INSTRUCTIONSANDPOLICIES
Effective October 2017

Crohn’sColitisFoundation

NationalOffice

ResearchScientificProgramsDepartment

733ThirdAvenue, Suite510

NewYork,NY10017

Phone:646-943-7505

Website:

E-mail:

OUR MISSION:

TocureCrohn’sdiseaseandulcerativecolitis,andtoimprovethequalityoflifeofchildrenandadultsaffectedbythesediseases.

CONTENTS

Introduction...... 1

Objective...... 1

Eligibility/Restrictions...... 1

Completing the Application...... 2

Letter of Intent...... 3

Full Application...... 4

Summaries...... 5

Budget Period Detail...... 5

Budget Summary & Justification...... 6

Current & Pending Support...... 6

Organization Assurances...... 6

Attachments...... 7

Special Instructions...... 9

Review Process...... 10

Statement of Committee Impartiality...... 11

Notification...... 12

Budget & Policy Restrictions...... 12

Reporting Requirements...... 13

Foundation Patent & Intellectual Property...... 15

INTRODUCTIONANDSOURCE OFFUNDS

TheCrohn'sColitisFoundation(the Foundation) wasestablishedin1967tofindthecauseofand cureforCrohn'sdiseaseandulcerativecolitis,collectivelyknownasinflammatoryboweldiseases(IBD).Supportforourresearchprogramisprovidedbymembersandconcernedindividuals,corporationsandphilanthropicfoundations.

TheguidingmissionoftheFoundationistostimulateandencourageinnovativeresearchinthebasicbiomedicalandclinicalsciences,whichislikelytoincreaseourunderstandingoftheetiology,pathogenesis,therapy,andpreventionofinflammatoryboweldiseases.Collaborative effortsbetween basicscientistsandclinicians areencouraged.

Eachyear,theFoundationreceivesapproximately400requestsforLitwin IBD Pioneers, SeniorResearch,Training,and Studentsupport.Allproposalsaresubjectedtomultiplelevelsofpeerreviewthatidentifythemost meritorious andinnovativeprojectsforfunding.

OBJECTIVE

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
  • will improve diagnosis, therapy, or prevention of IBD.

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. Proposals related to translational science should have clear relevance to findings and observations in IBD patients.

APPLICANTELIGIBILITY\INDEPENDENCE

  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 Investigatorposition 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.
  3. There can be only one Principal Investigator for each proposal.

Eligibilityisnot restrictedbycitizenshiporgeography.

PROPOSAL ELIGIBILITY\RESTRICTIONS

  • The submitted research proposal must be in the field of inflammatory bowel diseases.
  • Only one proposal may be submitted for this award per submission date.
  • Applicants may not simultaneously submit the same or similar application for a Senior Research, Career Development, or Research Fellowship Award.
  • Successful applicants may not hold concurrent Foundation awards; however, applications for new projects may be submitted six months prior to the termination of an awardee’s current grant.

1

COMPLETINGTHEAPPLICATION

DeadlineandSubmissionRequirements

The Foundation usesProposalCentralsystem, byAltum, forallofitsapplicationsubmissions.

Eachapplicantneedsto submitaletterofintent(LOI)priortosendinga fullapplication.TheLOIis reviewed competitively and only those approved are invited to submit a full application.Theletterofintentismandatoryforallnewapplications.Resubmissionsdonotrequirealetterofintent.

LOIs can be submitted throughout the year, with two 8-week blackout periods just prior to the semi-annual deadlines for full applications. Decisions on the LOI are made within four to six weeks. If the decision falls after the deadline for submission of the full grant application, or the grant applicant does not have sufficient time to prepare a full application to meet the grant-filing deadline, then the full grant applicationmay be submitted and reviewed in the subsequent review cycle.IfyourLOIisapproved,youwillreceiveane-mailwiththelinktosubmitafullapplication.ApplicationsshouldbesubmittedonProposalCentralbythe duedatesindicatedbelow. You will also be notified if an LOI is declined or a revised application is requested.

Ifyouhavequestionsregardingtheelectronicprocess,contactthe Foundation byphoneat646-943-7505orviaemailat.

ApplicationTimetable

Letterofintent toapplydue / Ongoing / Ongoing
Blackout Date: No LOIs accepted / December 1 – January 13 / May 1 – June 30
FullOnlineApplicationdue / January14* / July1*
Review / April - June / November -December
Boardof Trustees / April - June / November -December
Start Date / July1 / January1
ProgressReportDue / April 1 / October1

*Shouldthedeadlinedatefallonaweekendornationalholiday,thesubmissiondeadlinewillbeextendedtothefollowingbusiness day.

GrantsDepartmentContactInformation

Foranyquestionsor concernspleasecontact theFoundationGrantsDepartment:Telephone: 646-943-7505; Email: .

*Pleasenotethat theremaybe a delayinresponsesclosetotheapplicationdeadlinesduetothehighnumber ofapplicant correspondence.

1

LETTER OF INTENT

(Stage1 of the application process)

EachapplicantmustsubmitaLetter ofIntent (LOI) priorto sendingafullapplication.The LOI ismandatoryfor allnewapplications.Resubmittedapplicationsor applicants to the BMRP whose previous LOI has already been approved donotrequire aletterofintent. Thoseintending toresubmit anapplicationorbypasstheLOIstageshouldsendnotification ncludingthetypeofapplicationthatwillberesubmitted,previoussubmissioncycle,and thePI'sfullnameandemailaddress.

Reviewers of Letters of Intent are asked to comment on the following items

  1. scientific strength of the proposal
  2. innovative nature of the ideas
  3. strength of the Principal Investigator and scientific environment
  4. suggestions that would improve the project and its chances of helping patients with IBD

ChallengesPriority

Donorsfrequently haveaninterestinfundingparticular typesofIBDresearch.PleasecheckonePriorityAreathat isaddressedby yourproject.

TypeofDisease

Selectoneofthefollowingoptions:

  • Crohn’sdisease
  • Ulcerativecolitis

EligibilityQuiz

You are required to complete an eligibility quiz. These questions are included on the Title Page of the LOIsubmission site. Your answers will determine if you are eligible for aLitwin IBD Pioneers award and if you can continue with the LOI process.

Principal Investigator (PI)

PIisdefinedastheonepersonresponsible totheFoundationfor scientificandtechnicaldirection oftheproject.

OrganizationInformation

Thisindicateswhere thePIislocatedand wherethestudy will take place.

Abstract

Space limitation 250 words.

ProjectTitle

Fillin the project title.Donot useabbreviationsunlessabsolutelynecessary.

ScientificSummaryof 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. Space limitation 3 pages.

Relevanceofthe ProjecttoIBD

Provideadescriptionofhowthisprojectisclinically relevant, benefits patients with IBD and can be readily translated to improve the care of human IBD in the near future. Space limitation 1/2 page.

Note: Stakeholderreviewersactivelyparticipateasvotingmembersinthe peer-reviewprocess.Theseindividualswilllookspecificallyfor therelationofthestudyto IBD.It isthe applicant’sresponsibilityto clearlydescribetheseaspects ineasilyunderstandablelanguagefor the stakeholderreviewers.Failure to dosomay resultin a lower recommendedpriorityscore.

Attachments

Pleaseupload thefollowing tothissection:

  • NIHBiosketch/CV
  • References cited in application

FULLAPPLICATION

(Stage 2 ofthe applicationprocess)

Thefull applicationisdueoneitherofthefollowingdeadlines:July1 orJanuary14.Access to theelectronicversionwillbeclosedby5:00pmEToneither deadline.

Copiesofthefullapplicationmust besubmittedvia theProposalCentralsystem. TheFoundation is nolongeracceptingpaper copiesof theapplication.

Note:Nosupplementalmaterialswillbeacceptedafter thesubmissiondeadlineunlessrequestedbystafffor administrativepurposesor requestedbythe reviewersforclarification.

Eachsection oftheonlineapplicationislisted below:

TITLEPAGE

ProjectTitle

Fillinprojecttitle. If thisisaresubmission, thetitleshouldbethesameastheoriginalapplication.

ChallengesPriority

Donorsfrequently haveaninterestinfundingparticular typesofIBDresearch.PleasecheckonePriorityAreathat isaddressedby yourproject.

APPLICANT/PI

Principal Investigator

PIisdefinedastheonepersonresponsible tothefoundationfor scientificandtechnicaldirectionof theproject.Althoughco-PIsarepermitted,only one PIcanbeindicatedasthemainpoint ofcontact.

OrganizationInformation

Thisisthelocationofwhere the leadPIislocatedandwherethestudywilltakeplace.

INSTITUTIONANDCONTACTS

GrantAdministrationInformation

Intheeventanawardismade,providethenameandaddressoftheperson,atthegranteeinstitution,whowilladministerthegrant.

KEYPERSONNEL

Pleasenoteanykeymembers ofthisprojectsuchascollaborators, mentors, etc.

SUMMARY

LayAbstract/GeneralAudienceSummary

Yourlaysummary shouldbe aclear, conciseoverviewinsimplifiedlanguage,appropriatefornon-scientificreviewers.Youneedtoprovideenoughessentialinformationthat the stakeholderreviewerswillbeableto evaluateyourapplication.The laysummaryshouldinclude thefollowinginformation:

  • Whatquestionwillthisproject attempt toanswer?
  • Whyisthisquestionimportant toIBD?
  • What isthestudydesign?
  • Howdo the hypothesisandspecificaims fit withthe Foundation’sscientificpriorities?
  • Will thisresearch,ifsuccessful,improve the care of human IBD in the near future?Ifso, howwillthisproject doso?

Alsoinclude a brief glossary ofanyscientifictermsincludedinyourlay summary.

Space limitation 1/2 page.

ScientificSummaryof Project

TheScientificSummaryshouldprovide a clear,conciseoverviewoftheproposedwork,includingthebackground, objective,orhypothesisanditssupportingrationale; specificaimsofthe studyfor generalscientificaudience.

Space limitation 1/2 page.

Relevanceofthe ProjecttoIBD

Provideadescriptionofhowthisprojectisexplicitlyclinically relevant, benefiting patients with IBD, and readily translatable to improve the care of human IBD in the near future.

Space limitation 1/2 page.

Theabovethreesectionswillbeevaluatedaspartofyourapplicationaswellasusedtoinform theFoundation’sNationalBoardof Trusteesandthegeneralpublicof thenatureof thiswork;therefore, donot includeproprietaryorconfidential information.

BUGETPERIODDETAIL

ProjectStartDate

Include the date on which youexpect to start thisproject.Fundedapplicationsfor thespringcyclewouldbeginonJuly1.Fundedapplicationsin thefallcycle wouldbeginonJanuary1ofthefollowingyear.

EstimatedLengthofProject

Howlongitwill take you to completethework.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.

PercentageEstimationofAmountofTimeAllocated tothisProject

Describehowyourtime(inpercentages) isallocatedinyourcurrentpositionat thisinstitution.

PercentageofFringeBenefitsPaidbyYourInstitution

What is the percentage (of your salary) paid by your institution for fringe benefits, such as medical insurance, etc.

DetailedBudget PagesforYear1*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. There is no fixed upper or lower limit of funding, but awards are generally not funded above $130,000, including 10% direct costs.

Completethee-form total budget for firstyear.

  • PI Title ofPosition-Hisorherofficialtitleat institution
  • PIDirectCosts
  • PIIndirect Costs

BUDGET SUMMARYANDJUSTIFICATION

Pleaseprovidejustificationastothe amountofsupport requested.

CURRENTANDPENDINGSUPPORT

CurrentFinancial Support

Ifyouhavecurrent financialsupportfor thisproject, typeintothetextboxthename oftheinstitute/groupthatfundsthisresearch.

PendingApplications

Ifyoudonot haveany currentpendingapplicationspleaseleaveblank.

Ifyoudohavecurrent pendingapplications, typein thetitle oftheaward(s) andthe nameoftheagencyfromwhichyouareawaitingaresponse.Inthe attachment section,attachanabstractfor eachapplicationyoulistinthissection.

It isthepolicy ofthe Crohn’sColitisFoundationnot tofundprojectsthat aresupportedallorinpart byanother agency. Thismeansthatprojectsareconsidered tooverlapifthereareanysharedSpecificAimsorareasofbudgetaryoverlapor percentofeffortdedicated tothe other project.The PeerReviewCommitteewill makethefinaldecisionregardinganyquestionsofoverlap. Theonlyexceptionsare: institutionalsupport.Uploadasanattachmentinthe“EvidentialEnclosure” a descriptionofanyinstitutionalsupportprovidedby yourinstitution. ThedetailsshouldincludeInstitutionalcommitment tothesupportof theapplicant’ssalary;andthecurrent term ofthe applicant’sappointment.Pleasenotethat theinstitutionalsupport doesnot decrease thechances ofobtainingsupport from the Foundation,rather, suchsupportisfrequentlyconsideredbythePeer ReviewCommitteeasimportant evidenceforinstitutionalcommitment tothe proposedresearchproject.

ORGANIZATIONASSURANCES

Human/AnimalStudiesApproval

Allactivitiesinvolvinghumansubjectsorvertebrateanimalsmust beapprovedbyanappropriateinstitutionalreviewboard(IRB)orequivalentprior tothestart dateofaward.Indicatewith“Yes”or “No”response. Ifyes,indicatedateofapprovalandattachapprovalinthatAttachmentsSection.

CopiesoftheIRB approvalshouldbeprovided totheFoundationResearch Department. Ifapprovalisnotavailableatthetimeofapplication,provide a date ofanticipatedapproval. Allrequiredassurancesmustbereceivedbeforethestart dateof theapprovedgrant.

ATTACHMENTS

ResearchPlan/Protocol*Required

Thedescriptionoftheproposedresearchprojectmust include thefollowingitemsinsufficient detail topermit evaluationofthescientificmerit ofthe study.Thiscannotexceed6pages, singlespaced.Thelengthsindicatedbelowareincludedasa guidelineandnot required. Applicationsexceeding the pagelimitmaynotbereviewed.

  1. OverallObjectives(oneor twoparagraphs)
  • Brieflyoutline thegeneralscientificobjectives
  1. Specificaims(nomorethan 1/2page)
  • Describeconciselyandrealisticallywhatthe specificresearchdescribedinthisapplicationisintendedtoaccomplish.Specificallyoutlineaims foryear1 andyear2 (if applicable),andgoals,deliverables,andtimelines.Stateanyhypothesesto betested.
  1. Background-includingpreliminarydata(nomorethan2pages)
  2. Outlinethepreviousworkintheareabyothers,andthepreliminarydataorpreviousstudiesbytheinvestigator(s). Preliminary data are not required for an application submission.
  3. Ifthisisarenewalapplication,includeacopyofyourmostrecentProgressReporthere(ProgressReport isnot countedaspartofthesixpages).
  4. Detaileddescriptionof methodsandmaterialstobeused(nomorethan3pages)
  5. Provideadetaileddiscussionoftheexperimentaldesign,procedures,andmaterialstobeused toaccomplish theSpecificAims.
  6. Describeprotocols,includingmethodsfornewtechniques,andexplaintheadvantagesoverexistingmethodologies.
  7. Discussthekindsofdataexpectedtobeobtainedandthemeansbywhichdatawillbeanalyzedandinterpreted.
  8. Justifytheuse ofanyanimalmodels(i.e.,choiceofspecies,number used,etc.).
  9. Discusspotentialdifficultiesand/orlimitationsoftheproposedproceduresandalternativeapproachesto achieveaims.
  10. Significanceandrelevanceoftheproposedresearchto Crohn'sdiseaseand/or ulcerativecolitis(nomorethan1/2page)
  • Justifythesignificanceoftheresultsofthisprojecttoadvancing IBD diagnosis, therapy, or prevention.Specificallyidentifythegaps and/or pioneering approachesthisprojectisintended tofill.
  1. FacilitiesAvailable to carryout the ProposedStudies(oneor twoparagraphs- not included in overall 6 page limit)
  • Describethefacilitiesavailable,includingsquarefootage,equipment,animalcarefacilities,andotherenvironmentalfactors.Payparticularattentiontothoseitemsrequiredforsuccessfulcompletionofthisproposal.Include adescriptionfor eachfacilityto be involved.
  • Pertinent ReferencesLiteraturecitationsshouldbelistedinthissection,at the end ofthe ResearchPlan.***Thesearenotcountedaspart ofthe 6-pagelimit.

FormattingtheApplication

Applicantsmustadhereto thefollowinginstructionsincompletingthe proposalsectionsthat makeuptheelectronicversionoftheapplication.

  • Pleaseremember to insert your nameinthe headeroneachformintheattachment section.
  • Fontsize:Use12-point TimesNewRomanor11-pointArialastheminimum font size forthetext ofthe application. A 10-pointTimesNewRomanor 10-pointArialfonttypemaybeusedfor figures, legends,andtables.
  • Single-spacedtextisacceptable,andspacebetweenparagraphsisrecommended.
  • Margins:Themarginsof your text shouldbeat least1”allaround,unlessaform withdifferentmarginsissuppliedintheApplicationTemplatesorForms.

ResubmissionMaterial *Requiredifa Resubmission

Pleasefollowtheseguidelineswhenresubmittinganapplication:

  • “Replyto PreviousReview”,letternotto exceedthreepages.The lettershouldclearlyandsuccinctlyaddressthe pointsraisedinthe previousreviewanddirect the reviewerto thespecificsectionsofthe Research

Protocolwhere revisionshavebeenmade.

Revisedportionsofthetextchangedinresponsetothereviewers’comments shouldbehighlighted(e.g.: boldtype, linein themargin,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.

Includecopiesofthefollowing:

  • Critiques(SummaryStatement)of theoriginalapplication
  • Budget pages ofpreviousapplication
  • OverallobjectivesandSpecificAims ofpreviousapplication

Previouslysubmittedmaterialisnotconsideredpart ofthethree-pageresubmissionmateriallimit.

Lettersof Collaboration

Attachsupportingletter(s).

Applicants’CV or NIHBiosketch*Required

AttachtheCV or NIHBiosketchfortheapplicant. Limit CV to 10 pages. A five-page NIH Biosketch is preferred.

References/Appendices-Optional (part ofAttachmentssection)

Uploadedreferencematerialmayinclude,butnot limitedto:

  • Articlereferences
  • Abstracts
  • Originalpictures
  • OtherLetters ofSupport

Humanand/orAnimal Approvals-Optional

UploadIRBapprovalsforhumanandanimalresearch

NewVendor FormandW9 *Required(partof Attachmentssection)

Complete sothat,inthe eventofaward, theinstitutioniseligible toreceivepayment from the Foundation.Thisdocumentshouldincludethename ofinstitutionaslistedontheW9aswellasanattachedW9forreference.Thisisrequiredevenifinstitutionhas receivedFoundationfundinginthepast.

VALIDATEANDSIGNATUREPAGE

Oncetheapplicationisvalidated,youcansubmitthe application.Thesignaturepageisnot requiredbytheFoundationandshouldbeprintedonly ifyoudesireforyourpersonalrecords.

SPECIALINSTRUCTIONS

Applicantsfallingintoanyof the followingcategoriesshouldreadthe"SpecialInstructions"sectionpertaining tothem beforeattemptingto completetheapplication:

  • ForeignApplicants
  • ClinicalTrials

Special Instructionsfor ForeignApplicants

  • Completebudget request must beinU.S. dollars -WewillNOTconvert.
  • Pleasebeawarethatyoushouldgivemoredetailsthanyoumightbeaccustomed,especiallyintheareasofbackgroundmaterialandpreliminarydata,experimentaldesign,andavailablefacilities andbudgetaryitems(in particular,percent ofeffortandsalaryrequestsforkeypersonnel).

***ALLMATERIALSANDREPORTSMUSTBE IN ENGLISH.
FAILURETODO SO WILLRESULT INAREJECTEDAPPLICATION.

Special Instructionsfor Clinical Trials

TheResearchPlanwillneedtoincludeeverythingrequiredintheApplicationPreparationsection,plusthefollowinginformation:

Specific Aims:

Theseshouldincludeadelineationoftheprimaryandsecondaryendpointstobemeasuredwithanappropriateexplanationoftherelativeimportanceofthevariousendpoints.

Significance:

Theapplicationshouldclearlystatetheneedforthestudyandhowtheresultswouldimpactontheprevailingpracticeinthisarea.

ExperimentalDesign andMethod:

Theinclusionandexclusioncriteriashouldbelisted,andtheprocedure(s)tobeutilizedforassignmentofpatientstoexperimentalgroupsshouldbedescribed.Thestudydesignfortheinterventionstobeusedshouldbepresentedindetailincludingtherationalefortheparticulardesignchosenandprocedurestoassurecompliancewithandimplementationoftheproposedprotocol.Potentialbiasesintheproposedprotocolandhowthey willbeaddressedshouldbepresented.

Clinical,laboratory,andphysiologicaltests shouldbedescribedincludingmethodsofrandomization.Finally,assumptionsandcalculationsto arriveat theproposedsamplesizeshouldbeincluded.

Theavailabilityofpatientsforthe proposedstudy,includingthe specificcharacteristicsthatarerequired forthegroupshouldbepresented.Approachesshouldbeoutlinedthatwillbeusedfortherecruitment,retention,andfollow-upoftherequirednumberofpatients.Datashouldbepresentedsupportingrecruitmentandretentionestimates.Plansshouldbedescribedforpatientprotection,includinginformedconsent,monitoringofdataforsafety,andearlytermination,asrequired.Appropriateinformedconsentformsfromallparticipatinggroups(centers)shouldbeincluded as an attachment, not subject to space restrictions.Projectedratesofpatientenrollmentshouldbeincluded.Ifenrollmentfallsbehindprojectedlevels,fundingmaybedelayedorterminated.

Theorganizationofthestudyandhow thetrialwillbemanagedshouldbedescribed,includingthe functionofanyinternalorexternaladvisorycommitteesandanydataandsafetymonitoringgroups.Inmulticentertrials,youshouldprovideadescriptionoftheresponsibilityandroleofadatacoordinatingcenter,andpoliciesandmethodsconcerningblindingofstudyresults.Accordingly,aplanshouldbesubmitteddescribingtheprocedureforthecoordinationofallparticipatingcenters.TheFoundationdoesnotassumeresponsibilityfortheconductoftheactivitiesthatthegrantsupportsortheactsofthegrantrecipientasbothareunderthedirectionandcontrolofthegranteeinstitutionandsubjecttotheinstitution’smedicalandscientificpolicies.GranteeinstitutionsmustsafeguardtherightsandwelfareofindividualswhoparticipateassubjectsinresearchactivitiesbyreviewingproposedactivitiesthroughanInstitutionalReviewBoard,asspecifiedby theNationalInstitutesofHealthOfficefor HumanResearchProtections,USDepartmentofHealthandHumanServices.Thesepoliciesapplytoapplicantsandapplicantinstitutionsaswell.Finally,a timetableforcompletionofthevariousphasesofthetrialshouldbepresented.

A procedureorplan fordatamanagementshouldbedescribed,includingdatacollectionforms,ifavailable.Dataanalysismethodologylinkingtheanalysestothehypothesestobetestedshouldalsobeincluded.Primaryandsecondaryendpointsshouldbeclearlydefined,justified,andrelatedtothepowercalculations.

EvidentialEnclosures:

Encloselettersofcommitmentfromeachparticipatingcenter,signedbythecooperatinginvestigatorandbusinessofficial.Inaddition,informedconsentformsandevidenceofHumanStudiesapprovalfromallparticipatingcentersshouldbeincludedinthissection.

CurriculumVitae:

Biographicalsketchesofallkeyinvestigators,centerdirectors,andmultidisciplinaryteammembersshouldbeincluded.

Facilities:

Clinical,datamanagement,andlaboratoryfacilitiesshouldbedescribedindetailforallparticipatinginstitutions, whereapplicable.

Budget:

Atotaloverallbudgetandacompletejustifiedbudgetforeachyearofsupportshouldbepresented.This program is designed for pilot grants that have a maximum of two years support. Ifthetrialisdesignedformorethanthetwo-yearperiod,completejustifiedbudgetsforthefutureyearsandaplanforsecuringfundingforadditionalyear(s)mustbeincluded.Ifthestudyinvolvesmultiplecenters,acompositematrixshouldbesubmitted,whereapplicable.Ifpartsofthecostsofthetotaltrialaretobeprovidedbysourcesotherthanthe Foundation,thesecontributionsshouldbepresentedindetailalongwithsupportinglettersfromappropriateandresponsibleindividuals.Additionalbudgetinformationwillneedtobesubmittedasattachment(s).Theseformsneedtocompletedanduploadedintheattachmentsectionprovided.Theformscanbefoundin theformsectionofthe Foundation website.

REVIEWPROCESS

Applicationsarereviewedinafour-stepprocess:

  1. Internal Review of LOIs

LOIs are reviewed upon submission for innovation, conformity with the goals of the program and potential scientific and clinical impact by the Director and internal scientific staff of the Crohn’s and Colitis Foundation. A decision will be reached within 4-6 weeks of LOI submission and conveyed to the applicant. Only approximately 50% of LOIS are approved for full grant submissions. If approved for full proposal application, suggestions to improve the application are included.

  1. PeerReviewofApplications
    The Litwin IPB Pioneers awardapplicationsarereviewedbyagrantsreviewcommittee.Thereviewcommitteeiscomposedofbasic, translationalandclinicalIBDresearchersinavarietyoffields.Thecommitteegenerallyhasbetween15-20members;leadersintheirareasofexpertiseandseveral stakeholderreviewers.Inaddition,ad-hocmembersmaybeaddedinordertoprovideexpertiseincertainarea(s),dependingonthecompositionoftopicsofthesubmissions. Eachapplicationisassignedaprimaryandsecondaryreviewer(andwhennecessary,atertiaryreviewer). Many members of the review committee have held this award in previous years.

Reviewersarerequiredtoprepareawrittenevaluationoftheapplication,addressingthefollowingSelectionCriteria:

  • OverallImpact:Allresearchsupportedbythe Foundation mustexamineaspectsofandhaveadirectapplicationtoCrohn'sdiseaseand/orulcerativecolitis.Itistheapplicant'sresponsibilitytoexplainthe relevanceand innovation ofthe proposalto IBD and specifically to the Litwin IBD Pioneer objectives.
  • ResearchPlan:Thisincludesexcellenceofhypothesis,experimentaldesign,andthelikelihoodoftheproposedresearchtoproducesignificantnewinformationthatwillimprove management of IBD patients.
  • ExcellenceofInvestigatorandResearchEnvironment:Investigatorqualificationstobeexaminedarescholasticbackground,researchexperience,achievementsandpublications, as well as their potential to successfully accomplish the aims of the proposal.Environmentalcriteriaincludeavailabilityofappropriatespaceandequipment, consultants, etc.

Membersofthereviewcommitteemeet todiscussandvotetoeitherapproveordisapprove.Ifapproved,theapplicationisthenrankedbyeachcommitteemember,usingascoringsystemidenticaltothatpreviouslyusedbytheNationalInstitutesofHealth:1.0beingthehighestrankingand9.0thelowest.

3.ReviewbyGrants Council

ThoseprojectsinthefundablerangeareexaminedandrankedbytheGrantsCouncilinrespecttotheFoundation'sgoals,asoutlinedinthedocument,"ChallengesinIBD".(Documentmaybefoundonthe“Science Professional”sectionat

4. BoardofTrusteesApproval

FollowingtheGrantsCouncilmeeting,theChief Scientific Officer of the FoundationpresentstheGrantCouncil’srecommendationsforfundingatthenextmeetingofBoardofTrustees.The Foundation’sBoardofTrustees,withinputfromtheNationalTreasurerandPresidentregardingbudgetaryconstraintsforthefiscalyear,thenapprovesthepaymentofgrants.

STATEMENTOF COMMITTEE IMPARTIALITY

Toensure thatthepeerreviewprocessundertaken bythe Foundation'sgrantsreviewcommitteesisfair and unbiased,the following proceduresarein place:

  1. AnAd HocReviewCommitteeis setupto reviewanyofthe following:
  2. Applicationsubmittedor sponsored bya Litwin IBP Pioneers Committeemember or their trainees.
  3. TheApplicantmentoredbyaLitwin IBD Pioneers GrantReviewCommittee member/chair inthelastfiveyears.
  1. Ifa member ofcommitteeanswered"yes" toanyof the following,itisconsidered aconflict andmustnotparticipateinthe evaluation ofthatapplication.(MUSTleavetheroom)
  • Areyouakeypersonnel/collaborator onthisproposal(<5%effort)?
  • Haveyouandthe applicantworkedatthesameinstitutionin the lastthree years?
  • Haveyoucollaborated withtheapplicantinthelastthreeyears?
  • Haveyouco-authored/publisheda publication inthelastthree years?
  • Areyoua formerfellow/mentorforthe applicant?
  • Areyouandanykeypersonnel on theapplication(5%effort) currentlyatthesameinstitution,collaborating,and/or ina fellow/mentor relationship?
  • Doyouhaveanyotherconflictsreviewing thisapplication?

Eachcommittee member reviewer must certifythat tothe bestofhisorher knowledgehe/shehasdisclosed allconflictsofinterestthatheor she mayhavewiththe applications;heor she fullyunderstandstheconfidentialnatureofthereviewprocessandagrees tothe following:

  • To destroyor returnallmaterialsrelatedtoit;
  • Not to disclose or discussthematerialsassociatedwiththereview,the evaluation,or thereviewmeeting withanyother individual.
  • Not to disclose procurementinformation.
  • To refer allinquiriesconcerning thereviewtothechairpersonorFoundation staff.
  • To reviewtheFoundation“Guidelinesfor Maintaining Researchand PeerReviewIntegrity”

Takentogether,thesestepsattempttoavoidanyobviousconflictsofinterestamongmembersofthecommittee.

NOTIFICATION

Anawardordeclinationletterwillbesenttotheapplicantadvisinghim/heroffundingornon-funding.Adetailedcritiquesummarizingthecommittee'sdeliberationswillalsobeprovidedtotheapplicant.Applicationsthatarenotfundedmayberevisedandresubmitted.However,onlytworesubmissionsareallowed.Resubmittedapplicationswillbereviewedinthesamedetailandcompeteonanequalbasiswithallothernewapplications(seeinstructionsforresubmissions.) 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.

BUDGETPOLICIESANDRESTRICTIONS

General Policies andRestrictionsfor Litwin IBD ResearchAward

  1. Funding can be requested for up to two years, but awards are funded only one year at a time. Budgets should be appropriate for the project's scope of work and absolute needs. There is no fixed upper or lower limit of funding, but awards are generally not funded above $130,000, including 10% direct costs. Awards are made payable to the institution.
  1. The awards are not meant to be a major source of a principal investigator's salary. The Foundation will pay a fraction of the PI's salary commensurate with the time allotted to the project.
  2. ThesalaryrequestforthePIshouldbefiguredasapercentageoftheNIHmaximumtotalbasesalaryor $187,000.
  3. Forexample: IfthePIplanstodevote10%efforttotheproposedproject,thesalaryrequestshouldbecalculatedat 10% of$181,100 or $18,700.
  1. It is theapplicant's responsibilityto justifythebudget.Itemsnotadequatelyjustifiedwill not besupported.
  1. Requests for major equipment purchases (over $5,000) are not generally considered. Any equipment purchased under a Foundation award is for the use of the Principal Investigator, his collaborators and/or other researchers or trainees involved in inflammatory bowel diseases research. Title to equipment shall be vested in the institution withwhichtheprincipal investigator is associated. In the event the Foundation authorizes the transfer of a grant to another institution, equipment necessary for continuation of the research project purchased with the grant funds may be transferred to the new institution. Title to such equipment shall be vested in the new institution.
  1. The Litwin IBD Pioneers award applicants and collaborators are required to document all current and/or pending support from other funding sources. In cases where the applicant has been awarded support, in total or in part, for the proposed project from other funding agencies, The Foundation reserves the right to examine the extent of overlap by reviewing the Specific Aims and Budget pages of the application to other agencies. In addition, the applicant must indicate how adjustments will be made in this support if a Foundation award is received.
  1. Policyon allowableindirectcostsfor subcontracts:Indirectcostsmaynotexceed10%oftheawardee’sdirectcosts.Iftheawardeesubcontractsanyportionoftheworktoanotherinstitution,theawardeeinstitutionmayrequestuptoamaximumof10%ofthefirst$25,000ofthesubcontract’sdirectcosts.Subcontractholdersmayrequestnomorethan10%oftheirproposeddirectcostsforindirectcosts.Theawardeeinstitutionisresponsibleforalloversightofthesubcontractandmustincludefinancialaccountingsforthesubcontract(s)intheyearlyfinancialreportrequiredonFebruary1ofeachyear,thecloseofthe Foundation’sfiscal year.

REPORTING REQUIREMENTS

ProgressReports

Recipientsof Litwin IBD Pioneers awards are required to submit a progress report, outlining their accomplishments on the research project during the first 10months of the award. The progress report must address milestones agreed upon in the funding letter for the award. If a PI wishes to seek continuation funding, funding for a second year is based upon a satisfactory progress report that will undergo peer review by the review committee.

FinalScientific Report

ThefinalScientificReport,abriefsummaryofprogresstowardtheachievementoforiginallystatedaims,isdue 90 daysaftertheendofthe project.