NIH Grant Application Guide (http://grants.nih.gov/grants/funding/phs398/phs398.pdf)

Order Description

Instructions for preparing the Research Proposal
from the NIH Grant Application Guide (http://grants.nih.gov/grants/funding/phs398/phs398.pdf):
Content of Research Plan
The 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 page
2. Specific Aims
3. Research Strategy (Significance, Innovation and Approach) 4. References Cited
6. Protection of Human Subjects & recruitment plan
7. Inclusion of Women and Minorities
8. Inclusion of Children (if necessary)
10. Vertebrate Animals (if necessary)
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Specific Aims
State 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 Strategy
Organize the Research Strategy in the specified order and using the instructions provided below. Start each section with the appropriate section heading—Significance,

Innovation, Approach. Cite published experimental details in the Research Strategy section and provide the full reference in the Bibliography and References Cited

section.
(a) Significance
• Explain 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) Innovation
• Explain 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) Approach
• Describe 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 Subjects
If 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.
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Inclusion of Women and Minorities
Justify the use or exclusion of both genders and different minority groups.
Inclusion of Children
Justify the use or exclusion of children and/or infants.
Vertebrate Animals
If 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 that
which 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 Proposals
Overall 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 establish
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feasibility 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 Agencies
National Institute of Child Health and Human Development National Cancer Institute
National Center for Complementary and Alternative Medicine National Center for Advancing Translational Sciences National Eye Institute
National Heart, Lung, and Blood Institute
National Human Genome Research Institute
National Institute on Aging
National Institute on Alcohol Abuse and Alcoholism
National Institute of Allergy and Infectious Diseases
National 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 Research
National Institute of Diabetes and Digestive and Kidney Diseases National Institute on Drug Abuse
National Institute of Environmental Health Sciences
National Institute of General Medical Sciences
National Institute of Mental Health
National Institute on Minority Health and Health Disparities
National Institute of Neurological Disorders and Stroke
National Institute of Nursing Research
National Library of Medicine
National Center for Environmental Health
National Center for Injury Prevention and Control
National Center for Chronic Disease Prevention and Health Promotion National Institute for Occupational Safety and Health

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