Ryuichi_Ida
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Basic Structure of
Ethics Governance of Biobank
Ryuichi IDA
Member, Council on Bioethics, Japan Medical Association
Distinguished Visiting Professor, Doshisha university, Japan
Expert Conference on the Revision of the Declaration of Helsinki
World Medical Association
28/02 – 1/013/2013, Imperial Hotel Tokyo. Tokyo, Japan
* The view expressed in this presentation is strictly my personal one, and not
necessarily represent the opinion of the Japan Medical Association.
Characteristics of Biobank
– Need of new ethical structure
=Governance
! Large scale collections (population based)
! Collection and storage of human materials
together with personal information
! Samples stored anonymous but linked
! Multiple use
! Genomic information analyzed
Questions concerning establishment
and management
! Concern of the general public : consensus
! Anonymized but linked samples and data
! Recruitment
! New type of consent
! Confidentiality management
! Other ethical issues
Concern of the general public
! Biobank with genetic/genomic database consists of
personal information that may reveal the privacy of each
participants as well as groups and communities.
! A large scale biobank should be initiated or established
in consultation with the general public of the nation or of
the population as well as other stakeholders.
(potential participants, representatives of the
population/community or focus groups, patients
groups, industry, State, researchers’ community)
! The extent of consultation will vary following the nature,
purpose, size and risks and sensitivity of the data and
the access.
! Methods of consultations are diverse.
! Importance should be given to build up a consensus to
establishment of a biobank
Recruitment
Recruitment of participants of a large scale is a heavy task.
1) Understanding and Support of the public
Long process from public announcement of the project,
through public informing meetings and consultations, to
informed consent procedure.
2) Assurance of free will
Pressure of the community
(family, local community, state)
Prohibition of economic or social incentives
commercialization of human body and parts
Consent
Traditional informed consent procedure is inapplicable.
New type of consent is necessary
“One sample, for multiple purpose, stored for a long
time, anonymized but linked, and sometimes
periodically re-collected”
⇒”Linked anonymisation”
Purposes of research using collected samples are not
defined and necessarily multiple.
“Broad Consent”(?)
The donor should be let understand what is a biobank,
and how samples and information are stored and used.
The weight of importance shifts to the confifdentiality.
Withdrawal
! Graduation of withdrawal should be considered.
consent – collection – during storage/before
use – during use (research) – before publication
– after publication
! After each stage, the effect of withdrawal will be
gradually limited.
disposal of samples : all, remaining, or made
unlinked and not disposed
erasure of data : all, part (kinds of data)
Linked anonymisation
! Samples and data should be kept anonymous.
! However, the connection is indispensable between the
donor and the samples and the data.
Follow the evolution of the donor’s health/disease
Revise the evaluation and the meaning of the
samples and data with new scientific developments
! Double randamised anonymisation is universally
recommended and recognised.
! Linkage to a specific participant necessary for adding the
samples and the data of the person concerned.
Continuous sampling and data collecting from the same
person is a key element for a biobank.
System for confidentiality management
! Measures of confidentiality protection should be clearly built.
Security of stored samples, security of the data
! Custody of Code Registry
Designation of custodian of personal information
(identifiers, link between donor – personal data/information)
Duty of non-divulgation of information
Strictly protected data management (ex: stand-alone PC setting)
! Access limitation to the personal information
Limited access to personal information stored in the bank
Special authorization
Degree of access limitation may be proportionate of the purpose
The user (researchers and doctors) may only use personal
information which is deemed indispensable for a specific
research or application.
Need of Regulatory Regime
! For the efficient use of the sample and the
data stored in the biobank, a regulatory
regime should be established relating to
the purpose of use, intellectual property
rights, management of the whole biobank,
etc..
Basic Structure of Ethics
Governance of Biobank
! Triple principle
Transparency, accountability and traceability
! Three levels of control mechanism
Compliance control
quality control
access control
management control
Ethical control : Ethical review committee
“Public control” : public reporting and evaluation
! Need of national standard
Quality of the data
Degree of confidentiality protection
12
establishment
par-cipa-on
consent
storage
use
Public
announcement
/
Public
debate
Public
Consulta-on
Explanatory
Mee-ng
Consent
for
Banking
Withdrawal
-‐
total
or
par-al
Linkable
anonymisa-on
Measures
for
personal
data
protec-on
Access
Condi-on
for
use
BBDB
Biobank
/Gene-c
Database
Trans-‐
parency
Account-‐
ability
traceability
Compliance
measures
-‐-‐-‐-‐-‐-‐-‐-‐-‐-‐-‐-‐-‐-‐-‐-‐-‐-‐-‐-‐-‐
Quality
Access
Management
Ethical
Control
-‐-‐-‐-‐-‐-‐-‐-‐-‐-‐-‐-‐-‐
Ethics
Review
Social
Control
-‐-‐-‐-‐-‐-‐-‐-‐-‐-‐-‐-‐-‐-‐-‐-‐-‐-‐-‐-‐-‐
Publica-on
Evalua-on
State ＝ Legal
Basis
and
Uniform
Standards
Governance
of
Biobank
and
Database
For
DoH
revision
Should
DoH
include
provisions
on
biobank?
The
current
stage
of
development
of
medical
research
requires
some
ar-cles
on
biobank,
whether
or
not
men-oning
“biobank”.
A)
If
“biobank”
should
be
men-oned,
difficulty
=
defini-on
B)
If
we
remain
providing
only
ar-cles
regarding
the
issues
at
each
stages
of
biobank
process
without
men-oning
“biobank”,
this
efficient
tool
of
research
may
be
confused
with
other
procedures,
and
such
will
not
be
for
the
protec-on
and
interest
of
the
par-cipants/pa-ents.
Possible
solu-on
Men-on
“biobank,
but
leave
regulatory
framework
to
each
country’s
laws
and
regula-ons.
Soon
or
later,
a
kind
of
universal
standards
will
be
established,
in
order
to
facilitate
the
flow
of
the
qualified
data.
Merci.
Thank you.
ありがとうございました。