5. Institute-Initiated Programs
Starting in FY 2011
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 (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., were first funded) in FY 2011
are presented below according to NHLBI scientific programs. Also described are
trans-NIH and trans-PHS initiatives in which the NHLBI participates.
Heart and Vascular Diseases Program
Initiatives Being Renewed
Action To Control Cardiovascular Risk in Diabetes
Follow-Up Study (ACCORDION)
The purpose of this renewal is to support a post-trial
follow-up study after termination of trial-assigned treatments in the ACCORD
trial. The follow-up study will determine whether differences in mortality, CVD
events, and microvascular diseases identified during the trial persist or
change over time, and whether other differences emerge.
Antihypertensive and Lipid-Lowering Treatment To
Prevent Heart Attack Trial (ALLHAT)—Extension
The purpose of this extension is to enable the ALLHAT
Coordinating Center to support continued scientific contributions based on
extensive ALLHAT data and to expand collaborations with relevant scientific
communities.
Atherosclerosis Risk in Communities (ARIC)
The purpose of this renewal is to continue follow-up
of the ARIC cohort and community surveillance for the study of CHD, stroke, and
heart failure.
Cardiovascular Health Study (CHS): Core Support
The purpose of this renewal is to extend support for
the CHS infrastructure to facilitate continued access to study resources and
expertise by investigators who are new to the CHS; promote scientific
productivity, collaboration, and mentorship of junior investigators; provide
analytic support to existing CHS working groups; and assist in the
establishment of a new health services research working group.
New Approaches to Arrhythmia Detection and
Treatment
The purpose of this renewal is to improve the ability
to detect, prevent, and treat all forms of cardiac arrhythmias. This initiative
encourages small businesses to develop improved diagnostic and therapeutic
tools or devices for cardiac arrhythmia monitoring, detection, and
treatment.
Pediatric Heart Network
The purpose of this renewal is to evaluate, through
multicenter clinical research, therapeutic and management strategies for
children and adults with congenital heart defects and for children with
inflammatory heart disease, heart muscle disease, and arrhythmias.
Women's Health Initiative (WHI)
The purpose of this renewal is to enhance the study's
ability to investigate outcomes in subgroups and find rarer outcomes; determine
long-term effects of clinical trial interventions; maintain and enhance the
central database, data analysis capabilities, and biorepository; and conduct
research on aging in older women.
New Initiatives
Clinical Research Career Development Programs in
Emergency Medicine Research
The purpose of this RFA is to develop
multidisciplinary clinical research training programs in emergency medicine
that prepare physician-scientists for academic leadership roles and independent
research careers in emergency medicine.
Phenotype Finder in Data Resources (PFINDR): A Tool
To Support Cross-Study Data Discovery Among NHLBI Genomic Studies
The purpose of this RFA is to develop and apply
advanced informatics approaches to categorize phenotypic measures in multiple
datasets in data repositories to help researchers identify potentially relevant
genomic studies across cardiovascular, lung, blood, and sleep research
domains.
Lung Diseases Program
Initiatives Being Renewed
Lung Tissue Research Consortium
The purpose of this renewal is to continue support for
the Consortium to collect, process, and distribute lung tissue and associated
clinical data for research that focuses primarily on COPD and idiopathic
pulmonary fibrosis.
Severe Asthma Research Program
The purpose of renewing this RFA is to understand the
evolution of severe asthma by defining it at the molecular and cellular levels
longitudinally. Research findings will serve as a basis for designing
mechanism-based diagnostic, prognostic, and treatment strategies for severe
asthma in children and adults.
New Initiatives
Centers for Advanced Diagnostics and Experimental
Therapeutics in Lung Diseases (CADET) Stage I
The purpose of this RFA is to develop agents for
diagnosing and treating lung diseases and sleep-disordered breathing through
the use of strategies based on fundamental pathobiologic processes.
Common Pathogenetic Mechanisms of Lung Cancer and
COPD
The purpose of this RFA is to investigate common
pathogenetic mechanisms of lung cancer and COPD. Scientists will study
genotypic and phenotypic characteristics that determine individual
susceptibility and shared biochemical, molecular, and immunological pathways
that are involved in the origin and progression of both diseases.
Translational Programs in Lung Diseases
The purpose of this PAR is to support collaborative,
translational research that will move mechanistic research to clinical
applications to improve prevention, diagnosis, and treatment of lung diseases
and sleep disorders.
Utilization of a Human Lung Tissue Resource for
Vascular Research
The purpose of this RFA is to advance translational
efforts in lung vascular disease. Investigators will use human biospecimens
collected by the Pulmonary Hypertension Breakthrough Initiative to determine
the pathogenesis of pulmonary arterial hypertension.
Blood Diseases and Resources
Program
Initiative Being Renewed
Recipient Epidemiology and Donor Evaluation Study-III
(REDS-III)
The purpose of this renewal is to build on and extend
the findings of the original REDS and REDS-II programs and address new research
areas, including determining safe, effective blood banking and transfusion
medicine practices through a comprehensive, multi-targeted strategy involving
basic, translational, and clinical research to improve the benefits of
transfusion while reducing its risks.
New Initiatives
Innovators in Hemoglobinopathies Care Career
Development Award
The purpose of this RFA is to advance the research
career development of physician-scientists in SCD and thalassemia.
Individuals will address important questions about patient management and
translate research results into practice through the use of multidisciplinary
teams.
Planning Grants for Pivotal Clinical Trials in
Hemoglobinopathies
The purpose of this RFA is to support pilot studies to
obtain data that are critical for the design of robust clinical trials in the
hemoglobinopathies, SCD, and thalassemias.
Selected Topics in Transfusion Medicine
The purpose of this PAR is to study topics aimed at
improving the safety and availability of the blood supply and the practice of
transfusion medicine.
Trans-NHLBI
Initiatives Being Renewed
Ancillary Studies in Clinical Trials
The purpose of this renewal is to support
time-sensitive ancillary studies related to heart, lung, and blood diseases and
sleep disorders in conjunction with ongoing NIH- and non-NIH-supported clinical
trials.
Investigator-Initiated Multisite Clinical Trials
The purpose of this renewal is to support
investigator-initiated, multisite, Phase II and Phase III randomized controlled
clinical trials in areas relevant to the mission of the NHLBI.
Maintenance of NHLBI Biological Specimen
Repository
The purpose of this renewal is to continue support for
the repository of biologic specimens from NHLBI-sponsored epidemiological and
clinical studies. Under the direction of the NHLBI, the repository makes
specimens available to the scientific community for use in research related to
the NHLBI's mission.
Research Dissemination and Implementation Grants
The purpose of this renewal is to develop and test
strategies to accelerate the adoption and integration of efficacious or
guideline-based treatments and effective prevention modalities for heart, lung,
and blood diseases and sleep disorders in clinical, community, and other
settings.
New Initiatives
Cross Organ Mechanism-Associated Phenotypes for
Genetic Analyses of Heart, Lung, Blood, and Sleep Diseases (MAPGen for
HLBS)
The purpose of this RFA is to identify and
characterize common pathobiologic traits and mechanisms that cross organ
systems and diseases with the goal of redefining heart, lung, and blood
diseases and sleep disorders based on the findings.
MAPGen Knowledge Base and Coordination Center
The purpose of this RFA is to develop and implement a
knowledge base and Coordinating Center for the MAPGen for HLBS (above).
Next Generation Genetic Association Studies
The purpose of this RFA is to build on existing
genomic study findings with functional information gained by assessing cellular
profiles that are surrogates for disease phenotypes.
NHLBI Clinical Trial Pilot Studies
The purpose of this PAR is to support pilot studies to
fill gaps in scientific knowledge necessary to develop a competitive full-scale
clinical trial to evaluate interventions for the treatment and prevention of
heart, lung, and blood diseases and sleep disorders.
NHLBI Research Centers at Minority-Serving
Institutions
The purpose of this RFA is to support minority-serving
institutions in strengthening scientific faculty; augment predoctoral and
postdoctoral science education and research training; and improve research
infrastructure, capabilities, and resources in biomedical and behavioral
research related to heart, lung, and blood diseases and sleep disorders.
Programs of Excellence in Glycosciences
The purpose of this RFA is to translate emerging
discoveries in glycosciences into diagnostics and clinical applications and to
build research capacity in glycosciences relevant to heart, lung, and blood
diseases.
Science Moving TowArds Research Translation and
Therapy Program (SMARTT)
The purpose of this RFP is to assist investigators
with the processes needed to translate discoveries in the laboratory into
potential new therapies for heart, lung, and blood diseases. The Program will
provide manufacturing of synthetic, natural, or biologic products; pharmacology
and toxicology testing; preclinical and early phase clinical study design
support; and regulatory expertise.
Trans-NIH
Initiatives Being Renewed
Academic Research Enhancement Award (AREA)
The purpose of this renewal is to stimulate support
for biomedical, behavioral, or clinical research in educational institutions
that provide baccalaureate or advanced degrees for a significant number of the
Nation's research scientists, but that have not been major recipients of NIH
support.
Advancing Novel Science in Women's Health
Research
The purpose of this renewal is to support research
that will advance new concepts in women's health and the study of sex
differences.
Bioengineering Research Grants
The purpose of this renewal is to support basic and
applied multidisciplinary research that addresses biological, bioengineering,
or medical research problems. This initiative differs from Bioengineering
Research Partnerships (below) in that the research will be performed in a
single laboratory by a single investigator or by a small group of
investigators.
Bioengineering Research Partnerships
The purpose of this renewal is to support basic,
applied, and translational multidisciplinary research that addresses
biological, bioengineering, or medical research problems. A partnership of
multidisciplinary teams will apply an integrative, systems approach to develop
knowledge or methods to prevent, detect, diagnose, or treat disease or to
understand health and behavior.
Blood and Marrow Transplant Clinical Research Network
The purpose of this renewal is to evaluate
innovative treatment approaches and management strategies for children and
adults who are undergoing hematopoietic stem cell transplantation. The focus of
the initiative is to support multicenter Phase II and Phase III studies that
provide information to improve hematopoietic stem cell transplantation
therapy.
Diet Composition and Energy Balance
The purpose of this renewal is to investigate the role
of diet composition in energy balance. Scientists are seeking to understand the
impact of micro- or macronutrient composition on appetite, metabolism, and
energy expenditure and to determine the efficacy of diets that differ in micro-
or macronutrient composition, absorption, dietary variety, or energy density on
weight loss and weight maintenance.
Dissemination and Implementation Research in
Health
The purpose of this renewal is to support innovative
approaches to overcoming barriers to adopting and integrating evidence-based
interventions and guidelines that previous research has shown to be effective
but where implementation has been limited or significantly delayed.
Exploratory Collaborations With National Centers for
Biomedical Computing
The purpose of this renewal is to support
investigators who are collaborating with NIH Roadmap National Centers for
Biomedical Computing to engage in exploratory biomedical informatics and
computational biology research.
Exploratory Innovations in Biomedical Computational
Science and Technology
The purpose of this renewal is to promote research and
development in biomedical informatics and computational biology that will
support rapid progress in areas of scientific opportunity in biomedical
research.
Innovations in Biomedical Computational Science and
Technology Initiative
The purpose of this renewal is to solicit STTR grant
applications that propose innovative research in biomedical informatics and
computational biology to promote the progress of biomedical research.
Methodology and Measurement in the Behavioral and
Social Sciences
The purpose of this renewal is to improve the quality
of data collected in the behavioral and social sciences relevant to the mission
of the participating NIH Institutes.
Mouse Metabolic Phenotyping Centers Consortium
The purpose of this renewal is to provide the
scientific community with standardized, high-quality metabolic and physiologic
phenotyping services for mouse models of diabetes, diabetic complications,
obesity, and related disorders.
Understanding and Promoting Health Literacy
The purpose of this renewal is to encourage research
on health literacy concepts, theory, and interventions as they pertain to
prevention, healthy living, chronic disease management, patient-based health
care, cultural competence, and health disparities. Researchers will seek to
develop health literacy assessment methods, measure association between health
literacy and chronic illness, and evaluate health literacy interventions that
are designed to improve health outcomes in heart, lung, and blood diseases and
enhance understanding and use of genetic information in risk discussion.
New Initiatives
Biophysical and Biomechanical Aspects of Embryonic
Development
The purpose of this PAR is to encourage innovative and
high risk/impact research in the area of physics/mechanics of embryonic
development in model organisms. The focus of the initiative is to promote
research that will generate information about tissue mechanics relevant to
vertebrate development and will improve the understanding of the basis for
developmental disorders.
Deepwater Horizon Disaster Research Consortia
The purpose of this RFA is to investigate health
outcomes from exposure to the Deepwater Horizon disaster, including (a)
identifying those at greatest risk for adverse physical, mental, and behavioral
effects as a consequence of the disaster and other stressors encountered by
residents and (b) developing community-based approaches to respond to it and
future disasters.
Development of Multifunctional Drug and Gene Delivery
Systems
The purpose of this PAR is to develop multifunctional
drug and gene delivery systems that can target therapies to particular cells
and intracellular compartments, monitor delivery, and determine therapeutic
efficacy through integration of advanced imaging or sensing technologies into
the delivery system.
Knockout Mouse Phenotyping Program (KOMP2)
The purpose of this RFA is to support a systematic
program to generate live mice from embryonic cells that contain individual,
single-gene deletion of known and predicted protein-encoding genes in the mouse
genome, which was successfully generated by the Knockout Mouse Project (KOMP)
in collaboration with the International Knockout Mouse Consortium.
Lifestyle Interventions in Overweight and Obese
Pregnant Women Consortium
The purpose of this RFA is to evaluate lifestyle
interventions in overweight and obese pregnant women that are designed to
improve weight and metabolic outcomes in both the pregnant women and their
offspring.
New Strategies for Growing 3D Tissues
The purpose of this RFA is to understand how cells
respond to their environment and develop assays and methods to understand how
angiogenesis and organogenesis may instruct the creation of 3D-engineered
cellular aggregates.
Safe and Effective Instruments and Devices for Use in
the Neonatal Intensive Care Units
The purpose of this SBIR/STTR is to develop or improve
safe and effective instruments for monitoring and treating newborn and small
children.
Sleep and Social Environment: Basic Biopsychosocial
Processes
The purpose of this RFA is to investigate the
reciprocal interactions of the processes of sleep and circadian regulation and
function with behavioral and social environment processes.
Social Network Analysis and Health
The purpose of this PAR is to advance and expand the
utility of social network analysis and methods in studies of health and
disease. The goal is to encourage basic research that can lead to new
applications of social network methods and theory related to improving human
health.
Trans-PHS
New Initiatives
Community-Based Partnerships for Childhood Obesity
Prevention and Control Research
The purpose of this PA is to stimulate childhood
obesity research through community-based partnerships that include local,
state, and regional teams of researchers, policymakers, and other relevant
participants—such as community representatives, public health
practitioners, and educators.
Obesity Policy Research: Evaluation and Measures
The purpose of this PA is to conduct evaluation
research on obesity-related "natural experiments" (i.e., community and other
population-level public policy interventions that may affect diet and physical
activity behavior) and develop and validate relevant community-level measures
(i.e., instruments and methodologies to assess the food and physical activity
environments).
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