CCF RESEARCH GRANT APPLICATION 2009 GUIDELINES & REQUIREMENTS

The Children’s Cardiomyopathy Foundation (CCF) awards funds to support research related to all forms of cardiomyopathy affecting children under the age of 18 years. The goal of CCF’s research program is to advance medical knowledge on the disease and develop more accurate diagnostic methods, life- improving therapies, and ultimately a cure.

The Children’s Cardiomyopathy Foundation (CCF) accepts grant proposals on an annual basis for innovative basic, clinical or translational research relevant to the cause or treatment of cardiomyopathy in children. CCF’s grant program is designed to provide seed funding to investigators for the testing of initial hypotheses and collecting of preliminary data to help secure long-term funding by the National Institute of Health (NIH) and other major granting institutions. Funding is available in the range of US $25,000 - US $50,000 for total direct costs only. For grant renewals, CCF funding is limited to two years (consecutive or otherwise) of support.

Grant award decisions are made through a careful and detailed peer-review selection process. Scientific excellence and relevance to pediatric cardiomyopathy are the basic criteria for selecting supported research projects. CCF will issue one request for proposals in 2009. The deadline for grant submission is September 4, 2009 with final award decisions made by January 2010. Upon receipt of a signed letter of agreement from the selected investigator, CCF will disburse the funds in installments during the grant period.

I. Basic Requirements

The principal investigator must hold an MD, PhD or equivalent degree and reside in the United States or Canada. The investigator must have a faculty appointment at an accredited U.S. or Canadian institution and have the proven ability to pursue independent research as evidenced by original research publications in peer-reviewed journals.

II. Review Process

Each application will be reviewed by CCF’s medical advisors according to a pre-determined criteria. Independent recommendations and priority scores will then be forwarded to CCF ‘s Board of Directors where award decisions will be made based on the grant’s scientific merit and CCF’s research priorities. The proposals will be scored on the basis of:

1. Importance and impact: extent to which the research could make a significant contribution to the understanding and/or treatment of cardiomyopathy in children.

1 of 5 2. Focus and Innovativeness: the study's focus on understanding the genetic basis/causes of cardiomyopathy and its relationship to disease progression in children. Also the study's uniqueness and possibility of breakthrough findings. 3. Feasibility: quality of the science and qualifications of the investigator to carry out the proposed work, based on expertise, commitment and the availability of all the elements required for the project (laboratory, technology, reagents and human or animal subjects). 4. Prospect of long term funding: likelihood of subsequent NIH or other major funding to sustain the project or for any potential follow-up work

All applications will be held in the strictest confidence and all decisions by CCF are final.

III. Terms of the Award

1. Grant Period: One year funding period begins from the time of the award until the same time the following year (i.e. January 15, 2009 – January 15, 2010). 2. Site of Project: Awards can be made to public or private universities, hospitals and biomedical research institutions in the United States or Canada. The research shall take place only in the research facility specified in the submitted research proposal. In the event the primary investigator (PI) leaves his/her affiliated institution, the PI shall make necessary arrangements with their institution to permit transfer of research funds.

3. Changes of Status of Principal Investigator (PI): The PI must give the Foundation immediate written notice if there is any change or potential change in the PI's affiliated institution. Upon such notice and approval from CCF, the PI shall make arrangements to have the awarded funds transferred to the new institution the PI is affiliated with. If the PI ceases research in the field for which the grant was made, CCF will request the return of the unexpended grant funds.

4. Expenditures: The grant funds, as well as any earned interest, is made only for the purposes stated in the application and may not be expended for any other reason without CCF's prior written approval. Any funds not expended or committed for the purpose of the grant shall be promptly returned to the Foundation. The grant funds may not be used for any of the following items: institutional overhead, construction or renovation, purchase of major capital equipment, office equipment or furniture, travel (unless related to research study), tuition fees, journal subscriptions, dues or membership, or equipment service contracts.

5. Grants Administration: The grant funds shall be physically segregated and be shown separately on the PI's books for ease of reference and verification. Records of receipts and expenditures under the grant, as well as copies of reports submitted to CCF, should be kept for a reasonable period of time following completion of such receipts and expenditures.

6. Institutional Support: The proposed research must comply with the regulations of the PI's Institutional Review Board (IRB) related to research on human or animal subjects. A copy of the approval or pending approval document must be included with the grant application. The PI assumes sole responsibility for conducting the research and supervising the work of co-investigators. For clinical studies, the PI must demonstrate that access to a suitable caseload or patient population will be available for the study during the funding period.

2 of 5 7. Liability: CCF assumes no financial liability of any kind undertaken by the PI. The PI’s institution acknowledges that CCF is not legally liable for the conduct of the PI and it’s co- investigators.

8. Dissemination of Findings: All scientific data and/or findings resulting from work supported by CCF shall be made available to the public and scientific community through approved scientific channels such as national medical meetings and peer-reviewed publications. If it has been determined that the data will not be published, it shall still be made available to the public through CCF appointed sources. All presentations and publications must acknowledge CCF's support. Two reprints of each publication and preferably a PDF file should be forwarded to CCF for reference and inclusion on the Foundation website. 9. Progress Reports: The awarded PI will be expected to provide a six-month update as well as a formal twelve-month progress report with financial summary on the use of the grant funds. Each report should include a narrative account of what was accomplished by the expenditure of funds including a description of progress being made towards achieving the goals of the grant. One year after the completion of the grant, the grantee will be asked to fill out a final questionnaire to describe any publications or subsequent funding received as a result of the Foundation's seed funding.

10. References to Work: If the PI would like to announce the grant award, CCF requests that CCF's involvement be acknowledged and that any print or internet related notifications (i.e. marketing/promotion materials or press release) are approved by the Foundation before distribution.

IV. Application Process

Proposal narratives should be numbered consecutively at the bottom, single-spaced with 1 inch margins and using at least 12 point font. Please include the following items in your application, keeping in mind the maximum number of pages per section:

1. Title Page (2 pages) Please complete attached form and state name of research project on top line.

2. Project Abstract and Lay Person Summary (1 page each) Describe briefly and clearly the nature, objective, methods of procedure and significance of the proposed research project and how it relates to the goal of providing a better understanding of cardiomyopathy in children and/or improving the treatment or diagnosis of the disease (limit of 500 words). Include a separate abbreviated version of the abstract in a format and language suitable for presentation to lay persons (limit to 500 words). 3. Research Plan (5-7 pages excluding references) The narrative should cover: a. Title of project

b. Goals and objectives

c. Hypothesis and specific aims

3 of 5 d. Rationale

e. Methodology

f. Evaluation

g. Key personnel engaged in project (name, position, division/department, role in project)

h. Description of research facilities or scientific environment (laboratory space, clinical population etc.) available for the project.

i. Comment on the importance of CCF funding:  Allows you to pursue studies that would otherwise not be performed?  Supplements other sources of support?  Increases your competitiveness for other major funding sources?

j. Comment on significance of your work for the community of affected children and families:  Is it similar to or a direct extension of work that has been or is being performed elsewhere by other investigators?  Does the work complement or extend other studies that are being performed at your institution?  How novel are the studies that you describe?  Would such a proposal be competitive for NIH funding in its current form, or would you require additional preliminary data?  Do you anticipate that the support would lead to the generation of physical resources that might be useful to other investigators in the field? If so, would you be willing to make it widely available for collaborative work? 4. Budget Include complete research budget stating amount requested from CCF along with a list of additional funding sources. No administrative overhead or indirect costs will be supported. CCF does not cover institutional construction or renovation, purchase of major capital equipment other than directly needed for proposed research, office equipment or furniture, travel (except as required to perform a project), tuition fees, journal subscriptions, dues or memberships, printer or publishing costs. a. For personnel the budget should cover names, titles, time/percentage effort of all participants and requested salaries/fringe benefits. Other budget items might include supplies, equipment, travel and publications.

b. Include statement that the institution or other funding sources will absorb indirect costs.

c. Add brief budget justification

4 of 5 5. Biographical Sketch (3 pages) Please provide biographical sketches (NIH format preferred) for key personnel. It should include: .a Name and position

.b Education/training: List in reverse chronological order (starting with most recent course of study), institution & location, degree, year(s), field of study. Begin with baccalaureate or other initial professional degrees/appointments and include postdoctoral training.

.c Research and professional experience: list in reverse chronological order (starting with most recent) previous employment experience and honors including institution and location, position & title, experience and honors. Also list research projects completed during last 3 years and selected publications and invited works pertinent to the application. 6. Appendix Human subjects or vertebrate animal experimental IRB approval

V. Submission Format

Applicants must submit an electronic copy of the proposal in either MS Word or PDF format (application and supporting documents should be consolidated into one file) to [email protected]. Seven copies of the proposal should also be mailed and received at the below address no later than Friday, September 4, 2009:

Children’s Cardiomyopathy Foundation Attn: Lisa Yue, President 66 Hoover Drive Cresskill, NJ 07626 Tel: 866-808-2873, ext 901

Each hard copy should be clipped together and not stapled. Upon receipt of hard copies, a binder containing all submitted grants will be assembled and distributed to CCF’s medical advisors for review.

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