Oslo 22 November 2007 What lessons for Biometric regulation may be learned from biobank regulation?...
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Transcript of Oslo 22 November 2007 What lessons for Biometric regulation may be learned from biobank regulation?...
Oslo22 November 2007
What lessons for Biometric regulation may be learned from biobank regulation?
Graeme Laurie
Edinburgh Law SchoolDirector, AHRC Research Centre for Studies in
Intellectual Property & Technology Law
Biobank Regulation in the UK
UK Biobank: the Ethics & Governance Council
National DNA Database: Nuffield Council on Bioethics, Forensic Uses of Bioinformation (2007)
Biobank regulation in the UK
Why did attention to governance come about?
What problems and solutions proposed?
What lessons can be learned?
Which issues remain outstanding?
UK Biobank
Most ambitious longitudinal study in world
Relationship between genes and environment
Recruit 500,000 (40-69)
Blood and urine samples and questionnaire
Follow medical records throughout life
Permit future research access as broadly as possible
Protect participants and promises made the them
The “Regulation+” Experiment
Public concerns; public trust; project size
In parallel development of scientific protocol and Ethics and Governance Framework (EGF)
Establishment of independent Ethics and Governance Council to oversee UKB
U K B io bank E th ics and G ove rnance C o unc il
R elationships
U K B iobank Ltd
(U K charitable com pany)c o lla b o ra t in g w it h 2 2 u n iv e rs it ie s t h ro u g h 6
R e g io n a l C o lla b o ra t in g C e n t re s
E thics andGov ernance
C ouncil
Accountab le
F undsOversees and advises Accountab le
Accountab le
F unds (W T and M R C only)
FundersD e p a rt m e n t o f H e a lt h f o r E n g la n d a n d W a le s
M e d ic a l R e s e a rc h C o u n c ilS c o t t is h E xe c u t iv e
W e llc o m e T ru s tN o rt h W e s t D e v e lo p m e n t A g e n c y
Respective responsibilities
UK Biobank Ethics and Governance Framework
UK Biobank: Build a resource to support a diverse range of
health-related research for the public good Promote access to the resource within this aim Act as steward of the resource Protect participants' interests
Respective responsibilities
UK Biobank Ethics and Governance Framework
Ethics and Governance Council: Monitor and advise UKB on compliance with the
EGF Maintain independence of thought and action Speak about UKB not for UKB Protect participants' interests
Ethics and Governance Framework
Broad consent “to participate in UK Biobank” Lifetime commitment Confidentiality and security (but no control) Absolute right of withdrawal Re-consent required for access beyond the
purposes of UK Biobank (Access Policy)
Core questions for A&IP
1. Who should have access, who decides, and how?
2. How are scientific decisions taken which might require use of (depletable) samples?
3. What role might an Access Committee play? And what of an Ethics Council?
4. What IP policies or principles should guide use of the resource?
5. What might benefit sharing look like in practice?
Core principles and the EGF
Para 1.2.3 -
Participant privacy is of utmost important to UK Biobank and any requests for access to data in the resource will be subject to the most stringent security measures. Moreover, while the data in the UK Biobank resource are not depletable, the sample resource is finite and likely to be in considerable demand from academic and commercial groups in the UK and internationally. Consequently, privacy protection and efficient management of the samples to ensure that the greatest scientific value can be extracted from them are the two guiding principles that inform coordination of resource use.
More principles
Access is to be managed in order to:
Protect participants, honour commitments made to them and act within the scope of their consents;
Ensure compliance with legal and regulatory requirements
Prioritise access to those parts of the resource that are limited in availability (i.e. samples that are depletable);
Manage intellectual property rights in the resource and the results that flow from it.
Overarchingly...
Subject to these constraints, UK Biobank will encourage and provide access to the resource and the results that flow from it as widely and openly as possible in order to maximise its use and value for research.
This will include access for researchers from the academic, commercial, charity and public sectors, both in the UK and overseas.
Non-access
Para 1.2.5:
No identifiable individual’s test results will be provided to their doctors, their relatives or anyone else (e.g. employers or insurance companies). Nor will UK Biobank allow access to the resource by the police, security services or lawyers, unless forced to do so by the courts, and it will resist such access (in particular by seeking to be represented in all court applications).
Key elements of good governance
Clear purpose and justification for database Robust protection mechanisms Well-defined operational processes Independent oversight Transparency Accountability (cf- UKB and EGC)
UK National DNA Database
Largest DNA forensic database in world (p/c)
c.2 million samples to c.4million in last 3 years
Criminal detections at steady state of 20,000
“Recordable offences” - arrest is trigger for taking sample and indefinite storage
Requests for removal at police discretion
Suggestions to extend to “non-recordable” offences, e.f. dropping litter
Signs of function creep, e.g. Research
DNA Database: current situation
• Custodian Unit safeguards the integrity of the Database and develops policy
• The Database Strategy Board:– Home Office– Association of Chief Police Officers– Association of Police Authorities– Human Genetics Commission
• New Gov proposals: Ethics Group and Forensic Services Regulator
Proposed governance framework
Criticisms of Gov proposals
Lack of transparency
Issues of influence and control
Questions of independence
Concerns about accountability and trust
New Ethics Group
Remit and influence unclear
We recommend development of a ethics and governance framework on: remit relationship with Strategy Board responsibilities for reporting publicly and
handling complaints powers maintenance of independence
Removing DNA from the Database
Records are removed in ‘exceptional cases’ under discretion of Chief Constable
If current system of retaining DNA remains, we recommend: public guidelines on how to apply to have records
removed police to justify need for retention independent body to oversee requests
International exchange
EC wants direct, online access to DNA databases across Europe
The Prüm Treaty proposed for exchange of information across EU
We recommend: safeguards to protect sensitive information on the
UK DNA Database being shared with other countries
provisions in Prüm Treaty to ensure its operation is properly monitored
The future: new legislation?
Current legislation for forensic use of bioinformation is piecemeal
Need to think about future possibilities and challenges (eg – linkage to IDENT1)
We recommend: a statutory basis for the regulation of forensic
databases a greater commitment to openness and
transparency
Commonalities and differences
Role of consent and knowledge
Clarity of purpose
The risks of mission creep
Mechanisms for withdrawal
Provisions on access & sharing
What lessons?
Clear purpose and justification for database Robust protection mechanisms Well-defined operational processes Independent oversight Transparency Accountability
Outstanding issues
The role of the individual?
The roles of consent/knowledge/intrusion?
Future purposes of biometric collections?
Who will have access and from where?
Linkage of databases in the future?