Tackling legal challenges posed by population biobanks: reconceptualising consent requirements

This paper examines, from an Australian and international perspective, the phenomenon of population 'biobanks' (research platforms comprising collections of human genetic samples or 'biospecimens' and relevant personal information) and the legal challenges that this development presents. In particular, the paper focuses on the legal concept of consent and the tensions on the traditional understanding of consent that large-scale, long-term population biobanks exert. The aim of the paper is to review the operation of consent principles as they apply to population biobanks and to propose a way forward for how the consent concept can be reconceptualised to meet their demands. In particular, the paper argues for a more liberal approach which allows for 'broad' (or 'enlarged' or 'open') consent in circumstances where permission is sought for future use of samples in, as yet unspecified, genetic research. In pursuing this aim, the objectives underlying this paper are to ensure that unnecessary impediments to research are removed and, at the same time, to facilitate research participation and respect for autonomous choices by research subjects.     

Are we there yet? Best practices for diversity and inclusion in Australia

ABSTRACT

This article reports on the findings of a pilot research project investigating current best practices, operating within national law firms in Australia, that support women lawyers in their advancement to partnership and other leadership positions. Academic research and professional body reports suggest that current diversity and inclusion (D&I) initiatives across the private sector are not resulting in significant change to advancement, retention and attrition of women in the legal profession. However, work done by the Women Lawyers’ Association of New South Wales in Australia, through the Data Comparison Project (DCP), indicates that some firms have made better progress than others. Building on the DCP, this article presents the findings of a pilot project involving in-depth interviews with four of the top-achieving national law firms in Australia on gender equity criteria. It finds that these firms are collectively engaging with many of the best practice initiatives for D&I recommended by the current national and international research and scholarship, and in some instances go beyond international best practice. What is apparent, however, is that the current best practices have yet to achieve significant advancement of women, or to break through the glass ceilings that continue to operate for women in large Australian law firms.     

The ethical, legal and social implications of umbilical cord blood banking: learning important lessons from the protection of human genetic information

Internationally networked umbilical cord blood banks hold great promise for better clinical outcomes, but also raise a host of potential ethical and legal concerns. There is now significant accumulated experience in Australia and overseas with regard to the establishment of human genetic research databases and tissue collections, popularly known as "biobanks". For example, clear lessons emerge from the controversies that surrounded, stalled or derailed the establishment of some early biobanks, such as Iceland's deCODE, Autogen's Tonga database, a proposed biobank in Newfoundland, Canada, and the proposed Taiwan biobank. More recent efforts in the United Kingdom, Japan, Quebec and Tasmania have been relatively more successful in generating public support, recognising the critical need for openness and transparency, and ample public education and debate, in order to build community acceptance and legitimacy. Strong attention must be paid to ensuring that other concerns--about privacy, discrimination, informed consent, governance, security, commercial fairness and financial probity--are addressed in structural terms and monitored thereafter, in order to maintain public confidence and avoid a backlash that inevitably would imperil such research. Once lost, credibility is very difficult to restore.     

Participation of children in clinical trials: UK, European and international legal perspectives on consent

The Declaration of Helsinki was, until recently, the leading international code on the conduct of clinical trials on human subjects. The Council of Europe's Convention on Human Rights and Biomedicine (1997) and the ICH guidelines for Good Clinical Practice (1996) represent a significant step towards increased harmonization of standards in the conduct of medical experiments on human subjects. But in spite of emerging areas of consensus, there remain important areas of unclarity and divergence. Medical practitioners involved in paediatric research in the UK are concerned about the lack of certainty in the law, particularly on the application of consent rules to emergency research. This paper examines UK, European and International norms on the participation of children in medical research and compares the circumstances under which consent rules may be waived under each normative regime.     

Population bio-banks: a juridical analysis based on Icelandic and Estonian experience]

Large-scale collections of human biological samples and associated data are becoming increasingly common as a means of identifying, in a particular population, genetic predispositions to complex diseases that result from an interaction of environmental, lifestyle and genetic factors. This paper compares the recent experiences of Iceland and Estonia in the establishment of population biobanks as well as the specific law passed by both countries to deal with this matter. In the light of this comparative analysis, this paper summarizes the main ethical and policy dilemmas posed by large-scale biobanks and suggests some possible solutions to these new challenges.     

The implementation of the Nagoya ABS Protocol for the research sector: experience and challenges

Over the years, researchers in public institutions and universities have accessed genetic materials from a variety of sources, freely exchanged them with fellow researchers and institutions and shared their research results with foreign and local collaborators. The 2010 Nagoya Protocol regulating access to genetic resources is set to change this scenario. This treaty requires country parties to put in place enhanced ABS measures regulating access to their genetic resources and to provide for the sharing of benefits arising from their utilization. These measures include minimum access standards, mandatory prior informed consent of indigenous and local communities, compliance with the domestic laws or requirements of the provider country and monitoring the utilization of genetic resources. This is aimed at commercial research. Non-commercial public research which contributes to the conservation and sustainable use of biological diversity is encouraged, particularly in developing countries, through simplified measures. There are undoubtedly practical challenges in operationalizing this provision without impeding research in the sector most potentially affected by ABS measures. This article presents the results of a survey of the practices of such researchers in one developing country, namely Malaysia. It examines the potential implications for the national implementation of the Protocol. Given country specificities, this study highlights and shows the importance of increasing knowledge about existing practices for an efficient design and implementation by developing countries of a complex legislation such as the Nagoya ABS Protocol.     

Consent forms in genomics: the difference between law and practice

Consent forms are the principal method for obtaining informed consent from biomedical research participants. The significance of these forms is increasing as more secondary research is undertaken on existing research samples and information, and samples are deposited in biobanks accessible to many researchers. We reviewed a selection of consent forms used in European Genome-Wide Association Studies (GWAS) and identified four common elements that were found in every consent form. Our analysis showed that only two of the four most commonly found elements in our sample of informed consent forms were required in UK law. This raises questions about what should be put in informed consent forms for research participants. These findings could be beneficial for the formulation of participant information and consent documentation in the future studies.     

Exorcising excision: medico-legal issues arising from male and female genital surgery in Australia

Genital surgery is one of the most controversial and contested practices, yet it is frequently described and referred to with little or no attention to cultural and social context. This article examines the practice, performed on both men and women, and the extent to which it clashes with issues of consent and capacity, as well as multicultural concepts of toleration for minority group practices. It then questions why female genital surgery, unlike male genital surgery, is legally prohibited in Australia. It argues that such legal gender bias stems from a liberal conception of "tolerance" and the limits of consent in Australia, placing female genital surgery in an "unacceptable" category and male genital surgery in an "acceptable" category.     

Re Edwards (2011) 4 ASTLR 392: who owns a dead man's sperm?

Re Edwards (2011) 4 ASTLR 392; [2011] NSWSC 478 adds to the small line of cases to have considered whether a woman can not only require medical staff to remove sperm from her dead male partner, but whether she is justified in terms of law and international human rights to use it to create children. In this case a Justice of the New South Wales Supreme Court framed the issue as "what right does a woman have to take sperm from the body of her deceased partner so that she may conceive a child?" He did so, despite the manifest ambiguity and difficulty in characterising the legislative rights in this case, without referring to substantive human rights obligations under international Conventions to which Australia is a ratifying party (particularly Art 10 of the United Nations International Covenant on Economic, Social and Cultural Rights and Art 23 of the United Nations International Covenant on Civil and Political Rights. Technological advances such as those creating the possibility of capturing a dead person's sperm by electro-ejaculation and creating children by subjecting it to intracytoplasmic sperm injection in connection with in vitro fertilisation have altered the balance of individual and social interests in deciding who should be regarded as owning a dead man's sperm and how that relates to basic common law rights of bodily inviolability without free consent. It is to be regretted that in jurisdictions lacking relevant constitutional human rights, or legislation requiring coherence with international human rights, judges do not avail themselves in cases of statutory ambiguity of interpretative insights to be gained from legally binding human rights treaties to which Australia is a party.     

An empirical study of tissue banking in Australia: navigating regulatory and ethical challenges

Collections of tumour samples can be an invaluable resource for medical research. There are, however, numerous ethical and legal challenges associated with tumour banking. While there has been extensive discussion of these issues in the legal and ethical literature, there are few available empirical data in relation to the activities of tumour banks in Australia, their practices around ethically charged issues, and their success in implementing complex regulatory guidelines. The aim of this study was to gain more information about the activities of tumour banks in New South Wales, Australia, with a particular focus on their management of, and attitudes towards, ethical and regulatory issues. A survey of 27 tumour collection and research facilities was conducted using a 55-item questionnaire. There is significant heterogeneity of research methodologies as well as of methods for gaining consent and ensuring donor privacy, and there is general concern among the research community about ethical and regulatory issues related to tumour banking. Heterogeneity of practice and uncertainty about ethical and regulatory requirements is problematic in its potential to hinder research and its potential to generate the space for unethical practice, whether intentional or unintentional. There is a pressing need to address these issues so that tumour banks can be used in the most ethical and efficient way possible.     

The conflict of understanding the genetic make-up of man and his knowledge of it

The rapid development within the research of the human genome offers a great potential with regard to the diagnosis of genetic diseases but it also bears dangers of misuse. The starting point for avoiding these dangers is the autonomy of the individual, i.e. that the information about his genetic constitution should only be ascertained with his explicit consent. It is the duty of law to protect the individual and his relatives - who might also be concerned - without undermining the right to self-determination. Furthermore, it is discussed whether genetic tests should be limited to "health purposes" only. The problem of this limitation, however, is to define the term "health purposes" particularly when the criterion of "quality of life" is also taken into consideration. In order to assure a responsible handling of the genetic data, genetic analysis and especially the counselling of the subject should be reserved to the medical profession, since only a real understanding of the individual's genetic constitution with all risks and chances will enable him to make an informed and self-determined decision.     

Running the gauntlet: An examination of initiation/hazing and sexual abuse in sport

Abstract

When does sport initiation become sexual abuse? What can sport organisations do to ensure that the practice of sport is a safe and high quality experience for all? In this paper research on the initiation practices used by the military and North American universities and sport teams is used to explore links between such practices and physical and sexual abuse. In particular, the dynamics of peer abuse, consent and expressions of masculinity are examined. We question whether there can be acceptable initiation practices in sport (Hoover, 1999) and challenge the place of these ‘macho rituals’ (Weinstein et at, 1995) in sport. We make particular use of an expanded version of the continuum of sexual abuse (Brackenridge, 1997b) and of the sport imperatives identified by Kirby, Greaves and Hankivsky (2000). The paper concludes with recommendations for best practices in athlete-centred sport.     

Right,Crime, and Court: Toward a Unifying Political Conception of International Law

It is widely acknowledged that human rights law (hereafter, HRL) and international criminal law (hereafter, ICL) share core normative features. Yet, the literature has not yet reconstructed this underlying basis in a systematic way. In this contribution, I lay down the basis of such an account. I first identify a similar tension between a “moral” and a “political” approach to the normative foundations of those norms and to the legitimate role of international courts (hereafter, ICs) and tribunals adjudicating those norms. With a view to bring the debate forward, I then turn to the practices of HRL and international criminal law (hereafter, ICL) to examine which of those approaches best illuminates some salient aspects of the adjudication of ICs. Finally, I argue that the political approach best explains the practice. While each preserves a distinct role, HRL and ICL both establish the basic conditions for the primary subject of international law (HRL and ICL, for the purpose of this article), namely the state, to legitimately govern its own subjects constructed as free and equal moral agents.     

Courts and sentencing research on contemporary China

As a leading player in the international community and the projected economic powerhouse in the twenty-first century, China's significance in the international community has been recognized around the world. The construction of its legal system, particularly the criminal justice system, has also received increasing global attention. As the cornerstone of the criminal justice system, the courts and sentencing laws and practices underlie many of the fundamental ideas of a fair and just legal system. This article reviews research on courts and sentencing in contemporary China published after 1990, focusing on the following three areas: (1) research on law and legal reforms with regard to courts and sentencing; (2) research on the determinants of criminal sentencing; and (3) research on capital punishment.     

Population genetic studies: is there an emerging legal obligation to share benefits?

It appears that large-scale population genetic studies are the necessary next step in genomics research. Such studies promise to provide correlative data to permit researchers to understand the etiology of a vast array of complex human diseases. Simultaneously, such studies are increasingly seen as yet another mechanism for the developed world to benefit at the expense of the developing world. In fact, a recent World Health Organization Report suggests that "without explicit attention at the international level, the initial technological fruits of genomics are likely to consist primarily of therapeutic and diagnostic applications for conditions affecting large populations in rich countries." (World Health Organization, Genomics and World Health, 2002). In developed and developing countries alike, there are concerns that the pharmaceutical industry stands to gain at the expense of the population(s) from which population genetic data are derived. In light of the current interest concerning ongoing population genetic studies and an increasing interest by many countries, Canada included, in embarking on large-scale population genetic research, it is appropriate to consider the concept of benefit-sharing as a potential mechanism to assuage these concerns. It is the author's position that by virtue of common law equitable principles and developing norms in international law, including the Human Genome Organization Statement on Benefit-Sharing, that there are principled legal and ethical reasons to compel the sharing of benefits that accrue from the commercialization of the resulting data. Using the United Nations Convention on Biological Diversity and the Bonn Guidelines as a model, I suggest that appropriate benefit-sharing mechanisms have been considered in the context of non-human biological materials and that these same mechanisms may be applicable in the context of international and intra-national population genetic studies.     

Inhumane,cruel, and degrading treatment of criminal prisoners throughout the world

Recent international policy has focused on assuring the human rights of criminal prisoners. Because of the difficulty and cost of comparative research, little is known about the success of these efforts. In this study, by utilizing a secondary data source, we are able to examine various indicators of inhumane and cruel practices in 155 nations. Substandard conditions and violations of basic human rights are found in over one-half of the nations. The levels of economic development, religion, and political structure are found to be related to a nation's prison practices.     

Law and Institutional Legitimacy in the Practice of Human Rights

The Heart of Human Rights develops an account of human rights as legal entities that serve important moral purposes in a legitimate international human rights practice. This paper examines Allen Buchanan’s general concept of institutional legitimacy and aims to expand that concept by emphasizing its connection with several ideas developed in the book about the nature and function of a system of international human rights. When it incorporates those ideas, Buchanan’s ‘Metacoordination View’ can be seen to set a standard of legitimacy not only for assessments of an international scheme of human rights institutions, but also for the basic institutional structures of domestic states. Furthermore, we can see how the nature and function of human rights in the international practice of human rights bears on legitimacy assessments of particular domestic institutions.     

Trafficking in persons and victim health in Australia

This article explores the health problems experienced by victims of trafficking in persons in Australia and analyses the domestic support schemes established to assist these victims. It focuses specifically on the health of adult, female victims who constitute the majority of identified victims, and who are the principal recipients of government support services. Domestic experiences and support schemes are reviewed in the light of international law and best practice guidelines. Recommendations are made to improve the health services available to victims of trafficking in persons in Australia.