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Consent Waiver (Marquette University)

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Marquette University

Revised 04/17/2013



Protocol#:



ORSP#:

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SponsorTra ckin g#:



InstitutionalReviewBoard

WaivertoObtain/Document/AlterInformedConsent



Wheneverpossible,potentialresearchsubjects shouldbegivenan explanationofwhattheirvoluntaryparticipation

entailsasitrelatestotherisks,benefits,alternatives,studyactivities,andconfidentialityoftheIRBapprovedstudy.The

potentialsubject’sagreementtoparticipateistypicallydocumented(e.g.,signedbysubject)onanIRBapproved

consentform.However,theDepartmentofHealthandHumanServicesallowsanIRBtoapprove,(a)awaiverof

consent,(b)analternativeformofconsent,or(c)awaiverofdocumentationofconsentsolongascertaincriteriaare

met.



Note:

 TheIRBcannotapprovewaiversofthe

consentforresearchthatissubjecttoFDAregulations,exceptfor

plannedemergency/acutecareresearchasprovidedunderFDAregulations.

 “Consent”appliestoadults(18andolder).

 “Assent”appliestominors(17andyounger).

 “ParentalPermission”appliestoparentsofminors.

 “ObtainDocumentation”referstoobtaining

thesubject’ssignature.



Directions:IfyouarerequestingIRBapprovaltowaive,alter,ornotdocumentinformedconsent,completethis

addendumandincludeitwithyourIRBsubmission.



SECTION1:Thisrequestisto(checkallthatapply):



Waivetherequirementtoobtaininformedconsent/assent[COMPLETESECTION2&3]

Altertherequiredelementsofconsent/assent[COMPLETESECTION2&3]

Waivetherequirementtoobtaindocumentationofinformedconsent/assent[COMPLETESECTION2&4]



SECTION3:AnswerallA’sORB’sandprovideanexplanationforhowyourprojectmeetseachcriteriaforwaivingor

alteringtheconsentprocess.



A1.Theresearchordemonstrationprojectistobeconductedby,orsubjecttotheapprovalof,stateorlocal

governmentofficials.

SECTION2:Brieflyexplainwhyyouaremakingthisrequest.E.g.,studydoesnotinvolveinteractingwithhuman

subjects,obtainingsignedconsentswouldbetheonlyidentifiablelink,thesubjectpopulationareundocumented

residents,onlinesurveyortelephoneinterviewprojectsonly,etc.

 YES

 NO



A1.Theresearchisdesignedtostudy,evaluate,orotherwiseexamine:(i)publicbenefitorserviceprograms;(ii)

proceduresforobtainingbenefitsorservicesunderthoseprograms;(iii)possiblechangesinoralternativestothose

programsorprocedures;or(iv)possiblechangesinmethods orlevelsof

paymentforbenefitsorservicesunderthose

programs.

 YES

 NO



A2.Theresearchcouldnotpracticablybecarriedoutwithoutthewaiveroralteration.

 YES

 NO



OR



B1.Explainhowtheresearchinvolvesnomorethanminimalrisktothesubjects;



B2.Explainhowthewaiveroralterationwillnotadverselyaffecttherightsandwelfareofthesubjects;



B3.Explainhowtheresearchcouldnotpracticablybecarriedoutwithoutthewaiveror

alteration;and



B4.Wheneverappropriate,explainhowthesubjects willbeprovidedwithadditionalpertinentinformationafter

participation.



SECTION4:AnswerallA’sORB’sandprovideanexplanationforhowyourprojectmeetseachcriteriaforwaivingthe

requirementtodocumentconsent.



A1.Wouldtheonlyrecordlinkingthesubjectandtheresearchbetheconsentdocument?

 YES

 NO



A2.Wouldtheprincipalriskbepotentialharmresultingfromabreachofconfidentiality?

 YES

 NO



A3.Willeachsubjectbeaskedwhethertheywantasignedcopyoftheconsentform?

 YES

 NO

OR



B1.Doestheresearchpresentnomorethanminimalrisktothesubject?

 YES

 NO



B2.Doesitinvolveproceduresforwhichwrittenconsentisnormallyrequiredoutsideoftheresearchcontext?E.g.,MRI

scans,clinicaltreatment,etc.

 YES

 NO

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Completed 25 July 2020

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