Cape_Town_12-Arnason

Vilhjálmur Árnason
Biobanks
Expert Conference on the Revision of the
Declaration of Helsinki
WMA, Cape Town, December 5–7, 2012
The issues
• Obtaining information
• The question of consent
– articles 24 and 25
• Protecting information
• Access to information
– Article 23
• Returning information
– article 33
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What kind of biobanks?
• In my discussion, I am concerned with organized
collection of human biological samples – and the
data (medical, genealogical, life-style) associated
with them – used for research purposes. In
particular, I have in mind large population-based
biobanks as resources for genetic research
• These biobanks have raised various challenges for
existing ethical frameworks, but I will only address
three which are pertinant for a possible revision of
DoH
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Entering a biobank
• A major ethical challenge raised by biobanks
concerns the question of consent
• The DoH states (art 24)
– In medical research involving competent human subjects,
each potential subject must be adequately informed of the
aims, methods, … the anticipated benefits and potential
risks of the study and the discomfort it may entail …
• This is ill suited for database/biobanks research
where future research uses cannot be specified at
the time of consent which might require frequent
recontact. Hence the need for a separate article:
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Article 25 (2008)
• “For medical research using identifiable human
material or data, physicians must normally seek
consent for the collection, analysis, storage
and/or reuse. There may be situations where
consent would be impossible or impractical to
obtain for such research or would pose a threat
to the validity of the research. In such situations
the research may be done only after
consideration and approval of a research ethics
committee.”
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Analysis
• Specific informed consent no longer required
– “consent for collection, analysis, storage and/or
reuse“
• Is this sufficient?
• It depends on how “consent“ is fleshed out
• Two main options
• One time open consent
• Wide consent with the right to withdraw
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Permission based on trust
• Open consent relying on ethics committees to
decide on the use of samples
• It is debated whether this can be regarded as
a consent at all since the participants‘ decision
is not based on any knowledge of the use of
the samples. It is a permission based on trust
– One argument for this policy is that it would
maximize the research flexibility and thus the
benefits to be reaped from the biobanks resource
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The question of benefits
• Clear public benefits can be used as an argument to
counter emphasis on consent (context of
reciprocity). The medical benefits of population
biobank research remain controversial.
• The ethos of voluntariness (DoH, 22), the objectives
of non-deception and non-coercion, are also
important public benefits or interests at stake
– Participants should not be regarded as a passive resource
to be mined for maximum benefits, restricting ethical
issues to those of protection and security. There is a public
interest in facilitating conditions for agency
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Consent with a right to withdraw
• The ethos of voluntariness and the ethos of
trust can be reconciled through a policy of a
broad consent for participation in biobank
research, provided that participants
– are informed on a regular bases of the nature of
the ongoing research using the biobank
– are given ways to withdraw from particular
research projects
– these procedures would underpin trust and public
awareness/engagement
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A suggestion
• Change to article 25
– “For medical research using identifiable human material or
data, physicians must normally seek consent for the
collection, analysis, storage and/or reuse. There may be
situations where consent would be impossible or
impractical to obtain for such research or would pose a
threat to the validity of the research.
research may be done only
after consideration and approval of a research ethics
committee.”
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Protection
• Secure protection of confidentiality of samples
should not be used as a reason against obtaining
consent or the right to withdraw from research
• It should serve as a reason for participants to decide
whether to enter samples into biobanks and not
withdrawing from research projects
• This amounts to controlling access to the data and
their use and ensuring that medical and personal
information is exclusively used for research purposes
and is not shared with third parties
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Returning information
• While samples have been collected for many
biobanks with the intention of doing basic genetic
research for production of generalizable knowledge,
the question of responsible return of information to
individuals is increasingly discussed.
• This relates to DoH, article 33
– At the conclusion of the study, patients entered into the
study are entitled to be informed about the outcome of
the study and to share any benefits that result from it, for
example, access to interventions identified as beneficial in
the study or to other appropriate care or benefits.
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Guidelines
• Managing return needs to be based on the
ethical principles of non-maleficence,
beneficence and respect for autonomy
• Incidental findings should be returned iff they
– are analytically valid
– reveal risk of a serious health condition that can
be acted upon, cured or prevented
– There is no indication that the recipient would
prefer not to know
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Responsible return
• Was the question of return raised in the initial
consent form?
• Answer to this does not provide a necessary
condition for returning results. This needs to be
assessed in a context of clinical counselling.
• The relevant thing is to find out whether people
would like to be informed of a genetic finding for
which there are established therapeutic or
preventive interventions or other available actions
that might change the clinical course of the disease.
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Addition to DoH
• In light of recent developments in biobanks
research and future prospects, there is a need
to add a statement about return of findings in
the DoH
• This could possibly be done by adding a
sentence to article 33 that would specifically
address responsible return of incidental
findings in the course of research on human
material or by a short new article.
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Sources
• V. Árnason: “Coding and Consent. Moral Challenges of the Database Project in
Iceland”, Bioethics 18 (2004:1), 39–61.
• V. Árnason: “Database Research: Public and Private Interests”, Cambridge
Quarterly of Health Care Ethics 20 (2011:4), 563–571.
• A Cambon-Thomsen: “The social and ethical issues of post-genomic human
biobanks“. Nature Reviews. Genetics 5 (2004), 866–873.
• F. Colledge, B. Elgar, H.C. Howard: “The impact of paragraph 25 on informed
consent for biobank samples“. Institute for Biomedical Ethics. Ppt. Lecture.
• M. Knoppers, M.H. Abdul Rahman: “Biobanks in the Literature”. In: A. Capron, ed.
Ethical Issues in Governing Biobanks: Global Perspectives (Ashgate 2008), 13–22.
• WHO. Genetic Databases: Assessing the Benefits and Impact on Human and
Patient Rights
• WMA Declaration on Ethical Considerations regarding Health Databases, 2002.
• S.M. Wolf et. al.: “Managing incidental findings and research results in genomic
research involving biobanks“. Genetics in Medicine 14 (2012:4), 361–384.
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Thank you!
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