led by prof mark henaghan multi-disciplinary & international incl bioethics centre
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Led by Prof Mark Henaghan
Multi-disciplinary & International
incl Bioethics Centre
richman.wee@otago.ac.nz
Funded by Led by
Rethinking Privacy Safeguards
for
Emerging Technologies &
Research in Genomics
Anonymity?
Sequencing the Human Genome
Human Genome Project*
2003 12 to 13 years
US$ 2.3 billion
Jim Watson’s**
2007 2 months ~ US$ 1 million
*Many samples collected, few processed, ‘combined’ *Many samples collected, few processed, ‘combined’ genomegenome donor identities protecteddonor identities protected**Made available publicly … but …**Made available publicly … but …
‘Buy’ your personal genome !
4 Mar 2008
“Big Spender Dan Stoicescu is paying a company to map his genome.” US$ 350,000
Knome’sfirst customer
The US$ 1000 Genome !
within a few days
Univ of California at San Diego Scientists Win Grant to Develop $1,000 Sequencing Technology
9 Oct 2006
Current Genomics Research
Genome Wide Association Studies GWAS
rapidly scanning complete sets of DNA or genomes of many people
find gene variations associated with a particular disease
use information to detect, treat and prevent disease
’eventually’ screen?
Current Genomics Research (2)
UK Wellcome Trust Case Control Consortium
Nature 7 Jun 2007
largest ever genetics study of common diseaseslargest ever genetics study of common diseases
17,000 people in the UK & their DNA17,000 people in the UK & their DNA
££ 9 million 9 million
40 research groups, 500 scientists, dozens of 40 research groups, 500 scientists, dozens of instnsinstns
analysed almost 10 billion pieces of genetic info, analysed almost 10 billion pieces of genetic info, over 2 yearsover 2 years
Emerging Ethical and Societal Expectations
Re-contacting Participants
* Unexpected discoveries
* Incidental findings
* Expectations and overseas consensus emerging
among research, clinical, bioethics communities
Withdrawal from ongoing & future research
Research Design, Practice & Regulatory Policy (2)
Research Design - Maximum protection
* Anonymisation (irreversible de-identification)
But if should re-contact participants?
* Need to re-identify
So how?
* Use coded info & tissue(reversible de-identification)
Research Design, Practice & Regulatory Policy (3)
‘Coded’
* A step away from being ‘anonymised’ – by intentionally (or accidentally!) destroying the
key
Selectively withholding particular genomic info * limiting
* ‘degrading’ (masking, scrambling)* removing uniquely/strongly identifying
info(rare gene variants)
Research Design, Practice & Regulatory Policy (4)
Separate regulatory regimes:
* Information – eg Privacy Act & HIPC
* Human Tissue – eg HDC Code of Consumers’ Rights
Tissue can & will continue provide great amount of information
but, for wider sharing opportunities tissue is finite
cf digital information about that tissue
What if ... ?
… extract completely … data from human tissue … store in a digital medium
eg external hard drive?
many more steps away … but a step closer with each tech development & research
A question of how fast & when ??
Projecting ahead ...
So far, what to do if anonymisation desirable
More challenging - over time,
anonymisation truly achievableto protect privacy ?
rethinkgreater or different safeguards needed?
Statutory Provision?Protect Research Participants’
information
* Power to issue statutory Certificate of Confidentiality
* authorises Researchers to protect Participants’ identity
* by withholding Participants’ identifying characteristics from those not connected with the research
* Authorised Researchers may not be compelled to disclose – in any “civil, criminal, administrative, legislative or other proceedings” – information that would reveal the identity of research participants
* eg Public Health Service Act 301 (d), 42 USC 241(d)
Jim Watson’s personal genome
Published and publicly available ... but
* partially withheld-Alzheimer’s risk
* Jim’s own health
* health status of family members
- grandmother- his sister- son Rufus
Rethinking Privacy Safeguards
for
Emerging Techs & Rsch in Genomics The ability to
sequence, scan and screen –
scary or savvy ?
For a copy, go to ‘Resources’ @
www.otago.ac.nz/law/genome/
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