The recent in vitro derivation of gamete‐like cells from mouse embryonic stem (mES) cells is a major breakthrough and lays down several challenges, both for the further scientific investigation and for the bioethical and biolegal discourse. We refer here to these cells as gamete‐like (sperm‐like or oocyte‐like, respectively), because at present there is still no evidence that these cells behave fully like bona fide sperm or oocytes, lacking the fundamental proof, i.e. combination with a normally derived gamete of the opposite (...) sex to yield a normal individual. However, the results published so far do show that these cells share some defining features of gametes. We discuss these results in the light of the bioethical and legal questions that are likely to arise would the same process become possible with human embryonic stem (hES) cells. (shrink)

What's wrong with designer children, bionic athletes, and genetic engineering.

In this book, Alan Wertheimer seeks to identify when a transaction or relationship can be properly regarded as exploitative--and not oppressive, manipulative, or morally deficient in some other way--and explores the moral weight of taking ...

The precautionary principle (PP) is thought by many to be a useful strategy for action and by many others useless at best and dangerous at worst. We argue that it is a coherent and useful principle. We first clarify the principle and then defend it against a number of common criticisms. Three examples from nanotechnology are used; nanoparticles and possible health and environmental problems, grey goo and the potential for catastrophe, and privacy risks generated by nanoelectronics.

In discussions of the ethics of human gene therapy, it has become standard to draw a distinction between the use of human gene transfer techniques to treat health problems and their use to enhance or improve normal human traits. Some dispute the normative force of this distinction by arguing that it is undercut by the legitimate medical use of human gene transfer techniques to prevent disease - such as genetic engineering to bolster immune function, improve the efficiency of DNA repair, (...) or add cellular receptors to capture and process cholesterol. If disease prevention is a proper goal of medicine, these critics argue, and the use of gene transfer techniques to enhance human health maintenance capacities will help achieve that goal, then the “treatment/enhancement‘ distinction cannot define the limits of legitimate gene therapy. In this paper, I argue that a line can be drawn between prevention and enhancement for gene therapy (and thus between properly medical and nonmedical uses of gene therapy), but only if one is willing to accept two rather old-fashioned claims: 1) Some health problems are best understood as if they were entities in their own right, reifiable as processes or parts in a biological system, with at least as much ontological objectivity and theoretical significance as the functions that they inhibit. 2) Legitimate preventive genetic health care should be limited to efforts to defend people from attack by these more robust pathological entities, rather than changing their bodies to evade social injustices. (shrink)

Participants in some clinical trials are at risk of being harmed and sometimes are seriously harmed as a result of not being provided with available, relevant risk information. We argue that this situation is unacceptable and that there is a moral duty to disclose all adverse clinical trial results to participants in clinical trials. This duty is grounded in the human right not to be placed at risk of harm without informed consent. We consider objections to disclosure grounded in considerations (...) of commercial interest, and we argue that these concerns are insufficient to override the moral duty to disclose adverse clinical trial results. However, we also develop a proposal that enables commercial interests to be protected, while promoting the duty to disclose adverse clinical trial results. (shrink)

Biobank research is potentially fruitful. It is argued that broad consent is acceptable for future research on biological material because a) the benefit is high, b) it pays respect to people’s autonomy, c) it is consistent with current practices and d) because the risk is low. Furthermore, broad consent should be allowed if information is handled safely, people can withdraw and expanded research should be approved by an ethics review board. However, these arguments are flawed and the criteria for broad (...) consent are either too restrictive to allow any research or fail to address important challenges with biobank research. Broad consent for biobank research can hide substantial ethical challenges and threaten trust in research. This does not mean that biobank research should be abandoned or that people cannot authorise future research on donated biological material. (shrink)

Opposition to inducement payments for research subjects is an international orthodoxy amongst writers of ethics committee guidelines. We offer an argument in favour of these payments. We also critically evaluate the best arguments we can find or devise against such payments, and except in one very limited range of circumstances, we find these unconvincing.

ABSTRACT Can philosophers come up with persuasive reasons to allow or to ban human reproductive cloning? Yes. Can philosophers agree, locally and temporarily, which practices related to cloning should be condoned and which should be rejected? Some of them can. Can philosophers produce universally convincing arguments for or against different kinds of human cloning? No. This paper analyses some of the main arguments presented by philosophers in the cloning debate, and some of the most important objections against them. The clashes (...) between the schools of thought suggest that philosophers cannot be trusted to provide the public authorities, or the general public, a unified, universally applicable view of the morality of human reproductive cloning. (shrink)

We have a reason to use information which is available about such genes in our reproductive decision-making; (3) couples should selec.

In this paper the authors argue that research ethics committees should not be paternalistic by rejecting research that poses risk to people competent to decide for themselves. However it is important they help to ensure valid consent is sought from potential recruits and protect vulnerable people who cannot look after their own best interests. The authors first describe the tragic deaths of Jesse Gelsinger and Ellen Roche. They then discuss the following claims to support their case: competent individuals are epistemologically (...) and ethically in the best position to say which risks are reasonable for them, so RECs should be no more restrictive than the “normal” constraints on people taking risks with themselves; RECs do not judge individual competence ; individual liberty is mostly limited by what serves the public interest, and RECs do not determine public interest; RECs may have a paternalistic role in preventing exploitation of competent people vulnerable to the use of incentives, and in protecting the interests of incompetent people; however, the moral and political authority of RECs has not been established in this respect. (shrink)

The treatment-enhancement distinction draws a line between services or interventions meant to prevent or cure conditions that we view as diseases or disabilities and interventions that improve a condition that we view as a normal function or feature of members of our species. The line drawn here is widely appealed to in medical practice and medical insurance contexts, as well as in our everyday thinking about the medical services we do and should assist people in obtaining.

The institutional review board is the social-oversight mechanism charged with protecting research subjects. Performing this task competently requires that the IRB scrutinize informed-consent procedures, the balance of risks and potential benefits, and subject-selection procedures in research protocols. Unfortunately, it may be said that IRBs are spending too much time editing informed-consent forms and too little time analyzing the risks and potential benefits posed by research. This time mismanagement is clearly reflected in the research ethics literature. A review of articles published (...) between 1979 and 1990 in IRB: A Review of Human Subjects Research, for example, reveals a large number of articles on informed consent and confidentiality and considerably fewer on the assessment of risks and potential harms, study design, and subject-selection procedures. (shrink)

It is commonly thought that exploitation is unjust; some think it is part of the very meaning of the word 'exploitation' that it is unjust. Those who think this will suppose that the just society has to be one in which people do not exploit one another, at least on a large scale. I will argue that exploitation is not unjust by definition, and that a society (such as Our own) might be fundamentally just while nevertheless being pervasively exploitative. I (...) do think that exploitation is nearly always a bad thing, and will try to identify the moral belief which makes most of us think it is. But I will argue that its badness does not always consist in its being unjust. (shrink)

In order to explore public views on nanobiotechnology (NBT), convergence seminars were held in four places in Europe; namely in Visby (Sweden), Sheffield (UK), Lublin (Poland), and Porto (Portugal). A convergence seminar is a new form of public participatory activity that can be used to deal systematically with the uncertainty associated for instance with the development of an emerging technology like nanobiotechnology. In its first phase, the participants are divided into three “scenario groups” that discuss different future scenarios. In the (...) second phase, the participants are regrouped into three “convergence groups”, each of which contains representatives from each of the three groups from the first phase. In the final third phase, all participants meet for a summary discussion. This pilot project had two aims: (1) to develop and assess the new methodology and (2) to gather advice and recommendations from the public that may be useful for future decisions on nanobiotechnology (NBT). Participants emphasized that they wanted the technology to focus on solutions to environmental and medical problems and to meet the needs of developing countries. The need for further public participation and deliberation on NBT issues seemed to be acknowledged by all participants. Many of them also raised equality concerns. Views on the means by which NBT should be steered into socially useful directions were more divided. In particular, different views were expressed on how much regulation of company activities is needed to curb unwanted developments. The participants’ responses in a questionnaire indicate that the methodology of the convergence seminars was successful for decision-making under uncertainty. In particular, the participants stated that their advice was influenced both by access to different possible future developments and by the points of view of their co-participants, which is what the method is specifically intended to achieve. (shrink)

The Concept of Law is the most important and original work of legal philosophy written this century. First published in 1961, it is considered the masterpiece of H.L.A. Hart's enormous contribution to the study of jurisprudence and legal philosophy. Its elegant language and balanced arguments have sparked wide debate and unprecedented growth in the quantity and quality of scholarship in this area--much of it devoted to attacking or defending Hart's theories. Principal among Hart's critics is renowned lawyer and political philosopher (...) Ronald Dworkin who in the 1970s and 80s mounted a series of challenges to Hart's Concept of Law. It seemed that Hart let these challenges go unanswered until, after his death in 1992, his answer to Dworkin's criticism was discovered among his papers. In this valuable and long-awaited new edition Hart presents an Epilogue in which he answers Dworkin and some of his other most influential critics including Fuller and Finnis. Written with the same clarity and candor for which the first edition is famous, the Epilogue offers a sharper interpretation of Hart's own views, rebuffs the arguments of critics like Dworkin, and powerfully asserts that they have based their criticisms on a faulty understanding of Hart's work. Hart demonstrates that Dworkin's views are in fact strikingly similar to his own. In a final analysis, Hart's response leaves Dworkin's criticisms considerably weakened and his positions largely in question. Containing Hart's final and powerful response to Dworkin in addition to the revised text of the original Concept of Law, this thought-provoking and persuasively argued volume is essential reading for lawyers and philosophers throughout the world. (shrink)

It is often claimed that from the moment of conception embryos have the same moral status as adult humans. This claim plays a central role in many arguments against abortion, in vitro fertilization, and stem cell research. In what follows, I show that this claim leads directly to an unexpected and unwelcome conclusion: that natural embryo loss is one of the greatest problems of our time and that we must do almost everything in our power to prevent it. I examine (...) the responses available to those who hold that embryos have full moral status and conclude that they cannot avoid the force of this argument without giving up this key claim. (shrink)

Recent legal rulings concerning the status of advance statements have raised interest in the topic but failed to provide any definitive general guidelines for their enforcement. I examine arguments used to justify the moral authority of such statements. The fundamental ethical issue I am concerned with is how accounts of personal identity underpin our account of moral authority through the connection between personal identity and autonomy. I focus on how recent Animalist accounts of personal identity initially appear to provide a (...) sound basis for extending the moral autonomy of an individual - and hence their autonomous wishes expressed through an advance directive - past the point of severe psychological decline. I argue that neither the traditional psychological account nor the more recent Animalist account of personal identity manage to provide a sufficient basis for extending our moral autonomy past the point of incapacity or incompetence. I briefly explore how analogies to similar areas in law designed to facilitate autonomous decision, such as wills and trusts, provide at best only very limited scope for an alternative justification for granting advance statements any legal or moral authority. I conclude that whilst advance statements play a useful role in formulating what treatment is in a patient’s best interests, such statements do not ultimately have sufficient moral force to take precedence over paternalistic best interest judgements concerning an individual’s care or treatment. (shrink)

The discussion of the adequacy of Karl Marx''s definition of exploitation has paid insufficient attention to a prior question: what is a definition? Once we understand Marx as offering a reference-fixing definition in a model we will realise that it is resistant to certain objections. A more general analysis of exploitation is offered here and it is suggested that Marx''s own definition is a particular instance of the general analysis which makes a number of controversial moral assumptions.

The cochlear implant controversy involves questions about the nature of disability and the definition of “normal” bodies; it also raises arguments about the nature and significance of culture and the rights of minority cultures. I defend the claim that there might be such a thing as “Deaf culture” and then examine how two different understandings of the role of culture in the lives of individuals can lead to different conclusions about the rights of Deaf parents in relation to their children, (...) and about the ethics of public funding for research on cochlear implants. An argument asserting the rights of minority cultures to equal respect and consideration within a multicultural society, informed by communitarian political philosophy, offers the best prospect for the defence of the unique culture(s) of the Deaf. (shrink)

This essay analyzesexploitation in biomedical research in terms ofthree basic elements: harm, disrespect, orinjustice. There are also degrees ofexploitation, ranging from highly exploitationto minimally exploitation. Althoughexploitation is prima facie wrongful,some exploitative research studies are morallyjustified, all things considered. The reasonan exploitative study can still be ethical isthat other moral considerations, such as theautonomy of the research subject or the socialbenefits of research, may sometimes justifystudies that are minimally exploitative. Calling a research project exploitative doesnot end the debate about the merits (...) of thestudy but invites one to ask additionalquestions about how the study is exploitative,and whether the study is justifiablenevertheless. (shrink)

Classifying research proposals by risk of harm is fundamental to the approval process and the most pivotal risk category in most regulations is that of “minimal risk.” If studies have no more than a minimal risk, for example, a nearly worldwide consensus exists that review boards may sometimes: (1) expedite review, (2) waive or modify some or all elements of informed consent, or (3) enroll vulnerable subjects including healthy children, incapacitated persons and prisoners even if studies do not hold out (...) direct benefits to them. The moral and social purposes behind this threshold are discussed along with relevant views from the National Commission, NBAC, NHRPAC, Grimes v. Kennedy Krieger Institute, The Nuremberg Code, and The WMA's Declaration of Helsinki. Representative policies from Australia, Canada, South Africa, the U.S., and CIOMS are reviewed revealing different understandings of this sorting threshold. Six of nine frequently cited interpretations of “minimal risk” are untenable. The “absolute” interpretation of the “routine examination” standard is defended as best. (shrink)

Guidelines for health research focus on protecting individual research subjects. It is also vital to protect the communities involved in health research. In particular, a number of studies have been criticized on the grounds that they exploited host communities. The present paper attempts to address these concerns by providing an analysis of community exploitation and, based on this analysis, determining what safeguards are needed to protect communities in health research against exploitation. (edited).

It is sometimes suggested that new research in such areas as artificial intelligence, nanotechnology and genetic engineering should be halted or otherwise restricted because of concerns about possible catastrophic scenarios. Proponents of such restrictions typically invoke the precautionary principle, understood as a tool of policy formulation, as part of their case. Here I examine the application of the precautionary principle to possible catastrophic scenarios. I argue, along with Sunstein (Risk and Reason: Safety, Law and the Environment. Cambridge University Press, Cambridge, (...) 2002) and Manson (Environmental Ethics, 24: 263–274, 2002), that variants of the precautionary principle that appear strong enough to support significant restrictions on future technologies actually lead to contradictory policy recommendations. Weaker versions of the precautionary principle, which do not have this feature, do not appear strong enough to support restrictions on future technologies. (shrink)

: The current difference in attitude toward germ-line enhancement in humans and nonhumans is unjustified. Society should be more cautious in modifying the genes of nonhumans and more bold in thinking about modifying our own genome. I identify four classes of arguments pertaining to germ-line enhancement: safety arguments, justice arguments, trust arguments, and naturalness arguments. The first three types are compelling, but do not distinguish between human and nonhuman cases. The final class of argument would justify a distinction between human (...) and nonhuman germ-line enhancement; however, this type of argument fails and, therefore, the discrepancy in attitude toward human and nonhuman germ-line enhancement is unjustified. (shrink)

The institutional review board is the social-oversight mechanism charged with protecting research subjects. Performing this task competently requires that the IRB scrutinize informed-consent procedures, the balance of risks and potential benefits, and subject-selection procedures in research protocols. Unfortunately, it may be said that IRBs are spending too much time editing informed-consent forms and too little time analyzing the risks and potential benefits posed by research. This time mismanagement is clearly reflected in the research ethics literature. A review of articles published (...) between 1979 and 1990 in IRB: A Review of Human Subjects Research, for example, reveals a large number of articles on informed consent and confidentiality and considerably fewer on the assessment of risks and potential harms, study design, and subject-selection procedures. (shrink)

For decades, worries about undue inducement have Pervaded clinical research, and are especially common when research is accompanied by payment or conducted in developing countries. Few ethical judgments carry as much moral opprobrium or are thought to undermine the ethical soundness of a clinical trial as thoroughly as undue inducement. Indeed, the admonition to prevent undue inducement is one of the few explicit instructions in the Common Rules requirements for informed consent.Despite their long history and pervasiveness, charges of undue inducement (...) in clinical research are almost always mistaken. Indeed, I will advance an even more radical claim: Aresearch trial that otherwise fulfills the fundamental ethical requirements for human subjects research inherently cannot create the possibility of undue inducement because substantial risk of serious harm isprecluded. Charges of undue inducement tend to express displaced and mislabeled ethical concerns about other aspects of human subjects research. Consequently, claims of undue inducement should rarely be made, and when they are advanced should be treated with skepticism, placing a heavy burden of proofon those advancing such charges. (shrink)

Eugenicists in the 1930s and 1940s emphasised our moral responsibilities to future generations and the importance of positively selecting traits that would benefit humanity. In 1935 Herbert Brewer recommended ‘Eutelegenesis’ so that that future generations are not only protected from hereditary disease but also become more intelligent and fraternal than us. The development of these techniques for human use and animal husbandry was the catalyst for the cross fertilization of moral ideas and the development of a critical procreative morality. While (...) eugenicists argued for a new critical morality, religious critics argued against artificial insemination because of its potential to damage important moral institutions. The tension between critical and conservative procreative morality is a feature of the contemporary debates about reproductive technologies. This and some of the other aspects of the early and contemporary debates about artificial insemination and reproductive technologies are discussed in this article. (shrink)

: This paper examines ethical issues related to medical practices with children and adults who are members of a linguistic and cultural minority known as the DEAF-WORLD. Members of that culture characteristically have hearing parents and are treated by hearing professionals whose values, particularly concerning language, speech, and hearing, are typically quite different from their own. That disparity has long fueled a debate on several ethical issues, most recently the merits of cochlear implant surgery for DEAF children. We explore whether (...) that surgery would be ethical if implants could deliver close to normal hearing for most implanted children, thereby diminishing the ranks of the DEAF-WORLD. The ethical implications of eugenic practices with the DEAF are explored, as are ethical quandaries in parental surrogacy for DEAF children, and their parallels in transracial adoption. (shrink)

Biomedical research is so important that there is a positive moral obligation to pursue it and to participate in itScience is under attack. In Europe, America, and Australasia in particular, scientists are objects of suspicion and are on the defensive.i“Frankenstein science”5–8 is a phrase never far from the lips of those who take exception to some aspect of science or indeed some supposed abuse by scientists. We should not, however, forget the powerful obligation there is to undertake, support, and participate (...) in scientific research, particularly biomedical research, and the powerful moral imperative that underpins these obligations. Now it is more imperative than ever to articulate and explain these obligations and to do so is the subject and the object of this paper.Let me present the question in its starkest form: is there a moral obligation to undertake, support and even to participate in serious scientific research? If there is, does that obligation require not only that beneficial research be undertaken but also that “we”, as individuals and “we” as societies be willing to support and even participate in research where necessary?Thus far the overwhelming answer given to this question has been “no”, and research has almost universally been treated with suspicion and even hostility by the vast majority of all those concerned with the ethics and regulation of research. The so called “precautionary approach”9 sums up this attitude, requiring dangers to be considered more likely and more serious than benefits, and assuming that no sane person would or should participate in research unless they had a pressing personal reason for so doing, or unless they were motivated by a totally impersonal altruism. International agreements and protocols—for example, the Declaration of Helsinki10 and the CIOMS Guidelines11—have been directed principally at …. (shrink)

Due to modern biochemistry and, in particular, recent developments in genomics, proteomics, and bioinformatics, human samples have become the most important raw materials for advancement in the health sciences. Such material has been at the center of fundamental biomedical research for a long time. What is new is its increased usefulness in research with direct clinical relevance, such as the development of drugs. Because of the larger commercial involvement in such research, this has also led to greater economic interests in (...) human biological material and in the information that can be extracted from it. (shrink)

Certain kinds of medical treatment are often held to be morally unacceptable because they are an 'interference with nature'. I suggest a way in which we can make sense of such ideas. We can make significant choices only against a background of conditions which we regard as 'natural', and these will typically include such facts as those of birth and death, of youth and age, and of sexual relations. I argue, however, that such ideas, though intelligible, do not establish any (...) valid moral objection to, for instance, the use of ovarian tissue for assisted conception. (shrink)

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)

The physician who upholds the Hippocratic oath is supposed to be loyal to his or her patients. This requires choosing only the therapy that the physician believes is best for the patient. However, knowing what is best requires randomized clinical trials. Thus, clinicians must be willing to recruit their patients to be assigned at random to one of two therapies in order to determine which is best based on the highest standards of pharmacological science.

The dual-use dilemma arises in the context of research in the biological and other sciences as a consequence of the fact that one and the same piece of scientific research sometimes has the potential to be used for bad as well as good purposes. It is an ethical dilemma since it is about promoting good in the context of the potential for also causing harm, e.g., the promotion of health in the context of providing the wherewithal for the killing of (...) innocents. It is an ethical dilemma for the researcher because of the potential actions of others, e.g., malevolent non-researchers who might steal dangerous biological agents, or make use of the original researcher’s work. And it is a dilemma for governments concerned with the security of their citizens, as well as their health. In this article we construct a taxonomy of types of “experiments of concern” in the biological sciences, and thereby map the terrain of ethical risk. We then provide a series of analyses of the ethical problems and considerations at issue in the dual-use dilemma, including the impermissibility of certain kinds of research and possible restrictions on dissemination of research results given the risks to health and security. Finally, we explore the main available institutional responses to some of the specific ethical problems posed by the dual-use dilemma in the biological sciences. (shrink)

The paper defends the permissibility of paying inducements to research subjects against objections not covered in an earlier paper in Bioethics. The objections are that inducements would cause inequity, crowd out research, and undesirably commercialize the researcher‐subject relationship. The paper shows how these objections presuppose implausible factual and/or normative claims. The final position reached is a qualified defence of freedom of contract which not only supports the permissibility of inducements but also offers guidance to ethics committees in dealing with practical (...) problems that might arise if inducements are offered. (shrink)

Most known technology serves to ingeniously adapt the world to the physical and mental limitations of human beings. Humankind has acquired awesome power with its rather limited means. Nanotechnological capabilities further this power. On some accounts, however, nanotechnological research will contribute to a rather different kind of technological development, namely one that changes human beings so as to remove or reduce their physical and mental limitations. The prospect of this technological development has inspired a fair amount of ethical debate. Here, (...) proponents and opponents of such visions of human enhancement are criticized alike for engaging in speculative ethics. This critique exposes a general pattern that extends to other nano-, bio-, or neuroethical debates. While it does not apply to all discussions of “enhancement technologies” it does apply to all ethical discourse that constructs and validates an incredible future which it only then proceeds to endorse or critique. This discourse violates conditions of intelligibility, squanders the scarce and valuable resource of ethical concern, and misleads by casting remote possibilities or philosophical thought-experiments as foresight about likely technical developments. In effect, it deflects consideration from the transformative technologies of the present. (shrink)

The precautionary principle has its origins in debates about environmental policy, but is increasingly invoked in bioethical contexts. John Harris and Søren Holm argue that the principle should be rejected as incoherent, irrational, and representing a fundamental threat to scientific advance and technological progress. This article argues that while there are problems with standard formulations of the principle, Harris and Holm's rejection of all its forms is mistaken. In particular, they focus on strong versions of the principle and fail to (...) recognize that weaker forms, which may escape their criticisms, are both possible and advocated in the literature. (shrink)

The idea of splitting off cells from embryos to clone human beings sounds so bizarre and dangerous that one would think the practice should not be permitted. A closer look reveals its ethical acceptability.

We analysed research ethics committee (REC) letters. We found that RECs frequently identify process errors in applications from researchers that are not deemed “favourable” at first review. Errors include procedural violations (identified in 74% of all applications), missing information (68%), slip-ups (44%) and discrepancies (25%). Important questions arise about why the level of error identified by RECs is so high, and about how errors of different types should be handled.

Recent policy in relation to clinical research proposals in the UK has distinguished between two types of review: scientific and ethical. This distinction has been formally enshrined in the recent changes to research ethics committee structure and operating procedures, introduced as the UK response to the EU Directive on clinical trials. Recent reviews and recommendations have confirmed the place of the distinction and the separate review processes. However, serious reservations can be mounted about the science/ethics distinction and the policy of (...) separate review that has been built upon it. We argue here that, first, the science/ethics distinction is incoherent, and, second, that RECs should not only be permitted to consider a study’s science, but that they have anobligation do so. (shrink)

Research involving human subjects is much more stringently regulated than many other nonresearch activities that appear to be at least as risky. A number of prominent figures now argue that research is overregulated. We argue that the reasons typically offered to justify the present system of research regulation fail to show that research should be subject to more stringent regulation than other equally risky activities. However, there are three often overlooked reasons for thinking that research should be treated as a (...) special case. First, research typically involves the imposition of risk on people who do not benefit from this risk imposition. Second, research depends on public trust. Third, the complexity of the moral decision making required favors ethics committees as a regulative solution for research. (shrink)

The leading ethical position on placebo-controlled clinical trials is that whenever proven effective treatment exists for a given condition, it is unethical to test a new treatment for that condition against placebo. Invoking the principle of clinical equipoise, opponents of placebo-controlled trials in the face of proven effective treatment argue that they (1) violate the therapeutic obligation of physicians to offer optimal medical care and (2) lack both scientific and clinical merit. We contend that both of these arguments are mistaken. (...) Clinical equipoise provides erroneous ethical guidance in the case of placebo-controlled trials, because it ignores the ethically relevant distinction between clinical trials and treatment in the context of clinical medicine and the methodological limitations of active-controlled trials. Placebo controls are ethically justifiable when they are supported by sound methodological considerations and their use does not expose research participants to excessive risks of harm. (shrink)

It is important to be able to offer an account of which activities count as scientific research, given our current interest in promoting research as a means to benefit humankind and in ethically regulating it. We attempt to offer such an account, arguing that we need to consider both the procedural and functional dimensions of an activity before we can establish whether it is a genuine instance of scientific research. By placing research in a broader schema of activities, the similarities (...) and differences between research activities and other activities become visible. It is also easier to show why some activities that do not count as research can sometimes be confused with research and why some other activities can be regarded only partially as research. Although the concept of research is important to delimit a class of activities which we might be morally obliged to promote, we observe that the class of activities which are regarded as subject to ethical regulation is not exhausted by research activities. We argue that, whether they be research or not, all the activities that are likely to affect the rights and interests of the individuals involved and impact on the rights and interests of other individuals raise ethical issues and might be in need of ethical regulation. (shrink)