Litwin IBD Pioneers

Overview

The Litwin IBD Pioneers initiative, formerly known as the Broad Medical Research Program at the Crohn’s & Colitis Foundation, supports innovative clinical and translational research projects with the potential to impact the treatment of IBD patients in the near future. The program encourages novel research into the diagnosis, identification of clinically relevant subsets, treatments, and cures for inflammatory bowel diseases (IBD) and funds innovative pilot research so that scientists can test their initial ideas and generate preliminary data.

Litwin IBD Pioneers supports researchers who are exploring all possible opportunities for diagnostic and therapeutic improvements, including novel, out-of-the-box ideas, and funds innovative and pioneering ideas that have a clinically relevant focus. Additionally, the program is open to investigators from other disciplines new to the IBD field, as well as countries outside the United States.

Eligibility

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* The applicant institution must be a non-profit, charitable institution, such as a university, hospital, or research organization.
* Applications are accepted from institutions worldwide.
* The applicant who wishes to take on the Principal Investigator position must have a faculty appointment at the institution. For this, we request that the applicant's university or institution (particularly the Grants and Contracts personnel) send us a statement confirming that the applicant is or is not able to apply as a Principal Investigator from his/her institution.
* There can be only one Principal Investigator for each proposal.
* Proposal must be relevant to IBD, which includes Crohn's diseaseand/or ulcerative colitis.
* Only one application is allowed per applicant per submission date.
* Simultaneous submission of the same application for other awards is not permitted.

Application Details

LITWIN IBD PIONEERS PROGRAM
INSTRUCTIONS AND POLICIES
Crohn’s & Colitis Foundation National Office
Research & Scientific Programs Department
733 Third Avenue, Suite 510
New York, NY 10017
Phone: 646-943-7505
Web site: http://www.crohnscolitisfoundation.org
E-mail: litwinprograms@crohnscolitisfoundation.org
MISSION of the Crohn’s and Colitis Foundation:
To cure Crohn’s disease and ulcerative colitis, and to improve the quality of life of children and adults affected
by these diseases.
Revised 2021

INTRODUCTION AND SOURCE OF FUNDS
The Crohn's & Colitis Foundation (the Foundation) was established in 1967 to find the cause of and cure for
Crohn's disease and ulcerative colitis, collectively known as inflammatory bowel diseases (IBD). Support for
our research program is provided by members and concerned individuals, corporations and philanthropic
foundations.
The guiding mission of the Foundation is to stimulate and encourage innovative research in the basic
biomedical and clinical sciences, which is likely to increase our understanding of the etiology,
pathogenesis, therapy, and prevention of inflammatory bowel diseases. Collaborative efforts between
basic scientists and clinicians are encouraged.
Each year, the Foundation receives approximately hundreds of requests for research support. All proposals
are subjected to multiple levels of peer review that identify the most meritorious and innovative projects for
funding.
Litwin IBD Pioneers would not be possible without the incredible generosity of the Pittelman and
Swarzman families, who support this program in honor of their late father and grandfather, Leonard Litwin.
We are grateful for their visionary commitment. Additional support is provided through the Crohn's & Colitis
Foundation's annual giving program and donors.
SCOPE & OBJECTIVES
The objective of the Litwin IBD Pioneers Research Award is to help persons with inflammatory bowel
diseases by supporting innovative, early-stage research that opens new avenues for diagnosis, therapy,
and prevention of these diseases. The program will consider funding clinical or translational IBD research
projects that:
• Are innovative;
• Are in the early stages of exploration; and
• Have the potential to improve diagnosis, therapy, management, or prevention of IBD and their complications.
Proposals must be clinically relevant and must have the potential to benefit patients with IBD. The program is
designed to support research that can be readily translated to improve the care of human IBD in the near
future. Examples of projects include, but are not limited to clinical trials; observational clinical studies;
biomarker identification; and evaluation of novel therapeutic modalities. Proposals related to translational
science should have clear relevance to findings and observations in IBD patients. Proposals relating to
investigation of basic disease mechanisms in animal models or in vitro systems are not typically prioritized
under this mechanism; applicants may consider other Foundation programs, such as the Senior Research
Award program, for such projects.
All applicants for Foundation funding should take into account the current research priorities of the
organization, as described in a comprehensive document, Challenges in IBD Research. These priorities are
revised every 5 years based on input from leaders in the IBD research community and additional stakeholders
including IBD patients. The most current Challenges in IBD document can be accessed using the following
link: https://academic.oup.com/ibdjournal/issue/25/Supplement_2
PROJECT FUNDING & DURATION
Projects may be proposed with an expected duration of 1-2 years. However, awards are initially made only
for the first year of the project. If a PI wishes to seek continuation funding, PI may apply for a second year
of funding (renewal); awarding of second year funding will be competitive and based on evaluation of
progress toward milestones initially projected for the first year of the project.
Budgets should be appropriate for the project's scope of work and resources necessary to complete the
goals. All necessary costs for conduct of the study can be budgeted, including items such as personnel,
supplies, equipment, publications costs, and travel. Awards are not funded above $130,000 per year,
including 10% indirect costs, for clinical studies (including studies involving clinical sample analysis); and
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not above $110,000, including 10% indirect costs, for laboratory-based studies. Indirect costs cannot
exceed 10% of total direct costs. Thus, if the applicant is successful in obtaining the initial award
(for year 1 activities) and a renewal award, the maximum total funding for the project would be
$260,000. No further continuation of funding will be considered beyond the first renewal award.
APPLICANT 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. For this reason, we request that the applicant's university or institution (particularly
the Grants and Contracts personnel) send us a statement confirming that the applicant is or is not able
to apply as a Principal Investigator from his/her institution.
3. There can be only one Principal Investigator for each proposal.
Eligibility is not restricted by citizenship or geography.
PROPOSAL ELIGIBILITY & RESTRICTIONS
• Only one proposal may be submitted for this award per submission date.
• Applicants for Litwin award may not simultaneously submit another application focused on the same research
topic for another Foundation funding program.
• The submitted research proposal must be in the field of inflammatory bowel diseases.
COMPLETING THE APPLICATION
Submission Process
The Foundation uses the proposalCENTRAL system for all of its application submissions. To access
submission forms, navigate to: https://proposalcentral.com
Select the “Grant Opportunities” tab and select “Crohn’s & Colitis Foundation”.
Each applicant needs to submit a Letter of Intent (LOI) prior to sending a full application. The LOI is reviewed
competitively and only those approved are invited to submit a full application. The Letter of Intent is
mandatory for all new applications. Resubmissions do not require a letter of intent.
If your LOI is approved, you will receive an e-mail and will be able to access the full proposal submission form
in ProposalCENTRAL. Critiques of the LOI will be provided; applicants are encouraged to consider these
critiques when preparing the full proposal. Applications should be submitted on proposalCENTRAL by the due
dates indicated below. You will also be notified if an LOI is declined or if a revised application is requested.
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Application Timetable
*Should the deadline date fall on a weekend or national holiday, the submission deadline will be extended
to the following business day. *NOTE: Dates and submission cycles are subject to change by the
Foundation. Please reference the Foundation website or contact Foundation staff.
Contact Information
For any questions or concerns please contact the Foundation grants office:
Telephone: 646-943-7505; Email: litwinprograms@crohnscolitisfoundation.org.
Please note that there may be a delay in responses close to the application deadlines due to the high
number of applicant inquiries.
LETTER OF INTENT
(Stage 1 of the application process)
Each applicant must submit a letter of intent (LOI) prior to submitting a full proposal for consideration. LOIs
are reviewed by committee and selected on a competitive basis. LOIs that do not address the program criteria
will be rejected. Each section of the LOI must be completed fully to be eligible for funding consideration.
Resubmissions do not require an LOI. PIs intending to resubmit an application in a given cycle need to inform
the Foundation by the respective LOI submission deadline by sending an email to:
loibypass@crohnscolitisfoundation.org with the following information:
• Subject line: Resubmission – LOI Bypass Request
• Body of email: PI name, PI email address, project title, and original proposal number
Resubmissions are allowed within three years of the initial application submission. After three years, a new
LOI is required.
Reviewers of the Letters of Intent are asked to evaluate the LOI and to provide a brief critique regarding:
1. Scientific merit
2. Alignment with Litwin program objectives
3. Principal Investigator qualifications and scientific environment
LOI form sections are described below. Please complete the LOI online in proposalCENTRAL and adhere to
the character limitations of each section and the other requirements as outlined.
 Project title. Do not use abbreviations.
 Type of Disease -Select one of the following
o Crohn’s Disease
o Ulcerative Colitis
 Type of Research - Select one of the following
o Basic
o Translational
o Clinical (Please see section on Special Instructions for Clinical Trials, if applicable)
 Challenges Priority: Please check one or more of the Challenges priority areas that is addressed by
your project. (For more information about Challenges, see Scope section above.) You may check
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“other,” but please be prepared to explain why the topic of your research proposal should be considered
a priority area for funding.
 Estimated total requested budget for activities to be completed in the first year. (See Budget section.)
 Indicate if the application is a resubmission.
 3 keywords.
 Enable other users to access this application. You can designate colleagues and allow them to access
and manage the application here.
 Applicant/PI (Principal Investigator): PI is defined as the one person responsible to the Foundation for
scientific and technical direction of the project. While a project can have Co-PIs and senior collaborators,
only one person and awardee organization can be the point of contact responsible for technical and
financial management of the award scientific outcomes and reports.
 Institution & Institutional Contacts. This indicates where the PI is located and where the study will take
place. The Foundation does not make awards to individuals.
 Key Personnel. Fill in key personnel, titles, affiliations & email addresses for all senior personnel and
collaborators. This is important in order to avoid conflicts of interest during review.
 Scientific Summary of Project. The Scientific Summary should provide a clear overview of the proposed
work, including background (or hypothesis and its supporting rationale) and specific aims of the study.
It should be concise but allow the review committee to assess the scientific merit and recommend it for
full submission. Maximum 3000 characters.
 Relevance and Significance of the Project to IBD. Provide a description of how this project addresses
unmet needs in IBD, is related to the Foundation’s research priorities, outlined in Challenges in IBD,
and how it will further both research and the Foundation’s mission. (For more information about
Challenges in IBD, please see Scope section above.) The LOI must state how the research proposal is
related to an area outlined in Challenges in IBD, or if not related to areas outlined in Challenges in IBD,
the LOI must state why the research proposal is so innovative that it should be considered a
priority for funding despite not being described as a priority in that document. For Litwin applicants,
this section should also address why the proposal is innovative and has clinical or translational
relevance. Scoring will be negatively impacted if the LOI does not address these areas. Maximum 3000
characters.
 Attachments: Please upload the following to this section:
o PI biosketch/CV
o Description of project including specific objectives (up to 3 pages)
FULL PROPOSAL
(Stage 2 of the application process)
Important Note on Scientific and Funding Overlap
The Crohn’s & Colitis Foundation reserves the right not to fund projects that are supported all or in part by
another agency. Projects are considered to overlap if there are any shared Specific Aims or budgetary overlap
or overlap of percent of effort dedicated to the other project. The review committee will make the final decision
regarding any questions of overlap.
Clinical trials requiring Foundation support in addition to outside support will be considered. Please see
section on Special Instructions for Clinical Trials, if applicable.
Additionally, there is an exception for institutional support (PI faculty package, discretionary funds, etc.). If this
is applicable to this proposal, a description of any institutional support provided by the institution should be
uploaded to the section “Evidential Enclosure”. The details should include institutional commitment to the
support of the applicant’s salary; and the current term of the applicant’s appointment. Please note that the
institutional support does not decrease the chances of obtaining support from the Foundation, rather, such
support is frequently considered by the review committee as important evidence for institutional commitment
to the proposed research project.
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Each section of the online application is listed below:
TITLE PAGE Project Title
Fill in project title. If this is a resubmission, the title should be the same as the original application.
Challenges Priority
Donors frequently have an interest in funding particular types of IBD research. Please check one Priority Area
that is addressed by your project.
APPLICANT/ PI Principal Investigator
PI is defined as the one person responsible to the foundation for scientific and technical direction of the
project. Although co-PIs are permitted, only one PI can be indicated as the main point of contact.
Organization Information
This is the location of where the lead PI is located and where the study will take place.
INSTITUTION AND CONTACTS Grant Administration Information
In the event an award is made, provide the name and address of the person, at the grantee institution, who
will administer the grant.
KEY PERSONNEL
Please note any key members of this project such as collaborators, mentors, etc.
SUMMARY
Lay Abstract/General Audience Summary
Your lay summary should be a clear, concise overview in simplified language, appropriate for non-scientific
reviewers. You need to provide enough essential information that the stakeholder reviewers will be able to
evaluate your application. The lay summary should include the following information:
• What question will this project attempt to answer?
• Why is this question important to IBD?
• What is the study design?
• How do the hypothesis and specific aims fit with the Foundation’s scientific priorities?
• Will this research, if successful, improve the care of human IBD, in the near future? If so, how will this
project do so?
Also include a brief glossary of any scientific terms included in your lay summary. Space limitation 1/2 page.
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 general
scientific audience. Space limitation 1/2 page.
Relevance of the Project to IBD
Provide a description of how this project is explicitly clinically relevant, benefiting patients with IBD, and readily
translatable to improve the care of human IBD in the near future. Space limitation 1/2 page.
The above three sections will be evaluated as part of your application as well as used to inform the
Foundation’s National Board of Trustees and the general public of the nature of this work; therefore, do not
include proprietary or confidential information.
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BUGET PERIOD DETAIL
Project Start Date
Include the date on which you expect to start this project. Funded applications for the spring cycle would begin
on July 1. Funded applications in the fall cycle would begin on January 1 of the following year.
Estimated Length of Project
How long it will take you to complete the work. Funding can be requested for up to two years, but grants are
funded only one year at a time. If a PI wishes to seek continuation funding for one additional year, funding for
a second year is competitively reviewed based upon a satisfactory Progress Report and degree to which the
first year research activities reached the individualized milestones established for the project, which are
provided in the award letter.
Percentage Estimation of Amount of Time Allocated to this Project
Describe how your time (in percentages) is allocated in your current position at this institution.
Percentage of Fringe Benefits Paid by Your Institution
What is the percentage (of your salary) paid by your institution for fringe benefits, such as medical insurance,
etc.
Detailed Budget Pages for Year 1 only * Required *
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. The Crohn’s & Colitis Foundation adheres to the NIH salary cap limits.
Awards are not funded above $130,000, including 10% indirect costs, for clinical trials, and not above
$110,000, inclusive of 10% indirect costs, for laboratory- based studies.
Complete the e-form total budget for first year.
• PI Title of Position- His or her official title at institution
• PI Direct Costs
• PI Indirect Costs
BUDGET SUMMARY AND JUSTIFICATION
Please provide justification as to the amount of support requested. Although the detailed budget will reflect
the year 1 request, the budget justification should summarize two years of funding. Second year funds are
contingent on the approval of a separate competing renewal submission. See section on SUBMITTING FOR
A YEAR 2 COMPETING RENEWAL.
CURRENT AND PENDING SUPPORT
Current Financial Support
If you have current financial support for this project, type into the text box the name of the institute/group
that funds this research.
Pending Applications
If you do not have any current pending applications please leave blank.
If you do have current pending applications, type in the title of the award(s) and the name of the agency from
which you are awaiting a response. In the attachment section, attach an abstract for each application you list
in this section.
It is the policy of the Crohn’s & Colitis Foundation not to fund projects that are supported all or in part by
another agency. This means that projects are considered to overlap if there are any shared Specific Aims or
areas of budgetary overlap or percent of effort dedicated to the other project. The Peer Review Committee
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will make the final decision regarding any questions of overlap. The only exceptions are: institutional support.
Upload as an attachment in the “Evidential Enclosure” a description of any institutional support provided by
your institution. The details should include Institutional commitment to the support of the applicant’s salary;
and the current term of the applicant’s appointment. Please note that the institutional support does not
decrease the chances of obtaining support from the Foundation, rather, such support is frequently considered
by the Peer Review Committee as important evidence for institutional commitment to the proposed research
project.
ORGANIZATION ASSURANCES
Human/Animal Studies Approval
All activities involving human subjects or vertebrate animals must be approved by an appropriate
institutional review board (IRB) or equivalent prior to the start date of award. Indicate with “Yes” or “No”
response. If yes, indicate date of approval and attach approval in that Attachments Section, if available.
Copies of the IRB approval should be provided to the Foundation Research Department. If approval is not
available at the time of application, provide a date of anticipated approval. All required assurances must be
received before the start date of the approved grant.
ATTACHMENTS
Research Plan/Protocol* Required
The description of the proposed research project must include the following items in sufficient detail to permit
evaluation of the scientific merit of the study. This cannot exceed 6 pages, single spaced. The lengths
indicated below are included as a guideline and not required. Applications exceeding the page limit may not
be reviewed.
1. Overall Objectives (one or two paragraphs)
• Briefly outline the general scientific objectives
2. Specific aims (no more than 1/2 page)
• Describe concisely and realistically what the specific research described in this application is intended
to accomplish. Specifically outline aims for year 1 and year 2 (if applicable), and goals, deliverables, and
timelines. State any hypotheses to be tested.
3. Background - including preliminary data (no more than 2 pages)
• Outline the previous work in the area by others, and the preliminary data or previous studies by the
investigator(s). Preliminary data are not required for an application submission.
• If this is a renewal application, include a copy of your most recent Progress Report here
(Progress Report is not counted as part of the six pages).
4. Detailed description of methods and materials to be used (no more than 3 pages)
a. Provide a detailed discussion of the experimental design, procedures, and materials to be used to
accomplish the Specific Aims.
b. Describe protocols, including methods for new techniques, and explain the advantages over existing
methodologies.
c. Discuss the kinds of data expected to be obtained and the means by which data will be analyzed and
interpreted.
d. Justify the use of any animal models (i.e., choice of species, number used, etc.).
e. Discuss potential difficulties and/or limitations of the proposed procedures and alternative approaches
to achieve aims.
5. Significance and relevance of the proposed research to Crohn's disease and/or ulcerative colitis (no
more than 1/2 page)
• Justify the significance of the results of this project to advancing IBD diagnosis, therapy, or prevention.
Specifically identify the gaps and/or pioneering approaches this project is intended to fill.
6. Facilities Available to carry out the Proposed Studies (one or two paragraphs - not included in overall
6 page limit)
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• Describe the facilities available, including square footage, equipment, animal care facilities, and other
environmental factors. Pay particular attention to those items required for successful completion of this
proposal. Include a description for each facility to be involved.
• Pertinent References Literature citations should be listed in this section, at the end of the Research
Plan. *These are not counted as part of the 6-page limit.
Formatting the Application
Applicants must adhere to the following instructions in completing the proposal sections that make up the
electronic version of the application.
• Please remember to insert your name in the header on each form in the attachment section.
• Font size: Use 12-point Times New Roman or 11-point Arial as the minimum font size for the text of the
application. A 10-point Times New Roman or 10-point Arial font type may be used for figures, legends, and
tables.
• Single-spaced text is acceptable, and space between paragraphs is recommended.
• Margins: The margins of your text should be at least 1” all around, unless a form with different margins
is supplied in the Application Templates or Forms.
Resubmission Material *Required if a Resubmission
Please follow these guidelines when resubmitting an application:
• “Reply to Previous Review”, letter not to exceed three pages. The letter should clearly and succinctly
address the points raised in the previous review and direct the reviewer to the specific sections of the
Research Protocol where revisions have been made.
Revised portions of the text changed in response to the reviewers’ comments should be highlighted (e.g.:
bold type, line in the margin, underlined, etc.). A one-page summary of how the revised application addresses
the primary concerns of the review should be included as the first page of the scientific portion. This page
does not count against the 6 page space limitation of the text.
Include copies of the following:
• Critiques (Summary Statement) of the original application
• Budget pages of previous application
• Overall objectives and Specific Aims of previous application
Previously submitted material is not considered part of the three-page resubmission material limit.
Letters of Collaboration
Attach supporting letter(s).
Applicants’ CV or NIH Biosketch *Required
Attach the CV or NIH Biosketch for the applicant. Limit CV to 10 pages. A five-page NIH Biosketch is preferred.
References/ Appendices - Optional (part of Attachments section)
Uploaded reference material may include, but not limited to:
• Article references
• Abstracts
• Original pictures
• Other Letters of Support
Human and/or Animal Approvals - Optional
Upload IRB approvals for human and animal research, if available.
VALIDATE AND SIGNATURE PAGE
Once the application is validated, you can submit the application. The signature page is not required by the
Foundation and should be printed only if you desire for your personal records.
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SPECIAL INSTRUCTIONS
Applicants falling into any of the following categories should read the "Special Instructions" section pertaining
to them before attempting to complete the application:
• Foreign Applicants
• Clinical Trials
Special Instructions for Foreign Applicants
• Complete budget request must be in U.S. dollars - We will NOT convert.
• Please be aware that you should give more details than you might be accustomed, especially in the
areas of background material and preliminary data, experimental design, and available facilities and
budgetary items (in particular, percent of effort and salary requests for key personnel).
*ALL MATERIALS AND REPORTS MUST BE IN ENGLISH. FAILURE TO DO SO WILL RESULT IN A
REJECTED APPLICATION.
Special Instructions for Clinical Trials
The Research Plan will need to include everything required in the Application Preparation section, plus the
following information:
Specific Aims:
These should include a delineation of the primary and secondary end points to be measured with an
appropriate explanation of the relative importance of the various end points.
Significance:
The application should clearly state the need for the study and how the results would impact on the prevailing
practice in this area.
Experimental Design and Method:
The inclusion and exclusion criteria should be listed, and the procedure(s) to be utilized for assignment of
patients to experimental groups should be described. The study design for the interventions to be used should
be presented in detail including the rationale for the particular design chosen and procedures to assure
compliance with and implementation of the proposed protocol. Potential biases in the proposed protocol and
how they will be addressed should be presented.
Clinical, laboratory, and physiological tests should be described including methods of randomization. Finally,
assumptions and calculations to arrive at the proposed sample size should be included.
The availability of patients for the proposed study, including the specific characteristics that are required for
the group should be presented. Approaches should be outlined that will be used for the recruitment, retention,
and follow-up of the required number of patients. Data should be presented supporting recruitment and
retention estimates. Plans should be described for patient protection, including informed consent, monitoring
of data for safety, and early termination, as required. Appropriate informed consent forms from all participating
groups (centers) should be included as an attachment, not subject to space restrictions. Projected rates of
patient enrollment should be included. If enrollment falls behind projected levels, funding may be delayed
or terminated.
The organization of the study and how the trial will be managed should be described, including the function
of any internal or external advisory committees and any data and safety monitoring groups. In multicenter
trials, you should provide a description of the responsibility and role of a data coordinating center, and policies
and methods concerning blinding of study results. Accordingly, a plan should be submitted describing the
procedure for the coordination of all participating centers. The Foundation does not assume responsibility for
the conduct of the activities that the grant supports or the acts of the grant recipient as both are under the
direction and control of the grantee institution and subject to the institution’s medical and scientific
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policies. Grantee institutions must safeguard the rights and welfare of individuals who participate as subjects
in research activities by reviewing proposed activities through an Institutional Review Board, as specified
by the National Institutes of Health Office for Human Research Protections, US Department of Health and
Human Services. These policies apply to applicants and applicant institutions as well. Finally, a timetable for
completion of the various phases of the trial should be presented.
A procedure or plan for data management should be described, including data collection forms, if available.
Data analysis methodology linking the analyses to the hypotheses to be tested should also be included.
Primary and secondary end points should be clearly defined, justified, and related to the power calculations.
Evidential Enclosures:
Enclose letters of commitment from each participating center, signed by the cooperating investigator and
business official. In addition, informed consent forms and evidence of Human Studies approval from all
participating centers should be included in this section.
Curriculum Vitae:
Biographical sketches of all key investigators, center directors, and multidisciplinary team members should
be included.
Facilities:
Clinical, data management, and laboratory facilities should be described in detail for all participating
institutions, where applicable.
Budget:
A total overall budget and a complete justified budget for each year of support should be presented. This
program is designed for pilot grants that have a maximum of two years support. If the trial is designed for
more than the two-year period, complete justified budgets for the future years and a plan for securing funding
for additional year(s) must be included. If the study involves multiple centers, a composite matrix should be
submitted, where applicable. If parts of the costs of the total trial are to be provided by sources other than
the Foundation, these contributions should be presented in detail along with supporting letters from
appropriate and responsible individuals. Additional budget information will need to be submitted as
attachment(s). These forms need to completed and uploaded in the attachment section provided. The forms
can be found in the form section of the Foundation web site.
SUBMITTING FOR A YEAR 2 COMPETING RENEWAL
The Crohn’s & Colitis Foundation has established a new submission process, to request for a Year 2
Competing Renewal. The Fall 2019 Cycle began the usage of a formal submission that includes a
proposalCENTRAL mechanism to make your request.
This is open to all active awardees who have completed their Year One milestones, but is not relevant to
Litwin IBD Pioneer Awardees who already have Year 2 Funding. Previous Year 2 requests that were rejected,
and converted to no cost extensions can resubmit a renewal request using this opportunity.
A Year 2 Competing Renewal application can be submitted if you have met the year 1 milestones.
If you are ready to apply, please make a request to the Grants Team,
litwinrenewals@crohnscolitsfoundation.org for an invitation to the submission portal. Renewal requests will
no longer be accepted, as an upload in your proposalCENTRAL profile.
Following the directions of the online submission, please include a copy of the original funded Litwin proposal,
progress report, detailed budget, budget justification and etc.
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REVIEW PROCESS
1. Review of LOIs
LOIs are reviewed upon submission for innovation, conformity with the goals of the program and potential
scientific and clinical impact. If approved for full proposal application, suggestions to improve the application
may be included.
2. Peer Review of Applications
The Litwin IPB Pioneers award applications are reviewed by a grants review committee. The review committee
is composed of basic, translational, clinical IBD researchers and lay stakeholders from a variety of fields. The
committee generally has between 15-20 members; leaders in their areas of expertise and several stakeholder
reviewers. In addition, ad-hoc members may be added in order to provide expertise in certain area(s),
depending on the composition of topics of the submissions. Each application is assigned a primary and
secondary reviewer (and when necessary, a tertiary reviewer). Many members of the review committee have
held this award in previous years.
Reviewers are required to prepare a written evaluation of the application, addressing the following
Selection Criteria:
• Overall Impact: All research supported by the Foundation must examine aspects of and have a direct
application to Crohn's disease and/or ulcerative colitis. It is the applicant's responsibility to explain the
relevance and innovation of the proposal to IBD and specifically to the Litwin IBD Pioneer objectives and
the Foundation’s Challenge Area priorities.
• Research Plan: This includes excellence of hypothesis, experimental design, and the likelihood of the
proposed research to produce significant new information that will improve management of IBD
patients.
• Excellence of Investigator and Research Environment: Investigator qualifications to be examined are
scholastic background, research experience, achievements and publications, as well as their potential
to successfully accomplish the aims of the proposal. Environmental criteria include availability of
appropriate space and equipment, consultants, etc.
Members of the review committee meet to discuss and vote to either discuss or not discuss the application.
If approved, the application is then ranked by each committee member, using a scoring system identical to
that previously used by the National Institutes of Health: 1.0 being the highest ranking and 9.0 the lowest.
3. Review by Grants Council
Those projects in the fundable range are examined and ranked by the Grants Council in respect to the
Foundation's goals, as outlined in the document, "Challenges in IBD” (see Scope section above).
4. Board of Trustees Approval
Following the Grants Council meeting, the Chief Scientific Officer of the Foundation presents the Grant
Council’s recommendations for funding at the next meeting of Board of Trustees. The Foundation’s Board
of Trustees, with input from the National Treasurer and President regarding budgetary constraints for
the fiscal year, then approves the payment of grants.
STATEMENT OF COMMITTEE IMPARTIALITY
To ensure that the peer review process undertaken by the Foundation's grants review committees is fair and
unbiased, the following procedures are in place:
1. An Ad Hoc Review Committee is set up to review any of the following:
 Application submitted or supported by a Litwin IBP Pioneers Committee member or their trainees.
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 The Applicant mentored by a Litwin IBD Pioneers Grant Review Committee member/chair in the last
five years.
 Are you a key personnel/collaborator on this proposal?
2. If a member of committee answered "yes" to any of the following, it is considered a conflict and must not
participate in the evaluation of that application (MUST leave the room).
• Have you and the applicant worked at the same institution in the last three years?
• Have you collaborated with the applicant in the last three years?
• Have you co-authored/published a publication in the last three years?
• Are you a former fellow/mentor for the applicant?
• Are you and any key personnel on the application (> 5% effort) currently at the same
institution, collaborating, and/or in a fellow/mentor relationship?
• Do you have any other conflicts reviewing this application?
Each committee member reviewer must certify that to the best of his or her knowledge he/she has disclosed
all conflicts of interest that he or she may have with the applications; he or she fully understands the
confidential nature of the review process and agrees to the following:
• To destroy or return all materials related to it;
• Not to disclose or discuss the materials associated with the review, the evaluation, or the review
meeting with any other individual.
• Not to disclose procurement information.
• To refer all inquiries concerning the review to the chairperson or Foundation staff.
• To review the Foundation “Guidelines for Maintaining Research and Peer Review Integrity”
Taken together, these steps attempt to avoid any obvious conflicts of interest among members of
the committee. For full information regarding the peer review integrity policy of the Crohn’s & Colitis
Foundation, please refer to the policy at the following link:
https://www.crohnscolitisfoundation.org/science-and-professionals/research/pdfs/guidelines-for-
maintaining.pdf
NOTIFICATION
An award notification or rejection letter will be sent to the applicant advising him/her of funding or non-funding.
A detailed critique summarizing the committee's deliberations will also be provided to the applicant.
Applications that are not funded may be revised and resubmitted. However, only two resubmissions are
allowed. Resubmitted applications will be reviewed in the same detail and compete on an equal basis with all
other new applications (see instructions for resubmissions.) The award letter will include individualized
milestones for the award that will outline progress toward the goals and Aims that are necessary for second
year renewal.
ADDITIONAL AWARD POLICIES AND REPORTING REQUIREMENTS
Final Scientific Report
The final Scientific Report, a brief summary of progress toward the achievement of originally stated aims, is due
90 days after the end of the project.
Financial Reports
Annual financial reports will be due three months after the end of each project year. For example, annual finance
reports for awards beginning on January 1 will be due on April 1. Annual financial reports for awards beginning
on July 1, will be due on October 1. Annual reports should contain the all expenditures from the previous year.
The final financial report will include all expenditures for the entire length of the project. Please use template
provided via proposalCENTRAL.
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Signatures of the Principal Investigator and the institution’s financial officer are required on this report. Any
unexpended funds must be returned to the Foundation upon termination of the project. Final payment will be
held until receipt and approval of final reports.
Policy on return of funds
Unspent balances at the end of the project of up to $100 (one hundred dollars) can remain at the awardee
institution and be allocated to support the PI’s research efforts.
Unspent balances at the end of the project of more than $100 (one hundred dollars) must be returned in full to
the Foundation.
Payment Schedule
Payments will commence after award execution. The first payment of the year one budget (50% of the budget
period award) will be released once the award is activated. The second payment (the remaining 50%) will be
made six (6) months later. Year two payments will follow the same payment schedule after the receipt and
approval of the annual progress report. Year three payments will follow upon satisfactory approval of the annual
progress report. Year three payments will begin with 50% of the award paid initially, 30% of the budget period
released after six (6) months and the final 20% will be released upon approval of the final progress reports.
Budget changes recommended by the review committee, if any, are included within the award letter.
Payments may be made via electronic transfer. Acknowledgement of payment by the grantee institution is not
required. We require a banking letter from the awarded institution at time of acceptance.
Personnel compensated in whole or part with funds from the Foundation are not considered employees of the
Foundation. Institutions are responsible for issuing the appropriate IRS tax filings for all individuals receiving
compensation from the Foundation and are responsible for withholding and paying all required federal, state,
and local taxes with regards to such compensation. Thus, these and any other tax consequences are the
responsibility of the individual recipient and grantee institution.
Institutions must maintain separate accounts for each grant, with substantiating invoices available for audit by
representatives of the Foundation. The Foundation is not responsible for expenditures made prior to the start
date of the grant, or if the complete budget is expended prior to quarterly payments or any expenditures that
exceed the total amount of the award. The Foundation will follow the payment schedule outlined in the award
letter. Please refrain from sending invoices to the Foundation from the institution as these will not be paid in the
manner they are received.
The Foundation research grants are not designed to cover the total cost of the research proposed nor the
investigator’s entire compensation. The grantee’s institution is expected to provide the required physical facilities
and administrative services normally available in an institution.
Policy on no-cost extension
In the event the research is delayed, an extension is required and a no-cost extension request form and
documentation must be e-mailed to postaward@crohnscolitisfoundation.org no later than 60 days before the
end of the project period. This request must be made on institutional letterhead and signed by both the PI and
the Institutional Official.
Multiple no-cost extensions may be considered based on the research involved.
Please ensure that annual progress and financial reports have been uploaded in proposalCENTRAL before
submitting a no-cost extension request, as requests will not be considered for awards with outstanding required
reports.
The no-cost extension request form and instructions are available on the Foundation’s website.
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Request for leave will be handled on a case-by-case basis.
Policy on publications and award acknowledgment
Publications resulting from research activities supported by the Foundation should contain the following
acknowledgement:
Supported by the Crohn’s & Colitis Foundation, award number xxxxxx, project title xxxxx.
The Foundation’s support should also be acknowledged by the awardee and by the awardee institution in all
public communication of work resulting from this grant, including scientific abstracts (where permitted), posters
at scientific meetings, press releases or other media communications, and Internet-based communications.
The Foundation shall receive timely and prior notice of any publications based upon the funded research and a
copy of the publication should be uploaded onto the award record in proposalCENTRAL.
Policy on patents and intellectual property
It is understood that submission of a proposal for funding consideration indicates that both PI and Institution
are informed of and agree with the Foundation’s Patent and Intellectual Property Policy, available for
download on the Foundation’s website. Awards are made with the understanding that the Foundation will
receive written notification of the filing of any letters of patent for any discovery made based on work funded
by the Foundation.
THE FOUNDATION PATENT AND INTELLECTUAL PROPERTY POLICY
All inventions or intellectual property (“Property”) that results from research supported, in whole or in part, by
grant awards from the Foundation must be reported in writing at the earliest possible time to Foundation. The
grantee institution agrees to notify the Foundation within a reasonable time, preferably within 30 days, of
receiving an invention disclosure or other notice indicating existence of a Property and to notify the Foundation
immediately of the decision to apply for letters of patent or other legal protection for the Property. The
Foundation agrees to keep all information confidential and not to release any information relating to such
inventions, intellectual property or applications for protection to any third party, except as specifically set forth
below or upon written agreement with the grantee institution, which consent cannot be unreasonably withheld.
All patenting expenses or intellectual property application expenses shall be borne by the grantee institution.
Title to all Property shall reside with the grantee institution to the extent that such title is claimed by the
institution under its institutional patent policy or procedure. If a grantee institution has no established
institutional patent policy or procedure for administering inventions or intellectual property, or if the
institutional patent policy or procedure does not claim rights for the institution or individual inventor, then
Foundation shall have the right to determine the disposition of the Property rights in accordance with the
provisions set forth below.
Distribution of income derived from any Property, which might include equity disposition, shall be shared by
the grantee institution and the Foundation on mutually agreeable terms, such terms to be determined as soon
as practicable, preferably prior to any licensing or commercial exploitation of the Property, and in any event no
later than six months after first receipt of income. Such distribution shall be guided by the principle that the
Foundation’s proportion of the income shall be reasonably related to the Foundation’s proportion of support
for the research leading to the Property. The grantee institution agrees to notify the Foundation within a
reasonable time of beginning negotiations with potential licensees and to notify the Foundation upon execution
of any license or other agreement to commercialize the Property. The grantee institution will provide a copy of
the license or other agreement, or an excerpt of the financial terms relevant to the Foundation’s right to income
from the Property together with the name of the licensee, the subject matter
of the license and any other terms relevant to the foundation, including without limitation whether such
license is exclusive or nonexclusive.
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If any Property is made with or results from the joint support of the foundation and another organization, that
organization, the grantee institution, and the Foundation will confer, in good faith, to arrive at a mutually
satisfactory disposition of the Property rights guided by the principle that distributions of income be made
in proportion to each party’s contribution of support for the research leading to the Property.
No patent, patent application or other type of protection for a Property shall be abandoned without first
notifying the Foundation and giving the Foundation a reasonable opportunity to take title to the Property.
If grantee institution does not effectuate a license to Property within four (4) years from the date that such
Property is disclosed in writing through an invention disclosure or similar form to the grantee institution
by the principal investigator, then the Foundation shall have the right to introduce to the grantee
institution one or more bona fide potential licensees and the grantee institution shall enter into
good faith negotiations for license of the Property with such potential licensee(s). Upon consummation
of any such license, the Foundation’s introduction of the licensee to the grantee institution shall be counted
to the benefit of the Foundation in calculating its share of any income from the Property. The grantee
institution agrees that when it licenses a Property, it will use reasonable efforts to obligate the
licensee to exert its best efforts to commercialize or cause to be commercialized the Property as rapidly
as practical, consistent with sound and reasonable business practices and judgment, and reserve the
right to terminate the license upon a failure by licensee to do so. If the grantee institution relicenses any
Property, the Foundation shall be entitled to a share of any relicensed Property income according to the
principles set forth above.
The Foundation reserves the right to public acknowledgment for Property resulting from research supported by
the Foundation. However, the Foundation’s name and logo may not be used in association with any Property
without the prior written approval of the Foundation.
The Foundation shall have use of the Property without payment of royalties or license fees solely for the
use by the Foundation for its own intramural or public education purposes, but not for any of its grantee
institutions.
Awardees and grantee institutions are responsible for ensuring that there are no inconsistencies in their
consulting or business agreements that conflict with this policy.
Policy on award transfer
Recipients may transfer their grant from one institution to another. Projects that have been funded for six months
or longer will be administratively reviewed after full details of the new environment and budget have been
provided.
The change of institution request form and instructions are available on the Foundation’s website or contact
postaward@crohnscolitisfoundation.org.
Required:
A. Written authorization from the Signing Official at the new institution accepting the award
B. Letter of release from present institution relinquishing the award
C. Updated Address of PI and Organization
D. Signature page with PI and Institutional Official Signatures
E. Full details of the new environment and budget
F. New personnel – names, time spent on the award
G. Description of any changes to the original protocol
H. IRB certificate/research consent forms if applicable
I. A financial accounting from the present institution within 30 days of the transfer
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All the above documents must be received and approved by the Foundation before the award can be
transferred. An official letter will be sent to the awardee as soon as all transactions concerning this transfer
have been completed.
Payments to the new institution will not be sent until a final accounting and a check for any unexpended funds
have been received from the original institution and the transfer has been approved by the foundation.
Withdrawal of Application
Please advise the Foundation promptly, in writing, should you decide to withdraw your application for any
reason. Your letter should include your name, type of award, project title, reference number, and reason for
withdrawal.
Change of Address
Notify the Foundation in writing of any changes of address, email or phone number, following the submission
of an application.
For more post-award policies and requirements, please visit the Foundation’s website or send an email:
Website: http://www.crohnscolitsfoundation.org
Email: postaward@crohnscolitisfoundation.org
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