The question whether rights to health care should be altered by smoking behaviour involves wideranging implications for all who indulge in hazardous behaviours, and involves complex economic utilitarian arguments. This paper examines current debate in the UK and suggest the major significance of the controversy has been ignored. That this discussion exists at all implies increasing division over the scope and purpose of a nationalised health service, bestowing health rights on all. When individuals bear the cost of their own health (...) care, they appear to take responsibility for health implications of personal behaviour, but when the state bears the cost, moral obligations of the community and its doctors to care for those who do not value health are called into question. The debate has far-reaching implications as ethical problems of smokers' rights to health care are common to situations where health as a value comes into conflict with other values, such as pleasure or wealth. (shrink)

Preventive medicine is sometimes criticised as it contributes to medicalization of normal life. The concept ‘medicalization’ has been introduced by Zola to refer to processes in which the labels ‘healthy’ and ‘ill’ are made relevant for more and more aspects of human life. If preventive medicine contributes to medicalization, would that be morally problematic? My thesis is that such a contribution is indeed morally problematic. The concept is sometimes used to express moral intuitions regarding the practice of prevention and health (...) promotion. Through analysis of these intuitions as well as some other moral concerns, I give an explication of the moral problems of medicalization within the context of preventive medicine. (shrink)

As I write this, in November 1971, people are dying in East Bengal from lack of food, shelter, and medical caxc. The suffering and death that are occurring there now axe not inevitable, 1101; unavoidable in any fatalistic sense of the term. Constant poverty, a cyclone, and a civil war have turned at least nine million people into destitute refugees; nevertheless, it is not beyond Lhe capacity of the richer nations to give enough assistance to reduce any further suffering to (...) very small proportions. The decisions arid actions of human beings can prevent this kind of suffering. Unfortunately, human beings have not made the necessary decisions. At the individual level, people have, with very few exceptions, not responded to the situation in any signihczmt way. Generally speaking, people have not given large sums to relief funds; they have not written t0 their parliamentaxy representatives demanding increased government assistance; they have not demonstrated in the streets, held symbolic fasts, or done anything else directed toward providing thc refugees with the means to satisfy their essential needs. At thc government level, no govcrmmcnt has given the sort of massive aid that would enable the refugees to survive fm: more than a few days. Britain, for instance, has given rather more than most countries. It has, to date, given £14,750,000. For comparative purposes, B1~itain’s share of thc nonreccverabla development costs of the Anglo-French Concorde project is already in excess of £275,000,000, and on present estimates will reach £440,000,¤00. The implication is that the British government values a supersonic transport more than thirty times as.. (shrink)

ABSTRACTJohn Harris suggests that participation in or support for research, particularly medical research, is a moral duty. One kind of defence of this position rests on an appeal to the past, and produces two arguments. The first of these arguments is that it is unfair to accept the benefits of research without contributing something back in the form of support for, or participation in, research. A second argument is that we have a social duty to maintain those practices and institutions (...) that sustain us, such as those which contribute to medical knowledge. This argument is related to the first, but it does not rely so heavily on fairness. Another kind of defence of the duty to research rests on an appeal to the future benefits of research: research is an effective way to discharge a duty to rescue others from serious illness or death, therefore we have a duty to research. I suggest that all three of Harris' lines fail to provide a compelling duty to research and spell out why. Moreover, not only do the lines of argument fail in their own terms: in combination, they turn out to be antagonistic to the very position that Harris wants to defend. While it is not my intention here to deny that there might be a duty to research, I claim that Harris' argument for the existence of such a duty is not the best way to establish it. (shrink)

In a recent article, I argued that Ploug and Holm’s ‘meta-consent’ proposal should be rejected for biobank governance. This was because, although meta-consent is permissible, it is both burdensome and ethically omissible. There is no ethical reason why funders should undertake the additional costs. Ploug and Holm have sought to respond to these arguments. Here, it is noted that not only do they fail to adequately refuse the case against meta-consent, they fail to even engage with the arguments, either misunderstanding (...) them or ignoring them. In their response, Ploug and Holm unwittingly provide the basis of an even stronger case against meta-consent. They argue that broad consent has a built in tendency to expire, while also holding that broad consent should be one of the options available in meta-consent. Meta-consent thus ends up being more like dynamic consent, but, arguably, even more burdensome and costly. (shrink)

This first volume in the four-volume series The Moral Limits of the Criminal Law focuses on the "harm principle," the commonsense view that prevention of harm to persons other than the perpetrator is a legitimate purpose of criminal legislation. Feinberg presents a detailed analysis of the concept and definition of harm and applies it to a host of practical and theoretical issues, showing how the harm principle must be interpreted if it is to be a plausible guide to the lawmaker.

Over the past couple of decades, there has been an ongoing, often fierce, debate about the ethics of biobank participation. One central element of that debate has concerned the nature of informed consent, must specific reconsent be gained for each new use, or user, or is broad consent ethically adequate? Recently, Thomas Ploug and Søren Holm have developed an alternative to both specific and broad consent: what they call a meta-consent framework. On a meta-consent framework, participants can choose the type (...) of consent framework they require, for different kinds of use, different types of user and so on. Meta-consent involves a distinctive kind of design of the consent process. Here it is argued, first, that although a meta-consent framework does not wrong participants, Ploug and Holm understate the likely costs and burdens of such a framework, so there are good practical reasons not to offer it. Second, although Ploug and Holm allude to some ethical considerations that might seem to ground an ethical argument for providing meta-consent, they do not offer any sound argument, and it does not wrong participants in any way to fail to offer them the opportunity to design their own consent process. (shrink)

In 1972, the young philosopher Peter Singer published "Famine, Affluence and Morality," which rapidly became one of the most widely discussed essays in applied ethics. Through this article, Singer presents his view that we have the same moral obligations to those far away as we do to those close to us. He argued that choosing not to send life-saving money to starving people on the other side of the earth is the moral equivalent of neglecting to save drowning children because (...) we prefer not to muddy our shoes. If we can help, we must--and any excuse is hypocrisy. Singer's extreme stand on our moral obligations to others became a powerful call to arms and continues to challenge people's attitudes towards extreme poverty. Today, it remains a central touchstone for those who argue we should all help others more than we do. As Bill and Melinda Gates observe in their foreword, in the age of today's global philanthropy, Singer's essay is as relevant now as it ever was. This attractively packaged, concise edition collects the original article, two of Singer's more recent popular writings on our obligations to others around the world, and a new introduction by Singer that discusses his current thinking. (shrink)

Not all intellectual property rights grant the right to exclude that is indicative of “property rules,” as that term was used by Guido Calabresi and A. Douglas Melamed in their seminal article. Some intellectual property rights are “liability rules,” in which the right holder has an entitlement to compensation for use of the protected invention, not a right to preclude the use. Although patent laws normally grant a right to exclude others from use of the protected invention as a default, (...) most countries’ laws allow the government to convert the patent property rule into a liability rule through a compulsory license. It has been noted, for example, that by the end of the 1950s, the U.S. had issued compulsory licenses covering 40 to 50 thousand patents, including substantial portions of the patent portfolios of AT&T, General Electric, IBM, and Xerox. The U.S. Supreme Court recently expressed a willingness to accept liability rules over injunctions in some patent infringement cases. (shrink)

Most of us are inclined to believe that blackmail is clearly immoral and are thus quite content that it be criminalized. Justifying this belief, however, turns out to be more of a problem than it might at first seem. In particular, it is difficult if not impossible to distinguish cases of blackmail from other hard economic transactions.

An imperfect duty such as the duty to aid those in need is supposed to leave leeway for choice as to how to satisfy it, but if our reason for a certain way of satisfying it is our strongest, that leeway would seem to be eliminated. This paper defends a conception of practical reasons designed to preserve it, without slighting the binding force of moral requirements, though it allows us to discount certain moral reasons. Only reasons that offer criticism of (...) alternatives can yield requirements, but our reasons for particular ways of satisfying imperfect duties merely count in favor of the acts in question. When the state is authorized to take over charitable obligations, it should not be seen as enforcing fulfillment of our imperfect duties, but rather as forcing us to help fulfill collective duties that may be substantially modified by transfer to the state, replacing imperfect duties with perfect. Besides the cost to us in freedom of choice there is a moral cost to replacing the virtuous motives of charity with those that tend to accompany paying taxes. However, a compensating feature of state involvement is the fact that its more precise demands come with limits. (shrink)

Approximately two billion people lack access to medicines globally. People living with HIV, cancer patients, those suffering from tuberculosis or malaria, and other populations in desperate need of life-saving medicines are increasingly unable to access existing preventative, curative, and life-prolonging treatments. In many cases, treatment may be unavailable or inaccessible for even some of the most common and readily treatable health concerns, such as hypertension. In the developing world, many of the factors that contribute to making the world’s most vulnerable (...) and marginalized populations particularly susceptible to illness also operate to restrict their access to medicines. As a result of dramatic economic inequities and widespread poverty, it is not profitable for most originator pharmaceutical companies to develop new medicines for sale in developing markets or to lower the cost of existing drugs so that they are affordable for the majority of these populations. (shrink)

Researchers increasingly rely on large data sets of health information, often linked with biological specimens. In recent years, the argument has been made that obtaining informed consent for conducting records-based research is unduly burdensome and results in ?consent bias.? As a type of selection bias, consent bias is said to exist when the group giving researchers access to their data differs from the group denying access. Therefore, to promote socially beneficial research, it is argued that consent should be unnecessary. After (...) analyzing the biostatistics evidence and bioethics arguments, the article concludes that (1) claims about the amount of consent bias are overstated; (2) commonly used statistical methods usually can account for consent bias; and (3) any residual effects of consent bias are below an acceptable level of imprecision and constitute a reasonable social cost for conducting ethically responsible research. (shrink)

ABSTRACT A major moral problem in relation to the deCODE genetics database project in Iceland is that the heavy emphasis placed on technical security of healthcare information has precluded discussion about the issue of consent for participation in the database. On the other hand, critics who have emphasised the issue of consent have most often demanded that informed consent for participation in research be obtained. While I think that individual consent is of major significance, I argue that this demand for (...) informed consent is neither suitable nor desirable in this case. I distinguish between three aspects of the database and show that different types of consent are appropriate for each. In particular, I describe the idea of a written authorisation based on general information about the database as an alternative to informed consent and presumed consent in database research. (shrink)

Research drawn from data contained in medical records is a common and immensely important means of scientific investigation in epidemiology and health services research. It provides valuable knowledge regarding risk factors for disease, the safety of pharmaceuticals and medical procedures, and the quality of medical care. Electronic information technology has greatly enhanced the capability of conducting research using medical records, but it has also generated increasing concern about invasions of privacy. Both practical and scientific considerations militate against soliciting consent for (...) population-based observational research. Retrospective review of existing medical records, especially with large samples, poses insuperable barriers to locating human subjects in order to obtain their informed consent. When efforts are made to obtain informed consent for prospective research drawn from disease and treatment registries, mounting evidence has accumulated that substantial selection biases are introduced into the data, as those who consent are not necessarily representative of the population of relevant patients. (shrink)

In this article we provide an in-depth description of a new model of informed consent called ‘meta consent’ and consider its practical implementation. We explore justifications for preferring meta consent over alternative models of consent as a solution to the problem of secondary use of health data for research. We finally argue that meta consent strikes an appropriate balance between enabling valuable research and protecting the individual.

In this response to Neil Manson’s latest intervention in our debate about the best consent model for biobank research we show, contra Manson that the ‘expiry problem’ that affects broad consent models because of changes over time in methods, purposes, types of data used and governance structures is a real and significant problem. We further show that our preferred implementation of meta consent as a national consent platform solves this problem and is not subject to the cost and burden objections (...) that Manson raises. (shrink)

Research into personal health data holds great potential not only for improved treatment but also for economic growth. In these years many countries are developing policies aimed at facilitating such research often under the banner of ‘big data’. A central point of debate is whether the secondary use of health data requires informed consent if the data is anonymised. In 2013 the Danish Minister of Health established a new register collecting data about all ritual male childhood circumcisions in Denmark. The (...) main purpose of the register was to enable future research into the consequences of ritual circumcision. This article is a study into the case of the Danish Circumcision Registry. We show that such a registry may lead to various forms of harm such as 1) overreaching social pressure, 2) stigmatization, 3) medicalization of a religious practice, 4) discrimination, and 5) polarised research, and that a person may therefore have a strong and legitimate interest in deciding whether or not such data should be collected and/or used in research. This casts doubt on the claim that the requirement of informed consent could and should be waived for all types of secondary research into registries. We finally sketch a new model of informed consent – Meta consent – aimed at striking a balance between the interests in promoting research and at the same time protecting the individual. Research participants may have a strong and legitimate interest in deciding whether or not their data should be collected and used for registry-based research whether or not their data is anonymised. (shrink)

Increasingly, bioethicists defend informed consent as a safeguard for trust in caretakers and medical institutions. This paper discusses an ‘ideal type’ of that move. What I call the trust-promotion argument for informed consent states:1. Social trust, especially trust in caretakers and medical institutions, is necessary so that, for example, people seek medical advice, comply with it, and participate in medical research.2. Therefore, it is usually wrong to jeopardise that trust.3. Coercion, deception, manipulation and other violations of standard informed consent requirements (...) seriously jeopardise that trust.4. Thus, standard informed consent requirements are justified.This article describes the initial promise of this argument, then identifies challenges to it. As I show, the value of trust fails to account for some commonsense intuitions about informed consent. We should revise the argument, commonsense morality, or both. (shrink)

The ongoing legal and bioethics debates on consent requirements for collecting, storing, and utilizing human biological material for purposes of basic and applied research—that is, genomic research biobanking—have already managed to pass through three ostensibly dissimilar stages.

In biobanks, a broader model of consent is often used and justified by a range of different strategies that make reference to the potential benefits brought by the research it will facilitate combined with the low level of risk involved (provided adequate measures are in place to protect privacy and confidentiality) or a questioning of the centrality of the notion of informed consent. Against this, it has been suggested that the lack of specific information about particular uses of the samples (...) means that such consent cannot be fully autonomous and so is unethical. My answer to the title question is a definite ‘yes’. Broad consent can be informed consent and is justified by appeal to the principle of respect for autonomy. Indeed, I will suggest that the distinction between the various kinds of consent is not a distinction between kinds of consent but between the kinds of choice a person makes. When an individual makes a choice (of any kind) it is important that they do so according to the standards of informed consent and consistent with the choice that they are making. (shrink)

ABSTRACT A major moral problem in relation to the deCODE genetics database project in Iceland is that the heavy emphasis placed on technical security of healthcare information has precluded discussion about the issue of consent for participation in the database. On the other hand, critics who have emphasised the issue of consent have most often demanded that informed consent for participation in research be obtained. While I think that individual consent is of major significance, I argue that this demand for (...) informed consent is neither suitable nor desirable in this case. I distinguish between three aspects of the database and show that different types of consent are appropriate for each. In particular, I describe the idea of a written authorisation based on general information about the database as an alternative to informed consent and presumed consent in database research. (shrink)

In a recent article in theJournal of Medical Ethics,Neil Manson sets out to show that the meta-consent model of informed consent is not the solution to perennial debate on the ethics of biobank participation. In this response, we shall argue that (i) Manson’s considerations on the costs of a meta-consent model are incomplete and therefore misleading; (ii) his view that a model of broad consent passes a threshold of moral acceptability rests on an analogy that misconstrues how biobank research is (...) actually conducted and (iii) a model of meta-consent is more in tune with the nature of biobank research and enables autonomous choice. (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)