ParticipantInformation and InformedConsent Form

INSERT STUDY TITLEHERE

Investigator:INSERTINFORMATIONHERE

Co‐investigator(s): INSERTINFORMATIONHERE

Sponsor:INSERTINFORMATIONHERE

Thisconsentformmaycontainwordsthatyoudonotunderstand.Pleaseaskthestudyinvestigator(s)orthestudycoordinator(s)toexplainanywordsorinformationthatyoudonotclearlyunderstand.

Introduction

YouarebeingaskedtotakepartinaresearchstudysponsoredbyINSERTINFORMATIONHERE(the‘sponsor’).Beforeyoudecidewhetherornottotakepartinthestudyyoushouldreadthisinformation.Itisveryimportantthatyoureadandunderstandthefollowingparticipantinformation sheet.This formexplainsthe study, includingthe risksand benefitsoftaking partinthestudy.Youwillbegiventhisinformationsheettokeep.Pleasefeelfreetoaskthestudyinvestigator(s)orresearchstaffanyquestionsthatwillhelpyouunderstandthestudyandwhatyouareexpectedtodo.Beforeyouagreetotakepartinthisstudy,youmaytakethisinformationhomeanddiscussitwithafamilymemberoryourfamilydoctor.IfyouareaFirstNationsperson,oranindigenouspersonwhohascontactwithspiritual“elders”youmaywanttotalkwiththembeforeyouproceedwithbeingpartofthisstudy.Pleaseaskifthereisanythingthatisnotcleartoyouorifyouwouldlikemoreinformationbeforedecidingwhether or not totakepart in the study.

UptoINSERTPARTICIPANTNUMBERHEREparticipantswithINSERTMEDICALCONDITION(ifapplicable)HEREwillbeincludedinthestudyatthissite,whichwilltakeplaceinKingston,Ontario.ThestudyhasbeenreviewedforethicalcompliancebytheQueen’sUniversityHealthSciencesandAffiliatedTeachingHospitalsResearchEthicsBoard.Thisgroupisresponsibleforsafeguardingthesafety,rightsandwell‐beingofhumanparticipants.ThetrialwillbeconductedinkeepingwithinternationalqualitystandardswhichhavebeenadoptedbyHealthCanada.

Version: InsertDateHere / Page1of13 / Participant’sInitials
Sponsor: InsertSponsor’sNameHere
StudyNo:InsertSponsor’sStudyProtocolHere / Date

PurposeoftheStudy

YouarebeingaskedtoparticipateinthisresearchstudybecauseyouhavebeendiagnosedwithINSERTMEDICALCONDITIONHERE.Inthissection:

  • Explainwhatthestudydrugbeingusedinthestudyisandhowitcouldimprovetheconditionoftheparticipantparticipatingintheresearchstudy;
  • Explainhowmanyparticipants atthissiteand elsewhere will be participating;
  • Usuallyincludeastatementforinvestigationaldrugsthatstates“Themedicationbeingtestedinthisstudyiscurrentlynot“onthemarket”(availableforyoutobuy)inanycountryandtherefore,will notbeavailabletoyouafterthestudyends”;
  • Explainwhatthepurpose/aims ofthestudy are;
  • Brieflyexplainthedrugdosage (Howmuch?How often?Route ofadministration?).

VoluntaryParticipationandWithdrawal

Yourparticipationinthisstudyisvoluntaryandyouwillbegivenadequatetimetodecidewhetheryouwishtoparticipateinthisstudy.Youmaydeclinetoparticipateorarefreetowithdrawfromthetrialatanytimewithoutreason,withoutpenaltyorlossofbenefitstowhichyouareotherwiseentitled.Yourdecisiontodeclinetoparticipateorwithdrawwillnotaffectthestandardofcareyoureceiveoryourrelationshipwithyourinvestigator(s).Ifyoudonotwishtoparticipateorifyouwithdrawfromthetrial,neitheryourcurrentnorfuturemedicalcarewillbeadverselyaffected.Ifyoudodecidetoleavethestudyhowever,wewouldlikeyoutoattendonefinalvisittoassessmostoftheproceduresthatwereplannedforthefinalvisit.Thisisimportantforyoursafetyandwell‐being.Inaddition,allunusedstudymedicationmustbereturnedatthistime.

Ifyouagreetoparticipateinthetrial,theinvestigator(s)/studycoordinator(s)willensure,withyouragreement,thatyourfamilydoctorisinformedaboutyourparticipation.Theinvestigator(s)mayalsoremoveyoufromthestudyatanytimewithoutyourconsentforreasonsthatinclude:yourfailuretofollowstudyrequirements;theoccurrenceofunusualorserioussideeffects;anytimetheinvestigator(s)thinksitisinyourbestinterest;thestudyhasended;and/orattherequestofthestudysponsor.Ifthisweretohappen,youwouldbeinformedofthereason(s).YouwillbeinformedpromptlyofanyimportantfindingsthatdevelopwithINSERTSTUDYDRUGNAMEHEREduringthecourseofthestudy,whichmightchange yourdecisiontocontinueinthe study.

BenefitfromParticipatinginthisStudy

Alltests,examinations,andmedicalcarerequiredaspartofthisstudywillbeprovidedatnocost.Moreover,otherindividuals livingwithINSERTMEDICALCONDITIONHEREmaybenefitfromtheoverallconclusiontobedrawnfromtheresultsofthisstudy.Thereisnoguaranteethatyouwillreceiveanymedicalbenefitfromparticipatinginthisstudy.

AlternativeTreatments

YoudonotneedtoparticipateinthisstudytoreceivetreatmentforyourINSERTMEDICALCONDITIONHERE.Yourinvestigator(s)willdiscussthesealternativeswithyou.

StudyProcedures

Duringthe study youwill be askedto participate forup to INSERTTIMEFRAME.ThestudycomprisesofINSERTNUMBEROFCLINICVISITStothelaboratorythatoccuratdesignatedtimeintervals.EachclinicvisitwilllastfromINSERTTIMEFRAMEinduration(seeAppendix1forsamplecharttoincludeintheInformationandConsentForm).

Allprocedureswillbecarefullyexplainedbytheinvestigator(s)/studycoordinator(s)andyoushouldaskwheneveryouneedmoreinformation. Youmustprovideconsenttoparticipatein

thisstudybeforeyoucanperformanystudy‐relatedprocedures.

INSERTALLTYPESOF

TESTSASWELLASHOWTHETESTSAREPERFORMEDHERE.

INSERTALLSPECIALINSTRUCTIONS(especiallywithholdingofcertainmedications)FORVISITSHERE.Includeastatement(ifapplicable)indicatingtoparticipantsthatiftheyforgot towithhold certain medicationsonthedayof their clinic visit that theymust contacttheinvestigator(s)/studycoordinator(s)asyourvisitmayneedtoberescheduledandthatitisimportantthatparticipantsnotifytheinvestigator(s)/studycoordinator(s)ofanychangesinyourmedicationsduringthestudy,asthisinformationwillbenotedinyourmedicalrecordandmayaffectfurtherparticipationin the study.

Clinic Visits

Inserthereadetailedaccountofwhatwillhappenateachstudyvisit(i.e.step bystepbreakdownofvisit)duringthescreening,treatment,andfollow‐upperiod.Anexampleincludesthefollowing:

ScreeningPeriod(Visits1‐3)

TheScreeningPeriodwilllastfrom2‐3weeksdependingonwhetherornotyouhavepreviouslyusedcertainmedicationspriortoentryintothestudy.Duringthistimethestudystaffwillevaluatewhetheryouareeligibletoparticipateinthestudyandcollectbaselinemedicalinformation.YoumaybeaskedtostoptakingcertainmedicationsthroughoutthestudyafterVisit1.Youwillnottakeanystudymedicationduringthisperiod.Thesevisitswilllastabout1hourto3hours.Thefollowingproceduresandactivitieswillbeperformedtodetermineifyouqualify:

ScreeningVisit1

Duringthefirstscreeningvisit,studypersonnelwillcompletethefollowingprocedures:

  • Explaintoyouthepurposeofthisresearchstudyindetail.Ifyouarewillingtoparticipateinthestudyyouwillbeaskedtosignanddatetheinformedconsentform;
  • Reviewaspecificsetofcriteriatodetermineifyouareeligibletoparticipatein the study;
  • Recordyourdemographicinformationandmedicalhistory;
  • Performaphysicalexaminationincludingheartrate,bloodpressure,weightandheighttomakesurethatyoudonothaveanyphysicalormedicalproblemsthatwouldpreventyoufromsafelyparticipatinginthestudy;
  • Performanelectrocardiogram(ECG),asimpletestthatrecordsinformationabouttheelectricalactivityofyourheart;
  • Askyouquestionsaboutyoursmokinghabits;
  • Withdrawn some blood to detect what might prevent you from safelyparticipating in the study;
  • Forwomenofchildbearingage,aurinesamplewillbecollectedtomakesureyou are notpregnant;
  • Performabreathingtest,exercisetest,andbodycompositiontest;
  • Recordanyadverseeventsthatoccurredinthepreviousweek(s);
  • Recordanymedicationthatyoutookinthepreviousweek(s);
  • Administerquestionnaires;
  • Instructyouonthecompletionofaparticipantdiary/reportcard;
  • Instruct you on what will occur at your next clinic visitand assign an appointment (date/time).

Potential Risks and Discomforts

Yourprogressinthestudywillbecarefullymonitoredtoensureyoursafetyandwell‐being.Theinvestigator(s)willbeavailabletorespondtoyouifyoufeelworse.Itispossiblethatyoumayexperiencesideeffectsfromthestudymedication.Or,themedicationmayhavenobeneficialeffectandasaresultyoumayfeelthatyourconditionisnotimprovingormaybeworsening.Informyourinvestigator(s)/studycoordinator(s)immediatelyifthisoccurs,andhe/shewillassessyourconditionandmakechangestoyourtreatmentifitisrequired.Ifnecessary,youwillbewithdrawnfromthestudy.

Itisveryimportantthatyoutake your studymedicationinthe manner thatyour investigator/studycoordinator(s)hasdescribed.Ifyoumissanydose(s)youmusttelltheinvestigator(s)/studycoordinator(s)atyournextvisittotheclinic.Pleaseremembertoreturnyourpartiallyusedoremptymedicationtotheinvestigator(s)/studycoordinator(s)ateachvisit.Beforetakinganynewprescriptionornon‐prescriptionmedicationwhileonstudy,pleaseconsultyourinvestigator(s)/studycoordinator(s).

A.INSERTNAMEOFSTUDYDRUG:

Explainallpossiblesideeffects and risks associated with the study drug. This informationisusuallyprovidedbytheindustrysponsorandcanbeinsertedhere.

B.INSERTNAME(S)OFALLOTHERITEMSADMINISTEREDTOPARTICIPANTS:

Explainallpossible side effectsandrisksassociatedwithotherdrugs,devices,vitamins,mineralsandsupplementsgiventotheparticipantswhileparticipatinginthestudy.Thisinformationisusuallyprovidedbytheindustrysponsorandcanbeinsertedhere.

C.OtherMedicines:

Explain all possible side effects and risks associated with withholding of certainmedicationswhileparticipatinginstudy.

E.Pregnancy:

Explainallpossiblesideeffectsandrisksassociatedwithbecomingpregnantorfatheringa childwhile participating inthe study.

F.Tests/Procedures:

Explainall possible sideeffectsandrisksassociated withall testsandproceduresutilizedinthestudy(i.e.laboratorytests,diagnostictests).Besuretoincludeanydevicesgivenouttoparticipantstoutilizeathomeforparticipantdiaries(i.e.activitymonitors,bloodpressuremonitors).

Trial‐RelatedInjury

Ifyoubecomeillorinjuredasadirectresultofparticipatinginthisstudy,necessarymedicaltreatmentwillbeavailableatnoadditionalcosttoyou.Yoursignatureonthisformonlyindicatesthatyouhaveunderstoodtoyoursatisfactiontheinformationregardingyourparticipationinthestudyandagreetoparticipateasaparticipant.Inno waydoes thiswaive yourlegalrightsnorreleasetheinvestigator,thestudysponsororinvolvedinstitutionsfromtheirlegalandprofessionalresponsibilities.

Compensation

YouwillreceiveuptoINSERTAMOUNTHEREforthecompletedstudytocompensatefortravel,foodandotherreasonableoutofpocketexpensesthataredirectlyrelatedtoyourparticipationinthestudy.Therewillbenocosttoyou,toanyprivatemedicalinsurance,ortothepublichealthinsuranceplanforstudyproceduresforyourparticipationinthestudy.Therewillbenochargetoyouforthestudymedicationoranyothertestsdoneaspartofthestudy.

The investigator isbeing compensatedby the sponsor for his participationinthe trial fordirectcostsassociatedwiththestudy(i.e.salariesoftheresearchassociate(s)andprincipalinvestigator/sub‐investigatorforcarryingoutallstudy‐relatedprocedures,costofperformingprocedures(i.e.laboratoryservices,breathingtests,exercisetests),equipmentandsuppliescosts,travelandpublicationcosts,andanyotherunforeseencoststhatmayarisewithinthestudy).The institutionstowhichthe studyisbeingconducted, Queen’sUniversityandKingstonGeneralHospital Research Institute,arebeingcompensatedbythesponsorforitsparticipationinthetrialforindirectcostsassociatedwiththestudy(i.e.occupancycost,buildinguse,centraladministration,librarycost,centralcomputingservicescostsandanyotherunforeseencoststhatmayarisewithinthestudy).

Confidentiality

Allmedicalrecordsandresearchmaterialsinwhichyouareidentifiedwillbekeptconfidentialandwillnotbemadepubliclyavailable,unlessrequiredbyapplicablelawsand/orregulationsandwillonlybeusedforthepurposeoftheresearchstudyasstatedinthestudyobjectivesabove.Forthisstudy,theinvestigator(s)/studycoordinator(s)willneedtoaccessyourpersonalhealthrecordsforhealthinformationsuchaspastmedicalhistoryandtestresults.Ifyouagree,theinvestigator(s)/studycoordinator(s)mayalsocontactyourfamilyphysicianandyourotherhealthcareproviderstoobtainadditionalmedicalinformation.

Tomakesurethatthehealthinformationcollectedinthisstudyisaccurate,itwillneedtobecheckedfromtimetotimeagainstyourmedicalrecords.Alimitednumberofrepresentativesfromthestudysponsoringdrugcompany,INSERTSPONSOR’SNAMEHERE,theresearchethics review board,governmentregulatoryauthoritiesincludingHealthCanada, the US FoodandDrugAdministration(FDA)andotherforeignregulatoryagenciesmayneedtoseetheserecordsinordertomonitortheresearchandverifytheaccuracyofthestudydata.Yourmedicalrecordsmaybeexaminedinconnectionwiththisstudyorfurtheranalysesrelatedtoit.Theresultsof thestudymaybepublishedinaprofessionaljournalorpresentedatscientificmeetingsortogovernmentregulatoryauthorities;however,youridentitywillNOTbedisclosedinthosepresentations.Ifyoudecidetowithdrawfromthisstudy,yourmedicalrecordswillbemadeavailableasdescribedabove.

Bysigningthisconsentform,youareauthorizingthecollection,useanddisclosureofinformation,reporting,andtransferofdatacollectedfromthisstudy,includingpersonaldatasuchasyourdateofbirth,toINSERTSPONSOR’SNAMEHEREandregulatoryauthoritieswithinandoutside Canadaforthepurposesofthisstudyandfurtheranalysesrelatedtoit.Ondocuments,yourdateofbirthandassignedstudynumberwillonlyidentifyyou.Yournamewillnotbedisclosedoutsidetheresearchclinic.Youhavetherighttolookatyourmedicalrecordsandcorrectanyerrorsaboutyourselfbycontactingtheprincipalinvestigator,unlessthisisnotallowedbyapplicablelaws.

Participant’sResponsibilities

Listallresponsibilitiesoftheparticipantforparticipatinginthisstudy.Examplesinclude,butnotlimitedto:

  • Ifyouaretreatedbyanotherdoctor(forexample,inanemergency)youshouldinformthemofyourinvolvementinthisstudy.
  • Youwillnotbeallowedtoparticipateinanyotherinvestigationaldrugstudieswhileyouareinvolvedinthisstudy.
  • Youmustfollowtheinstructionsprovidedbytheinvestigator(s)/studycoordinator(s)andcometoallscheduledstudyvisitsandbereasonablyavailableforcontactbyphoneifneeded.
  • Youmustbringyourunusedstudymedication,allemptycontainers,andcompletedstudydiariestoeachofyourstudyvisitsaswellasanexplanationforanylostormissingstudymedication.
  • If you decide todropoutor are withdrawnfrom this studyyou will be askedtocomeinassoonaspossibleaftertakingyourlastdoseofstudymedicationandhaveafinalphysicalexamination.Thedoctorwillaskaboutanymedicationsyouaretakingandhowyouare feeling.
  • Youmaybeaskednottotakesomeofyourusualmedicationsforcertainperiodsofthestudy.Ifyouarenotabletogowithoutyourmedication(s)beforeyourappointment,youshouldresumeorcontinuetakingthemedicationsandrescheduleyourtestingdayappointment.
  • Ifduringthestudyachangeinyourusualmedicationsisnecessary;youareaskedtoinformthestudydoctorinadvance.Theinteractionwithcertainmedicationsandthestudydrugisunknownandcertainmedicationsarenotallowedinthisstudy.
  • Youmusttelltheinvestigator(s)/studycoordinator(s)aboutanychangesinyourhealthorproblemsthatyouarehaving.
  • Youmusttelltheinvestigator(s)/studycoordinator(s)aboutanymedicationsorremedies,includingnaturalorherbalproducts,whichyouaretakingeveniftheyareobtained without a prescription.

FurtherInformation

Youhavetherightatanytimetorequestinformationfromtheinvestigator(s)aboutyourcondition.Youmayalsorequestthatanyotherperson,includingyourpersonaldoctor,begiventhisinformationandacopyofthisform.

Duringthecourseofanyresearchproject,newinformationmaybecomeavailable.Ifthishappens,yourinvestigator(s)/studycoordinator(s)willtellyouaboutit,anddiscusswithyouwhetheryouwanttocontinuetakingpartinthestudy.Ifyoudecidetowithdraw,yourinvestigator(s)/studycoordinator(s)willarrangeforyourcontinuedcare.Ifyoudecidetocontinue takingpartyouwillbeasked tosign a newconsent form thatthelocal research ethicsboardcommitteehasapproved.

Undercertaincircumstancesyourinvestigator(s)orthesponsormaydecidetotakeyououtofthestudy.Circumstanceswhenthismayoccurinclude:

a)Youdonotfollowthedirectionsoftheinvestigator(s)/studycoordinator(s)fully;

b)Youdevelopaseriousillnessthatisnotrelatedtothestudy;

c)Yourinvestigator(s) decidesthatthe studyis notinyourbestinterests;

d)Thesponsor,theregulatoryagencyorethicscommitteedecidestostopthestudy;

e)Youbecomepregnant,intendtobecomepregnant,arenursingachildduringthisstudyorintendtofathera child.

Ifyoudofinishthestudyearlyforanyoftheabovereasonsyouwillbeaskedtoattendafinalvisittoensureyoursafetyandcompletethecollectionofstudydata.

PLEASETAKEACOPYOFTHISINFORMATIONANDCONSENTFORMHOMEWITHYOU

If you have any ethics concerns please contact the Queen’s University Health Sciences and Affiliated Teaching Hospitals Research Ethics Board (HSREB) at 1-844-535-2988 (Toll free in North America) or email the HSREB Chair at .

Ifyouhaveanyquestionsduringthestudy,orifyouexperienceanysideeffects,pleasecontact:

INSERTPRINICIALINVESTIGATOR’sNAMEandTELEPHONEHEREINSERTCO‐INVESTIGATOR(S)NAMEandTELEPHONEHERE INSERTSTUDYCOORINATOR’SNAMEandTELEPHONEHERE

INSERTBACK‐UPSTUDYCOORINATOR’SNAMEandTELEPHONEHEREINSERTDEPARTMENTHEAD’sNAMEandTELEPHONEHERE

HSREB Chair: 1-844-535-2988 (Toll free in North America)

APPENDIX1:SCHEDULEOFACTIVITIES

VISITS / Visit Number
ScreeningPeriodTreatment 1 Period Washout Treatment 2 Period
12345678
Study Days / ‐21to‐15 / ‐14 / ‐9to ‐4 / 0 / 21 / 36to
39 / 42 / 63
Informedconsent signed.* / X
Reviewof current medications used. / X
Reviewinclusion/exclusioncriteria with participant. / X / X / X / X
Medical history. / X
Demographics (race, date of birth,gender)recorded. / X
Smoking history andcurrent smokingstatus recorded. / X
Complete physicalexamination thatincludesblood pressure, oxygen levels,heartrate (pulse) check, weight,height. / X / X
Brief examination thatincludesbloodpressure, oxygen levels, heartrate(pulse) check, weight. / X / X / X / X / X / X
Reviewof anyside effectsor changes inmedical condition (i.e. adverse events)orchanges in medications sincelastvisit. / X / X / X / X / X / X / X
12‐lead electrocardiogram(an ECG to
lookat the participant’s heart activity). / X** / X** / X** / X / X / X / X / X
Blood andurineanalysis. / X / X / X / X / X
Pregnancy test(women only). *** / X / X
Questionnaires completed. / X / X / X / X / X
DiaryTraining. / X
Return andreviewof Diary. / X / X / X / X / X / X / X
Study drugprovided. / X / X
Return of studydrug. / X / X

*Theinformedconsentwillbesignedpriortoanystudyprocedureperformed. **Assessmentsconductedtofamiliarizeparticipantstostudytestprocedures.

***Thepregnancytestwillbeperformedonallwomenofchild‐bearingpotential unlessaparticipantis >60yearsold or>1yearpost‐menopausal orhadatotalorpartialhysterectomyortuballigation.

PARTICIPANTINFORMED CONSENT FORM

  • IhavereadandIunderstandtheinformationinthisformthatdescribesthepurposeandnatureof thisstudy.
  • Theinvestigatororhisdelegatehasdiscussedthisstudywithme.Ihavebeengivenampletimeandopportunitytoinquireaboutdetailsofthetrialandtodecidewhetherornottoparticipateinthetrial.Ihavereceivedanswersthatfullysatisfyallmyquestions.
  • IunderstandthatifIdonotparticipateorifIdiscontinuemyparticipation,IwillnotloseanybenefitsnorwillIloseanylegalrightsifIdecidetodiscontinue.
  • IunderstandthatmyparticipationinthisstudyiscompletelyvoluntaryandthatIamfreetowithdrawfromthisstudyatanytimewithouthavingtogiveareasonforwithdrawing.
  • Irealizethatitismyresponsibilitytoreporttotheinvestigator(s)/studycoordinator(s)allchangesinmyphysicalormentalconditionduringthestudy.
  • Havingread,initialed,anddatedall12pagesofthispatientinformationandconsentformandunderstandingtherequirementsofthestudy;mysignaturebelowindicatesthatIvoluntarilyconsenttoparticipateinthisstudyandallowaccesstomypersonalmedicalrecords,providedthatconfidentialityismaintained.
  • IunderstandthatIwillreceiveacopyofthispatientinformationandconsentform.

NotificationtoYourPhysician

Pleaseindicatebelowwhetheryouwantustonotifyyourprimarycarephysicianoryourspecialistofyourparticipationinthisstudy.

Yes, I wantmyprimary care physician/specialist informed ofmyparticipation.

No, I do not wantmyprimary care physician/specialist informed ofmyparticipation.I do not have aprimary care physician/specialist.

Theinvestigator(s) is myprimary care physician/specialist.

Participant NameParticipantSignatureDate(DD/MMM/YY)(Please print)

Nameof Person ConductingConsent / Signature of Person Conducting / Date(DD/MMM/YY)
Process (Please print) / Consent Process

Nameof Principal InvestigatorSignature of Principal InvestigatorDate(DD/MMM/YY)(Please print)

PLEASE PERSONALLY DATE YOUR SIGNATURE

StatementoftheInvestigator

Theabove‐mentionedparticipanthasbeenexplainedthenatureofthisstudy,theknownrisksandpossiblebenefitsinvolvedinparticipatinginthisstudy,thealternativetreatments,thathe/shehastheoptiontoparticipateinthisstudyandmaywithdrawatanytimewithoutaffectingtheirusualmedicalcare.

I,oroneofmymedicalcolleagues,willbeavailableatanytimeforemergencypurposes.

Nameof Principal InvestigatorSignature of Principal InvestigatorDate(DD/MMM/YY)(Please print)

* PLEASE PERSONALLY DATE YOUR SIGNATURE