Medical Law International

While modern genomics research often adheres to community norms emphasizing open data sharing, many genomics institutes and projects have recently nuanced such norms with a corpus of data release policies. In particular, publication moratoria and data retention policies have been enacted to ‘reward’ data producers and ensure data quality control. Given the novelty of these policies, this article seeks to identify and analyse the main features of data retention and publication moratoria policies of major genomics institutes and projects around the world. We find that as more collaborative genomics projects are created, and further genomic research discoveries are announced, the need for more sophisticated yet practical and effective policies will increase. Reward systems should be implemented that recognize contributions from data producers and acknowledge the need to remain dedicated to the goals of open data sharing. To this end, in addition to the current choices of employing data retention or publication moratoria policies, alternative models that would be easier to implement or less demanding on open science should also be considered.

The UK Clinical Trials Regulations were amended in 2006 and 2008 to facilitate research on medicinal products administered in emergency situations. The Regulations, which implement the EU Clinical Trials Directive, had previously required prior consent to participation in a clinical trial from either the participant or the participant’s legal representative. These amendments put emergency research on medicinal products on a similar footing to research on other types of invasive emergency treatment. This article argues that this was a positive development from the perspective of science and society and one for which there is a strong ethical basis. Nonetheless, it is argued that the UK Regulations cannot be interpreted consistently with European law without distortion contrary to the rule of law. It is also argued that the Directive needs to be amended or replaced to ensure a proper balance between the interests of participants and the interests of science and society. A number of specific suggestions are made, and the proposals made by the European Commission in July 2012 are supported. It is, however, argued that more needs to be done to protect the conduct of emergency trials from the conflicts of interests and biases that generally beset clinical trials.

In the context of maternal–fetal surgery (MFS), an attempt to justify pregnant women and physicians’ moral obligations toward the fetus has been made based on the concept of ‘the fetus as a patient’. Somewhere else, we have questioned the internal coherence and consistency of this position. Here, we propose an alternative to the concept of ‘the fetus as a patient’, as the foundation of physicians’ moral obligations in the context of MFS. In light of Deryck Beyleveld’s interpretation of the precautionary principle and in light of Alan Gewirth’s theory of human rights, we propose what we think is a morally and procedurally justified argument for the existence of physicians’ moral obligations toward the women and fetuses they care for in the context of MFS.

Chinese informed consent law is in a period of fundamental transition. The recently enacted Tort Liability Law offers a new way of thinking about Chinese informed consent law in the therapeutic setting. It includes distinctive provisions relevant to informed consent, thereby creating a generous duty to inform, including a duty to inform about alternative treatment options. However, the rule as presently cast suffers from a lack of detail and clarity, fails to clearly identify the distinctiveness of the duty to disclose, and may be criticised for being all-embracing and overambitious. Nevertheless, one has reason to be optimistic about the future of Chinese informed consent law. This article offers a detailed tour through the new Tort Liability Law in the specific context of disclosure to patients and sets out certain suggestions for future development. These suggestions include that Chinese law should clearly distinguish the task of information disclosure from diagnosis and treatment, should introduce the ‘materiality’ test of information disclosure, and should also acknowledge the role of professional regulation in honouring and promoting the doctrine of informed consent. In the course of this examination, the author draws comparisons with the laws of Japan and also Commonwealth countries, including Asian common law jurisdictions, such as Singapore and Malaysia.