Led by Prof Mark Henaghan Led by Multi-disciplinary & International incl Bioethics Centre richman. wee@otago. ac. nz Funded by
Rethinking Privacy Safeguards for Emerging Technologies & Research in Genomics
Anonymity?
Sequencing the Human Genome 2003 12 to 13 years Human Genome Project* 2007 2 months Jim Watson’s** US$ 2. 3 billion ~ US$ 1 million *Many samples collected, few processed, ‘combined’ genome donor identities protected **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’s first 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 diseases 17, 000 people in the UK & their DNA £ 9 million 40 research groups, 500 scientists, dozens of instns analysed almost 10 billion pieces of genetic info, over 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 achievable to protect privacy ? rethink greater 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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