barriers and tools to the present and future of population genetics pr bartha maria knoppers canada...
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Barriers and Tools to the Present and Future of Population Genetics
Pr Bartha Maria KnoppersCanada Research Chair
in Law and Medicine
HGM 2006
CE Recommendation Rec(2006)4 of the Committee of Ministers to member states on research on biological materials of human origin, March 2006
Article 17
1. A population biobank is a collection of biological materials that has the following characteristics:
i. the collection has a population basis;
ii. it is established, or has been converted, to supply biological materials or data derived therefrom for multiple future research projects;
iii. it contains biological materials and associated personal data, which may include or be linked to genealogical, medical and lifestyle data and which may be regularly updated;
iv. it receives and supplies materials in an organised manner.
Council of Europe
HUGO Ethics Committee
Recognizing:
• The potential global good arising from genetic research;
• The scientific and clinical uses of genomic databases;
• The potential for conflicts between the free flow of information that is crucial to research advances and the legitimate rights to return from research expenditure;
• The potential risk of misusing genetic data;
• The need to rapidly place primary genomic sequences in the public domain.
Statement on Human Genomic Databases, 2002
Recommendations:
1. Human genomic databases are global public goods.
a. Knowledge useful to human health belongs to humanity.
b. Human genomic databases are a public resource.
c. All humans should share in and have access to the benefits of databases […]
HUGO Ethics Committee (continued)
Statement on Human Genomic Databases, 2002
Barriers
Tools
Future ?
Outline
Nature Reviews Genetics – Feb. 2006 Ethics watch: Tool-sharing issues in coherent population-based research Bartha Maria Knoppers and Alastair Kent
Nature Reviews Genetics – Jan. 2006 Ethics watch: Policy barriers in coherent population-based research Bartha Maria Knoppers and Alastair Kent
« Realpolitik »
• Time
• $$$
• Infrastructures
• Monogenic model
• Perceptions
• Governance
Wendler D. One-time general consent for research on biological samples. BMJ. 2006; 332(7540):544-547.
“Data from more than 33 000 people around the world
support offering individuals a simple choice of whether or
not their samples can be used for research purposes, with
the stipulation that an ethics committee will decide the
studies for which their samples are used.
This approach offers a method that could be adopted
across institutions and around the world.”
Lowrance WW. Access to collections of data and materials for health research. Medical Research Council and Wellcome Trust, 2006, p.36
“Few issue clusters are identified by researchers
as so urgently needing resolution as those
surrounding confidentiality and anonymisation.
They are not unique to data sharing activities, but
they are central to them.”
Knoppers BM, Saginur M. The Babel of genetic data terminology. Nature Biotechnology. 2005; 23(8):925-7
Tools
• Principles for population studies
• Semantic interoperability
• Population studies toolbox
• Broad consent
• Public aggregated datasets
• Prospective harmonization
RMGAStatement of Principles on the Ethical Conduct of
Human Genetic Research Involving Populations, 2003
Principles:• Individuality• Diversity • Complexity• Reciprocity• Solidarity• Security • Accountability • Equity • Citizenry • Universality
http://www.popgen.info/
The Academy of Medical Sciences. Personal Data for Public Good: Using Health Information in Medical Research. January 2006, p.4.
“Identifiable data can be used for medical
research without consent, provided that
such use is necessary and is proportionate
with respect to privacy and public interest
benefits.”
http://www.hapmap.org/
Public Population Project in Genomics (P3G)
P3G Objectives:• Connect the leading public population genomics projects.• Provide necessary coordination, harmonization and standardization so the combined results be used for the advancement of science around the world.• Develop common understanding of the socio-ethical and legal issues• Foster a deeper understanding of the relative contribution of genetic and non-genetic determinants to health and disease.• Transfer this knowledge to the international community so as to optimize benefits for public health.
http://www.p3gconsortium.org/
P3G General Assembly
P3G Board of Directors
P3G Steering Committee
IWG 1(Social/Clinical/Environmental)
P3G Secretariat
Core
IWG 2Informatics
IWG 3Ethics and Governance
IWG 4Epidemiology/Biostatistics
CoreCoreCore
Core Core Core
Core
Core Core Core Core
FundersAuditors
P3G OBSERVATORY
P3G Operational Chart
3
Regular MemberAssociate MemberIndividual Member
P3G Membership
3
Future ?
• Sovereignty and sharing
• Common heritage?
• Global public goods?
• Public trusteeship?