Ethical issues in international biomedical research: an overview

Human subjects research has been the focus of numerous controversies over the years. The dilemma lies between the potential harm to individuals who participate in research and the knowledge to be gained from the research study that might benefit society. When research is conducted in developing countries by researchers and sponsors from the United States and other industrialized countries, differences in history, culture, politics, wealth, and power between the countries give rise to unique challenges. In this Article, the author identifies several ethical issues to be considered when research is conducted in developing countries and provides the legal and ethical framework for their resolution.     

HIV vaccines in Canada: legal and ethical issues--an overview

In July 2002 the Legal Network released an overview paper on legal and ethical issues related to an HIV vaccine in Canada. The paper, which is based on a more detailed report prepared in collaboration with the Centre for Bioethics of the Clinical Research Institute of Montréal, calls for the establishment of a Canadian HIV Vaccine Plan.     

New Malaise: Bioethics and Human Rights in the Global Era

Recent transnational HIV research projects have raised questions about the ethics of research in developing countries, and with good reason. Lower ethical standards are often applied in these settings, yet the field of bioethics has remained relatively quiet on the subject, concerning itself primarily with issues that only affect affluent countries. Here we call for a new focus on equity and human rights in bioethics.     

The Ethical Health Lawyer: An Empirical Assessment of Moral Decision Making

Writing in 1999, legal ethics scholar Brad Wendel noted that "[v]ery little empirical work has been done on the moral decision making of lawyers." Indeed, since the mid-1990s, few empirical studies have attempted to explore how attorneys deliberate about ethical dilemmas they encounter in their practice. Moreover, while past research has explored some of the ethical issues confronting lawyers practicing in certain specific areas of practice, no published data exists probing the moral mind of health care lawyers. As signaled by the creation of a regular column "devoted to ethical issues arising in the practice of health law" in the Journal of Law, Medicine & Ethics , the time to address the empirical gap in the professional ethics literature is now. Accordingly, this article presents data collected from 120 health care lawyers. Presenting this population with a number of hypothetical scenarios relating to how they would respond when confronting an ethical dilemma without an obvious solution or when facing a situation in which their personal values were in tension with their professional obligations, this article represents a first step toward better understanding how lawyers who practice in health care settings understand and resolve the moral discomfort they encounter in their professional lives.     

Regulating developments in embryonic stem cell research in Africa: a third person's perspective

Among the many advances in modern biotechnology, embryonic stem (ES) cell research has raised perhaps the most intense debate over the ethical, legal and policy issues involved. This debate has centred inter alia on the lives and well-being of the donors or participants in clinical trials, the presumed lives of embryos, the possibility of reproductive cloning, and government funding, among others. These ethical, legal and policy issues tend to overlap and cut across all strata of society, with opponents of the research calling for prohibition and proponents calling for promotion. One important question is whether African countries should regulate to limit or promote developments in ES cell research. This article argues that, in view of the dynamism of modern biotechnology, African countries should regulate in such a way as to maximise the benefits while minimising the disadvantages associated with the research.     

Navigating tissue banking regulation: conceptual frameworks for researchers, administrators, regulators and policy-makers

In the "post-genomic" age of biomedical research, researchers often wish to utilise collections of human tissue. This type of research raises many ethical and legal issues and anyone wishing to use such collections is faced with an enormously complex set of regulatory requirements, many of which are still ambiguous, reflecting ongoing ethical and legal debate. Whilst there is no way of entirely avoiding such regulatory complexity and ambiguity, conceptual frameworks can assist those who wish to use, administer, authorise and generate policy on tissue banking research. Two conceptual frameworks are described here: a taxonomy of tissue banking practices, aimed at assisting those who need to ensure that tissue banks meet ethical and legal requirements; and a "syncretic" approach to policy-making, for those who wish to generate new policy, or streamline existing policy relating to tissue banking research.     

HIV vaccines: current challenges and future directions

Volume seven of the Review will mark the tenth anniversary of the Canadian HIV/AIDS Legal Network with a series of articles that describe past developments and future directions in several areas of policy and law related to HIV/AIDS. The following article is the first of these, discussing current challenges and future directions in the development of and access to HIV vaccines. It argues that governments are under public health, ethical, and legal obligations to develop and provide access to HIV vaccines. It further explains what is required for governments to fulfill their obligations: additional commitment and resources for HIV vaccine development in the context of increased global research and development regarding diseases of the poor; increased support and advocacy for partnerships to develop HIV vaccines; enhanced regulatory capacity in every country to review, approve, and monitor HIV vaccines; and assurance of global supply of, procurement of, delivery of, and access to vaccines in the context of efforts to increase global access to public health measures and technologies.     

Lessons from European population genetic databases: comparing the law in Estonia, Iceland, Sweden and the United Kingdom

The advent of large-scale, population genetic databases (PGDs) in several countries around the world marks a significant development in human DNA banking and genetic research. The European countries that have led the way in the development of PGDs are Iceland, Sweden, Estonia and the U.K. In legal terms, the emergence of PGDs has been far from straightforward as such projects pose a range of difficult and complex issues for the law to address. This article canvasses the current law in Iceland, Estonia, Sweden and the U.K. on four fundamental issues of principle pertaining to PGDs, in order to illustrate the difficulties that have emerged around PGDs, highlight key areas of legal concern, and shed light on possible ways forward. It compares and contrasts the differing legal positions and lawmakers' responses to date in these four European countries that have established PGDs or are seeking to do so. The four fundamental issues examined are: (1) consent, especially for secondary research purposes; (2) ownership of biological samples, data and databases; (3) the rights of certain third parties to gain access to, and to use, PGD biological samples and data; and (4) benefit sharing, including the provision of feedback and genetic counselling to participants. This analysis may offer some guidance for policymakers in other jurisdictions where PGDs have been proposed or are being established.     

Introduction: International Perspectives on Health Policy

This special issue of Law & Policy examines legal, bioethical, and social science perspectives on the critical problems and choices arising from the rapid changes in the health care systems throughout the industrialized world. Advances in medical technology, the rising costs of health care, and the aging of the industrial populations have made health care a crucible for many of the broader policy concerns facing the world in the new millennium. The purpose of the special issue was for these issues to be addressed in a multidisciplinary forum, to add to the broader spectrum of socio–legal scholarship. Scholars from diverse countries examined a variety of issues from ethical, social science, and clinical perspectives.     

FAMILY SUPPORT AND MAINTENANCE: EMERGING ISSUES IN SOME DEVELOPING COUNTRIES WITH MIXED JURISDICTIONS

Family support and maintenance laws in several developing countries with mixed legal traditions derived from colonial and local laws are based on a litigation model. This model often fails to give adequate legal relief in the socioeconomic context of poverty. The situation is made worse by inequitable and gender‐biased inheritance laws. This article will use examples mainly from countries in South Asia and Commonwealth Africa to demonstrate how reformist legislation and constitutional jurisprudence in the area of public law and judicial activism highlight the issues that must be addressed if the legal system is to provide an effective system of family support and maintenance.     

Barcelona 2002: law, ethics, and human rights. Advancing research and access to HIV vaccines: a framework for action

In light of the continuing spread of HIV infection and the devastating impact of the disease on lives, communities, and economies, particularly in the developing world, the investment in new treatments, vaccines, and microbicides has clearly been inadequate. Efforts must be intensified to develop effective HIV vaccines and to ensure that they are accessible to people in all parts of the world. This article is a summary of a paper by Sam Avrett presented at "Putting Third First: Vaccines, Access to Treatments and the Law," a satellite meeting held at Barcelona on 5 July 2002 and organized by the Canadian HIV/AIDS Legal Network, the AIDS Law Project, South Africa, and the Lawyers Collective HIV/AIDS Unit, India. In the article, Avrett calls for immediate action to increase commitment and funding for HIV vaccines, enhance public support and involvement, accelerate vaccine development, and plan for the eventual delivery of the vaccines. The article briefly outlines steps that governments need to take to implement each of these objectives. The article also provides a menu of potential actions for vaccine advocates to consider as they lobby governments.     

Report on complementary/alternative health care and HIV/AIDS

In 2001, the Canadian HIV/AIDS Legal Network published a lengthy report on Complementary/Alternative Health Care and HIV/AIDS: Legal, Ethical & Policy Issues in Regulation. The document is the first in a series of papers to be produced by the Legal Network on priority legal and ethical issues related to HIV/AIDS care, treatment, and support. The article below summarizes the contents of the report.     

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 “process” of field research in the courtoom

This article is meant to contribute to understanding the process of “live” courtroom research by describing and reflecting upon the choices my colleagues and I made in a recently completed study of judicial behavior. In light of the tremendous need for such research and in recognition of the perils attendant to conducting it, social scientists must begin to articulate in detail their philosophy, strategies, and methods of study in the actual courtroom setting. The present article discusses the methodological and ethical issues that we faced in the context of the research project on trial judges' verbal volved in our courtroom research included: (1) developing the theory and purpose of study, (2) organizing entry and logistics in the field, (3) assessing ethical costs and benefits, (4) gathering field data and developing methods that accommodate the field setting, and (5) understanding follow-up and ethical concerns after the research is over.     

Life after death: preservation of the immortal seed

In today's brave new world, women who suffer the loss of their husband or lover can call upon medical science to create a souvenir baby. The rights of the decedent over his genetic material and the rights of the child who is created therefrom are the subject of an evolving legal process. This Essay examines legal, moral and ethical issues which arise from post-mortem artificial insemination. It discusses the attendant conflicts of procreative rights, finality of probate, psychological issues, international law, and recent cases. Ultimately, comprehensive legislation must be enacted to address these issues.     

The Duty of States to Assist Other States in Need: Ethics, Human Rights, and International Law

In this article, Gostin and Archer explore the varied lenses through which governments are obligated to address humanitarian needs. States'responsibilities to help others derive from domestic law, political commitments, ethical values, national interests, and international law. What is needed, however, is clarity and detailed standards so that States can operationalize this responsibility, making it real for developing countries. Transnational cooperation needs to be more effective and consistent to provide assistance for the world's poorest and least healthy people.     

Legal perceptions of forensic DNA profiling part I: a review of the legal literature

A forensic biologist is usually involved in the criminal justice system process somewhere between the police and the legal system, interacting in a practical context regularly and extensively with both. Forensic DNA research and development commonly involves initiatives that encroach into the neighbouring domains of the law enforcement or legal agencies. Despite this level of association, establishing meaningful cross-disciplinary communication and understanding within the justice system remains a challenge. As an example, there is an abundance of literature relating to forensic DNA profiling in legal and criminological periodicals. Such journals are perhaps outside the regular reading of forensic scientists and much of the legal discussion appears to go unnoticed. This situation is understandable; however, it is also undesirable particularly as forensic DNA developments are intertwined with significant changes in legislation and contentious issues of privacy, civil liberty and social justice. This paper attempts to address this shortcoming directly by summarising - from the viewpoint of a forensic scientist - some of the discussion in the legal literature. In particular the review focuses on discussion raising ideological and ethical concerns. Awareness of these views is of relevance to forensic science. It assists us to accurately place DNA evidence into context and to develop its role in achieving the broader criminal justice system objectives. Understanding the discussion also provides a way to enter the debate and communicate at an appropriate level the true potential of DNA to the legal community.     

Cultural Challenges to Biotechnology: Native American Genetic Resources and the Concept of Cultural Harm

This article examines the intercultural context of issues related to genetic research on Native peoples. In particular, the article probes the disconnect between Western and indigenous concepts of property, ownership, and privacy, and examines the harms to Native peoples that may arise from unauthorized uses of blood and tissue samples or the information derived from such samples. The article concludes that existing legal and ethical frameworks are inadequate to address Native peoples' rights to their genetic resources and suggests an intercultural framework for accommodation based on theories of intergroup equality and fundamental human rights.     

Which bank? A guardian model for regulation of embryonic stem cell research in Australia

In late 2005 the Legislation Review: Prohibition of Human Cloning Act 2002 (Cth) and the Research Involving Human Embryos Act 2002 (Cth) recommended the establishment of an Australian stem cell bank. This article aims to address a lack of discussion of issues surrounding stem cell banking by suggesting possible answers to the questions of whether Australia should establish a stem cell bank and what its underlying philosophy and functions should be. Answers are developed through an analysis of regulatory, scientific and intellectual property issues relating to embryonic stem cell research in the United Kingdom, United States and Australia. This includes a detailed analysis of the United Kingdom Stem Cell Bank. It is argued that a "guardian" model stem cell bank should be established in Australia. This bank would aim to promote the maximum public benefit from human embryonic stem cell research by providing careful regulatory oversight and addressing ethical issues, while also facilitating research by addressing practical scientific concerns and intellectual property issues.