Adebamowo-Perspectives-on-Biobanking

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Biobanks)and)Genomics)– Perspectives)from)Africa
Clement)Adebamowo)
MD)FACS)FWACS) DSc
Chairman)of)National)Health)Research)Ethics)Committee) of)Nigeria,)Federal)Ministry)of)Health,)Abuja,)FCT,)NigeriaJ
PI)West)African)Bioethics)Training)ProgramJ)
Professor)of)Cancer)Epidemiology,)Department) of)Epidemiology)and)Public)Health,)
Associate)Director)(Population) Sciences))Greenebaum)Cancer)Center,)Member)of)the)Institute)of)Human)Virology,)University)of)Maryland)
School)of)Medicine,)Baltimore,)MD)21201
cadebamowo@som.umaryland.edu
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Characteristics, of,African,health,research,
environment, and,their,implication,for,research
• Health,indices,,resources,and,access
– Poor,health,indices
– Poor,health,infrastructure
– Limited,access,to,good,quality,health,care
• Patterns,of,diseases,and,health
– Persistent,communicable,diseases
– Rapidly,progressing,nonBcommunicable,diseases,epidemic
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Characteristics,of,African,health,research,environment,and,
their,implication,for,research
• SocioBeconomic,parameters
– Poverty,and,rapid,transformation,in,income,levels
– Urbanization,– reduced,physical,activity,,changing,diet
– Religion,,culture,and,practices
• Education
– Low,levels,of,health,professionals’,knowledge,about,
genomics
– Low,levels,of,general,population’s,knowledge,about,
health,in,general,and,genomics,in,particular
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Biobanks
• Biobanks,are,now,an,increasingly,common,tool,of,biomedical,
research,throughout,the,world
• While,pathology,laboratories,in,Africa,have,often,stored,residual,
tissue,samples,from,biopsies,and,autopsies,for,long,periods,after,
primary,utilization,,and,used,such,tissues,in,research,,the,
modern,concept,of,biobanks,is,new,to,the,continent
• A,characteristic,of,most,prospective,biobanks,is,that,samples,and,
data,are,collected,for,longBterm,future,use,,not,just,for,a,single,
project
• At,the,time,of,establishment,of,collections,of,samples,and,
related,data,,it,is,not,known,and,it,is,impossible,to,anticipate,all,
the,studies,may,eventually,use,this,resource
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Genomic,research,and,biobanking,in,Africa
• Given,that,African,research,currently,accounts,for,2.5%,of,global,
health,research,despite,having,most,of,the,intractable,and,emerging,
health,problems,,it,is,important,to,ensure,that,biobanking,and,
genomics,research,are,used,to,effectively,contribute,to,African,
research,enterprise,because:
– Genomics,research,supported,by,biobanking,offer,pathways,to,
new,solutions,for,Africa’s,old,public,health,problems,– HPV,DNA,
testing,is,better,than,Pap,smear,in,reducing,mortality,from,
cervical,cancer,B NEJM.,2009;,360:,1385B94
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Genomic,research,and,Africa
– Results,of,genomics,research,in,Africa,informs,understanding,and,
application,of,research,in,other,populations,B Variation,in,APOL1,
gene,may,contribute,to,high,rates,of,kidney,disease,in,African,
Americans,Science.,2010;,329:,841B5
– Genomics,research,has,potential,to,contribute,to,reduction,in,
global,health,inequalities,through,“an,enhanced,translational,
genomics,and,population,sciences,agenda”,CEBP,2011;,20:,2105,B
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– Genomics,research,tends,to,be,a,catalyst,for,systemBwide,
innovation,,interest,and,investment,in,medical,research,in,general
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Genomic,research,and,biobanking,in,Africa
• Biobanking,as,part,of,research,in,Africa,is,required,because,of:
– Role,of,Africa,in,human,ancestry
– Huge,genomic,,socioBeconomic,,cultural,(diet,,religion,,
practices),,climatic,heterogeneity,on,the,continent,and,their,
impact,on,health,and,diseases
– Potential,for,huge,contributions,to,understanding,disease,
pathways,,new,approaches,to,treatment,and,prevention,,
drug,discovery,and,pharmacogenomics
– Widespread,use,and,contribution,of,genomics,research,in,
developed,countries
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Medical,records,and,health,databases
• Most,African,health,care,systems,are,plagued,by,challenges,with,
recording,and,maintaining,health,databases
• Health,systems,in,Africa,were,traditionally,set,up,and,funded,to,
respond,to,acute,illnesses,such,as,infectious,diseases,and,trauma,
and,not,to,complex,diseases,that,require,long,term,management,
and,follow,up
• There,has,therefore,been,minimal,investment,in,health,databases,
and,medical,records
• Recent,interventions,like,PEPFAR,led,to,creation,of,large,databases,
often,targeted,to,meeting,reporting,requirements,of,funding,
agencies
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Controversies, B Power,disequilibrium, at,individual,level,
• Concern,about,the,perceived,“value”,of,the,contributions,of,the,
individual
– For,example,how,do,we,compare,the,contributions,,recognitions,and,
rewards,given,to,
• (a),Raji,– an,11,year,old,Yoruba,boy,with,Burkitt’s,lymphoma,
whose,cells,,in,1963,,gave,rise,to,the,Raji,cell,line,– the,first,
continuous,human,cell,line,of,hematopoietic,origins,(Pulvertaft,
JV.,Cytology,of,Burkitt’s,tumour,(African,lymphoma).,Lancet,1:,
238B240,,1964),with,
• (b),the,anonymous,Yoruba,participant,in,the,first,phase,of,the,
International,HapMap,project,who,genome,was,one,of,the,first,to,
be,completely,sequenced,and,
• (c).,Henrietta,Lacks,of,HeLa,cells,fame
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Controversies,– diminution,of,the,value,assigned,to,individuals,
and,to,community,particularly,when,data,is,deBidentified,or,
anonymized
• Where,am,I?,
• Where,are,we?,
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Controversies, – Trust,as,the,most,important,ethical,basis,for,
participation, in,research,
• Trust,– is,the,commonest,reason,we,found,why,people,participate,in,
genomics,research.
• Yet,,these,are,often,people,who,have,little,trust,in,their,government,or,
political,systems
• The,manifestation,of,trust,within,the,research,context,is,highly,nuanced
• Significant,variations,exist,between,communities,in,the,expression,and,
manifestations,of,this,trust
• Has,not,received,as,much,or,as,rigorous,an,evaluation,as,required,
because,it,is,difficult,to,study,objectively
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Challenges,– Trust,and,consent
• Majority,of,the,respondents,supported,the,use,of,broad,consent,
for,biobank research,,while,a,significant,minority,prefer,tiered,
and,restricted,consent,approach,because,they,want,to,receive,
feedback,on,donated,samples,and,would,like,to,know,the,
research,that,could,be,done,with,their,specimen,in,the,future
– I»prefer»the»tiered»consent,»but»may»thereafter»give»a»broad»consent»if»I»
am»given»feedback»on»what»has»been»done»with»my»specimen.Male,
Medical,Doctor,urban,B6,– Kano
– I»would»like»to»be»informed»before»my»specimen»is»used»for»another»
research»(i.e.»tiered»consent).»Even»when»I»have»moved»away»from»my»
previous»location,»inquiries»should»be»made»at»my»previous»location»for»
my»where»about.
Male,Spokesperson,rural,D1,B Enugu
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Challenges,– Trust,and,consent
• Since»I»would»not»give»broad»consent,»I»will»not»permit»sharing»of»my»
specimen.»The»other»group»of»researchers»should»approach»me»for»use»of»
my»specimens.»I»will»have»no»objection»if»you»want»to»take»it»abroad»for»
analysis,»provided»other»participants»allow»that.
Male,Community,Leader,urban,B4,– Kano
• For»me»there»no»problem»if»you»share»my»specimen»with»other»researchers.»
For»example»when»I»was»doing»my»diploma» programme,»I»went»to»another»
place»to»obtain»my»data»and»they»agreed»to»share»with»me.»If»I»have»a»
disease»and»they»want»to»take»my»specimen»abroad,»they»should»let»me»
know.»Though,»my»reason»is»to»get»the»information» so»that»I»can»seek»for»
solution.
Male,Spokesperson,rural,C14,B FCT
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Controversies, B Intersection, between, culture,
and,biobanking
• The,banking,of,body,fluids,and,tissues,may,raise,significant,
concerns,at,the,intersection,of,science,,religion,and,culture.,
Illustrative,experience,of,use,of,umbilical,cord,blood,for,
research
• Certain,biological,samples,have,very,high,and,significant,
cultural,values
• Research,and,banking,of,such,samples,raise,significant,
cultural,and,ethical,concerns,in,the,community
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• Lay»opinion»about»the»afterbirth
– Umbilical»cord»or»afterbirth»is»a»dangerous»thing»to»play»with»in»Yoruba»land,»since»it»
connects»the»»child»to»the»mother,»Yoruba»believe»that»how»it»is»handled»can»change»the»
destiny»of»a»child.
– That»is»what»many»pregnant»women»fear»during»childbirth and»they»are»eager»to»collect»
the»umbilical»cord»and»after»birth»and»give»it»to»the»father»of»the»child»(husbands).
– Yoruba,says “ki aye»ma»fi»bi»omo mu»wa”»– (May»we»not»be»vulnerable»to»our»enemies»
through»the»umbilical»cord)
• A,traditional,religion,priest,
– burning»the»umbilical»cord»is»best»thing»to»do»and»it»must»done»when»people»are»not»
around,»may»be»in»the»night»at»a»location»that»is»wet,»so»that»that»child»life’s»will»be»cool»
and»prosperous.
• A,Senior,Nursing,Officer
– the»importance»of»the»afterbirth»is»that»after»a»woman»has»had»sex»with»a»man»and»
missed»her»period,»God»will»put»the»placenta»beside»the»fetus»and»this»brings»about»the»
cordial»relationship»between»mother»and»child»that»is»responsible»for»the»child’s»breath»
and»the»child’s»feedings
Controversies,B Intersection,between,culture,and,biobanking
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Controversies, – Sharing,of,biological,samples
• Sample,export,and,ownership
– Research,participants,often,express,concern,about,transfer,of,
samples,to,specific,countries,and,use,in,specific,types,of,research
– My»consent»has»to»be»obtained»again»before»you»share»my»
specimen»with»other»researchers.»I»am»a»health»worker»I»know»
what»am»heading»to. B Male,Medical,Doctor,urban,D9,B Enugu
– You»can»share»my»specimen»with»other»researchers,»I»do»not»have»
problem»with»that.»You»may»also»take»the»samples»to»others»
countries»as»long»as»it»is»not»used»for»human»cloning»and»things»
that»Christianity»will»frown»at.»Female,Pharmacist,Urban,D18,B
Enugu
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Controversies, – feedback,of,results
• Participants,in,general,wanted,some,form,of,feedback.,Where,
the,results,of,the,research,is,likely,to,be,related,to,heritable,
treatable,or,untreatable,serious,illness,,participants,strongly,
favoured,return,of,results
– I»need»feedback»on»my»result.»Since»I»will»give»you»my»specimen»on»trust,»I»
will»require»feedback,»and»if»it»is»not»done»I»will»be»worried.
Male,Traditionalist,and,previous,research,participant,urban,A8,
– It»is»important»for»me»to»know,»if»the»biobank»discover»something»serious»
about»my»health,»they»should»let»me»know.»
Female,Pharmacist,Urban,D18,– Enugu
– I»should»be»given»counselling»before»am»given»any»feedback.»It»should»
involve»preNcounselling.Male,Medical,Doctor,urban,D9,B Enugu
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Controversies, – Impact,of,religion
• Christians,and,Muslims,alike,wanted,their,religion,to,be,taken,
account,of,with,respect,to,how,their,donated,samples,are,used.
– Anything»related»to»health,»my»Muslim»religion»is»not»against»it. Female,
Pharmacy,Technician/spokesperson,urban,B3,B Kano
– Like»I»mentioned»before,»the»samples»may»be»used»for»unethical»practices»
such»as»human»cloning»which»will»interfere»with»my»Christian»belief.»
Uncertainty»on»this»and»limited»knowledge»on»the»religious»implication»on»
my»action»can»make»me»change»my»mind»of»participating»in»the»research.»
Female,Pharmacist,Urban,D18,B Enugu
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Controversies, – Impact,of,religion
• My»concern»is»that»they»may»use»the»biobank»for»something»that»will»
not»please»God,»for»example»occultism.»From»the»research,»those»
that»did»not»know»they»had»disease»will»get»to»know»it.»It»may»be»
HIV/AIDS»and»it»will»affect»them»psychologically.» I»will»feel»bad»if»
they»keep»our»specimens»without»carrying»out»research»on»them,»
because»I»believe»they»will»get»back»to»one»of»us»as»a»feedback»if»they»
carry»out»research»on»our»specimen.»If»there’s»segregation»whereby»
they»give»some»people»feedback»and»I»am»not»given»I»will»not»be»
happy.
• Male,Spokesperson,rural,C14,B FCT
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Controversies, – Impact,of,genomic,research,and,
biobanking,on,ethnicity
• Information,on,ethnicity,may
– Raise,specter,of,discrimination,and,stigmatization,against,individuals,or,
communities
– Engender,a,sense,of,pride,and,accomplishment
• The,people,of,AbaBAlamu,for,example,were,proud,of,their,
contribution,to,the,HapMap,because
– It,reflected,restored,ethnic,leadership,and,pride,in,education,and,science
– They,were,contributing,to,deBstigmatization,of,Nigerians
– They,were,contributing,to,the,health,and,prosperity,of,African,Americans
– They,were,contributing,meaningfully,to,global,advancement,in,health,and,
science
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Controversies, – Use,of,health,records
• Many,respondents,do,not,have,any,concerns,about,use,of,,
information,from,their,medical,records,because,they,believe,they,
had,nothing,to,hide.
• The,main,concern,was,the,general,issue,of,donors’,anonymity,
when,information,is,being,made,available,in,the,public,domain.,
• However,confidentiality,was,considered,a,significant,issue.,
Respondents,felt,that,if,they,are,not,confident,about,the,
procedures,in,place,to,respect,participants’,confidentiality,,they,
may,withdraw,participation.,
• Respondents,,believed,that,if,information,is,properly,encoded,or,
encrypted,it,will,not,be,accessible,to,people,unauthorized.,
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Relevant,sections,of,Nigerian,Health,Law
• In,2014,,Nigeria,enacted,a,law,whose,purpose,is,to,“provide,a,
framework,for,the,regulation,,development,and,management,
of,a,national,health,system,and,set,standards,for,rendering,
health,services,in,the,federation,,and,for,related,matters”
• In,many,parts,this,law,is,similar,to,laws,passed,in,South,Africa,,
and,Sudan,,and,possibly,other,African,countries
• This,law,established,the,National,Health,Research,Ethics,
Committee,and,contains,several,sections,that,deal,with,health,
records,and,databases
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Relevant,sections,of,Nigerian,Health,Law
• All,information,concerning,a,user,,including,information,relating,to,
his,or,her,health,status,,treatment,or,stay,in,a,health,
establishment,is,confidential
• The,person,in,charge,of,a,health,establishment who,is,in,
possession,of,a,user’s,health,records,shall,set,up,control,measures,
to,prevent,unauthorised,access,to,those,records,and,to,the,
storage,facility,in,which,,or,system,by,which,,records,are,kept.
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Relevant,sections,of,Nigerian,Health,Law
• Any,person,who—
– (a),fails,to,perform,a,duty,imposed,on,them,under,subsection,(1);
– (b),falsifies,any,record,by,adding,to,or,deleting,or,changing,any,
information,contained,in,that,record;
– (c),creates,,changes,or,destroys,a,record,without,authority,to,do,so;
– (d),fails,to,create,or,change,a,record,when,properly,required,to,do,so;
– (e),provides,false,information,with,the,intent,that,it,be,included,in,a,
record;
– (f),without,authority,,copies,any,part,of,a,record;
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Relevant,sections,of,Nigerian,Health,Law
– (g),without,authority,,connects,the,personal,identification,elements,of,a,
user’s,record,with,any,element,of,that,record,that,concerns,the,user’s,
condition,,treatment,or,history;
– (h),gains,unauthorised,access,to,a,record,or,recordBkeeping,system,,
including,intercepting,information,being,transmitted,from,one,person,,
or,one,part,of,a,recordBkeeping,system,,to,another;
– (i),without,authority,,connects,any,part,of,a,computer,or,other,
electronic,system,on,which,records,are,kept,to— (i),any,other,computer,
or,other,electronic,system;,or (ii),any,terminal,or,other,installation,
connected,to,or,forming,part,of,any,other,computer,or,other,electronic,
system;,or
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Relevant,sections,of,Nigerian,Health,Law
– without,authority,,modifies,or,impairs,the,operation,of—(i),any,part,
of,the,operating,system,of,a,computer,or,other,electronic,system,
on,which,a,user’s,records,are,kept;,or (ii),any,part,of,the,
programme,used,to,record,,store,,retrieve,or,display,information,on,
a,computer,or,other,electronic,system,on,which,a,user’s,records,are,
kept,,commits,an,offence,and,is,liable,on,conviction,to,
imprisonment,for,a,period,not,exceeding,two,years,or,to,a,fine,of,
N250,000.00,or,both,a,fine,and,such,imprisonment.
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NHREC,guidance,on,biobanks,and,materials,transfer,
agreements,B http://nhrec.net/nhrec/
• National,code,for,health,research,ethics
– SubBcodes,dealing,with,other,aspects,of,health,research
• Forms,for,registration,of,ethics,committees,and,biobanks
• Prototype,documents
• Access,to,educational,materials,and,guidance,documents
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Acknowledgement
• This,work,was,supported,by,grant,number,D43,TW007091,and,
3R25TW007091B06S2, from,the,Fogarty,International,Centre,and,
the,National,Human,Genome,Research,Institute,of,the,United,
States,National,Institutes,of,Health
• Mr,Michael,Igbe,(Attitude,to,Biobanking,in,Nigeria),,Mr.,Lawrence,
Fagbemiro,(Ethics,of,Genomics,Tests,for,NCDs,in,Nigeria),,Dr.,
Onochie,Okoye,(Future,unspecified,use,research,in,Nigeria),,Mrs.,
Banke,Adeleke
• Supported,by,staff,and,students,of,the,West,African,Bioethics,
Training,Program,Nigeria