WSU Facultydmc Staffkci Staffoakwoodstaffother (Specify)

Instructions

Please submit this completedform, alongwiththe required attachmentsasinstructed.If thisrequest isapproved, the officewill return a .pdf copy, with signature,within 5-10 business days. Thisdocument must beincluded with your submission.If thisis strictlya changein keypersonnel, please complete sections #1,#3,#4, and #12 only.

PleaseselecttheExternalIRByouwishtoutilize
WIRB®
NCI CIRB*
Smart IRB**Participating Institution(specify): Other Institution(specify):
*If you selectedNCI CIRB above, please selectyour sitepreference(s) from the following: Wayne StateUniversity/ KarmanosCancer Institute (CIRB Signatory)...... MI020
DetroitMedicalCenter-HCC(CIRBAffiliate)...... MI053
HuronValley-SinaiHospital(CIRBAffiliate)...... MI127
WeisbergCancerTreatmentCenter(CIRBComponent)...... MI220 McLarenSite(s)………………………………………………..……..……specifySiteNumber(s):
**Alist ofSmart IRB participating institutionsisavailable atsmartirb.org
1.PrincipalInvestigator(PI),ProjectTitle,andEndorsements
Name of PI: / PISignature: / Phone:
Department: / Fax:
Division: / E-mail:
CampusAddress: / Pager:

2.StatusofPrincipalInvestigator(checkallthatapply)

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WSU FacultyDMC StaffKCI StaffOakwoodStaffOther (specify):

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3.FormCompletedBy:
Name: / Title:
Phone: / E-mail:

4.ProjectTitle

Title:

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5.SponsorandContactInformation
Sponsor: / Phone:
Contact Name: / Title:

6.Training

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All Investigators and other keypersonnelare required totake theWayne StateUniversityeducationaltraining program ontheProtection ofHuman Participantsfound at you, asPI,completed thistraining? Yes No

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7.EndorsementsandFinancialConflictofInterestDisclosure

Objectivity in researchis akeycomponent of any researchproject.One methodfor maintainingobjectivityistohaveall individuals involvedinthe researchdesign, development, or data evaluation/analysisdiscloseanypotentialand/or realfinancialconflict of interest.This includes allpersonnellistedinresponseto questions#1 and

#12.

Examplesofrelevant relationshipsforpotentialconflict of interest include but arenotlimitedto:

Receivingpast,current, or expectingfutureincome in theformofsalary; stock or stock options/warranties; equity;dividends; royalties; profit sharing;capital gain;forbearanceorforgiveness of a loan;interestin realor personal property; or involvement inalegalpartnershipwiththesponsor;

receivingpast,current, or expecting future income intheformof consulting fees; honoraria;gifts;giftstotheUniversity;or paymentsresultingfromseminars; lecturesor teachingengagements;or serviceona non-federaladvisorycommittee or review panel;

servinginacorporate or for-profit leadership position,suchas executive officer;boardmember; fundraisingofficer;agent; memberof ascientificadvisory board;member of ascientific reviewcommittee; or member of adatasafety monitoringcommittee, regardless of compensation;and/or

inventorona patent or copyright involving technology/processes/products licensed, orexpectedtobelicensedtothesponsor.

YoucanfindtheResearchConflictofInterestPolicyat

Ifany responsebelow is“yes”, there must bean “IndividualFinancialConflict of InterestDetailed DisclosureForm”submitteddirectlytotheFCOI Committeeprior tosubmissionof thisprotocol,andthen annuallyorwithin 30-days of anychangethatmay occur.Ifthisformisnotsubmitted,theprotocol cannotbeapproved.The form andmoreinformationareavailableat: additionalinformation, pleasecontact the ResearchComplianceManagerat313-577-1862 (office)or313-577-0384(fax).

PRINCIPAL INVESTIGATOR:

For studentsor individuals without aWSU faculty appointment, a WSU facultysupervisor/sponsor or authorized signatory (e.g., officialfrom DMC, KCI, etc.) isrequired.

Do you, your spouse or domesticpartner, and/ordependent children have a potential and/or realfinancial conflict of interest withthesponsor of this project (including all secondary sources)?

NOYES(ifyes,please includeWSU Memo of Understanding/Agreementto FCOIManagement Plan with thissubmission)

In signing the description ofthis research project, thePIagreesto accept primary responsibilityfor the scientificand ethical conduct of theresearch, as approved bythe IRB, and abide bythe IRB’spoliciesandprocedures. The project cannot beginuntil theInvestigatorhasreceived documentation or IRB review andfinal approval.

Signature of PrincipalInvestigatorPrinted nameTitleDate

DEPARTMENTCHAIR/DEAN or AUTHORIZEDSIGNATORY:

Do you, your spouse or domesticpartner, and/ordependent children have a potential and/or realfinancial conflict of interest withthesponsor of this project (including all secondary sources)?

NOYES(ifyes,please includeWSU Memo of Understanding/Agreementto FCOIManagement Plan with thissubmission)

In signing the description ofthis research project, theDepartmentChair, Dean, Institute/Center Director or other authorized Signatorycertifiesthat

(1) appropriate support willbe providedfor the researchproject, including adequate facilitiesand staff,and(2) appropriate scientific andethical oversight hasbeen, and will be, provided.

Signature of WSU DepartmentChair/Dean or Authorized Signatory Printed nameTitleDate

If PI isa student, or an individual without aWSU facultyappointment,the above signaturemust bethatof the Chair/Dean at WSU or authorized Signatory (e.g., officialfrom DMC, KCI,etc.).

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8.InvestigationalNewDrug(IND),InvestigationalDeviceExemption(IDE),HumanitarianDeviceExemption(HDE)
Doesthisstudy involvean IND application? / No / Yes / (if yes, IND# / )
Doesthisstudy involvean IDE? / No / Yes / (if yes, IDE# / )
Doesthisstudy involvean HDE? / No / Yes / (if yes, HDE# / )
Specifythename ofthe organization or individual who holdsthe IND/IDE/HDE, or select “Not Applicable”: / Name/Organization/IndividualholdingIND/IDE/HDE:NotApplicable
If the study does not yet have an IND/IDE number, please explain the FDA application status:

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9.AccesstoMedicalRecords
Will you obtainthe subjects’ authorization toaccesstheir health care records (containing PHI) during the courseof the study? / No / Yes / (ifYes, complete and include the WSU HIPAA SummaryForm)
Will you identify potential subjects by“pre” screening health carerecords without subjects’consent or authorization? / No / Yes / (ifYes, complete and include the WSU HIPAA SummaryForm)

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10.OtherComplianceConsiderations
Doestheresearchrequire anyof the following approvals?IfYes, must provide approval letter withthissubmission.
EmbryonicStemCellResearchOversight Committee (ESCRO) / No / Yes / (If“Yes” provide letter)
Institutional BiosafetyCommittee(IBC) / No / Yes / (If“Yes” provide letter)
Radiation Safety Committee(RSC) / No / Yes / (If“Yes” provide letter)
MaterialsTransfer Agreement (MTA) / No / Yes / (If“Yes” provide letter)
Detroit Medical Center (DMC) review / No / Yes / (If“Yes” provide letter)
KarmanosCancer Institute Protocol Review & MonitoringCommittee(PRMC) / No / Yes / (If“Yes” provide letter)
McLaren Health Care review / No / Yes / (If“Yes” provide letter)

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11.TransferInformation Hasthe WSUIRBdeclinedtoreview,tabled,deferred, disapproved, orterminatedthisresearchstudypriortosubmission?

NoYesIf“Yes”, complete the questionsbelow …

Please provide the IRB correspondence / Provided / N/A (If “N/A”, explain:)
Please fillout the IRBTransfer form posted at / Completed / N/A (If “N/A”, explain:)
Are there participantsenrolled in thisstudy? / Yes / No

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12.KeyPersonnelNEWSECTION
Brieflydescribe ALL other keyor studypersonnel* on the study,theirrole in the study, and disclose any potentialand/or real financial conflict of interest. If a response is“Yes”, a Financial Conflict of Interest Detailed Disclosure form must becompleted then submittedto theWSUFinancialConflictof Interest Committee.The FCOI disclosure form can befound at keypersonnelare required to take the Wayne StateUniversityeducationaltraining program ontheProtection ofHuman Participantsfound at
Pleasenotethat ANY change in Key Personnelmust be resubmitted (usingthisform) for administrative review.
Name: / Division/Department: / Research Role: / E-Mail Address:
This isan:AdditionDeletionIfaddition, do you, your spouseor domesticpartner, or anyofyour dependent children have a potentialand/or real financial conflictof interest withthe sponsor of thisproject (including all secondary sources)? Yes No Ifdeletion, nosignature needed.
Signature:IsCITITrainingup-to-date?Yes No(Mustbe completeprior to proceeding)
Name: / Division/Department: / Research Role: / E-Mail Address:
This isan:AdditionDeletionIfaddition, do you, your spouseor domesticpartner, or anyofyour dependent children have a potentialand/or real financial conflictof interest withthe sponsor of thisproject (including all secondary sources)? Yes No Ifdeletion, nosignature needed.
Signature:IsCITITrainingup-to-date?Yes No(Mustbe completeprior to proceeding)
Name: / Division/Department: / Research Role: / E-Mail Address:
This isan:AdditionDeletionIfaddition, do you, your spouseor domesticpartner, or anyofyour dependent children have a potentialand/or real financial conflictof interest withthe sponsor of thisproject (including all secondary sources)? Yes No Ifdeletion, nosignature needed.
Signature:IsCITITrainingup-to-date?Yes No(Mustbe completeprior to proceeding)
Name: / Division/Department: / Research Role: / E-Mail Address:
This isan:AdditionDeletionIfaddition, do you, your spouseor domesticpartner, or anyofyour dependent children have a potentialand/or real financial conflictof interest withthe sponsor of thisproject (including all secondary sources)? Yes No Ifdeletion, nosignature needed.
Signature:IsCITITrainingup-to-date?Yes No(Mustbe completeprior to proceeding)
Name: / Division/Department: / Research Role: / E-Mail Address:
This isan:AdditionDeletionIfaddition, do you, your spouseor domesticpartner, or anyofyour dependent children have a potentialand/or real financial conflictof interest withthe sponsor of thisproject (including all secondary sources)? Yes No Ifdeletion, nosignature needed.
Signature:IsCITITrainingup-to-date?Yes No(Mustbe completeprior to proceeding)
Name: / Division/Department: / Research Role: / E-Mail Address:
This isan:AdditionDeletionIfaddition, do you, your spouseor domesticpartner, or anyofyour dependent children have a potentialand/or real financial conflictof interest withthe sponsor of thisproject (including all secondary sources)? Yes No Ifdeletion, nosignature needed.
Signature:IsCITITrainingup-to-date?Yes No(Mustbe completeprior to proceeding)
Name: / Division/Department: / Research Role: / E-Mail Address:
This isan:AdditionDeletionIfaddition, do you, your spouseor domesticpartner, or anyofyour dependent children have a potentialand/or real financial conflictof interest withthe sponsor of thisproject (including all secondary sources)? Yes No Ifdeletion, nosignature needed.
Signature:IsCITITrainingup-to-date?Yes No(Mustbe completeprior to proceeding)
Name: / Division/Department: / Research Role: / E-Mail Address:
This isan:AdditionDeletionIfaddition, do you, your spouseor domesticpartner, or anyofyour dependent children have a potentialand/or real financial conflictof interest withthe sponsor of thisproject (including all secondary sources)? Yes No Ifdeletion, nosignature needed.
Signature:IsCITITrainingup-to-date?Yes No(Mustbe completeprior to proceeding)
Name: / Division/Department: / Research Role: / E-Mail Address:
This isan:AdditionDeletionIfaddition, do you, your spouseor domesticpartner, or anyofyour dependent children have a potentialand/or real financial conflictof interest withthe sponsor of thisproject (including all secondary sources)? Yes No Ifdeletion, nosignature needed.
Signature:IsCITITrainingup-to-date?Yes No(Mustbe completeprior to proceeding)
Name: / Division/Department: / Research Role: / E-Mail Address:
This isan:AdditionDeletionIfaddition, do you, your spouseor domesticpartner, or anyofyour dependent children have a potentialand/or real financial conflictof interest withthe sponsor of thisproject (including all secondary sources)? Yes No Ifdeletion, nosignature needed.
Signature:IsCITITrainingup-to-date?Yes No(Mustbe completeprior to proceeding)
Name: / Division/Department: / Research Role: / E-Mail Address:
This isan:AdditionDeletionIfaddition, do you, your spouseor domesticpartner, or anyofyour dependent children have a potentialand/or real financial conflictof interest withthe sponsor of thisproject (including all secondary sources)? Yes No Ifdeletion, nosignature needed.
Signature:IsCITITrainingup-to-date?Yes No(Mustbe completeprior to proceeding)
Name: / Division/Department: / Research Role: / E-Mail Address:
This isan:AdditionDeletionIfaddition, do you, your spouseor domesticpartner, or anyofyour dependent children have a potentialand/or real financial conflictof interest withthe sponsor of thisproject (including all secondary sources)? Yes No Ifdeletion, nosignature needed.
Signature:IsCITITrainingup-to-date?Yes No(Mustbe completeprior to proceeding)

“Study personnel”arepersons engaged in the collection of dataor haveaccessto data throughintervention or interactionwith the participant,including the

consent process, or have access tothe participant’s identifiable privateinformation. Thismay includecollaborators, fellows, residents,researchassistants, etc.

To be completed by the WSU IRB Administration Office

Date received:
Intent to apply to NCI CIRB approved by: / Amanda C. Reese, MA
Manager, WSU IRB Operations
Signature / Date signed

SubmissionChecklist

ExternalIRBRequestCoverSheetandReviewAuthorizationForm
Description: / Completed?Y/N / N/A
HaveboththePIandDepartmentChair/Dean/Signatorysigned
page2 oftheform,question#7?
InformedConsentdocument(s)–becertaintoutilizetemplateprovided
IstheWayneStateUniversityCompensationforInjurysection includedinthedocument?
IstheHIPAAAuthorizationincludedinthedocument?
IsthePHIoutlinedintheconsentdocument(s)thesameas
statedintheHIPAASummaryForm?
General
IsthePIsignatureontheHIPAASummaryform?
IfaWaiverofHIPAAAuthorizationisrequested(i.e.,toscreen
foreligibleparticipants),isSectionDoftheHIPAASummaryFormiscompletedandtheWaiver Agreementissigned?

OtherNotes: