Describe how the concepts methods technologies treatments services or preventative interventions that drive this field will be changed if the proposed aims are achieved.
NIH Grant Application Guide (http://grants.nih.gov/grants/funding/phs398/phs398.pdf)Order DescriptionInstructions for preparing the Research Proposalfrom the NIH Grant Application Guide (http://grants.nih.gov/grants/funding/phs398/phs398.pdf):Content of Research PlanThe Research Plan consists of the following items as applicable. Begin each section of the Research Plan with a section header.The Research Strategy is composed of three distinct sections Significance Innovation and Approach.1. Cover page2. Specific Aims3. Research Strategy (Significance Innovation and Approach) 4. References Cited6. Protection of Human Subjects & recruitment plan7. Inclusion of Women and Minorities8. Inclusion of Children (if necessary)10. Vertebrate Animals (if necessary)7Specific AimsState concisely the goals of the proposed research and summarize the expected outcome(s) including the impact that the results of the proposed research will exert on the research field(s) involved.List succinctly the specific objectives of the research proposed e.g. to test a stated hypothesis create a novel design solve a specific problem challenge an existing paradigm or clinical practice address a critical barrier to progress in the field or develop new technology.Specific Aims are limited to one page.Research StrategyOrganize the Research Strategy in the specified order and using the instructions provided below. Start each section with the appropriate section headingSignificance Innovation Approach. Cite published experimental details in the Research Strategy section and provide the full reference in the Bibliography and References Cited section.(a) SignificanceExplain the importance of the problem or critical barrier to progress in the field that the proposed project addresses.Explain how the proposed project will improve scientific knowledge technical capability and/or clinical practice in one or more broad fields.Describe how the concepts methods technologies treatments services or preventative interventions that drive this field will be changed if the proposed aims are achieved.(b) InnovationExplain how the application challenges and seeks to shift current research or clinical practice paradigms.Describe any novel theoretical concepts approaches or methodologies instrumentation or intervention(s) to be developed or used and any advantage over existing methodologies instrumentation or intervention(s).Explain any refinements improvements or new applications of theoretical concepts approaches or methodologies instrumentation or interventions.(c) ApproachDescribe the overall strategy methodology and analyses to be used to accomplish the specific aims of the project. Unless addressed separately in the Resource Sharing Plan include how the data will be collected analyzed and interpreted as well as any resource sharing plans as appropriate.Discuss potential problems alternative strategies and benchmarks for success anticipated to achieve the aims.References Cited Provide a bibliography of any references cited in the Research Plan. Each reference must include names of all authors (in the same sequence in which they appear in the publication) the article and journal title book title volume number page numbers and year of publication. Include only bibliographic citations. Follow scholarly practices in providing citations for source materials relied upon in preparing any section of the application.The references should be limited to relevant and current literature. While there is not a page limitation it is important to be concise and to select only those literature references pertinent to the proposed research.Protection of Human SubjectsIf the proposed research will not involve human subjects but involves human specimens and/or data from subjects applicants must provide a justification in this section for the claim that no human subjects are involved.Do not use the protection of human subjects section to circumvent the page limits of the Research Strategy.8Inclusion of Women and MinoritiesJustify the use or exclusion of both genders and different minority groups.Inclusion of ChildrenJustify the use or exclusion of children and/or infants.Vertebrate AnimalsIf vertebrate animals are involved in the project address each of the five points below. This section should be a concise complete description of the animals and proposed procedures.1. Provide a detailed description of the proposed use of the animals for the work outlined in the Research Strategy section. Identify the species strains ages sex and numbers of animals to be used in the proposed work.2. Justify the use of animals the choice of species and the numbers to be used. If animals are in short supply costly or to be used in large numbers provide an additional rationale for their selection and numbers.3. Provide information on the veterinary care of the animals involved.4. Describe the procedures for ensuring that discomfort distress pain and injury will be limited to thatwhich is unavoidable in the conduct of scientifically sound research. Describe the use of analgesic anesthetic and tranquilizing drugs and/or comfortable restraining devices where appropriate to minimize discomfort distress pain and injury.5. Describe any method of euthanasia to be used and the reason(s) for its selection. State whether this method is consistent with the recommendations of the American Veterinary Medical Association (AVMA) Guidelines on Euthanasia. If not include a scientific justification for not following the recommendations.For additional information see http://grants.nih.gov/grants/olaw/VASchecklist.pdf.Do not use the vertebrate animal section to circumvent the page limits of the Research Strategy.Instructions for reviewing Research ProposalsOverall Impact. Reviewers will judge overall impact/priority to reflect their assessment of the likelihood for the project to exert a sustained powerful influence on the research field(s) involved in consideration of the following scored review criteria and additional review criteria (as applicable for the project proposed).Review Criteria. Reviewers will consider each of the review criteria below in the determination of scientific and technical merit. An application 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.Significance. Does the project address an important problem or a critical barrier to progress in the field? If the aims of the project are achieved how will scientific knowledge technical capability and/or clinical practice be improved? How will successful completion of the aims change the concepts methods technologies treatments services or preventative interventions that drive this field?Innovation. 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?Approach. Are the overall strategy methodology and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Are potential problems alternative strategies and benchmarks for success presented? If the project is in the early stages of development will the strategy establish910feasibility and will particularly risky aspects be managed?If the project involves clinical research are the plans for 1) protection of human subjects from research risks and 2) inclusion of minorities and members of both sexes/genders as well as the inclusion of children justified in terms of the scientific goals and research strategy proposed?Protections for Human Subjects. Evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects 2) adequacy of protection against risks 3) potential benefits to the subjects and others 4) importance of the knowledge to be gained and 5) data and safety monitoring for clinical trials.Inclusion of Women Minorities and Children. When the proposed project involves human subjects and/or NIH-defined clinical research the reviewer will evaluate the proposed plans for the inclusion (or exclusion) of individuals on the basis of sex/gender race and ethnicity as well as the inclusion (or exclusion) of children to determine if it is justified in terms of the scientific goals and research strategy proposed.Vertebrate Animals. Evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following five points: 1) proposed use of the animals and species strains ages sex and numbers to be used; 2) justifications for the use of animals and for the appropriateness of the species and numbers proposed; 3) adequacy of veterinary care; 4) procedures for limiting discomfort distress pain and injury to that which is unavoidable in the conduct of scientifically sound research including the use of analgesic anesthetic and tranquilizing drugs and/or comfortable restraining devices; and 5) methods of euthanasia and reason for selection if not consistent with the AVMA Guidelines on Euthanasia. For additional information see http://grants.nih.gov/grants/olaw/VASchecklist.pdf.NIH AgenciesNational Institute of Child Health and Human Development National Cancer InstituteNational Center for Complementary and Alternative Medicine National Center for Advancing Translational Sciences National Eye InstituteNational Heart Lung and Blood InstituteNational Human Genome Research InstituteNational Institute on AgingNational Institute on Alcohol Abuse and AlcoholismNational Institute of Allergy and Infectious DiseasesNational Institute of Arthritis and Musculoskeletal and Skin Diseases National Institute of Biomedical Imaging and Bioengineering National Institute on Deafness and Other Communication Disorders National Institute of Dental and Craniofacial ResearchNational Institute of Diabetes and Digestive and Kidney Diseases National Institute on Drug AbuseNational Institute of Environmental Health SciencesNational Institute of General Medical SciencesNational Institute of Mental HealthNational Institute on Minority Health and Health DisparitiesNational Institute of Neurological Disorders and StrokeNational Institute of Nursing ResearchNational Library of MedicineNational Center for Environmental HealthNational Center for Injury Prevention and ControlNational Center for Chronic Disease Prevention and Health Promotion National Institute for Occupational Safety and Health
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