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.     

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.     

Management research in criminal justice: Exploring ethical issues

While there has been a steady increase of management research in criminal justice organizations in recent years, far too little attention has been devoted to the dilemmas surrounding these research efforts. The first dilemma is associated with the treatment of information or data while the second is associated with the treatment of human subjects. The purpose of this paper is to begin the debate in this sensitive area by exploring the primary ethical issues of each dilemma which must be constructively dealt with by management researchers if they are to avoid potential harm to their subjects, while at the same time, assure the validity of their results. Finally, several strategies which appear useful in addressing these ethical issues will be considered.     

Sub-Saharan African randomised clinical trials into male circumcision and HIV transmission: methodological, ethical and legal concerns

In 2007, WHO/UNAIDS recommended male circumcision as an HIV-preventive measure based on three sub-Saharan African randomised clinical trials (RCTs) into female-to-male sexual transmission. A related RCT investigated male-to-female transmission. However, the trials were compromised by inadequate equipoise; selection bias; inadequate blinding; problematic randomisation; trials stopped early with exaggerated treatment effects; and not investigating non-sexual transmission. Several questions remain unanswered. Why were the trials carried out in countries where more intact men were HIV-positive than in those where more circumcised men were HIV-positive? Why were men sampled from specific ethnic subgroups? Why were so many participants lost to follow-up? Why did men in the male circumcision groups receive additional counselling on safe sex practices? While the absolute reduction in HIV transmission associated with male circumcision across the three female-to-male trials was only about 1.3%, relative reduction was reported as 60%, but, after correction for lead-time bias, averaged 49%. In the Kenyan trial, male circumcision appears to have been associated with four new incident infections. In the Ugandan male-to-female trial, there appears to have been a 61% relative increase in HIV infection among female partners of HIV-positive circumcised men. Since male circumcision diverts resources from known preventive measures and increases risk-taking behaviours, any long-term benefit in reducing HIV transmission remains uncertain.     

Methodological and ethical issues in child abuse research

The child abuse literature was surveyed but found lacking in analyses of fundamental ethical and procedural issues. The present paper, supported by a review of the relevant research, explores the problems surrounding the definition of physical child abuse, the gender and recruitment of subjects, the use of informed consent and deception, and the problem of maintaining confidentiality in this area. Greater detail in reporting of methods employed by researchers is recommended as an important first step to expanding discussion of these issues.     

Legal and ethical considerations of forensic anthropological research

In the UK, Forensic Anthropology is maturing rapidly, consequently demanding discussion of previously overlooked yet fundamental principles of this discipline. UK law and ethics are interpreted from a forensic anthropological standpoint. First, the influence of UK law and ethics on the stages of forensic anthropological research (the collection, analysis and storage of human remains) are discussed. Existing ethical codes of conduct are investigated for their relevance to researching forensic anthropologists. It is concluded that: when appropriately interpreted, UK law and ethics are extremely influential on forensic anthropological research; debate within this area is required; and that an understanding of the law and ethical thought is vital for the successful growth of forensic anthropology in the UK.     

Corpse identification in mass disasters and other violence:the ethical challenges of a humanitarian approach

In October 2022,the Centre for Ethics of Yenepoya University hosted a national workshop entitled:\"Respect for human dignity of the unidentified dead from mass disasters and other violence:strategies for the ethical management of biological samples and personal data\".The aim was to explore and share experience and ethical considerations regarding the management and identification of human remains in the event of disasters,with the purpose to arrive at a general consensus about what constitutes the ethical foundation of the management of unidentified human remains in forensic practice and,in particular,contextualizing this in India.The main ethical consideration that emerged was tracing the missing and identifying the dead are crucial to maintaining or restoring basic human rights and responsible relief activities.Identification is not only an organizational and scientific achievement but,regardless of circumstances,also necessarily and always an activity with significant political,epistemic,and philosophical relevance and consequence.In India,it could be important to consider new legal provisions for the management of human samples so that this would provide a starting point for the treatment of human remains managed for forensic purposes with uniformity in the country.Another important step in which governments should take part regards the involvement and education of the general public to develop their interest in this important goal.In the field of forensic anthropology,artificial intelligence can support,through the use of algorithms,the decision-making process that leads to the identification of the victim or its remains.Furthermore,they can be used to extract new knowledge from huge databases and shorten identification through computer automation of data binding activities.Applying artificial intelligence tools in forensic sciences to collect new information from massive datasets to enhance knowledge,and reduce human subjectivity and errors,provides a greater scientific basis that could improve the strength of the evidence and support the admissibility of expert evidence.In light of the general lack of national/international guidance about ethical oversight for identification and care of human remains,the fact that regulations are frequently not adequate to govern ethical aspects,we hope that an internationally recognized body should develop such guidance in collaboration with relevant organizations.     

The ethical implications of prospective payment and corporate medical practice: A research agenda

The major trends in the growth of prospective payment and the corporatization of medical practice in the United States are examined. In particular, the ethical implications of these changes in the context of the multiple system goals of access, cost containment, and quality are considered. Considerable concern is being expressed that with the dominant emphasis on cost containment, the principles of access and quality might be compromised. This paper formulates a research agenda to address this question, based on a review and synthesis of empirical evidence and hypotheses about the probable or actual impact of these changes on the multiple health system goals. A basic premise is that ethical judgments should be grounded in empirical evidence about what actually is or will be.     

Legal and ethical issues in microbicides research and development in Canada

The Canadian AIDS Society (CAS) recently completed a report entitled Microbicides Development and Delivery in Canada: Legal, Ethical and Human Rights Issues. The report builds on Canadian and international experience and was written in consultation with Canadian community and international experts. It is available on the CAS website (www.cdnaids.ca) and from the Canadian HIV/AIDS Information Centre (www.aidssida.cpha.ca) as of September 2004. In this article the report's author, Anna Alexandrova, argues that Canada needs to develop a microbicides development and delivery strategy that addresses research and development issues, outlines possible roles for meaningful community participation, and provides guidelines on funding, promotion, licensing, and distribution.     

Transnational organized crime challenges for future research

This essay and review seeks to assess the state of empirical research on transnational organized crime, drawing on a review of the English language academic literature. It identifies major themes and research questions as well as methodological approaches, and summarizes key findings. It also addresses challenges to meaningful research, arguing that internationally coordinated research projects will be necessary in the future to arrive at the insights necessary to inform theory and policy.