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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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