Oslo 22 November 2007

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            22 November 2007

What lessons for Biometric regulation may
  be learned from biobank regulation?

                Graeme Laurie
              Edinburgh Law School
 Director, 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
   Protect participants and promises made the
      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
UK Biobank Ethics and Governance Council

              Accountable              Department of Health for England and Wales
                                                Medical Research Council
                                                   Scottish Executive
                                                     Wellcome Trust
                   (WT and MRC only)
 Ethics and                                 North West Development Agency
  Council          Oversees and advises        Funds        Accountable

                                                  UK Biobank Ltd
                                           (UK charitable company)
                                          collaborating with 22 universities through 6
                                               Regional Collaborating Centres
          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
       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
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
     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
       Prioritise access to those parts of the resource that
        are limited in availability (i.e. samples that are
       Manage intellectual property rights in the resource
        and the results that flow from it.

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

This will include access for researchers from the
academic, commercial, charity and public sectors,
both in the UK and overseas.
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
      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
       public guidelines on how to apply to have records
       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
       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
     a greater commitment to openness and
     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?

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