5. Institute-Initiated Programs
Starting in FY 2012
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 Experts (BEE), and the National Heart,
Lung, and Blood Advisory Council (NHLBAC). The advisory committees and the
BEE, 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. Other initiatives take the form of Program Announcements (PAs)
or Program Announcements with special receipt, referral, or review
considerations (PARs). Applications and proposals submitted in response to
RFAs and RFPs compete among themselves for specific "set-aside" funds. Applications submitted in response to PAs or PARs generally compete with other
investigator-initiated applications for funding.
RFA, RFP, and PA concepts prepared by the Institute are presented
to the BEE, which reviews and prioritizes them. The concepts, along with the
comments from the BEE, 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, PAs, and PARs are announced in the NIH Guide to
Grants and Contracts.
Applications and proposals submitted in response to RFAs and RFPs
are reviewed by peer review panels convened by the NHLBI. Applications
submitted in response to PAs and PARs are reviewed by the NIH Center for
Scientific Review.
Descriptions of new or
competitively renewed Institute-initiated programs that began (i.e. , Type 1 or
Type 2) in FY 2012 are presented below according to NHLBI scientific programs. Also described are trans-NIH, trans-PHS, and Interagency initiatives in which
the NHLBI participates.
Heart and Vascular Diseases
Program
Initiatives Being Renewed
Cardiovascular Cell Therapy Research Network: Regional
Clinical Centers and Data Coordinating Center
The purpose of these renewals is to maintain an infrastructure to
develop, coordinate, conduct, and evaluate multiple collaborative clinical
trials designed to improve the management of CVD. Investigators will be
evaluating innovative stem cell-based therapies.
Heart Failure Clinical Research Network: Regional Clinical
Centers and Data Coordinating Center
The purpose of these renewals is to maintain an infrastructure to
develop, coordinate, and conduct multiple collaborative clinical trials to
improve heart failure outcomes. The clinical centers initiative is structured
to support concurrent, small- to intermediate-sized randomized clinical trials
that can be completed within 2 to 5 years; it is not designed to fund large,
Phase III studies.
New Initiatives
Basic Research in Calcific Aortic Valve Disease
The purpose of this RFA is to encourage innovative molecular and
physiological research that could lead to early diagnosis or effective medical
therapy for calcific aortic valve disease through new diagnostic biomarkers or
new therapeutic targets.
Pilot Studies To Develop and Test Novel, Low-Cost Methods for
the Conduct of Clinical Trials
The purpose of this RFA is to
develop and test low-cost methods to conduct clinical trials. This effort
encourages new and innovative designs that have not been tested in previous
studies and hold potential to increase the efficiency and reduce the cost of
conducting clinical trials.
Toward an Improved Understanding of HDL Function
The purpose of this PA is to develop, validate, and standardize
assays to measure HDL function and biomarkers for HDL function and to identify
new pathways and potential therapeutic targets related to HDL function.
Lung Diseases Program
Initiative Being Renewed
Novel Therapies for Lung Diseases—Phase II Clinical
Trials
The purpose of this renewal is to conduct proof-of-concept Phase
II clinical trials that test an innovative intervention for a lung disease or a
cardiopulmonary disorder from sleep that has the potential to cause a
significant change in clinical management.
New Initiatives
Development and Testing of a Case-Finding Methodology in COPD
The purpose of this RFA is to design and test tools for identifying
individuals who are likely to have undiagnosed COPD.
Early Cystic Fibrosis Lung Disease Studies in Humans
The purpose of this RFA is to characterize the origins of CF lung
disease in infants and young children, elucidate mechanisms of disease
development and progression, and identify targets and strategies for early
interventions.
Genomic Research in AAT-Deficiency and Sarcoidosis Study
(GRADS): Clinical Centers and Genomics and Informatics Center
The purpose of this program is to conduct genomic, microbiomic,
and phenotypic studies in patients with alpha-1 antitrypsin deficiency or
sarcoidosis to elucidate pathogenetic mechanisms or identify predictors of
disease development and progression.
Getting From Genes to Function in Lung Disease
The purpose of this PA is to characterize the function of genes
and their associated variants that have been identified by GWAS or other
genetic approaches. Investigators will use integrated approaches across
scientific disciplines to determine the pathobiological function of the genes.
Lung Repair and Regeneration Consortium: Research Centers
and Administrative Coordinating Centers
The purpose of these RFAs is to establish multidisciplinary teams
of investigators who will develop cutting-edge technologies, innovative
strategies, and new ideas to accelerate research progress on lung regeneration
and repair.
Molecular Imaging of the Lung—Phase 1
The purposes of this RFA are to identify molecular targets that
are relevant to lung health and diseases for probe development in combination
with innovative imaging approaches and to validate the developed probes in
cells and in vivo animal models. The eventual goal
is to generate sufficient preclinical data to support an investigational new
drug submission with the U.S. Food and Drug Administration for initial
testing in humans.
Pulmonary Vascular-Right Ventricular Axis Research Program
The purpose of this RFA is to acquire disease-defining knowledge
of the pulmonary vascular-right ventricular axis in humans leading to improved
and targeted diagnostics and therapeutics for right ventricular failure.
Blood Diseases and Resources Program
Initiative Being Renewed
Clinical Hematology and Transfusion Medicine Research Career
Development Program
The purpose of this renewal is to develop and evaluate
multidisciplinary career development programs in nonmalignant hematology and
transfusion medicine that will equip new investigators with the knowledge and
skills to address complex problems in blood diseases and transfusion medicine.
New Initiatives
Clinical Trials Development Resource for Hematologic
Disorders
The purpose of this RFA is to provide a resource of expert
consultants to assist investigators in the development of multisite clinical
trials for hematologic disorders. This RFA is linked to two NHLBI RFAs: the
Clinical Trials Planning Studies for Rare Thrombotic and Hemostatic Disorders
and the NHLBI Clinical Trial Pilot Studies.
Clinical Trials Planning Studies for Rare Thrombotic and
Hemostatic Disorders
The purpose of this RFA is to support the planning phase of Phase
III multicenter investigator-initiated clinical trials focused on either rare
hemostatic and thrombotic disorders or more common hemostatic and thrombotic
disorders that occur rarely in special patient populations (e.g. , neonates,
children, pregnant women).
Early-Phase Clinical Trials for Blood Cell Therapies
The purpose of this PAR is to conduct early-phase clinical trials
to evaluate innovative cell therapies to treat blood diseases and to improve
the outcome of hematopoietic stem cell transplantations.
Sickle Cell Disease: Inflammation, Thrombosis, and Vascular
Dysfunction
The purpose of this PA is to identify new pathways and regulatory
mechanisms that may be as important in the pathophysiology of SCD as red blood
cell sickling. Researchers will study the role of the immune and coagulation
systems in the vaso-occlusive pathologies that are associated with SCD.
Translational Research Centers in Thrombotic and Hemostatic
Disorders
The purpose of this RFA is to enhance the translation of basic
research discoveries that could lead to improved prevention, diagnosis, and
treatment for thrombotic and hemostatic disorders. Investigators will advance
early stage translational research, integrating applied and basic science to
move research discoveries toward clinical application.
Understanding Mechanisms of Terminal Erythroid Maturation
The purpose of this RFA is to study the development of erythroid
precursors into mature red blood to improve understanding of the molecular
mechanisms that regulate late stages of erythroid maturation.
Trans-NHLBI
Initiatives Being Renewed
NHLBI Investigator-Initiated Resource-Related Research
Projects
The purpose of this renewal is to enhance the capabilities of
ongoing basic, translational, and clinical research by developing resources or
infrastructures that are available to the scientific community for furthering
research relevant to the NHLBI mission.
Research Dissemination and Implementation Grants
The purposes of this renewal are to develop and test innovative
approaches to translating efficacious treatments and effective prevention
strategies for heart, lung, and blood diseases and sleep disorders to clinics,
communities, and other settings; and to examine the effectiveness of
interventions as they are disseminated and implemented in real-world settings.
New Initiatives
Anchoring Metabolomic Changes to Phenotype
The purpose of this RFA is to facilitate metabolomic phenotyping
of existing cohorts and improve understanding about the role of metabolites in
the functional pathways and molecular mechanisms that contribute to an observed
phenotype.
Management of HIV-Related Lung Disease and Cardiovascular
Comorbidity
The purpose of this RFA is to develop optimal intervention
strategies for HIV-related lung disease, with or without comorbid CVD, to
reduce morbidity and mortality associated with these conditions.
Maximizing the Scientific Value of the NHLBI Biologic
Specimen Repository: Scientific Opportunities
The purpose of this RFA is to conduct exploratory research in
heart, lung, and blood diseases and blood resources using biospecimens stored
in the NHLBI Biologic Specimen Repository.
NHLBI Translational Research Implementation Program
(TRIP)—Limited Competition
The purpose of this RFA is to accelerate the translation of new
therapeutic interventions derived from fundamental research discoveries for
treatment and prevention of cardiovascular, lung, and blood diseases through
planning and execution of well-designed clinical trials that demonstrate safety
and efficacy. Only successful Stage 1 investigators can apply for Stage 2
studies to conduct the clinical trials planned and developed during Stage 1.
Short-Term Institutional Training Grant for Clinician
Scientists in Pediatric Respiratory, Sleep, and Hematology/Transfusion Medicine
The purpose of this RFA is to develop and enhance research
training opportunities in basic or clinical research in pediatric respiratory,
sleep, and hematology and transfusion medicine for medical and health
professional students.
Trans-NIH
Initiatives Being Renewed
Improving Diet and Physical Activity Assessment
The purpose of this renewal is to stimulate innovative research
that will enhance the quality of measurements of dietary intake and physical
activity.
Midcareer Investigator Award in Patient-Oriented Research
The purpose of this renewal is to support midcareer
health-professional doctorates or equivalents by providing them with "protected
time" to devote to patient-oriented research and to act as research mentors
primarily for clinical residents, clinical fellows, and junior clinical
faculty.
Nanoscience and Nanotechnology in Biology and Medicine
The purpose of this renewal is to study basic biological
phenomena and engineer nanotechnology solutions that will enable biomedical
breakthroughs in the diagnosis, treatment, and management of diseases and
traumatic injuries.
Nutrition and Diet in the Causation, Prevention, and
Management of Heart Failure
The purpose of this renewal is to develop a satisfactory science
base for rational nutritional management of patients in various stages of heart
failure and for preventive approaches in high-risk individuals.
Reducing Health Disparities Among Minority and Underserved
Children
The purpose of this renewal is to conduct research that can be
used to reduce health disparities among children. Specific targeted research
includes biobehavioral studies that incorporate multiple factors that affect
child health disparities (e.g. , biological, lifestyle, environmental, social,
economic, institutional, and cultural and family influences); studies that
focus on the specific health promotion needs of children with a known illness
and disability; and studies that test and evaluate the comparative
effectiveness of health promotion interventions that are conducted in
traditional and nontraditional settings.
New Initiatives
Life After Linkage: The Future of Family Studies
The purpose of this RFA is to integrate novel molecular data with
existing genotype and phenotype data in families to identify and characterize
genes that influence complex disorders.
Methods and Approaches for Detection of Gene–Environment
Interactions in Human Disease
The purpose of this PAR is to develop and test innovative statistical,
analytical, and bioinformatic approaches for identifying gene–environment
interactions of complex human diseases.
Reducing the Impact of Hypertension in Low- and Middle-Income
Countries
The purpose of this RFA is to establish a highly interactive
consortium of investigators who will develop effective interventions for
expanding sustainable hypertension prevention and control programs at the
local, regional, and national levels in low- and middle-income countries.
Trans-PHS
Initiatives Being Renewed
Community Participation in Research
The purpose of this renewal is to support intervention research
on health promotion, disease prevention, and health disparities that
communities and researchers jointly conduct.
Predictive Multiscale Models for Biomedical, Biological,
Behavioral, Environmental, and Clinical Research
The purpose of this renewal is to develop multiscale models of
biological and behavioral systems that can be used as tools to address a range
of biomedical, biological, behavioral, environmental, and clinical problems.
Interagency
New Initiative
Virtual Reality Technologies for Research and Education in
Obesity and Diabetes
The purpose of this RFA is to encourage investigators from
academic, small business, and technology transfer communities to explore the
potential of virtual reality technologies for addressing obesity and diabetes
through behavioral science research and through the development of practical
tools that can be used at the clinical and public health levels to prevent and manage
these conditions.
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