competitive renewal applications.  The initial award will be made for
a period of five years.  Budgets of applications for new and renewal
support will be stringently reviewed within these guidelines.

RESEARCH OBJECTIVES

Background

A major goal of the Pregnancy and Perinatology (PP) Branch of the
Center for Research for Mothers and Children (CRMC) of the NICHD is
the prevention of diseases and disorders during pregnancy and
infancy.  Too many infants are born too soon, too small for their
gestational age, or with an abnormality in development initiated
prior to birth or shortly thereafter that causes immediate or delayed
abnormality in structure or function.  If all newborns were free of
defects and were mature enough to cope during the first month of
life, much of this nation's infant mortality and morbidity could be
eliminated.

The PP Branch invites applications for research centers to develop
new knowledge about diseases and disorders of pregnancy and infancy
with the aim of reducing infant morbidity and mortality.  By issuing
this RFA, the CRMC is indicating its wish to encourage investigator
interest in developing multidisciplinary research efforts that will
advance knowledge in areas important to its mission.

A PERC grant is used to promote and support multidisciplinary
research efforts in areas where (a) knowledge gaps are not being
sufficiently addressed by ongoing research, or (b) there are needs to
stimulate and intensify efforts in promising research areas.
Research areas for PERC grants have been and will continue to be
identified by CRMC and PP in consultation with outside advisors.
Through the PERC programs for mothers and infants, NICHD has
undertaken concerted biomedical and behavioral research efforts
directed toward improving pregnancy outcome and ensuring infant
survival and well-being.  PERCs are located throughout the United
States and presently are addressing the issues listed in the PURPOSE
paragraph above.

Research Goals and Scope

In addition to the areas addressed in the current PERCs, which
continue to be of interest, it is recognized that other medical
problems need to be approached in the same multidisciplinary fashion.
Clinical studies may include etiologic mechanisms, improvement of
diagnostic techniques, and various aspects of prevention and
management.  All investigative approaches can be used from molecular
biology to cellular, organ or whole organism physiology, epidemiology
as well as clinical evaluations.  The PERC in rural health may
address, among other problems, distance to available medical
facilities and the effect on rates of preventable illnesses and
disease.  Supported research may be carried out in experimental
animals.  The development of animal models may be necessary in
selected areas.  A minimum of one subproject must address issues in
patients.

Research concerns include, but are not necessarily limited to, the
following:

1.  High-Risk Pregnancies (e.g., diabetes, hypertension, drug abuse)
- Effects upon pregnancy, fetal development, and neonatal adaptation.

2.  Intrauterine Growth - All aspects that may contribute to the
regulation of fetal growth such as role of growth factors, hypoxia,
nutrients, hormones, infections; placental function; regulation of
maternal blood volume and uterine and umbilical blood flow;
methodology to assess fetal health and development.

3.  Perinatal Toxicology and Pharmacology - Effects of drug
administration to the mother or fetus on gestation and pregnancy
outcome; neonatal toxicology and pharmacology; drug distribution in
tissues; role of nutrition, stage of pregnancy, placental function,
and maternal or fetal disease; interplay of genetic composition and
environment; drug action during perinatal period on both mother
and/or fetus and newborn infant.

4.  Initiation of Labor - Normal and abnormal mechanisms and outcomes
in term, preterm, and/or postterm births.

5.  Neonatal Disorders - Adaptation, response to external stimuli,
unique nutritional requirements, response to acute and chronic injury
(including asphyxia, ROP, BPD, NEC), remodeling and repair, immune
function, and development.

6.  Perinatal epidemiology and clinical research addressing the
special needs of rural populations.  Overall goals are similar to the
ones stated above; developing and testing interventions to reduce
infant mortality, low birth weight, intrauterine growth retardation,
and preterm delivery as they apply to stable and statewide rural
populations.

One center will be awarded to applications addressing issues
mentioned in the first five bullets and the other center to an
application focused on rural health.

STUDY POPULATIONS

SPECIAL INSTRUCTIONS TO APPLICANTS REGARDING IMPLEMENTATION OF NIH
POLICIES CONCERNING INCLUSION OF WOMEN AND MINORITIES IN CLINICAL
RESEARCH STUDY POPULATIONS

NIH policy is that applicants for NIH clinical research grants and
cooperative agreements will be required to include minorities and
women in study populations so that research findings can be of
benefit to all persons at risk of the disease, disorder or condition
under study; special emphasis should be placed on the need for
inclusion of minorities and women in studies of diseases, disorders
and conditions which disproportionately affect them.  This policy is
intended to apply to males and females of all ages.  If women or
minorities are excluded or inadequately represented in clinical
research, particularly in proposed population-based studies, a clear
compelling rationale should be provided.

The composition of the proposed study population must be described in
terms of gender and racial/ethnic group.  In addition, gender and
racial/ethnic issues should be addressed in developing a research
design and sample size appropriate for the scientific objectives of
the study.  This information should be included in the form PHS 398
in Sections 1-4 of the Research Plan AND summarized in Section 5,
Human Subjects.

Applicants are urged to assess carefully the feasibility of including
the broadest possible representation of minority groups.  However,
NIH recognizes that it may not be feasible or appropriate in all
research projects to include representation of the full array of
United States racial/ethnic minority populations (i.e., Native
Americans (including American Indians or Alaskan Natives),
Asian/Pacific Islanders, Blacks, Hispanics).

The rationale for studies on single minority population groups should
be provided.

For the purpose of this policy, clinical research includes human
biomedical and behavioral studies of etiology, epidemiology,
prevention (and preventive strategies), diagnosis, or treatment of
diseases, disorders or conditions, including but not limited to
clinical trials.

The usual NIH policies concerning research on human subjects also
apply.  Basic research or clinical studies in which human tissues
cannot be identified or linked to individuals are excluded.  However,
every effort should be made to include human tissues from women and
racial/ethnic minorities when it is important to apply the results of
the study broadly, and this should be addressed by applicants.

For foreign awards, the policy on inclusion of women applies fully;
since the definition of minority differs in other countries, the
applicant must discuss the relevance of research involving foreign
population groups to the United States' populations, including
minorities.

If the required information is not contained within the application,
the application will be returned.

Peer reviewers will address specifically whether the research plan in
the application conforms to these policies.  If the representation of
women or minorities in a study design is inadequate to answer the
scientific question(s) addressed AND the justification for the
selected study population is inadequate, it will be considered a
scientific weakness or deficiency in the study design and will be
reflected in assigning the priority score to the application.

All applications for clinical research submitted to NIH are required
to address these policies.  NIH funding components will not award
grants or cooperative agreements that do not comply with these
policies.

LETTER OF INTENT

Prospective applicants are asked to submit, by February 7, 1994, a
letter of intent that includes a descriptive title of the proposed
research; the name, address, and telephone number of the Principal
Investigator; the identities of other key personnel and participating
institutions; and the number and title of the RFA in response to
which the application may be submitted.

Although a letter of intent is not required, is not binding, and does
not enter into the review of subsequent applications, the information
that it contains is helpful in planning for the review of
applications.  It allows NICHD staff to estimate the potential review
workload and to avoid conflict of interest in the review.  The letter
of intent is to be sent to Dr. Charlotte Catz at the address listed
under INQUIRIES.

APPLICATION PROCEDURES

Detailed guidelines are found in "NICHD Research Center Programs" -
P50 specialized research center guidelines (hereafter called NICHD
Center Guidelines).  The guidelines include the following
restrictions:  (1) a five-year total program funding period, (2) at
least three projects at all times, and (3) each core serving as a
resource for at least three projects at all times.  The NICHD Center
Guidelines may be obtained from Dr. Charlotte Catz at the address
listed under INQUIRIES.

Applicants for P50 grants must propose a program of not fewer than
three and not more than six related and integrated research projects
of high quality that provides a multidisciplinary, yet unified
approach to the problem to be investigated.  Each project must be
fully developed within the prescribed 20-page limit.  The applicant
cannot rely upon a site visit to explain the proposed research.  The
center program must have at least three projects at all times.

The principal investigator for the PERC must be a scientist who can
provide strong, effective administrative and scientific leadership.
He/she will be responsible for the organization and operation of the
PERC and for communication with the NICHD on scientific and
operational matters.  Scientific personnel and institutional
resources capable of providing a strong research base in the field
specified must be available.  In addition, the institution and
pertinent departments have to show a strong commitment to the
center's support.

Both administrative and research core facilities must be adequately
described and documented (see NICHD Center Guidelines) to show how
they will support the proposed research.  Cores must support a
minimum of three research projects at any one time during the entire
five-year period of support.  A description of the population
available to carry out the clinical studies is needed, indicating
what studies are planned.

Interdisciplinary collaboration among center scientists is considered
a necessity for an effective PERC program.  As part of the
application, a plan must be submitted indicating how continuing
interaction among participating scientists will achieve an
interdisciplinary approach to the problem to be studied.  It is a
goal of the NICHD to promote active collaboration among PERCs.  To
accomplish this goal, successful applicant(s) will be encouraged to
participate in the collaborative efforts of established PERC
programs.

A complete application must be prepared using research grant
application form PHS 398 (rev. 9/91) following both the PHS 398
instructions and the NICHD P50 Center Guidelines.  Appropriate human
subject and animal welfare documentation must be submitted before the
review.  Applications must be identified by checking the "YES" box in
Item 2a and typing in the words "RFA HD-94-013" in Item 2a on the
front page of the grant application form.  This RFA indicates plans
by NICHD to make two awards in fiscal year 1994-95 (one in perinatal
medicine, and one in perinatal rural health).  Application must be
received by April 10, 1994.  Late or incomplete applications will not
be accepted.  Instructions in the PHS 398 (rev. 9/91) grant
application kit must be followed, and the RFA label (supplied in the
application kit) must be attached to the bottom of the face page of
the original grant application and placed on top of the entire
package.  The original and three copies of the application should be
mailed or delivered to:

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

Two copies of the application must also be sent to:

Susan Streufert, Ph.D.
Division of Scientific Review
National Institute of Child Health and Human Development
Building 6100E, Room 5E03F
Bethesda, MD  20892
Telephone:  (301) 496-1485

REVIEW CONSIDERATIONS

Applications will be received by the NIH Division of Research Grants
and reviewed for completeness.  Incomplete applications will be
returned to the applicant.  NICHD staff will review the applications
for responsiveness to the RFA.  Applications judged to be
nonresponsive will be returned.  Responsive applications may be
subjected to a triage by a peer-review group to determine the
scientific merit relative to the other applications received in
response to this RFA.  NICHD will withdraw from competition those
applications judged to be non-competitive and will notify the
applicant and institutional official.  Those applications judged to
be competitive will be further evaluated for scientific and technical
merit by a review group convened solely for this purpose by the
Division of Scientific Review, NICHD.  Following review by the
Initial Review Group, applications will be evaluated by the National
Advisory Child Health and Human Development Council at its September
1994 session.  The earliest possible funding date is September 29,
1994.  Review procedures and criteria are detailed in the P50
Specialized Research Center Grant Guidelines.  Applications will be
reviewed under the criteria indicated below:

1.  Significance of the proposed research program to the CRMC
perinatal research mission.

2.  Scope and breadth of the center's program, the component research
projects, and core units.

3.  Suitability of the program's central theme for a cooperative
research effort.

4.  Multidisciplinary scope of the program and provisions for
coordinating the research projects and core units.

5.  Leadership and scientific stature of the program director and
his/her ability to meet the program's demands of time and effort.

6.  Adherence to NIH policy regarding inclusion of women and
minorities.

The review of the projects and core units will consider:

1.  Scientific merit of each project and the relation of the project
to the central theme of the overall program (a simple compilation of
several R01-type projects loosely related will not be acceptable).

2.  Technical merit, cost effectiveness, and quality control of each
core unit (each core should be used by at least three research
projects).

3.  The appropriateness of the research projects' use of core
services.

4.  Qualifications, experience, and commitment of the investigators
responsible for the research projects or core units and their ability
to devote the required time and effort to the program.

5.  Appropriateness of budgetary requests.

6.  The adequacy of the means proposed for protecting against risks
to human subjects, animals, and/or environment.

7.  Participation of a suitable number of responsible, experienced
investigators.

8.  Academic and physical environment as it bears on patients, space,
and equipment, and on the potential for interaction with scientists
from other departments and institutions.

9.  Arrangements for internal quality control of ongoing research,
the allocation of funds, day-to-day management, contractual
agreements, and internal communication and cooperation among the
investigators in the program.

10.  Presence of an administrative and organizational structure
conducive to attaining the objectives of the proposed program.  The
existence of an external advisory board and a description of its
function are necessary.

11.  Institutional commitment to the requirements of the program.

INQUIRIES

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

Direct inquiries regarding programmatic issues and address the letter
of intent to:

Dr. Charlotte Catz
Center for Research for Mothers and Children
National Institute of Child Health and Human Development
Building 6100E, Room 4B03E
Bethesda, MD  20892
Telephone:  (301) 496-5575
FAX:  (301) 402-2085

Inquiries regarding budgetary issues may be directed to:

Mr. Douglas Shawver
Office of Grants and Contracts
National Institute of Child Health and Human Development
Building 6100E, Room 8A17F
Bethesda, MD  20892
Telephone:  301) 496-1303

Schedule

Letter of Intent Receipt Date:        February 7, 1994
Application Receipt Date:             May 24, 1994
Initial Review:                       July 1994
Review by National Advisory Council:  September 1994
Anticipated Award Date:               September 29, 1994

AUTHORITY AND REGULATIONS

This program is described in the catalog of Federal Domestic
Assistance No. 13.965, Research for Mothers and Children.  Awards
will be made under the authority of the Public Health Service Act,
Sections 1004, 301 and 444, and administered under PHS grants
policies and Federal Regulations 42 CFR Part 52 and 45 CFR Part 74.
This program is not subject to A-95 Clearinghouse or Health Systems
Agency Review.

.

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