Full Grant Proposal Instructions

Full proposals are considered only by invitation from the NOCSAE Board of Directors and are due on Thursday September 1, 2016, at 5 p.m. EST. (Note that full grant proposals are now due one month earlier than in previous years). One paper copy of the full application must be mailed to the NOCSAE Research Director, and one complete electronic PDF copy of the application must be emailed to the NOCSAE Research Director.

CONTENTS OF THE GRANT PROPOSAL

NOCSAE only funds proposals that are scientifically sound and in keeping with the high academic standards set forth by federal granting agencies. The NOCSAE research grant program’s application models the mechanics set forth by the National Institutes of Health. Font size in text should be Arial 11, and margins may not be smaller than 0.5″, unless otherwise specified.  Failure to comply with the specific instructions set forth herein may adversely impact the review of your application by the NOCSAE Grant Review Committee.

1. COVER PAGE

A fully completed Cover Page must be included with the proposal using this version (not prior versions) of the form.

2. PROJECT SUMMARY ABSTRACT
The purpose of the project summary abstract is to describe succinctly every aspect of the proposed project. It should contain a statement of objectives and methods to be employed. Members of the NOCSAE Grant Review Committee who are not primary reviewers may rely heavily on the project summary abstract to understand your application. Consider the significance and innovation of the research proposed when preparing the Project Summary. The project summary abstract (excluding title and investigator information) may be no longer than 30 single-spaced lines of text, and must use the provided one-page Abstract and should be written in Arial 11 font throughout. The text of the body must be structured using the headings as indicated in the Abstract form. Do not justify the right margin, and do not include tables or figures. Indicate how the project relates to the goals of NOCSAE. Describe concisely the research design and methods for achieving these goals. Avoid summaries of past accomplishments and use of the first person. This abstract is meant as a succinct and accurate description, in layman’s terms, of the proposed work. All content of the abstract – including investigators and roles and abstract body – should not exceed one page.

3. TABLE OF CONTENTS

4. BUDGET
All budget and budget justifications should conform to the NOCSAE budget template. NOCSAE is interested in funding awards under two separate mechanisms: (1) small pilot developmental studies (not to exceed $50,000 in direct costs for one year), and (2) traditional research projects (not to exceed $250,000 in direct costs over two years). Proposals requesting funds greater than these amounts will only be considered upon invitation from the NOCSAE Board of Directors. Competitive renewals are acceptable. Institutional overhead costs may be covered to a maximum of 20% of direct costs- minus equipment and tuition. The budget should list names and roles of all personnel to be involved in the project during the 12 or 24 month period. In cases where an individual cannot be identified at the time of submission it is acceptable to provide proposed position title and role. The budget should indicate whether the appointment of an individual is full time or part time for each individual and the percentage of that appointment to be devoted to the research program.
• Funds may be used to support investigators, technicians, research assistants, students, and fellows. Fringe benefit costs for these personnel may be included. If graduate student support is included indicate the amount of tuition and amount of stipend separately. If equipment is purchased, each item of equipment must be listed if it has a unit acquisition cost of $500 or more. Please give justification for travel costs, significant items of equipment, and any unusual costs. Travel costs should not exceed $1200 in any year and is limited to domestic travel. Do not include secretarial, telephone or other administrative costs. Budgeted salary support should not exceed National Institutes of Health (NIH) salary caps for the year in which the application is submitted. For 2016 proposals salaries for faculty on 12 month appointments should not exceed $187,000 (9 month appointment salaries should not exceed $138,825).

5. BIOGRAPHICAL SKETCHES
Biographical sketches should be included for all key study personnel and contributors. NOCSAE has adopted the use of the NIH Biographical sketch. Biosketches should include all four sections: A. Personal Statement; B. Positions and honors; C. Contribution to Science; D. Research support. Each biosketch should not exceed five pages.

6. FACILITIES AND OTHER RESOURCES
Demonstrate that the resources are in place to conduct the proposed work. List the facilities to be used and their capacities, pertinent capabilities, relative proximity and extent of availability. List also the major equipment items already available, including the location and present pertinent capabilities of each. If your proposal seeks funding for new equipment, provide evidence of institutional support with respect to providing new space to accommodate the equipment.

7. SPECIFIC AIMS
List the broad, long term objectives and the goal of the specific research proposed (e.g. to test a stated hypothesis, create a novel design, solve a specific problem, challenge an existing paradigm or clinical practice, or address a critical barrier to progress in the field). The specific aims are limited to one page.

8. RESEARCH STRATEGY
Research Strategy is limited to no more than six (6) single-spaced pages regardless of funding level being requested. The Research Strategy is organized into three sections: Significance, Innovation, and Approach. The assessment of the research strategy will largely determine on whether or not the application is favorably recommended for funding. See section below on “Scored Review Criteria” for more information about these sections.

9. PROTECTION OF HUMAN AND ANIMAL SUBJECTS
The applicant must state whether or not human or animal subjects are to be involved in the research. If institutional ethics approval has already been provided please include a copy of the approval letter in the appendices. This section should include the following subsections:
- Risks to human subjects, animal subject involvement
- Adequacy of protection of risks –recruitment and informed consent. Protections against risks.
- Potential benefits of proposed research to human subjects and others.
- Importance of the knowledge to be gained.
- Data and safety monitoring plan.
- Inclusion of women, minorities, and children.
It is the responsibility of the Principal Investigator and his/her institution to ensure the work is conducted with the required approval and within the appropriate guidelines. A letter from the institutional review board of the principal investigator’s host institution stating approval of the study must be provided to NOCSAE before funds will be issued to the institution.

10. INTELLECTUAL PROPERTY
State whether or not you expect the project to result in the development of anything deemed patentable. NOCSAE is committed to transparency in its Research Grant Program, and evaluates all actual, potential, or perceived conflicts of interest. A  Disclosure Statement of financial interests must be completed and submitted for all key personnel.

11. APPENDICES
Copies of publications (not to exceed three) pertinent to the proposed research by the principal investigator may be included. They must be published or in press. Letters of support and copies of questionnaires and relevant testing forms should also be included as appendices. Appendices should not be used to circumvent the page limits specified above. Reviewers are not obligated to read the appendices.

SCORED REVIEW CRITERIA

The NOCSAE Grant Review Committee will consider each of the review criteria below in the determination of scientific merit, and give a separate score for each. 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.

1. SIGNIFICANCE – Does the project address an important barrier to progress 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, techniques, treatments, services, or preventive interventions that drive this field?
2. INVESTIGATORS – Are the principal investigators, collaborators, and other researchers well suited to the project? Do new investigators have appropriate experience and training? If established have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If project is multi-PI or collaborative do investigators have proper abilities in their leadership approach, governance, and organizational structure appropriate for the project?
3. INNOVATION – Does the proposal 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 or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation or interventions proposed?
4. APPROACH – Is the overall strategy, methodology, and analysis well-reasoned and appropriate to accomplish the specific aims of the research? 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? 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 genders, as well as the inclusion of children, justified in terms of the scientific goals and research strategy proposed?
5. ENVIRONMENT – 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?

INTRODUCTION (Resubmissions only)
A one page introduction should highlight the key changes to your original proposal, and identify where these changes appear in the new research strategy. Introductions should only be submitted with resubmissions. Resubmission proposals are only accepted by invitation of the NOCSAE Board of Directors. A vertical bar in the left margin of text should identify areas of considerable change in the Specific Aims and Research Strategy.

NOCSAE RESEARCH DIRECTOR
Frederick O. Mueller                                   919-537-8948 – PHONE
537 Carolina Meadows Villa                       919-636-0752 – CELL
Chapel Hill, NC 27517                                mueller537@nc.rr.com