Melbourne Law School - Research Publications
Now showing items 1-12 of 820
Why genomics researchers are sometimes morally required to hunt for secondary findings
BACKGROUND: Genomic research can reveal 'unsolicited' or 'incidental' findings that are of potential health or reproductive significance to participants. It is widely thought that researchers have a moral obligation, grounded in the duty of easy rescue, to return certain kinds of unsolicited findings to research participants. It is less widely thought that researchers have a moral obligation to actively look for health-related findings (for example, by conducting additional analyses to search for findings outside the scope of the research question). MAIN TEXT: This paper examines whether there is a moral obligation, grounded in the duty of easy rescue, to actively hunt for genomic secondary findings. We begin by showing how the duty to disclose individual research findings can be grounded in the duty of easy rescue. Next, we describe a parallel moral duty, also grounded in the duty of easy rescue, to actively hunt for such information. We then consider six possible objections to our argument, each of which we find unsuccessful. Some of these objections provide reason to limit the scope of the duty to look for secondary findings, but none provide reason to reject this duty outright. CONCLUSIONS: We argue that under a certain range of circumstances, researchers are morally required to hunt for these kinds of secondary findings. Although these circumstances may not currently obtain, genomic researchers will likely acquire an obligation to hunt for secondary findings as the field of genomics continues to evolve.
Drawing the line on in vitro gametogenesis
In vitro gametogenesis (IVG) might offer numerous research and clinical benefits. Some potential clinical applications of IVG, such as allowing opposite-sex couples experiencing infertility to have genetically related children, have attracted support. Others, such as enabling same-sex reproduction and solo reproduction, have attracted significantly more criticism. In this paper, we examine how different ethical principles might help us to draw lines and distinguish between ethically desirable and undesirable uses of IVG. We discuss the alleged distinction between therapeutic and non-therapeutic uses of assisted reproduction in the context of IVG, and show how it is both problematic to apply in practice and theoretically dubious. We then discuss how the ethical principles of reproductive justice and beneficence apply to IVG for opposite-sex reproduction, same-sex reproduction, and solo reproduction. We suggest that these principles generate strong reasons for the use of IVG for opposite-sex and same-sex reproduction, but not for solo reproduction.
Trust in genomic data sharing among members of the general public in the UK, USA, Canada and Australia
Trust may be important in shaping public attitudes to genetics and intentions to participate in genomics research and big data initiatives. As such, we examined trust in data sharing among the general public. A cross-sectional online survey collected responses from representative publics in the USA, Canada, UK and Australia (n = 8967). Participants were most likely to trust their medical doctor and less likely to trust other entities named. Company researchers were least likely to be trusted. Low, Variable and High Trust classes were defined using latent class analysis. Members of the High Trust class were more likely to be under 50 years, male, with children, hold religious beliefs, have personal experience of genetics and be from the USA. They were most likely to be willing to donate their genomic and health data for clinical and research uses. The Low Trust class were less reassured than other respondents by laws preventing exploitation of donated information. Variation in trust, its relation to areas of concern about the use of genomic data and potential of legislation are considered. These findings have relevance for efforts to expand genomic medicine and data sharing beyond those with personal experience of genetics or research participants.
Members of the public in the USA, UK, Canada and Australia expressing genetic exceptionalism say they are more willing to donate genomic data
Public acceptance is critical for sharing of genomic data at scale. This paper examines how acceptance of data sharing pertains to the perceived similarities and differences between DNA and other forms of personal data. It explores the perceptions of representative publics from the USA, Canada, the UK and Australia (n = 8967) towards the donation of DNA and health data. Fifty-two percent of this public held 'exceptionalist' views about genetics (i.e., believed DNA is different or 'special' compared to other types of medical information). This group was more likely to be familiar with or have had personal experience with genomics and to perceive DNA information as having personal as well as clinical and scientific value. Those with personal experience with genetics and genetic exceptionalist views were nearly six times more likely to be willing to donate their anonymous DNA and medical information for research than other respondents. Perceived harms from re-identification did not appear to dissuade publics from being willing to participate in research. The interplay between exceptionalist views about genetics and the personal, scientific and clinical value attributed to data would be a valuable focus for future research.
Germline Gene Editing and the Precautionary Principle
The precautionary principle aims to influence decision‐making in contexts where some activity poses uncertain but potentially grave threats. This perfectly describes the controversy surrounding germline gene editing. This article considers whether the precautionary principle should influence how we weigh the risks and benefits of human germline interventions, focusing especially on the possible threats to the health of future generations. We distinguish between several existing forms of the precautionary principle, assess their plausibility and consider their implications for the ethics of germline modification. We also offer a novel form of the precautionary principle: the sufficientarian precautionary principle. Some plausible versions of the precautionary principle recommend placing somewhat greater weight on avoiding threats to future generations than on achieving short‐term benefits. However, no plausible versions of the precautionary principle entail that we should outright reject the use germline gene editing in human reproduction and some, such as the sufficientarian version, might endorse its use.
Mental health, mental capacity, ethics, and the law in the context of COVID-19 (coronavirus)
The emergence of the COVID-19 (coronavirus) pandemic in late 2019 and early 2020 presented new and urgent challenges to mental health services and legislators around the world. This special issue of the International Journal of Law and Psychiatry explores mental health law, mental capacity law, and medical and legal ethics in the context of COVID-19. Papers are drawn from India, Australia, the United Kingdom, Ireland, Germany, Portugal, and the United States. Together, these articles demonstrate the complexity of psychiatric and legal issues prompted by COVID-19 in terms of providing mental health care, protecting rights, exercising decision-making capacity, and a range of other topics. While further work is needed in many of these areas, these papers provide a strong framework for addressing key issues and meeting the challenges that COVID-19 and, possibly, other outbreaks are likely to present in the future.
REASONABLE EXPECTATIONS OF PRIVACY AND DISCLOSURE OF HEALTH DATA
(OXFORD UNIV PRESS, 2019-06-01)
The law of confidence allows for a range of defined circumstances in which confidential patient information (CPI) can be disclosed without breach of confidence-including statutory gateway and overriding public interest. Outside such circumstances, current guidance to health professionals (the 'standard account') assumes that CPI can only be lawfully disclosed with patient consent. This article argues that the standard account has not yet caught up with judgments, post the Human Rights Act 1998 coming into force, which have reinterpreted the law of confidence in the light of Article 8 of the European Convention on Human Rights. In particular, the article explains the significance of the concept of a 'reasonable expectation of privacy' to an action for breach of confidence and thus to legal liability for disclosure of health data. It argues that conformity with a reasonable expectation of privacy provides an alternative account for the lawful disclosure of CPI, and may provide a more sustainable and authentic approach to meeting obligations under the law of confidence than the standard account. The article concludes with recommendations for an evolution of the standard account in a way that could allow restatement of associated concepts (such as consent) free from particular pressure to bend them out of shape. The evolution proposed continues to bring to the fore the patient perspective and allows protection of their 'reasonable expectations' regarding uses of data collected about them rather than those of the profession.
LEGAL BASES FOR DISCLOSING CONFIDENTIAL PATIENT INFORMATION FOR PUBLIC HEALTH: DISTINGUISHING BETWEEN HEALTH PROTECTION AND HEALTH IMPROVEMENT
(OXFORD UNIV PRESS, 2015-06-01)
The disclosure of confidential patient data without an individual's explicit consent should be for purposes that persons have reason to both expect and accept. We do not currently have the required level of clarity or consistency in understanding regarding the disclosure of confidential patient information for public health purposes to support effective public dialogue. The Health Service (Control of Patient Information) Regulations 2002 establish a legal basis in England and Wales for data to be disclosed for public health purposes without patient consent. Under the Regulations, there is more than one potential route towards lawful processing: Data may be processed for public health purposes under both Regulations 3 and 5. The alternatives have different safeguards and conditions attached, and their respective applicability to processing for purposes of public health improvement is currently unclear and subject to review. Beyond the need for clarity regarding the safeguards applicable to processing for particular public health purposes, there are reasons to prefer recognition that Regulation 5 is the most appropriate legal basis for disclosure when the purpose is public health improvement rather than public health protection. Where health improvement, rather than protection, is the aim, there is no justification for discarding the additional safeguards associated with processing under Regulation 5.
Moral uncertainty and the farming of human-pig chimeras
(BMJ PUBLISHING GROUP, 2019-07-01)
It may soon be possible to generate human organs inside of human-pig chimeras via a process called interspecies blastocyst complementation. This paper discusses what arguably the central ethical concern is raised by this potential source of transplantable organs: that farming human-pig chimeras for their organs risks perpetrating a serious moral wrong because the moral status of human-pig chimeras is uncertain, and potentially significant. Those who raise this concern usually take it to be unique to the creation of chimeric animals with 'humanised' brains. In this paper, we show how that the same style of argument can be used to critique current uses of non-chimeric pigs in agriculture. This reveals an important tension between two common moral views: that farming human-pig chimeras for their organs is ethically concerning, and that farming non-chimeric pigs for food or research is ethically benign. At least one of these views stands in need of revision.
Public Health, Intellectual Property, and the Trade and Investment Law Challenges to Australia and Uruguay’s Tobacco Packaging Laws
(Koninklijke Brill NV, 2020)
Tobacco industry internal documents now in the public domain show that in the 1990s, when researchers first proposed that tobacco products be sold in ‘plain packaging’ with large graphic health warnings as a way to reduce the promotional effects of tobacco packaging, the tobacco industry responded with a strategy to recast public debate on the measures in terms of trade and intellectual property rights instead of in terms of health. Despite receiving le-gal advice that these arguments did not have merit, the tobacco industry claimed, over decades and across jurisdictions, that plain packaging and graphic health warnings would expropriate their trademarks, violate international intellectual property agreements, and create barriers to trade.
A Factorial Survey Investigating the Effect of Disclosing Parental Intellectual Disability on Risk Assessments by Children's Social Workers in Child Safeguarding Scenarios
(Oxford University Press (OUP), 2020)
Literature suggests that, as parents, people with intellectual disabilities experience disproportionately high rates of child removal compared to other groups. A factorial survey of 191 children's social workers investigated the effect of disclosing parental intellectual disability (ID) upon risk assessments in a range of hypothetical child safeguarding scenarios. The case scenarios depicted a range of child safeguarding situations and parents' ID status was randomly included as an additional item of information. The data were fitted into a generalised ordinal logistic regression model. Findings indicate that when presented with scenarios considered to be less risky, the parental ID disclosure contributed significantly to a higher risk assessment score. However, when presented with scenarios that were considered more risky, the additional parental ID disclosure did not significantly contribute to a higher score. These findings indicate that the risk associated with parental ID is not fixed but relative to the situation in which it is encountered. The research concludes that in cases of low risk, the effect of parental ID is identified as a support need, whereas the lesser contribution of the disclosure to assessments of higher risk cases may indicate that parental ID is overlooked.
The ‘Rights’ Way to Democratize the Science–Policy Interface in International Environmental Law? A Reply to Anna-Maria Hubert
(Oxford University Press (OUP), 2020)
Science is widely regarded as being necessary for effective international environmental decision-making and risk assessment processes. However, it is equally well recognized that uncertainties or the complexity of phenomena under study mean that science may only offer partial knowledge for environmental problems in many circumstances. ‘Democratization’ of science is often proposed as a solution to this dilemma. This may involve incorporating a wider spectrum of expert views and public inputs in risk assessments of new technologies, public participation in science through so-called ‘citizen science’ initiatives or the application of the precautionary principle. This reply reviews these approaches and contrasts them with another tantalizing possibility offered by Anna-Maria Hubert’s article; a human rights-based approach drawing on the ‘oft-neglected’ right to science. It assesses the extent to which a rights-based approach, utilizing the right to science, offers a way to bridge the gap between science and democracy in contested international environmental legal decision-making processes. While it concludes that there are important potential benefits to the application of the right to science in international environmental law, it is far from clear that it provides a panacea given the limitations on the right expressed in the international human rights instruments in which it is found, such as the International Covenant on Economic, Social and Cultural Rights. Instead, the right to science can be seen as placing another thumb on the scales – alongside the precautionary and participatory approaches – in favour of enabling broader, more democratically accountable decision-making in cases of uncertain science and contested environmental risks.