montefiore medical center蒙特非奥里医疗中心

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1、IRB#______________MONTEFIOREMEDICALCENTERALBERTEINSTEINCOLLEGEOFMEDICINEINSTITUTIONALREVIEWBOARDCOMMITTEEONCLINICALINVESTIGATIONSADDENDUMTOGENERALAPPLICATIONFORAPPROVALOFRESEARCHPROJECTREQUESTFORWAIVER/ALTERATIONOREXEMPTIONFROMHIPAAAUTHORIZATIONANDINFORME

2、DCONSENTPrincipalInvestigatorName:ProtocolTitle:Whichofthefollowingareyourequesting(selectallthatapply):HIPAAAuthorizationWaiver/Alteration(CompletePage1)InformedConsentWaiver(CompletePage2)HIPAAAuthorizationExemption(CompletePage3)OralInformedConsent(Com

3、pletePage2)WAIVER/ALTERATIONOFTHEREQUIREMENTFORUSEOFAHIPAAAUTHORIZATIONFORMThisformpermitsinvestigatorstorequestawaiveroralterationofindividualauthorizationtouseanddiscloseprotectedhealthinformationforstudyrelatedpurposes(requiredunderthePrivacyRegulation

4、softheHealthInsurancePortabilityandAccountabilityAct(HIPAA),orforamorelimitedpurposesuchastherecruitmentofpotentialstudysubjects(knownasa“partialwaiver”).SECTION1.(CompleteifrequestingHIPAAAuthorizationWaiver/Alteration,InformedConsentWaiver,and/orOralInf

5、ormedConsent.)1.Doestheresearchpresentmorethanminimalriskofharmtothesubject?(Minimalriskisdefinedastheprobabilityandmagnitudeofharmordiscomfortarenotgreaterthanthoseordinarilyencounteredindailylifeorduringtheperformanceofroutinephysicalorpsychologicaltest

6、s).Theriskofsubjectprivacyshouldbedeliberatedwhenconsideringrisks.PleaseseetheAECOM/MMCPolicyentitledPolicyfortheUseofPatientMedicalRecordInformationinResearchandRecruitmentofResearchParticipantsYesNo2.Willthewaiver/alterationadverselyaffecttherightsandwe

7、lfareofthesubjects?YesNo3.Cantheresearchbepracticablycarriedoutwithoutthewaiver/alteration?*Ifitisimpracticabletoobtainindividualauthorization,pleasedescribewhy?YesNo*4.Cantheresearchbepracticablycarriedoutwithoutaccesstoanduseofprotectedhealthinformation

8、?Ifitisimpracticabletoconductthisresearchwithoutaccesstoidentifiedhealthinformation,pleasedescribewhy:YesNo*5.Whatisyourplantoprotectidentifiersfromimproperuseanddisclosure?6.Willthepatientidentifiersbedestroyedatth