Form 1. Cover page Proposal Packet Updated 01/09/2017 Request for funding Select one: Aurora Cancer Care Research Award Cardiac Research Award Date: Cardiovascular Surgery Research Award Sullivan Cardiac Research Award for Residents and Fellows Principal investigator: (Include terminal degree) Project title: Department: Address: Street address City, State Zip Phone: ( ) Fax: ( ) Email: Total amount requested: $ Permission to publish Permission is hereby given to publish the submitted abstracts if selected for funding. PI signature Date Printed name For fellows/residents only: Chairperson /Director Signature: Indicates application endorsement and approval Date Chairperson /Director Printed Name: Mentor Signature: Date Mentor Printed Name: 1
Form 2. Project Abstracts Limit both abstracts to one page Lay abstract. Please provide a short abstract, written in lay terms, for release to the general public if chosen for funding. Please provide a short scientific abstract. Scientific abstract 2
Form 3. Project Description (Limit to five pages) Background Explain the ideas and reasoning that prompted the proposed study should be briefly stated. Relevance of the proposed study to the research award mission is required. Preliminary data is not required for application, but may be included. Study Purpose Give a concise statement of the purpose and intent of the project. Hypothesis Give a clear statement of the hypotheses or research question(s) to be answered. Specific Aims or Study Objectives State concise, testable aims used to analyze the hypothesis. Suggested format, To determine/evaluate/assess whether Methods Design and methodology details for each aim/objective. Should discuss general experimental/methodological approaches, but should not be as specific as the Methods section of a research paper. Sub-sections may include: Rationale & Approach Interpretation Potential Problems and Alternative Approaches Statistical Analyses: Sample size (must be based on power analysis), variables, statistical methods Timeline List a detailed schedule of work for the project. Start date should correlate with guidelines. Dissemination and Future Funding Plan Describe plan for publication and presentation of results in peer-reviewed journals, scientific conferences, and/or online data sharing repositories. Describe how research will continue after the award period ends and identify external funding. Human/Animal Protections Briefly discuss the study s human/animal protection plans and how you will avoid or limit possible harm. 3
Form 4. References 4
Form 5. Key Personnel and Other Significant Contributors See example page 14 Key personnel begin with the principal investigator and then include other individuals who contribute to the scientific development or execution of a project in a substantive, measurable way, whether or not compensation is requested. Key Personnel must have at least 5% effort on the project. Name Project role % effort Organization Other significant contributors Other significant contributors are individuals who commit to contribute to the scientific development or execution of the project, but do not commit any specified measurable effort to the project. These individuals are typically presented by % effort or "as needed." Individuals with measurable effort over 5% should be listed under Key Personnel. Name Project role Organization 5
Form 6. Requested Budget See example page 15 Requested Budget Budget category Detailed budget for entire budget period Personnel Name Role % Effort Annual base salary Salary requested Fringe benefits* Total Personnel subtotal Supplies (Itemize by category in budget justification) Equipment (Maximum of 30% of the budget) Patient care costs Travel Other expenses (itemize) Total direct costs Consortium/contractual costs: direct costs $ (Attach detailed budget; indirect costs not allowed) Total funding request *Fringe benefits at Aurora Health Care are calculated at 23.9% of the base salary (as of Feb. 2016). Other institutions will have different fringe benefit rates. Note: Salary support should only be requested for personnel who would not be able to perform the work proposed unless it is funded by the award. Personnel who are employed by Aurora Health Care to carry out the work as part of their normal job duties should not request salary support from the award. Copy and use this form for any additional required budget information, such as for subawards to other institutions. 6
Form 8. Budget Justification (Limit to three pages) A. Personnel name, role (X% effort, 12 months) Explain what this person is doing and why they re qualified to do it. Please include the principal investigator and all other personnel, regardless of whether they are receiving funding for this project. Examples: John Smith, MD, Principal investigator (10% effort, 12 months) $12,480 Dr. Smith will serve as principal investigator for this grant. He will oversee all aspects of the work and coordinate the research. He will work with administration to meet the goals stated in the proposal, as well as report on the findings. Dr. Smith will present the results of this study at national scientific conferences. Dr. Smith is Chief Neurosurgeon at Aurora Health Care and Director of the Neurosurgery Fellows Program. Through these roles, he is experienced at assessing neurosurgery techniques and working with the community to improve outcomes. Jane Doe, PhD, Co-investigator (5% effort, 12 months) cost-share Dr. Doe will be a co-investigator and brings expertise in the field of neural stem cells. As Chief of Neural Stem Cell Studies at the Stem Cell University, she has researched neural stem cells and their clinical implications for 20 years. Dr. Doe will grow and treat neural stem cell cultures, perform RNA and protein analyses, and write/submit publications. B. Supplies Include small equipment purchases (under $5,000), as well as disposable supplies, such as computers, software, drugs, lab supplies, etc. List and describe general supply categories if over $1,000. If possible, briefly explain how costs were estimated. C. Equipment Typically any item that costs at least $5,000 and has a lifespan of at least one year. Specify the equipment type and give more details when possible, such as the vendor, model, and how price was determined. Explain why this equipment is critical for project success. D. Patient Care Costs Specify whether the costs are in-patient or out-patient and for which procedures. Show calculations including number of patients and costs per test/treatment. Please note that these costs do not include tests done in research/commercial laboratories, patient travel/lodging costs, or participant compensation, which are covered by Other Costs. E. Travel Explain why the travel is important to the project. Specify the destination/purpose (such as a conference), number of total trips, and number of people traveling. Explain how costs were calculated. F. Other Expenses If it doesn t fit elsewhere, then put it here. Other Expenses includes the cost of animals, maintenance, service fees (such as non-clinic tests), communications, printing, mileage, publications, consultants, location rentals, patient compensation, etc. List each type of expense, state its necessity, and explain how costs were determined. 8
Form 9. Biographical Sketches five pages maximum each. OMB No. 0925-0001 and 0925-0002 (Rev. 10/15 Approved Through 10/31/2018) 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: John Doe era COMMONS USER NAME (credential, e.g., agency login): POSITION TITLE: Cardiovascular Physician 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 Example University, Milwaukee, WI BS 1980 Example University, Milwaukee, WI MD 1994 Medicine University Hospital, Milwaukee, WI Resident 2000 Internal Medicine University Hospital, Milwaukee, WI Fellow 2002 Cardiology A. Personal Statement Briefly describe why you are well-suited for your role(s) in this project. 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/or your past performance in this or related fields. 1. You may cite up to four peer-reviewed published papers or research products that highlight your experience and qualifications for this project. B. Positions and Honors List in chronological order positions held since the completion of your most recent degree, concluding with your present position. List any relevant academic and professional achievements and honors. C. Contribution to Science Briefly describe up to five of your most significant contributions to science. Each contribution should be no longer than one-half page, including citations. 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. You may cite up to four peer-reviewed published papers or research products that are relevant to the contribution. D. Additional Information: Research Support and/or Scholastic Performance Research Support List selected ongoing and completed research projects for the past three years (Federal or non-federal support). Briefly indicate the overall goals of the projects and your responsibilities. 9
Form 10. PD/PI Assurance Updated 01/09/2017 The Aurora Research Institute requires caregivers to confirm they understand and accept the responsibilities associated with serving as a program director/principal investigator (PD/PI) for Aurora Health Care. The PD/PI Assurance includes standard language required of any PD/PI submitting an intramural or extramural application. Please review the statement and sign below. Proposal name: Program Director/Principal Investigator (PD/PI) Signature for Proposal In signing, I certify that I, as the program director/principal investigator (PD/PI) on the above referenced proposal, agree to this text. I certify that I have identified all space, personnel, equipment and budgetary needs associated with the proposal, and that the proposal and this form are accurate and complete in all regards, including technical and scientific matters, adherence to sponsor's guidelines, budget and required clearances. I further certify that: (1) The information submitted within the application is true, complete and accurate to the best of my knowledge; (2) I have received all necessary approvals for any commitments made on behalf of Aurora Health Care in the proposal, including, but not limited to salary cost sharing and caregiver time. (3) Any false, fictitious or fraudulent statements or claims may subject me to criminal, civil or administrative penalties; and (4) I agree to accept responsibility for the scientific conduct of the project and to provide the required progress reports if a grant is awarded as a result of the application. Program Director/Principal Investigator (PD/PI) Signature for Awards I certify that I, as the PD/PI, upon receipt of award for the above referenced proposal, understand that by responding, I agree to this text. In order for Aurora Research Institute to carry out its obligations, and as a condition of and in consideration of my participation in this sponsored research or other activity at Aurora Health Care: I agree to comply with the provisions of the executed award agreement between Aurora Research Institute and the sponsor. I agree that I will comply with the provisions of the award from the sponsor and will cooperate in assuring that Aurora Research Institute s obligations to fulfill those terms are met. I agree to disclose promptly to the Aurora Research Institute any invention, computer software potentially patentable or to which the sponsor has rights under the agreement, or mask work made by me in whole or in part, whether solely or jointly with others during and in the course of such supported research or other activity. I will cooperate in assuring that the sponsor's rights in intellectual property are fully protected. If an invention is funded in whole or in part by a federal agency or if the sponsored research agreement requires Aurora to grant rights in the invention to the sponsor, I hereby assign rights to any such invention to Aurora s designated patent and intellectual property management organization. I will execute all papers necessary to file patent applications on the invention and to establish the federal government's or other sponsor's rights in the invention. I confirm that I have not entered, and will not in the future enter, into any agreement or other obligation to another person, company or sponsor with respect to any rights in inventions, discoveries or copyrightable material that are in conflict with the obligations contained in this agreement. I agree to be responsible for assuring that all persons participating in the project, other than clerical or nontechnical persons, prior to commencing work on the project become familiar with the terms and conditions in the agreement between the sponsor and Aurora. I confirm that I have a current Conflict of Interest (COI) filed with my the COI SMART system. I also confirm that I am compliant with the Financial Conflict of Interest (FCOI) training within last four years and the CITI Human subjects training within the last three years when required on the research I conduct. I agree to the responsibilities associated with serving as the PD/PI. PD/PI Signature Date Printed name 10
Letters of Collaboration Attach letters of collaboration from external personnel or consultants here. Below is a sample letter of collaboration, which should include your external personnel/collaborator s/consultant s signature and commitments being made (such as time, supplies, cost, etc.). [Letterhead] June 26, 2017 <insert PI name> <insert title> Aurora Health Care <address> <address> Dear <PI name>, I am pleased to commit the support of <institution or organization> to the success of the project, <project title>, should it be funded. I have an understanding of the importance of <insert project purpose>. <insert a few more sentences about your experience in this area and why you re qualified to contribute> I will contribute to the project by <insert contribution>. For collaborators: To that end, I am committed to providing X% effort over the next year on the project. For paid contractors/consultants: Our fee for these services is $X over the course of one year (X hours at $X/hr). We are very excited for the opportunity to contribute to this project and look forward to this collaboration. Sincerely, <insert collaborator s name> <collaborator s title> <collaborator s contact info> 11
Appendix Remove if not using. This space may only include surveys, questionnaires, data collection instruments, and large lists of variables. Make sure to reference Appendix materials in the Project Description. Do not use this space to circumvent page limits for the Project Description; circumventing will result in this page being removed from your application before review. 12
Checklist Prior to submission, all applicants should check for the following components: Application packet Form 1. Application packet cover page with principal investigator signature Form 2. Lay and scientific abstract Form 3. Project description. Limited to five, single-spaced pages, including figures. Form 4. References Form 5. Key personnel and other significant contributors Form 6. Requested Budget Form 7. In-Kind Budget Form 8. Budget justification (limited to two pages) Form 9. Biographical sketches for each key personnel (limited to five pages each) Form 10. Program Director/Principal Investigator Assurance Signed letters of collaboration, if applicable (required for all external personnel, consultants, or subcontractors) Appendix - optional NEW: All applicants who propose use of biospecimen(s) in research must: Obtain approval from the Aurora Biospecimen Utilization Committee via Natalie Polinske prior to submission of application. General information Application is written in Arial or Times New Roman black font with a minimum of 11-point typeface with at least ½ inch margins. The application is submitted as a single document via email by 11:59 p.m. CST on the due date. The PD/PI has ensured that they have protected time and other departmental approvals as necessary to perform the research. Do not send additional materials. 13
Examples Example Key Personnel and Other Significant Contributors Key personnel begin with the principal investigator and then include other individuals who contribute to the scientific development or execution of a project in a substantive, measurable way, whether or not compensation is requested. Key Personnel must have at least 5% effort on the project. Name Project role % effort Organization John Doe, MD Principal investigator 10% Aurora Health Care Jane Doe, PhD Co-investigator 10% Aurora Health Care Joe Guy Research Assistant 20% Aurora Health Care Bill Scott, PhD Co-investigator 10%, cost share Aurora Health Care Other significant contributors Other significant contributors are individuals who commit to contribute to the scientific development or execution of the project, but do not commit any specified measurable effort to the project. These individuals are typically presented by % effort or "as needed." Individuals with measurable effort over 5% should be listed under Key Personnel. Name Project role Organization Jose Corvas, PhD Biostatistician Aurora Health Care Greg Kim, MD Cardiac Surgery Adviser Aurora Health Care 14
Examples Example Requested Budget Budget category Detailed budget for entire budget period Personnel Name Role % Effort Annualized base salary Salary requested Fringe benefits* Total John Doe, MD PI 10% $100,000 $10,000 $2390 $12,390 Jane Doe, PhD Co-I 10% $100,000 $10,000 $2390 $12,390 Research Joe Guy Assistant 20% $40,000 $8,000 $1912 $9,912 TBD Biostatistician 2% $80,000 $1,600 $382 $1982 Personnel subtotal $36,674 Supplies (Itemize by category in budget justification) $8,000 Equipment (Maximum of 30% of the budget) Patient care costs Travel $2,000 Other expenses (itemize) $3,000 Publication $2,500 License Fees $500 Total direct costs $49,674 Consortium/contractual costs: direct costs (Attach detailed budget; indirect costs not allowed) Total funding request $49,674. 15