- FY 2012 Funding and Operating Guidelines more
- NIH Clinical Research Trials and You more
- Notice of Intent to Publish a Funding Opportunity Announcement for the NHLBI Centers for Accelerated Innovations - NOT-HL-11-157 more
- Identifying Heart, Lung, and Blood Disease-Causing Variants (R01) more
- NHLBI Will No Longer Participate in the Investigator-Initiated Innovative Research Grant (R21) Program more
- The NHLBI has issued a correction to FOA - RFA-HL-12-015 more
- Early Phase Clinical Trials in Imaging and Image-Guided Interventions (R21) more
- CT Surgical Trials Network Request for Satellite A Fib Ablation Sites – Applications Due April 21st more
- Registration Now Open for the 13th Annual NIH SBIR/STTR Conference more
- Notice of Correction for Shared Instrumentation Grant Program (S10) more
- Phase II Clinical Trials of Novel Therapies for Lung Diseases (UM1) RFA-HL-12-022 more
- Nutrition and Diet in the Causation, Prevention, and Management of Heart Failure, Two FOAs Announced more
- NHLBI Lung Repair and Regeneration Consortium and Administrative Coordinating Center (U01) more
- Getting from Genes to Function in Lung Disease, NHLBI (R01) more
- Toward An Improved Understanding of HDL Function, NHLBI (R01) more
- NIH Transformative Research Projects Program (R01) more
- Notice of Discontinuation of National Cancer Institute Participation in the Academic Career Award (Parent K07) more
- NCI: Clinical Proteomic Technologies for Cancer Initiative (CPTC): Proteome Characterization Centers (U24) more
- NHLBI: New Strategies for Growing 3D Tissues (R01 and R21) more
- NIH’s Center for Scientific Review (CSR) Highlights Changes and Updates more
- NCI Education and Career Development Program (R25) more
- NCI Academic-Industrial Partnerships for Translation of in vivo Imaging Systems for Cancer Investigations (R01) more
- NCI / NHLBI R01 — Common Pathogenetic Mechanisms of Lung Cancer and COPD more
- NHLBI R01 — Ancillary Studies in Clinical Trials more
- NIH Heart Center Seeking CT Surgeon Research Fellow more
- NHLBI Investigator Initiated Multi-Site Clinical Trials (Collaborative R01) more
- Cardiothoracic Surgery Network Request for Satellite Sites -- March 15th Deadline more
- NIH Notice: 2010 Salary Limitation on Grants more
- New NIH Recovery Act Funding Opportunities more
- NIH Program Announcements for NCI and NHLBI – Opening in January more
- NCI Funding Opportunity: Prediction Models for Cancer Risk and Prognosis (R01/R21) more
- NHLBI New Funding Opportunity (R34) to Support Clinical Trial Pilot Studies more
- NIH: Shorter applications better aligned to the review criteria more
- FDA Pediatric Clinical Trials Workshop, October 29-30, 2009 more
- NHLBI Announces Structural Change more
- NHLBI Funding Opportunity (R01) more
- Dr. David H. Harpole named co-chair of the NCI Lung Cancer Steering Committee more
- Dr. Marc Moon appointed to serve on the FDA's Circulatory System Devices Panel. more
- NHLBI / NCI Stimulus-Funded Grant Proposals Due April 27 more
- NCI -- Allowable Salary Levels on Career Awards more
- NIH Notice: Salary Limitation on Grants more
- AHRQ Mentored Clinical Scientist Research Career Development Award (K08) more
- K23 Mentored Patient-Oriented Research Career Development Award more
- K08 Mentored Clinical Scientist Research Career Development Award more
- New NIH Registration Process to Reimburse Reviewers more
- CSR Announces Updated Study Sections more
- NIH Peer Review System Updates for FY 2010 Funding more
- Dr. Andrew S. Wechsler appointed as Senior Advisor to the Division of Cardiovascular Diseases of the National Heart, Lung, and Blood Institute more
- NHLBI Seeks Leader for the Division of Cardiovascular Diseases (DCVD) more
- A2 applications to be eliminated more
- Encouraging Early Transition to Research Independence: Modifying the NIH New Investigator Policy to Identify Early Stage Investigators (NOT-OD-08-121) more
- Elias A. Zerhouni to End Tenure as Director of the National Institutes of Health more
- Enhancing NIH Peer Review Activity Implementation Timeline more
- Stats reveal bias in NIH grant review more
- NIH Extramural Loan Repayment Programs more
- Stem Cells and Cancer (R21) Funding Opportunity more
- NIH-Supported Midcareer Development Award Program. more
- NHLBI (R01) Request for Applications: Developmental Origins of Altered Lung Physiology and Immune Function more
- Revision of NIH Policy Concerning Concurrent Support from Mentored Career Development (K) Award and a Research Grant more
- NHLBI Does Not Accept R21 Applications Primarily Related to Cancer Research more
- NIH Gives Reviewers New Flexibility Submitting Applications more
- NIH Notice: Salary Limitation on Grants more
- AATS Progress in Achieving Goals for Peer Review of Cardiothoracic Surgical Grant Proposals to NIH more
FY 2012 Funding and Operating Guidelines
The National Heart, Lung, and Blood Institute (NHLBI) and the National Institutes of Health (NIH) have posted their FY 2012 Funding and Operating Guidelines. The NHLBI will continue to apply NIH cost management guidelines when making fiscal year 2012 grant awards. Funds will be restored as appropriate for FY 2012 awards previously made at the 90% provisional amount. Although funding decisions are usually made in priority score or percentile order, final funding decisions are based on considerations of program relevance, overlap with existing programs, availability of funds, and NHLBI Advisory Council recommendations. More information, including payline information and future year commitments on FY 2012 new and competing renewal awards can be found at http://www.nhlbi.nih.gov/funding/policies/operguid.htm
Notice of Intent to Publish a Funding Opportunity Announcement for the NHLBI Centers for Accelerated Innovations - NOT-HL-11-157
The National Heart, Lung, and Blood Institute (NHLBI) intends to publish a Funding Opportunity Announcement (FOA) to establish Centers for Accelerated Innovations (CAI) that will address the problems that hinder the critical, early steps necessary to translate novel scientific advances and discoveries into commercially viable diagnostics, devices, therapeutics, and tools that improve patient care and advance public health.
The notice is provided to allow prospective applicants time to consider the CAI Program and develop essential collaborations and plans prior to submitting an application in response to the published FOA. The FOA is expected to be published in the NIH Guide for Grants and Contracts in Spring 2012 with an expected receipt date in Fall 2012. The FOA will utilize the U54 funding mechanism, which is a cooperative agreement that requires significant interaction between the awardees and the NHLBI staff. More information about the upcoming FOA, may be found at the following link: http://grants.nih.gov/grants/guide/notice-files/NOT-HL-11-157.html.
Identifying Heart, Lung, and Blood Disease-Causing Variants (R01)
The NHLBI has announced an initiative intended to stimulate research to identify heart, lung, and blood disease-causing rare variants using the extensive exome data generated by the American Recovery and Reinvestment Act of 2009 (ARRA) GO exome sequencing project (GO ESP), CHARGE-S, and related genomic data.
The objective of this new initiative is to encourage investigators to identify and fill in specific gaps in the GO ESP exome dataset(s) to maximize the usefulness of this newly established resource for the complex diseases important to NHLBI. The effort will require multidisciplinary collaborations involving epidemiologists, population geneticists, statistical geneticists, laboratory genomics experts, and diseases experts. Potential gaps might be related to ethnic diversity, phenotypes that need additional power, analysis of the data in different ways, further validation of findings, and replication or follow-up studies in well chosen cohorts. The specific gaps and approaches to meet the needs will be provided by the applicants. Applications are due February 8, 2012 and February 8, 2013, by 5:00 PM local time of applicant organization.
NHLBI Will No Longer Participate in the Investigator-Initiated Innovative Research Grant (R21) Program
The R21 grant is meant to facilitate the award of larger regular research project grant (R01) applications by providing investigators with limited funds and time to pursue initial studies to obtain preliminary data for larger, more fully developed research projects. However, the NHLBI has determined that this grant mechanism is not having the effect or the impact on its research grant portfolio in the manner for which it was originally intended.
The NHLBI will no longer be a co-sponsor for the NIH R21 Parent Announcement, NIH Exploratory Developmental Research Grant Program. Consequently, the NHLBI will no longer accept investigator-initiated R21 applications in response to the NIH’s Parent Funding Opportunity Announcement (FOA). This new policy is described in NIH Guide Notice NOT-HL-11-154.
For general information and questions regarding the R21 program, please visit: http://www.nhlbi.nih.gov/funding/r21.htm.
The NHLBI has issued a correction to FOA - RFA-HL-12-015
The purpose of the original FOA is to encourage innovative molecular and physiological research that could lead to early diagnosis or effective medical therapy for calcific aortic valve disease. Applications from investigators in related fields (for example, mineralization and bone physiology, extracellular matrix physiology, and molecular imaging) are strongly encouraged.
Correction: The original maximum award period was listed as four years. The new language sets the maximum award period to five years.
For more information on this FOA, please visit: http://grants.nih.gov/grants/guide/rfa-files/RFA-HL-12-015.html.
Early Phase Clinical Trials in Imaging and Image-Guided Interventions (R21)
This Funding Opportunity Announcement (FOA) is intended to support clinical trials conducting preliminary evaluation of the safety and efficacy of imaging agents, as well as an assessment of imaging systems, image processing, image-guided therapy, contrast kinetic modeling, and 3-D reconstruction and other quantitative tools. As many such preliminary evaluations are early in development, this FOA will provide investigators with support for pilot (Phase I and II) cancer imaging clinical trials, including patient monitoring and laboratory studies. This FOA builds upon the success of its predecessor FOA, PAR-08-147 entitled "Quick-Trials for Imaging and Image-Guided Interventions: Exploratory Grants (R21)". Through this FOA, funding is primarily provided for early phase clinical trials that are designed and developed in such a way as to facilitate completion within 2 years. For more information, please visit: http://grants.nih.gov/grants/guide/pa-files/PAR-11-216.html.
CT Surgical Trials Network Request for Satellite A Fib Ablation Sites – Applications Due April 21st
The Cardiothoracic Surgical Trials Network (CTSN) is pleased to announce the solicitation of additional Satellite Sites (investigative sites outside the CTSN) to participate in the Network trial SURGICAL ABLATION VERSUS NO SURGICAL ABLATION FOR PATIENTS WITH PERSISTENT OR LONGSTANDING PERSISTENT ATRIAL FIBRILLATION UNDERGOING MITRAL VALVE SURGERY. These Satellite Sites will enhance recruitment, provide additional clinical expertise, and participate in the intellectual output of the Network.
The CTSN was established in 2007 with support from the National Heart, Lung, and Blood Institute (NHLBI), the National Institute of Neurological Disorders and Stroke (NINDS) at the National Institutes of Health (NIH), and the Canadian Institutes of Health Research (CIHR).
The goal of the Cardiothoracic Surgery Network (CTSN) is to establish a cooperative network of cardiac surgery programs to promulgate the use of evidence-based medicine in surgical practice. The Network is intended to design, conduct, and analyze important, randomized clinical trials and observational studies, disseminate the results, and thereby translate the findings into clinical practice.
Please use the attached link to view the related documents and download an application. The application deadline is April 21, 2011.
Registration Now Open for the 13th Annual NIH SBIR/STTR Conference
Registration is now open for the 13th Annual NIH Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) Conference will be held June 22 & 23, 2011, at the Natcher Auditorium located on the NIH Campus in Bethesda, MD. The theme of this year’s annual conference is “Translating Medical Discoveries into Health Products.” It encompasses two full days of in-depth information about the NIH SBIR and STTR programs. Topics span the entire SBIR/STTR funding process from identifying funding opportunities to application preparation, electronic submission, post award administration, and transitioning into the marketplace. A poster session will also be included this year to provide attendees the opportunity to learn from previous awardees and to foster discussions that may lead to collaborations. For more information including agenda, registration and conference information please visit: http://grants.nih.gov/grants/funding/SBIRConf2011/index.html.
Notice of Correction for Shared Instrumentation Grant Program (S10)
The National Center for Research Resources (NCRR) has issued a notice to correct PAR-11-081, Shared Instrumentation Grant Program (S10) (http://grants.nih.gov/grants/guide/pa-files/PAR-11-081.html) published in the NIH Guide on December 16, 2010. The purpose of this Notice is to notify applicants of inconsistencies between the Funding Opportunity Announcement (FOA) instructional text for several application attachments and the attachment numbers as they appear in the new ADOBE-FORMS-B1 application forms. For example, the FOA referred to the "Other Attachments" item on the Other Project Information form as being item #11 although it is actually labeled item #12 on the form. Please refer back to the FOA text for specific changes identified with the text "Old Instructions" and "New Instructions." Aside from these minor label adjustments, the substance of the instructions remains unchanged. All other aspects of this FOA remain unchanged.
Phase II Clinical Trials of Novel Therapies for Lung Diseases (UM1) RFA-HL-12-022
The National Heart, Lung, and Blood Institute, and National Institutes of Health have issued a Funding Opportunity Announcement (FOA) to solicit research applications to conduct Phase II clinical therapeutic trials that have the potential to advance development of novel therapies for a lung disease or a cardiopulmonary disorder of sleep. Each application will propose one Phase II interventional trial that will most likely use physiological or biochemical rather than clinical endpoints along with at least one smaller basic ancillary research study that is tightly related to the clinical question. Although definitive Phase III trials will not be supported, the proposed studies must provide proof of concept for a novel intervention that has high potential for modifying current treatments and could be disease modifying. This program enhances opportunities for translational research with the central emphasis on clinical studies. Research conducted would provide high quality data that could lead to efficacy or Phase III trials in networks or investigator-initiated trials. Furthermore, this research will provide important pathogenetic understanding of responses to treatments. Close interaction between clinical and basic researchers required in this program should promote translation of basic science ideas into the clinical setting and expand on ideas from clinical observations that can be pursued in the basic laboratory. For more information including Letter of Intent and Application due dates please visit: http://grants.nih.gov/grants/guide/rfa-files/RFA-HL-12-022.html.
Nutrition and Diet in the Causation, Prevention, and Management of Heart Failure, Two FOAs Announced
The initiative issued by The National Heart, Lung, and Blood Institute (NHLBI), National Institute on Aging (NIA), and Office of Dietary Supplements (ODS), National Institutes of Health (NIH), will renew a Funding Opportunity Announcement (FOA) (R01) to encourage submission of investigator-initiated research applications on the role of nutrition and diet in the causation, prevention, and treatment of cardiomyopathies and heart failure. Mechanistic, translational, and applied interdisciplinary research applications with rigorous hypothesis-testing designs for projects in humans or animals are of interest. The overall goal 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. Applications will be accepted after May 5, 2011. For more information on this Research Project Grant, please visit: http://grants.nih.gov/grants/guide/pa-files/PA-11-165.html.
In conjunction, The NHLBI, NIA and ODS have announced a Exploratory/Developmental Research Grant Award (R21) to encourage submission of exploratory or developmental research applications on the role of nutrition and diet in the causation, prevention, and treatment of cardiomyopathies and heart failure. The evolution and vitality of the biomedical sciences require a constant infusion of new ideas, techniques, and points of view. These may differ substantially from current thinking or practice and may not yet be supported by substantial preliminary data. By using the R21 mechanism, the NHLBI, NIA and ODS seeks to foster the introduction of novel scientific ideas, model systems, tools, agents, targets, and technologies that have the potential to substantially advance research on nutrition and diet in the causation, prevention and management of heart failure. More information on this FOA is available by visiting: http://grants.nih.gov/grants/guide/pa-files/PA-11-166.html.
NHLBI Lung Repair and Regeneration Consortium and Administrative Coordinating Center (U01)
NHLBI invites applicants to participate in the Lung Repair and Regeneration Consortium (LRRC). The Consortium seeks to bring together multidisciplinary teams of investigators, cutting edge technologies, innovative strategies, and new ideas to catalyze research on lung regeneration and repair. The purpose of this opportunity is to attract new expertise into multidisciplinary teams to investigate novel hypotheses relevant to lung repair/regeneration and to develop a highly interactive and synergistic Consortium of investigators. The application deadline is February 10, 2011. For more information please visit: http://grants.nih.gov/grants/guide/rfa-files/RFA-HL-12-006.html
NHLBI also seeks applications to participate as the Administrative Coordinating Center (ACC) for the Lung Repair and Regeneration Consortium (LRRC). The Consortium will assemble multiple independent research projects, each with a multi-disciplinary team of Principal Investigators, to develop new reagents, models and/or tools to advance research focused on lung repair and regeneration, and will develop a skills development Core for trainees. The application deadline is February 10, 2011. For more information please visit: http://grants.nih.gov/grants/guide/rfa-files/RFA-HL-12-010.html
Getting from Genes to Function in Lung Disease, NHLBI (R01)
NHLBI seeks applications that propose to characterize the function of gene(s) and their associated variants identified by genome-wide association studies (GWAS) or other genetic approaches to be involved in lung diseases. Studies should use integrated approaches across scientific disciplines to determine the pathobiological function of these genes. The deadline for applications is February 5, 2011. Please visit http://grants.nih.gov/grants/guide/pa-files/PA-11-011.html for more information.
Toward An Improved Understanding of HDL Function, NHLBI (R01)
A new opportunity issued by the NHLBI encourages grant applications that propose to develop, validate, and standardize assays to measure HDL function and biomarkers for HDL function and to identify novel genes, pathways, and potential HDL targets in the relationship to HDL function. The NHLBI seeks innovative methods to determine HDL functional properties. Projects that will explore HDL functional pathways, new genes and therapeutics related to HDL function are also encouraged. The deadline for applications is February 5, 2011, by 5:00 PM. For more information, please visit: http://grants.nih.gov/grants/guide/pa-files/PA-11-012.html
NIH Transformative Research Projects Program (R01)
As part of its series of Common Fund programs, the National Institutes of Health (NIH) invites transformative Research Project Grant (R01) applications from organizations proposing groundbreaking, exceptionally innovative, high risk, original and/or unconventional research with the potential to create new scientific paradigms or challenge existing ones. Projects must clearly demonstrate potential to produce a major impact in a broad area of biomedical or behavioral research.
The Application due date is October 27, 2010. For more information, please visit: http://grants.nih.gov/grants/guide/rfa-files/RFA-RM-10-010.html#PartII
Notice of Discontinuation of National Cancer Institute Participation in the Academic Career Award (Parent K07)
National Cancer Institute (NCI) informs potential applicants that, beginning with applications due on October 12, 2010, and thereafter, the NCI will no longer participate in the Funding Opportunity Announcement for the Academic Career Award (Parent K07) PA-10-058, meaning that the NCI will not accept K07 applications submitted in response to that FOA.
The following Institutes and Center will continue to participate: National Institute on Aging (NIA), National Institute on Alcohol Abuse and Alcoholism (NIAAA), National Center for Complementary and Alternative Medicine (NCCAM). For further information, contact Susan N. Perkins at the National Cancer Institute: email@example.com.
NCI: Clinical Proteomic Technologies for Cancer Initiative (CPTC): Proteome Characterization Centers (U24)
In an effort to build upon the proteomic standards, technologies, standard operating procedures, workflows, and reproducibility of protein identification and quantification developed through the Clinical Proteomic Technologies for Cancer initiative (CPTC); the NIH is soliciting grant applications to build a multidisciplinary collaborative team of Proteome Characterization Centers (PCCs). These PCCs are expected to advance multi-institutional and transdisciplinary interactions using data and selected biospecimens from cancer genomics programs to systematically define the functional cancer proteome that derives from alterations in cancer genomes, discover and verify protein (and peptide) biomarkers, and in doing so, drive the development of proteomic technologies.
Application Receipt Date: September 29, 2010
For more information or to apply: http://grants.nih.gov/grants/guide/rfa-files/RFA-CA-10-016.html
NHLBI: New Strategies for Growing 3D Tissues (R01 and R21)
Two Funding Opportunity Announcements have been issued that seek to improve the understanding of how cells respond to their environment and to develop accurate assays and methods to understand how organogenesis may instruct the creation of functional 3D engineered cellular aggregates. This program will require collaborations of scientists from two or more disciplines such as developmental biology, computational science and systems biology, cell biology, tissue engineering, chemistry, physics, or organ physiology. Use of the multiple PI mechanism is strongly encouraged.
For more information on R01: http://grants.nih.gov/grants/guide/rfa-files/RFA-HL-11-025.html
For more information on R21: http://grants.nih.gov/grants/guide/rfa-files/RFA-HL-11-026.html
NIH’s Center for Scientific Review (CSR) Highlights Changes and Updates
CSR publishes Peer Review Notes to inform reviewers, NIH staff and others of news related to grant application review policies, procedures and plans. The complete issue of the Peer Review notes can be found online at http://cms.csr.nih.gov/NewsandReports/PeerReviewNotes/. Below is a synopsis of recent updates which may be of interest to cardiothoracic surgeon researchers.
New limits on resubmitted applications
NIH expects a new application to include substantial changes in all sections of the research plan that represent a significant change in direction and approach. "Applicants need to know they cannot simply change the title or wording of their old applications," said director Toni Scarpa. The definition of what constitutes a new application has not changed, but NIH and CSR have posted additional guidance to applicants to explain how NIH determines if an application is a new one (A0) or an unacceptable second submission of a previous application (A2). View How CSR Evaluates Applications for Overlap or Exceeding Resubmission Limits" http://cms.csr.nih.gov/ResourcesforApplicants/OverlapEvaluation.htm. Updated Integrated Review Groups (IRGs)
The NIH Guide defines the last due date to submit a legal A2 application: Applicants who are allowed to submit two resubmissions for their “grandfathered” A0 application must submit their A2 application no later than the appropriate due date for cycle III, these deadlines are available at: http://grants.nih.gov/grants/guide/notice-files/not-od-10-080.html.
CSR works to align its study sections to adequately review applications in their respective fields. It has adjusted and created new study sections in six of its IRGs, including:
Tips on writing bulleted critiques
The guidelines for all the new and updated study sections are posted on CSR’s review group description Web pages: http://www.csr.nih.gov.
- Vascular and Hematology IRG
The Molecular and Cellular Hematology Study Section was established by merging the Erythrocyte and Leukocyte Biology and Hematopoiesis Study Section
- Interdisciplinary Molecular Sciences and Training; Bioengineering Sciences and Technologies; and Biological Chemistry and Macromolecular Biophysics IRGs
The Enabling Bioanalytical and Imaging Technologies Study Section was developed by merging the Microscopic Imaging and Spectroscopy Study Section in the Bioengineering Sciences and Technologies IRG with the Enabling Bioanalytical and Biophysical Technologies Study Section in the Biological Chemistry and Macromolecular Biophysics IRG. The new study section is moving into the Interdisciplinary Molecular Sciences and Training IRG.
Examples of Well Written and Poorly Written Critiques and tips for writing bulleted critiques can be found http://cms.csr.nih.gov/PeerReviewMeetings/ReviewerGuidelines/.
NCI Education and Career Development Program (R25)
This purpose of this funding opportunity is to support the development and implementation of institutional curriculum-dependent predoctoral/postdoctoral programs in the areas of cancer prevention and control, behavioral and population sciences research, nutrition, epidemiology, and/ or biostatistics.
For more information and to apply: http://grants.nih.gov/grants/guide/pa-files/PAR-10-165.html
NCI Academic-Industrial Partnerships for Translation of in vivo Imaging Systems for Cancer Investigations (R01)
This funding opportunity encourages applications from research partnerships formed by academic and industrial investigators to accelerate the translation of either animal or human in vivo imaging, image guided, and/or spectroscopic systems and methods designed to solve targeted cancer problems for cancer research, clinical trials, and/or clinical practice. The partners on each application will establish an inter-disciplinary, multi-institutional research team to implement a coherent strategy to develop and translate the proposed system or methods with potential for significant impact on preclinical, single, or multisite clinical studies. This opportunity supports clinical trials that emphasize optimization and validation of the performance of imaging systems, including devices, agents and/or methods.
For more information and to apply: http://grants.nih.gov/grants/guide/pa-files/PAR-10-169.html
NCI / NHLBI R01 — Common Pathogenetic Mechanisms of Lung Cancer and COPD
The purpose of this Funding Opportunity is to foster an interactive research program that brings together researchers from the pulmonary and cancer communities to investigate the common pathogenetic mechanisms of lung cancer and COPD. Applications with multiple PIs or with a PI leading a team of scientists from multiple disciplines (cancer, COPD, immunology, genomics, computational biology, proteomics, bioinformatics) are strongly encouraged.
Applications from institutions/organizations are sought to identify the fundamental etiopathogenetic commonalities between lung cancer and Chronic Obstructive Pulmonary Disease (COPD) in order to characterize: (a) the genotypic and phenotypic characteristics that determine individual susceptibility; and (b) the shared biochemical, molecular, and immunological pathways involved in the origin and progression of the two diseases.
Application Receipt Date(s): June 18, 2010
For more information, go to http://grants.nih.gov/grants/guide/rfa-files/RFA-HL-11-002.html
NHLBI R01 — Ancillary Studies in Clinical Trials
The purpose of this Funding Opportunity is to solicit research grant applications to conduct time-sensitive ancillary studies related to heart, lung, and blood diseases and sleep disorders in conjunction with ongoing clinical trials and other large clinical studies supported by NIH or non-NIH entities. The program establishes an accelerated review/award process to support the crucial time frame in which these ancillary studies must be performed. Time-sensitive ancillary studies include those that require active longitudinal data collection and thus need to begin recruiting subjects as close as possible to the start of the parent study. The ancillary study can address any research questions related to the mission of NHLBI for which the parent study can provide participants, infrastructure, and data. The parent studies most often will be a clinical trial, but also can be an observational study or registry that can provide a sufficient cohort of well-characterized patients.
Application Receipt Date(s): May 28, 2010, September 30, 2010, January 28, 2011
For more information, go to http://grants.nih.gov/grants/guide/rfa-files/RFA-HL-10-024.html
NIH Heart Center Seeking CT Surgeon Research Fellow
The NIH Heart Center at Suburban Hospital is recruiting for a Research Fellow in the Cardiothoracic Surgery Research Program. The successful candidate would join a group of investigators examining cardiac stem cell treatment, MRI guided cardiac surgery, and cardiac xenotransplantation. Applicants will have a Ph.D., and/or a M.D. with postdoctoral experience in surgery.
The focus of the research is to provide exposure and experience to the aforementioned research projects with the opportunity for independent investigation over a 1 to 2 year period commencing in the Summer/Fall 2010. Salary is commensurate with research experience and accomplishments. Benefits will be included with this position (i.e. health insurance, vacation, etc.). Applicants should send a CV, a brief statement of research interests, and the names and contact information of three references to:
Keith Horvath, M.D.
Cardiothoracic Surgery Research Program
NIH Heart Center at Suburban Hospital
Building 10, Room 2N246
10 Center Drive, Bethesda, MD 20892, USA
Closing date for receipt of applications is April 16th 2010.
NHLBI Investigator Initiated Multi-Site Clinical Trials (Collaborative R01)
This Funding Opportunity Announcement is to provide a vehicle for submitting grant applications for investigator-initiated multi-site (Phase II or Phase III) randomized, controlled clinical trials.
Opening Date: May 5, 2010
For more details on the implementation of the new salary limitation, please visit: http://grants.nih.gov/grants/guide/pa-files/PAR-10-096.html
Cardiothoracic Surgery Network Request for Satellite Sites -- March 15th Deadline
The NHLBI’s Cardiothoracic Surgery Network was established in 2007 to design, conduct, and analyze important randomized trials and observational studies. In an effort to enhance recruitment and clinical expertise, the Network is providing an opportunity for investigative Satellite Sites outside of its Network to participate in two ischemic mitral regurgitation trials that are underway and enrolling patients.
The application deadline is March 15th and all sites will be notified of the decision by April 1st. For more information about the Satellite Site application and selection process and to view the guidelines, please visit the Network’s website.
NIH Notice: 2010 Salary Limitation on Grants
The Consolidated Appropriations Act, 2010, Public Law 111-117, restricts the amount of direct salary of an individual under an NIH grant to Executive Level I of the Federal Executive Pay scale. The Executive Level I annual salary rate was $196,700 for the period January 1 through December 31, 2009.
EFFECTIVE January 1, 2010, the Executive Level I salary level increased to $199,700.
For more details on the implementation of the new salary limitation, please visit:
New NIH Recovery Act Funding Opportunities
||Methodology Development in Comparative Effectiveness Research (RC4) – Opens January 26, 2010|
This FOA invites applications to enhance, develop, or evaluate methodologies to improve the efficiency, validity, and credibility of comparative effectiveness research (CER) studies. CER encompasses a wide array of methodologies, including technology assessment, meta-analysis, systematic reviews, observational studies, and experimental trials. Each of these methodologies suffers from substantial weaknesses that limit their ability to rapidly provide information sought by patients, clinicians, and other stakeholders to make robust evidence-based decisions on clinical practice and public policy. Research is needed to develop better methods for measuring or reducing these weaknesses, which include, for example, confounding bias in observational studies and selection bias in randomized trials.
For More information and application instructions: http://grants.nih.gov/grants/guide/rfa-files/RFA-OD-10-009.html
||NIH Directors Opportunity for Research in Five Thematic Areas (RC4) – Opens February 15, 2010|
This FOA seeks proposals to develop and implement critical research innovation in one or more of the following:
- Applying Genomics and Other High Throughput Technologies
- Translating Basic Science Discoveries into New and Better Treatments
- Using Science to Enable Health Care Reform
- Focusing on Global Health
- Reinvigorating the Biomedical Research Community
The research supported by this program should have high short-term impact, and a high likelihood of enabling growth and investment in biomedical research and development, public health, and health care delivery. This program will support projects that will benefit from significant three-year funds without the expectation of continued NIH funding beyond this period.
For More information and application instructions: http://grants.nih.gov/grants/guide/rfa-files/RFA-OD-10-005.html
NIH Program Announcements for NCI and NHLBI – Opening in January
NCI Funding Opportunity: Prediction Models for Cancer Risk and Prognosis (R01/R21)
At present, few funded studies focus on the development, application, and validation of risk prediction models for individuals at average or high risk of cancer or on models for estimating prognosis and/or response to treatment of patients with cancer.
This opportunity encourages applications from those working in the field of cancer control and prevention to improve existing models for cancer risk and prognosis. The program is designed to support research to develop new and refine existing cancer risk prediction, prognostic, and response to therapy models and to validate them in appropriate populations. In xparticular, it will provide a mechanism under which investigators can address two major challenges in model development, namely integrating diverse types of data and ensuring adequate validation. These models may:
Opening Date: January 5, 2010 (Earliest date an application may be submitted)
- identify individuals at high risk of developing a new cancer or a recurrence who may benefit from targeted screening, treatment, or other interventions.
- aid in the design and planning of clinical cancer prevention, screening, and treatment trials.
- enable the development of benefit-risk indices, estimation of the population burden and cost of cancer, and evaluate the impact of a specific intervention or treatment.
Application Due Date(s): Standard dates apply
Expiration Date: January 8, 2013
NHLBI New Funding Opportunity (R34) to Support Clinical Trial Pilot Studies
National Heart Lung and Blood Institute invites applications proposing pilot studies to obtain data that is critical for the design of robust clinical trials. This funding opportunity should be used to fill gaps in scientific knowledge necessary to develop a competitive full-scale clinical trial.
Appropriate pilot studies might demonstrate feasibility of an intervention or an experimental design, estimate intervention parameters, or gather other data important for the design of a trial. Grants that propose solely to write a protocol or manual of operations or to develop infrastructure for a clinical trial will not be considered appropriate for this announcement. Applications must demonstrate that the proposed pilot studies are both necessary and sufficient to permit the design of the clinical trial.
NHLBI anticipates that the R34 award period will yield more competitive investigator-initiated clinical trial grant applications and more robust and successful clinical trials that evaluate interventions for the treatment or prevention of heart, lung, blood, or sleep disorders.
The total project period for an application submitted in response to this funding opportunity may not exceed three years. Direct costs are limited to $450,000 over a three-year period, with no more than $225,000 in direct costs allowed in any single year.
Opening Date: January 16, 2010 (Earliest date applications may be submitted)
Letter of Intent Receipt Date(s): 30 days prior to standard application due dates.
Application Due Date(s): Standard dates apply, please see http://grants.nih.gov/grants/funding/submissionschedule.htm
More Information and Application Instructions: http://grants.nih.gov/grants/guide/pa-files/PAR-10-005.html
NIH: Shorter applications better aligned to the review criteria
Starting with applications due January 25, 2010, and beyond, applicants will have new forms and instructions to apply for all NIH grants. The R01 grant application and most others will be shorter and better aligned to the review criteria. Detailed information has been posted in the NIH Guide: http://grants1.nih.gov/grants/guide/notice-files/NOT-OD-09-149.html.
FDA Pediatric Clinical Trials Workshop, October 29-30, 2009
The Food and Drug Administration (FDA) is announcing a public workshop entitled "Pediatric Clinical Trials Workshop: Unmet Needs, Trial Designs and Clinically Meaningful Safety and Effectiveness Outcomes." The purpose of the public workshop is to solicit information from primary and secondary health care providers, academia, industry, and professional societies on various aspects of device clinical trials involving pediatric diseases and patients.
Information from this public workshop will help stimulate interest in pediatric device clinical trial research methods, and develop topics for further discussion regarding the safety of pediatric device clinical trials. The information gathered in this and future workshops will help to develop future guidance for developing safe clinical trials for devices intended for pediatric patients. We encourage participation and comments from workshop attendees on the topics and questions discussed.
|Specialty Discussion topics include:|
||Pediatric Musculoskeletal Disease|
||Pediatric Cardiovascular Disease|
||Pediatric Abdominal and GI diseases|
||Pediatric Neurologic Disorders|
||Pediatric Genitourinary Diseases|
||Pediatric Speech and Audiologic Disorders and|
||Diagnostics for pediatric patients: Challenges|
Dates and Times: October 29, 2009, 8 a.m. to 5:30 p.m. and October 30, 2009, from 8 a.m. to 12 noon.
Location: Holiday Inn College Park located off I-95 at 10000 Baltimore Ave., College Park, MD 20740. The hotel front desk number is 1-301-345-6700.
Please see instructions for registration and for providing comments at http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/ucm170938.htm.
NHLBI Announces Structural Change
The National Heart, Lung and Blood Institute (NHLBI) announces that the Division of Cardiovascular Diseases (DVD) and the Division of Prevention and Population Sciences (DPPS) will merge to form the Division of Cardiovascular Sciences (DCVS) in order to align the Institute's administrative structure with its cardiovascular programs which now effectively span basic, clinical, and population research. The merger follows the resignation of Dr. Marvin Konstam as chief of the DVD at the NHLBI. Dr. Michael Lauer, currently the Director of the DPPS, will be serving as Director of the new Division, and Dr. Sonia Skarlatos, currently Acting Director of the Division of Cardiovascular Diseases, will be serving as Deputy Director. There was considerable overlap in the interests of both divisions in their long term strategic plans and this structural change positions the DCVS for central leadership and cross-branch interactions. Dr. Lauer is highly regarded by members of both prior divisions and by their respective branches and this is seen as a thoughtful move that strategically aligns the interests of both of the prior divisions. From the viewpoint of the cardiac surgical community, this reorganization has no important consequence as the branch chiefs within that component previously designated the DVD, all remain the same and the responsibilities for each remain the same. Readers who have a more detailed interest are referred to a recent article in the Journal of the American College of Cardiology entitled, “News from the NHLBI,” which was published in volume 54 of the 2009 edition on pages 265-268.
NHLBI Funding Opportunity (R01)
Systems Biology Collaborations -- This Funding Opportunity encourages R01 applications from institutions/organizations that propose collaborative systems biology research projects by multi-disciplinary teams to advance the understanding of normal physiology and perturbations associated with heart, lung, blood, and sleep diseases and disorders. Multi-disciplinary expertise across experimental and computational domains is required and the multi-PI mechanism is allowed, as integration across these domains is a critical element of the proposed research plan. For a full description of this FOA please visit: http://grants.nih.gov/grants/guide/pa-files/PAR-09-214.html
Dr. David H. Harpole named co-chair of the NCI Lung Cancer Steering Committee.
Dr. David H. Harpole, co-chair of the AATS Scientific Affairs and Government Relations (SAGR) Committee has been named co-chair of the National Cancer Institute (NCI) Lung Cancer Steering Committee. The recently developed NCI Committee oversees all Phase II and Phase III lung cancer trials in the US, develops State of the Science Development Meetings to prioritize strategies for NCI-supported clinical trials and sets up future NCI grant funding opportunities. Dr. Harpole is the first surgeon to hold this position.
Dr. Marc Moon appointed to serve on the FDA's Circulatory System Devices Panel.
In March 2009, AATS member Marc R. Moon, M.D., who is the Joseph C. Bancroft Professor of Surgery at Washington University in Saint Louis, was appointed to serve on the Circulatory System Devices Panel in the Center for Devices and Radiological Health of the Food and Drug Administration. Dr. Moon will serve a 4-year term on the panel, which is responsible for the evaluation and approval of novel medical/surgical devices related to the circulatory system, including ventricular assist and intracardiac prostheses, percutaneous coronary and valvular repair or replacement instrumentation, and endovascular grafts.
The evaluation process consists of detailed pre-meeting review of clinical study reports, safety and effectiveness data, and product labeling generated by the applicant in preparation for the panel. Panel members then participate in open and closed discussions with industry representatives, culminating in a recommendation regarding whether or not sufficient information has been provided to support the approval or disapproval of the product.
The Agency recruited Dr. Moon for his expertise in the application of novel medical devices to bring external knowledge and opinions to the evaluation process of products that may ultimately be available to cardiothoracic surgeons across the country.
NHLBI / NCI Stimulus-Funded Grant Proposals Due April 27
The National Heart Lung and Blood Institute (NHLBI) and the National Cancer Institute (NCI) have posted information regarding its participation in the American Recovery and Reinvestment Act of 2009 (AARA) www.nhlbi.nih.gov/funding/index.htm and http://challenge.nci.nih.gov/
including details on the new Challenge Grants in health and science research. Please note some of these Challenge Grants may be of particular interest to cardiothoracic surgeons. Descriptions and application information for the grants are available at http://grants.nih.gov/grants/funding/challenge_award/Omnibus.pdf. The NHLBI and NCI Challenge Grants have an application deadline of April 27, 2009. The NHLBI must obligate all of the stimulus funds received by September 2010.
Funds are available in these categories:
• Behavior, Behavioral Change and Prevention
• Biomarker Discovery and Validation
• Clinical Research
• Comparative Effectiveness Research
• Enabling Technologies
• Enhancing Clinical Trials
• Health Disparities
• Information Technology for Processing Health Care Data for Research
• Regenerative Medicine
• Stem Cells
• Translational Science
More details on the overall NIH’s role in the ARRA are available at www.nih.gov/about/director/02252009statement_arra.htm.
NCI -- Allowable Salary Levels on Career Awards
The National Cancer Institute (NCI) has changed the allowable levels of salary support for early career and midcareer investigators. Effective January 1, 2009, the salary cap is set at $100,000 per year with a 75% percent effort for K08 and $30,000 in research development support. The remaining effort may be devoted to clinical, teaching, and/or other research pursuits and activities consistent with the objectives of the awarded grant. For more information, see http://grants.nih.gov/grants/guide/notice-files/NOT-CA-09-013.html.
NIH Notice: Salary Limitation on Grants
The Consolidated Appropriations Act, 2008, Public Law 110-161, restricts the amount of direct salary of an individual under an NIH grant to Executive Level I of the Federal Executive Pay scale. The Executive Level I annual salary rate was $191,300 for the period January 1 through December 31, 2008.
EFFECTIVE January 1, 2009, the Executive Level I salary level increased to $196,700.
For more details on the implementation of the new salary limitation, please visit: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-09-037.html
AHRQ Mentored Clinical Scientist Research Career Development Award (K08)
This Agency for Healthcare Research and Quality (AHRQ) program prepares qualified individuals for careers that have a significant impact on the quality, safety, efficiency, and effectiveness of health care for all Americans. This program provides support and “protected time” to individuals with a clinical doctoral degree for an intensive, supervised research career development experience in health services research. The award can be used both by individuals who propose to newly embark in heath services research training and those who had a hiatus in their research careers because of illness or family circumstances. The award is also available to promote research workforce diversity by providing enhanced research career development opportunities. Candidates interested in pursuing careers in patient-oriented research are eligible to apply for this award at AHRQ.
Application Due: March 9, 2009. For more details on the AHRQ Mentored Clinical Scientist Research Career Development Award, please visit: http://grants.nih.gov/grants/guide/pa-files/PAR-09-085.html
K23 Mentored Patient-Oriented Research Career Development Award
This K23 award is to support the career development of investigators who have made a commitment to focus their research endeavors on patient-oriented research. Prospective candidates are encouraged to contact the relevant Institute or Center (IC) staff for IC-specific programmatic and budgetary information: Table of Institute and Center Contacts.
For more information on this award visit:
K08 Mentored Clinical Scientist Research Career Development Award
This K08 program is to prepare qualified individuals for careers that have a significant impact on the health-related research needs of the Nation. This program represents the continuation of a long-standing NIH program that provides support and “protected time” to individuals with a clinical doctoral degree for an intensive, supervised research career development experience in the fields of biomedical and behavioral research, including translational research. Prospective candidates are encouraged to contact the relevant Institute or Center (IC) staff for IC-specific programmatic and budgetary information: Table of Institute and Center Contacts.
For more information on this award visit:
New NIH Registration Process to Reimburse Reviewers
A new simplified registration process is in place to facilitate disbursement of honoraria and expenses to reviewers for their valued participation in peer review meetings. The new system replaces the U.S. Central Contractor Registration (CCR) system that NIH used previously for this purpose.
Reviewers are urged to start registering in the new system beginning January 17, 2009.
The new system will require reviewers to log-in to the RA Commons https://commons.era.nih.gov/commons/ with their user name and password and update their Personal Profile, and then link to a secure payment system.
Please follow these step-by-step instructions: http://grants.nih.gov/grants/peer/reviewer_instructions_payment.doc
The new system has many advantages over the CCR system:
- The secure payment site is controlled by the NIH Office of Financial Management and information entered as part of the new registration process will be kept secure and confidential.
- Only you can access your information with your eRA Commons log-in.
- Reviewers will not be spammed by third party solicitations.
- The registration process is greatly simplified.
- Annual renewal of the registration is not required. However, NIH will rely on reviewers to maintain and update their financial institution, residential address and other information. This is particularly important if a reviewer shifts residence or moves to another bank.
- NIH is committed to ensuring that all reviewers receive their disbursements as efficiently as possible and would like to thank you for your continued support of the NIH peer review process during this transition.
For more details go to:
CSR Announces Updated Study Sections
The Center for Scientific Review (CSR) has updated and enhanced its study section descriptions. The three most relevant to Cardiothoracic Surgeons are as follows:
Bioengineering, Technology, and Surgical Sciences [BTSS]
Reviews grant applications in the interdisciplinary fields of surgery and bioengineering. Within BTSS there is a balance between basic, translational, and clinical research and application and development of emerging cross-cutting technologies relevant to the cardiac system.
Surgery, Anesthesiology, and Trauma Study Section [SAT]
Reviews applications in the disciplines of surgery, anesthesiology, and critical care. Sepsis and injury studies reviewed by SAT often address the host response to these complex insults such as trauma, disseminated infection, or surgical stress, with a general focus on systemic metabolic, hormonal, or immune responses to infection and multi-organ damage.
Myocardial Ischemia and Metabolism [MIM]
Reviews applications involving basic and applied aspects of myocardial ischemia/reperfusion, coronary circulation, and myocardial metabolism. It includes the review of studies using molecular, genetic, cellular, biochemical, pharmacological, genomic, proteomic, and physiological approaches to define normal and pathological processes. MIM examines investigations at all levels of organization, ranging from in vitro models of simulated ischemia in isolated cells to whole animal models.
For a full listing and description of study section updates, please visit the CSR Website at: http://cms.csr.nih.gov/PeerReviewMeetings/CSRIRGDescriptionNew/
NIH Peer Review System Updates for FY 2010 Funding
In June 2007, the NIH initiated a formal, agency-wide effort to review the NIH peer review system. After careful deliberation and consideration of the recommendations resulting from this year-long effort, a number of key actions will be implemented including:
Dr. Andrew S. Wechsler appointed as Senior Advisor to the Division of Cardiovascular Diseases of the National Heart, Lung, and Blood InstituteMuch of the function of the DCVD relates to administration of the extramural grant program. A very significant amount of its resources are directed at the initiation of new programs that are perceived to forward its mission in each of the above areas. Trials of new therapies, gathering of critical thought leaders, initiation of RFP's in focused areas, novel training approaches, translational research and advanced devices are all part of the "discretionary" component of its efforts. The special needs of cardiothoracic surgeon have come to the foreground through these evolving therapeutic technologies. Within the appropriate confines of confidentiality we anticipate frequent reports that outline novel opportunities for CT surgeons.
On November 1, 2008, Dr. Andrew S. Wechsler was appointed as Senior Advisor to the Division of Cardiovascular Diseases (DCVD) of the National Heart, Lung, and Blood Institute (NHLBI). The DCVD has 5 divisions:
NHLBI Seeks Leader for the Division of Cardiovascular Diseases (DCVD)
This position is an extraordinary opportunity for a physician/scientist ready to make a career move into a role with immense potential and ensure that the public investment in the future of medical research and education will be well used, serving both the profession and society. The Director of DCVD assumes a policy-making role, shaping the future of cardiovascular research in this country and leading internationally-renowned programs that integrate basic science and clinical research. The Director of DCVD will have vision, creativity, and the ability to recruit talented individuals and build teams.
Applications are due by December 1, 2008. You can view the position ad at http://www.nhlbi.nih.gov/about/jobs/index.htm#DCVD. If you have a personal interest in this position or would like to suggest a top quality candidate, please respond to NHLBIIOD@mail.nih.gov.
A2 applications to be eliminated
Beginning with original new applications (i.e., never submitted) and competing renewal applications submitted for the January 25, 2009 due dates and beyond, the NIH will accept only a single amendment to the original application.
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Encouraging Early Transition to Research Independence: Modifying the NIH New Investigator Policy to Identify Early Stage Investigators (NOT-OD-08-121)
National Institutes of Health
This notice describes a change in NIH New Investigator policies designed to encourage early transition to independence. Under this policy, New Investigators within ten years of completing their terminal research degree or within ten years of completing their medical residency will be designated Early Stage Investigators (ESIs). Traditional NIH research grant (R01s) applications from ESIs will be identified and the career stage of the applicant will be considered at the time of review and award.
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Elias A. Zerhouni to End Tenure as Director of the National Institutes of Health
National Institutes of Health (NIH)
Bethesda, Md, September 24, 2008 — Elias A. Zerhouni, M.D., the director of the National Institutes of Health, today announced his plans to step down at the end of October 2008 to pursue writing projects and explore other professional opportunities.
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Stats reveal bias in NIH grant review
The system used by the US National Institutes of Health (NIH) to evaluate grant proposals does not adequately compensate for reviewer bias, a new study concludes.
The assessment of grant reviews generated by more than 14,000 reviewers suggests that the NIH needs to overhaul the peer-review system it uses to rank proposals, according to biostatistician Valen Johnson of the University of Texas M.
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Enhancing NIH Peer Review Activity Implementation Timeline
September 17, 2008 MEMO TO: NIH Grantee Community
FROM: Director, NIH
SUBJECT: Enhancing NIH Peer Review Activity Implementation Timeline
The NIH Peer Review Oversight Committee and three subgroups consisting of NIH program, review, grants management and evaluation staff have developed an initial implementation timeline for the Enhancing Peer Review activity. The recommendations that are being implemented are based on the result of the diagnostic phase and significant dialogue with both the internal and external communities regarding enhancements to the review system (please see http://enhancing-peer-review.nih.gov for an overview of the Enhancing Peer Review effort). I view these enhancements as progress towards ensuring the continuation of NIH’s world renowned peer review system.
Although the subgroups are continuing to work out specific details of the implementation plans, I want to share with you the first of the preliminary implementation plans for the 2009 through 2010 calendar years as follows:
Priority Area 1 – Engage the Best Reviewers
Priority Area 2 – Improve the Quality and Transparency of Review
- Improve Reviewer Retention: In 2009, new reviewers will be given additional flexibility regarding their tour of duty, and other efforts will be undertaken to improve retention of standing review members.
- Recruit the Best Reviewers: A toolkit, incorporating best practices for recruiting reviewers, will be made available to all ICs in 2009.
- Enhance Reviewer Training: In spring 2009, training will be available to reviewers and SROs related to the changes in peer review.
- Allow Flexibility through Virtual Reviews: Pilots will be conducted in 2009 on the feasibility of using high-bandwidth support for review meetings to provide reviewers greater flexibility and alternatives for in-person meetings.
Priority Area 3 – Ensure Balanced and Fair Reviews across Scientific Fields and Career Stages, and Reduce Administrative Burden
- Improve Scoring Transparency and Scale: Review criteria-based scoring on 1 to 7 scale commences in May 2009. Reviewers will provide feedback through scores and critiques for each criterion in a structured summary statement.
- Provide Scores for Streamlined Applications: In 2009, streamlined applications will receive a preliminary score.
- Shorten and Restructure Applications: Shorter (12-page research plan) R01 applications (with other activity codes scaled appropriately) will be restructured to align with review criteria for January 2010 receipt dates.
- Fund the Best Science Earlier and Reduce Need for Resubmissions: To ensure that the largest number of high quality and meritorious applications receive funding earlier and to improve system efficiency, NIH is considering separate percentiling of new and resubmitted applications and permitting one amended application.
- Review Like Applications Together: NIH is establishing an Early Stage Investigator (ESI) designation. In 2009, NIH will evaluate clustering ESI applications for review. The same approach will be considered for clinical research applications.
The enhancing peer review activity has been an intensive year-long effort. Many of you have contributed valuable feedback and input and I’d like to take this opportunity to convey my appreciation and specially thank you for your input.
Updates and details will be posted at http://enhancing-peer-review.nih.gov and published in the monthly Extramural Nexus (subscribe at https://list.nih.gov/cgi-bin/wa?SUBED1=extramuralnexus&A=1) as they are known. Also, several notices will be posted in the NIH Guide detailing specific elements of this implementation.
Elias A. Zerhouni, M.D.
NIH Extramural Loan Repayment Programs
The NIH announces a Loan Repayment Program for qualified health professionals who contractually agree to engage in NIH mission-relevant research for at least two years, and who agree to engage in such research for at least 50 percent of their work schedule (not less than 20 hours per week based on a 40-hour work week). Each of the five extramural Loan Repayment Programs provide for the repayment of educational loan debt of up to $35,000 annually for qualified health professionals performing research within the mission of NIH at domestic, non-profit, or government entities. The five extramural Loan Repayment Programs have specific eligibility requirements and funding set-asides.
Loan Repayment Programs applications will be accepted annually from September 1 through December 1, 8:00 p.m. EST. Applications must be submitted electronically using the NIH Loan Repayment Program Website, www.lrp.nih.gov.
Stem Cells and Cancer (R21) Funding Opportunity
The National Cancer Institute (NCI), and the National Institute on Aging (NIA) have issued a funding opportunity announcement to encourage research in all aspects of tumor stem cell biology, including the molecular and biochemical regulation of embryonic and adult stem cell behavior relevant to tumor formation. This opportunity intends to stimulate efforts on isolation and characterization of tumor stem cells from a large spectrum of tumors. Individuals with the skills, knowledge, and resources necessary to carry out the proposed research are invited to work with their institution/organization to develop an application for support. The total project period for an application submitted in response to this funding opportunity may not exceed 2 years. Direct costs are limited to $275,000 over an R21 2-year period, with no more than $200,000 in direct costs allowed in any single year. More information on this program can be found at http://grants.nih.gov/grants/guide/pa-files/PA-08-165.html.
NIH-Supported Midcareer Development Award Program.
The NIH announces a Midcareer Investigator Award in Patient-Oriented Research. Under this program, mid-career health-professional doctorates or equivalent who are typically at the Associate Professor level or the equivalent will receive support for protected time to devote to Patient-Oriented Research and to act as research mentors primarily for clinical residents, clinical fellows and/or junior clinical faculty. Candidates must commit 3-6 person months (equivalent to 25 to 50% effort) to conducting patient-oriented research and mentoring. Applicants may request three to five years of support (at least three years are required). For more information please visit: http://grants.nih.gov/grants/guide/pa-files/PA-08-151.html.
NHLBI (R01) Request for Applications: Developmental Origins of Altered Lung Physiology and Immune Function
The purpose of this NHLBI R01 is to solicit applications that propose to perform research that will enhance the understanding of how the pre- and postnatal environments affect the interplay of the lung and immune system during development resulting in sustained changes in lung physiology and immune function that compromise respiratory health and outcomes. More information can be found at http://grants.nih.gov/grants/guide/rfa-files/RFA-HL-08-009.html.
Revision of NIH Policy Concerning Concurrent Support from Mentored Career Development (K) Award and a Research Grant
NIH mentored K awards are intended to support a period of mentored career development in preparation for a role as an independent researcher in biomedical and behavioral science. NIH allows K awards recipients to hold concurrent support from their K award and a competing research grant when recognized as a Principal Investigator (PI) or subproject Director of a multi-project NIH grant. Currently mentored K award recipients in the last two years of their support period are permitted to reduce the level of effort required for the K award and replace that effort with effort on an NIH research grant or subproject provided they remain in a mentored situation. The new policy change detailed at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-065.html expands eligible grants to include research grants obtained from any Federal agency; clarifies when the research grant may be obtained relative to the years remaining on the K award; and clarifies that status as a PI on a multiple PI award also confers eligibility.
NHLBI Does Not Accept R21 Applications Primarily Related to Cancer Research
The purpose of this Notice is to advise investigators who plan to submit applications under the parent FOA (PA-06-181) for the NIH Exploratory/Developmental Research Grant (R21) award mechanism that the NHLBI does not accept the assignment of applications which focus primarily on cancer. Since there are some areas of overlapping interest, e.g., basic aspects of hematological malignancies resulting from disruptions in hematopoiesis, myeloproliferative and myelodysplastic disorders, or the use of hematopoietic stem cell transplantation and other cellular therapies, applicants are strongly encouraged to contact the NHLBI before submitting an application in response to this FOA.
For More Information: http://grants.nih.gov/grants/guide/notice-files/NOT-HL-08-113.html
NIH Gives Reviewers New Flexibility Submitting Applications
Green Light for Continuous Submission: NIH has just increased the incentives for scientists to serve as chartered or permanent members on its peer review groups so it can improve reviewer recruitment to better identify the most promising research for funding. These researchers, who typically serve four years reviewing NIH grant applications, now have more flexibility in submitting their own grant applications.
A recent NIH Guide Notice explains a new policy that gives these reviewers the option to submit—as soon as they are developed—R01, R21 or R34 applications that would normally be submitted for standard submission dates. Chartered members are strongly encouraged to add a cover letter to their applications requesting this option. This new policy was developed to help chartered reviewers, who can be disadvantaged by deadlines that force them to develop their own applications while reviewing those submitted to NIH by others. These reviewers may still request a review by a standing study section other than their own. In this case, they must submit their applications in accord with established deadlines. The current windows for reviewers to submit many of these applications late will remain available. These windows will also remain available for temporary reviewers and those serving on Special Emphasis Panels.
Continuous submission will be carefully evaluated to see whether eligibility should be extended. View the NIH Guide Notice at http://grants1.nih.gov/grants/guide/notice-files/NOT-OD-08-026.html.
NIH Notice: Salary Limitation on Grants
Every year since 1990 Congress has legislatively mandated a provision limiting the direct salary that an individual may receive under an NIH grant. For FY 2008, Public Law 110-161: Consolidated Appropriations Act, 2008 restricts the amount of direct salary to Executive Level I of the Federal Executive Pay scale. The Executive Level I annual salary rate was $186,600 for the period January 1 through December 31, 2007.
EFFECTIVE January 1, 2008, the Executive Level I salary level increased to $191,300.
For more details on the implementation of the new salary limitation, please visit: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-035.html
AATS Progress in Achieving Goals for Peer Review of Cardiothoracic Surgical Grant Proposals to NIH
By Dr. Andrew S. Wechsler
For some years there has been growing concern for the peer review process put into place by the NIH about five years ago. The current method disperses grants by a system designation, irrespective of origin. Many grants previously reviewed by specially constituted study sections with strong surgical representation are now being reviewed by study sections, oftentimes unpopulated by any surgeons. Moreover, grants submitted by surgeons are no longer clustered in study sections particularly knowledgeable in the nuances of surgical investigation, appreciative of the translational nature of many grant applications and frequently are composed of members with a strong bias towards more fundamental investigation.
This trend was documented recently by Drs. Mann, Tendulkar, Birger, Howard and Ratcliffe in an article available in e-print and scheduled to appear in the December or January issue of the “Annals of Surgery”. During the interval from 1982 to 2004 the number of applications from surgical scientists failed to keep up proportionately with applications from other scientists by about 50%. Moreover, the success rate of grants from surgical scientists was importantly lower than the success rate for total NIH awards. Ratcliffe and his coauthors indicated that only about 2% of all NIH awards are to surgeon scientists.
The AATS Scientific Affairs and Government Relations committee has worked diligently to reverse the current method of grant assignment, initially by appealing to the CSR but more recently through direct contact with the director of NIH and the director of the NHLBI. On August 29,2007 the AATS represented by Drs. Pedro DelNido, Irving Kron and Andrew Wechsler had the opportunity to meet with NIH Director Zerhouni, Dr. Scarpa the Director of the CSR, and the Directors of the Surgical Sciences, Biomedical Imaging and Bioengineering Integrated Review Group and Cardiovascular Sciences Integrated Review Group. The meeting was facilitated by Mr. John Porter and Ms. Beth Halpern of Hogan and Hartson who have been working with the AATS to help the organization gain greater access to the key decision makers.
The meeting was cordial and frank. The position of the AATS was received quite sympathetically and there appeared to be accord that more surgical representation in study groups assessing surgical grants was needed as well as an effort to promote clustering of those grants. Several key issues emerged that will be addressed by AATS leadership which include:
- A need for more, high quality surgical reviewers to participate in the grant review process. The AATS has committed to providing names of those willing to serve to NIH and NIH is considering ways to facilitate the review process for clinically busy surgeons. Moreover, for those who serve as reviewers, the NIH has approved a policy of allowing continuous submission for their own grants, rather than using the usual deadlines associated with grant cycles.
- A general willingness to “cluster surgical grants” with some burden of responsibility on the person submitting to identify the study section they deem most appropriate to review the work being indicated in a letter at the time of submission.
- A desire to evaluate “peer reviewed” grants that have reviews thought to be of poor quality or which demonstrate a lack of understanding of the importance of the proposed work in the surgical clinical or investigative domain.