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FULLBOARDNEWSTUDYREVIEWCHECKLIST

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Page1of2January21,2013



InstitutionalReviewBoard

OfficeofResearchCo m plia nce



NewStudyReviewChecklist

V.1



NEWSTUDYFULLBOARDREVIEWCHECKLIST



Directions:Thepurposeofthischecklististoprovidedocumentationofdeterminingwhetheraprojectmeetsthe

criteriaforapprovalataconvenedfullboardmeeting.PleasecontacttheIRBstaffifyouareunabletoreviewthis

studyorhaveaconflictofinterestrelatedtothisresearchor

review.



I.GENERAL

ProjectTitle:



PrincipalInvestigator:



MUIRB#:HR‐

Reviewer:



ForMeetingDate:



II.REVIEWCRITERIA:

1. Allappropriatedocumentsareincludedforreview.

☐YES



☐NO ☐NA

2. Riskstoparticipants areminimizedbyusingprocedureswhichareconsistent

withsoundresearchdesignanddonotunnecessarilyexposeparticipantstorisk.

☐YES



☐NO ☐NA

3. Riskstoparticipants areminimizedwheneverappropriate,byusingprocedures

alreadybeingperformedontheparticipantsfordiagnosticortreatment

purposes.

☐YES ☐NO ☐NA

4. Riskstoparticipants arereasonableinrelationtoanticipatedbenefits,ifany,to

participants,andtheimportanceoftheknowledgethatmayreasonablybe

expectedtoresult. 

☐YES ☐NO ☐NA

5. Selectionofparticipantsisequitabletakingintoaccountthepurposesofthe

research,thesettinginwhichtheresearchwillbeconducted,thespecial

problemsofresearchinvolvingvulnerablepopulations,theselectio ncriteriaand

therecruitmentprocedures.

☐YES ☐NO ☐NA

6. Informedconsentwillbesoughtandappropriatelydocumentedfromeach

prospectivesubjectorthesubject’slegallyauthorizedrepresentative.Ifawaiver

toobtain,documentoraltertherequir ementsofinformedconsentisbeing

requested,thereisadequatejustificatio ntodoso.

☐YES ☐NO ☐NA

7. Whenappropriate,theresearchplanmakesadequateprovisionformonitoring

thedatacollectedtoensurethesafetyofparticipants .

☐YES ☐NO ☐NA

8. Whenappropriate,thereareadequateprovisionstoprotecttheprivacyof

participantsandtomaintaintheconfidentialityofdata.

☐YES ☐NO ☐NA

9. Areadequatesafeguardstillinplaceforparticipantswhoarelikelytobe

vulnerabletocoercionorundueinfluence? 

☐YES ☐NO ☐NA

Page2of2January21,2013

10. Aretheresignificantnewfindingsconcerningthisres earchthatmightaffectthe

willingnessofparticipantstocontinuetotakepartintheresearch.Ifthereare

significantnewfindings,aretheyadequatelyconveyedtotheparticipants?

☐YES ☐NO ☐NA

11. Doanyreportsofnon‐complianceorparticipantcomplaintsrepresent

unanticipatedeventsorproblemsinvolvingriskstoparticipantsorothersor

seriousorcontinuingnon‐compliance?

☐YES ☐NO ☐NA

III.EXPEDITEDCATEGORY9RECOMMENDATION

1. Researchpreviouslyreviewedandapprovedbythefullboardmaybeapproved

forfuturecontinuingreviewsunderexpeditedcategory9ifconditionsa,b,andc

aremet:

(a) Theresearchisnotconductedunderaninvestigationalnewdrugapplication

(IND)orinvestigationaldeviceexemption(IDE);and

(b) Noadditional

riskshavebeenidentifiedsinceIRBreviewataconvened

meeting;and

researchinvolvesnogreaterthanminimalrisk. 

Basedon(a)and(b),wouldyourecommendfuturecontinuingreviewsforthis

studyundercategory9?If

so,thecommitteewillberecommendedtovoteon

thisfor(c).

☐YES ☐NO ☐NA



IV.DETERMINATION

☐

Recommendapprovalwithnochangesorstipulations

☐

Recommenddisapprove

☐

Recommendapprovalwithchangesorstipulations(usecomment boxbelow)

 COMMENTS



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Completed 11 February 2020

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