The phrase “minimal risk,” as defined in the United States’ federal research regulations, is ambiguous and poorly defined. This article argues that most of the ambiguity that one finds in the phrase stems from the “daily life risks” standard in the definition of minimal risk. In this article, the author argues that the daily life risks standard should be dropped and that “minimal risk” should be defined as simply “the probability and magnitude of the harm or discomfort anticipated in research (...) are not greater than those encountered during the performance of routine physical or psychological examinations or tests”. (shrink)

This essay reviews six different approaches to intellectual property. It and argues that none of these accounts provide an adequate justification of intellectual property laws and policies because (1) there are many different types of intellectual property, and (2) a variety of incommensurable values play a role in the justification of intellectual property. The best approach to intellectual property is to assess and balance competing moral values in light of the particular facts and circumstances.

Most of the discussion in bioethics and health policy concerning social responsibility for health has focused on society’s obligation to provide access to healthcare. While ensuring access to healthcare is an important social responsibility, societies can promote health in many other ways, such as through sanitation, pollution control, food and drug safety, health education, disease surveillance, urban planning and occupational health. Greater attention should be paid to strategies for health promotion other than access to healthcare, such as environmental and public (...) health and health research.Lifestyle plays a major role in most of the illnesses in industrialised nations.1 Six of the 10 leading factors contributing to the global burden of disease are lifestyle related: unsafe sex, high blood pressure, tobacco use, alcohol use, high cholesterol and obesity.2 Lifestyle-related illnesses also contribute to the rising costs of healthcare. Spending on healthcare accounts for about 16% of the gross domestic product in the USA, or US$1.9 trillion.3 Although smoking has declined steadily there since the 1960s, smoking-related medical expenses are still about US$75.5 billion per year.4 Obesity, which has been climbing in the past two decades, accounts for about US$75 billion in healthcare costs there each year.5 Alcoholism and drug addiction in the USA account for annual healthcare costs of about US$22.5 billion and US$12 billion, respectively.6,7 Federal government spending on healthcare relating to HIV/AIDS is over US$13 billion per year.8Given the well-documented relationship between lifestyle, disease burden and healthcare costs, it makes economic and medical sense to hold individuals morally responsible for their health-related choices. While this view has a great deal of intuitive appeal, it also faces numerous objections.9–12 First, holding individuals entirely responsible for their own health conflicts with medicine’s obligation to treat the sick and society’s obligation …. (shrink)

This essay develops a framework for thinking about the moral basis for the commodification of human reproductive materials. It argues that selling and buying gametes and genes is morally acceptable although there should not be a market for zygotes, embryos, or genomes. Also a market in gametes and genes should be regulated in order to address concerns about the adverse social consequences of commodification.

Inappropriate authorship is a common problem in biomedical research and may be becoming one in bioethics, due to the increase in multiple authorship. This paper investigates the authorship policies of bioethics journals to determine whether they provide adequate guidance for researchers who submit articles for publication, which can help deter inappropriate authorship. It was found that 63.3% of bioethics journals provide no guidance on authorship; 36.7% provide guidance on which contributions merit authorship, 23.3% provide guidance on which contributions do not (...) merit authorship, 23.3% require authors to take responsibility for their contributions or for the article as a whole, 20% provide guidance on which contributions merit an acknowledgement but not authorship, 6.7% require authors to describe their contributions, and only 3.3% distinguish between authorship in empirical and conceptual research. To provide authors with effective guidance and promote integrity in bioethics research, bioethics journals should adopt authorship policies that address several important topics, such as the qualifications for authorship, describing authorship contributions, taking responsibility for the research and the difference between authorship in empirical and conceptual research. (shrink)

Informed consent is one of the foundational ethical and legal requirements of research with human subjects. The Nuremberg Code, the Helsinki Declaration, the Belmont Report, the Common Rule and many other laws and codes require that research subjects make a voluntary, informed choice to participate in research.12345 Informed consent is based on the moral principle of respect for autonomy, which holds that rational individuals have a right to make decisions and take actions that reflect their values and preferences. 6 Whereas (...) most guidelines and codes also require that informed consent be properly documented, informed consent is much more than signing a piece of paper: It is a continuous process of communication between the investigator and the research subject. 7 Because the body of knowledge impacting a study frequently changes, subjects should receive information from investigators after they have enrolled in a study, such as significant new findings that may affect their decision to participate in research or clinically useful tests results. 8910 In large studies, some investigators use newsletters to update subjects on the progress of research and other developments.11Most of the ongoing communications between investigators and subjects involve little more than information sharing, without revisiting the decision to participate in research or signing any additional documents. Sometimes, however, it may be necessary for subjects to reaffirm their decision to participate, to re-consent, or to sign or re-sign a document. 8 Re-consent can be defined as an action in which a subject makes the decision to participate in research once again. Re-consent is different from reaffirming a commitment to participate in a study, because in re-consent one actually reconsiders the information necessary to make decision, whereas in reaffirmation one simply expresses …. (shrink)

In this short paper, we respond to critics of our original paper, The agony of agonal respiration: is the last gasp necessary?. A common thread in both Hawryluck’s and Kuhse’s responses is the difficulties encountered when using the agent’s intentions to make moral distinctions between using neuromuscular blocking drugs to palliate versus using neuromuscular blocking drugs to kill. Although this difficulty does exist we maintain that the intentions of the physician must matter when providing end-of-life care.

Various U.S. laws, such as the Clean Air Act and the Food Quality Protection Act, require additional protections for susceptible subpopulations who face greater environmental health risks. The main ethical rationale for providing these protections is to ensure that environmental health risks are distributed fairly. In this article, we (1) consider how several influential theories of justice deal with issues related to the distribution of environmental health risks; (2) show that these theories often fail to provide specific guidance concerning policy (...) choices; and (3) argue that an approach to public decision making known as accountability for reasonableness can complement theories of justice in establishing acceptable environmental health risks for the general population and susceptible subpopulations. Since accountability for reasonableness focuses on the fairness of the decision-making process, not the outcome, it does not guarantee that susceptible subpopulations will receive a maximum level of protection, regardless of costs or other morally relevant considerations. (shrink)

This paper addresses the appropriate role for public input into priority setting for federal funding of biomedical research and development. The public should be involved in priority setting because researchers should be publicly accountable, because the public has a right to oversee government activities, and because public input is needed to assess normative questions related to the burden of disease and health care needs. On the other hand, political factors arising from public input can also hamper the governmentÕs ability to (...) allocate funds according to the burden of disease or to promote the progress of biomedical science. When it comes to public input into R & D priority setting, more is not necessarily better. What is needed is the right balance of public and expert decision making with respect to the setting of biomedical R & D priorities. (shrink)

This essay analyzes the concept of public trust in science and offers some guidance for ethicists, scientists, and policymakers who use this idea defend ethical rules or policies pertaining to the conduct of research. While the notion that public trusts science makes sense in the abstract, it may not be sufficiently focused to support the various rules and policies that authors have tried to derive from it, because the public is not a uniform body with a common set of interests. (...) Well-focused arguments that use public trust to support rules or policies for the conduct of research should specify (a) which public is being referred to (e.g. the general public or a specific public, such as a particular community or group); (b) what this public expects from scientists; (c) how the rule or policy will ensure that these expectations are met; and (d) why is it important to meet these expectations. (shrink)

Those objecting to human DNA patenting frequently do so on the grounds that the practice violates or threatens human dignity. For example, from 1993 to 1994, more than thirty organizations representing indigenous peoples approved formal declarations objecting to the National Institutes of Health's bid to patent viral DNA taken from subjects in Papua New Guinea and the Solomon Islands. Although these were not patents on human DNA, the organizations argued that the patents could harm and exploit indigenous peoples and violate (...) their cultural values. NIH eventually dropped one of its patent applications.On May 18, 1995, 180 religious leaders, led by biotechnology critic Jeremy Rifkin, held a press conference objecting to DNA patenting in Washington, D.C. In their “Joint Appeal against Human and Animal Patenting,” these leaders decried any attempt to patent nature. Some of the more outspoken members of the Joint Appeal likened DNA patenting to slavery, while others objected to treating human beings as marketable commodities. In his recent book, The Biotech Century, Rifkin rehashed the objections to DNA patenting voiced by members of the Joint Appeal. (shrink)

: In the last two decades, scientists, government officials, and science policy experts have expressed concerns about the increasing role of financial interests in research. Many believe that these interests are undermining research by causing bias and error, suppression of results, and even outright fraud. This paper seeks to shed some light on this view by (1) explicating the concept research bias, (2) describing some ways that financial interests can cause research biases, and (3) discussing some strategies for mitigating or (...) managing the influence of financial interests. These strategies include (a) using government funds to counter-balance privately funded research, (b) increasing public input into government funding decisions, (c) disclosing and managing conflicts of interest in research, (d) auditing data, (e) expanding access to data. Since it is neither possible nor desirable to eliminate financial interests from research, the wisest policy is to manage and counter-balance these interests for the good of science and society. (shrink)

The Common Rule is a set of regulations for protecting human participants in research funded by the Department of Health and Human Services, which has been adopted in part by 17 federal agencies. It includes four different subparts: Subpart A, Subpart B, Subpart C, and Subpart D. The Common Rule has not been significantly revised since 1981 although some significant changes may be forthcoming. The Food and Drug Administration has adopted its own regulations for the protection of human participants, which (...) are similar to the Common Rule in many key areas, such as the structure and function of the Institutional Review Board, and the criteria for approving research. (shrink)

Biotechnology and the Human Good by C. Ben Mitchell, Edmund D. Pellegrino, Jean Bethke Elshstain, and Scott B. Rae is a thoughtful, carefully argued perspective on the ethics of new developments in biotechnology, such as human enhancement, human germ-line engineering, cloning, nanotechnology, and cybernetics.

Modern science is big business. Governments, universities, and corporations have invested billions of dollars in scientific and technological research in the hope of obtaining power and profit. In The Price of Truth, David B. Resnik examines some of the important and difficult questions resulting from the financial and economic aspects of modern science.

Ethics in scientific research has never been more important. Recent controversies over the integrity of data in federally funded science, the manipulation and distortion of privately sponsored research, cloning, stem cell research, and the patenting of DNA and cell lines, illustrate the need for a more thorough education in ethics for researchers at all levels. Now in its second edition, Responsible Conduct of Research provides an introduction to many of the social, ethical, and legal issues facing scientists today. The fully (...) updated volume includes three brand new chapters and additional cases for discussion, as well as analysis of the latest issues and problems in research ethics. Featuring chapters that treat such topics as ethical decision-making, research misconduct, and intellectual property, this new edition will be an indispensable resource for students and teachers, academics and industry professionals alike. (shrink)

Psychopaths routinely disregard social norms by engaging in selfish, antisocial, often violent behavior. Commonly characterized as mentally disordered, recent evidence suggests that psychopaths are executing a well-functioning, if unscrupulous strategy that historically increased reproductive success at the expense of others. Natural selection ought to have favored strategies that spared close kin from harm, however, because actions affecting the fitness of genetic relatives contribute to an individual’s inclusive fitness. Conversely, there is evidence that mental disorders can disrupt psychological mechanisms designed to (...) protect relatives. Thus, mental disorder and adaptation accounts of psychopathy generate opposing hypotheses: psychopathy should be associated with an increase in the victimization of kin in the former account but not in the latter. Contrary to the mental disorder hypothesis, we show here in a sample of 289 violent offenders that variation in psychopathy predicts a decrease in the genetic relatedness of victims to offenders; that is, psychopathy predicts an increased likelihood of harming non-relatives. Because nepotistic inhibition in violence may be caused by dispersal or kin discrimination, we examined the effects of psychopathy on (1) the dispersal of offenders and their kin and (2) sexual assault frequency (as a window on kin discrimination). Although psychopathy was negatively associated with coresidence with kin and positively associated with the commission of sexual assault, it remained negatively associated with the genetic relatedness of victims to offenders after removing cases of offenders who had coresided with kin and cases of sexual assault from the analyses. These results stand in contrast to models positing psychopathy as a pathology, and provide support for the hypothesis that psychopathy reflects an evolutionary strategy largely favoring the exploitation of non-relatives. (shrink)

Susan Schneider (2019) has proposed two new tests for consciousness in AI (artificial intelligence) systems, the AI Consciousness Test and the Chip Test. On their face, the two tests seem to have the virtue of proving satisfactory to a wide range of consciousness theorists holding divergent theoretical positions, rather than narrowly relying on the truth of any particular theory of consciousness. Unfortunately, both tests are undermined in having an ‘audience problem’: Those theorists with the kind of architectural worries that motivate (...) the need for such tests should, on similar grounds, doubt that the tests establish the existence of genuine consciousness in the AI in question. Nonetheless, the proposed tests constitute progress, as they could find use by some theorists holding fitting views about consciousness and perhaps in conjunction with other tests for AI consciousness. (shrink)

In Gorgias, Socrates stands accused of argumentative "foul play" involving manipulation by shame. Polus says that Socrates wins the fight with Gorgias by shaming him into the admission that "a rhetorician knows what is right . . . and would teach this to his pupils" . And later, when Polus himself has been "tied up" and "muzzled" , Callicles says that he was refuted only because he was ashamed to reveal his true convictions. These allegations, if justified, directly undermine Socrates' (...) claim to be improving his interlocutors by argument. For if Socrates' use of shame tends to produce insincere assertion, then elenchus cannot serve as a tool for moral reform. In an important recent paper, Jessica Moss presents a new apologia for Socrates on these old charges. According to Moss, although Socrates adopts a strategy of shaming rather than reasoning his interlocutors into agreement, this is legitimate because his appeals to shame function as appeals to a moral sense, which connect a person to his own "deep" convictions. Moreover, she claims that shame "can be a more effective tool of persuasion than reason," for it is capable, where reason is not, of dislodging a person's "intuitive" moral beliefs. This essay argues that each of these points is mistaken. (shrink)

The concept of hysteria is traced from Hippocrates, where it was thought to be caused by a wandering uterus, through Galen and up to Freud. Throughout the history of medicine from the early Greeks up to the end of the nineteenth century, the definition and diagnosis of hysteria had a function similar to that found in the persecution of witchcraft: it sought to eradicate the outbursts of nonconforming and emotionally threatening conduct of women. At the beginning of the twentieth century, (...) however, the category virtually disappears from psychiatric nosologies. (shrink)

Purpose. The aim of the article is to clarify the content of the concept of culture as an explication of vitality within the philosophy of life and its further modifications in current problems of contemporary. The analysis performed standing from the point, that contrasting of nature and culture is irrelevant, since culture does not contradict natural determinants and patterns, but rather qualitatively alters them. So, are justified the idea of culture as a phenomenon that exist accordingly and in proportion to (...) nature, need to form its potential and content and not contradict the axioms and values of life. Theoretical basis. In the theoretical field of philosophy of life, the local development of the problem of culture as an explication of vitality produces grounds for analytical and prognostic activity concerning meaningful transformations in a separate historical and social horizon. The fundamental categories of culture: spirit, value, symbol, freedom, justice and harmony receive the requested content and meaning. The idea of the constancy and super-naturality of cultural universals is illusory and dangerous. The consequences of such a "non-cosmological" justification of freedom and will, and the assertion of values, that contradict the logic of life, are the global environmental, economic and social crisis of our time. Originality. The originality of the authors’ thought lies in the interpretation of the essence of culture as an explication of vitality, as a logical and natural extension of life. In this formulation of the problem of culture, the possibility of reconciling the natural, social and value determinants of human life is formed. Theorists of the philosophy of life substantiated the primacy and supremacy of the values of life over the values and meanings of culture. The position of authors position consists in the need to understand culture as an environmentally appropriate and dimensional phenomenon, the content and strategies of which are determined by a single ontology. Conclusions. The analysis let authors understand the voluntarily chaotic element of life. Culture in its philosophical analysis took on a clearer anthropomorphic dimension: the immanent logic of being in substantiating the essence and purpose of man and the value of his being localized the universe of transcendence in the concept of "living world", "inhabited space", "human, too human". Accordingly, the range of cultural evaluations has been polarized: from the approving statement of its vital essence, to the disparaging calls for its reform. The chaotic state of voluntarily acts is transformed into cultural codes and stereotypes by rationalization. The modern global nature of crisis phenomena, both in the worldview, in the social, and in the ecological dimension, requires reformatting the understanding of culture as a continuation of nature, and not its antipode. (shrink)