Ethical Concerns Over Testing on Human Subjects

A Joint Subcommittee of the Scientific Advisory Board and the FIFRA Scientific Advisory Panel recently issued a report to the U.S. Environmental Protection Agency (USEPA) concerning the use of data derived from testing on human subjects. The authors address both scientific and ethical issues pertaining to such research and conclude that as long as certain conditions are met, the deliberate exposure of voluntary subjects to potentially dangerous levels of pesticides can be both scientifically and ethically sound. I argue that there are further ethical problems not adequately addressed in the report. In particular, there are serious concerns about fairness and exploitation in connection with paid volunteers, which also raise questions about the degree to which the conditions of non-coercion and informed consent are likely to be met. The primary aim of this paper is to bring these issues more fully into the discussion. I also consider briefly the constraints placed on legitimate justifications of human studies by the requirement that the promotion of public safety be the ultimate purpose of the studies. This will help to clarify which reasons in support of human studies are in principle legitimate, which will in turn better enable us to weigh them against the ethical concerns about fairness and exploitation.     

Ethical issues in medical research in the developing world: a report on a meeting organised by Fondation Mérieux

This paper reports on a multidisciplinary meeting held to discuss ethical issues in medical research in the developing world. Many studies, including clinical trials, are conducted in developing countries with a high burden of disease. Conditions under which this research is conducted vary because of differences in culture, public health, political, legal and social contexts specific to these countries. Research practices, including standards of care for participants, may vary as a result. It is therefore not surprising that ethical issues emerge. This meeting sought to identify and discuss these issues from the perspectives of the many actors in such research, including community representatives, with a view to finding ethical and pragmatic solutions to these issues. Dialogue between these actors was also promoted, with a view to identifying the need to develop such dialogue in future.
Drawing from the experiences of the speakers, the colloquium attempted to outline some answers to several key questions characterising the field today. Experiences related to epidemiologic research, vaccine trials, drug trials, diagnostic tests and to some fundamental ethical issues in health research. Speakers were from different countries, disciplines and professions. The meeting provided a forum for consultation and debate between different ethics actors. Both encouraging findings and challenges emerged.     

Ancianos frágiles polimedicados: ¿es la deprescripción de medicamentos la salida?

Deprescribing is the process of reconstructing multiple medication use by review and analysis and which concludes with dose modification, replacement or elimination of some drugs or adding others. Its development is intended to resolve tensions and contradictions between two sets of questions: 1/is life expectancy shorter than the time the drug takes to obtain a benefit?, and 2/are the goals of prescribing-deprescribing consistent with those of care? The validity of the rationale on deprescribing is based on scientific and ethical reasons. The usefulness and safety of many drugs that frail elderly or terminally ill takes is unknown, and other drugs may cause troublesome or severe side effects. Thus, in some cases their removal could be justified, being substantially safe doing so.     

The ethical landscape of gene drive research

Gene drive technology has immense potential. The ability to bypass the laws of Mendelian inheritance and almost ensure the transmission of specific genetic material to future generations creates boundless possibilities. But alongside these boundless possibilities are major social and ethical issues. This article aims to introduce gene drive technology, some of its potential applications, and some of the social and ethical issues that arise during research into the technology. For example, is investigation into gene drives hubristic? Would applications of gene drives count as technological fixes? Or does research into such a technology sit on a slippery slope or lock us in to its full‐scale use? Are there perverse effects of engaging in research, and, most importantly, who ought to be included in the decision‐making process regarding research and field trials? Understanding the basic ethical landscape of this technology will prove invaluable to the public, scientists, and policy‐makers as research moves forward.     

Tailor-made pharmacotherapy: future developments and ethical challenges in the field of pharmacogenomics

Pharmacogenomics is the study of the myriad interactions between genes and pharmacotherapy. Developments in pharmacogenomics have changed and will affect pharmaceutical research, drug development and the practice of medicine in a significant way. In this article, we make an inventory of the ethical implications that might arise as a result of possible developments in pharmacogenomics and investigate whether the present ethical framework will be able to adequately answer arising questions. We think that many of the questions related to the consequences of pharmacogenomics are answerable along the lines of present ethical thinking. We also believe, however, that many 'changes of degree' may result in a 'change of kind.' We therefore think that pharmacogenomics may potentially have such a profound influence on scientific research and the pharmaceutical industry, the practice of medicine and society at large, that this will generate its own unique dynamic, which will require new ethical research. We suggest that the notion of 'responsibility' will be a major focus of such research.     

Xenotransplantation: a problematic world behind a glamorous facade

The discussion about the ethics of xenotransplantation seems to focus upon the benefits for individual patients and the potential risks for human society, in general, to contract a newly emerging retrovirus. In these risk-benefit considerations, the moral concern for the research animals involved appears to be absent. This is remarkable, because the presumed successful xenograft is not expected very soon. A lot of basic problems in pig and primate xenotransplantations still need solving. These new experiments in our own biomedical laboratories raise questions regarding animal welfare and ethical justification in the light of possible alternative strategies. In this article, I discuss some of the moral issues related to preclinical, fundamental xenotransplantation research.     

Ethical Issues in the Use of Data from Testing of Human Subjects to Support Risk Assessment

The public understands and supports the ethical use of human subjects in medical research, recognizing the unique role for this type of study in the development of new drugs and therapeutic strategies for treatment of disease. The use of data from human subjects can also be of value in understanding the circumstances under which individuals exposed to chemicals in the food supply, in the workplace, or in the environment might experience toxicity, i.e., in support of risk assessment. However, questions have been raised as to whether this latter type of research is ethical, or can be performed in an ethical manner. Under what circumstances is it acceptable to intentionally expose human subjects to potentially toxic agents? This is an extremely important issue for the risk assessment community to address, because it affects in a fundamental way the types of information that will be available to conduct human health risk assessments. Four papers in this issue offer viewpoints on the value of human data, the circumstances under which human subjects might be exposed to toxic chemicals for research purposes, the ethical problems associated with this research, and the role of human vs. animal data in the development of toxicity values for human health risk assessment     

Xenotransplantation: A Problematic World Behind a Glamorous Facade

The discussion about the ethics of xenotransplantation seems to focus upon the benefits for individual patients and the potential risks for human society, in general, to contract a newly emerging retrovirus. In these risk-benefit considerations, the moral concern for the research animals involved appears to be absent. This is remarkable, because the presumed successful xenograft is not expected very soon. A lot of basic problems in pig and primate xenotransplantations still need solving. These new experiments in our own biomedical laboratories raise questions regarding animal welfare and ethical justification in the light of possible alternative strategies. In this article, I discuss some of the moral issues related to preclinical, fundamental xenotransplantation research.     

The ethics of HIV research in developing nations

This paper discusses a dispute concerning the ethics of research on preventing the perinatal transmission of HIV in developing nations. Critics of this research argue that it is unethical because it denies a proven treatment to placebo-control groups. Since studies conducted in developed nations would not deny this treatment to subjects, the critics maintain that these experiments manifest a double standard for ethical research and that a single standard of ethics should apply to all research on human subjects. Proponents of the research, however, argue that these charges fail to understand the ethical complexities of research in developing nations, and that study designs can vary according to the social, economic, and scientific conditions of research. This essay explores some of the ethical issues raised by this controversial case in order to shed some light on the deeper, meta-ethical questions. The paper argues that standards of ethical research on human subjects are universal but not absolute: there are some general ethical principles that apply to all cases of human subjects research but the application of these principles must take into account factors inherent in particular situations.     

Research versus practice: The dilemmas of research ethics in the era of learning health‐care systems

In this article we attempt to answer the question of how the ethical and conceptual framework (ECF) for a learning health‐care system (LHS) affects some of the main controversies in research ethics by addressing five key problems of research ethics: (a) What is the difference between practice and research? (b) What is the relationship between research ethics and clinical ethics? (c) What is the ethical relevance of the principle of clinical equipoise? (d) Does participation in research require a higher standard of informed consent than the practice of medicine? and (e) What ethical principle should take precedence in medicine? These questions allow us to construct two opposite idealized positions on the distinction between research and practice: the integration model and the segregation model of research and practice. We then compare the ECF for an LHS with these two idealized positions. We argue that the ECF for a LHS does not, in fact, solve these problems, but that it is a third, separate position in the relationship between research ethics and clinical ethics. Moreover, we suggest that the ECF for a LHS raises new ethical problems that require additional ethical analysis and justification. Our article contributes to the discussion on the relationship between research ethics and clinical ethics, revealing that although a learning health‐care system may significantly change the landscape of health care, some ethical dilemmas still require resolving on both theoretical and policy‐making levels.     

The ethics of animal research: a UK perspective

The Nuffield Council on Bioethics, an independent body in the United Kingdom, has published a 2005 report titled The Ethics of Research Involving Animals. The Report, produced by a Working Party that represented a wide range of views, seeks to clarify the debate that surrounds this topic and aims to help people identify and analyze the relevant scientific and ethical issues. The Working Party considered the arguments surrounding whether animal research yields useful results, and recommends that its predictability and transferability should be evaluated more fully, particularly in controversial areas. Commonly encountered ethical questions and arguments were considered in order to understand what lies behind disagreement on the moral justification of animal research. Four possible ethical positions on animal research, which represent points on a continuum, are described. Despite the range of views that exist among members of the Working Party, the Report presents a "Consensus Statement" that identifies agreement on several important issues. Building on this statement, recommendations are made for improving the quality of the debate and promoting the 3Rs (refinement, reduction, and replacement).     

Using learning networks to understand complex systems: a case study of biological,geophysical and social research in the Amazon

Developing high‐quality scientific research will be most effective if research communities with diverse skills and interests are able to share information and knowledge, are aware of the major challenges across disciplines, and can exploit economies of scale to provide robust answers and better inform policy. We evaluate opportunities and challenges facing the development of a more interactive research environment by developing an interdisciplinary synthesis of research on a single geographic region. We focus on the Amazon as it is of enormous regional and global environmental importance and faces a highly uncertain future. To take stock of existing knowledge and provide a framework for analysis we present a set of mini‐reviews from fourteen different areas of research, encompassing taxonomy, biodiversity, biogeography, vegetation dynamics, landscape ecology, earth‐atmosphere interactions, ecosystem processes, fire, deforestation dynamics, hydrology, hunting, conservation planning, livelihoods, and payments for ecosystem services. Each review highlights the current state of knowledge and identifies research priorities, including major challenges and opportunities. We show that while substantial progress is being made across many areas of scientific research, our understanding of specific issues is often dependent on knowledge from other disciplines. Accelerating the acquisition of reliable and contextualized knowledge about the fate of complex pristine and modified ecosystems is partly dependent on our ability to exploit economies of scale in shared resources and technical expertise, recognise and make explicit interconnections and feedbacks among sub‐disciplines, increase the temporal and spatial scale of existing studies, and improve the dissemination of scientific findings to policy makers and society at large. Enhancing interaction among research efforts is vital if we are to make the most of limited funds and overcome the challenges posed by addressing large‐scale interdisciplinary questions. Bringing together a diverse scientific community with a single geographic focus can help increase awareness of research questions both within and among disciplines, and reveal the opportunities that may exist for advancing acquisition of reliable knowledge. This approach could be useful for a variety of globally important scientific questions.     

Increasing the Understanding of Plant Invasions in Southern South America: First Symposium on Alien Plant Invasions in Chile

The first symposium on Alien Plant Invasions in Chile was held in southern Chile in November of 2002. Chile represents an interesting setting to study biological invasions because of its long history of introductions, and its high rate of endemisms that makes it more prone to invasions. However, little is known about plant invasions in Chile and the country lacks a clear policy on alien species. The speakers at the symposium discussed their research on several aspects of alien plant invasions in southern Chile and Argentina. They also elaborated a list of future challenges of plant invasion ecology for the area. The package of recommendations may be useful for other developing countries with similar state of knowledge of their flora and similar environmental and economic issues. We expect that this type of meeting will help to stimulate the scientific debate about invasion ecology and the development of coordinated research to answer local questions, while contributing to find generalities in plant invasion patterns and processes.     

Society and ethics - the genetics of disease

Established guidance for the protection of human subjects in research has provided the framework for research and clinical practice in genetics. Three key principles to emerge are the requirements for consent, privacy and confidentiality. However, recent research on genetic susceptibility to common diseases indicates that it may be more difficult to decide if and when genetic testing will be appropriate. Risks of disease may be low and interventions may not be available. Today, debate is primarily focussed on ethical issues raised by the use and storage of genetic information. One of the earliest experiences of genetic testing for some people is likely to be in the area of pharmacogenetics. Debate about ethical issues has been focused on the implications of patient stratification, particularly with regard to the availability of medicines for small groups and the significance of racial variation in response to medicines. The possible use of personal genetic information by insurance companies and employers has also been an issue that legislators have taken seriously.     

Links between ecology and ecophilosophy,ethics and the requirements of environmental management

Abstract This paper concerns the ways that our philosophical attitudes to the environment can influence the appropriateness of methodologies for solving environmental problems. Sometimes a public perception is expressed that science takes scant regard of the concerns of the people affected. Is it possible for scientists and managers to respond to such concerns and still fulfil the logical and methodological rigour that their discipline demands? I believe we have to address fundamental issues of definitions and meaning before useful debate can occur among parties interested in environmental decision-making. Delving into the ideas behind our everyday practices of environmental management should promote re-evaluation of our beliefs, attitudes and concerns about nature. I examine environmental science from both ethical and managerial perspectives. I explore how our assumptions and attitudes might influence ecology, in particular issues raised by environmental impacts and conservation. The major points argued here are:

• 1 Any legal requirements of environmental investigations must be met, but perhaps we should act more in line with the spirit of legislation.
• 2 The managerial imperatives of environmental investigations need to be examined closely because of widely perceived problems with the use of science in impact assessment. We must change either our methods of assessment or the regulations and administration of environmental impact assessment (EIA).
• 3 Science is not paramount in the processes of environmental decision-making. We need to be aware of how psychosocial factors affect the ultimately political decisions about environmental problems.
• 4 Philosophy and ethics offer a range of perspectives that may benefit ecology. Scientists need to be aware of these just as they should be of their own leanings about how we treat nature.
• 5 Scientists need to translate social concerns or demands about the environment into properly defined scientific questions, and then study them as a matter of urgency.
• 6 Ecology needs to guide ecophilosophers and environmental ethicists as to how nature works, why we expect variability in ecosystems, what is naturalness, and other issues where a scientific understanding of nature has progressed beyond the point where these observers of ecology have so far taken inspiration.

     

The past, the future and the biology of memory storage

We here briefly review a century of accomplishments in studying memory storage and delineate the two major questions that have dominated thinking in this area: the systems question of memory, which concerns where in the brain storage occurs; and the molecular question of memory, which concerns the mechanisms whereby memories are stored and maintained. We go on to consider the themes that memory research may be able to address in the 21st century. Finally, we reflect on the clinical and societal import of our increasing understanding of the mechanisms of memory, discussing possible therapeutic approaches to diseases that manifest with disruptions of learning and possible ethical implication of the ability, which is on the horizon, to ameliorate or even enhance human memory.     

Instituting a research ethic: chilling and cautionary tales

The ethical review of research on human beings, and indeed the ethical review of broader ranges of human activity, is a growth industry. I want to look here at the ethical review of research on humans and raise some questions about the direction it is taking. I am pessimistic about where the institutions that we have set up are leading us and I want to sound a warning note and suggest some changes that are needed in the practice of ethical review.     

Ethical aspects of anti-Alzheimer drugs: experiences of caregivers

The development and use of acetylcholinesterase inhibitors raise ethical issues. Ethical issues concern the consequences of an early diagnosis, the creation of unreasonable hope, possible negative effects of rivastigmine use, problems concerning stopping with rivastigmine, the patient role in decision-making and the possibility of conflicting interests. Within the ethical literature, hypotheses about the meaning of this drug for the patients have been formulated. This research aimed to investigate the experiences of caregivers of patients who used rivastigmine. The data have been collected by semi-structured interviews. The study included 12 caregivers of rivastigmine users. The--preliminary--results seem to indicate that theoretical considerations should be modified in the light of the experiences of caregivers. For example, problematic consequences of an early diagnosis and the creation of unreasonable hope did not appear in this study. Also problems concerning the rising awareness of cognitive decline were not found. In the interest of a further ethical debate concerning the development and use of antidementia drugs it is important to modify these theoretical considerations.     

Ethics and scientific publication

This article summarizes the major categories of ethical violations encountered during submission, review, and publication of scientific articles. We discuss data fabrication and falsification, plagiarism, redundant and duplicate publication, conflict of interest, authorship, animal and human welfare, and reviewer responsibility. In each section, pertinent historical background and citation of relevant regulations and statutes are provided. Furthermore, a specific case(s) derived from actual situations is(are) presented. These cases were chosen to highlight the complexities that investigators and journals must face when dealing with ethical issues. A series of discussion questions follow each case. It is our hope that by increasing education and awareness of ethical matters relevant to scientific investigation and publication, deviations from appropriate conduct will be reduced.