Human Genome Research Project

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Human Genome Research Project University of
Otago Funded by the New Zealand Law Foundation
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Newborn Screening
Envisioning Changing Expectations and Future
Proofing
Richman Wee Project Manager Law
Foundation-sponsored Human Genome Research Project
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Prelude

• What started off interest in this
• Own thinking to date
• - tidying up the clutter
• re presentation at H Screening Symposium
  Oct2005
• - dancing around the most stirring issue,
• re informed consent

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Today
Look at the issue of Informed Consent blood
spot collection use (immediate and
subsequent/secondary) storage/destruction/re
turn transfer Parental consent Decision-m
aking authority and process awareness,
communication, information disclosure,
participation for the responsible care of
and interest of newborns
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Re-examining Rethinking Language and Concepts
(Legal/Ethical)
Roles Interests Purpose(s) Purpose(s)
Expectation(s) Rights Responsibilities Consent
Authorisation
Picture UK Newb Scn Prog Ctr, Policies and
standards, Apr 2005, page 23
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Interests of various parties

• Whose and what interests?
• Taking stock, weighing, reconciling all
  interests, to extent possible, with the aim of
• advancing relevant and key interests
• Balancing likelihood of Harm vs Benefit
• How can joint/shared responsibilities, duties and
  rights generally and overall be better
  exercised or respected in the (best) interest of
  relevant party/ies?
• Sense of time immediate, short-term, long-term

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and the bigger picture

• How
• - provide benefits and protect from harm
• - promote relevant interests as best as possible
• - fulfil the purpose(s) intended/agreed
  keeping clearly
• in mind and observing the central purpose
• - meet expectations
• - help support decision-makers exercise their
• responsibilities
• ?

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Interests whose ?
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• Expectations
• Expectations within, and broadening, the
• context of the purpose(s) of an
• intervention

Whose?
What?
When?
Why?
How to meet them?
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Responsibilities (cf rights) for care of the
newborn
Newborn
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Authorisation - Examining Consent
Justification Not necessary? Not
desirable? Not practicable?
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Authorisation - Comparing and Examining Consent
Types of Consent (cf. Refusal) A. Explicit
/ Express Consent B. Exceptions to explicit /
express consent 1. Emergency 2.
Legislation (Statutory Authorisation)
public health, mental health legislation as
per Wildeman Downie
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Authorisation - Comparing and Examining Consent
C. Implied Consent (1) Subsumed Consent i.
sub-procedure or necessarily incidental to
procedure explicitly consented to ii. contains a
blanket consent to other unspecified
procedures - significant nexus As per
Wildeman Downie
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Authorisation - Comparing and Examining Consent

• C. Implied Consent (cont.)
• (2) Consent inferred from conduct
• (3) Routine procedures
• (4) Reasonable consent
• D. No Consent (Arguments from Impracticality)
• (1) Too costly
• (2) Too complex
• as per Wildeman Downie

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Authorisation - Comparing and Examining Consent
Presumed Consent (Iceland Biobank, cadaveric
organ procurement) Deferred Consent (emergency
research) Generic Consent for Genetic Screening
(Annas 1994) Proxy Consent (children, organ
donation by legally competent, some research
contexts) Substitute / Surrogate Consent
(legally incompetent, PVS, circumcision)
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Authorisation

• Who from?
• Hierarchical (legally recognised) ordering ?
• What (substantive/content) ?
• When seek it ?
• How seek it ?

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Authorisation

• Not intended to circumvent/undermine the notion
  of Consent
• Intended, as a starting point, to reflect and
  convey more accurately what is going on
• Promote relevant interests and meet expectations
• Support responsible care of newborns

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Postlude

• Voluntary participation having built-in
  barometer as
• an indicator also requiring initiatives to
  support
• promotion of awareness understanding
• Community/ies-dependent over time (bottom-up
  cf
• top-down, but consider dynamic exchange)

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Led by Prof Mark Henaghan, Dean of Law, Otago
Sponsored by NZ Law Foundation web
www.otago.ac.nz/law/genome e-mail
genome.lawpolicy_at_otago.ac.nz