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ResearchModule

Patient Education Manual

Leukemia / Bone Marrow Transplant (BMT)Program of British Columbia

BCCRCTerry Fox Lab, 13th Floor

675 West 10th Avenue

Leukemia / BMTAdministration

10th Floor

1. Leukemia/BMT Daycare Outpatient Unit

2. Cell Separator Unit (CSU)3. Outpatient Clinics4. Thrombosis Clinic

5. HRCTU6th Floor (Krall Centre)in Centennial Pavilion

Leukemia/BMT Inpatient Unit (T15A) Reception/Unit Clerk 604-875-4343

Leukemia/BMT Daycare Outpatient Unit (CP6 A/B) Reception/UnitClerk604-875-4073•Afterhours,calltheInpatientUnit604-875-4343

Cell Separator Unit – CSU (CP6 C) Reception604-875-4962•BookingClerk604-875-4626 AfterHourscallLocatingandaskfortheCSUnurseordoctoroncall604-875-5000

BMT Doctor(writeyourdoctor’snumberinhere)__________________________________

Hematology Research & Clinical Trials Unit (HRCTU) Supervisor 604-875-4111,local62887 Afterhoursemergencies,calltheInpatientUnit 604-875-4343 Fax 604-875-5552

HematologyCellBankofBC ProjectCoordinator 604-875-4111,local67409 Fax 604-875-5552

Social Workers T15InpatientUnitOffice 604-875-4941 CP6DaycareOutpatientUnitOffice 604-875-4697

Pharmacist 604-875-4077

Occupational Therapist 604-875-4343

Nutritionist 604-875-4343

Physiotherapist 604-875-4343

Leukemia/BMT Program Administration Office 604-875-4863

Medical Services Plan of BC and Fair Pharmacare 604-683-7151or1-800-663-7100

Leukemia/BMT Inpatient Unit (T15A) Reception/Unit Clerk 604-875-4343

Leukemia/BMT Daycare Outpatient Unit (CP6 A/B) Reception/UnitClerk604-875-4073•Afterhours,calltheInpatientUnit604-875-4343

Cell Separator Unit – CSU (CP6 C) Reception604-875-4962•BookingClerk604-875-4626 AfterHourscallLocatingandaskfortheCSUnurseordoctoroncall604-875-5000

BMT Doctor(writeyourdoctor’snumberinhere)__________________________________

Hematology Research & Clinical Trials Unit (HRCTU) Supervisor 604-875-4111,local62887 Afterhoursemergencies,calltheInpatientUnit 604-875-4343 Fax 604-875-5552

HematologyCellBankofBC ProjectCoordinator 604-875-4111,local67409 Fax 604-875-5552

Social Workers T15InpatientUnitOffice 604-875-4941 CP6DaycareOutpatientUnitOffice 604-875-4697

Pharmacist 604-875-4077

Occupational Therapist 604-875-4343

Nutritionist 604-875-4343

Physiotherapist 604-875-4343

Leukemia/BMT Program Administration Office 604-875-4863

Medical Services Plan of BC and Fair Pharmacare 604-683-7151or1-800-663-7100

Contents

Introduction 1

Frequently Asked Questions 2Whatisclinicalresearch? .......................................................................................................... 2

Whatisaclinicalresearchtrial? ................................................................................................. 2

Whycarryoutaclinicalresearchtrial? ...................................................................................... 3

Whatarethephasesofaclinicalresearchtrialandwhatdotheymean? ................................ 3

WhattypesofresearchtrialsarebeingconductedbytheLeukemia/BMTProgram? .............. 5

Whatisitliketobetreatedinaclinicalresearchtrial? ............................................................. 5

Howareresearchtrialpatientsprotected? .............................................................................. 6

Howismyconfidentialityprotectedinaresearchtrial? ........................................................... 7

WhataremyrightsifIparticipateinaresearchtrial? ............................................................... 7

AmIeligible? ............................................................................................................................. 7

WhatquestionsshouldIasktheresearchstaff? ........................................................................ 8

WhatquestionsshouldIaskmyselftodecideifentering aclinicalresearchtrialisrightforme? ...................................................................................... 9

WherecanIfindmoreinformation? ......................................................................................... 9

Hematology Cell Bank of British Columbia 11WhatistheHematologyCellBankofBC? ............................................................................ 12

Whyisresearchinblooddiseasesandcancersnecessary? ..................................................... 12

Whatistranslationalresearch? ................................................................................................ 13

MakingaDecision ................................................................................................................... 13

Feelingoverwhelmed? ........................................................................................................... 14

Whatkindofhumanspecimensarecollected? ....................................................................... 14

SpecimenDonation ................................................................................................................. 15

WhatifIchangemymind? ...................................................................................................... 15

ProvidingPersonalHealthInformation ................................................................................... 16

PrivacyandConfidentiality ...................................................................................................... 16

HematologyCellBankResearch ............................................................................................. 17

Introduction

The Leukemia/Bone Marrow Transplant (BMT) Program of British Columbia (BC) is committed to

advancingourknowledgeofblooddisordersandmeetingtheneedsofpatientsforwhomweprovide

care.Theadvancementofknowledgecanbeachievedthroughresearch.Researchcurrentlyongoingwithin

theLeukemia/BMTProgramincludestranslationalresearch viatheHematologyCellBankofBritishColumbia

(BC)andclinicaltrialsresearchthroughtheHematologyResearchandClinicalTrialsUnit(HRCTU).

Thepurposeofthisdocumentistohelpyouunderstandmoreabouthownewtreatmentsaredeveloped,

howtoevaluatethebenefitsandrisksofaclinicalresearchtrialforyourselfandwhatquestionstoaskto

decideifaclinicalresearchtrialisrightforyou.

Acknowledgement

TheHRCTUandLeukemia/BMTProgramofBCwouldliketoacknowledgepatientsfortheircontribution

toscientificknowledgeandadvancementinthetreatmentofblooddisorders.

Introduction

Discovery of newdrug in lab Drug tested in lab

and on animals

Health Canada approvesInvestigational New Drug

applications

The drug can now be testedon humans in a clinical trial

L/BMTPatientEducationManual•ResearchModule

Frequently Asked Questions

What is clinical research?Research is an incremental process that moves forward in small and carefully planned steps. Usually

researchbeginsasbasicscienceinthelabandafteryearsoftestingincellsandtissues,testingisdoneon

animalmodelsusinghumancells.Aftertreatmentsprovesuccessfulinanimals,thesetreatmentsmaybe

testedonpeoplethroughclinicalresearchtrials.

New Drug Development

2 33

Researchisan

incrementalprocess thatmovesforward insmalland

carefullyplanned steps.

What is a clinical research trial?Aclinicalresearchtrial isaresearchstudydesignedto

answerquestionsaboutthesafetyandeffectiveness

of a drug or treatment. These research trials

followarigorousscientificprocesswithbuilt-

in safeguards for patients who volunteer

andareselectedforresearch.Mostclinical

research involves the testing of a new

drug in anorderly seriesof steps, called

phases. The process starts with small

trialstestingthesafetyofatreatmentand

then moves towards progressively larger

trials. The larger trials compare the safety

and effectivenessof the new therapy to the

currentlyacceptedstandardofcare.

It is important to remember that in a clinical research

trial, researchers do not know if the new treatment will be

more effective than the current standard of care treatment.

Why carry out a clinical research trial?Inaclinicalresearchtrial,thefocusoftheresearchistofindoutif:

• anewtreatmentissafe

• anewtreatmentisbetter,thesame,ornotasgoodaswhatiscurrentlybeingoffered.

Clinicalresearchtrialsalsohelpscientistsandphysicianstoanswervariousquestionsaboutnewtherapies

suchas:Whatdiseasesshouldtheybeusedfor?Whatdoseofanewdrugismosteffective?Whichpatients

canbenefitmost?

Whennewtreatmentsprovetobesafeandeffective,theyaremadeavailabletothepublic.

What are the phases of a clinical research trial and what do they mean? Toparticipate in a clinical research trial,patientsmust firstmeet screeningcriteria.The tableson the

followingpagesprovidedetailsoneachphaseofaclinicalresearchtrial.

FrequentlyAskedQuestions2 33


Phase I Trials

Summary

•Earliesttrialsinthelifeofanewdrugortreatment

•Usuallysmallertrials;recruitmentislowfrom15to50patients

•SincePhaseItrialsareusuallythefirsttimeadrugisgiventoapatient, thefirstfewpatients,orcohorts,aregivenasmalldoseofthedrug.

•Thedoseisthengraduallyincreasedwitheachgroup.Theeffect ismonitoreduntilthebestdoseisdetermined.

•PhaseItrialsrequiresignificanttimecommitmentfrompatients becausetheyinvolvefrequentbloodtestsandsideeffectsmonitoring.

•Oftenpatientswithacancerthatlacksordoesnotrespondto standardtreatmentparticipate.

Objectives

•Todeterminesafedoserange

•Todeterminesideeffects

•Todeterminehowthedrugworksinthebody(pharmacologicbehavior)andhowthebodycopeswithandexcretesthedrug(pharmacokineticstudies)

•Todeterminehowwellthedrugworks(efficacy)

Benefits •Patientsmaynotdirectlybenefitfromparticipatingintheclinicalresearchtrial.

Risks •Unpredictablesideeffectscanoccur.

Phase II Trials

Summary

•Toevaluatetheeffectivenessinalargerpopulation, usuallylessthan100patients

•Oftenfocusoncancersforwhichnoeffectivetreatmentexists orthataremostlikelytoshowaresponsetotherapy

•Allpatientsreceivethesamedose.

Objectives•Toassesseffectivenessofdrugortherapy

•Toassessforadditionalsafetyinformation


Risks•Unpredictablesideeffectsmayoccur.

•Trialsareoftentooshorttodeterminelongtermbenefits.

4 55

Phase III Trials

Summary

•Largetrialswith100+patients

•Multi-centre,oftenglobal

•Survivaltimeandqualityoflifemeasured

•Subjectsare‘randomized’toagroup:theStudyGroup—receivingstudytherapy,ortheControlGroup—receivingstandardofcare.

Objectives •Todeterminewhetheranewtherapyordrugismoreeffectiveorhasfewersideeffectsthanstandardofcare


Risks•Newtreatmentsarenotalwaysbetterthanorevenasgoodasstandardofcare.

•Sideeffectsmaybeworsethanthoseassociatedwithstandardofcare.

•UnexpectedsideeffectsmayoccurdespiteprecedingPhaseIandPhaseIItrials.

What types of research trials are being conducted by the Leukemia/BMT Program?

•Drugtherapy:newchemotherapydrugsoranewcombinationofdrugs

•Targeteddrugtherapy:drugsdesignedtointerferewithcellfunctionsofspecific

cancercells,resultingincancercelldeath

•Stemcelltransplantationprocedures

•Supportive therapy: treatments to reduce disease or treatment-related side

effectssuchasinfection

•Translationalresearch(seeHematologyCellBankofBritishColumbiasectiononpage11)

What is it like to be treated in a clinical research trial?Theclinicalresearchtrialprocessdependsonthekindoftrialbeingconducted.Theresearchteamincludes

doctors,nursesandotherhealthcareprofessionals.Theycheckthehealthofthepatientsatthebeginning

ofthetrial,givespecificinstructionsforparticipatinginthetrial,monitorthepatientscarefullyduringthe

trial,andstayintouchafterthetrialiscompleted.Someresearchtrialsinvolvemoretestsanddoctorvisits

thanthepatientwouldnormallyhaveforanillnessorcondition.Foralltypesoftrials,thepatientworks

witharesearchteam.Clinicalresearchtrialparticipationismostsuccessfulwhentheresearchprotocolis

carefullyfollowedandthereisfrequentcontactwiththeresearchstaff.


Beforeatrialcangoahead,the

EthicsBoardmustbesatisfiedthattheresearchtrialaddressesanimportantscientificquestion,iswellplanned,isassafeaspossibleforthepatients,andisethicallysound.


How are research trial patients protected?All researchprotocols inCanadaareconductedaccording toGoodClinicalPractice (GCP).GCP is an

internationalethicalandscientificqualitystandard.Itprovidesguidanceforthedesign,conduct,performance,

monitoring,auditing,recording,analyses,andreportingofclinicalresearchtrials.GCPprovidesassurance

thatthedataandreportedresultsarecredibleandaccurate,andthattherights,integrity,andconfidentiality

oftrialsubjectsareprotected.

Beforearesearchprotocolcanbeputintopractice,itmustobtaintwolevelsofapproval:HealthCanada

(nationalregulatoryagency)andanindependentEthicsCommittee.Approvalatthesetwolevelsensures

thattheresearchprotocolisscientificallysound,thatitadherestoGCPandlocalregulationsandthatthe

safety of the patient is not jeopardized (i.e., the potential benefits outweigh the

risksassociatedwiththenewdrug).EthicsCommitteesarecomposedofan

independentgroupofprofessionalsdesignatedtoreviewandapprovethe

research protocol, InformedConsent Forms, study advertisements,

andpatientbrochurestoensurethatthestudyissafeandeffective

forhumanparticipation.

In the Leukemia/BMT Program, a committee of nurses and

doctors reviews all clinical research trials proposed by the

Leukemia/BMTProgram.ThepurposeoftheReviewCommittee

istoensurethattheresearchtrialsmeettheneedsofpatients

in the Leukemia/BMT Program. Once the research protocol

has been accepted by the Leukemia/BMT Program Review

Committee,theresearchprotocolmustthenbeapprovedby

theEthicsBoard.Beforeatrialcangoahead,theEthicsBoard

mustbesatisfiedthattheresearchtrialaddressesanimportant

scientificquestion,iswell-planned,isassafeaspossibleforthe

patients,andisethicallysound.

Before participating in any clinical research trial, patients must

sign a consent form to ensure that they are fully informed and

thoroughlyunderstandtheresearchprotocolandtherisksandbenefits

oftheirparticipation.

6 77

Takingpartin

researchisvoluntary.

FrequentlyAskedQuestions

How is my confidentiality protected in a research trial?

What is PIPEDA?

ThePersonal InformationProtection andElectronicDocumentsAct (PIPEDA) is partof theCanadian

PrivacyLawandestablishesprinciplesforthecollection,use,anddisclosureofpersonalandidentifiable

information that is part of commercial activity (e.g., physician practices, pharmacies, private labs,

pharmaceuticalcompanies,etc.).PIPEDArequiresobtainingconsent for thecollectionofpersonaland

identifiable information, informing researchpatientsof theirprivacy rights andproviding themwithan

opportunitytoknowwhatpersonalinformationisbeingcollected,forwhatpurpose,howitwillbeused,

disclosed,andprotected.

Yourmedicalinformationisconfidential,butindividualsinvolvedinmonitoringtheconductoftheresearch

andrecordinginformationonthetreatmentsmayneedtoaccessyourrecordsinthepresenceofhospital

research peronnel. These individuals may be representatives of the research sponsors, such as the

NationalCancerInstituteofCanada(NCIC)orthedrugcompanysupplyingthetrialdrug.Theymayalso

berepresentativesfromregulatorybodiessuchasHealthCanada’sHealthProtectionBranch.

Anyformsorpaperworkrecordingyourinformationandresultswillidentifyyoubyacodenumberonly,

andyournamewillneverappearinanypublicationsresultingfromtheresearch.

What are my rights if I participate in a research trial?Youdonotwaiveorsignawayyourlegalrightsbysigningconsenttoaresearch

trial.Takingpart inresearch isvoluntary.Thismeansyoumaychoosenot

totakepart,ormaywithdrawyourconsentandleavetheresearchtrialat

anytime.Ifyouwithdrawfromordeclinearesearchtrial,yourdoctorwill

discussfurthertreatmentswithyouandcontinuetotreatyourdiseasewith

thebestmeansavailable.Ifthereareotherclinicalresearchtrialopportunities

relevanttoyoulaterinyourtreatment,thesewillbeofferedtoyou.

Am I eligible?Inadditiontoyoudecidingwhethertheresearchtrialisrightforyou,yourhematologistwillhavetomake

sureyouare right for theresearch trial.Allpatientsmustmeet theeligibilitycriteriaaswritten in the

researchprotocol.Aftertheconsentformissigned,teststodeterminethestatusofyourdiseaseandother

baselinetests,suchasblood,urine,orhearttestsmaybenecessarytodetermineyoureligibility.

6 77

Questions to Ask

Yourself•DoIfeelcomfortable

receivingatreatmentwhoserisksandbenefitsaresomewhatunknown?

•CanIdedicatethetimeneededtoparticipateinthisresearchtrial?

•WillIbeabletomanageiftakingpartintheresearchtrialmeansImightmissmorework?

•AmIsatisfiedthatmydecisionisrightforme,andnotadecisionthatisbeingmadeto

pleasesomeoneelse?

•DoIhavesupportivefamily,friendsorcaregiverswhocanhelpmeifIexperiencespecialproblemssuchasnausea,tiredness,headaches,

diarrhea?


What questions should I ask the research staff?•Whattreatmentoptionsareavailabletome?

•Whyisthisresearchbeingdone?Whatotherclinicalresearchtrialswiththis

medicationhavebeendone?

•WillIgetaplacebo?

•WhatinconvenienceswouldIfaceaspartofparticipatinginthetrial?

•Howmuchadditionaltimeisrequiredtoparticipateinthistrial?

•Howlongistheresearchtrial?

•WillIhaveresponsibilitiessuchaskeeping

arecordorfillingoutformsaboutmy

health?

•Whatarethemainsideeffectsofthe

researchmedication?

•Whatarethepossibleriskstome,

comparedtostandardtreatment?

•Whataretheprosandconsof

participatinginthisclinical

researchtrial?

•Willtherebereasonable

reimbursementofthe

costofmytravelfor

researchvisits?

•WhatifIchange

mymind?

•Whathappenswhen

theresearchisover?

•CanItakemyregular

medicationswhile

participatinginthis

research?

8 99

What questions should I ask myself to decide if entering a clinical research trial is right for me?

•DoIfeelcomfortablereceivingatreatmentwhoserisksandbenefitsaresomewhatunknown?

•CanIdedicatethetimeneededtoparticipateinthisresearchtrial?

•WillIbeabletomanageiftakingpartintheresearchtrialmeansImightmissmorework?

•AmIsatisfiedthatmydecisionisrightforme,andnotadecisionthatisbeingmade

topleasesomeoneelse?

•DoIhavesupportivefamily,friendsorcaregiverswhocanhelpmeifIexperience

specialproblemssuchasnausea,tiredness,headaches,diarrhea?

Where can I find more information?Additionalinformationcanbefoundonthefollowingwebsites:

• BC Cancer Agency www.bccancer.bc.ca

•BC Cancer Agency Research Ethics Board www.bccancer.bc.ca/RES/REB/default.htm

•Health Canada – Drug & Health Products www.hc-sc.gc.ca/dhp-mps/prodpharma/index_e.html

• Canada Trials www.canadatrials.com

•Canadian Cancer Society http://www.cancer.ca/Canada-wide/Aboutcancer/Treatment/Clinicalresearchtrials.aspx?sc_lang=en

• Leukemia & Lymphoma Society: Fighting Blood Cancers www.LLS.org

•ICH Guidance E6: Good Clinical Practice: Consolidated Guidelines http://www.hc-sc.gc.ca/dhp-mps/prodpharma/applic-demande/guide-ld/ich/efficac/e6-eng.php#1

•Dana-Farber Cancer Institute www.dana-farber.org

•Clinical research trials.gov www.clinicaltrials.gov

•Centerwatch www.centerwatch.com

•US Food & Drug Administration (FDA)

www.fda.gov/oashi/clinicaltrials/clintrialdoc.html


Notes

L/BMTPatientEducationManual•ResearchModule 10


Hematology Cell Bankof British Columbia

10

Donatingresearchspecimens

iscompletelyvoluntaryandyouarefreetodecline.


What is the Hematology Cell Bank of BC? TheHematologyCellBankofBCisabankthatstoreshumanspecimens.Thesespecimensmayinclude

samplesofblood,bonemarrowandothertissues.Wecallthebanka‘CellBank’becauseit isthecells

withinthebloodandbonemarrowthatarestoredandusedbyscientistsforresearchpurposes.

Withyourwrittenconsent, specimensarecollectedwhena routinemedicalprocedure, suchasblood

work,isperformed.ThespecimensarestoredintheCellBankforscientiststouseforresearch.Specimens

donated to the bank are not used for blood transfusions or for transplant purposes. These donated

specimensareusedsolelyforresearchpurposes.

ScientistswhowishtousespecimensstoredintheCellBank

mustmeet the requirements of the BCCancerAgency

ResearchEthicsBoard(anindependentethicsboardthat

reviewsallscientificresearchprojectsthatusehuman

specimens). The researcher must also demonstrate

to a scientific review committee that their work has

scientificmerit.

Atthetimeofyouradmissiontohospitalorwhenyouvisitthe

medicalclinic,youwillhaveanopportunitytoreadtheconsentformfor

theHematologyCellBankofBCanddecideifyouwouldliketoparticipateinthisresearch.Yourphysician

oraclinicalresearchnursewillmeetwithyouandansweranyquestionsyoumayhave.Youarefreeto

discussthiswithyourfamilyorclosefriends.Whateverdecisionyoumakeaboutdonatingspecimens,your

treatmentwillremainthesame.

Donatingresearchspecimensiscompletelyvoluntaryandyouarefreetodecline.

Why is research in blood diseases and cancers necessary?

What can research tell us?

“Samplesofbonemarrowandbloodcellsfromhealthydonorsandpatientswithmalignantdisease,like

leukemia, are extremely important to researchers….Obtaining new understanding about healthy and

malignantbloodcellsandinvestigatingtheircommonanduniquepropertiesarekeystrategiestodeveloping

newandmoreeffectivewaysoftreatingpatientswithblooddisordersormalignancies.”

Dr. Connie Eaves, Senior Scientist, Terry Fox Lab

Everydaythebodynormallyproducesbillionsofnewwhitebloodcells,redbloodcells,andothercells.

Occasionally,somethinggoeswrongwiththegrowthandbehaviourofthebloodcellsandablooddisease

orcancerdevelops.Currently,notmuchisknownabouthownormalbloodcellsbecomediseasedorturn

12 1313

“Samplesofbonemarrow

andbloodcellsfromhealthydonorsandpatientswithmalignantdisease,likeleukemia,areextremely

importanttoresearchers….

Obtainingnewunderstandingabouthealthyandmalignantbloodcellsandinvestigatingtheircommonanduniquepropertiesarekeystrategiestodevelopingnewandmoreeffectivewaysoftreatingpatientswithblooddisordersormalignancies.”

Dr.ConnieEaves,SeniorScientist,

TerryFoxLab

What can research tell us?

TheHematologyCellBankofBC

into cancers. Scientists research the development of disease

andcancerinthebloodtohelpunderstandhowthebloodcells

growandtohelpdevelopsaferandmoreeffectivetreatments.

What is translational research?Youmayhearyourphysicianorresearchersinthemedia

talkabout ‘translationalresearch’orsometimesthis

maybereferredtoas‘benchtobedside’research.

Whatdoesthismean?AsdefinedbytheNational

Cancer Institute, “Translational research is a

termused to describe the process bywhich

theresultsofresearchdoneinthelaboratory

are used to develop new ways to diagnose

and treatdisease.” Suchdiscoveries typically

begin at the ‘bench’ with basic research in

the laboratory and then progresses to the

clinicallevel,orthepatient’s‘bedside’withnew

treatments.Scientistsprovideclinicianswithnew

tools to help treat patients and clinicians provide

scientistsaccesstospecimensandclinicaldatatohelp

furtherresearch.

Making a DecisionYoumaybe feelingveryoverwhelmedbyyourrecentdiagnosisandhospitalization.Thephysiciansand

nursesunderstandthatthisisaverydifficulttimeforyouandyourfamily.Youmaybeapproachedtomake

severaldecisionsregardingtreatmentandresearchparticipationwithverylittletimetoconsidereither.

Everyeffortwillbemadetorespectyourneedsatthistime.Weencourageyoutoinvolveyourfamilyin

discussionsabouttreatmentandresearch.

Sometimes, decisions about treatmentorparticipation in researchneed tobedecided in a very short

periodof time.Treatmentmaybeginsoonafteryouareadmittedtohospital.Youmaybeadmittedto

hospital with little warning or preparation. Specific tests may be required to further determine your

eligibilitytoparticipateinresearchtrialstotreatyourdiseaseandresearchersstudyingyourdiseasemay

needspecimensbeforeyoubegintreatment.Thismayrequirethatyoumakethesedecisionsthedayyou

areadmittedtohospitalorthedayyouhavebeengivenadiagnosisofyourdiseasebyyourphysician.

12 1313

Thephysiciansandclinical

researchnursesspeakingwithyouabouttreatmentandresearchparticipationunderstand

thatyoumay befeelingoverwhelmed.

Feelfreeto askquestions.

Feeling Overwhelmed?


Feeling overwhelmed? Thephysiciansandclinicalresearchnursesspeakingwithyouabouttreatmentandresearchparticipation

understandthatyoumaybefeelingoverwhelmed.Feelfreetoaskquestions.

What kind of human specimens are collected?

Samples from Patients

Youmayhaveonetypeofspecimencollectedorseveraltypes.Specimensmaybecollectedatdifferent

periodsthroughoutyourtreatmentwiththeL/BMTProgram.Thesespecimensmayinclude:

•Bloodsamples

•Bonemarrowmaterial

(frombonemarrowbiopsy

proceduresorbonemarrow

harvest)

•Peripheralbloodstemcells

•Leukapheresissamples(Leukapheresisisa

proceduretoreducethewhitebloodcell

count)

Samples from Healthy Donors

Specimensdonated fromhealthy individuals

help scientists understand how healthy

bloodcellscomparetodiseasedbloodcells.

Thesespecimensmaybedonatedbyyour

familymemberoranunrelateddonoratthe

timetheyaredonating foryour transplant.

With their consent, a specimen will be

collected and stored in the Cell Bank for

scientificresearch.Removingthesespecimens

fromthedonationwillnotinanywayaffectyour

transplant.Thesespecimensmayinclude:

•Bloodsamples

•Peripheralbloodstemcells

14 1515

Specimensarecollectedatthe

timeyouarescheduledtohaveapre-plannedproceduresothatonlyoneneedlepokewillberequiredtocollect

thesespecimens.


Specimen Donation

What to Expect

Withyourconsent,specimensofbloodandbonemarrowmaterialwillbecollectedatthetimeyouare

scheduledforbloodcollection,abonemarrowbiopsyorbonemarrowharvest.Thephysicianornurse

collecting the specimenwill concentrateoncollecting specimens that are required foryour treatment

or diagnosis first, research specimens will be collected after these

importantspecimensareobtained.

Specimensarecollectedatthetimeyouarescheduledto

haveapre-plannedproceduresothatonlyoneneedle

pokewillberequiredtocollectthesespecimens.

If you are donating peripheral blood stem cells

foratransplant,asamplewillbetakenfromthe

collection bag. Youmay be asked to have one

additional blood sample collected outside of a

pre-plannedprocedure,butyouwillnotbeasked

to have additional bone marrow biopsies or stem

cell collectionprocedures. Sometimes youmay require

aprocedurecalledleukapheresistoreduceyourwhiteblood

cell count.Thewhiteblood cells collected from this proceduremay

alsobedonatedtotheCellBank.

What if I change my mind?•Yourparticipationisentirelyvoluntary.

•Youmaywithdrawatanytime.

•Your decision not to participatewill not affect the treatment you receive as a

patientoftheL/BMTProgram.

•Nofurtherspecimenswillbecollectedfromyou.

•Specimensalreadycollectedmaybedestroyeduponyourrequest.

•Specimensalreadyreleasedtoascientistwillnotbedestroyed.

14 1515

Theremaybetimeswhena

scientistmayneedtoknowmoreaboutyou.Providingpersonalhealthcareinformationhelpsthescientistlearnmoreaboutthediseaseandhowithasaffectedyou.


Providing Personal Health Information

Why do I need to provide information from my health records?

Theremaybe timeswhena scientistmayneed toknowmoreabout you.This informationhelps the

scientistlearnmoreaboutthediseaseandhowithasaffectedyou.Theinformationascientistmayneed

mayinclude:

•Thedateofyourdiagnosis

•Yourdiagnosis

•Yourage

•Yourgender

•Yourgeneralhealthhistory

•Thetreatmentyouhaveorwillreceive

•Yourfamilyhealthhistory

Privacy and Confidentiality

How will my privacy be protected?

Every effort will be made to protect your privacy. Each

specimendonatedby youwill be given a codenumber.All

information that identifies youwill be removed.All scientists

who require further health information about you sign a

confidentiality agreement. No information identifying you will be

releasedinpublicationsorgivenatpresentationsdescribingtheresearch

work.All information that identifies youwillbekeptbehind lockeddoorsor in

securepasswordprotectedcomputerfiles.Allrequestsforclinicaldatawillbecloselyprotectedunderthe

oversightoftheHematologyCellBankofBC.

Researchrecordsandmedicalrecordsidentifyingyoumaybeinspectedinthepresenceofrepresentatives

ofHealthCanadaandtheBCCAResearchEthicsBoardforthepurposeofmonitoringtheresearch.

16 1717

What ifI change

mymind?

•Yourparticipationisentirelyvoluntary.

•Youmaywithdrawatanytime.

•Yourdecisionnottoparticipatewill notaffectthetreatmentyoureceive asapatientoftheL/BMTProgram.

•Nofurtherspecimenswillbe collectedfromyou.

•Specimensalreadycollectedmaybedestroyeduponyourrequest.

•Specimensalreadyreleasedtoascientistwillnotbe

destroyed.


Hematology Cell Bank Research

Can I decide what research my specimens will be used for?

Youwillnotbeabletodecidethespecificresearchyour

specimenswillbeusedfor,justaswhenyoudonatebloodto

abloodbank,youcannotdecidewhichpatientwillreceive

thatblood.Theuseofyourspecimenswillbereviewed

byapanelofresearchscientistsandclinicians.They

will review the scientist’s research proposal

to determine the use of the specimens. All

researchproposalsareapprovedbytheBC

CancerAgencyResearchEthicsBoard(an

independent ethics board that reviews

all scientific research projects that use

humanspecimens).

Will I know the results of the research using my specimens?

Researchusinghumanspecimenscan

take a long time. The results of the

researchmaynotbedetermined for

manyyears.Youwillnotbeinformed

of the results of that research, but

may hear of important discoveries

throughyourphysician.Recentresearch

publicationsarepostedonourwebsiteat

www.leukemiabmtprogram.com.

16 1717

Notes


Cited with Permission

Someinformationinthisbookletiscitedwithpermissionby:

•BCCancerAgency

•www.canadatrials.com

•Dana-FarberCancerInstitute

•TheLeukemia&LymphomaSociety(LLS)

18

Disclaimer:

Pleasenotethattheinformationcontainedinthismanualisnotintendedtoreplacetheadviceofyourhealthcareteam.

Usethisasareferenceandeducationguide.Consultyourhealthcareteamifyouhaveanyquestionsorconcerns.

18


Mailing Address:

Leukemia/BMTProgramAdministration

10thFloor,2775LaurelStreet

Vancouver,BC

V5Z1M9

Telephone:

604-875-4863

Web Site:

www.leukemiabmtprogram.com

©2010Leukemia/BMTProgramofBC

FirstEdition:April2010