Cincinnati Children S Hospital Medical Center

Digestive Health Center Pilot and Feasibility Grant Application 2015

Applications should be sent to Cynthia Wetzel, PhD Program Manager DHC at [email protected].

1. TITLE OF PROJECT (Do not exceed 81 characters, including spaces and punctuation.)

2. PRINCIPAL INVESTIGATOR New Digestive Diseases Investigator* No Yes 2a. NAME (Last, first, middle) 2b. DEGREE(S)

2c. POSITION TITLE 2d. TELEPHONE

2e. DIVISION 2f. E-MAIL ADDRESS

2g. DEPARTMENT/INSTITUE

3. HUMAN SUBJECTS RESEARCH 3a. Research Exempt If “Yes,” Exemption No. No Yes If ”Yes”, No Yes IRB Approval Date 3b. Federal-Wide Assurance No. 3c. Clinical Trial 3d. NIH-defined Phase III Clinical Trial 00002988 No Yes No Yes 4. Vertebrate Animals 4a. If “Yes,” IACUC Approval 5b. Animal Welfare Assurance No. A 3108-01 No Yes Date 5. IBC Protocol 5a. If “Yes,” Approval Date: 5b. Approval Number: No Yes

7. COSTS REQUESTED 6. DATES OF PROPOSED PERIOD OF Direct Costs ($) SUPPORT (month, day, year—MM/DD/YY)

From Through Total Costs ($) 06/01/16 5/31/17 10. The undersigned reviewed this application for a CCHMC DHC research award and are familiar with the policies, terms, and conditions of CCHMC concerning research support and accept the obligation to comply with all such policies, terms, and conditions. Principal Investigator: Division Chief/Dept Chair/Institute Director of Primary Applicant:

Signature of Division Chief/Dept Chair/Institute Director of Signature of Primary Applicant Date Primary Applicant Date Face Page Form Page Program Director/Principal Investigator (Last, First, Middle):

PROJECT SUMMARY: Using technical language, briefly describe the research design and rationale for achieving the stated goals.

RELEVANCE: Using no more than two or three sentences, describe the relevance of this research to public health.

DIVISION, DEPARTMENT OR INSTITUTE KEY PERSONNEL. Use continuation pages as needed to provide the required information in the format shown below. Start with Principal Investigator. List all other key personnel in alphabetical order, last name first. Name Organization Role on Project

Form Page 2 Principal Investigator/Program Director (Last, First, Middle): J. DHC Pilot and Feasibility Grant Application K. TABLE OF CONTENTS

Page Numbers Face Page......

Project Summary, Relevance, Performance sites, Key Personnel......

Table of Contents......

Detailed Budget......

Budget Justification......

Biographical Sketch – Principal Investigator/Program Director ......

Other Biographical Sketches ......

Other Support of Principal Investigator only......

Research Plan......

A. Specific Aims......

B. Research Strategy…………...……………………………………………………………………...... A-B: not to exceed 5 pages

C. Human Subjects......

Protection of Human Subjects (Required if Item 4 on the Face Page is marked “Yes”)...... Data and Safety Monitoring Plan (Required if Item 4c on the Face Page is marked “Yes” Phase I clinical trial)......

D. Vertebrate Animals......

E. Literature Cited......

F. Long term goals of the research project

G. Description of DHC Cores you will be utilizing

H. Letter from Division Director ......

I. Letters of Support (e.g., Consultants)......

Appendix (No page numbering necessary for Appendix.)

Check if Appendix is Included

Number of publications and manuscripts accepted for publication (not to exceed 5)

Form Page 3 L. DETAILED BUDGET FOR INITIAL BUDGET PERIOD FROM THROUGH M. DIRECT COSTS ONLY 6/01/16 5/31/17

PERSONNEL (Applicant organization only) Months Devoted to Project DOLLAR AMOUNT REQUESTED (omit cents) Summe ROLE ON Cal. Acad. INST.BASE SALARY FRINGE r NAME PROJECT Mnths Mnths SALARY REQUESTED BENEFITS TOTAL Mnths Principal 0 0 0 Investigator SUBTOTALS

CONSULTANT COSTS

EQUIPMENT (Itemize)

SUPPLIES (Itemize by category)

TRAVEL

PATIENT CARE COSTS INPATIENT OUTPATIENT ALTERATIONS AND RENOVATIONS (Itemize by category)

OTHER EXPENSES (Itemize by category)

TOTAL DIRECT COSTS FOR INITIAL BUDGET PERIOD (Item 10, Face Page) $

Form Page 4

Principal Investigator/Program Director (Last, First, Middle): JUSTIFICATION.

Form Page 5 BIOGRAPHICAL SKETCH Provide the following information for the Senior/key personnel and other significant contributors. Follow this format for each person. DO NOT EXCEED FIVE PAGES. NAME: eRA COMMONS USER NAME (credential, e.g., agency login): POSITION TITLE: EDUCATION/TRAINING (Begin with baccalaureate or other initial professional education, such as nursing, include postdoctoral training and residency training if applicable. Add/delete rows as necessary.) INSTITUTION AND LOCATION DEGREE (if applicable) Completion Date MM/YYYY

FIELD OF STUDY

NOTE: The Biographical Sketch may not exceed five pages. Follow the formats and instructions below.

A. Personal Statement Briefly describe why you are well-suited for your role in the project described in this application. The relevant factors may include aspects of your training; your previous experimental work on this specific topic or related topics; your technical expertise; your collaborators or scientific environment; and your past performance in this or related fields (you may mention specific contributions to science that are not included in Section C). Also, you may identify up to four peer reviewed publications that specifically highlight your experience and qualifications for this project. If you wish to explain impediments to your past productivity, you may include a description of factors such as family care responsibilities, illness, disability, and active duty military service.

B. Positions and Honors List in chronological order previous positions, concluding with the present position. List any honors. Include present membership on any Federal Government public advisory committee.

Page Biographical Sketch Format Page C. Contribution to Science Briefly describe up to five of your most significant contributions to science. For each contribution, indicate the historical background that frames the scientific problem; the central finding(s); the influence of the finding(s) on the progress of science or the application of those finding(s) to health or technology; and your specific role in the described work. For each of these contributions, reference up to four peer-reviewed publications or other non-publication research products (can include audio or video products; patents; data and research materials; databases; educational aids or curricula; instruments or equipment; models; protocols; and software or netware) that are relevant to the described contribution. The description of each contribution should be no longer than one half page including figures and citations. Also provide a URL to a full list of your published work as found in a publicly available digital database such as SciENcv or My Bibliography, which are maintained by the US National Library of Medicine.

D. Research Support List both selected ongoing and completed research projects for the past three years (Federal or non-Federally-supported). Begin with the projects that are most relevant to the research proposed in the application. Briefly indicate the overall goals of the projects and responsibilities of the key person identified on the Biographical Sketch. Do not include number of person months or direct costs.

Page Biographical Sketch Format Page Biosketch continuation page

Page Biographical Sketch Format Page Principal Investigator/Program Director (Last, first, middle): OTHER SUPPORT Provide other support for ONLY the Principal Investigator. Other Support includes all financial resources, whether Federal, non-Federal, commercial or institutional, available in direct support of an individual's research endeavors, including but not limited to research grants, cooperative agreements, contracts, and/or institutional awards. Training awards, prizes, or gifts do not need to be included.

There is no "form page" for other support. Information on other support should be provided in the format shown below, using continuation pages as necessary. Include the principal investigator's name at the top and number consecutively with the rest of the application. The sample below is intended to provide guidance regarding the type and extent of information requested. Refer to the specific instructions in Section I. For information pertaining to the use of and policy for other support, see “Policy and Additional Guidance.”

Format

NAME OF INDIVIDUAL ACTIVE/PENDING Project Number (Principal Investigator) Dates of Approved/Proposed Percent Source Project Effort Title of Project (or Subproject) Annual Direct Costs

The major goals of this project are… OVERLAP (summarized for each individual)

ACTIVE

PENDING

OVERLAP

Page Principal Investigator/Program Director (Last, First, Middle): A-B. Research Plan. Follow length guidelines- 5 pages: a. Specific Aims (1/2 page): Remember this is a 1-2 year pilot project. b. Research Strategy (4 ½ pages). Organize the Research Strategy into three sections - Significance, Innovation and Approach using the instructions provided below. Include a thorough, but concise description of the work leading up to your current hypothesis (applicants are not required to have extensive preliminary data since this is a pilot project).  Significance: Explain how the proposal will address an important problem or a critical barrier in the field. Also indicate how this proposal will generate significant preliminary data needed for an NIH grant application.  Innovation: Explain how the proposal challenges existing paradigms or clinical practice; address an innovative hypothesis or critical barrier in the field.  Approach: Describe the overall strategy, methodology, and planned statistical analyses used to accomplish the specific aims of the project. Include preliminary data, a rationale for experimental design and discuss any potential problems and solutions.

C. Human Subjects. Include all required sections required for a NIH application. See PHS 398 instructions.

D. Vertebrate Animals. Include 5 point narrative required for a NIH application – See PHS 398 instructions.

E. Literature Cited.

F. Brief description of long-term goals of the research project you plan to develop. What are the plans for future funding if the line of investigation is successful? Describe how the project is related to one of the themes of the DHC: 1) Chronic Liver Disease 2) Inflammatory and Diarrheal Diseases 3) Obesity and the Digestive System 4) Development and Digestive Diseases

G. Brief description of the proposed DHC Research Cores you will be utilizing. Click on links below for descriptions of the core services. 1) Gene and Protein Expression Core 2) Bioinformatics Core 3) Integrative Morphology Core 4) Pluripotent Stem Cell and Organoid Core 5) Clinical Component- Data Analysis and Management