Subject: (Copy) NIH GUIDE - V21(09) 03/06/92 - P2/2
From: Dot Baker <[email-masked]>
To: [email-masked]
Date: Mon, 30 Mar 92 08:14 EST

Hi,
     Part 29 of the 3/6/92 NIH Guide.  Please post to the NIH
Listserver as:   NIHGUIDE2.920306
 ---------------------------- Text of forwarded message -----------------------
 
$$XID NIHGUIDE 19920306 V21N09 P2O2 ************************************
o  Identification and analysis of the NF1 and NF2 gene products and
their functions in normal cellular physiology, in the pathophysiology
of neurofibromatosis, and in tumorigenesis.
 
o  Basic studies of neurodevelopmental mechanisms affected by
neurofibromatosis such as neural crest cell migration and
differentiation.
 
o  Understanding the nature and neurobiologic basis of the cognitive
impairment associated with NF1.
 
o  Development and assessment of new and innovative therapeutic
strategies for the many associated manifestations of NF1 and NF2.
 
STUDY POPULATIONS
 
SPECIAL INSTRUCTIONS TO APPLICANTS REGARDING IMPLEMENTATION OF NIH
POLICIES CONCERNING INCLUSION OF WOMEN AND MINORITIES IN CLINICAL
RESEARCH STUDY POPULATIONS
 
NIH and ADAMHA policy is that applicants for NIH/ADAMHA 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 must 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 must 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 must be included in the form PHS 398 in
Section 2, A-D of the research plan AND summarized in Section 2, E,
Human Subjects.  Applicants/offerors 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 must be provided.
 
For the purpose of this policy, clinical research is defined as 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 review will be deferred until the information is provided.
 
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.
 
APPLICATION PROCEDURES
 
Applications are to be submitted on the grant application form PHS 398
(rev. 9/91) according to instructions contained in the application kit.
Application kits are available from most institutional business offices
and may be obtained from the Office of Grants Inquiries, Division of
Research Grants, Westwood Building, Room 449, National Institutes of
Health, Bethesda, MD 20892, telephone 301-496-7441.
 
Check "yes" in item two on the face sheet of the application and type
"Neurofibromatosis, and PA-92-47."
 
Applicants for the P01 or P50 must use the application format as
described in the NINDS pamphlet, "Application Guidelines:  Program
Project and Clinical Research Center Grants," or the NCI pamphlet,
"Program Project Grant of the National Cancer Institute," which may be
obtained from the contacts listed under Inquiries.
 
Deadlines for the receipt of applications are February 1, June 1, and
October 1.  The completed original application and five legible copies
must be sent or delivered to:
 
Division of Research Grants
National Institutes of Health
Westwood Building, Room 240
Bethesda, MD  20892**
 
REVIEW CONSIDERATIONS
 
Applications will be assigned on the basis of established Public Health
Service referral guidelines.  Applications will be judged on scientific
merit and program relevance in accordance with NIH policy and
procedures involving peer review.  An initial review will be made by an
appropriate study section of the Division of Research Grants for
research grants and FIRST awards, and by an appropriate Institute or
Center committee for program project and center applications.  A second
level of review will be made by an appropriate national advisory
council.
 
AWARD CRITERIA
 
Applications will compete for available funds with all other approved
applications.  The following will be used in making funding decisions:
 
o  Quality of the proposed project as determined by peer review
 
o  Availability of funds
 
o  Program balance among research areas of the announcement
 
INQUIRIES
 
For further information regarding this announcement, potential
applicants may write or call:
 
Philip H. Sheridan, M.D.
Developmental Neurology Branch
National Institute of Neurological Disorders and Stroke
Federal Building, Room 8C10
Bethesda, MD  20892
Telephone:  (301) 496-6701
 
or
 
Michael R. Martin, Ph.D.
The Tumor Biology Program
National Cancer Institute
6120 Executive Plaza South, Room 630
Rockville, MD  20852
Telephone:  (301) 496-7028
 
For fiscal and administrative inquiries regarding this announcement,
potential applicants may write or call:
 
Gary P. Fleming, J.D.
Grants Management Branch
National Institute of Neurological Disorders and Stroke
Federal Building, Room 1004
Bethesda, MD  20892
Telephone:  (301) 496-9231
 
or
 
Robert Hawkins
Grants Administration Branch
National Cancer Institute
6120 Executive Plaza South, Room 243
Rockville, MD  20852
Telephone:  (301) 496-7933
 
AUTHORITY AND REGULATIONS
 
This program is described in the Catalog of Federal Domestic Assistance
No. 93.853, Clinical Research Related Neurological Disorders and
93.854, Biological Basis Research in the Neurosciences.  Awards are
made under authorization of the Public Health Service Act, Title IV,
Part A (Public Law 78-410, as amended by Public Law 99-150, 42 USC 241
and 285) and administered under PHS grants policies and Federal
Regulations 42 CFR 52 and 45 CFR Part 74.  This program is not subject
to the intergovernmental review requirements of Executive Order 12372
or Health Systems Agency review.
 
$$P3 END ************************************************************
 
$$P4 BEGIN PA-92-48 *************************************************
 
THE HEREDITARY ATAXIAS INCLUDING MACHADO-JOSEPH DISEASE
 
NIH GUIDE, Volume 21, Number 9, March 6, 1992
 
PA:  PA-92-48
 
P.T. 34; K.W. 1002019, 0765035, 1002058, 0745020, 0785055
 
National Institute of Neurological Disorders and Stroke
 
PURPOSE
 
The Convulsive, Developmental, and Neuromuscular Disorders Program of
the National Institute of Neurological Disorders and Stroke (NINDS)
encourages the submission of applications for research grants related
to the hereditary ataxias including Machado-Joseph Disease (MJD).  The
NINDS invites grant applications to support research on all aspects of
this heterogeneous group of inherited degenerative disorders including
pathophysiology, epidemiology, molecular genetics, diagnosis, and
treatment.
 
HEALTHY PEOPLE 2000
 
The Public Health Service (PHS) is committed to achieving the health
promotion and disease prevention goals of "Healthy People 2000," a
PHS-led national activity for setting priorities.  This program
announcement, The Hereditary Ataxias Including Machado-Joseph Disease,
is related to the priority areas of physical activity and fitness, and
chronic disabling conditions.  Potential applicants may obtain a copy
of "Healthy People 2000" (Full Report:  No. 017-001-474-0, or 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
 
Applications may be submitted by foreign and domestic, for-profit and
non-profit organizations, public and private, such as universities,
colleges, hospitals, laboratories, units of State and local
governments, and eligible agencies of the Federal Government.
Applications from minority individuals and women are encouraged.
However foreign institutions are not eligible for the First Independent
Research Support and Transition (FIRST) Award (R29).
 
MECHANISMS OF SUPPORT
 
Applicants may use the Research Project Grant (RO1), Research Program
Project (PO1), Research Center Grant (P50), and First Independent
Research Support and Transition Award (R29).  Prospective applicants
are encouraged to communicate with the NINDS program contact listed at
the end of the announcement regarding the appropriate funding
mechanism.
 
RESEARCH OBJECTIVES
 
The hereditary ataxias, in general, encompass a variety of degenerative
disorders, interchangeably referred to as spinocerebellar
degenerations, that are difficult to classify due to limited knowledge
of etiologic factors, variability of clinical manifestations, and
limited correlation between clinical signs and postmortem changes.
Onset of system degenerations may span a lifetime but often begin in
the first to second decade of life.
 
In the past, the hereditary ataxias have been categorized into
predominantly spinal, spinocerebellar, and pure cerebellar forms based
on a "typical" clinical picture and age of onset of signs and symptoms.
Familial inheritance has been clearly shown in many of these disorders,
and families may exhibit x-linked recessive, autosomal dominant or
recessive patterns.
 
The predominant presentation is the development of a chronic,
progressive ataxia with variable signs and symptoms referable to the
cerebellum and its afferent and efferent pathways, posterior columns,
pyramidal tracts, basal ganglia, brainstem nuclei, other brain regions
and peripheral nerve.  In addition, there may be visual impairment
(optic atrophy, pigmentary retinal degeneration), hearing dysfunction
(sensory neural hearing loss), dermatological manifestations,
hypogonadism, dementia, and, in some disorders, definable biochemical
or genetic abnormalities.
 
Though the clinical picture may be consistent within a family, there
may be gradations of presentation that result in overlap and somewhat
arbitrary distinctions, between disease entities.  Examples of diseases
addressed in this announcement include MJD, hereditary spinocerebellar
ataxias (Friedreich's Syndrome), hereditary cerebellar ataxias,
ataxia-telangiectasia, hereditary spastic paraplegia, Roussy-Levy and
Marinesco-Sjogren syndrome, abetalipoproteinemia (Bassen-Kornzweig
syndrome), Refsum's disease and dyssynergia cerebellaris myoclonica
(Ramsay Hunt syndrome).  One representative example of the hereditary
ataxias, MJD, is an autosomal dominant, hereditary, progressive motor
system disease initially identified among families of
Portuguese-Azorean descent but now identified worldwide in many ethnic
groups.  Three main syndromes have been described based on
heterogeneity of clinical expression felt to be phenotypic
variabilities of a single gene mutation.  The progressive neurological
deficits result in death from debilitation within 10 to 30 years of
onset.  To date, there is no genetic or biochemical marker.  There is
no effective treatment or cure.  Prevention depends on limited genetic
counseling of identified families.
 
In June 1991 an NINDS-sponsored international workshop on Research
Initiatives on Machado-Joseph Disease explored issues on the
description of the clinical spectrum and epidemiology, neuropathology
and neurochemistry, molecular genetics, and improving diagnosis and
treatment.  Research needs and priorities include more precise
diagnosis, elucidation of the pathophysiology, molecular genetics, and
treatment of this, and similar ataxic disorders.
 
The goals of this announcement are to stimulate research in both basic
science and clinical aspects related the hereditary ataxias including
MJD.  The scope of this program encompasses both animal and human
studies that would utilize a variety of experimental approaches and
methods.  A major emphasis is to expand research of the underlying
mechanisms of early brain degeneration inherent to each of the
hereditary ataxias.  Multidisciplinary and collaborative studies are
encouraged.  Examples of areas of potential research include, but are
not limited to, the following:
 
o  Standardized definitions and diagnoses:  research criteria and
classifications.
 
o  Longitudinal studies that describe the natural history of disease
and that provide complete descriptions of clinical signs and symptoms
of disease within families.
 
o  Neuroepidemiological studies of at-risk populations.
 
o  Experimental animal models with cerebellar system degenerations that
have features consistent with neuropathological changes of the
disorder.
 
o  Collaborative neuropathological studies on affected and at-risk
populations utilizing a variety of techniques that better identify the
first cells to be affected, the progression of the disease, and the
type of dysfunction that occurs in those cells prior to death.
 
o  Evaluate possible therapeutic interventions to retard the
progression of disease.
 
o  Neurochemical studies to define pathophysiology and to enable
premorbid diagnosis or risk determination.
 
o  Studies utilizing neurodiagnostic and neuroimaging modalities.
 
o  Collaborative efforts on genetic research with an interchange of
families, probes, and results towards identifying the defective gene(s)
and gene products.
 
STUDY POPULATIONS
 
SPECIAL INSTRUCTIONS TO APPLICANTS REGARDING IMPLEMENTATION OF NIH
POLICIES CONCERNING INCLUSION OF WOMEN AND MINORITIES IN CLINICAL
RESEARCH STUDY POPULATIONS
 
NIH and ADAMHA policy is that applicants for NIH/ADAMHA 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 must 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 must 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 must be included in the form PHS 398 in
Section 2, A-D of the research plan AND summarized in Section 2, E,
Human Subjects.  Applicants/offerors 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 must be provided.
 
For the purpose of this policy, clinical research is defined as 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 review will be deferred until the information is provided.
 
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.
 
APPLICATION PROCEDURES
 
Applications are to be submitted on the grant application form PHS 398
(rev. 9/91) according to instructions contained in the application kit.
Application kits are available from most institutional business offices
and may be obtained from the Office of Grants Inquiries, Division of
Research Grants, Westwood Building, Room 449, National Institutes of
Health, Bethesda, MD 20892, telephone 301-496-7441.
 
Check "yes" in item two on the face sheet of the application and type
"The Hereditary Ataxias Including Machado-Joseph, PA-92-48."
 
Applicants for the P01 or P50 must use the application format as
described in the NINDS pamphlet, "Application Guidelines: Program
Project and Clinical Research Center Grants," that may be obtained from
the contacts listed under INQUIRIES.
 
Deadlines for the receipt of applications are February 1, June 1, and
October 1.  The completed original application and five legible copies
must be sent or delivered to:
 
Division of Research Grants
National Institutes of Health
Westwood Building, Room 240
Bethesda, MD  20892**
 
REVIEW PROCEDURES
 
Applications will be assigned on the basis of established Public Health
Service referral guidelines.  Applications will be judged on scientific
merit in accordance with NIH policy and procedures involving peer
review.  An initial review will be made by an appropriate study section
of the Division of Research Grants for research grants and FIRST
awards, and by an appropriate Institute or Center committee for program
project and center applications.  A second level of review will be made
by an appropriate advisory council.
 
AWARD CRITERIA
 
Applications will compete for available funds with all other approved
applications.  The following will be used in making funding decisions:
 
o  Quality of the proposed project as determined by peer review
o  Availability of funds
o  Program balance among research areas of the announcement
 
INQUIRIES
 
For further information regarding this announcement, potential
applicants may write or call:
 
Giovanna M. Spinella, M.D.
Developmental Neurology Branch
Division of Developmental, Convulsive, and Neuromuscular Disorders
National Institute of Neurological Disorders and Stroke
Federal Building, Room 820
Bethesda, MD  20892
Telephone:  (301 496-5821
 
For fiscal and administrative inquires regarding this announcement,
potential applicants may write or call:
 
Gary P. Fleming, J.D
Grants Management Branch
National Institute of Neurological Disorders and Stroke
Federal Building, Room 1004
Bethesda, MD  20892
Telephone:  (301) 496-9231
 
AUTHORITY AND REGULATIONS
 
This program is described in the Catalog of Federal Domestic Assistance
No. 93.853, Clinical Research Related Neurological Disorders and
93.854, Biological Basis Research in the Neurosciences.  Awards are
made under authorization of the Public Health Service Act, Title IV,
Part A (Public Law 78-410, as amended by Public Law 99-150, 42 USC 241
and 285) and administered under PHS grants policies and Federal
Regulations 42 CFR 52 and 45 CFR Part 74.  This program is not subject
to the intergovernmental review requirements of Executive Order 12372
or Health Systems Agency review.
 
$$P4 END ************************************************************
 
$$P5 BEGIN PA-92-49 *************************************************
 
RESEARCH ON FERTILITY AND FERTILITY-RELATED BEHAVIOR
 
NIH GUIDE, Volume 21, Number 9, March 6, 1992
 
PA NUMBER:  PA-92-49
 
P.T. 34; K.W. 0413002, 0413001, 0404000, 0755020
 
National Institute for Child Health and Human Development
 
PURPOSE
 
The National Institute for Child Health and Human Development invites
applications for demographic and behavioral research on fertility, the
proximate determinants of fertility, and the causes and consequences of
fertility-related behaviors.
 
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 PA,
Research on Fertility and Fertility-Related Behavior, is related to the
priority areas of family planning and sexually transmitted diseases.
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
 
Applications may be submitted by foreign and domestic, for-profit and
non-profit organizations, public and private, such as universities,
colleges, hospitals, private research firms, units of State and local
governments, and eligible agencies of the Federal Government.
Applications from minority individuals and women are encouraged.
Applicants for First Independent Research Support and Transition
(FIRST) Awards (R29) must meet specific eligibility requirements.  In
addition, foreign applicants are not eligible for the FIRST Award.
 
MECHANISM OF SUPPORT
 
Mechanisms available for the support of this program include
research project grants (R01), and the FIRST Award (R29).
 
RESEARCH OBJECTIVES
 
Summary
 
This announcement invites behavioral and demographic research on
fertility, the proximate determinants of fertility, and the causes and
consequences of fertility-related behaviors.  The goal is to extend the
understanding of fertility and fertility-related behaviors in two
important ways:  first, by explaining recent developments in fertility
and their relationships to other social changes; and second, by
developing and testing new and expanded models at either the individual
or aggregate level to explain variation in fertility and related
behaviors.  In many instances, the success of this research may depend
on the development of new theoretical approaches and/or the development
of improved and innovative methods for measuring fertility-related
behaviors and the processes that influence them.
 
Background
 
Research on the causes and consequences of fertility behavior has
occupied demographers since population science emerged as a field of
study.  During the twentieth century this field has encompassed simple
descriptions of population levels, trends and differentials in
fertility as well as the development of complex causal models
explaining individual fertility behavior.  In the past decade, research
on fertility has been shaped by several factors, including trends in
fertility rates, a changing societal context for childbearing, and the
development of data and statistical tools for testing interdisciplinary
and multilevel models.  During the 1980s, fertility rates remained
stable throughout most of the developed world and declined to varying
degrees in the developing countries.  At the very end of the decade,
however, U.S. fertility showed signs of a renewed upturn, particularly
at the younger and older ages.  Recent decades have witnessed a
dramatic increase in the proportion of all births that occur out of
wedlock, from 5 percent in 1960 to 27 percent in 1989.  This change has
paralleled delays in the age of first marriage and increases in female
labor force participation.  Scientists' ability to develop empirical
models of the complex factors affecting fertility was greatly enhanced
by developments in statistics, computer technology, and a proliferation
of longitudinal and cross-sectional data sets.  However, data
limitations still hamper the integration and extension of much existing
research.
 
Research Sought
 
Research applications submitted in response to this announcement may
focus on any aspect of human fertility and may be grounded within a
broad range of disciplinary frameworks.  These may include but are not
limited to sociology, economics, psychology, anthropology, biology, and
public health.  Interdisciplinary approaches are encouraged. Research
on fertility may address any relevant aspect, including but not limited
to levels (numbers of births and fertility rates), birth timing, wanted
and unwanted childbearing, childbearing in and out of wedlock, and
variability in these factors within and across populations. The
proximate determinants of fertility include contraceptive practice,
union formation and sexual activity, fecundity, and pregnancy outcomes.
The following topics have been highlighted as promising areas for
research (but applications for grants to support research on other
aspects of fertility are welcome):
 
a.  In the U. S. and other developed countries, sexual activity and
childbearing have become increasingly disconnected from legal marriage.
Trends in premarital sexual activity, cohabitation and non-marital
childbearing have been well documented, but their causes and, to a
lesser extent, their implications are poorly understood.  What
underlies the early sexual involvement of many young people and the
choice of non-marital childbearing by increasing proportions of young
adults?  What factors contribute to the postponement of sexual activity
and the choice and maintenance of a stable union as a context for child
rearing?  Research is needed to examine the impact of economic and
social factors in shaping alternative strategies for childbearing and
child rearing and the family and contextual processes that shape norms
and values about sexual and reproductive behavior.  Further research is
also needed on the implications of current trends for children, adults,
and society.
 
b.  Lack of information on male behaviors related to family formation
creates a significant gap in fertility research.  Research on the
determinants and consequences of male fertility and fertility-related
behaviors is needed to complement knowledge gained from research
focused on women alone.  Research focusing on the couple as the
relevant unit in fertility analysis is also encouraged.  In order to
advance our understanding in this area, scientists are encouraged to
develop innovative methods of obtaining non-biased samples, and samples
that capture unmarried as well as married couples.
 
c.  Research is needed on the relationship between parenthood and other
familial and nonfamilial roles.  Specific topics include the
interrelation between processes of role choice, change, and
accommodation and fertility,  and factors, such as child care and
flexibility in the workplace, that ease or exacerbate role conflict.
We encourage development of new approaches to capturing the dynamic
aspects of entries to and exits from different adult roles, to
understanding the factors contributing to variability in life course
trajectories, and to accounting for selection processes in examining
the consequences of different trajectories for fertility behavior and
other life domains.
 
d.  The influence of context on fertility and fertility related
behavior requires further study.  Both normative and structural aspects
of context may influence fertility.  Context may be variously
interpreted to mean geographical context (the community, place of
residence or work), social contexts (such as the family, sexual
partnership, peer group), or institutional contexts (the church,
workplace or school).  Policy-relevant variables and program inputs may
also be viewed as contextual factors.  Innovative research designs for
capturing contextual effects and accounting for the effects of choice
of context are needed to advance research on this topic.
 
e.  Research is needed on the determinants of both short term and long
term trends in fertility.  A variety of explanations have been advanced
to account for short run variations in fertility levels in the
developed world, but none have received consistent support.  Further
work is needed to improve our understanding of the interrelations
between fertility and social and economic trends.  Our perspective on
the causes of long-run trends may be improved by examining the
interrelationships between family and institutional change and
fertility decline in a variety of settings.  Recent advances in
economic growth theory have suggested a connection between fertility
and economic growth that is modulated by human capital and
institutional factors.  Empirical testing of these relationships is
encouraged.
 
f.  Extension of existing research on the factors accounting for the
continuing high rate of unintended pregnancy is encouraged.  Topics of
current interest include how characteristics of couples and partners
affect contraceptive practice; how sexual behavior and contraception
contribute to defining, and are themselves shaped by, the nature and
meaning of relationships; the impact of concerns about sexually
transmitted disease on sexual and contraceptive decision-making; the
determinants of consistent and accurate method use; structural factors
affecting access to contraceptive methods and/or motivation to avoid
pregnancy; and issues related to measuring the "intendedness" of a
pregnancy.
 
g.  Research on the outcomes of unintended pregnancy is also
encouraged.  Relevant topics include the determinants and consequences
of giving birth, of parenting versus relinquishing for adoption, and of
marriage and alternative family living arrangements.  Innovative means
must be devised to avoid biased samples in designing this research.
 
h.  Motivational factors in fertility decision-making, the determinants
of fertility motivation and desires, and the process through which
individual motivations are translated into couple fertility decisions
also deserve study.  Relevant motivational factors may include not only
those directly related to childbearing but also those related to other
adult behaviors such as union formation and nonfamilial roles and
aspirations.  Advances in developing measures that capture multiple
dimensions of motivation, that distinguish motivation to become a
parent from motivation to prevent pregnancy or birth, and that may be
appropriately applied to both men and women need further development,
particularly among minority and low income populations.
 
i.  We encourage the extension of biosocial models of fertility and
fertility-related behaviors.  Existing research in this area has
documented the utility of models that incorporate biological, and
social, psychological, and economic variables.  These models have been
employed primarily for studying adolescents and may fruitfully be
extended to adult behaviors and to the investigation of the
intergenerational transmission of behavioral patterns.
 
Data Sources
 
Analysis of existing data is cost-efficient and is strongly encouraged
whenever scientific goals can be met.  Many data sets relevant to the
analysis of fertility and fertility related behaviors are publicly
available.  Among those relating to the U.S. population are the
National Surveys of Family Growth (and predecessors such as the
National Fertility Surveys and the Growth of American Families
Studies); the National Longitudinal Surveys, Youth Cohort and Child
Supplement; the National Survey of Families and Households; the
National Longitudinal Study of the High School Class of 1972; High
School and Beyond; National Education Longitudinal Study; data from the
Decennial Census and Current Population Survey (June supplements);
Vital Statistics data; the Panel Study of Income Dynamics; and the
Survey of Income and Program Participation.  Other relevant data sets
may be obtained through The Data Archive on Adolescent Pregnancy and
Pregnancy Prevention and the American Family Data Archive.  Applicants
are encouraged to contact program staff to discuss potential data
sources.
 
New data collection may be necessary whenever existing data resources
are not appropriate to the scientific aims of the study.  In many
cases, methodological components to research may be appropriate for
developing improved measures and measurement techniques.  If new data
collection is proposed, applicants are encouraged to design protocols
and samples that are efficiently tailored to the scientific needs of
the project.  Scientific sampling procedures are highly desirable to
ensure that sample biases do not undercut scientific objectives, but
the size and scope of samples may legitimately be limited in a manner
consistent with study objectives.  Applicants proposing new data
collection are encouraged to make their data available for use by other
researchers, and should indicate plans for accomplishing this in the
application.
 
STUDY POPULATIONS
 
Research may focus on U.S. and other developed world populations and
subgroups thereof, and on developing settings, as appropriate to the
scientific questions being examined. Cross-cultural comparisons may be
appropriate to specific scientific objectives.
 
SPECIAL INSTRUCTIONS TO APPLICANTS REGARDING IMPLEMENTATION OF NIH
POLICIES CONCERNING INCLUSION OF WOMEN AND MINORITIES IN CLINICAL
RESEARCH STUDY POPULATIONS
 
NIH and ADAMHA policy is that applicants for NIH/ADAMHA clinical
research grants and cooperative agreements are 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 must 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 must 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 must be included in the form PHS 398 in
Section 2, A-D of the Research Plan AND summarized in Section 2, E,
Human Subjects.  Applicants/offerers 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 must be provided.
 
For the purpose of this policy, clinical research is defined as 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 review will be deferred until the information is provided.
 
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
to cooperative agreements that do not comply with these policies.
 
APPLICATION PROCEDURES
 
Applications are to be submitted on the grant application form PHS 398
(rev. 9/91) and will be accepted at the standard application deadlines
as indicated in the application kit.
 
Application kits are available at most institutional business offices
and may be obtained from the Office of Grants Inquiries, Division of
Research Grants, National Institutes of Health, Westwood Building, Room
449, Bethesda, MD 20892, telephone 301/496-7441.  The title and number
of the announcement must be typed in Section 2 on the face page of the
application.
 
The completed original application and five legible copies must be sent
or delivered to:
 
Division of Research Grants
National Institutes of Health
Westwood Building, Room 240
Bethesda, MD  20892**
 
REVIEW PROCEDURES
 
Applications will be assigned on the basis of established Public Health
Service referral guidelines.  Applications will be reviewed for
scientific and technical merit by study sections of the Division of
Research Grants, NIH, in accordance with the standard NIH peer review
procedures.  Following scientific-technical review, the applications
will receive a second-level review by the appropriate national advisory
council.
 
AWARD CRITERIA
 
Applications will compete for available funds with all other approved
applications assigned to that ICD.  The following will be considered in
making funding decisions:
 
o  Quality of the proposed project as determined by peer review;
o  Availability of funds
o  Program balance
 
INQUIRIES
 
Written and telephone inquiries are encouraged.  The opportunity to
clarify any issues or questions from potential applicants is welcome.
 
Direct inquiries regarding programmatic issues to:
 
Christine A. Bachrach, Ph.D.
Center for Population Research
National Institute of Child Health and Human Development
Executive Plaza North, Room 611
6130 Executive Boulevard
Bethesda, MD  20892
Telephone:  (301) 496-1174
 
Direct inquiries regarding fiscal matters to:
 
Melinda B. Nelson
Office of Grants and Contracts
National Institute of Child Health and Human Development
Executive Plaza North, Room 505
6130 Executive Boulevard
Bethesda, MD  20892
Telephone:  (301) 496-5481
 
AUTHORITY AND REGULATIONS
 
This program is described in the Catalog of Federal Domestic Assistance
No. 93.864, Population Research.  Awards are made under authorization
of the Public Health Service 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.  This program is not subject to the intergovernmental review
requirements of Executive Order 12372 or Health Systems Agency review.
 
$$P5 END ************************************************************
 
$$P6 BEGIN PA-92-50 *************************************************
 
TECHNOLOGY DEVELOPMENT, MAPPING, AND DNA SEQUENCING IN SUPPORT OF THE
HUMAN GENOME PROGRAM
 
NIH GUIDE, Volume 21, Number 9, March 6, 1992
 
PA NUMBER:  PA-92-50
 
P.T. 34; K.W. 1215018, 0755045, 1002058, 1004017
 
National Center for Human Genome Research
 
PURPOSE
 
The National Center for Human Genome Research (NCHGR) invites
applications to support research that will significantly advance
progress toward achieving the scientific goals of the Human Genome
Program.  A summary of these goals are:  completion of a high density
genetic linkage map of the human genome; construction of a high-
resolution physical map comprised of large contigs (overlapping pieces
of cloned DNA); development of a "sequence-tagged site" (STS) map;
development of technology to reduce the expense of DNA sequencing
significantly below current cost; development of computer tools to
manage and provide access to mapping and sequencing data; examination
of the legal, ethical, and social implications of the Human Genome
Program; and research training.
 
ELIGIBILITY REQUIREMENTS
 
Domestic universities, medical colleges, hospitals, and other public,
private, and for-profit research institutions, including state and
local government units, are eligible. Foreign organizations are also
eligible to apply only for the research project grants (R01).
Applications from minority individuals and women are encouraged.
 
MECHANISM OF SUPPORT
 
Support for this program will be through research project grants (R01),
pilot projects and feasibility studies (R21), program project grants
(P01), and FIRST Awards (R29).  As part of this effort, the NCHGR
encourages the support of minority students and faculty interested in
the Human Genome Program through the traditional NIH funding mechanisms
and through minority supplements to ongoing research grants (see
announcement in the NIH Guide for Grants and Contracts, Vol. 21, No. 3,
Part 1 of 2, January 24, 1992).
 
Applications to support large, complex research programs through the
center grant mechanism will not be considered under this Program
Announcement.  Applications for P30 and P50 center grants may respond
to the Program Announcement in the NIH Guide for Grants and Contracts,
Vol. 18, No. 36, October 13, 1989.
 
RESEARCH OBJECTIVES
 
Background
 
The NIH Human Genome Program is envisioned as a 15-year project that
has very specific goals.  The NCHGR was established in October 1989 for
the purpose of planning and supporting the Human Genome Program at NIH
and coordinating the NIH component of this program with those of other
Federal agencies and international groups.  The goals for the first
five years of the U.S. Human Genome Program were established by a joint
advisory committee of the NIH and the Department of Energy and are set
forth in the document, "Understanding Our Genetic Inheritance - The
U.S. Human Genome Project:  The First Five Years - FY 1991-1995."
(This document is available from the Human Genome Management
Information System, Oak Ridge National Laboratory, Oak Ridge, TN
37831-6050; telephone, 615-576-6669).  These goals are:
 
o  construction of high-resolution genetic linkage maps based on DNA
markers with a goal of achieving an average spacing of 2 centimorgans
and gaps no greater than 5 centimorgans between markers, each of which
is identified by an STS (Olson et al., Science 245:1434, 1989);
 
o  construction of high resolution physical maps of chromosomes in
which contigs of at least 2 million base pairs are unambiguously
ordered and identified by STS spaced about 100,000 base pairs apart;
 
o  development of new methods for DNA sequencing that significantly
reduce the cost and increase the rate of sequencing;
 
o  development of computer tools, information systems, and strategies
for collecting, storing, retrieving, analyzing, interpreting, and
distributing large amounts of mapping and sequencing data;
 
o  examination of legal, ethical, and social implications of the Human
Genome Program (see Program Announcement in NIH Guide for Grants and
Contracts, Vol. 19, No. 4, January 26, 1990); and
 
o  research training (see Program Announcement in NIH Guide for Grants
and Contracts, Vol. 18, No. 25, July 21, 1989).
 
The objective of this Program Announcement is to stimulate research
that will assist the NCHGR in accomplishing both the short- and
long-term scientific goals of the Human Genome Program in the most
expeditious and cost-saving manner.  This Program Announcement
supersedes the one that was published in the NIH Guide for Grants and
Contracts, Vol. 19, No. 28, 1990.
 
In planning research projects, applicants should be cognizant of the
following:
 
Technology Development.  Although a number of the techniques currently
in use for mapping have proven useful in initial successes in building
megabase-size contigs and studying specific genomic regions, it is
anticipated that new technologies, strategies and approaches are still
needed to reach the final mapping goal of the Human Genome Program most
expeditiously and in a cost-effective manner.  Similarly, the
technology currently available for sequencing and data handling is not
capable of supporting the goals of the Human Genome Program in these
areas.  Therefore, in the first five years of the Human Genome Program,
emphasis will be placed on technology development in all phases of
mapping, sequencing and informatics.  For applications with the primary
objective of map construction, those that improve or propose new
technology as a significant component will be most competitive.  This
will also be the case in mapping, sequencing, and informatics
applications.  Research projects that focus on technology development
in the context of a particular disease gene are appropriate if such
projects have one or more of the overall objectives of the Human Genome
Program as a major research goal.
 
Collaborative Research.  In order to achieve the objectives of the
Human Genome Program, collaborations between biologists from various
disciplines, including human genetics, as well as between biologists
and non-biologists, such as chemists, physicists, information
scientists, and engineers, are essential.  The NCHGR strongly
encourages multidisciplinary collaboration to facilitate progress,
especially in technically sophisticated areas.
 
Duplication/Overlap.  A certain amount of duplication in research is
inevitable and, in fact, is useful for verifying or validating
experimental results.  However, given the limited resources and the
need to accomplish the goals of the Human Genome Program within the
proposed 15-year period, duplication of research, irrespective of
funding source, while encouraged, should be kept to a minimum.  To
assist applicants with respect to what research is supported through
the NCHGR, a list of the Human Genome Program grant portfolio is
available to potential applicants.
 
Sharing of Materials and Data.  The sharing of materials and data in a
timely manner is essential for progress towards the goals of the Human
Genome Program, to avoid unnecessary duplication, and to facilitate
research in other areas of biomedical research.  The Public Health
Service (PHS) policy requires the sharing of resources at the time of
publication.  For some projects that will be supported by the NCHGR,
this policy is not sufficient because certain kinds of data may not be
published in their entirety, while some information or resources need
to be shared more rapidly than at the time of publication.  Because the
type of research will dictate the conditions under which data and
materials should be shared, applicants should, in their applications,
discuss their plans for sharing data and materials and depositing data
and materials to appropriate repositories.  It is expected that,
whenever appropriate, resources such as cell lines, probes, and
sequence data, will be deposited expeditiously in public repositories.
 
Investigators may request funds to defray the costs of sharing
materials and submitting data to repositories in their applications.
However, such requests must be adequately justified.  For applications
assigned to the NCHGR, the plans for sharing will be reviewed for
adequacy by NIH staff and the National Advisory Council on Human Genome
Research prior to award of a grant.
 
Animal Models.  Research involving model systems will contribute
greatly to the Human Genome Program.  The five- year plan includes, as
one of its goals, the support of mapping and sequencing of the DNA of
five specific organisms: E. coli, S. cerevisiae, D. melanogaster, C.
elegans, and the laboratory mouse.  The Human Genome Program is,
therefore, interested in promoting research using these organisms.
However, research projects involving other model organisms may also
contribute significantly to the goals of the Human Genome Program.
Thus, applicants may propose to study model systems other than those
listed.  In those cases, the choice of organism must be justified in
terms of the overall objectives of the Program.  Whereas the "Research
Objectives" described below do not specify research to be conducted on
model organisms, such research is encouraged.
 
Pilot Projects or Feasibility Studies.  The NCHGR is interested in
supporting scientifically sound projects that are novel, creative, or
high risk/high payoff.  Applicants who seek funding to support such
research and need limited funding to conduct preliminary studies should
submit applications in response to the Program Announcement "Pilot
Projects or Feasibility Studies for Genomic Analysis," (see NIH Guide
for Grants and Contracts, Vol. 19, No. 28, July 27, 1990).
 
Specific Research Objectives
 
In order to achieve the goals of the Human Genome Program, applications
that propose to develop new approaches and strategies to mapping and
sequencing problems, as well as those that propose creative, novel,
high-risk/high-payoff strategies, are highly encouraged.  All
researchers applying for support should (l) address how the proposed
research will help accomplish the five-year goals; (2) discuss new
approaches and/or technology as part of the mapping or sequencing
strategy; (3) approach the problem in a comprehensive manner,
irrespective of the size of the project (e.g., in constructing a
physical map of a particular chromosome, emphasis should be placed on
constructing fully connected contigs, i.e., overlapping units of cloned
DNA, rather than just mapping available probes); (4) demonstrate that
there are adequate plans for:  (a) data management, (b) interacting and
collaborating with the rest of the scientific community working on
similar or related objectives, and (c) making data and resources
publicly available in a timely manner; and (5) in the case of specific
mapping and technology development applications, address how the
proposed research project will relate to or augment existing research
efforts.
 
Genetic Linkage Maps
 
High-density genetic linkage maps are important for attainment of the
goals of the Human Genome Program as they will facilitate (1) the
identification of gene locations and (2) the construction of a complete
physical map by allowing contigs (overlapping clones of DNA) to be
ordered with respect to one another.
 
The Human Genome Program has set as one of its goals during the first
five years the creation of a 2 to 5 centimorgan human genetic linkage
map.  A map of this resolution would require 1500 to 2000 informative
markers evenly spaced along the genome; in addition each DNA marker
would be defined by a unique STS.  An STS is defined as a DNA marker
that is unique in the genome and can be detected by the polymerase
chain reaction.  The STS concept has been promoted as a device that
will allow mapping data from different laboratories and from different
types of maps to be merged or assimilated.
 
To facilitate completion of a high-density genetic map, applications
are encouraged in the following areas:
 
o  Development of methods to rapidly and efficiently isolate, identify,
and map highly informative markers.
 
o  Expansion of the maps of individual chromosomes with the goal of
achieving a high-resolution map comprised of DNA markers with an
average spacing of 2 centimorgans and gaps no greater than 5
centimorgans, and with each marker identified by an STS.  Applications
are particularly encouraged for projects addressing those chromosomes
or regions of chromosomes where there are presently few markers or
those approaching the completion of the genetic map using a genomic,
rather than a chromosome-by-chromosome, strategy.
 
o  Improvement of methods for linkage analysis and ordering of markers.
 
o  Closure methods targeted to finding and mapping markers within gaps
in existing maps.
 
o  Technology development to accelerate completion of a 2-5 centimorgan
map of the human genome.
 
Physical Maps
 
A physical map is a very useful resource because it is the basis for
characterizing and isolating individual genes or other DNA regions of
interest and is a prerequisite for large-scale DNA sequencing.  There
are several types of physical maps including cytogenetic maps,
long-range restriction maps and contig maps.  To facilitate the
construction of a complete physical map, at least two aspects of
mapping need to be improved:  (1) the length of a DNA segment that can
be routinely covered by a single contig or spanned by a set of closely
spaced ordered markers must be increased and (2) methods for closure or
filling in the gaps between contigs also need to be developed or
improved.
 
To facilitate completion of a fully connected physical map, research
projects in the following areas are encouraged:
 
o  Development of methods for isolating large amounts of purified human
chromosomes, chromosome segments, and restriction fragments for mapping
and sequencing.
 
o  Development of cloning techniques that improve upon current
approaches to constructing complete physical maps.  The development of
reproducible methods that:  (1) ensure that cloned inserts are stable
and are at least one megabase in size, (2) avoid artifacts, such as
dimeric clones, and (3) ensure that cloned fragments derived from a
single chromosomal location are particularly encouraged.
 
o  Construction of overlapping sets of cloned DNA, or closely spaced,
unambiguously ordered DNA markers, with continuity over lengths of at
least 2 million base pairs.
 
o  Assembly of STS maps of individual human chromosomes with the goal
of having the STS markers spaced at approximately 100,000 base pair
intervals.
 
o  Development of methods or strategies to solve the problem of
closure.
 
o  Technology development to accelerate the completion of the physical
map of the human genome.
 
Sequencing
 
The ultimate goal of the Human Genome Program is to determine the
complete sequence of the human genome.  To date, the largest genome
that has been sequenced is a viral genome that is 240,000 base pairs in
length.  The human genome is 3 billion base pairs in length, four
orders of magnitude larger.  The current cost of DNA sequencing, in
laboratories that do it routinely, is estimated to be between $2-5 per
base pair of finished sequence.  If the entire human genome is to be
sequenced, the cost of sequencing must be significantly reduced.
Applications responding to this Program Announcement must address
innovative approaches, including automation, that will increase the
speed of sequencing megabases of DNA and significantly decrease the
cost of DNA sequencing to $0.50 or less per finished base pair within
five years.  Research projects are encouraged in the following areas:
 
o  Improvement of current technologies in order to reduce costs
significantly below current costs;
 
o  Development of new methods, technologies, and strategies for
large-scale sequencing including preparing and sequencing the DNA and
assembling the data.
 
Only applications that aim to develop new or significantly improved
current sequence technology should be submitted in response to this
Program Announcement.  Applications for routine sequencing will not be
supported by the NCHGR.  Applications to support feasibility studies
for large-scale DNA sequencing using advanced state-of-the-art
technology may be submitted only in response to a Request for
Applications that is issued periodically in the NIH Guide for Grants
and Contracts.
 
Informatics
 
The Human Genome Program will generate mapping and sequencing data from
many laboratories, both national and international. While some computer
tools and information systems for handling this type of data exist,
none have been tested on a large scale to determine their capabilities
to manage the voluminous amount and complexity of the data that will be
generated.  There is a need to develop appropriate computer tools and
information systems for the collection, storage, retrieval, and
distribution of mapping and sequencing data.  In addition to the
development of databases, it will be necessary to develop new methods
and tools for the analysis and interpretation of genome maps and DNA
sequences.  Research projects are encouraged in the following general
areas:
 
o  Development of effective software and database designs to support
laboratory-based, large-scale mapping and DNA sequencing projects.
Such projects should be undertaken in the context of actual mapping and
sequencing efforts.
 
o  Creation of database and/or software tools that provide easy access
to up-to-date physical and genetic mapping and DNA sequencing
information and allow linkage of these specific data sets.
 
o  Development of analytical tools that can be used in the assembly and
analysis of genomic data.
 
o  Technology development to accelerate the collection, storage,
retrieval, analysis, and distribution of mapping and sequencing data.
 
APPLICATIONS PROCEDURES
 
Applications are to be submitted on the grant application form PHS 398
(rev. 9/91).  Applications will be accepted on the receipt dates for
research grant applications (February 1, June 1, October 1).
Application kits are available at most institutional business and
grant/contract offices and may be obtained from the Division of
Research Grants, National Institutes of Health, Westwood Building, Room
240, Bethesda, MD 20892, telephone 301/496-7441.  The title and number
of this announcement must be typed in Item 2 on the face page of the
application.
 
The completed original application and five legible copies must be
delivered to:
 
Division of Research Grants
National Institutes of Health
Westwood Building, Room 240
Bethesda, MD  20892**
 
STUDY POPULATIONS
 
SPECIAL INSTRUCTIONS TO APPLICANTS REGARDING IMPLEMENTATION OF NIH
POLICIES CONCERNING INCLUSION OF WOMEN AND MINORITIES IN CLINICAL
RESEARCH STUDY POPULATIONS
 
NIH and ADAMHA policy is that applicants for NIH/ADAMHA 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
Section 2, A-D of the Research Plan AND summarized in Section 2, E,
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.
 
REVIEW CONSIDERATIONS
 
Applications in response to this announcement will be reviewed in
accordance with the usual NIH peer review procedures.
 
With the exception of program project (P01) applications, applications
will be reviewed for scientific and technical merit by an appropriate
study section in the Division of Research Grants.  Program project
applications will be evaluated by an appropriate review committee
managed by an Institute or Center.  Following the initial scientific
review, applications will receive a second-level review by the National
Advisory Council for Human Genome Research or another Council or Board.
 
Review Criteria
 
Review criteria that will be used to assess the scientific merit are:
 
o  Significance and originality of the research and methodological
approaches;
o  Feasibility of the research and adequacy of the experimental design;
o  Training, experience, research competence, and commitment of the
investigator(s);
o  Adequacy of the facilities and resources;
o  Appropriateness of the requested budget for the work proposed.
 
AWARD CRITERIA
 
Applications will compete for available funds with all other approved
applications.  The following will be considered in making funding
decisions:
 
o  Quality of the proposed project as determined by peer review;
o  Balance among research areas;
o  Availability of funds.
 
For those applications assigned to the NCHGR, the following additional
criteria will be used in making award decisions:
 
o  Potential for developing technology or strategies for accelerating
progress in mapping and sequencing the genomes of human and select
model organisms;
 
o  Value of the research for achieving the goals of the National Center
for Human Genome Research;
 
o  Adequacy of any plans proposed for managing data and sharing data
and resources in a timely manner;
 
In addition, priority will be given to applications from U.S.
institutions.
 
INQUIRIES
 
The program administrators and grants management officer welcome the
opportunity to discuss the program interests of the NCHGR and PHS
grants policy, respectively, with prospective applicants and current
grantees and encourages telephone, electronic and written inquiries.
For additional information, contact:
 
Genetic and Physical Mapping Grant Applications
 
Bettie J. Graham, Ph.D.
Chief, Research Grants Branch
National Center for Human Genome Research
Building 38A, Room 613
Bethesda, MD  20892
Telephone:  (301) 496-7531
E-mail:  [email-masked]
 
Sequencing and Technology Development Grant Applications
 
Robert L. Strausberg, Ph.D.
Program Director, Technology Development Program
National Center for Human Genome Research
Building 38A, Room 610
Bethesda, MD  20892
Telephone:  (301) 496-7531
E-mail:  [email-masked]
 
Informatics Applications
 
David Benton, Ph.D.
Assistant to the Director for Scientific Data Management
National Center for Human Genome Research
Building 38A, Room 610
Bethesda, MD  20892
Telephone:  (301) 496-7531
E-mail:  [email-masked]
 
PHS Grants Policy
 
Ms. Alice Thomas
Chief, Grants and Contracts Management Branch
National Center for Human Genome Research
Building 38A, Room 613
Bethesda, MD  20892
Telephone:  (301) 402-0733
 
AUTHORITY AND REGULATION
 
This program is described in the Catalog of Federal Domestic Assistance
No. 93.172.  Awards will be made under the authority of the Public
Health Service Act, Section 301 (Public Law 78-410, as amended 42
U.S.C. 241) and administered under PHS grants policies and Federal
Regulations 42 CFR Part 52 and 45 CFR Part 74.  This program is not
subject to the intergovernmental review requirements of Executive Order
12372 or to Health Systems Agency review.
 
$$P6 END ************************************************************