WPC =[@{f'@,%*X˿@9fS|֨q+"ͧ5@M m{R(<]<2r9A5,ƶ<:.rx0 r/Zh!u<ǥcпP]Ebm\|HE8Y-5Gh13BԆ$sg C 3wP~ A<(4j>E7fCOrv)u:%D^H5dqRNU{G]oj65f]\ӫz{i51g,!PD둺6#q6B_[(ZZ &mlֱFYd⛌4,#jSKBG(.]Uo0sK{`_?qY?*[lf*E鱁9LMV]$3>x*׫Ҝ-gy?k|]4#!UN %G 0kMMUB^ w@4FZi mkkkkE B\\ORSP\HPLJET4000-Q0(9 Z6Times New Roman RegularX(CgE$&%XX$XXX$*@UAZ*NewsGoth BT Roman4& E U!"D# $D%U&'D؂(&:i+003|x'U d gE!&l%XX$XXX$  _ &%%&l 4 %&CategoriesofResearchthatmaybeReviewedbytheInstitutionalReviewBoard(IRB)Throughan  ExpeditedReviewProcedure: 1  Researchactivitiesthat(1)presentnomorethanminimalrisktohumansubjects,and(2)involveonlyprocedureslistedinoneormoreofthefollowingcategories,maybereviewedbytheInstitutionalReviewBoardthroughtheexpeditedreviewprocedureauthorizedin45_CFR_Ԁ46.110and21_CFR_Ԁ56.110.  A.0 ` Theactivitieslistedshouldnotbedeemedtobeofminimalrisksimplybecausetheyare r  includedonthislist.Inclusiononthislistmerelymeansthattheactivityiseligibleforreviewthroughtheexpeditedreviewprocedurewhenthespecificcircumstancesoftheproposedresearchinvolvenomorethanminimalrisktohumansubjects. ` (#` (#   B.0 ` Thecategoriesinthislistapplyregardlessoftheageofsubjects,exceptasnoted. ` (#` (#   C.0 ` Theexpeditedreviewproceduremaynotbeusedwhereidentificationofthesubjects 0  and/ortheirresponseswouldreasonablyplacethematriskofcriminalorcivilliabilityorbedamagingtothesubjectsfinancialstanding,employability,_insurability_,reputation,orbestigmatizing,unlessreasonableandappropriateprotectionswillbeimplementedsothatrisksrelatedtoinvasionofprivacyandbreachofconfidentialityarenogreaterthanminimal. ` (#` (#   D.0 ` Theexpeditedreviewproceduremaynotbeusedforclassifiedresearchinvolvinghuman > subjects. ` (#` (#   E.0 ` _IRBs_Ԁareremindedthatthestandardrequirementsforinformedconsent(oritswaiver, d alteration,orexception)applyregardlessofthetypeofreview!expeditedorconvened!utilizedbytheIRB. ` (#` (#   F.0 ` Categoriesone(1)throughseven(7)pertaintobothinitialandcontinuingIRBreview.` (#` (#    ResearchCategories  P  0X, " XX0rr 1.0  Clinicalstudiesofdrugsandmedicaldevicesonlywhencondition(a)or(b)ismet:F (#(#  0  (a)84(#(#researchondrugsforwhichaninvestigationalnewdrugapplication(21_CFR_ԀPart312) ! isnotrequired.2 "4!4!  0  (b)84(#(#researchonmedicaldeviceswhich(1)donotrequireaninvestigationaldevice l!# exemptionapplication(21_CFR_ԀPart812);or(2)arecleared/approvedformarketingandarebeingusedinaccordancewiththeircleared/approvedlabeling. 4!4! A3) xdE$xA $ '  0  1Anexpeditedreviewprocedureconsistsofareviewofresearchinvolvinghumansubjectsby % ) theIRBchairorbyoneormoreexperiencedreviewersdesignatedbythechairfromamongmemberoftheIRBinaccordancewiththerequirementssetforthin45_CFR_Ԁ46.110. (#(#  0  2Researchonmarketeddrugsthatsignificantlyincreasestherisksordecreasesthe (-$- acceptabilityoftherisksassociatedwiththeuseoftheproductisnoteligibleforexpedited )$. review. *%/(#(# _rr 2.0  Collectionofbloodsamplesbyfingerstick,heelstick,earstick,or_venipuncture_Ԁasfollows:(#(#  0  (a)84(#(#fromhealthy,nonpregnantadultswhoweighatleast110pounds.Forthesesubjects, T theamountsdrawnmaynotexceed550mlinaneightweekperiodandcollectionmaynotoccurmorefrequentlythantwiceperweek;or 4!4!  0  (b)84(#(#fromotheradultsandchildren3,consideringtheage,weight,andhealthofthesubjects,  thecollectionprocedure,theamountofbloodtobecollected,andthefrequencywithwhichitwillbecollected.Forthesesubjects,theamountdrawnmaynotexceedthelesserof50mlor3ml/kginaneightweekperiodandcollectionmaynotoccurmorefrequentlythantwiceperweek. 4!4! rr 3.0  Prospectivecollectionofbiologicalspecimensforresearchpurposesbynoninvasivemeans. @" 0@"(#(#For    example:(a)hairandnailclippingsinanondisfiguringmanner; (#(#  0  (b)84(#(#deciduousteethattimeofexfoliationorifroutinepatientcareindicatesaneedfor Z  extraction; 4!4!  0  (c)84(#(#permanentteethifroutinepatientcareindicatedaneedforextraction;N 4!4!  0  (d)84(#(#excretaandexternalsecretions[includingsweat]; 4!4!  0  (e)84(#(#_uncannulated_Ԁsalivacollectedeitherinan_unstimulated_Ԁfashionorstimulatedby   chewing_gumbase_Ԁorwaxorbyapplyingadilutedcitricsolutiontothetongue; 4!4!  0  (f)84(#(#placentaremovedatdelivery;F4!4!  0  (g)84(#(#amnioticfluidobtainedatthetimeofruptureofthemembranepriortoorduringlabor;h4!4!  0  (h)84(#(#supraand_subgingival_Ԁdentalplaqueandcalculus,providedthecollectionprocedureis : notmoreinvasivethanroutineprophylactictechniques; 4!4!  0  (_i_)84(#(#_mucosal_Ԁandskincellscollectedbybuccalscrapingorswab,skinswab,ormouth  _washings_; 4!4!  0  (j)84(#(#sputumcollectedaftersalinemist_nebulization_.24!4! rr 4.0  Collectionofdatathroughnoninvasiveprocedures[notinvolvinggeneralanesthesiaorsedation] & routinelyemployedinclinicalpractice,excludingproceduresinvolvingxraysormicrowaves.  Wheremedicaldevicesareemployed,theymustbecleared/approvedformarketing.4For z example: (#(#  0  (a)84(#(#physicalsensorsthatareappliedeithertothesurfaceofthebodyoratadistanceand n donotinvolveinputofsignificantamountsofenergyintothesubjectoraninvasionofthesubjectsprivacy; 4!4!  0  (b)84(#(#weighingortestingsensoryacuity; "4!4!  0  (c)84(#(#magneticresonanceimaging;f!#4!4!  0  (d)84(#(#electrocardiography,electroencephalography,_thermography_,detectionofnaturally 8"$ occurringradioactivity,_electroretinography_,ultrasound,diagnosticinfraredimaging,_doppler_Ԁbloodflow,and_echocardiography_; 4!4!  0  (e)84(#(#moderateexercise,muscularstrengthtesting,bodycompositionassessment,and $' flexibilitytestingwhereappropriategiventheage,weight,andhealthoftheindividual. 4!4! rr 5.0  Researchinvolvingmaterials[data,documents,records,orspecimens]thathavebeencollected $'t"* orwillbecollectedsolelyfornonresearchpurposes,suchasmedicaltreatmentordiagnosis.5 4!4! A3) xd'E#'xA $'t"*  0  3Childrenaredefinedinthe_HHS_Ԁregulationsas personswhohavenotattainedthelegalage (U#, forconsenttotreatmentsorproceduresinvolvedinthisresearch,undertheapplicablelawofthejurisdictioninwhichtheresearchwillbeconducted.[45_CFR_Ԁ46.402(a)] (#(#  0  4Studiesintendedtoevaluatethesafetyandeffectivenessofthemedicaldevicearegenerally M+&0 noteligibleforexpeditedreview,includingstudiesofclearedmedicaldevicesfornew ,o'1 indications. N ,A(2(#(# _ -)3     "!!"!rr 5.0  Researchinvolvingmaterials[data,documents,records,orspecimens]thathavebeencollected  orwillbecollectedsolelyfornonresearchpurposes,suchasmedicaltreatmentordiagnosis.5! T(#(#  # 0  5Someresearchinthiscategorymaybeexemptfromthe_HHS_Ԁregulationsfortheprotectionof H humansubjects,accordingto45_CFR_Ԁ46.101(b)(4).Thislistingrefersonlytoresearchthatis  notexempt. (#(# #$$rr 6.0  Collectionofdatafromvoice,video,digital,orimagerecordingsmadeforresearchpurposes.H(#(# rr 7.0  Researchonindividualorgroupcharacteristicsorbehavior[includingbutnotlimitedtoresearch   onperception,cognition,motivation,identity,language,communication,culturalbeliefsorpractices,andsocialbehavior]orresearchemployingsurvey,interview,oralhistory,focusgroup,programevaluation,humanfactorsevaluation,orqualityassurancemethodologies.6 b (#(# rr 8.0  ContinuingreviewofresearchpreviouslyapprovedbytheconvenedIRBasfollows:  (#(#  0  (a)84(#(#(1)8` 4!4!wheretheresearchispermanentlyclosedtotheenrollmentofnewsubjects; ` `   0  04(#(#(2)8` 4(#4(#allsubjectshavecompletedallresearchrelatedinterventions;andZ ` !` !  0  04(#(#(3)8` 4(#4(#theresearchremainsactiveonlyforlongtermfollowupofsubjects;,| ` !` !  0  or(b)8` (#(#wherenosubjectshavebeenenrolledandnoadditionalriskshavebeen N  identified; ` `   0  or(c)8` (#(#wheretheremainingresearchactivitiesarelimitedtodataanalysis. ` `  rr 9.0  Continuingreviewofresearch,notconductedunderaninvestigationalnewdrugapplicationor F investigationaldeviceexemptionwherecategories2though8donotapplybuttheIRBhasdeterminedanddocumentedataconvenedmeetingthattheresearchinvolvesnogreaterthanminimalriskandnoadditionalriskshavebeenidentified. (#(# A3) xdE_xA ` %%& 0  5Someresearchinthiscategorymaybeexemptfromthe_HHS_Ԁregulationsfortheprotectionof A humansubjects,accordingto45_CFR_Ԁ46.101(b)(4).Thislistingrefersonlytoresearchthatis c notexempt. (#(# _&'%%'%_% 0  6Someresearchinthiscategorymaybeexemptfromthe_HHS_Ԁregulationsfortheprotectionof  humansubjects,accordingto45_CFR_Ԁ46.101(b)(2)and(b)(3).Thislistingrefersonlyto [ researchthatisnotexempt. (#(# 4XXX, "  4