Wiesing-Biobanks-WMA-Copenhagen-9-2015-3

The$mandate$of$the$WMA
Consent$issues
Urban&Wiesing
Institut&für&Ethik
und&Geschichte&der
Medizin
Copenhagen,& Sept.&15
The$mandate$of$the$WMA
• The$practical$view:
• Many&professions&are&involved&in&a&biobank&
• Physicians,&biologists,&chemists,&physiologists,&clinical&
researcher,&epidemiologists…
• A&declaration&that&addresses&all&these&professions&
makes&sense!
Institut für Ethik
und Geschichte der
Medizin
The$mandate$of$the$WMA
• The$legal$view:
• The&WMA&has&no&mandate&and&no&right&to&set&up&a&
norm&for&anyone&J
• except&for&its&own&members!
• The&legal&objections&are&stronger&than&the&practical&
advantages.
• Therefore,&in&accordance&with&the&Declaration&of&
Helsinki:&
Institut für Ethik
und Geschichte der
Medizin
The$mandate$of$the$WMA
• Declaration$of$Helsinki:$
• 2:&“Consistent&with&the&mandate&of&the&WMA,&the&
Declaration&is&addressed&primarily&to&physicians.&The&
WMA&encourages&others&who&are&involved&in&medical&
research&involving&human&subjects&to&adopt&these&
principles.”
Institut für Ethik
und Geschichte der
Medizin
The$mandate$of$the$WMA
• Declaration$of$Helsinki:$
• “Consistent&with&the&mandate&of&the&WMA,&the&
Declaration&is&addressed&primarily&to&physicians.&The&
WMA&encourages&others&who&are&involved&in&medical&
research&involving&human&subjects in&biobanks&to&adopt&
these&principles.”
Institut für Ethik
und Geschichte der
Medizin
Consent$issues
Institut&für&Ethik
und&Geschichte&der
Medizin
Consent$in$biobanks
• General$remarks:$
• There&is&no&ethically&uncontroversial&regulation&of&
informed&consent&in&the&case&of&biobanks.
• There&is&a&corridor&of&more&or&less&acceptable&
regulations.
• The&final&decision&on&ethical&principles&in&biobanks&is&a&
political&decision!
• Further&research&is&needed&to&clarify&the&practical&
results&of&specific&provisions.&
• =&The&final&political&decision&is&partially&not&‘evidence&
based’.
Institut für Ethik
und Geschichte der
Medizin
Consent$in$biobanks
• The$basic$problem:
• “Classical”&informed&consent:&The&patient&has&to&be&
informed&precisely&about&aim,&methods&etc.&of&each&
research&project.&
• Biobanks:&Made&for&numerous&projectsY&future&projects,&
future&aims&and&methods&are&not&foreseeable.
• Asking&for&informed&consent&for&each&project&is&not&
impossible&but&burdensome,&impractical
Institut für Ethik
und Geschichte der
Medizin
Consent$in$biobanks
• The$basic$problem:
• Tension&between&legal/moral&obligation&towards&the&
donor&(autonomy,&nonJmaleficience)&and&practicability,&
costs&and&burdens
• As&more&precise&as&more&complicated,&burdensome&
and&inhibiting&research
• A&type&of&consent&is&needed&that&is&ethically&appropriate&
and&also&feasible
Institut für Ethik
und Geschichte der
Medizin
Consent$in$biobanks:$the$basic$options
• No&consent
• Blanket&consent
• Broad&consent
• Checklist
• Study&specific&consent
• (Grady&et&al.,&AJOB&2015,&p.&36)
Institut für Ethik
und Geschichte der
Medizin
Consent$in$biobanks:$the$basic$options
• No&consent
• Blanket&consent
• Broad&consent
• Checklist
• Study&specific&consent
• (Grady&et&al.,&AJOB&2015)
Institut für Ethik
und Geschichte der
Medizin
Less&burden,
less&control
↕
More&burden,
more&control
Consent$in$biobanks
• The$basic$options:
• No&consent
J Do&not&obtain&donor&consent
J As&a&general&rule&unacceptable
• Blanket&consent
• Broad&consent
• Checklist
• Study&specific&consent
Institut für Ethik
und Geschichte der
Medizin
Consent$in$biobanks
• The$basic$options:
• No&consent
• Blanket&consent
J Consent&without&limitations&for&future&research
J As&a&general&rule&hardly&acceptable
• Broad&consent
• Checklist
• Study&specific&consent
Institut für Ethik
und Geschichte der
Medizin
Consent$in$biobanks
• The$basic$options:
• No&consent
• Blanket&consent
• Broad&consent
J “consent&for&an&unspecified&range&of&future&research&
subject&to&a&few&content&and/or&process&restrictions”&
(Grady&et&al.&2015,&AJOB,&p.&35)
J Which&content&and/or&process&restrictions?
• Checklist
• Study&specific&consent
Institut für Ethik
und Geschichte der
Medizin
Consent$in$biobanks
• The$basic$options:
• No&consent
• Blanket&consent
• Broad&consent
• Checklist
J Donor&chooses&the&type&of&future&studies
J Restriction&of&future&research.&If&no&consent&=&
burdensome,&hardly&practicable&to&get&new&informed&
consent
• Study&specific&consent
Institut für Ethik
und Geschichte der
Medizin
Consent$in$biobanks
• The$basic$options:
• No&consent
• Blanket&consent
• Broad&consent
• Checklist
• Study&specific&consent
J Consent&for&each&specific&future&study
J Impracticable&for&most&of&the&biobanks,&massive&
restriction&of&research,&burdensome
(Grady&et&al.,&AJOB&2015)
Institut für Ethik
und Geschichte der
Medizin
Consent$in$biobanks
• Meta$consent?
• New
• Hardly&known
• Experience?
• Applicable&on&a&global&level?
• Sophisticated&IT&expertise&is&needed
Institut für Ethik
und Geschichte der
Medizin
Consent$in$biobanks:$the$basic$options
• No&consent
• Blanket&consent
• Broad&consent
• Checklist
• Study&specific&consent
• (Grady&et&al.,&AJOB&2015,&p.&36)
Institut für Ethik
und Geschichte der
Medizin
Broad$Consent
• The$central$question:
• Which&limitations&in&broad&consent&are&ethically&
acceptable&and&practicable?
• Which&compromise&between&ethical&consideration&
regarding&the&right&of&the&donor&and&the&practicability&of&
a&biobank&is&the&most&acceptable&one?
J Regarding&the&content&of&the&initial&consent
J Regarding&the&governance&of&the&biobank
J Regarding&ongoing&communication&with&donors&
Institut für Ethik
und Geschichte der
Medizin
The$main$problem:$balancing$in$broad$consent
• More&or&less&specifications/restrictions&regarding&the&
future&research&projects
J and/or
• more&or&less&specifications&regarding&the&governance&of&
the&biobank
J and/or
• more&or&less&communication&with&donors
Institut für Ethik
und Geschichte der
Medizin
Broad$Consent
• Empirical&data:
• “The&empirical&data&thus&support&the&claim&that&
reasonable&persons&are&willing&to&provide&broad&
consent&for&future&research&with&their&biospecimens,&
provided&that&important&exceptions&are&taken&into&
account.”&(Grady&et&al.&2015,&AJOB,&p.&36)
• Empirical$data$are$not$ethical$arguments!$
Institut für Ethik
und Geschichte der
Medizin
Broad$Consent
• NonJempirical&arguments&in&favor&of&broad&consent:
• Regarding$the$donor:$
J The&rights&of&the&donor&can&be&sufficiently&respected
J Low&risk&to&donor&welfare
J Governance:&protects&the&interests&of&donors&
• Regarding$research:
J System&of&broad&consent:&low&costs&to&maintain
J Practicability
J Governance&protects&the&interests&of&research
J Communication:&learning&system,&transparency,&trust
Institut für Ethik
und Geschichte der
Medizin
Elements$of$Broad$Consent$(according&CIOMSJ
Guidelines,&draft&version)
• Broad$informed$consent describes$the$range$of$future$uses$in$
research$for$which$consent$is$given.$This$broad$informed$
consent$should$specify:$
• the&conditions&and&duration&of&storage&
• who&will&manage&access&to&the&materials&
• the&foreseeable&uses&of&the&materials,&whether&limited&to&an&
already&fully&defined&study&or&extending&to&a&number&of&wholly&or&
partially&undefined&studies&
• the&intended&goal&of&such&use,&whether&only&for&research,&basic&or&
applied,&or&also&for&commercial&purposes&
• the&possibility&of&unsolicited&findings&and&how&they&will&be&dealt&with
Institut für Ethik
und Geschichte der
Medizin
Additional$elements$of$initial$consent$in$
accordance$with$the$Declaration$of$Helsinki
• Benefit&sharing&(including&dissemination&of&knowledge)
• Institutional&affiliations&of&the&biobank
• Sources&of&funding
• Conflict&of&interests
• Inclusion&of&data&and&material&of&persons&not&able&to&
give&their&informed&consent&(including&minors)
• Implications&for&connected&others&and/or&the&individuals&
into&the&future
Institut für Ethik
und Geschichte der
Medizin
Elements$of$Broad$Consent,$Governance
• how&the&donor&can&retract&this&authorizationY
• how&the&quality&of&the&material&is&controlled,&ensuring&
the&physical&protection&and&maintenance&of&the&
materials
• how&confidentiality&of&the&link&between&biological&
specimens&and&personal&identifiers&of&the&donors&is&
maintained
• who&may&have&access&to&the&materials&for&future&
research,&and&under&which&circumstances
• which&body&may&review&research&proposals&for&future&
use&of&the&material
Institut für Ethik
und Geschichte der
Medizin
(following&CIOMS&Guidelines,&draft&version)
Elements$of$Broad$Consent,$OnJgoing$
Communication
• under&which&circumstances&donors&need&to&be&
recontacted
• how&participatory&engagement&with&patient&groups&or&
the&wider&community&is&organized
Institut für Ethik
und Geschichte der
Medizin
(following&CIOMS&Guidelines,&draft&version)
Exceptions
• Broad&consent&is&a&general&principle!
• Biobanks&are&different!
• There&might&be&few&exceptions:&
• It&might&be&acceptable&not&to&obtain&consent&
• It&might&be&more&appropriate&for&certain&biobanks&to&
limit&the&use&for&future&research&to&specific&studies&
J Depending&on&donor&population&(indigenous&people,&
diseases&with&high&potential&of&discrimination&…)&and&
other&circumstances
• This&must&be&considered&before&starting&a&biobank!
Institut für Ethik
und Geschichte der
Medizin
Summary
• Ethics&cannot&‘solve’&the&problem&of&consent&in&biobanks
• Finally:&A&declaration&is&a&political&statement
• The&basic&problem:&rights&of&the&donor&vs.&practicability
• Broad&consent&is&probably&the&most&acceptable&consent
• A&balance&between&specifications/restrictions&regarding&
future&research&projects,&specifications&regarding&the&
governance&and&intensity&of&communication&with&the&donors&
must&be&found.
• Exceptions:&Different&regulations&for&different&biobanks
• List&of&issues&to&be&mentioned&in&the&initial&consent:&see&
DoH,&CIOMS,&Grady&et&al.&2015,&Strech&et&al.&2015
Institut für Ethik
und Geschichte der
Medizin
•Do&not&invent&the&wheel&once&again!
Institut für Ethik
und Geschichte der
Medizin
The$mandate$of$the$WMA
Consent$issues
Urban&Wiesing
Institut&für&Ethik
und&Geschichte&der
Medizin
Copenhagen,& Sept.&15