Seeks to widen the scientific domain of emergency care research to include mental health research and nursing science and enable NIH competitive R01 investigators to conduct emergency care research at four supported institutions across the U. Early Career Training, fellowship, and career development opportunities. Lis Welniak, Ph. Career Transition Award K Li-Shin Huang, Ph. Division of Cardiovascular Sciences.
Office of Education. Division of Intramural Research. Funding for Training - Training and Career Development. Division of Lung Diseases. Laurel Kennedy. Division of Extramural Research Activities. David Schopfer, M. Reggie Brown. Karin F. Lidman, Ph. Taryn Cobb. Clinical Trial Required PA Independent Clinical Trials Not Allowed PA Supports the career development of individuals with a clinical doctoral degree, who have the potential to develop into productive, clinical investigators, and who have made a commitment to focus their research endeavors on patient-oriented research.
Susan Shero, Ph. Describe any special facilities used for working with biohazards or other potentially dangerous substances. Final Progress report: Describe the research accomplishments and training and career development during the K99 award.
All training and career development goals should be completed. Updated research plan 5 pages or less. Human Subjects: If the research will use human subjects, provide: A complete updated Human Subjects section, including an "Inclusion Enrollment Report".
Current IRB approval or expected approval date. Award is not made until final IRB approval is granted. Vertebrate Animals: If the research will use vertebrate animals, provide: A complete updated Vertebrate Animals section.
Copy of a sharing plan for any new model organisms that you propose to generate: All NIH applications and proposals that will produce new, genetically modified variants of model organisms and related resources are expected to include a sharing plan or to state why such sharing is restricted or not possible. Current Other Support page for the candidate. In addition to stating the biological significance of the research, indicate the project's relevance to the primary theme of the application.
In addition to the standard scientific description, the interactions among Projects and Core s must be described within each Project. Describe how inclusion of this Project within the Overall Program offers distinct advantage or scientific gain over pursuing the Project independently.
Letters of Support : Attach letters of support relevant to the Project. Specific Aims : List the broad long-range objectives and goals of the proposed research project. In addition to stating the biological significance of the research, indicate the Project's relevance to the primary theme of the application. In addition to the standard scientific description, the interactions among projects and core facilities should be described within each Project. Failure to include any of the following required letters will result in withdrawal of the application:.
Appendix: Only limited items are allowed in the Appendix. Introduction to Application: For Resubmission applications, an Introduction to Application is allowed for the Scientific Core component. Specific Aims: List in priority order, the broad, long-range objectives and goals of the proposed Scientific Core. Research Strategy : The application should list the Projects it will serve and services it will provide.
Scientific Cores must accelerate the pace of discovery via essential support for the aims of proposed research Projects. Hypothesis-driven aims are not required for Scientific Cores.
Research activities should only be conducted in the research projects. Describe the function of the Scientific Core as a resource to the Program Project.
Describe the facilities, techniques, and skills the Scientific Core will provide and the role of the Core Leader and each key participant. State the percentage of total dollars required to support each Project that will use each Scientific Core. Explain why the inclusion of this Scientific Core is essential to two or more of the individual research Projects and to the entire Program. Provide justification for the essential nature of this Scientific Core for the Program.
Scientific Core activities should not duplicate existing institutional resources. Letters of Support : Attach letters of support relevant to the Scientific Core.
Each proposed Scientific Core should include a separate letter. Failure to include the required letter s will result in withdrawal of the application. See Part 1. Section III. Part I. Overview Information contains information about Key Dates and times. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission.
When a submission date falls on a weekend or Federal holiday , the application deadline is automatically extended to the next business day. Organizations must submit applications to Grants. NIH and Grants. Applicants are responsible for viewing their application before the due date in the eRA Commons to ensure accurate and successful submission.
This initiative is not subject to intergovernmental review. Paper applications will not be accepted. Applicants must complete all required registrations before the application due date. Eligibility Information contains information about registration.
For assistance with your electronic application or for more information on the electronic submission process, visit How to Apply — Application Guide.
If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Dealing with System Issues guidance. See more tips for avoiding common errors. Upon receipt, applications will be evaluated for completeness and compliance with application instructions by the Center for Scientific Review and responsiveness by components of participating organizations , NIH.
Discuss the proposed Program Project Grant application with NHLBI program, review, and grants management staff via an in-person meeting or a conference call i.
Potential applicants are strongly encouraged to begin informal discussions with NHLBI scientific staff as early as possible in the process of planning their proposed research application, but no less than 10 weeks prior to the submission deadline. Applicants must include a cover letter with the application that identifies the NHLBI Program staff member s with whom they have been in contact regarding the application along with a copy of the written agreement letter from NHLBI.
If the Subtotal Direct Cost on the cover page of the application exceeds the amount the NHLBI agreed to accept, the application may be withdrawn or not awarded. The instructions in this section apply to all new, renewal, or resubmission applications, with the exception that renewal and resubmission applications do not need to obtain the staff consultation indicated in item 1. Applicants are required to follow the instructions for post-submission materials, as described in the policy.
Any instructions provided here are in addition to the instructions in the policy. Only the review criteria described below will be considered in the review process. The Tailored Review Committee is composed of scientific peers convened to review a Program Project Grant application in their area s of expertise. The Tailored Review Committee will:. The HLBP considers the review reports from the Tailored Review Committee, makes recommendations, and assigns an overall impact score to each application.
It may not change an individual Project assessment assigned by the Tailored Review Committee, but it is asked to provide written comments to be included in the summary statement if HLBP's impression of project merit significantly differs from the Tailed Review Committee.
The Heart, Lung, and Blood Program Project Review Committee HLBP will consider each of the specific considerations below and the evaluation of the Tailored Review Committee in the determination of scientific and technical merit, and in providing an overall impact score. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a Program that by its nature is not innovative may be essential to advance a field.
Is the Program as a whole scientifically compelling? Are there coordination and synergy of the individual research Projects and Cores towards the achievement of the central objectives of the Program? Will the integration of the individual Projects into a single Program be more beneficial than pursuing each Project independently? For renewal applications, have the Program's accomplishments made a major impact on the field or successfully achieved their original goals? Are the administrative and organizational structures sound?
A proposed Clinical Trial application may include study design, methods, and intervention that are not by themselves innovative but address important questions or unmet needs.
Additionally, the results of the clinical trial may indicate that further clinical development of the intervention is unwarranted or lead to new avenues of scientific investigation. The Tailored Review Committee will consider each of the six review criteria below in the determination of scientific and technical merit of each proposed research project, and give a separate numerical 1 to 9 score for each criterion.
A project does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field. Does the Project address an important problem or a critical barrier to progress in the field?
Is the prior research that serves as the key support for the proposed project rigorous? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field? In addition, for applications involving clinical trials. For trials focusing on clinical or public health endpoints, is this clinical trial necessary for testing the safety, efficacy or effectiveness of an intervention that could lead to a change in clinical practice, community behaviors or health care policy?
For trials focusing on mechanistic, behavioral, physiological, biochemical, or other biomedical endpoints, is this trial needed to advance scientific understanding?
Are the Leads, collaborators, and other researchers well suited to the Project? If Early Stage Investigators or those in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field s? Do they have appropriate expertise in study coordination, data management and statistics?
For a multicenter trial, is the organizational structure appropriate and does the application identify a core of potential center investigators and staffing for a coordinating center? How capable does the applicant appear to be with respect to conducting independent research? Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions?
Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed? Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the Project? Have the investigators included plans to address weaknesses in the rigor of prior research that serves as the key support for the proposed project?
Have the investigators presented strategies to ensure a robust and unbiased approach, as appropriate for the work proposed? Are potential problems, alternative strategies, and benchmarks for success presented?
If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed? Have the investigators presented adequate plans to address relevant biological variables, such as sex, for studies in vertebrate animals or human subjects?
Is the trial appropriately designed to conduct the research efficiently? Are potential ethical issues adequately addressed? Is the process for obtaining informed consent or assent appropriate? Is the eligible population available? Are the plans for recruitment outreach, enrollment, retention, handling dropouts, missed visits, and losses to follow-up appropriate to ensure robust data collection?
Are the planned recruitment timelines feasible and is the plan to monitor accrual adequate? Are the plans to standardize, assure quality of, and monitor adherence to, the trial protocol and data collection or distribution guidelines appropriate? Is there a plan to obtain required study agent s? Does the application propose to use existing available resources, as applicable?
Are planned analyses and statistical approach appropriate for the proposed study design and methods used to assign participants and deliver interventions? Are the procedures for data management and quality control of data adequate at clinical site s or at center laboratories, as applicable? Have the methods for standardization of procedures for data management to assess the effect of the intervention and quality control been addressed? Is there a plan to complete data analysis within the proposed period of the award?
Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed?
Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements? Does the application adequately address the capability and ability to conduct the trial at the proposed site s or centers?
Are the plans to add or drop enrollment centers, as needed, appropriate? Do the Program and institution provide a high-quality environment appropriate for the investigator's scientific and professional development?
Is there adequate evidence that the Program and institution are strongly committed to fostering the investigator's development scientifically and professionally?
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