Sharing of Genomic Data: Exploring the Privacy Implications of the Changing Status of Genomic Data.

This article explores the privacy implications of the changing status of genomic data and the consequences for genomic data-sharing. It sets out the theoretical framework for privacy protection in Australia and the centrality of the concept of "personal information" - information from which an individual is "reasonably identifiable". It examines the applicability of this legal framework to genomic data and the challenge from the ever-growing risk of identifiability of such data and implications for research participation and researchers' willingness to share genomic data. The article critiques the binary approach underpinning Australian privacy law based on whether data are "identified" or "de-identified" and highlights the difficulty of applying this distinction to genomic data given their changing status over time. It concludes by examining necessary reforms to provide individuals with more effective privacy protection over their genomic data and which would support data-sharing for genomic research.

Negligence and Health Innovation: Issues with the Standard of Care and the Need to Revisit the Voluntary Assumption of Risk.

This section examines current debates about the test for standards of care in negligence under the Civil Liability Acts in Australia, and how those debates may impact adversely on innovations in health care. It examines the recent history of attempts to define and regulate health innovation and compares them to judicial determinations from New South Wales that have potential to limit the protections otherwise afforded to competent professional practice. The section argues that, if those protections are eroded, alternative options to protect and encourage innovation should be explored, most especially a resuscitated defence of the voluntary assumption of risk.

The Essential Role of Data and Safety Monitoring Boards (DSMBs) in Ensuring the Ethics of Global Vaccine Trials to Address Coronavirus Disease 2019 (COVID-19O).

Coronavirus disease 2019 (COVID-19) vaccines are being developed and implemented with unprecedented speed. Accordingly, trials considered ethical at their inception may quickly become concerning. We provide recommendations for Data and Safety Monitoring Boards (DSMBs) on monitoring the ethical acceptability of COVID-19 vaccine trials, focusing on placebo-controlled trials in low- and middle-income countries.

Australian Perspectives on the Ethical and Regulatory Considerations for Responsible Data Sharing in Response to the COVID-19 Pandemic.

As the rush to understand and find solutions to the coronavirus disease 2019 pandemic continues, it is timely to re-examine the legal, social and ethical drivers for sharing health-related data from individuals around the globe. International collaboration and data sharing will be essential to the research effort. This raises the question of whether the urgent imperative to find therapies and vaccines may justify some temporary rebalancing of existing ethical and regulatory standards. The Global Alliance for Genomic Health is playing a leading role in collecting information about national approaches to these challenging questions. In this section, we examine some of the initiatives being taken in Australia against this global backdrop.

Unconventional Practice, "Innovative" Interventions and the National Law.

This column explores a recent health profession disciplinary case which throws light on the problems of unconventional interventions by medical practitioners under the Health Practitioner Regulation National Law Act 2009 (Qld). The case involved "innovative" practices which were later found to have been scientifically unsupported, dangerous to patients and grounds for cancelling the health practitioner's registration. This column looks at common features of these kinds of cases in Australia and then examines recent attempts by the Medical Board of Australia to draft policy guidance around the use of unconventional practice in medicine. This column concludes with a number of changes to improve the effectiveness of the proposed policy.

Gene Editing Clinical Trials Could Slip through Australian Regulatory Cracks.

In this column we explore the regulatory environment within which clinical trials involving new genome editing techniques are undertaken. Ostensibly, there is regulatory congestion in this area, with overlapping obligations through the national scheme for regulating gene technology, the national scheme for regulating the supply of therapeutic goods, and the human research ethics system, predominantly administered at the institutional level. In practice, however, the oversight of gene editing clinical trials is left almost entirely to human research ethics committees. Given the uncertain risks associated with such novel technologies, we conclude that it is opportune to reconsider the rigour of current Australian processes for assessing clinical trials involving gene-editing technology.

Correction to: Australia: regulating genomic data sharing to promote public trust.

This article was inadvertently published under a draft title.

Australia: regulating genomic data sharing to promote public trust.

The regulation of genomic data sharing in Australia is a confusing mix of common law, legislation, ethical guidelines, and codes of practice. Beyond privacy laws, which only apply to genomic data that meets the definition of personal information, the key regulatory lever is the National Health and Medical Research Council (NHMRC) National Statement for Ethical Conduct in Human Research ("National Statement") (2007). Compliance with the National Statement is a requirement for institutions to apply to the NHMRC for funding, and includes-among other things-requirements for review of most genomic research by Human Research Ethics Committees. The sections of the National Statement specifying requirements for research with human genomic data are currently under review, including proposed new requirements addressing the return of genetic research findings and oversight of transfer agreements. Ensuring the willingness of Australians to donate their genomic information and participate in medical research will require clarification and harmonisation of the applicable regulatory framework, along with reforms to ensure that these regulations reflect the conditions necessary to promote ongoing public trust in researchers and institutions.

Criteria for Decision-Making Capacity: Between Understanding and Evidencing a Choice.

Although the abilities to understand and to evidence a choice are universally recognised as necessary for decision-making capacity (DMC), they are not sufficient for DMC. Additional criteria such as "appreciation", "reasoning", and "using or weighing information" are often used, but the broad and under-defined nature of some of these additional legal criteria has resulted in diverse and sometimes inconsistent interpretations. This article canvasses jurisdictional variations in DMC criteria, focusing on common law and statutory tests in the United States, the United Kingdom and Canada. It proposes a more integrated framework for interpreting DMC beyond the understanding and evidencing a choice criterion by describing how, in addition to the familiar criterion of the ability to form adequate beliefs, "the ability to value" criterion can usefully fill that space. The article illustrates the potential usefulness of this framework by reviewing how the ability to form adequate beliefs and the ability to value are relevant in several challenging cases drawn from the legal literature and clinical experience.