Dual-track assessment directs research ethics committees to assess the risks of research interventions based on the unclear distinction between therapeutic and non-therapeutic interventions. The net risks test, in contrast, relies on the clinically familiar method of assessing the risks and benefits of interventions in comparison to the available alternatives and also focuses attention of the RECs on the central challenge of protecting research participants.Research guidelines around the world recognise that clinical research is ethical only when the risks to participants are (...) reasonable.1 Appropriate implementation of this requirement is vital to protecting research participants and allowing research to proceed when it poses acceptable risks. Unfortunately, as the US National Bioethics Advisory Commission notes: “current regulations do not further elaborate how risks and potential benefits are to be assessed, and little additional guidance is available to IRBs.”1The NBAC, as well as numerous commentators, recommend that research ethics committees , ethics review committees and institutional review boards should adopt what may be called dual-track risk assessment.2–5 Yet, dual-track assessment unnecessarily divides research interventions into two different categories before assessing their risks and relies on the unclear distinction between therapeutic and non-therapeutic interventions. As a result, dual-track assessment provides RECs with confusing guidance and has the potential to block valuable research that poses acceptable risks. This paper describes one alternative, the net risks test, and argues that this approach offers a better method for assessing research risks, one that puts RECs in a position to protect participants without blocking appropriate research studies.BACKGROUNDClinical research exposes participants to interventions and procedures to gather systematic data that may be used to improve overall health and well-being. To ensure that research is ethical, RECs must ensure that the risks and burdens to participants are not excessive and that …. (shrink)

A letter to the editor from Howard Brody, David Buchanan, and Franklin G. Miller in response to the recent article by Erik Malmqvist Understanding Exploitation," March-April 2011).

Although informed consent is important in clinical research, questions persist regarding when it is necessary, what it requires, and how it should be obtained. The standard view in research ethics is that the function of informed consent is to respect individual autonomy. However, consent processes are multidimensional and serve other ethical functions as well. These functions deserve particular attention when barriers to consent exist. We argue that consent serves seven ethically important and conceptually distinct functions. The first four functions pertain (...) principally to individual participants: (1) providing transparency; (2) allowing control and authorization; (3) promoting concordance with participants' values; and (4) protecting and promoting welfare interests. Three other functions are systemic or policy focused: (5) promoting trust; (6) satisfying regulatory requirements; and (7) promoting integrity in research. Reframing consent around these functions can guide approaches to consent that are context sensitive and that maximize achievable goals. (shrink)

Advances in life-saving technologies in the past few decades have challenged our traditional understandings of death. Traditionally, death was understood to occur when a person stops breathing, their heart stops beating and they are cold to the touch. Today, physicians determine death by relying on a diagnosis of ‘total brain failure’ or by waiting a short while after circulation stops. Evidence has emerged, however, that the conceptual bases for these approaches to determining death are fundamentally flawed and depart substantially from (...) the established biological conception of death. We argue that the current approach to determining death consists of two different types of unacknowledged legal fictions. These legal fictions were developed for practices that are largely ethically legitimate but need to be reconciled with the law. The considerable debate over the determination of death in the medical and scientific literature has not informed the public that vital organs are being procured from still-living donors and it seems unlikely that this information can remain hidden for long. Given the instability of the status quo and the difficulty of making the substantial legal changes required by complete transparency, we argue for a second-best policy solution: acknowledging the legal fictions involved in determining death to move in the direction of greater transparency. This may someday result in more substantial legal change to directly confront the challenges raised by life-sustaining and life-preserving technologies without the need for fictions. (shrink)

Transplantation of vital organs has been premised ethically and legally on "the dead donor rule" (DDR)—the requirement that donors are determined to be dead before these organs are procured. Nevertheless, scholars have argued cogently that donors of vital organs, including those diagnosed as "brain dead" and those declared dead according to cardiopulmonary criteria, are not in fact dead at the time that vital organs are being procured. In this article, we challenge the normative rationale for the DDR by rejecting the (...) underlying premise that it is necessarily wrong for physicians to cause the death of patients and the claim that abandoning this rule would exploit vulnerable patients. We contend that it is ethical to procure vital organs from living patients sustained on life support prior to treatment withdrawal, provided that there is valid consent for both withdrawing treatment and organ donation. However, the conservatism of medical ethics and practical concerns make it doubtful that the DDR will be abandoned in the near future. This leaves the current practice of organ transplantation based on the "moral fiction" that donors are dead when vital organs are procured. (shrink)

Ethical guidelines for conducting clinical trials have historically been based on a perceived therapeutic obligation to treat and benefit the patient-participants. The origins of this ethical framework can be traced to the Hippocratic oath originally written to guide doctors in caring for their patients, where the overriding moral obligation of doctors is strictly to do what is best for the individual patient, irrespective of other social considerations. In contrast, although medicine focuses on the health of the person, public health is (...) concerned with the health of the entire population, and thus, public health ethics is founded on the societal responsibility to protect and promote the health of the population as a whole. From a public health perspective, research ethics should be guided by giving due consideration to the risks and benefits to society in addition to the individual research participants. On the basis of a duty to protect the population as a whole, a fiduciary obligation to realise the social value of the research and the moral responsibility to distribute the benefits and burdens of research fairly across society, how a public health perspective on research ethics results in fundamental re-assessments of the proper course of action for two salient topical issues in research ethics is shown: stopping trials early for reasons of efficacy and the conduct of research on less expensive yet less effective interventions. (shrink)

Current guidelines on investigators' responsibilities to communicate research results to study participants may differ on whether investigators should proactively re-contact participants, the type of results to be offered, the need for clinical relevance before disclosure, and the stage of research at which results should be offered. Lack of consistency on these issues, however, does not undermine investigators' obligation to offer to disclose research results: an obligation rooted firmly in the principle of respect for research participants.

Data monitoring committees often are employed to review interim findings of randomised controlled trials. Interim findings are kept confidential until the data monitoring committee finds that they provide sufficiently compelling evidence regarding efficacy, typically because they have crossed the pre-defined statistical boundaries, or they raise serious concerns about safety. While this practice is vital to maintaining the scientific integrity of controlled trials and thereby ensuring their social value, it has been criticised as unethical. Commentators argue that withholding interim findings from (...) research participants is deceptive, inconsistent with valid informed consent, and a violation of respect for participants’ autonomy. The present article examines these arguments, focusing specifically on confidential data monitoring for efficacy. This practice need not be deceptive provided its use is disclosed to prospective research participants. In addition, confidential data monitoring does not make research participants worse off than they would be in the clinical setting and represents an acceptable limitation on the options available to prospective research participants. Taken together, these considerations suggest confidential data monitoring, subject to adequate safeguards, is ethically acceptable. (shrink)

Although established in the law and current practice, the determination of death according to neurological criteria continues to be controversial. Some scholars have advocated return to the traditional circulatory and respiratory criteria for determining death because individuals diagnosed as ‘brain dead’ display an extensive range of integrated biological functioning with the aid of mechanical ventilation. Others have attempted to refute this stance by appealing to the analogy between decapitation and brain death. Since a decapitated animal is obviously dead, and ‘brain (...) death’ represents physiological decapitation, brain dead individuals must be dead. In this article we refute this ‘decapitation gambit.’ We argue that decapitated animals are not necessarily dead, and that, moreover, the analogy between decapitation and the clinical syndrome of brain death is flawed. (shrink)

Bernard Williams charges that the moral psychology built into R. M. Hare’s utilitarianism is incoherent in virtue of demanding a bifurcated kind of moral thinking that is possible only for agents who fail to reflect properly on their own practical decision making. I mount a qualified defence of Hare’s view by drawing on the account of the ‘reactive attitudes’ found in P. F. Strawson’s ‘Freedom and Resentment’. Against Williams, I argue that the ‘resilience’ of the reactive attitudes ensures that our (...) taking an instrumental view of our dispositions to experience guilt and compunction, as Hare calls for us to do while engaged in ‘critical’ moral thinking, will not prevent us from experiencing these feelings as people ordinarily do while we are thinking ‘intuitively’. I also consider the implications of my argument for consequentialism more generally and (briefly) Kantianism. (shrink)

Late in 1990, the Center for the Study of Ethics in the Professions at Illinois Institute of Technology (lIT) received a grant of more than $200,000 from the National Science Foundation to try a campus-wide approach to integrating professional ethics into its technical curriculum.! Enough has now been accomplished to draw some tentative conclusions. I am the grant's principal investigator. In this paper, I shall describe what we at lIT did, what we learned, and what others, especially philosophers, can learn (...) from us. We set out to develop an approach that others could profitably adopt. I believe that we succeeded. (shrink)

BackgroundIn the Canadian Alliance for Healthy Hearts and Minds (CAHHM) cohort, participants underwent magnetic resonance imaging (MRI) of the brain, heart, and abdomen, that generated incidental findings (IFs). The approach to managing these unexpected results remain a complex issue. Our objectives were to describe the CAHHM policy for the management of IFs, to understand the impact of disclosing IFs to healthy research participants, and to reflect on the ethical obligations of researchers in future MRI studies.MethodsBetween 2013 and 2019, 8252 participants (...) (mean age 58 ± 9 years, 54% women) were recruited with a follow-up questionnaire administered to 909 participants (40% response rate) at 1-year. The CAHHM policy followed a restricted approach, whereby routine feedback on IFs was not provided. Only IFs of severe structural abnormalities were reported.ResultsSevere structural abnormalities occurred in 8.3% (95% confidence interval 7.7–8.9%) of participants, with the highest proportions found in the brain (4.2%) and abdomen (3.1%). The majority of participants (97%) informed of an IF reported no change in quality of life, with 3% of participants reporting that the knowledge of an IF negatively impacted their quality of life. Furthermore, 50% reported increased stress in learning about an IF, and in 95%, the discovery of an IF did not adversely impact his/her life insurance policy. Most participants (90%) would enrol in the study again and perceived the MRI scan to be beneficial, regardless of whether they were informed of IFs. While the implications of a restricted approach to IF management was perceived to be mostly positive, a degree of diagnostic misconception was present amongst participants, indicating the importance of a more thorough consent process to support participant autonomy.ConclusionThe management of IFs from research MRI scans remain a challenging issue, as participants may experience stress and a reduced quality of life when IFs are disclosed. The restricted approach to IF management in CAHHM demonstrated a fair fulfillment of the overarching ethical principles of respect for autonomy, concern for wellbeing, and justice. The approach outlined in the CAHHM policy may serve as a framework for future research studies.Clinical trial registrationhttps://clinicaltrials.gov/ct2/show/nct02220582. (shrink)

Critics of evolutionary psychology and sociobiology have advanced an adaptationists-as-right-wing-conspirators (ARC) hypothesis, suggesting that adaptationists use their research to support a right-wing political agenda. We report the first quantitative test of the ARC hypothesis based on an online survey of political and scientific attitudes among 168 US psychology Ph.D. students, 31 of whom self-identified as adaptationists and 137 others who identified with another non-adaptationist meta-theory. Results indicate that adaptationists are much less politically conservative than typical US citizens and no more (...) politically conservative than non-adaptationist graduate students. Also, contrary to the “adaptationists-as-pseudo-scientists” stereotype, adaptationists endorse more rigorous, progressive, quantitative scientific methods in the study of human behavior than non-adaptationists. (shrink)

MARXISM AND LIBERALISM edited by Ellen Frankel Paul, Fred D. Miller, Jr., Jeffrey Paul and John Ahrens New York: Basil Blackwell, 1986. 223 pp., $14?95 (paper) LIBERALISM by John Gray Minneapolis: University of Minnesota Press, 1986. 106 pp., $9.95 (paper).

This report describes the rationale, approaches, organization, and resource development leading to a large-scale deletion bin map of the hexaploid wheat genome. Accompanying reports in this issue detail results from chromosome bin-mapping of expressed sequence tags representing genes onto the seven homoeologous chromosome groups and a global analysis of the entire mapped wheat EST data set. Among the resources developed were the first extensive public wheat EST collection. Described are protocols for sequencing, sequence processing, EST nomenclature, and the assembly of (...) ESTs into contigs. These contigs plus singletons were used for selection of distinct sequence motif unigenes. Selected ESTs were rearrayed, validated by 5′ and 3′ sequencing, and amplified for probing a series of wheat aneuploid and deletion stocks. Images and data for all Southern hybridizations were deposited in databases and were used by the coordinators for each of the seven homoeologous chromosome groups to validate the mapping results. Results from this project have established the foundation for future developments in wheat genomics. (shrink)

Miller, D., G. Nadathur, F. Pfenning and A. Scedrov, Uniform proofs as a foundation for logic programming, Annals of Pure and Applied Logic 51 125–157. A proof-theoretic characterization of logical languages that form suitable bases for Prolog-like programming languages is provided. This characterization is based on the principle that the declarative meaning of a logic program, provided by provability in a logical system, should coincide with its operational meaning, provided by interpreting logical connectives as simple and fixed search instructions. (...) The operational semantics is formalized by the identification of a class of cut-free sequent proofs called uniform proofs. A uniform proof is one that can be found by a goal-directed search that respects the interpretation of the logical connectives as search instructions. The concept of a uniform proof is used to define the notion of an abstract logic programming language, and it is shown that first-order and higher-order Horn clauses with classical provability are examples of such a language. Horn clauses are then generalized to hereditary Harrop formulas and it is shown that first-order and higher-order versions of this new class of formulas are also abstract logic programming languages if the inference rules are those of either intuitionistic or minimal logic. The programming language significance of the various generalizations to first-order Horn clauses is briefly discussed. (shrink)

The American Journal of Bioethics, Volume 12, Issue 6, Page 56-58, June 2012.

Let ℜ be an o-minimal expansion of (ℝ, <+) and (φk)k∈ℕ be a sequence of positive real numbers such that limk→+∞f(φk)/φk+1=0 for every f:ℝ→ ℝ definable in ℜ. (Such sequences always exist under some reasonable extra assumptions on ℜ, in particular, if ℜ is exponentially bounded or if the language is countable.) Then (ℜ, (S)) is d-minimal, where S ranges over all subsets of cartesian powers of the range of φ.

In working his way through his complex conception of the relation of fiction and reality, [Henry] James thus found the unconscious moral dimension inextricably embedded within "realism" itself. In following the threads of realism back to consciousness itself, James invariably found there intertwined with its roots those aspects and elements that other theorists kept carefully separate. By exploring experience to its source, he found imagination. By following objective life from "out there" to conception, he found individual vision. By following the (...) seeming oneness of the passing show back to perception, he found infinite variation and multiplicity. By following the uncolored flux and flow of events to their embodiment in the fictional medium, he found coloration of personality. And by following the "felt life" back to the artist's "prime sensibility", James found there the "moral sense" and the "enveloping air of the artist's humanity"—that which gives "the last touch to the worth of a work." James E. Miller, Jr., professor of English at the University of Chicago, is the author of A Critical Guide to Leaves of Grass; Walt Whitman; F. Scott Fitzgerald: His Art and His Technique; J.D. Salinger; Theory of Fiction: Henry James; and numerous articles on American literature and education. He contributed "Catcher In and Out of History" to Critical Inquiry, Spring 1977. (shrink)

In lieu of an abstract, here is a brief excerpt of the content:BOOK REVIEWS 477 (p. 32), although some might consider him to have been an important historian of logic. I am not certain that citing Carnap and Heideggar (p. 75) can do much to clarify Vires. When one reads 'Henrique Estienne' and "Hipotiposes pirronicas" (p. 266) in an Italian book he is a bit taken aback and wonders whether the author has done his homework. The writer missed a golden (...) opportunity to connect Galileo to the tradition, for his still unpublished Quaestiones on logic and the De motu (both written before 1600) have many interesting comments which tie in directly with the material developed in this volume. This could have provided an excellent bridge to the next'century, when the analytic method began to take a more central role in scientific and methodological discussions. There is still room for a number of studies on the evolution of the analytic method during the Renaissance. Unfortunately Crescini's study barely scratches the surface of this immense subject. Let us hope that his book will at least have the effect of encouraging others to treat the matter with more care, in greater depth, and more exhaustively. The volume is provided with a preface by Giorgio Radetti, who claims more for it than it actually provides, as well as noting that it is the first part of a more comprehensive study by the same author on the formation of the analytic method in Cartesian philosophy (p. 5). The book has a useful index, but unfortunately no bibliography. CHARLESB. ScxiMrrr The University of Leeds Le thomisme et la pens#e italienne de la Renaissance. By Paul Oskar Kristeller. Conference Albert-le-Grand 1965. (Montr6ah Institut d'~tudes m~di~vales, and Paris: Vrin, 1967. Pp. 287. $6) Surprisingly little is known about the later history of Thomism. This brief but very rich lecture by Professor Kristeller, renowned historian of Italian Renaissance philosophy, examines one period in the later career of St. Thomas' thought. This study, based chiefly on unpublished source material, shows that Thomas was very much present to both the humanists and to the academic philosophers during the Renaissance. Such leading humanists as Lorenzo Valla, Giovanni Pico della Mirandola, and Marsilio Ficino, quote St. Thomas frequently and with approval. Even the unfavorable attitudes of Ermolao Barbaro or Baptista Mantuanus show that Thomas was already the most celebrated of mediaeval philosophers. The professors of philosophy at Italian universities, such as Pierre Pomponazzi, speak of Thomas with great respect and regard his theology as in conformity with the truths of faith, even when they reject his philosophy as being in disaccord with the authentic teaching of Aristotle. St. Thomas made a continuous contribution to the development of Renaissance theology and philosophy. Yet the principal Italian thinkers did not follow him strictly nor fall under his exclusive influence. Thomas is merely one of the most important sources, not the prevailing influence, in Renaissance thought. Ficino, for example, is,178 HISTORY OF PHILOSOPHY in accord with Thomas on certain important points, but his own theology is more in the spirit of Plato and Augustine. Professor Kristeller's vast learning is at the service of admirably balanced conclusions. Not everyone will agree with all his interpretations; Ficino perhaps did not imagine himself to be "constructing a system of philosophy" (p. 96) since the very title of his work, Theologia platonica, suggests that he continues, with new materials, the labor of mediaeval theolo#ans. And Ficino's doctrine of the continuity of the supernatural life of the soul in this world and the next (p. 120) seems to be completely in accord with Thomas. But the author's very careful scholarly method and sound general conclusions are beyond criticism. Two hitherto unpublished Latin texts are printed in critical edition at the end of the French lecture, the Opus aureum in Thomistas by Baptists Mantuanus, which is anti-Thomas, and the Opusculum ad Laurentium Medicem on beatitude, by Vincentius Bandellus, which is pro-Thomas. Like Professor Kristeller's fine lecture, these new texts are a permanent contribution to scholarship. PAUL J. W. MILLER University of Colorado The Anatomy of Leviathan. By F. S. McNeilly. (New York: St. Martin's Press, 1968. Pp... (shrink)

In this paper we prove three theorems about the theory of Borel sets in models of ZF without any form of the axiom of choice. We prove that if \documentclass[12pt]{minimal} \usepackage{amsmath} \usepackage{wasysym} \usepackage{amsfonts} \usepackage{amssymb} \usepackage{amsbsy} \usepackage{mathrsfs} \usepackage{upgreek} \setlength{\oddsidemargin}{-69pt} \begin{document}$${B\subseteq 2^\omega}$$\end{document} is a Gδσ-set then either B is countable or B contains a perfect subset. Second, we prove that if 2ω is the countable union of countable sets, then there exists an Fσδ set \documentclass[12pt]{minimal} \usepackage{amsmath} \usepackage{wasysym} \usepackage{amsfonts} \usepackage{amssymb} \usepackage{amsbsy} \usepackage{mathrsfs} \usepackage{upgreek} (...) \setlength{\oddsidemargin}{-69pt} \begin{document}$${C\subseteq 2^\omega}$$\end{document} such that C is uncountable but contains no perfect subset. Finally, we construct a model of ZF in which we have an infinite Dedekind finite \documentclass[12pt]{minimal} \usepackage{amsmath} \usepackage{wasysym} \usepackage{amsfonts} \usepackage{amssymb} \usepackage{amsbsy} \usepackage{mathrsfs} \usepackage{upgreek} \setlength{\oddsidemargin}{-69pt} \begin{document}$${D\subseteq 2^\omega}$$\end{document} which is Fσδ. (shrink)

In lieu of an abstract, here is a brief excerpt of the content:BOOK REVIEWS 477 (p. 32), although some might consider him to have been an important historian of logic. I am not certain that citing Carnap and Heideggar (p. 75) can do much to clarify Vires. When one reads 'Henrique Estienne' and "Hipotiposes pirronicas" (p. 266) in an Italian book he is a bit taken aback and wonders whether the author has done his homework. The writer missed a golden (...) opportunity to connect Galileo to the tradition, for his still unpublished Quaestiones on logic and the De motu (both written before 1600) have many interesting comments which tie in directly with the material developed in this volume. This could have provided an excellent bridge to the next'century, when the analytic method began to take a more central role in scientific and methodological discussions. There is still room for a number of studies on the evolution of the analytic method during the Renaissance. Unfortunately Crescini's study barely scratches the surface of this immense subject. Let us hope that his book will at least have the effect of encouraging others to treat the matter with more care, in greater depth, and more exhaustively. The volume is provided with a preface by Giorgio Radetti, who claims more for it than it actually provides, as well as noting that it is the first part of a more comprehensive study by the same author on the formation of the analytic method in Cartesian philosophy (p. 5). The book has a useful index, but unfortunately no bibliography. CHARLESB. ScxiMrrr The University of Leeds Le thomisme et la pens#e italienne de la Renaissance. By Paul Oskar Kristeller. Conference Albert-le-Grand 1965. (Montr6ah Institut d'~tudes m~di~vales, and Paris: Vrin, 1967. Pp. 287. $6) Surprisingly little is known about the later history of Thomism. This brief but very rich lecture by Professor Kristeller, renowned historian of Italian Renaissance philosophy, examines one period in the later career of St. Thomas' thought. This study, based chiefly on unpublished source material, shows that Thomas was very much present to both the humanists and to the academic philosophers during the Renaissance. Such leading humanists as Lorenzo Valla, Giovanni Pico della Mirandola, and Marsilio Ficino, quote St. Thomas frequently and with approval. Even the unfavorable attitudes of Ermolao Barbaro or Baptista Mantuanus show that Thomas was already the most celebrated of mediaeval philosophers. The professors of philosophy at Italian universities, such as Pierre Pomponazzi, speak of Thomas with great respect and regard his theology as in conformity with the truths of faith, even when they reject his philosophy as being in disaccord with the authentic teaching of Aristotle. St. Thomas made a continuous contribution to the development of Renaissance theology and philosophy. Yet the principal Italian thinkers did not follow him strictly nor fall under his exclusive influence. Thomas is merely one of the most important sources, not the prevailing influence, in Renaissance thought. Ficino, for example, is,178 HISTORY OF PHILOSOPHY in accord with Thomas on certain important points, but his own theology is more in the spirit of Plato and Augustine. Professor Kristeller's vast learning is at the service of admirably balanced conclusions. Not everyone will agree with all his interpretations; Ficino perhaps did not imagine himself to be "constructing a system of philosophy" (p. 96) since the very title of his work, Theologia platonica, suggests that he continues, with new materials, the labor of mediaeval theolo#ans. And Ficino's doctrine of the continuity of the supernatural life of the soul in this world and the next (p. 120) seems to be completely in accord with Thomas. But the author's very careful scholarly method and sound general conclusions are beyond criticism. Two hitherto unpublished Latin texts are printed in critical edition at the end of the French lecture, the Opus aureum in Thomistas by Baptists Mantuanus, which is anti-Thomas, and the Opusculum ad Laurentium Medicem on beatitude, by Vincentius Bandellus, which is pro-Thomas. Like Professor Kristeller's fine lecture, these new texts are a permanent contribution to scholarship. PAUL J. W. MILLER University of Colorado The Anatomy of Leviathan. By F. S. McNeilly. (New York: St. Martin's Press, 1968. Pp... (shrink)

The disagreement over whether Aristotle recognized rights in some form unavoidably involves disagreement over what rights are, and the theory of rights itself is still highly contested. There is no consensus concerning how " right'? is to be defined, how rights are to be theoretically grounded, or how rights theory is to be applied in particular circumstances. This is not, however, a good reason to dismiss the issue of whether there are rights in Aristotle: for Aristotle, like modern rights theorists, (...) is concerned about the moral and legal status of the individual within the community, and he expresses this in terms of claims of justice. The issue is worthy of study not only because it can lead to a deeper understanding of Aristotle's conceptions of justice and the common good, but also because it may shed valuable light on the theoretical foundations of human rights, since he offers a theory of political justice which is based on a metaphysical theory of human nature. (shrink)