Alastair_Campbell

Revision of the Declaration of
Helsinki: Biobanks
Professor Alastair V. Campbell
Chen Su Lan Centennial Professor in Medical Ethics
Director, Centre for Biomedical Ethics
National University of Singapore
Expert
 Conference
 on
 the
 Revision
 of
 the
 Declara5on
 of
 Helsinki
 
 
28
 February
 -­‐
 1
 March
 2013,
 Tokyo
 
 
Imperial
 Hotel
 Tokyo,
 Tokyo,
 Japan
 
 
Biobank – Definition
“A stored collection of genetic samples in the form of
blood or tissue that can be linked with medical and
geneological or lifestyle information from a specific
population, gathered using a process of generalised
consent”
Wolf, et al., 2012
Varieties of Biobanks
•  Prospective, recruitment of volunteers
•  Linking existing data bases and tissue banks
•  Disease specific
Why are Biobanks proliferating now?
Large epidemiological cohort studies are
not new – BUT:
•  Availability of huge numbers of genetic markers,
from Human Genome Project
•  New capacity to analyse very large numbers of
biological markers
•  Modern IT facilitates large and complex follow-up
studies
Why do Biobanks warrant unusual consideration?
 »   Very broad range of potential research
 »   Very broad range of future health information will be
captured
 »   Very large scale, many participants, necessarily
somewhat impersonal
 »   Broad range of researchers may access the data
 »   Data will be available for very long time
 »   Increasing pressure to link internationally
 »   Consent has to be broad as future uses cannot be
specified
How Can Biobanks Serve the Public Good?
 »   Health as an international communal enterprise
 »   People not profit
 »   How and who to define priorities?
Key Ethical Issues
 »   Harm and Benefit
 »   Consent
 »   Feedback
 »   Stewardship
Harm
3 types of possible harm
 »   Physical
 »   Psychological
 »   Informational
Consent
 »   Broad? Blanket? Generic? Implied?
 »   Extendable and Rescindable?
 »   Renewable? (How often?)
 »   Levels of withdrawal
– No further contact
– No further use or access
– Total withdrawal (samples destroyed)
Feedback (1)
 »   Excellent general communication essential to show
enterprise worthwhile.
 »   Feedback of individual health results from baseline
tests (eg. BP) seems reasonable
 »   But what of incidental findings and research results
relevant to participants?
Feedback (2)
•  Huge volume of data on each person, genetic and phenotypic,
applied to many different projects in aggregated form
•  Unethical to release data which cannot be interpreted, without
individual explanations and interpretations – genetic
counseling?
•  Most data will be meaningless until research completed
•  Quality standards of testing in research setting below those of
clinical laboratories
Points against feedback of individual results later
in project
Feedback (3)
 »   If findings are: analytically valid, reveal substantial
risk and clinically actionable
 »   If affected person wishes
 »   Relevance to others – offspring, relatives
Arguments for Selective Feedback
Stewardship
 »   Security Mechanisms
 »   Resisting Inappropriate Access
 »   Best Use of Depletable Resource
Best Use of Resource
 »   The main ethical issue of the future
 »   How to ensure fair usage?
 »   Who decides?
Participants?
Researchers?
Governance Bodies?
Conclusions – Points to Consider in
Revision of Helsinki Declaration
 »   Revision of Consent Provisions? (paragraphs 14 and
24)
 »   Governance Issues – Beyond Initial Ethics Approval
 »   Appropriate Access and Fair Distribution of Benefits
 »   Should Declaration Comment on Feedback?
References
Campbell AV. The ethical challenges of genetic
databases: safeguarding altruism and trust. King’s
Law Journal 18(2); 227-246 (2007)
Wolf, SM, et al. Managing incidental findings and
research results in genome research involving
biobanks and archived datasets. Genetics in
Medicine, 14 (2012), 361 – 384