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1、ItemsinredaremodificationsofconsentforchildrenInsertHSCLApprovalStatementincludedinapprovalnotificationemailINFORMEDCONSENTSTATEMENT_______________________________________________________(NameoftheStudy)INTRODUCTIONTheDepartmentof___________________attheUniversityofKansassupportsthepracticeofprotect
2、ionforhumansubjectsparticipatinginresearch.Thefollowinginformationisprovidedforyoutodecidewhetheryouwishtoparticipateinthepresentstudy.Youmayrefusetosignthisformandnotparticipateinthisstudy.Youshouldbeawarethatevenifyouagreetoparticipate,youarefreetowithdrawyourchildatanytime.Ifyoudowithdrawfromthis
3、study,itwillnotaffectyouroryourchild’srelationshipwiththisunit,theservicesitmayprovidetoyouoryourchild,ortheUniversityofKansas.PURPOSEOFTHESTUDYInsertdescriptionofthepurposeofthestudy.PROCEDURESInsertdescriptionoftheproceduresthatwillbefollowedinthestudy.Addresstheparticipants,i.e.“youwillbeaskedto…
4、”Includethetimecommitmentinvolved.Ifyouplantousevideooraudiotapes,pleasestatesohere.Alsostatewhatwillbedonewiththetapes,i.e.usedbytheresearchersonlyandstoredinalockedcabinet.RISKSInsertadescriptionofallburdens,inconveniences,pain,discomfortsandrisksassociatedwithparticipationinthestudy.Ifnorisksarea
5、nticipated,thisshouldbestatedexplicitly.BENEFITSInsertadescriptionofthepotentialbenefits,ifany,totheresearchsubject.Clarifyifthesearedirectbenefits(e.g.,tothesubject),orindirectbenefits,(e.g.,tosociety).Iftherearenoanticipatedbenefits,thisshouldbestatedexplicitly.PAYMENTTOPARTICIPANTSInsertastatemen
6、tregardingwhetherornotparticipantswillbepaidandifso,howmuchandonwhatschedule.Includethefollowingstatement:Page4of4Investigatorsmayaskforyoursocialsecuritynumberinordertocomplywithfederalandstatetaxandaccountingregulations.INFORMATIONTOBECOLLECTEDIncludeastatementaboutthetypeofinformation/datathatwil
7、lbecollectedabouttheparticipantandfamily,ifapplicable,(e.g.,health/backgrounddata)andbywhatmeans(e.g.,questionnaire).Forcollectionproceduresalreadymentionedintheproceduresection,alludetothemratherthan
