Standardization and omics science : technical and social dimensions are inseparable and demand symmetrical study

Standardization is critical to scientists and regulators to ensure the quality and interoperability of research processes, as well as the safety and efficacy of the attendant research products. This is perhaps most evident in the case of “omics science,” which is enabled by a host of diverse high-throughput technologies such as genomics, proteomics, and metabolomics. But standards are of interest to (and shaped by) others far beyond the immediate realm of individual scientists, laboratories, scientific consortia, or governments that develop, apply, and regulate them. Indeed, scientific standards have consequences for the social, ethical, and legal environment in which innovative technologies are regulated, and thereby command the attention of policy makers and citizens. This article argues that standardization of omics science is both technical and social. A critical synthesis of the social science literature indicates that: (1) standardization requires a degree of flexibility to be practical at the level of scientific practice in disparate sites; (2) the manner in which standards are created, and by whom, will impact their perceived legitimacy and therefore their potential to be used; and (3) the process of standardization itself is important to establishing the legitimacy of an area of scientific research.

Regulating IVF and pre-implantation tissue-typing for the creation of "saviour siblings" : a harm analysis

Scientific discoveries, developments in medicine and health issues are the constant focus of media attention and the principles surrounding the creation of so called ‘saviour siblings’ are of no exception. The development in the field of reproductive techniques has provided the ability to genetically analyse embryos created in the laboratory to enable parents to implant selected embryos to create a tissue-matched child who may be able to cure an existing sick child. The research undertaken in this thesis examines the regulatory frameworks overseeing the delivery of assisted reproductive technologies (ART) in Australia and the United Kingdom and considers how those frameworks impact on the accessibility of in vitro fertilisation (IVF) procedures for the creation of ‘saviour siblings’. In some jurisdictions, the accessibility of such techniques is limited by statutory requirements. The limitations and restrictions imposed by the state in relation to the technology are analysed in order to establish whether such restrictions are justified. The analysis is conducted on the basis of a harm framework. The framework seeks to establish whether those affected by the use of the technology (including the child who will be created) are harmed. In order to undertake such evaluation, the concept of harm is considered under the scope of John Stuart Mill’s liberal theory and the Harm Principle is used as a normative tool to judge whether the level of harm that may result, justifies state intervention or restriction with the reproductive decision-making of parents in this context. The harm analysis conducted in this thesis seeks to determine an appropriate regulatory response in relation to the use of pre-implantation tissue-typing for the creation of ‘saviour siblings’. The proposals outlined in the last part of this thesis seek to address the concern that harm may result from the practice of pre-implantation tissue-typing. The current regulatory frameworks in place are also analysed on the basis of the harm framework established in this thesis. The material referred to in this thesis reflects the law and policy in place in Australia and the UK at the time the thesis was submitted for examination (December 2009).

Identifying child sexual abuse within school contexts : policy problems and solutions, and a landmark case

As a strategy to identify child sexual abuse, most Australian States and Territories have enacted legislation requiring teachers to report suspected cases. Some Australian State and non-State educational authorities have also created policy-based obligations to report suspected child sexual abuse. Significantly, these can be wider than non-existent or limited legislative duties, and therefore are a crucial element of the effort to identify sexual abuse. Yet, no research has explored the existence and nature of these policy-based duties. The first purpose of this paper is to report the results of a three-State study into policy-based reporting duties in State and non-State schools in Australia. In an extraordinary coincidence, while conducting the study, a case of failure to comply with reporting policy occurred with tragic consequences. This led to a rare example in Australia (and one of only a few worldwide) of a professional being prosecuted for failure to comply with a legislative duty. It also led to disciplinary proceedings against school staff. The second purpose of this paper is to describe this case and connect it with findings from our policy analysis.

Children and consent to medical treatment

This chapter deals with the law concerning children and consent to medical treatment. Where a child under the age of 18 requires medical treatment, issues arise as to who may lawfully consent to the treatment and under what circumstances. Depending on the circumstances, consent may be given by the child’s parent or guardian; the child; or a court. The chapter provides a thorough treatment of Australian law about these issues and circumstances.

Finding a way through the ethical and legal maze : withdrawing medical treatment and euthanasia

This article examines Finnis' and Keown's claim that the intention/foresight distinction should be used as the basis for the lawfulness of withholding and withdrawing medical treatment, rather than the act/omission distinction which is currently used. I argue that whilst the intention/foresight distinction is sound and can apply to palliative pain relief hastening death, it cannot be applied to withholding and withdrawing medical treatment. Instead, the act/omission distinction remains the better basis for the lawfulness of withholding and withdrawal, and law reform is consequently unnecessary.

Recent developments : loss of chance in medical litigation : Tabet v Gett [2010] HCA 12.

Following the judgement of the High Court in Tabet v Gett [2010]HCA 12 handed down on 21 April 2010 it appears that in Australia there is now very limited scope for recovery in negligence for the loss of a chance of a better medical outcome.

Proof of causation in informed consent cases : establishing what the plaintiff would have done

A degree of judicial caution in accepting the assertion of a plaintiff as to what he or she would have done, if fully informed of risks, is clearly evident upon a review of decisions applying the common law. Civil liability legislation in some jurisdictions now precludes assertion evidence by a plaintiff. Although this legislative change was seen as creating a significant challenge for plaintiffs seeking to discharge the onus of proof of establishing causation in such cases, recent decisions suggest a more limited practical effect. While a plaintiff’s ex post facto assertions as to what he or she would have done if fully informed of risks may now be inadmissible, objective and subjective evidence as to the surrounding facts and circumstances, in particular the plaintiff’s prior attitudes and conduct, and the assertion evidence of others remains admissible. Given the court’s reliance on both objective and subjective evidence, statistical evidence may be of increasing importance.

Mental harm, rescuers and the Civil Liability Act 2002 (NSW)

At common law, a duty of care may be owed to a claimant who suffers nervous shock or pure mental harm due to witnessing, or hearing about, physical injury caused to another due to a defendant’s negligence. “Pure mental harm” is the ‘impairment of a person’s mental condition’ that is not suffered as a consequence of any other kind of personal injury to them. However, as many accidents have the potential to create a wide circle of mental suffering to bystanders, family members or others not physically injured themselves, it has traditionally been ‘thought impolitic that everybody so affected should be able to recover damages from the tortfeasor.’ ‘To allow such extended recovery would stretch liability too far.’ Nevertheless, whilst adopting a restrictive approach to liability, the common law courts have recognised that a defendant might owe a duty in relation to the pure mental harm suffered by one who foreseeably attends an accident scene to rescue another from a situation created by the defendant’s negligence.

The legal role of medical professionals in decisions to withhold or withdraw life-sustaining treatment : Part 1 (New South Wales)

This is the first article in a series of three that examines the legal role of medical professionals in decisions to withhold or withdraw life-sustaining treatment from adults who lack capacity. This article considers the position in New South Wales. A review of the law in this State reveals that medical professionals play significant legal roles in these decisions. However, the law is problematic in a number of respects and this is likely to impede medical professionals’ legal knowledge in this area. The article examines the level of training medical professionals receive on issues such as advance directives and substitute decision-making, and the available empirical evidence as to the state of medical professionals’ knowledge of the law at the end of life. It concludes that there are gaps in legal knowledge and that law reform is needed in New South Wales.

The legal role of medical professionals in decisions to withhold or withdraw life-sustaining treatment : Part 2 (Queensland)

This is the second article in a series of three that examines the legal role of medical professionals in decisions to withhold or withdraw life-sustaining treatment from adults who lack capacity. This article considers the position in Queensland, including the parens patriae jurisdiction of the Supreme Court. A review of the law in this State reveals that medical professionals play significant legal roles in these decisions. However, the law is problematic in a number of respects and this is likely to impede medical professionals’ legal knowledge in this area. The article examines the level of training medical professionals receive on issues such as advance health directives and substitute decision-making, and the available empirical evidence as to the state of medical professionals’ knowledge of the law at the end of life. It concludes that there are gaps in legal knowledge and that law reform is needed in Queensland.

The legal role of medical professionals in decisions to withhold or withdraw life-sustaining treatment : part 3 (Victoria)

This is the final article in a series of three that examines the legal role of medical professionals in decisions to withhold or withdraw life-sustaining treatment from adults who lack capacity. This article considers the position in Victoria. A review of the law in this State reveals that medical professionals play significant legal roles in these decisions. However, the law is problematic in a number of respects and this is likely to impede medical professionals’ legal knowledge in this area. The article examines the level of training that medical professionals receive on issues such as refusal of treatment certificates and substitute decision-making, and the available empirical evidence as to the state of medical professionals’ knowledge of the law at the end of life. It concludes that there are gaps in legal knowledge and that law reform is needed in Victoria. The article also draws together themes from the series as a whole, including conclusions about the need for more and better medical education and about law reform generally.

Queensland College of Teachers annual lecture 2010 : child protection

Teachers have a crucial role as “sentinels” for children who have been abused or neglected. This professional development session will provide a framework for understanding the types, incidence and causes of child abuse and neglect, and teachers’ role in reporting suspected cases. The session will provide participants with knowledge and skills to enable them to identify warning signs and indicators of child abuse and neglect, know the basis of their duties to report suspected cases of abuse and neglect, and respond to the needs of abused and neglected children at school. The presentation will focus on: • the reasons why child abuse and neglect can occur; • the different types of child abuse and neglect and their effects on children; • the warning signs and indicators of physical abuse, emotional abuse, sexual abuse and neglect; • applying knowledge of indicators to make judgements about risk of harm; • responding to indications of risk of harm, including complying with legislative and policy-based duties to report suspected child abuse and neglect.

Ending the life of the act/omission dispute: Causation in withholding and withdrawing life-sustaining measures

My aim in this paper is to challenge the increasingly common view in the literature that the law on end of life decision making is in disarray and is in need of urgent reform. My argument is that this assessment of the law is based on assumptions about the relationship between the identity of the defendant and their conduct, and about the nature of causation, which, on examination, prove to be indefensible. I then provide a clarification of the relationship between causation and omissions which proves that the current legal position does not need modification, at least on the grounds that are commonly advanced for the converse view. This enables me, in conclusion, to clarify important conceptual and moral differences between withholding, refusing and withdrawing life-sustaining measures on the one hand, and assisted suicide and euthanasia, on the other.