BROAD MEDICAL RESEARCH PROGRAM AT THE CROHN S & COLITIS FOUNDATION INFLAMMATORY BOWEL DISEASE GRANTS

BROAD MEDICAL RESEARCH PROGRAM AT THE CROHN S & COLITIS FOUNDATION INFLAMMATORY BOWEL DISEASE GRANTS The Crohn s & Colitis Foundation Website: http://www.broadmedical.org Phone: 646-484-1695 E-mail: infobmrp@crohnscolitisfoundation.org Questions or Issues with using proposalcentral? Please contact proposalcentral Customer Support at: pcsupport@altum.com 1-800-875-2562 New to proposalcentral? If this is your first time using proposalcentral, here are some tutorials on the following topics below to help you get started: 1) How to Register your Institution with proposalcentral (Institution Officials Only) 2) How to Register as a proposalcentral user 3) How to Create an Application using proposalcentral About Broad Medical Research Program at the Crohn s & Colitis Foundation For more information about the Broad Medical Research Program at the Crohn s & Colitis Foundation, please refer to our website at: http://www.broadmedical.org To see some of our most Frequently Asked Questions, please go to http://broadmedical.org/funding/faq.html Questions for Broad Medical Research Program at the Crohn s & Colitis Foundation? Please contact: Michael Parks Grants Manager Ph: (646) 484-1695 E-mail: infobmrp@crohnscolitisfoundation.org 1

TABLE OF CONTENTS General Information General Information... 3 BMRP Goals... 3 Policies... 3 Eligibility... 3 Budget... 3 General Submission Information... 4 Letter of Interest (LOI) LOI Information and Instructions... 5 How to Apply... 5 Putting Together the Letter of Interest... 5 Letter of Interest Submission via proposalcentral... 6 Grant Application Grant Application Information and Instructions... 8 Purpose... 8 Eligibility... 8 Grant Review Process... 8 Human and Animal Ethics Approval... 9 Funding Policies... 10 General Application Guidelines... 11 Putting Grant Application on proposalcentral... 11 Title Page... 11 Download Templates and Instructions... 11 Enable Other Users to Access This Proposal... 12 Applicant/PI... 12 Institution & Contacts... 12 Key Personnel... 12 2

Summary... 12 Budget Period Detail... 13 Budget Summary and Justification... 13 Current and Pending Support... 13 Organization Assurances... 14 Upload Attachments... 14 PI Data Sheet... 16 Validate... 16 Signature Page(s)... 16 Submit... 16 Questions and Additional Information... 16 Annual Progress Report (to replace the Continuation Application) Progress Report Guidelines and Instructions... 17 General Information... 17 Review Process... 18 General Progress Report Guidelines... 19 Progress Report Submission... 19 Summary of Project... 19 Results... 19 Progress Report... 19 Experimental Plan for the Next Year... 21 Response to Reviewers Comments (* only if a Year 1 Progress Report)... 21 Lay Description... 21 Submission Instructions... 22 Questions and Additional Information... 22 Example of Scheduled Items due to BMRP Example of Scheduled Items due to BMRP... 23 3

BROAD MEDICAL RESEARCH PROGRAM AT THE CROHN S & COLITIS FOUNDATION INFLAMMATORY BOWEL DISEASE GRANTS The Crohn s & Colitis Foundation General Information BMRP Goals The Broad Medical Research Program at the Crohn s & Colitis Foundation (BMRP) aims to help persons with inflammatory bowel diseases (IBD) by stimulating innovative, early stage research that opens new avenues for the diagnosis, therapy and prevention of these diseases. The BMRP will consider funding clinical or basic IBD research projects that: Are innovative Are in the early stages of exploration Will improve diagnosis, therapy or prevention of IBD; and Will lead to longer-term funding by more traditional granting agencies Proposals must be clinically relevant and must benefit patients with IBD. Proposals in the basic sciences should have clear relevance to findings and observations in IBD patients. For more information about the BMRP, please be sure to visit our website at http://www.broadmedical.org Policies ELIGIBILITY 1) The applicant institution must be a non-profit, charitable institution, such as a university, hospital, or research organization. Applications are accepted from institutions worldwide. 2) The applicant who wishes to take on the Principal Investigator position must have a faculty appointment at the institution. 3) There can be only one Principal Investigator for each proposal. BUDGET Funding can be requested for up to two years, but grants generally are funded only one year at a time. Funding for a second year is based upon a satisfactory Continuation Application, which will undergo peer review (for more information, please see the section on our website called Continuating Funding under Policies). 3

Budgets should be appropriate for the project s scope of work and absolute needs. All necessary costs for conduct of the study can be budgeted, including items such as personnel, supplies, equipment, publications costs and travel. There is no fixed upper or lower limit of funding, but keep in mind that we are a small foundation with limited funds. To see the range of funding we have awarded, see "Grant Funding Awarded Annually" in the "Program Statistics" section of our website. Travel costs to attend the Annual BMRP Investigator Meeting must be budgeted (see Meetings ). Funds awarded for travel and related costs to attend the BMRP Investigator Meeting are restricted and cannot be used for any other purpose without prior BMRP approval. The Principal Investigator is expected to attend the two day annual meeting. Travel to attend other scientific meetings is not allowed. Other travel that is necessary to conduct the study must be fully justified and itemized separately from the BMRP Investigator Meeting costs. Only economy airfare is allowable. The maximum indirect costs/overhead that can be requested is 10% based upon total direct costs. Once a grant is awarded, funds cannot be transferred out of direct costs to cover indirect or overhead costs even if less than the maximum allowed indirect costs were requested. Except as indicated above, all other rebudgeting to cover the necessary and reasonable costs of the research project is allowable without prior BMRP approval. If you have a particular project and budget in mind and wish clarification regarding whether it is appropriate, please contact us at infobmrp@crohnscolitisfoundation.org. General Submission Information BMRP applications are conducted through proposalcentral. Please use the site below to access available grant opportunities and submission instructions: https://proposalcentral.altum.com/grantopportunities.asp Each applicant needs to submit a Letter of Interest (LOI) prior to sending a Full Grant Application. The Letter of Interest is mandatory for all new applications. If your LOI is approved, you will receive an e-mail with the link to submit a Full Grant Application. Once submitted, you will receive an e-mail confirmation. If you have not received this within 48 hours of submission, please contact the BMRP. If it is determined that some part of the application was lost or did not transfer correctly during the submission process, BMRP has the option to Reject the application. If you are unsure, please contact BMRP to ensure that the issues are addressed and corrected. If you have questions regarding the application process, contact BMRP by phone at 646-484-1695 or via email at infobmrp@crohnscolitisfoundation.org. 4

BROAD MEDICAL RESEARCH PROGRAM AT THE CROHN S & COLITIS FOUNDATION INFLAMMATORY BOWEL DISEASE GRANTS The Crohn s & Colitis Foundation Letter of Interest INFORMATION AND INSTRUCTIONS How to Apply Applicants should submit a brief Letter of Interest (up to three pages, not including attachments) as the initial request for funding. Investigators whose Letters of Interest fit the BMRP's criteria and areas of interest will be invited to submit a Full Grant Application. We recommend you review Policies and Frequently Asked Questions prior to preparing a Letter of Interest. Putting Together the Letter of Interest: Below are the following items we ll need when putting together your PDF of the Letter of Interest: Letter of Interest Format The following information is part of the three-page limit: Title of the project Specific hypothesis or question to be investigated Methodology Data analysis Anticipated outcomes The following items (except for #1) are required, but not part of the threepage limit: 1) Supportive information, such as references, preliminary data or recent publications, may be included. You may also include suggestions for potential reviewers and also indicate individuals with potential conflicts of interest. 5

2) State why your project fits the BMRP's criteria (see "BMRP Goals"), including its relevance and likely benefits to patients with IBD in the next several years. 3) Briefly describe the laboratory or clinical environment. 4) Indicate the estimated total budget (see Budget under Policies ) and the period for which funding is requested. Keep in mind that we are interested in funding exploratory projects in order to test new ideas and directions in IBD research. Thus, funding requests should be in concert with the foundation s purpose. 5) Provide the principal investigator s e-mail and postal addresses. 6) Attach the investigator s curriculum vitae(s) or biographical sketch(es) INCLUDE THE CVs/BIOSKETCHES as separate attachments from the rest of the Letter of Interest Letter of Interest Submission via proposalcentral 1) Go to https://proposalcentral.altum.com/grantopportunities.asp, and click "Apply Now" to access the BMRP opportunities page. 2) Title Page: a. Project Title: Fill in the project title. Do not use abbreviations unless absolutely necessary. b. Project Budget and Duration: Fill in the Budget information in U.S. Dollars only (please do not include cents). Fill in your estimated Project Start Date and Project End Date. 3) Download Templates and Instructions: These are downloads for your use, if needed. 4) Enable Other Users to Access This Proposal: Use this section if you wish to have other members of your team edit or view the application. 5) Applicant/PI: The PI (Principal Investigator) is defined as the one person responsible to the Foundation for scientific and technical direction of the project. Please be sure to enter all required PI information here. 6) Institution & Contacts: This is the location of where the PI is located and where the study will take place. Please enter all required Institution information here. 7) Summary: a. Scientific Summary of Project The Scientific Summary should provide a clear, concise overview of the proposed work, including the background, objective, or hypothesis and its supporting rationale; specific aims of the study for the general scientific audience. 6

b. Relevance of the Project to IBD Provide a description of how this project is explicitly related to IBD and how it will further both research and BMRP s mission. 8) Attachments: Please upload the following to this section: a. Required for proposalcentral and BMRP: i. Letter of Interest ii. PI Biosketch (or CV) b. Optional: i. Approval Letter to Act as Principal Investigator: * The applicant who wishes to take on the Principal Investigator position must have a faculty appointment at the institution. ii. Key Personnel Biosketch / CV: If you wish to include the biosketches/cvs of other personnel (Co-Investigators, collaborators, consultants, lab technicians, etc.), attach those here. iii. Preliminary Data: This option, along with Publications and References below, correspond with the optional supportive information located on Page 5 above. iv. Publications v. References 9) Validate / Submit: Use these sections to review your Letter of Interest submission, and once fully complete, click Submit. You are all set! 7

BROAD MEDICAL RESEARCH PROGRAM AT THE CROHN S & COLITIS FOUNDATION INFLAMMATORY BOWEL DISEASE GRANTS The Crohn s & Colitis Foundation GRANT APPLICATION INFORMATION AND INSTRUCTIONS PURPOSE The Eli and Edythe Broad Foundation established the Broad Medical Research Program (BMRP) for inflammatory bowel disease (IBD) research in 2001, and it merged with the Crohn s & Colitis Foundation of America in 2014. We are interested in funding clinical or basic IBD research projects that: a. are innovative; b. are in the early stages of exploration; c. will improve diagnosis, therapy or prevention of IBD; and d. will lead to longer-term funding by more traditional granting agencies. Proposals must be clinically relevant and must benefit patients with IBD. Proposals in the basic sciences should have clear relevance to findings and observations in IBD patients. A primary purpose of BMRP grants is to facilitate innovative IBD research to enable the Principal Investigator to obtain longer-term funding from other agencies. The crucial experiments that are necessary to validate the hypothesis should be done as early as possible in year one. If your hypothesis is confirmed by your preliminary data, we would expect you to apply for other longer-term funding during year one. Continuation support is possible if you made good progress and can document the need for a second year from the BMRP in order to strengthen your chances for other funding. ELIGIBILITY The applicant institution must be a nonprofit, charitable institution, such as a university, hospital, or research organization. Applications are accepted from institutions worldwide. The Principal Investigator must be someone with a faculty appointment at the institution. There can be only one Principal Investigator for each proposal. GRANT REVIEW PROCESS A committee does not review proposals. Instead, leading investigators in each research area or topic write individual reviews and suggestions to improve the proposals. Reviews are 8

conducted anonymously to encourage candid comments. So far, more than 2,787 reviewers from 45 countries have helped the BMRP review proposals. The reviewers do not see each other s reviews and do not meet to forge a consensus report. Therefore, reviews can be different or even contradictory in some of the opinions or suggestions. The Principal Investigator receives excerpts from the reviewers comments that could be helpful in revising or improving the proposal. Grant and continuation application reviewers are required to sign confidentiality agreements prior to being sent the proposals in order to protect the investigators ideas. Reviewers comments are advisory to the BMRP. The final decision on grant funding is made by the BMRP. Grant proposals are selected for funding based on their scientific strength, innovative value, and relevance to IBD diagnosis, therapy, or prevention. Preference is given to proposals conducted with patients or patient materials and with strong potential for clinical applicability in the foreseeable future. Every attempt is made to ensure that there are no conflicts of interest between the investigators and their reviewers. Principal Investigators are encouraged to inform us of potential conflicts of interest so that we can avoid them in the review process. You may suggest the names of potential reviewers. Please provide their complete mailing address, telephone number, fax number, e-mail address and area(s) of expertise. If you are invited to submit a grant application or a revised proposal, it is up to you to decide what is an appropriate suggestion by a reviewer. Reviewers might not agree with each other or they could be incorrect. If you decide not to follow some of the reviewers' suggestions, you should explain your reasons clearly in a separate "Response to the Reviewers" document. Keep in mind that we might not use the same reviewers who evaluated your previous submission. Should you have any questions or concerns regarding the peer reviewers' comments, we encourage you to contact us. The reviewers of the original or revised grant application may not be the same as those who reviewed the original Letter of Interest or grant application. We do provide a copy of the Letter of Interest reviewers comments to the grant application reviewers. Grant reviewers are asked to comment on the following categories: a. Is the proposal scientifically sound? b. How innovative is this project for IBD research? c. Evaluate the research expertise of the investigators. d. Strength of support facilities and environment. e. Appropriateness of the budget. f. Provide suggestions to improve the proposal and its chances of helping patients with IBD. g. Overall evaluation. HUMAN and ANIMAL ETHICS APPROVAL Prior to any funding, applicants utilizing Human and/or Animal subjects must provide proof of appropriate institutional review committee approval for these activities. Since 9

obtaining institutional approval for use of humans or animals may take some time, please begin this process at the same time as you write your grant proposal so that funding will not be delayed. If your project involves the use of humans, please send signed approval documentation from your Institutional Review Board (IRB) or Human Ethics committee and upload it into your Grant Application submission on proposalcentral. Please refer to Human/Animal Subject Assurance in the Upload Attachments section on Page 15. If your project involves the use of animals, please send signed approval documentation from your Institutional Animal Care and Use Committee (IACUC) or Animal Ethics committee. Please refer to Human/Animal Subject Assurance in the Upload Attachments section on Page 15. Please be aware that we would like you to work on securing this documentation in parallel with submitting your Grant Application. However, we do not want you to delay submitting your Grant Application to us if you have not received your approval letter(s) yet. Therefore, we request that you send us your Grant Application now, and you may submit your approval letter(s) to us at any time during the review process. FUNDING POLICIES 1. Funding can be requested for up to two years, but grants generally are funded only one year at a time. Funding for a second year is based upon a satisfactory Continuation Application, which will undergo peer review. 2. Budgets should be appropriate for the project s scope of work and absolute needs. All necessary costs for conduct of the study can be budgeted, including items such as personnel, supplies, equipment, publications costs, and travel. There is no fixed upper or lower limit of funding, but keep in mind that we are a small foundation with limited funds. 3. Travel costs to attend the Annual BMRP Investigator Meeting must be budgeted. This is a two-day meeting that will tentatively be held in New York City. Funds awarded for travel and related costs to attend the BMRP Investigator Meeting are restricted and cannot be used for any other purpose without prior BMRP approval. Travel to attend other scientific meetings is not allowed. Other travel that is necessary to conduct the study must be fully justified and itemized separately from the BMRP Investigator Meeting costs. Only economy airfare is allowable. 4. The maximum indirect costs/overhead that can be requested is 10% based upon total direct costs. Once a grant is awarded, funds cannot be transferred out of direct costs to cover indirect or overhead costs even if less than the maximum allowed indirect costs was requested. 5. The BMRP provides initial funding for generating preliminary data rather than serving as the final granting source for completing a project. Utmost efforts should be made to generate sufficient preliminary data in the first year in order to compete successfully elsewhere for funding. Funding for a second year is contingent upon demonstrated maximal 10

progress in year one, validation of the original premise, and clear need for additional preliminary data rather than completion of a project. GENERAL APPLICATION GUIDELINES 1. Applications must be typed in English. 2. The font used must be easy to read. The preferred fonts are either Arial 11 point or Times New Roman 12 point. 3. Review the BMRP website at http://www.broadmedical.org for the latest information about the program. Putting Grant Application on proposalcentral 1. Title Page: a. Project Title: Fill in the project title. Do not use abbreviations unless absolutely necessary. b. Amount Requested: This is the total amount requested. If you are requesting 2 years of support, enter the total (Year 1 + Year 2) budget amount here. If only requesting 1 year of support, enter that amount here. Enter this information in U.S. Dollars only (please do not include cents). c. Proposal Type: Select New. Do not select any other option. d. Sub-Program: i. Basic: Select this if you plan on only using Animal samples (or none) ii. Clinical: Select this if you plan on only using Human samples iii. Basic & Clinical: Select this if you plan on using both Human and Animal samples e. Have you submitted this proposal before?: i. If you are sending in a Revised Grant Application, please select Yes. ii. If this is the original Full Grant Application, please select No in this box. f. If a resubmission, please select the appropriate application from the list of your prior submissions, submitted through proposalcentral: i. In this box, if this is a Revised Grant Application, select the appropriate application that you had previously submitted to the BMRP with regard to this revision. ii. If your prior Grant Application was not on proposalcentral, select Prior Proposal Not in proposalcentral g. Prior Proposal Number: If you are submitting a Revised Grant Application, enter the previous Proposal ID number into this box. 11

2. Download Templates and Instructions: These are downloads for your use. Please be sure to have your Institutional Officer complete the following templates: a. New Vendor Form b. Affidavit of Nonprofit Status of Foreign Applicant Organizations only to be completed by foreign institutions that have not been prior grantees of the Broad Medical Research Program at the Crohn s & Colitis Foundation. 3. Enable Other Users to Access This Proposal: Use this section if you wish to give other members of your team permission to edit or view the application. 4. Applicant/PI: The PI (Principal Investigator) is defined as the one person responsible to the Foundation for scientific and technical direction of the project. Please be sure to enter all required PI information here. 5. Institution & Contacts: This is the location of where the PI is located and where the study will take place. Please enter all required Institution information here, including the emails of your Institution s Signing Official, Financial Officer, and Grants Administrator. 6. Key Personnel: Enter the email addresses of other key personnel on the team, such as Co-Investigators, collaborators, consultants, lab technicians, etc. 7. Summary: a. Lay Summary: In terms that a non-scientist could understand, describe the study, explain its innovative nature, and the proposal s relevance/significance for diagnosis, therapy, or prevention of IBD. If the grant is funded, this summary will be placed on the BMRP website and will be used for disseminating information regarding the grant to the public. b. Scientific Abstract: Clarify its relevance/significance for IBD patients and explain the innovative nature of the proposal. If the grant is funded, this abstract will be placed on the BMRP website and will be used for disseminating information regarding the grant to the public. Therefore, do not include any information that you consider confidential or that could jeopardize your potential patent rights. c. How the Project Meets the Goals of the BMRP: Please explain how this project will be innovative, in the early stages of exploration and improve diagnosis, therapy or prevention IBD in the near future, and lead to longer-term funding by more traditional granting agencies. d. Enter Keyword: Please enter one General Area of Research for your project from the dropdown menu: i. Colon Cancer in IBD Patients ii. Diagnostic Methods iii. Enteric Flora Interaction with the Gut iv. Genetics v. Immunology vi. Infectious Agents vii. Other Pathogenic Factors and Mechanisms viii. Other Therapeutic Approaches 12

e. Budget Period Detail: If you are requesting 2 years of support, make sure to complete both Period 1 and Period 2. i. Start Date: Enter the start date you wish for your Budget Period ii. End Date: Enter the end date you wish for your Budget Period * NOTE: For each Start and End Date, we generally request that it be filled out in terms of a full year, with the Start Date set at the beginning of a month, and the End Date at the end of the month prior to a full year. So for example: START DATE: 11/01/2014 END DATE: 10/31/2015 iii. Personnel Costs: List all individuals working on the project (including those who will not be paid), and state their percentage of effort. iv. Non-Personnel Costs: Please enter all non-personnel costs that will be requested for the project in the following categories: 1. Equipment 2. Supplies 3. Travel Note: Travel to attend other scientific meetings is not allowed. Travel that is necessary to conduct the study must be fully justified and itemized separately from the BMRP Investigator Meeting costs. 4. BMRP Travel Must be budgeted. Funds awarded for travel and related costs to attend the BMRP Investigator Meeting are restricted and cannot be used for any other purpose without prior BMRP approval. The Principal Investigator is expected to attend the two day annual meeting. Only economy airfare is allowable. 5. Other Expenses: Enter any other needed costs that do not fit within any of the above categories. v. Indirect Costs: Please make sure that your indirect costs do not exceed 10% of your total Direct Costs. f. Budget Summary and Justification: i. Budget Summary: Please review all the costs that you had inputted in the previous section ii. Budget Justification: Enter your budget justification for the project. Include a description of what each of the personnel will be doing on the project and explaining the need for the funds. g. Current and Pending Support: Provide current and pending support for the PI only. Other Support includes all financial resources, whether Federal, non- Federal, commercial or institutional, available in direct support of an individual's 13

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. h. Organization Assurances: If you are using Human and/or Animal samples, please complete the questions in this section. Also, be sure to attach your approval letter(s) in Upload Attachments section (see below). i. Upload Attachments: Please upload the following to this section: i. Required for proposalcentral and BMRP: 1. Research Plan / Protocol: Your protocol must include the following information in the order presented, and cannot exceed ten pages. a. Specific Aims (including hypothesis); b. Background; c. Rationale and Relevance to IBD patients; and d. Methodology, including data analysis. 2. References: Complete your list of references with regard to the Research Plan / Protocol. 3. Timeline: A Timeline must be provided indicating when the experiments will be done in each year. The Timeline cannot exceed one page. Be sure to schedule the most crucial experiments early in the first year. 4. Curriculum Vitae/PI: The Curriculum Vitae must contain the educational and training background, professional positions, and peer reviewed publications. 5. Facilities and Environment Statement: Describe the relevant institutional space, instrumentation, and resources available, such as patient population, etc. 6. New Vendor Form: Download the New Vendor Form attachment, and have an Institutional Officer complete all banking information on the form. 7. Signed Signature Page: With the help of your Institutional Officials, please complete the Signed Signature Page, which you can download in the section entitled: Signature Page(s) 8. W-9 Form or W-8EXP Form: Have your Institutional Official complete either the W-9 form (for U.S. institutions) or W-8EXP form (for foreign institutions). 9. Banking Letter: Provide an official signed letter from your organization s bank, confirming your institution s full banking details checking and wiring information. Banking letters should 14

be signed letters from each PI's institution that list the following information: 1. Institution s Bank name and address 2. Account number and ACH/Wire number 3. Swift Code (This is especially important for foreign PIs) 10. We need this to be signed but the bank or someone in the authority that can confirm the information in the letter is correct. ii. Required for BMRP, but optional for proposalcentral s system: 1. Affidavit of Nonprofit Status of Foreign Applicant Organizations: ONLY FOR FOREIGN ORGANIZATIONS who have never been funded by the Broad Medical Research Program at the Crohn s & Colitis Foundation. For an applicant organization located outside of the U.S.A., a copy of a ruling or determination letter from the IRS classifying it as tax exempt in the United States by virtue of being an organization described in Code Section 501(c)(3) and either a public charity under Code Section 509(a)(1) or (2) or as a private operating foundation under Code Section 4942(j)(3). If an IRS ruling or determination letter is not available, the institution will need to submit an affidavit on a form provided by the BMRP attesting to the institution s charitable, educational purposes. Because pulling this information together may take some time, it is suggested that you request your institutional official to evaluate the form now. The form will be required to be submitted before funding is made. If this documentation from your institution is already on file with the BMRP, it is not necessary to submit it again. 2. Proof of Institution Nonprofit Charitable Status for U.S. Organizations: ONLY FOR U.S.A. ORGANIZATIONS who have never been funded by the Broad Medical Research Program at the Crohn s & Colitis Foundation. For an applicant organization located in the U.S.A., this would be the determination letter from the Internal Revenue Service (IRS) confirming the organization is one described in Section 501(c)(3) of the Internal Revenue Code (Code) and is not a private foundation by reason of being described under Code Section 509(a)(1), (2) or (3), or that it is a private operating foundation under Code Section 4942(j)(3). If your organization is a supporting organization described in Code Section 509(a)(3), we would also need proof, in the form of an affidavit signed by an officer of the organization and otherwise meeting the requirements of the IRS, that the organization is either a type 1 or type 2 supporting organization or that it is a functionally integrated type 3 supporting organization. If this documentation from your institution is already on file with 15

the BMRP, it is not necessary to submit it again. 3. Human/Animal Subject Assurance: Prior to any funding, applicants utilizing Human and/or Animal subjects must provide proof of appropriate institutional review committee approval for these activities. a. Human Samples: Attach your signed approval documentation from your Institutional Review Board (IRB) or Human Ethics committee b. Animal Samples: Attach your signed approval documentation from your Institutional Animal Care and Use Committee (IACUC) or Animal Ethics committee iii. Optional for BMRP: 1. Response to the Reviewers Comments: If you are including your Response to Reviewers Comments for a previous version of your proposal (Letter of Interest or prior Grant Application), this should be attached here as a separate document. 2. Curriculum Vitae Co-Investigator: The Curriculum Vitae must contain the educational and training background, professional positions, and peer reviewed publications. 3. Letter of Collaboration: If you have a letter from a collaborator that you wish to include with your application, attach it via this option. 4. Appendix / Additional Material: You may submit up to 10 relevant items of Additional Material may be submitted with the proposal. This includes: preliminary data, manuscripts, reprints, data collection instruments, questionnaires, etc. j. PI Data: Fill in your Date of Birth from your Professional Profile k. Validate: Click the Validate button to make sure you have included everything that is required of your application. l. Signature Page(s): Please have you and your Institutional Official complete and sign the Signature Page and attach to the Upload Attachments section. m. Submit: Click the Submit button, and you are all set! QUESTIONS AND ADDITIONAL INFORMATION For additional information regarding the grant process, please see the FAQ s (Frequently Asked Questions) section of our website. It is updated regularly and contains the most current information. For questions that are not addressed by our website, please contact: 16

Michael Parks Grants Manager Broad Medical Research Program at the Crohn s & Colitis Foundation E-mail: mparks@crohnscolitisfoundation.org Phone: 1-646-484-1695 Fax: 1-310-775-4067 Website: http://www.broadmedical.org BROAD MEDICAL RESEARCH PROGRAM AT THE CROHN S & COLITIS FOUNDATION INFLAMMATORY BOWEL DISEASE GRANTS The Crohn s & Colitis Foundation PROGRESS REPORT FOR CONTINUATION FUNDING GUIDELINES AND INSTRUCTIONS GENERAL INFORMATION BMRP grants aim to facilitate innovative IBD research while enabling the Principal Investigator to obtain long-term funding from other agencies. The crucial experiments that are necessary to validate the hypothesis should be completed as early as possible in Year 1. It is expected that grantees apply for other long-term funding during Year 1 if the hypothesis of the award is confirmed by preliminary data. Continuation support is possible if grantee can document the need for a second year from the BMRP in order to strengthen the chances for other funding. Starting 09/01/2014, the BMRP will require a Progress Report within Year 1 of funding. This will replace the formerly implemented Continuation Application process, and will be completed whether or not you wish to seek funding for a second year. The Progress Report is due two months before the grant end date if the applicant is planning to submit for a second year of funding, otherwise the final report is due no later than ninety days after the grant end date. For example, if grant period is from January 1, 2014 December 31, 2014, the deadline for the Progress Report would be November 1, 2014 (to apply for second year of funding). IMPORTANT NOTE: Submission of the Progress Report and Financial Expenditure Report is required to receive the 4 th quarterly payment of your grant s funding for the current award period. The 4 th quarterly payment will be withheld until the Progress Report and Financial Expenditure Report have been received and approved on Proposal Central. 17

Please be aware that the Progress Report may require revisions. This will be at the director s discretion and will allow submission after the target deadline if more time is needed to demonstrate adequate progress. A No Cost Time Extension of the project is also possible by written request. Please note that a late submission, even if funded, could result in a temporary lapse in funding. REVIEW PROCESS In order to expedite the review process, the director of the BMRP will review the Progress Report and make a decision to see if funding for Year 2 is warranted for the project. If a decision cannot be made instantly by the director, then the Progress Report will be distributed to peer reviewers with expertise on the project s topic. In this special case, leading investigators in each research area or topic will write individual reviews about the project s progress. Reviews are conducted anonymously to encourage candid comments. The reviewers will not be able to view each other s reviews and will not meet to forge a consensus report. The reviewers will be required to accept the BMRP s confidentiality agreement prior to being sent the Progress Report in order to protect the investigators ideas. The reviewers of the Progress Report may or may not be the same as those who reviewed the original Grant Application. A copy of the funded Grant Application will be provided to the reviewers of the Progress Report for reference. The Principal Investigator will receive excerpts from the reviewers comments that may prove helpful in revising or improving the proposal. Please note reviewers comments are advisory to the BMRP. The final decision for continuation funding is made by the BMRP. Funding for a second year is contingent upon demonstrated maximal progress in Year 1, validation of the original premise and clear need for additional preliminary data rather than completion of a project. Every attempt to ensure there are no conflicts of interest between the investigators and their reviewers will be made. Principal Investigators are encouraged to inform us of potential conflicts of interest so that we can avoid them in the review process. If a Progress Report is required at our request based on the reviewers comments, it will be up to the grantee to decide what is an appropriate suggestion by a reviewer. Reviewers might not agree with each other or they could be incorrect. If the grantee decides not to follow any of the reviewers' suggestions, an additional "Response to the Reviewers document must be completed clearly explaining reasons for disagreement. Any questions or concerns regarding the peer reviewers' comments are encouraged by the BMRP and can be addressed at the contact information provided above. Should the BMRP director request reviewers to evaluate the Progress Report, the Reviewers are asked to evaluate the following areas: a. Evaluate achievements during the currently funded year: 18

(i) Has the progress to date been reasonable? (ii) Has the initial hypothesis been substantiated by the findings? (iii) Will the findings create significant progress in IBD research and clinical practice? b. Evaluate the plan for the next year: (i) Is a second year of funding needed in order to obtain longer-term funding from other agencies? (ii) Is the proposed plan for the next year scientifically sound? (iii) How innovative is the next year's plan for IBD research? (iv) Is the proposed budget for the next year appropriate? (v) Will the proposed work improve the lives of patients with IBD? c. Indicate suggestions for the applicant regarding: (i) The progress report. (ii) The experimental plan for the next year. d. If this project was submitted for funding to other sources and evaluated during the currently funded year, would the proposal for an additional year of BMRP funding remedy the other agency's criticisms and make this project more competitive for national funding? GENERAL PROGRESS REPORT GUIDELINES 1) The font used must be easy to read. Preferred fonts are either Arial 11 point or Times New Roman 12 point. 2) Complete either a W-9 form (for U.S. institutions) or W-8EXP form (for foreign institutions). 3) Provide an official signed Banking Letter from your institution s bank, confirming your institution s full banking details checking and wiring information. Refer back to my notes on the Banking Letter in the Grant Application section (on Page 14). PROGRESS REPORT SUBMISSION Please review the Progress Report Template available in proposalcentral in the Deliverables section of the Award page. Complete the sections requested. There are no page limitations, but short and concise responses are greatly appreciated! The Progress Report is composed of the following sections: 1) Summary of Project: Brief summary of the general goals and specific aims of the project. Grantee may include a copy of the STATEMENT OF PURPOSE AND SPECIFIC AIMS page from your original application. 19

Describe whether there has been any change in the research direction. If the goals or aims are different from those originally proposed and reviewed, indicate how and why they have been changed. 2) Results: Concise description of the studies conducted during the budget year, the results obtained (positive or negative), and their significance to the field. Include a statement of the progress made toward the achievement of each of the originally stated goals and aims, and indicate any technical problems that may be important during the remainder of the project. Outline the methods learned in the laboratory. This section should not exceed 750 words. 3) PROGRESS REPORT (All sections must be addressed and each question must be answered.) a) Progress i) Describe the major achievements for this project to date. ii) If there have been no major achievements, explain why. iii) Describe any negative results or failed experiments during the period. b) What is the significance of the achievements to inflammatory bowel disease (IBD) diagnosis, therapy or prevention? c) Research Plan Changes i) Did you modify the research plan? If so, why and in what way? ii) Were there any unexpected directions or changes in the project based on the data generated so far? iii) Would you have done your experiments any differently knowing what you know now? Explain. d) Have there been any changes to the investigators originally slated to work on this project? If so, please explain. e) Indicate whether the study involves human subjects or animals and complete the following information: i) The number of subjects originally described to be studied in the currently funded year; ii) The number studied so far in the currently funded year; iii) The number to be completed during the balance of the currently funded year; and iv) If the number of human or animal subjects to be completed during this currently funded year is either less or more than originally projected, explain why. f) List all publications, abstracts and presentations resulting from this grant. If you have not yet provided a copy of this material to the BMRP, attach one copy to this application. **NOTE: Please add your publications/other support/patents to the "Publications, Other Support, and Patent Follow-Up" web form in the Deliverables section on Proposal Central. If the form's not there, please contact me at mparks@crohnscolitisfoundation.org, and I'll provide you a form to complete. 20

g) Have you applied to other funding agencies to continue to work on this project? i) If YES, please provide the following information: (1) Name of the funding agency. (2) Funding status (e.g., pending, received, or not funded). (3) Type of grant requested (e.g., research grant, fellowship, career award). (4) A copy of the peer review evaluations received. (5) If funded by the other agency, please also include: (a) Total amount awarded (direct plus indirect) for the entire project period. (b) Number of years of support received. (c) Year in which funding began. ii) If you have not applied to other funding agencies to continue to work on this project, why not? When do you anticipate applying to other agencies for continued funding of this project? Which agencies? iii) How will an additional year of funding from the BMRP prepare you for applying elsewhere for support of this project? h) Disclose and describe any patents resulting in whole or in part from the BMRP supported project. 4) EXPERIMENTAL PLAN FOR THE NEXT YEAR (All sections must be addressed) a) Describe and justify the work you would like to accomplish in the coming year: i) Why do you need additional preliminary data to apply for future funding of the project? ii) Specific aims; iii) Methodology; iv) Analysis; v) Anticipated outcomes; and vi) Relevance to IBD diagnosis, prevention and treatment. b) If your study involves human or animal subjects, indicate the number anticipated to be studied in the coming year. **SPECIAL NOTE FOR YEAR 1 PROGRESS REPORTS: Awardees must include a 2-3 page Response to the Reviewers Comments document specifically addressing each of the criticisms found in the Peer Review Comments that were included with the Award Letter. A copy of the Peer Review Comments should be attached to the Response Letter. 5) Lay Description (Brief description of your progress in lay terms) The lay description is used for educating our members and donors on the content and importance of the research portfolio. Write your lay description so it is understandable to a 6th-7th grade reader, so the reader should be able to correctly describe it to someone else. Here are some additional pointers: 21

Bullet points of your Scientific Goals: Project Description Background: 100 words or less Bullet Points of Scientific Goals Brief summary of findings at the first year progress Significance to IBD: 50 words or less o If this project succeeds, what will be the accomplished and how could it ultimately improve patient care? Looking ahead (what are the objectives for the coming year) o Describe what new information will be learned. **Define all scientific terms. Words like pathogenesis or cytokines may not be common to lay persons. SUBMISSION INSTRUCTIONS 1) Attach one electronic copy of the Progress Report and the BMRP Financial Expenditure Report into the Deliverables section of your BMRP Grant Award on Proposal Central. If you have any questions, please send an e-mail to the following address: Michael Parks Grants Manager Broad Medical Research Program at the Crohn s & Colitis Foundation mparks@crohnscolitisfoundation.org 2) Your Progress Report will go under review after BMRP receipt of the electronic signed application. QUESTIONS AND ADDITIONAL INFORMATION For questions, please contact: Michael Parks, Grants Manager E-mail: mparks@crohnscolitisfoundation.org Phone: 1-646-484-1695 Fax: 1-310-775-4067 mp 6/15/17 22

Example of Scheduled Items due at BMRP: The following is a simple example of which scheduled items are due to the BMRP and when, if you received a Year 1 award and a Year 2 award. For this example: Year 1 s award period will be from January 1, 2014 December 31, 2014; and Year 2 s award period will be from January 1, 2015 December 31, 2015 Year 1: 1. Annual Progress Report due 2 months prior to Year 1 s end date (i.e., November 1, 2014) This is needed in order to receive your 4 th quarterly payment of your Year 1 award. 2. Financial Expenditure Report due 2 months prior to Year 1 s end date (i.e., November 1, 2014) This is needed in order to receive your 4 th quarterly payment of your Year 1 award. ** No Cost Time Extension requests are due 1 month prior to Year 1 s end date (i.e., December 1, 2014) Year 2: 1. Annual Progress Report due 2 months prior to Year 2 s end date (i.e., November 1, 2015) This is needed in order to receive your 4 th quarterly payment of your Year 2 award. 2. Financial Expenditure Report due 2 months prior to Year 2 s end date (i.e., November 1, 2015) This is needed in order to receive your 4 th quarterly payment of your Year 2 award. ** No Cost Time Extension requests are due 1 month prior to Year 2 s end date (i.e., December 1, 2015) After the Grant Award ends: 1. Final Progress Report due 3 months after the Grant Award s end date (i.e., April 1, 2016) 2. Financial Financial Report 3 months after the Grant Award s end date (i.e., April 1, 2016) 23