This book focuses on experimentation that is carried out on human beings, including medical research, drug research and research undertaken in the social sciences. It discusses the ethics of such experimentation and asks the question: who defends the interests of these human subjects and ensures that they are not harmed? The author finds that ethical research depends on the adequacy of review by committee. Indeed most countries now rely on research ethics committees for the (...) protection of the interests of the human participants in research. Dr McNeill analyses how successful these committees are in balancing the interests of science with the interests of human subjects. (shrink)
There have been serious controversies in the latter part of the 20th century about the roles and functions of scientific and medical research. In whose interests are medical and biomedical experiments conducted and what are the ethical implications of experimentation on subjects unable to give competent consent? From the decades following the Second World War and calls for the global banning of medical research to the cautious return to the notion that in controlled circumstances, medical research on human (...) subjects is in the best interest of the given individual and the broader population, this book addresses the key implications of experimentation on humans. This volume covers major ethical themes within biomedical research providing historical, philosophical, legal and policy reflections on the literature and specific issues in the field of research on human subjects. Focusing on special populations (the elderly, children, prisoners and the cognitively impaired) it represents the most up-to-date review of the special ethical and legal conflicts that arise with relation to experimentation on subjects from these groups. In the light of current initiatives for law reform pertaining to research ethics the world over, this volume provides a timely, comprehensive and provocative exploration of the field. The volume has been carefully organized to present important philosophical perspectives on organizing principles that should underlie any practical application. A forward-looking historical review of the regulatory regimes of principal jurisdictions, including of the legal controls already in place, provides the backdrop for future policy initiatives. Additionally, in the light of global restructuring of health care systems, several chapters have been devoted to epidemiological research and related issues. (shrink)
Spectacular treatment disasters in recent years have made it clear that informal "let's-try-it-and-see" methods of testing new proposals are more risky now than ever before, and have led many to call for a halt to experimentation in clinical medicine. In this easy-tp-read, philosophical guide to humanexperimentation, William Silverman pleads for wider use of randomized clinical trials, citing many examples that show how careful trials can overturn preconceived or ill-conceived notions of a therapy's effectiveness and lead to (...) a clearer understanding of clinical anomalies. Because it gives careful guidance on setting up trials and avoiding conceptual pitfalls, this book will be of great interest to all epidemiologists and clinical statisticians, and to a wide varitey of clinicians, pharmacologists, and nurses. Since it requires no medical or statistical knowledge, it will also appeal to ethicists, lawyers, and the general public. (shrink)
Biomedical research on humans is an important part of medical progress. But, when lives are at risk, safety and ethical practices need to be the top priority. The need for the committees that regulate and oversee such research -- institutional review boards, or IRBs -- is growing. IRB members face difficult decisions every day. Evaluating the Science and Ethics of Research on Humans is a guide for new and veteran members of IRBs that will help them better understand the (...) issues involved and the tasks they will be required to perform. The most important purpose of an IRB is to protect the lives of human participants. For three major research areas -- drugs, medical devices, and genetic information -- Dennis J. Mazur shares the methods he has found useful in protecting human participants through the systematic review of scientific protocols and informed consent forms and through adherence to the federal regulations that apply. New members will gain understanding of how proposed research projects are to be reviewed from both scientific and ethical dimensions, how and when to ask key questions of principal investigators, how to work with principal investigators and research teams to ensure the best protection of human participants, and why to schedule regularly spaced reviews of a project that may have adverse outcomes. Based on Mazur's thirty years of research experience, this accessible and informative guide will give all IRB members the tools they need to protect human lives and facilitate the research process. (shrink)
This paper was delivered at the 2009 annual conference of the National Council on Ethics in Human Research. It is a reflective piece based on many years of experience with human research ethics and the role of Research Ethics Boards in human participant research.
Increasing European co-operation must take place in many areas, including medical ethics. Against the background of common cultural norms and pluralistic variation within political traditions, religion and lifestyles, Europe will have to converge towards unity within the field of medical ethics. This article examines how such convergence might develop with respect to four major areas: European research ethics committees, democratic health systems, the human genome project and rules for stopping futile treatments.
Since its inception as an international requirement to protect patients and healthy volunteers taking part in medical research, informed consent has become the primary consideration in research ethics. Despite the ubiquity of consent, however, scholars have begun to question its adequacy for contemporary biomedical research. This book explores this issue, reviewing the application of consent to genetic research, clinical trials, and research involving vulnerable populations. For example, in genetic research, information obtained from an autonomous research participant may have significant (...) bearing on the interests of family members who have not consented to the study. This casts doubt on the adequacy of consent for such studies. This book also questions the assumptions that informed consent is essential and that it satisfactorily protects the principle of individual autonomy. It reviews recent empirical studies that challenge the possibility of truly informed consent and highlights the extent to which consent is governed by social norms and expectations. It also investigates how consent might be of secondary importance in some circumstances, for example when a research project appears to protect a public or community interest. (shrink)
In response to widespread concern about illegal drug use and the associated risk of the spread of HIV/AIDS, a study was undertaken to examine whether it was, in principle, feasible to conduct a trial providing heroin to dependent users in a controlled manner. Such a trial involves real ethical issues which are examined in this paper. The general issues examined are: should a trial be an experiment or an exercise in public policy?; acts and omissions; countermobilization; termination of a trial, (...) and payment for drugs and for a trial. The specific issues examined are: selection of trial participants; privacy; issues for staff working on a trial; coupling the trial with other treatment, and issues for researchers. A number of alternative approaches to the various ethical issues are presented and discussed. (shrink)
Bernard Rollin historically and conceptually examines the ideology that denies the relevance of ethics to science. Providing an introduction to basic ethical concepts, he discusses a variety of ethical issues relevant to science and how they are ignored, to the detriment of both science and society. These issues include research on human subjects, animal research, genetic engineering, biotechnology, cloning, xenotransplantation, and stem cell research. Rollin also explores the ideological agnosticism that scientists have displayed regarding subjective experience in humans (...) and animals, and its pernicious effect on pain management. (shrink)
Medicine in the twenty-first century is increasingly reliant on research to guarantee the safety and efficacy of medical interventions. As a result, the need to understand the ethical issues that research generates is becoming essential. This volume introduces the principal areas of concern in research on human subjects, offering a framework for understanding research ethics, and the relationship between ethics and compliance. Research Ethics brings together leading scholars in bioethics and the topics covered include the unique (...) concerns that arise in specific areas of research such as gene therapy and stem cell research. Individual chapters also address the ethical issues that arise when conducting research with specific populations such as infants or adolescents, and the volume looks at important emerging issues in human subjects research, namely financial conflicts of interest and the interpretation of scientific data. (shrink)
Since it is now broadly acknowledged that ethics should receive early consideration in discourse on emerging technologies, ethical debates tend to flourish even while new fields of technology are still in their infancy. Such debates often liberally mix existing applications with technologies in the pipeline and far-reaching visions. This paper analyses the problems associated with this use of ethics as “preparatory” research, taking discourse on human enhancement in general and on pharmaceutical cognitive enhancement in particular as an (...) example. The paper will outline and discuss the gap between the scientific and technological state of the art and the ethical debates, pointing out epistemic problems in this context. Furthermore, it will discuss the future role of genuine ethical reflection in discourse on human enhancement, arguing also that such discourse needs to include a technology assessment—in the broad sense of the term—which encompasses, inter alia, anthropological perspectives and aspects of social theory. (shrink)
Background Ethics committees typically apply the common principles of autonomy, nonmaleficence, beneficence and justice to research proposals but with variable weighting and interpretation. This paper reports a comparison of ethical requirements in an international cross-cultural study and discusses their implications. Discussion The study was run concurrently in New Zealand, UK, Israel, Canada and USA and involved testing hypotheses about believability of testimonies regarding alleged child sexual abuse. Ethics committee requirements to conduct this study ranged from nil in Israel (...) to considerable amendments designed to minimise participant harm in New Zealand. Assessment of minimal risk is a complex and unreliable estimation further compounded by insufficient information on probabilities of particular individuals suffering harm. Estimating potential benefits/ risks ratio and protecting participants' autonomy similarly are not straightforward exercises. Summary Safeguarding moral/humane principles should be balanced with promotion of ethical research which does not impede research posing minimal risk to participants. In ensuring that ethical standards are met and research has scientific merit, ethics committees have obligations to participants (to meet their rights and protect them from harm); to society (to ensure good quality research is conducted); and to researchers (to treat their proposals with just consideration and respect). To facilitate meeting all these obligations, the preferable focus should be promotion of ethical research, rather than the prevention of unethical research, which inevitably results in the impediment of researchers from doing their work. How the ethical principles should be applied and balanced requires further consideration. (shrink)
Whats human rights got to do with it? That is, whats human rights got to do with the June 2004 report of the Social Sciences and Humanities Research Ethics Special Working Committee to the Inter-Agency Advisory Panel on Research Ethics. The disturbing answer is not enough. Certain key recommendations of the working committee, it is suggested, would unacceptably weaken the researchers legal and moral accountability to research participants. Those particular recommendations rely on misguided references to academic (...) freedom and the nature of the non-medical research context. In fact, universal human rights, and the legal instruments in which they are embodied ought to inform the research endeavor at every stage; from problem selection to analysis and conclusions. This will lead us closer to shared truths rather than simply to the academic elites vision of truth. Without sufficient regard for the human rights of research participants academic freedom itself is not possible. (shrink)
A dialogical approach to understanding Islamic ethics rejects objectivist methods in favor of a conversational model in which participants accept each other as rational moral agents. Hans-Georg Gadamer asserts the importance of agreement upon a subject matter through conversation as a means to gaining insight into other persons and cultures, and Jürgen Habermas stresses the importance of fairness in dialogue. Using human rights as a subject matter for engaging in dialogue with Islamic scholars, Muslim perspectives on issues such (...) as democracy, toleration, and freedom of conscience emerge. A capabilities approach to human rights, such as that developed by Martha Nussbaum, enables the coexistence of multiple religious ethical visions while insisting upon the need to protect and nurture essential human abilities. (shrink)
Comparative religious ethics is a complicated scholarly endeavor, striving to harmonize intellectual goals that are frequently conceived as quite different, or even intrinsically opposed. Against commonly voiced suspicions of comparative work, this essay argues that descriptive, comparative, and normative interests may support rather than conflict with each other, depending on the comparison in question, and how it is pursued. On the basis of a brief comparison of the early Christian Augustine of Hippo and the early Confucians Mencius and Xunzi (...) on the topic of "human nature," this paper advocates a particular account of comparative religious ethics, and argues for the complexity of the idea of "human nature." Different elements of this family of concerns are central to religious ethics generally, and to theories and practices of moral development and personal formation specifically. (shrink)
The encyclical proclaims the centrality of human development, which includes acting with gratuitousness and solidarity in pursuing the common good. This paper considers first whether such relationships of gratuitousness and solidarity can be analysed through the prism of traditional theories of social psychology, which are highly influential in current management research, and concludes that certain aspects of those theories may offer useful tools for analysis at the practical level. This is contrasted with the analysis of such relationships through Aristotelian (...) virtue ethics (in particular as interpreted by MacIntyre 1985 , 1998 , 1999 ), which is emerging as a strong force in the field of business ethics, and which has strong conceptual similarities with the ideas put forward by Benedict XVI. Aristotelian virtue ethics offers a better fit with the aims of the encyclical at the theoretical level but it presents a number of challenges at the practical level, which the paper suggests may be addressed through the integration in its analysis of human action of models derived from social psychology. (shrink)
This essay is a brief attempt to summarize and evaluate the contributions that "Democracy and Tradition" makes to the field of comparative ethics. It is argued that the potential impact of these contributions would be strengthened by engagement with the common morality already imbedded in international human rights norms.
For centuries, religion and philosophy have been the primary basis for efforts to guide humans to be more ethical. However, training in ethics and religion and imparting positive values and morality tests such as those emanating from the categorical imperative and the Golden Rule have not been enough to protect humankind from its bad behaviors. To improve ethics education educators must better understand aspects of human nature such as those that lead to “self-deception” and “personal bias.” Through (...) rationalizations, faulty reasoning and hidden bias, individuals trick themselves into believing there is little wrong with their own unethical behavior. The application of science to human nature offers the possibility of improving ethics education through better self-knowledge. The author recommends a new paradigm for ethics education in contemporary modern society. This includes the creation of a new field called “applied evolutionary neuro-ethics” which integrates science and social sciences to improve ethics education. The paradigm can merge traditional thinking about ethics from religious and philosophical perspectives with new ideas from applied evolutionary neuro-ethics. (shrink)
All investigators funded by the National Institutes of Health are now required to receive training about the ethics of clinical research. Based on a course taught by the editors at NIH, Ethical and Regulatory Aspects of Clinical Research is the first book designed to help investigators meet this new requirement. The book begins with the history of human subjects research and guidelines instituted since World War II. It then covers various stages and components of the clinical trial process: (...) designing the trial, recruiting participants, ensuring informed consent, studying special populations, and conducting international research. Concluding chapters address conflicts of interest, scientific misconduct, and challenges to the IRB system. The appendix provides sample informed consent forms. This book will be used in undergraduate courses on research ethics and in schools of medicine and public health by students who are or will be carrying out clinical research. Professionals in need of such training and bioethicists also will be interested. (shrink)
When ethics committees evaluate the research proposals submitted to them by biomedical scientists, they can seek guidance from laws and regulations, their own beliefs, values and experiences, and from the theories of philosophers. The starting point of this paper is that philosophers can only be helpful to the members of ethics committees if they take into account in their models both the basic moral intuitions that most of us share and the consequences of people's choices. A moral view (...) which can be labelled as a consequentialist interpretation of mid-level principlism is developed, defended and applied to some real-life and hypothetical research proposals. (shrink)
David Luban is one of the world's leading scholars of legal ethics. In this collection of his most significant papers from the past twenty-five years, he ranges over such topics as the moral psychology of organisational evil, the strengths and weaknesses of the adversary system, and jurisprudence from the lawyer's point of view. His discussion combines philosophical argument, legal analysis and many cases drawn from actual law practice, and he defends a theory of legal ethics that focuses on (...) lawyers' role in enhancing human dignity and human rights. In addition to an analytical introduction, the volume includes two major previously unpublished papers, including a detailed critique of the US government lawyers who produced the notorious 'torture memos'. It will be of interest to a wide range of readers in both philosophy and law. (shrink)
Scientific research and ethics -- Ethical theory and decision making -- Data acquisition and management -- Mentoring and professional relationship -- Collaboration in research -- Authorship -- Publication and peer review -- Misconduct in research -- Intellectual property -- Conflicts of interest and scientific objectivity -- The use of animals in research -- The use of human subjects in research -- The use of vulnerable subjects in research -- Genetics, cloning, and stem cell research -- International research.
On 25 April 2002, the German Parliament has passed a strict new law referring to stem cell research. This law took effect on July 1, 2002. The so-called embryonic Stem Cell Act ( Stammzellgesetz â StZG ) permits the import of embryonic stem (ES) cells isolated from surplus IvF-embryos for research reasons. The production itself of ES cells from human blastocysts has been prohibited by the German Embryo Protection Act of 1990, with the exception of the use of ES (...) cells which exist already. The debate on the legitimate use of ES cells escalated, after the main German research funding agency, the Deutsche Forschungsgemeinschaft (DFG), unexpectedly published new guidelines recommending are stricted use of human ES cells for research. Meanwhile, the debate has ethically dividedsociety, political parties, government and church members into a group supporting and a group rejecting ES cell research. The arguments in favour of such a research can be summarized as arguments derived from a new ethics ofhealing calling for a therapeutic imperative, whereas the arguments against can be summarized as arguments violating the fundamental principle of human dignity as they imply the destruction of human embryos. This article willtry to present and evaluate various ethical arguments founded on the latest biological and medical data on the potential use of stem cell technologies. It will finally come to the conclusion that ES cell research is opposed to human dignity, since the procedures of isolating ES cells require the destruction and instrumentalization of human embryos. Human embryos are human beings at a very early stage of their development, fully possessing the ability of completing their development. At this very early stage, human embryos are extremely dependent and fragile, and thus vulnerable corporealities. Vulnerability and human dignity demand the protection of the embryo's corporeal integrity. Hence, this essay will try to propagate research with adult stem(AS) cells, a procedure which does not require the destruction of human embryos; with regard to the necessary plasticity, it should be emphasized that AS cells very much resemble ES cells. (shrink)
Many ethical concerns surrounding human genetics studies remain unresolved. We report here the situation in Cameroon.Objectives: To describe the profile of human genetic studies that used Cameroonian DNA samples, with specific focus on i) the research centres that were involved, ii) authorship, iii) population studied, iv) research topics and v) ethics disclosure, with the aim of raising ethical issues that emerged from these studies.Method: Bibliometric Studies; we conducted a PubMed-based systematic review of all the studies on (...) class='Hi'>human genetics that used Cameroonian DNA samples from 1989 to 2009.Results and Discussion: Fifty articles were identified, involving predominantly research centres from Europe (64%) and America (32%). Only 7 (14%) Cameroonian institutions and 14 (28%) Cameroonian authors were associated with these publications.At least 52% of publications were devoted to population genetics (variation/migration patterns) amongst 30 Cameroonian ethnic groups. Very few studies concerned public health related genetic issues and only 5 (10%) references were found for hemoglobinopathies like sickle cell anaemia. Almost all DNA samples are ‘banked’ outside of the African continent.Capacity building, rights to the genetic information and benefits to the individuals, communities and populations who contribute to these studies are addressed.Conclusions: 1) Our data suggests the need for a wider debate towards building capacity and addressing ethical issues related to human genomic research in sub-Saharan Africa and specifically in Cameroon; 2) National ethical guidelines and regulations concerning the collection, use and storage of human DNA are urgently needed in Cameroon. (shrink)
The “Universal Declaration of Human Rights” and the “Geneva Declaration” by the World Medical Association, both in 1948, were preceded by the foundation of the United Nations in New York (1945), the World Medical Association in London (1946) and the World Health Organization in Geneva (1948). After the end of World War II the community of nations strove to achieve and sustain their primary goals of peace and security, as well as their basic premise, namely the health of (...) class='Hi'>human beings. All these associations were well aware of the crimes by medicine, in particular by the accused Nazi physicians at the Nuremberg Doctors Trial (1946/47, sentence: August 1947). During the first conference of the World Medical Association (September 1947) issues of medical ethics played a major role: and a new document was drafted concerning the values of the medical profession. After the catastrophe of the War and the criminal activities of scientists, the late 1940s saw increased scrutiny paid to fundamental questions of human rights and medical ethics, which are still highly relevant for today’s medicine and morality. The article focuses on the development of medical ethics and human rights reflected in the statement of important persons, codes and institutions in the field. (shrink)
Since the birth of the first test-tube baby, Louise Brown, in 1977, we have seen truly remarkable advances in biotechnology. We can now screen the fetus for Down Syndrome, Spina Bifida, and a wide range of genetic disorders. We can rearrange genes in DNA chains and redirect the evolution of species. We can record an individual's genetic fingerprint. And we can potentially insert genes into human DNA that will produce physical warning signs of cancer, allowing early detection. In fact, (...) biotechnology has progressed to such a point that virtually any kind of genetic manipulation, if not already possible, is just around the corner. But these breakthroughs also raise serious ethical and moral dilemmas that we are only now beginning to confront. In Wonderwoman and Superman, noted medical ethicist John Harris offers the first thorough analysis of the moral dilemmas created by the revolution in molecular biology. Covering a wide array of recent innovations, Harris discusses, for example, the moral decisions involved and the consequences of creating egg and embryo banks. Who should be allowed to use such resources? Should recipients be screened? Should such banks be open for public or private use? And does it cheapen life to make embryos available for sale? In another chapter, Harris examines the question of conceiving children chiefly for organ donation, focusing on the recent case of a woman who wanted to have a second child to provide a bone marrow donor for her first child sick with leukemia (she intended to abort the fetus if its bone marrow did not genetically match that of her living child). In this case, the medical staff had to decide whether they should perform in-vitro fertilization, knowing that the mother did not satisfy the clinic's criteria (there was no father), and also knowing the potential for abortion. Discussing the ethics of the mother's choice and the clinic's choice, Harris asks whether it is morally correct to create a child as an organ donor, whether the future child would suffer, whether it is worth any suffering to be born, and who has the right to weigh the various factors (both moral and physiological) involved in making these decisions. Delving into a multitude of issues such as when life begins, when suffering is needless, and whether we should play God, Wonderwoman and Superman provides not only a thought-provoking inquiry into the potential and actual ethical dilemmas created by the many advances in biotechnology, but challenges us to learn to choose responsibly and to face the moral implications of the choices that confront us. (shrink)
Human papillomavirus (HPV) infection is the world’s most common sexually transmitted infection. It is a prerequisite for cervical cancer, the second most common cause of death in cancer among women worldwide, and is also believed to cause other anogenital and head and neck cancers. Vaccines that protect against the most common cancer-causing HPV types have recently become available, and different countries have taken different approaches to implementing vaccination. This paper examines the ethics of alternative HPV vaccination strategies. It (...) devotes particular attention to the major arguments for and against one strategy: voluntary, publicly funded vaccination for all adolescent boys and girls. This approach seems attractive because it would protect more people against cervical cancer and other HPV-related cancers than less inclusive alternatives, without the sacrifice of autonomy that a comparably broad compulsory programme would require. Also, the herd immunity that it would likely generate would protect those who remain unvaccinated, a major advantage from a justice perspective. However, there is a possibility that a HPV vaccination programme targeting all adolescents of both sexes is not considered sufficiently cost-effective. Also, it might pose more difficulties for achieving informed consent than comparable vaccination programmes against other diseases. Ultimately, society’s choice of HPV vaccination strategy requires careful consideration not only of the values at stake but also of available and emerging scientific evidence. (shrink)
This is the first re-publication and first English translation of regulations concerning HumanExperimentation which were binding law prior to and during the Third Reich, 1931 to 1945. The introduction briefly describes the duties of the Reichsgesundheitsamt, which formulated these regulations. It then outlines the basic concept of the Richtlinien for protecting subjects and patients on the one hand and for encouraging New Therapy and HumanExperimentation on the other hand. Major issues, like personal responsibility of (...) the physician or researcher, teaching of ethics of research and therapy, and research and therapy on vulnerable populations, are compared with the regulations in the Nuremberg Code and subsequent regulations influenced by the Nuremberg Code. CiteULike Connotea Del.icio.us What's this? (shrink)
This essay explores some moral problems raised by experimentation involving the human fetus. In the first part of the essay three examples of fetal experimentation from the medical literature are described in some detail. Next, the ethical and legal arguments employed in the two major existing public policy-documents on fetal experimentation are analyzed. Finally, the author seeks to identify four fundamental presuppositions which underlie divergent normative positions on the problem of fetal experimentation.
Human enhancement, in which nanotechnology is expected to play a major role, continues to be a highly contentious ethical debate, with experts on both sides calling it the single most important issue facing science and society in this brave, new century. This paper is a broad introduction to the symposium herein that explores a range of perspectives related to that debate. We will discuss what human enhancement is and its apparent contrast to therapy; and we will begin to (...) tease apart the myriad intertwined issues that arise in the debate: (1) freedom & autonomy, (2) health & safety, (3) fairness & equity, (4) societal disruption, and (5) human dignity. (shrink)
This is a comprehensive and practical guide to the ethical issues raised by different kinds of medical research, and is the first such book to be written with the needs of the researcher in mind. Clearly structured and written in a plain and accessible style, the book covers every significant ethical issue likely to be faced by researchers and research ethics committees. The author outlines and clarifies official guidelines, gives practical advice on how to adhere to these, and suggests (...) procedures in areas where official recommendations are vague or absent. This invaluable handbook will help researchers identify and address the ethical issues at an early stage in the design of their studies, to avoid unnecessary delay and to safeguard the wellbeing of patients and healthy volunteers. It will also be extremely useful to members of research ethics committees. (shrink)
United States military medical ethics evolved during its involvement in two recent wars, Gulf War I (1990–1991) and the War on Terror (2001–). Norms of conduct for military clinicians with regard to the treatment of prisoners of war and the administration of non-therapeutic bioactive agents to soldiers were set aside because of the sense of being in a ‘new kind of war’. Concurrently, the use of radioactive metal in weaponry and the ability to measure the health consequences of trade (...) embargos on vulnerable civilians occasioned new concerns about the health effects of war on soldiers, their offspring, and civilians living on battlefields. Civilian medical societies and medical ethicists fitfully engaged the evolving nature of the medical ethics issues and policy changes during these wars. Medical codes of professionalism have not been substantively updated and procedures for accountability for new kinds of abuses of medical ethics are not established. Looking to the future, medicine and medical ethics have not articulated a vision for an ongoing military-civilian dialogue to ensure that standards of medical ethics do not evolve simply in accord with military exigency. (shrink)
Introduction -- Facing up to paternalism in research ethics -- Preface to a theory of consent transactions in research : beyond valid consent -- Should we worry about money? -- Exploitation in clinical research -- The interaction principle.