A. Cover page

1. Title of Project: Self-explanatory

2. Principal Investigator: List the name of the one person responsible for the scientific and ethical conduct of the project.

3. Collaborator(s): List any collaborators for the project.

4. Dates of Project: List beginning and ending dates for the project.

5. Performance Site(s): List site(s) (building and rooms) where the work will be performed.

6. Budget: List the total amount requested.

7. Compliance and Training. Indicate if the project will involve human subjects, vertebrate animals, ionizing radiation, etc. as indicated in the table.

8. Grant Program: Collaborative

9. Career Status: See Instructions.

10. Proposal Type: Indicate whether this is a New Proposal, 1^st Resubmission or final submission.

11. Previous RC Support: Give the dates of the last Grant support period (if any) which was funded for the Principal Investigator by the Research Committee (RC). List the date of submission of the Final Report for this prior support.

12. Research Area: Indicate the area of research.

Signatures: Self-explanatory.

B. Abstract:

Provide an abstract of the proposal using no more than 200 words. Include a statement of hypothesis, Specific Aims, brief general description of methodology to be employed and a specific statement of how the data generated will be used to compete for extramural research funding.

C. Biographical sketch

Use the current NIH Biosketch form. Include biosketches for all key personnel.

D. Research Strategy

Response to Critiques: Resubmissions only (limit 2 pages)

Research Plan: (limit to a total of 8 pages).

1. Goals: Provide concise statements of:

a) the long term research goals of the investigator;

b) how the proposed project will enhance competitiveness for extramural funding. This should take the form of a specific statement of intent, including the name of the intended agency and target date for submission of an application for a grant or contract offering.

2. Specific Aims and Hypotheses: Provide a concise statement of hypotheses to be tested; list specific aims of the project.

3. Background and Significance: Do not write an exhaustive review. Provide a summary of the current knowledge in this field. Highlight gaps in understanding and unresolved controversies.

4. Preliminary studies: If appropriate, provide pertinent data from the P.I.'s laboratory that support the proposal. Provide sufficient detail for the reviewer to understand the nature of these data and their relationship to the proposal.

5. Procedural detail: **New Criteria**

a. Experimental design: Describe the design of studies that are to be performed to address the Specific Aims. Discuss the choice and use of model systems, surgical techniques, interview techniques, physiological models, tissue culture systems, control groups, time courses, dose regimens, etc. For human studies, describe criteria used for subject selection. Describe how data obtained will be analyzed.

b. Methodology: Describe the methods of laboratory analysis and data collection and analysis. If any work is to be performed by other laboratories or service facilities, (on a collaborative or fee for service basis), so state. If fee for-service work is a part of the proposal, specify and justify the number of "units" of such a service required.

***New Criteria***

c. Summary: Clearly state the 'Scientific Premise' as per NIH guidelines; address 'Rigor and Reproducibility'; describe the exact experiments to be performed using SOMRC funds; and justify how these experiments will improve the competitiveness of the subsequent NIH proposal.

E. Facilities available:

State where these studies will be performed. List major items of equipment available in the P.I.'s laboratory or through cooperative agreement. Document any such cooperative arrangement with a letter of agreement from the director of that laboratory which states that the equipment is available for the proposed use.

F. Collaborative arrangements:

If the project requires the services of others, describe the role of these collaborators (or fee for service laboratories). Provide written assurance of the willingness and ability of these people to participate. In the case of fee for-service work, also include a statement of charges for the services to be performed. Normally this will take the form of a letter from the individual collaborator or service.

G. Budget:

1. Budget itemization: Using the following categories, provide a budget, and itemize any category totaling over $500.

a. Supplies

b. Animal care and use: Where appropriate, itemize expenses for animal purchase shipping and care. Include costs per animal, as well as numbers of animals and days of maintenance.

c. Laboratory and other services: If fee for-service work is required (e.g. flow cytometry, patient interviews, chart reviews and statistical analysis, protein sequencing, blood chemistry, pathology, radiology, etc.) so indicate. List the number of tests or other units of service required from the Methodology section, as well as the cost for each unit. Enter the total amount requested. If at all possible, such services should come from within the University community.

d. Other expenses: Itemize by category.

2. Budget justification: For any fee for service work and for each category of expense, provide a brief description of the intended use with sufficient detail to enable the reviewer to understand the relevance and necessity of the expense.

3. Budget exclusions: The Research Committee has no a priori restrictions on funding. However, all budget items must be fully justified, and the committee will critically evaluate each item with regard to necessity, potential duplication and alternative means of support. In general, funding for consultants’ fees, clerical support, patient care and hospital costs will be difficult to justify. Faculty salaries, travel & equipment are not funded.

H. Checklist:

Fill out the checklist to insure that your application is complete.