Human Genome Research Project University of Otago Funded by the New Zealand Law Foundation.

Human Genome Research ProjectUniversity of Otago

Funded by the New Zealand Law Foundation

Newborn Screening:

Richman Wee

Project ManagerLaw Foundation-sponsored Human Genome Research Project

Envisioning Changing Expectations and

Future Proofing

• 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

Prelude

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

Today

Re-examining & Rethinking

Language and Concepts (Legal/Ethical)

Picture:

UK Newb Scn Prog Ctr,

Policies and standards,

Apr 2005, page 23

Roles Interests

Purpose(s) Purpose(s) & Expectation(s)

Rights Responsibilities

Consent Authorisation

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

?

CommunityCommunity/ies/ies

HealthcareHealthcareProvidersProviders

StateState(instns &(instns &

processes)processes)

ParentsParents

NewbornNewborn

Interests – whose ?

Expectations- Expectations within, and broadening, the

context of the ‘purpose(s)’ of an

intervention

When?

Whose?

What?

How to meet

them?

Why?

Responsibilities (cf rights)

… for care of the newborn

ParentsParents

HealthcareHealthcareProvidersProviders

Newborn

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

• 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)

Postlude

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]