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

2. Newborn Screening: Richman Wee Project Manager Law Foundation-sponsored Human Genome Research Project Envisioning Changing Expectations and Future Proofing

3. 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

4. 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

5. Re-examining & Rethinking Language and Concepts (Legal/Ethical) Picture: UK Newb Scn Prog Ctr, Policies and standards, Apr 2005, page 23 RolesInterests Purpose(s) Purpose(s) & Expectation(s) RightsResponsibilities ConsentAuthorisation

6. 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

7. 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 ?

8. Newborn Parents State (instns & processes) HealthcareProviders Community/ies Interests – whose ?

9. Expectations - - Expectations within, and broadening, the context of the ‘purpose(s)’ of an intervention When? Whose? What? How to meet them? Why?

10. Responsibilities (cf rights) … for care of the newbornHealthcareProvidersParents Newborn

11. Authorisation - Examining ‘Consent’ Justification: Not necessary? Not desirable? Not practicable?

12. 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

13. 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

14. 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

15. 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)

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

17. 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

18. 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

19. Led by Prof Mark Henaghan, Dean of Law, Otago Sponsored by NZ Law Foundation web: www.otago.ac.nz/law/genomewww.otago.ac.nz/law/genome e-mail: genome.lawpolicy@otago.ac.nzgenome.lawpolicy@otago.ac.nz