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.     

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 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.     

The role of coronial autopsies in a context of decreasing hospital autopsies: an investigation of the issues

This article scrutinises the argument that decreasing hospital autopsy rates are outside the control of medical personnel, based as they are on families' unwillingness to consent to autopsy procedures, and that, as a consequence, the coronial autopsy is the appropriate alternative to the important medical and educational role of the autopsy It makes three points which are well supported by the research. First, that while hospital autopsy rates are decreasing, they have been doing so for more than 60 years, and issues beyond the simple notion of consent, like funding formulae in hospitals, increased technology and fear of litigation by doctors are all playing their part in this decline. Secondly, the issue of consent has as much to do with families not being approached as with families declining to give consent. This is well supported by recent changes in hospital policy and procedures which include senior medical personnel and detailed consent forms, both of which have been linked to rising consent rates in recent years. Finally, the perception that coronial autopsies are beyond familial consent has been challenged recently by legislative changes in both Australia and the United States of America which allow objections based on religion and culture to be heard by coroners. For these reasons, it is argued that medical personnel need to focus on increasing hospital autopsy rates, while also addressing the complex ethical issues associated with conducting medical research within the context of the coronial autopsy.     

Ethics of Population-Based Research

This paper considers the morally relevant ways in which population-based research is a distinct type of human subjects research that have unique moral considerations relevant for public health practitioners and researchers. By defining population-based research, the authors distinguish it from public health practice and then consider, in more detail, the ways in which population-based research differs from clinical human subjects research. Based upon the distinctions between these types of research and practice, they identify five important issues that arise in the design and conduct of certain kinds of population-based research. The authors hope that public health practitioners find these distinctions useful in determining when their work may actually be population-based research and that public health researchers use them to identify the areas where ethical issues in their research may arise.     

Legal,ethical and clinical implications of prescribing involuntary,life-threatening treatment: the case of the Sunshine Kid

Involuntary treatment is a concept often familiar to psychiatrists. In clinical practice, it usually involves the hospitalization and pharmacological management of patients with severe mental disorders. However, the scope of involuntary treatment is not limited to the management of mental illness alone. Psychiatric patients afflicted with medical illnesses may require hospitalization and invasive procedures for optimal management of these disorders. The following case illustrates a dilemma in which a psychotic patient refuses life-saving medical treatment; however, the treatment itself carries significant risk of morbidity and mortality. This article reviews the ethical, legal and clinical implications of making such difficult treatment decisions.     

The rise of neuroskepticism

The increasing popularity of functional neuroimaging technologies in multiple disciplines has gained attention from within and outside the field of neuroscience. As the scope of research employing functional neuroimaging technologies broadens, there appears to also be a growing concern about the use of these technologies and the related social, ethical and legal issues. These concerns have been coined 'neuroskepticism'. First, we review how the term neuroskepticism has been previously used and defined. Second, we examine review and commentary articles published in journals with top impact factors, probing the presence and evolution of neuroskepticism within these articles. Results demonstrate a wide, but expected, range of issues associated with functional neuroimaging. It also appears that neuroskepticism is increasing as functional neuroimaging technologies gain popularity, which may indicate the presence of a classic Gartner Hype Cycle.     

Posthumous reproduction and the meanings of autonomy

In recent years there has been considerable debate over the legal and ethical issues associated with posthumous reproduction. This article analyses recent cases and legal regulation of reproductive technologies in Australia. The issues associated with posthumous reproduction are explored through a consideration of the nature of an individual's interest in their reproductive material. The suitability of a property-based model as a means of conceptualising interests in reproductive material is explored. The article concludes that the issues in this area need to be analysed in terms of autonomy interests that are understood relationally.     

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.     

Independent Neuropsychological Evaluations

Unlike clinical practice, entering the realm of independent neuropsychological evaluations and similar types of nonclinical evaluations is an area of professional practice for which most neuropsychologists have little to no training. Many ethical and professional issues and challenges arise with such frequency in this type of work that it would be difficult to justify not being prepared for them. For the practitioner looking for guidance and standards of professional conduct in this arena, there are few comprehensive resources that address the range of issues raised by these types of evaluations and/or a clear standard by which to assess their competence. The purpose of this article is to provide a primer (and/or refresher) to acquaint the practitioner with some of the more salient issues associated with conducting these types of assessments and to review the pertinent literature that is evolving in relation to best practices in this area.     

Ethics, Information Technology, and Public Health: New Challenges for the Clinician-Patient Relationship

Increasingly widespread adoption of health information technology tools in clinical care increases interest in ethical and legal issues related to the use of these tools for public health and the effects of these uses on the clinician-patient relationship. It is argued that patients, clinicians, and society have generally uncontroversial duties to support civil society's public health mission, information technology supports this mission, and the effects of automated and computerized public health surveillance are likely to have little if any effect on the clinician-patient relationship. It is also suggested, nevertheless, that electronic public health surveillance raises interesting and important ethical issues, some of which can be addressed if not resolved by empirical research, especially regarding patient preferences about secondary use of health data and their moral obligation to contribute to population- based health.     

The forensic evaluation and treatment of children: ethics and values

This article will review the history of ethics and values in the forensic evaluations and treatment of children. Topics to be discussed include paternalism, advocacy, parental responsibility, and legal doctrine of parens patriae. Various aspects of the treatment of children, including medications, behavior modification, and psychotherapy, are also examined for ethical considerations. Agency consultation in conflicts of ethics that are associated with public laws are also addressed. The ethical implications of the use of children in any research as research subjects is also addressed.     

“Worth It If It Saves Just One Life”? Ethical Reservations Regarding AMBER Alert

This article provides an exploratory ethical critique of the AMBER Alert system. Using illustrative examples of actual AMBER Alerts and the public discourse regarding them, it notes potentially problematic impacts on victims and/or offenders, and investigation of child abduction cases, as well as the public discourse about the system in particular and threats to children in general. None of these issues have been adequately addressed either by system operators in their public portrayals of the system or rigorous research as to their practical impacts, or in the suggestion of possible remedies. At the heart of the open and unresolved ethical quandaries confronting the AMBER Alert system lies a failure on the part of system operators and supporters to acknowledge apparent limits to the system's effectiveness, and an exaggeration of its capacities in the absence of adequate evidence, which should be sought in earnest through rigorous research. The article argues that system operators should discuss AMBER Alert more candidly and downplay expectations to avert at least some of the problems its facile portrayal can engender. The article also provides directions for future research on the system—research which could either show some of the ethical reservations that are cited to be moot, or reveal ways they could be resolved.     

环境刑法的伦理基础及其对环境刑法新发展的影响

环境伦理与环境刑法的发展具有互动性。环境刑法必须遵循环境伦理的导向性指引,同时环境刑法对环境伦理具有能动作用。随着环境伦理的不断发展,人们逐步认识到人类中心主义环境伦理观的局限与非人类中心主义环境伦理观的困境,折中的可持续发展环境伦理观成为环境刑法之伦理基础。可持续发展环境伦理观影响着环境刑法的新发展,这主要表现在环境法益的扩容和环境犯罪设置向刑事犯的逐步转化方面。     

Cloning and stem cell research: a critical overview of the present legislative regime in Australia and the way forward

The application of stem cell research in biomedical science has recently sparked debates similar to the calls nearly 25 years ago for a ban involving recombinant DNA. This article critically examines the present legislative framework in Australia governing stem cell research and cloning, after briefly seeking a clear understanding of what these procedures involve, as well as suggesting an ethical paradigm within which these issues can be approached. The deficiencies in the proposed legislative framework are also highlighted. Australia has a duty to future generations to pursue the benefits unlocked by this type of research and it is hoped that the next two years will lead to more insights regarding the potential of such research and hence a revision of the present legal impediments.     

Resolving legal, ethical, and human rights challenges in HIV vaccine research

In the absence of a cure for AIDS, attention has turned to the possibility of developing a preventive vaccine for HIV infection. Yet many scientific, ethical, legal, and economic obstacles remain. At the current rate, the development and production of an effective vaccine could take 15 to 20 years or longer. If tens of millions more HIV infections and deaths are to be avoided in the coming decades, vaccine research needs to be greatly expedited. Furthermore, it must be undertaken ethically, and the products of this research must benefit people in developing countries. This article, an edited and updated version of a paper presented at "Putting Third First," addresses challenges arising in HIV preventive vaccine research in developing countries. It does not address clinical research in developing countries relating to treatments or therapeutic vaccines. Nor does it address legal and ethical issues relating to HIV vaccine research in industrialized countries, although similar issues arise in both contexts. The article concludes that while ethical codes are silent on the obligation to undertake research and development, international law provides strong legal obligations--particularly with regard to industrialized states--that should be invoked to accelerate HIV vaccine development, and distribution.     

Ethical,legal, social,and policy issues in the use of genomic technology by the U.S. Military

Advances in genomic science are attracting the interest of the U.S. military for their potential to improve medical care for members of the military and to aid in military recruitment, training, specialization, and mission accomplishment. While researchers have explored the ethical, legal, and social issues raised by the use of genomic science in a wide variety of contexts, there has been virtually no examination of these issues in connection with the use of genomics by the military. This article identifies potential uses of genomic science by the military, proposes an applicable ethical and legal framework, and applies the framework to provide ethical and legal guidance for military decision-makers.     

Procedural justice and ethical decision making

Procedural justice, in the form of voice and respectful treatment by supervisor, and ethical decision making are examined in this research. Ethical decision making is hypothesized to be a direct function of moral intent, as indicated by willingness to use moral criteria in decision making. Moral intent is, in turn, expected to be a function of the decision-making context, including perceptions of voice, respect and trust between supervisor and subordinate, and moral climate. Individual moral development is also expected to have a positive effect on moral intent. Results generally support the model, with two exceptions. First, perception of voice has a negative effect on moral intent, while caring climate and respectful supervisory relations have the expected positive effect on moral intent. These results suggest either a compensatory model of ethical decision making or a complacency effect. Second, individual characteristics had very little effect on either the decision made or the level of moral intent developed, save for one decision. These results suggest an important overlooked variable, the salience of issues for procedural justice concerns.     

"Holding the child down" for treatment in paediatric haematology: the ethical,legal and practice implications

Very little has been written about involuntary treatment for adult patients and even less about such treatment for paediatric patients. Ethical dilemmas for nurses in such situations have not been clearly articulated and there are no clear guidelines available in this area. The following findings from a qualitative, longitudinal study on the psycho-social aspects of treatment for childhood leukaemia and related diseases are offered as preliminary work on this important professional issue. The feelings of parents when confronted with the necessity of holding their child down so that they may receive probably curative treatments for acute lymphoblastic leukaemia are described and some of the ethical and legal issues confronting nurses who provide these treatments are explored.     

Legal liability and research ethics boards: the case of neuroimaging and incidental findings

Neuroimaging research covers a wide range of intriguing issues from revealing brain structures to investigating what happens in our brain when we lie. The field appears to be thriving, but skepticism and alertness to the various ethical, scientific, policy and philosophical challenges associated with it also appear to be on the rise. One particularly complex issue concerns what to do with incidental findings that emerge during the course of neuroimaging research. Research ethics boards (REBs) play a central role in research oversight. In this paper, we will consider some of the potential issues associated with REB liability in negligence in the context of incidental findings in neuroimaging research.