consent for participation - university of tennessee college of 田纳西大学学院参与-同意

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1、(MUSTBEWRITTENINSECONDPERSONUSING12PITCHFONT)Mustincludea1.5MarginatthetoporBottom,ConsentforParticipationUniversityofTennesseeCollegeofMedicineChattanooga/ErlangerHealthSystem960EastThirdStreetChattanooga,Tennessee37403TitleofProject:PrincipalInvestigator:Co-Investigator(s):PrintedNameofPati

2、ent_______________________________________GENERALINFORMATION:YouarebeingaskedtoparticipateintheabovetitledclinicalresearchstudyconductedatErlangerHealthSystem.Youhavetheoptionnottoparticipateinthisstudy.Thestudywilllastfor()months/yearsandtherewillbeapproximately_____patientsinvolvedinthisstu

3、dy.PURPOSEOFSTUDY:Thepurposeofthisresearchisasfollows:EXAMPLES;Testthesafetyofdrug/interventionandseewhateffects(goodandbad)ithasonmeandmytypeofconditionorFindthehighestdoseofadrugthatcanbegivenwithoutcausingseveresideeffects.Findoutwhateffects(goodandbad)drug/interventionhasonmeandmytypeofco

4、ndition.Comparetheeffects(goodandbad)ofthenewdrug/interventionwithcommonly-useddrug/interventiononmeandmytypeofconditiontoseewhichisbetter.Thisresearchisbeingdonebecause_________________________________________________________.[Explaininoneortwosentences.Examplesare:“Currently,thereisnoeffect

5、ivetreatmentforthistypeofcancer,”or“Wedonotknowwhichofthesetwocommonlyusedtreatmentsisbetter.”]DESCRIPTIONOFSTUDY:[Providesimplifiedschemaand/orcalendar.]VersionDate:_________Pt.Initials:_______________[Forrandomizedstudies:]Youwillbe“randomized”intooneofthestudygroupsdescribedbelow.Randomiza

6、tionmeansthatyouwillbeputintoagroupbychance.Itislikeflippingacoin.Neitheryounortheresearcherwillchoosewhatgroupyouwillbein.Youwillhaveanequal/oneinthree/etc.chanceofbeingplacedinanygroup.[Fornonrandomizedandrandomizedstudies]Byparticipatinginthisstudy,youwillhavethefollowingtestsandprocedures

7、performed:[Listproceduresandtheirfrequencyunderthecategoriesbelow.Forrandomizedstudies,listthestudygroupsandundereachdescribecategoriesofprocedures.Includewhetherapatientwillbeathome,inthehospital,orinanoutpatientsetting.Ifobjectivesincludeac