Transcript No Slide Title

Human Genome Research Project
University of Otago
Funded by the New Zealand Law Foundation
Newborn Screening:
Envisioning Changing Expectations and
Future Proofing
Richman Wee
Project Manager
Law Foundation-sponsored Human Genome Research Project
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
Today
Look at the issue of ‘Informed Consent’
blood spot
collection
use (immediate and subsequent/secondary)
storage/destruction/return
transfer
Parental consent
Decision-making authority and process…
awareness, communication, information disclosure,
participation for the responsible care of
and interest of newborns
Re-examining & Rethinking
Language and Concepts
(Legal/Ethical)
Picture:
Roles
Interests
Purpose(s)
Purpose(s) & Expectation(s)
Rights
Responsibilities
Consent
Authorisation
UK Newb Scn Prog Ctr,
Policies and standards,
Apr 2005, page 23
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
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
?
Interests – whose ?
Parents
Community
/ies
Newborn
Healthcare
Providers
State
(instns &
processes)
Expectations
- Expectations within, and broadening, the
context of the ‘purpose(s)’ of an
intervention
Whose?
What?
Why?
How to meet
them?
When?
Responsibilities (cf rights)
… for care of the newborn
Healthcare
Providers
Newborn
Parents
Authorisation
- Examining ‘Consent’
Justification:
Not necessary?
Not desirable?
Not practicable?
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
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
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
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)
Authorisation
• Who from?
• Hierarchical (legally recognised) ordering ?
• What (substantive/content) ?
• When seek it ?
• How seek it ?
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
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)
Led by Prof Mark Henaghan, Dean of Law, Otago
Sponsored by NZ Law Foundation
web: www.otago.ac.nz/law/genome
e-mail: [email protected]