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5. Institute-Initiated Programs Starting in FY
2005
More than two-thirds of the research supported by the
NHLBI is initiated by individual investigators; the remainder is initiated by
the Institute. Institute-initiated programs are developed in response to
evolving national needs, Congressional mandates, and advances in scientific
knowledge. Each initiative represents the outcome of extensive discussions and
thorough reviews by representatives of the scientific community, Institute
advisory committees, the Board of Extramural Advisors (BEA), and the National
Heart, Lung, and Blood Advisory Council (NHLBAC). The advisory committees and
the BEA, together with professional societies and NHLBI staff, continually
review the progress of research within the NHLBI program areas, assess newly
acquired knowledge, and identify research topics that offer the best
opportunities or constitute the greatest needs. This planning process
contributes to policy development at the national level by setting priorities
among programs and establishing budgets for individual programs and
projects.
Initiatives generally emanate as Requests for
Applications (RFAs) for grants, including cooperative agreements, or Requests
for Proposals (RFPs) for contracts. A smaller number of initiatives take the
form of Program Announcements (PAs). Applications and proposals submitted in
response to RFAs and RFPs compete among themselves for specific "set-aside"
funds. Applications submitted in response to PAs generally compete with other
investigator-initiated applications for funding.
RFA, RFP, and PA concepts prepared by the Institute
are presented to the BEA, which reviews and prioritizes them. The concepts,
along with the comments from the BEA, are then sent to the NHLBAC for review,
comment, and concurrence. Initiatives that receive the concurrence of the
NHLBAC are considered further by the NHLBI Director in the context of the
Institute's budget, program priorities, review workload, and proposed
mechanisms. These considerations guide the Director's subsequent decisions to
approve initiatives for release. RFAs, RFPs, and PAs are announced in the
weekly publication, the NIH Guide to Grants and Contracts.
Applications and proposals submitted in response to
RFAs and RFPs are reviewed by the NHLBI. Applications submitted in response to
PAs are reviewed by the NIH Center for Scientific Review.
Descriptions of the Institute-initiated programs that
began or were renewed (i.e., were funded) in FY 2005 are presented below
according to NHLBI scientific program. Also described are trans-NIH and
interagency initiatives in which the NHLBI is participating.
Heart and Vascular Diseases
Program
Initiatives Being Renewed
Atherosclerosis Risk in Communities (ARIC)
Study
The purpose of this renewal is to assess trends in
incidence of myocardial infarction (MI) and heart failure and to continue
identification of their risk factors in four diverse communities. Specifically,
the study will extend community surveillance of trends in MI incidence through
2009 and beyond age 74, initiate surveillance of heart failure, and continue
investigation of new risk factors (e.g., first time reports of carotid
intimal-medial thickness predicting CHD and stroke) for CHD and heart failure
in the ARIC cohort subjects aged 45-64 at study entry.
Cardiovascular Health Study: Transition
Phase
The purpose of this renewal is to enhance the use of
data and samples from the Cardiovascular Health Study (CHS) during a transition
period from the current contract-funded, NHLBI-directed program to one directed
by a steering committee of investigators with independently acquired grants.
The goals are to maintain the core coordinating center and laboratory support;
continue follow-up of participants for cardiovascular events and maintenance of
sample repository; ensure open access to CHS data and specimens for the entire
scientific community; and promote innovative use of the resource by new
collaborators who will develop independently funded research projects.
Family Blood Pressure Program
Extension
The purpose of this renewal is to identify and
characterize the genes that contribute to hypertension and related conditions
in multiple racial groups. The program will also investigate the pathways
through which genetic variation translates into differences in blood pressure
levels and risks of hypertension.
Genetics of Coronary Artery Disease in
Alaska Natives (GOCADAN) Study
The purpose of this renewal is to identify and map the
genes that contribute to CVD in a population of isolated Alaska Natives whose
traditional lifestyle is being altered by mechanization and a westernized diet.
The population is beginning to show a marked acceleration in the prevalence of
atherosclerosis and coronary artery disease.
Strong Heart Study
The purpose of this renewal is to extend support for
Phase V of the Strong Heart Study, which is evaluating CVD and its risk
factors, especially obesity and type 2 diabetes, in American Indians. Phase V
seeks to determine the genetic and environmental contributors of CVD in
extended families; continue the mortality and morbidity surveillance of the
original cohort along with initiating annual mortality surveillance and limited
morbidity follow-up of the noncohort family members; and re-examine family
members so that changes in risk factors can be analyzed and genetic effects on
changes can be estimated.
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New Initiatives
Community-Responsive Intervention To
Reduce Cardiovascular Risk in American Indians and Alaska
Natives
The purpose of this cooperative agreement is to
evaluate the effectiveness of behavioral interventions such as weight
reduction, regular physical activity, and smoking cessation to reduce
cardiovascular risk in American Indians and Alaska Natives. Investigators will
develop and test culturally appropriate interventions that can be incorporated
into clinical programs of the community health care systems or delivered
through public-health approaches in Native communities.
Specialized Centers of Clinically Oriented
Research in Cardiac Dysfunction and Disease
The purpose of this SCCOR is to improve understanding
of the disease process within the myocardium through multidisciplinary research
that integrates molecular, structural, mechanical, and electrical elements into
a cohesive picture. The goal is to translate research findings into more
effective methods of treatment, diagnosis, and prevention of cardiac disorders,
including ischemic and other cardiomyopathies, left ventricular dysfunction,
metabolic abnormalities, congestive heart failure, and rhythm disturbances.
Because some segments of the population suffer from heart disease
disproportionately, investigators will emphasize research that addresses issues
related to health disparities.
Lung Diseases Program
Initiative Being Renewed
Acute Respiratory
Distress Syndrome Clinical Network (ARDSNet)
The purpose of this renewal is to conduct controlled
clinical trials of treatments and management practices for acute lung injury
and acute respiratory distress syndrome.
New Initiatives
Causes and Mechanisms of COPD
Exacerbations
The purpose of this RFA is to investigate the causes
of, and the molecular pathways involved in, acute exacerbation of COPD. The
goal is to identify specific new targets for more effective preventive and
therapeutic interventions.
Idiopathic Pulmonary Fibrosis Clinical
Research Network
The purpose of this RFA is to establish a clinical
research network to design and perform multiple therapeutic trials in patients
with newly diagnosed idiopathic pulmonary fibrosis. The trials will evaluate
existing or new medications, combinations of medications, and defined
management strategies.
Pathogenesis of SARS Lung Disease: In
Vitro Studies and Animal Models
The purpose of this PA is to encourage research that
will rapidly advance understanding of the pathogenesis of severe SARS in the
lung using in vitro techniques, existing animal models of related coronavirus
infections, and appropriate animal models of SARS.
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Blood Diseases and Resources
Program
Initiative Being Renewed
Thalassemia Clinical Research
Network
The purpose of this renewal is to conduct clinical
trials to evaluate existing and new therapies for thalassemia. The network will
move effective therapies from the laboratory to the bedside through rapid and
systematic collaborative testing in phase II and phase III clinical trials.
New Initiatives
Cellular and Genetic Discovery Toward
Curative Therapy in Myeloproliferative Disorders (MPD)
The purpose of this RFA is to stimulate research to
discover cellular and genetic markers associated with the origin and
progression of MPD. Investigators will ultimately seek to translate research
findings into innovative treatments that will cure MPD.
Development of a Health-Related Quality of
Life Questionnaire in Sickle Cell Disease
The purpose of this RFP is to develop a quality of
life questionnaire and related materials to be used in clinical trials and
outcomes research among adults with SCD, and subsequently to assist researchers
who choose to use the new products.
Improved Therapy for Hemophilia and
Hereditary Bleeding Disorders
The purpose of this RFA is to develop improved
therapies, with the goal of finding a cure, for hemophilia and other hereditary
bleeding disorders. The focus is on stimulating research to improve therapy,
and enhance understanding of immune response and safety issues related to new
therapeutics, gene transfer, or cell-based therapies for bleeding disorders.
The RFA is cosponsored by the National Hemophilia Foundation.
Myelodysplastic Syndrome: Seeking Cure
Through Discovery on Pathogenesis and Disease Progression
The purpose of this RFA is to determine the etiology
and pathophysiology of myelodysplastic syndrome. Investigators will ultimately
seek to find a cure for the syndrome.
Specialized Centers of Clinically Oriented
Research (SCCOR) in Transfusion Biology and Medicine
The purpose of this SCCOR is to foster
multidisciplinary research in transfusion biology and medicine that will
improve the safety, efficacy, and availability of blood, blood components, and
plasma derivatives. Investigators will apply their findings to evaluate the
best approaches to provide blood- and bone-marrow-derived components to
patients.
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Trans-NHLBI
Initiatives Being Renewed
Competing Continuation Awards of SBIR
Phase II Grants for Heart, Lung, Blood, and Sleep Disorders
The purpose of this renewal is to support SBIR Phase
II awardees in further pursuing development and assessment of devices or
conducting preclinical studies of products or devices relevant to the NHLBI
mission prior to clinical evaluation and Federal regulatory agency
approval.
NHLBI HBCU Research Scientist Award
Extension
The purpose of this renewal is to facilitate research
capacity building at the four historically black colleges and universities
(HBCU) that were awarded the NHLBI Research Scientist Awards in 1996 to conduct
biomedical or behavioral research in cardiovascular, lung, or blood health and
disease, transfusion medicine, or sleep disorders. The program seeks to
increase the number of minority individuals involved in biomedical and
behavioral research and to reduce health disparities.
NHLBI Minority Institutional Research
Training Program
The purpose of this renewal is to provide full-time
research training to graduate, postdoctoral, or health professional students at
minority schools for investigative careers in cardiovascular, pulmonary, and
blood diseases and sleep disorders.
Programs of Excellence in Gene Therapy for
Heart, Lung, and Blood Diseases
The purpose of this renewal is to continue support to
the four NHLBI Programs of Excellence in Gene Therapy initiated in FY 2000. The
renewal will emphasize preclinical projects to facilitate the translation of
gene therapy into clinical studies, clinical studies to test safety and
efficacy of gene therapy, National Cores to provide resources and services to
NHLBI investigators at no cost, and training positions in clinical projects to
train M.D. and Ph.D. scientists in conducting gene therapy clinical trials.
New Initiatives
Bioengineering Approaches to Energy
Balance and Obesity
The purpose of this RFA is to encourage engineers,
physical scientists, and scientists from other relevant disciplines with
expertise in obesity and nutrition to develop and evaluate new technologies,
instrumentation, and medical devices to address clinical problems related to
energy balance, intake, and expenditure. The goal is to increase the number of
useful technologies and tools available to scientists to facilitate research
and support behavioral changes to address such problems as weight control and
obesity.
NHLBI Clinical Proteomics
Programs
The purpose of this RFA is to establish clinical
proteomics programs to validate existing and new candidate protein markers that
will enable early detection of heart, lung, and blood diseases and sleep
disorders. The programs will facilitate validation of protein panels that will
not only provide diagnostic and prognostic information, but also mechanistic
insight into therapeutic responses and new targets for interventions. In
addition, the RFA seeks to establish a high-quality education and skills
development program to ensure that scientists develop the expertise needed to
address the complex challenges in clinical proteomics.
NHLBI Programs of Excellence in
Nanotechnology
The purpose of this RFA is to create multidisciplinary
teams capable of developing and applying nanotechnology and nanoscience
solutions to the diagnosis and treatment of heart, lung, and blood diseases and
sleep disorders.
Pulmonary Complications of Sickle Cell
Disease
The purpose of this RFA is to encourage collaborative
research between investigators in hematology and pulmonary science that
combines basic and clinical approaches. The goals are to translate basic
research findings into clinical applications to treat pulmonary complications
of SCD and to encourage clinical and basic research on the role of upper airway
obstruction and sleep disturbances in acute chest syndrome and other pulmonary
complications of SCD.
Specialized Centers for Cell-Based Therapy
(SCCT) for Heart, Lung, and Blood Diseases
The purpose of this RFA is to establish SCCT to
conduct preclinical and clinical studies on cell-based therapy for treatment of
heart, lung, and blood diseases. Investigators will seek to translate basic
research findings into clinical applications for treatment of heart, lung, and
blood diseases. They will have 1 to 2 years to do preclinical studies to meet
the requirements for an Investigational New Drug application prior to
initiating clinical studies. By the beginning of the third year, the centers
should be ready to initiate clinical studies.
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Trans-NIH
Initiatives Being Renewed
Jackson Heart Study
The purpose of this renewal is to investigate genetic
and environmental causes of CVD in blacks. It also will build research
capabilities in minority institutions, address the critical shortage of
minority investigators in epidemiology and prevention, and reduce barriers to
dissemination and utilization of health information in a minority
population.
Phamacogenetics Research Network and
Knowledge Base
The purpose of this renewal is to continue support for
a network of collaborative groups that are investigating the influence of human
genetic variations on the response to drugs and using the information to
develop a public pharmacogenetic knowledge base.
New Initiatives
Asthma Exacerbations: Biology and Disease
Progression
The purpose of this RFA is to elucidate the mechanisms
and consequences of asthma exacerbation; define the pathways that are altered
during resolution of exacerbations; and determine their impact on lung
function, physiology, and disease state. Research findings will provide the
basis for developing more effective treatments that will control symptoms and
exacerbations while maintaining or improving lung function.
Bioengineering Research
Partnerships
The purpose of this PA is to support multidisciplinary
research teams in applying integrative, systems approaches to improve
understanding of disease and its diagnosis, treatment, and prevention or to
understand health and behavior.
Centers of Excellence in Translational
Human Stem Cell Research
The purpose of this RFA is to establish Centers of
Excellence in Translational Human Stem Cell Research to accelerate the
application of the latest advances in human stem cell biology to the
development of diagnostic or therapeutic uses for human disorders. The Centers
will bring together basic stem cell biologists and clinicians with
disease-specific expertise, physicians and surgeons skilled in new modes of
cell delivery, and investigators experienced in developing and assessing animal
models of human diseases to create new interdisciplinary research teams and to
conduct preclinical studies for cell-based therapy.
Prevention and Treatment of Childhood
Obesity in Primary Care Settings
The purpose of this RFA is to test, in a primary care
setting, interventions to prevent excessive weight gain in children at risk for
obesity and to prevent further weight gain or to promote weight loss in those
who are already obese. Interventions will focus on improving dietary and
physical activity behaviors.
Mentored Scientist Development Award in
Research Ethics (K01)
The purpose of this PAR is to support research ethics
training in biomedical, behavioral, or public health research, particularly
research involving human participants, by health professionals working at
academic and other health-related institutions. The candidate must identify a
mentor with extensive research and academic experience in ethical issues
related to biomedical research.
Molecular Screening Assay Development for
Sickle Cell Disease
The purpose of this RFA is to support the development
and adaptation of biological assays for automated, high throughput screening of
compounds that can potentially be used to improve the understanding of the
biology of SCD and lead to new agents for treatment.
Midcareer Investigator Award in
Patient-Oriented Research (K24)
The purpose of this PA is to encourage established,
midcareer clinician scientists to devote more time to patient-oriented research
and to act as research mentors for beginning clinical investigators.
Salt Sensitivity Diagnostic
Test
The purpose of this PA is to stimulate research
focused on developing a noninvasive or minimally invasive, rapid, and practical
diagnostic test for salt sensitivity of blood pressure in patients during
routine physical examination. Ideally, the test should correlate with the
long-term changes with blood pressure resulting from high salt intake.
School-Based Intervention To Prevent
Obesity
The purpose of this PA is to encourage partnerships
between academic institutions and school systems to develop and evaluate
behavioral interventions designed to increase children's physical activity and
decrease the amount of time that they devote to sedentary activities such as
watching television or playing computer games.
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Trans-PHS
New Initiatives
Characterization of Genetic Variants of
HIV and Other Blood-Borne Viruses
The purpose of this initiative is to characterize
emerging genetic variants of HIV and other agents transmitted by blood
transfusion and to determine their effect on the performance of licensed tests
used to screen donated blood.
Development of Serological Assays To
Distinguish Incident HIV Infections in Vaccine Recipients Developing HIV
Antibodies During Field Tests
The purpose of this initiative is to develop an
enzymatic immunoassay for the differential diagnosis of HIV-1 infection in the
presence of HIV vaccine- generated antibodies. The project is predicated on the
need to distinguish true HIV infections from vaccine-induced antibody responses
in populations receiving newly formulated complex HIV vaccines.
Mechanical Circulatory Support for
End-Stage Heart Failure: Interagency Registry
The purpose of this RFP is to establish a data and
clinical coordinating center to manage a registry of patients receiving a
mechanical circulatory support device to treat heart failure. The registry will
chronicle device implantation procedures, indications, and outcomes; identify
complications and risk factors for complications; develop predictive outcome
models; provide blood and tissue for genomic and proteomic investigations;
generate evidence to permit better device development, patient selection, and
operating procedures; and generate hypotheses for clinical trials and studies
that will improve clinical outcomes.
Interagency
New Initiative
Understanding and Promoting Health
Literacy
The purpose of this PA is to increase scientific
understanding of the nature of health literacy and its relationship to healthy
behaviors, illness prevention and treatment, chronic disease management, health
disparities, risk assessment of environmental factors, and health outcomes.
Such knowledge will enable health care and public health systems to serve
individuals and populations more effectively and to employ strategies that
reduce health disparities in the population.
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