Post on 20-Mar-2018
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
L/BMTPatientEducationManual•ResearchModule
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
Benefits •Patientsmaynotdirectlybenefitfromparticipatingintheclinicalresearchtrial.
Risks•Unpredictablesideeffectsmayoccur.
•Trialsareoftentooshorttodeterminelongtermbenefits.
4 55
Phase III Trials
Summary
•Largetrialswith100+patients
•Multi-centre,oftenglobal
•Survivaltimeandqualityoflifemeasured
•Subjectsare‘randomized’toagroup:theStudyGroup—receivingstudytherapy,ortheControlGroup—receivingstandardofcare.
Objectives •Todeterminewhetheranewtherapyordrugismoreeffectiveorhasfewersideeffectsthanstandardofcare
Benefits •Patientsmaynotdirectlybenefitfromparticipatingintheclinicalresearchtrial.
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.
FrequentlyAskedQuestions4 55
Beforeatrialcangoahead,the
EthicsBoardmustbesatisfiedthattheresearchtrialaddressesanimportantscientificquestion,iswellplanned,isassafeaspossibleforthepatients,andisethicallysound.
L/BMTPatientEducationManual•ResearchModule
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?
L/BMTPatientEducationManual•ResearchModule
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
FrequentlyAskedQuestions8 99
Notes
L/BMTPatientEducationManual•ResearchModule 10
Leukemia / Bone Marrow Transplant (BMT)Program of British Columbia
Hematology Cell Bankof British Columbia
10
Donatingresearchspecimens
iscompletelyvoluntaryandyouarefreetodecline.
L/BMTPatientEducationManual•ResearchModule
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?
L/BMTPatientEducationManual•ResearchModule
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.
TheHematologyCellBankofBC
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.
L/BMTPatientEducationManual•ResearchModule
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.
TheHematologyCellBankofBC
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
L/BMTPatientEducationManual•ResearchModule
Cited with Permission
Someinformationinthisbookletiscitedwithpermissionby:
•BCCancerAgency
•www.canadatrials.com
•Dana-FarberCancerInstitute
•TheLeukemia&LymphomaSociety(LLS)
18
Disclaimer:
Pleasenotethattheinformationcontainedinthismanualisnotintendedtoreplacetheadviceofyourhealthcareteam.
Usethisasareferenceandeducationguide.Consultyourhealthcareteamifyouhaveanyquestionsorconcerns.
18
Leukemia / Bone Marrow Transplant (BMT)Program of British Columbia
Mailing Address:
Leukemia/BMTProgramAdministration
10thFloor,2775LaurelStreet
Vancouver,BC
V5Z1M9
Telephone:
604-875-4863
Web Site:
www.leukemiabmtprogram.com
©2010Leukemia/BMTProgramofBC
FirstEdition:April2010