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1、GuidanceonDevelopinganInformedConsentStatementElementsofanInformedConsentStatement(ICS)See45CFR46.116(1998)1-Thatthestudyinvolvesresearch;2-Thepurposesoftheresearch;3-Theexpectedlengthoftimeofresearchparticipation;4-Theprocedurestobeperformedandwhich,ifany,areexperimental;5-Reasonablyforeseeableris
2、ksanddiscomforts;6-Reasonablyexpectedbenefitstosubjectsorothers;7-Alternatives,includingtreatment,thatcouldbenefittheindividualmorethanresearchparticipation;8-Thelevelofconfidentialityprotectinganyidentifiableinformationrecordedonthesubject;9-Whethercompensationandmedicaltreatmentwillbeavailablefor
3、injuriesresultingfromresearch;10-Theidentityoftheperson(s)tonotifyifthesubjecthasquestionsorsuspectsresearch-relatedinjury;and11-Thatparticipationisvoluntary,refusalwillnotbepenalized,andparticipationmayceaseatanytimewithoutpenalty.SAMPLEINFORMEDCONSENTSTATEMENTYouarebeingaskedtotakepartinaresearch
4、projectcalled[Theprojecttitlegoeshere]conductedby[Investigator’sname,degree,andaffiliation].Thepurposeofthisstudyis[tolearnmoreaboutwhateverthetopicis].Theexpectedlengthoftimeofyourparticipationis[fillthisin].Duringthecourseofthisstudy,thefollowingwilloccur:[usinglaylanguage,describestep-by-stepwha
5、twillberequiredof,ordoneto,theresearchsubject.Statewhatinformationwillbegatheredandwhetherbyinterviews,recordextraction,etc.]Thepossibleriskstoyouasyoutakepartinthisstudymaybethoughtsandfeelingsofsadnessasyouthinkaboutyourpast,yourfamily,andwhatyoudidtogethere[Replaceourexamplewithacompletedescript
6、ionoftherisks].Youhavebeentoldthat,shouldyouwantto,youcanbereferredtostaffat[theDTCOffice]totalkaboutthisexperienceafterwards[ifthisisnecessary].Youwillnotbenefitdirectlyfromtakingpartinthisstudy.Yourcharges,sentence,courtconditions,programrequirementsoryourtreatmentbyAOCstaffwillnotchange.Answerin
7、gquestionsmayhelppeopleknowmoreabout[whateverthetopicis].Sincethisresearchdoesnotinvolvetreatment,therearenoalternativetherapiesortreatment.Youmaychoosenottotakepart.Allanswersthatyougivewillbekeptconfident
