Safety testing of biological pharmaceuticals is often carried out by contract testing laboratories which perform these tests on behalf of the drug’s developer. These laboratories are confronted with a number of ethical issues related to selling their services, maintaining confidentiality, and the handling of results. This paper outlines these issues, and, by way of illustration, discusses how one such laboratory addresses them.

Despite the (serious) global concerns about the safety and genetic stability of genetically modified organisms, the Malaysian National Biosafety Board (NBB) has recently approved the field testing for genetically modified (GM) male mosquitoes. With this development, bioethical issues, which in some respect could adversely impinge on the social, economic and environmental aspects of the society, have surfaced, and these concerns must be addressed by the authorities concerned. In reviewing this application, the National Biosafety Board has followed the (...) requirements of the Biosafety Act 2007, which was created to strike a balance between promoting biotechnology and at the same time protecting against its potential environmental and human health risks in Malaysia. However, the 2007 Act fails to adequately take into account any bioethical issues in spite of the inclusion of a provision on socio-economic consideration. As part of an ongoing doctoral research project, and by way of an instrumental critique of the 2007 Act, the present paper attempts to address the role and function of the Malaysia biosafety legal framework in governing bioethical concerns relating to Genetically Modified Organisms (GMOs) within the current biotechnology background in Malaysia. Additionally, the paper suggests that the ambiguity of the provisions contained within the 2007 Act in governing such concerns, representing wider societal interests and welfare, in some ways might defeat the balancing role that this act was originally intended to fulfil. (shrink)

Besides having potential medical and biosafety applications, as well as challenging the foundations of biological engineering, xenobiology can also shed light on the epistemological and metaphysical questions that puzzle philosophers of science. This paper reviews this philosophical aspect of xenobiology, focusing on the possible multiple realizability of life. According to this hypothesis, what ultimately matters in understanding life is its function, not its particular building blocks. This is because there should, in theory, be many different ways to build the (...) same function. The possibility of multiple realizability was originally raised in the context of AI’s hypothesized capacity to realize mental functions. Because we still do not have any incontrovertible examples of digital minds, not to mention alien life of foreign biochemistry, the best way to test this philosophical idea is to examine the recent results and practices of synthetic biology and xenobiology. (shrink)

The scope of noninvasive prenatal testing (NIPT) could expand in the future to include detailed analysis of the fetal genome. This will allow for the testing for virtually any trait with a genetic contribution, including “non-medical” traits. Here we discuss the potential use of NIPT for these traits. We outline a scenario which highlights possible inconsistencies with ethical decision-making. We then discuss the case against permitting these uses. The objections include practical problems; increasing inequities; increasing the burden of (...) choice; negative impacts on the child, family, and society; and issues with implementation. We then outline the case for permitting the use of NIPT for these traits. These include arguments for reproductive liberty and autonomy; questioning the labeling of traits as “non-medical”; and the principle of procreative beneficence. This summary of the case for and against can serve as a basis for the development of a consistent and coherent ethical framework. (shrink)

Prenatal genetic testing is becoming available for an increasingly broad set of diseases, and it is only a matter of time before parents can choose to test for hundreds, if not thousands, of genetic conditions in their fetuses. Should access to certain kinds of fetal genetic information be limited, and if so, on what basis? We evaluate a range of considerations including reproductive autonomy, parental rights, disability rights, and the rights and interests of the fetus as a potential future (...) child. We conclude that parents should be able to access information that could be useful during pregnancy, but that testing for non-medical information should be limited. Next, we argue that the government lacks a compelling state interest in regulating prenatal genetic testing and propose that regulation should occur through medical professional organizations. Finally, we present a framework for determining what testing physicians should recommend, offer neutrally, or not offer at all. (shrink)

Canada has recently published a new Clinical Practice Guideline on the diagnosis and management of brain death. It states that consent is not necessary to carry out the interventions required to make the diagnosis. A supporting article not only sets out the arguments for this but also contends that ‘UK laws similarly carve out an exception, excusing clinicians from a prima facie duty to get consent’. This is supplemented by the claim that recent court decisions in the UK similarly confirm (...) that consent is not required, referencing two judgements in _Battersbee_. We disagree with the authors’ interpretation of the law on consent in the UK and argue that there is nothing in _Battersbee_ to support the conclusion that consent to testing is not necessary. Where there is a disagreement about testing for brain death in the UK, court authorisation is required. (shrink)

Starting from the ‘Dewey Lectures’, Rawls presents his conception of justice within a contextualist framework, as an elaboration of the basic ideas embedded in the political culture of liberal-democratic societies. But how are these basic ideas to be justified? In this article, I reconstruct and criticize Rawls’s strategy to answer this question. I explore an alternative strategy, consisting of a genealogical argument of a pragmatic kind – the kind of argument provided by authors like Bernard Williams, Edward Craig and Miranda (...) Fricker. I outline this genealogical argument drawing on Rawls’s reconstruction of the origins of liberalism. Then, I clarify the conditions under which this kind of argument maintains vindicatory power. I claim that the argument satisfies these conditions and that pragmatic genealogy can thus partially vindicate the basic ideas of liberal-democratic societies. (shrink)

Background Noninvasive prenatal testing (NIPT) designed to screen for fetal genetic conditions, is increasingly being implemented as a part of routine prenatal care screening in the United States (US). However, these advances in reproductive genetic technology necessitate empirical research on the ethical and social implications of NIPT among populations underrepresented in genetic research, particularly Black women with sickle cell disease (SCD).Methods Forty (N = 40) semi-structured interviews were conducted virtually with Black women in the US (19 participants with SCD; (...) 21 participants without SCD) from June 2021 to January 2022. We employed a qualitative approach to examine the study participants’ perceptions of the potential advancement of NIPT for screening SCD in the fetus. Data were analyzed using NVivo 12 qualitative software.Results The themes revealed the complexities involving the intersectional lived experiences of SCD, prenatal care, lack of synergy among health providers, and NIPT decision-making. The results further revealed that even when Black women have shared commonalities in their lived experiences while navigating SCD and motherhood, their perceptions of NIPT screening technologies are divergent.Conclusion Expanding the ethical discourse on the social implications of NIPT is critical to fully elucidate how Black women perceive NIPT’s utility, particularly as NIPT advances to screen for SCD in the fetus. Neglecting to include Black women with genetic conditions in empirical studies on NIPT may contribute to ongoing health inequities and limit and constrain reproductive choices among Black women with and without SCD. (shrink)

Volume 20, Issue 6, June 2020, Page 22-24.

Non-invasive prenatal testing is at the forefront of prenatal screening. Current uses for NIPT include fetal sex determination and screening for chromosomal disorders such as trisomy 21. However, NIPT may be expanded to many different future applications. There are a potential host of ethical concerns around the expanding use of NIPT, as examined by the recent Nuffield Council report on the topic. It is important to examine what NIPT might be used for before these possibilities become consumer reality. There (...) is limited research exploring views of women on possible future uses of NIPT, particularly those of women who have undergone NIPT. In this study, we examined the views of women who undertook NIPT previously on the acceptability of and interest levels in using NIPT for a number of current and possible future applications. These included several medical conditions encompassing psychiatric, neurodevelopmental and adult-onset conditions as well as non-medical traits such as intelligence. One thousand women were invited to participate and 235 eligible surveys were received. Women generally reported an interest in using NIPT for medical conditions that severely impacted quality of life and with an onset earlier in life and stressed the importance of the accuracy of the test. Concerns were raised about the use of NIPT for non-medical traits. Respondents indicated that termination of pregnancy was not their only reason for testing, particularly in the case of sex. These results can further inform the ethical debate around the increasing integration of NIPT into healthcare systems. (shrink)

Predictive genetic testing is now routinely offered to asymptomatic adults at risk for genetic disease. However, testing of minors at risk for adult-onset conditions, where no treatment or preventive intervention exists, has evoked greater controversy and inspired a debate spanning two decades. This review aims to provide a detailed longitudinal analysis and concludes by examining the debate's current status and prospects for the future. Fifty-three relevant theoretical papers published between 1990 and December 2010 were identified, and interpretative content (...) analysis was employed to catalogue discrete arguments within these papers. Novel conclusions were drawn from this review. While the debate's first voices were raised in opposition of testing and their arguments have retained currency over many years, arguments in favour of testing, which appeared sporadically at first, have gained momentum more recently. Most arguments on both sides are testable empirical claims, so far untested, rather than abstract ethical or philosophical positions. The dispute, therein, lies not so much in whether minors should be permitted to access predictive genetic testing but whether these empirical claims on the relative benefits or harms of testing should be assessed. (shrink)

Background Over the last decades, the neurosciences, behavioral sciences, and the social sciences have all seen a rapid development of innovative research methods. The field of bioethics, however, has trailed behind in methodological innovation. Despite the so-called “empirical turn” in bioethics, research methodology for project development, data collection and analysis, and dissemination has remained largely restricted to surveys, interviews, and research papers. We have previously argued for a “Design Bioethics” approach to empirical bioethics methodology, which develops purpose-built methods for investigation (...) of bioethical concerns. In this paper we compare a research tool created using a design bioethics approach to a “methods-as-usual” approach in empirical bioethics. Methods Our study compared dimensions of engagement with a digital game we created, called “Tracing Tomorrow,” to a standard vignette survey. The two tools investigated the same subject matter, digital phenotyping for mental health, in a sample of 301 UK adolescents. Results Participants who played the game reported a greater sense of presence, emotional engagement, cognitive absorption, and mental health ethics insight, compared to participants who completed the vignette survey. Perceived authenticity and curiosity/motivation to learn more was equivalent for both methods. Conclusion The results of this study highlights the importance of purpose-built methodology for empirical bioethics research. (shrink)

Sripada has recently advanced a new account for asymmetries that have been uncovered in folk judgments of intentionality: the ?Deep Self model,? according to which an action is more likely to be judged as intentional if it matches the agent's central and stable attitudes and values (i.e., the agent's Deep Self). In this paper, we present new experiments that challenge this model in two ways: first, we show that the Deep Self model makes predictions that are falsified, then we present (...) cases that it cannot account for. Finally, we discuss how the Deep Self model could be modified to accommodate these new data. (shrink)

Adding instructional time and holding teachers accountable for teaching social studies are touted as practical, logical steps toward reforming the age-old tradition of marginalization. This qualitative case study of an urban elementary school, examines how nine teachers and one administrator enacted district reforms that added 45 min to the instructional day and implemented a series of formative and summative assessments. Through classroom observations, interviews, time journals, and official school documents, this article describes underlying perceptions and priorities that were barriers to (...) any positive impact time or testing might have afforded social studies. Two recommendations emerge from results: 1) time structures need to provide space for the teaching of and planning for social studies; and 2) testing can have positive outcomes, but these are limited when assessments structures are hierarchical, misaligned, and poorly communicated. (shrink)

Can we experience emotion without the feeling of accelerated heartbeats, perspiration, or other changes in the body? In his paper “What is an emotion”, William James famously claimed that “if we fancy some strong emotion and then try to abstract from our consciousness of it all the feelings of its bodily symptoms, we find we have nothing left behind” (1884, p. 193). Thus, bodily changes are essential to emotion. This is known as the Subtraction Argument. The Subtraction Argument is still (...) used to support Embodied theories of emotion. Proponents of Disembodied theories, however, have different intuitions regarding the role of bodily changes in the experience of emotion. In order to advance this debate, I conducted a series of studies testing people’s intuitions regarding the Subtraction Argument. Results show that, against James’ claims, most people consider that their hypothetical (Study 1) and actual (Study 2) emotions persist in the absence of bodily feelings. Furthermore, Study 1 found that participants’ responses were not related to individual differences in reflection or interoceptive awareness. These results pose a problem for Embodied theories of emotion and challenge extant explanations for the persistence of emotional experience in cases of impaired interoception. (shrink)

Two main types of philosophical arguments have been given in support of the claim that the citizens of affluent societies have stringent moral duties to aid the global poor: “positive duty” arguments based on the notion of beneficence and “negative duty” arguments based on noninterference. Peter Singer’s positive duty argument (Singer 1972) and Thomas Pogge’s negative duty argument (Pogge 2002) are among the most prominent examples. Philosophers have made speculative claims about the relative effectiveness of these arguments in promoting attitudes (...) and behaviors that could lead to the alleviation of poverty. In this article we present the results of two empirical studies that evaluate these claims, and suggest that both arguments have a modest effect on people’s attitudes and behaviors regarding global poverty. In a replication of the second study, the negative duty argument, in particular, had a statistically significant effect on donations. We discuss the theoretical and practical significance of these results and suggest directions for further research on the role that philosophical arguments can play in engendering concern and action on pressing moral problems. (shrink)

What consciousness exactly is remains an unsettled issue among both philosophers and biologists. Three aspects of consciousness are generally recognized: awareness consciousness (through connection...

Determining whether US companies and some of the persons involved in them are acting ethically when conducting the research described in the Havrix Case and the Surfaxin Trial requires reflection on the moral objections that could be raised against what they did. Given the wide range of possible moral objections, it would be folly to try to display and discuss them all in the space of this essay. I concentrate then on a kind of moral objections that strike me as (...) especially interesting, plausible, and important. I try to work out whether such objections are valid and, if so, what significance they have for the conduct of the pharmaceutical companies in question — and for the conduct of ourselves as citizens of democratic countries under whose jurisdiction these companies operate. (shrink)

The notion of being a burden to others is mostly discussed in the context of care‐intensive diseases or end‐of‐life decisions. But the notion is also crucial in decision‐making at the beginning of life, namely regarding prenatal testing. Ever more sophisticated testing methods, especially non‐invasive prenatal testing (NIPT), allow the detection of genetic traits in the unborn child that may cause disabilities. A positive result often influences the decision of the pregnant women towards a termination of the pregnancy. (...) Thus, critics claim that these testing methods send a negative message to people with disabilities. At the core of this is what we call the burden assumption. This assumption claims that children with disabilities are necessarily a burden to others, especially to their parents and other family members. In this paper, we discuss what being a burden to others means in this context and how such an attitude can be avoided without restraining reproductive autonomy. A closer examination shows that the burden assumption is mostly based on misinformation and a false model of disability. Empirical studies as well as narrative evidence from parents who raise a child with disabilities show that the burden assumption is wrong. Raising a child with disabilities does not necessarily mean a decrease in the quality of life. We show how the burden assumption can be challenged through an advanced genetic counselling that combines empirical evidence with narratives from a first‐person perspective. (shrink)

This article explores the role of sustainable living experiments as devices of public engagement. It engages with object-centred perspectives in the sociology of science and technology, which have characterized public experiments as sites for the domestication of technology, and as effective instruments of public involvement, because, in part, of the seductive force of their use of empirical forms of display. Green living experiments, which are conducted in the intimate setting of the home and reported on blogs, complicate this understanding, insofar (...) as they seek to format socio-material practices as sites of involvement. This has implications for how we conceive of the relations between public involvement and everyday material practices. While the latter are often located outside the public sphere, green living experiments extend the publicity genre of `being intimate in public' to things. It also follows that green living experiments do not so much solve but rather articulate problems of public involvement. (shrink)

Clark Glymour defined bootstrap-confirmation as a three-place relation: “Evidence E bootstrap confirms hypothesis H with respect to theory T.“ By an ingenious choice of examples, David Christensen has shown that Glymour's definition is satisfied in a class of cases in which confirmation seems to be highly counterintuitive. Responding to Christensen's criticism, Glymour revised his 1980 definition of bootstrap confirmation, by introducing an additional condition that rules out Christensen's counterexamples.

This article describes three experiments that would advance our understanding of the import of data already generated by scientific work on free will and related issues. All three can be conducted with existing technology. The first concerns how reliable a predictor of behavior a certain segment of type I and type II RPs is. The second focuses on the timing of conscious experiences in Libet-style studies. The third concerns the effectiveness of conscious implementation intentions. The discussion of first two experiments (...) highlights some important problems with certain inferences made on the basis of existing data in scientific work on free will. The discussion of the third calls attention to powerful evidence that conscious intentions sometimes are among the causes of corresponding actions. This evidence has been largely ignored in the literature on free will. (shrink)

Predictive genetic testing for susceptibility to psychiatric conditions is likely to become part of standard practice. Because the onset of most psychiatric diseases is in late adolescence or early adulthood, testing minors could lead to early identification that may prevent or delay the development of these disorders. However, due to their complex aetiology, psychiatric genetic testing does not provide the immediate medical benefits that current guidelines require for testing minors. While several authors have argued non-medical benefits (...) may play a crucial role in favour of predictive testing for other conditions, little research has explored such a role in psychiatric disorders. This paper outlines the potential non-medical benefits and harms of psychiatric genetic testing in minors in order to consider whether the non-medical benefits could ever make such testing appropriate. Five non-medical themes arise in the literature: psychological impacts, autonomy/self-determination, implications of the biomedical approach, use of financial and intellectual resources, and discrimination. Non-medical benefits were prominent in all of them, suggesting that psychiatric genetic testing in minors may be appropriate in some circumstances. Further research needs to empirically assess these potential non-medical benefits, incorporate minors in the debate, and include normative reflection to evaluate the very purposes and motivations of psychiatric genetic testing in minors. (shrink)

Two first-order logic theories are definitionally equivalent if and only if there is a bijection between their model classes that preserves isomorphisms and ultraproducts (Theorem 2). This is a variant of a prior theorem of van Benthem and Pearce. In Example 2, uncountably many pairs of definitionally inequivalent theories are given such that their model categories are concretely isomorphic via bijections that preserve ultraproducts in the model categories up to isomorphism. Based on these results, we settle several conjectures of Barrett, (...) Glymour and Halvorson. (shrink)

Beauchamp and Childress’ definition of autonomous decision‐making includes the conditions of intentionality, understanding, and non‐control. In genetics, however, a relational conception of autonomy has been increasingly recognized. This article aims to empirically assess aspects of social influence in genetic testing decision‐making and to connect these with principlist and relational theories of autonomy. We interviewed 18 adult genetic counsellees without capacity issues considering predictive genetic testing for cancer predisposition for themselves and two counselling physicians in Switzerland. We conducted a (...) qualitative analysis, building on a grounded theory study about predictive genetic testing decision‐making. We found that some participants agreed to predictive genetic testing predominantly because relatives wanted them to do it, with some even acting contrary to their own convictions. Others, in contrast, based their decision on purely individualistic reasons but expressed difficulties in explaining their decision to their social environment. Healthcare professionals had a critical influence on decision‐making in many cases without being manipulative, as perceived by counsellees. Still, cases of coercion and social pressure occurred within social relationships. In conclusion, predictive genetic testing decision‐making includes relational and individualistic aspects, and both are compatible with autonomous decision‐making. While the principlist and relational notions of autonomy compete on a theoretical level, they are two sides of the same coin when used as analytical lenses for genetic testing decision‐making. Social acceptance of refusal of testing should be improved to mitigate social pressure. Individuals should be encouraged to decide for themselves how much their social environment influences their decision regarding predictive genetic testing. (shrink)

Aiming at the vulnerability of wireless network, this paper proposed a method of WiFi penetration testing based on Kali Linux which is divided into four stages: preparation, information collection, simulation attack, and reporting. By using the methods of monitoring, scanning, capturing, data analysis, password cracking, fake wireless access point spoofing, and other methods, the WiFi network penetration testing with Kali Linux is processed in the simulation environment. The experimental results show that the method of WiFi network penetration (...) class='Hi'>testing with Kali Linux has a good effect on improving the security evaluation of WiFi network. (shrink)

Recently, there have been a number of lawsuits in the United States in which families objected to performance of apnoea testing for determination of brain death. The courts reached conflicting determinations in these cases. We discuss the medicolegal complications associated with apnoea testing that are highlighted by these cases and our position that the decision to perform apnoea testing should be made by clinicians, not families, judges, or juries.

Although self‐testing apps, a form of mobile health (mHealth) apps, are often marketed as empowering, it is not obvious how exactly they can empower their users—and in which sense of the word. In this article, I discuss two conceptualisations of empowerment as polar opposites—one in health promotion/mHealth and one in feminist theory—and demonstrate how both their applications to individually used self‐testing apps run into problems. The first, prevalent in health promotion and mHealth, focuses on internal states and understands (...) empowerment as an individual process. However, this version of empowerment has been accused of paternalism and responsibilisation. The second, feminist version considers structural conditions and foregrounds collective, political change, whose realisation is not obviously attainable for an individually used app. By pointing out the flaws of the positions that focus on either internal states or external conditions, and by engaging with theory from critical phenomenology, I argue that the interplay between them is where empowerment can take place. I propose to formulate empowerment in phenomenological terms as a shift in being‐in‐the‐world and discuss how this conceptualisation of empowerment would avoid the criticism of previous empowerment narratives while being realisable by self‐testing apps. (shrink)

The ability to determine genetic predisposition to cancer represents an opportunity to expand cancer control efforts in a manner that was previously unimaginable. This possibility also forces individual patients, families, health care professionals, and society to confront difficult questions about genetic knowledge. Although genetic testing or screening for cancer risk may hold promise of cancer control benefits, this prospect also raises significant ethical and legal concerns that must inform and shape policy decisions. In “Cancer Genetic Susceptibility Testing,” Benjamin (...) Wilfond and the Cancer Genetic Screening Consortium present a status report and an ambitious agenda for future examination of ethical and policy issues in this embryonic field. The paper provides a provocative and timely discussion of some extremely vexing issues, but it also misses on several critical points. (shrink)

By some estimates one-third of American corporations now require their employees to be tested for drug use. These requirements are compatible with general employment law while promoting the public's interest in fighting drug use. Moreover, the United States Supreme Court has ruled that drug testing programs are constitutionally permissible within both the public and the private sectors. It appears mandatory drug testing is a permanent fixture of American corporate life. (Bakaly, C. G., Grossman, J. M. 1989).

By some estimates one-third of American corporations now require their employees to be tested for drug u se. The se requ iremen ts are com patible with general employment law while prom oting the public's in terest in figh ting drug use. Mo reover , the Unite d State s Supreme Court has ruled that drug tes ting prog rams a re cons titutionally p ermiss ible within both the public and the private sectors. It appears m andatory drug tes (...) ting is a permanent fixture of American corporate life. (Bakaly, C. G., Grossman, J. M. 1989) The legal roots of m anda tory drug testing are found in the com mon la w doctrin e of "employment at will." That doctrine states that either party to an employment contract can termina te the contract for any reason, at any time, unless the contract specifies otherwise. As the Court h eld in Adair v. United States (208 U.S. 161, 175-6, 1908), the employer "was at liberty, in his d iscretion , to discha rge [the e mploy ee] from service w ithout givin g any reason for so do ing." In unqualified form, this doctrine would give employers effective control over employees. Employers could establish any requirements they wished for prospective and current employees. Not only could they decline to hire employees who will refuse drug tests, they could likewise decline to hire people with characteristics, beliefs, or behavior they dislike. Employees must endure these requirements or seek emplo yment elsewhere. However, since m ost peo ple hav e limited job opp ortunities , they will be forced to "a ccept" these require ments , no ma tter how objection able. Courts and legislatures have since recognized the abuses this 283 284 Drugs, Morality, and the Law.. (shrink)

This article calls into question the charge that frequentist testing is susceptible to the base-rate fallacy. It is argued that the apparent similarity between examples like the Harvard Medical School test and frequentist testing is highly misleading. A closer scrutiny reveals that such examples have none of the basic features of a proper frequentist test, such as legitimate data, hypotheses, test statistics, and sampling distributions. Indeed, the relevant error probabilities are replaced with the false positive/negative rates that constitute (...) deductive calculations based on known probabilities among events. As a result, the ampliative dimension of frequentist induction—learning from data about the underlying data-generating mechanism—is missing. *Received August 2009; revised January 2010. †To contact the author, please write to: Department of Economics, Virginia Tech, Blacksburg, VA 24061; e-mail: [email protected]. (shrink)

This paper aims to critique the phenomenon of advanced patient autonomy and choice in healthcare within the specific context of self-testing devices. A growing number of self-testing medical devices are currently available for home use. The premise underpinning many of these devices is that they assist individuals to be more autonomous in the assessment and management of their health. Increased patient autonomy is assumed to be a good thing. We take issue with this assumption and argue that self- (...) class='Hi'>testing provides a specific example how increased patient autonomy and choice within healthcare might not best serve the patient population. We propose that current interpretations of autonomy in healthcare are based on negative accounts of liberty to the detriment of a more relational understanding. We also propose that Kantian philosophy is often applied to the healthcare arena in an inappropriate manner. We draw on the philosophical literature and examples from the self-testing process to support these claims. We conclude by offering an alternative account of autonomy based on the interrelated concepts of relationality, care and responsibility. (shrink)

Chow's endorsement of a limited role for null hypothesis significance testing is a needed corrective of research malpractice, but his decision to place this procedure in a hypothetico-deductive framework of Popperian cast is unwise. Various failures of this version of the hypothetico-deductive method have negative implications for Chow's treatment of significance testing, meta-analysis, and theory evaluation.

Checklists have been used to improve quality in many industries, including healthcare. The use of checklists, however, has not been extensively evaluated in clinical ethics consultation. This article seeks to fill this gap by exploring the efficacy of using a checklist in ethics consultation, as tested by an empirical investigation of the use of the checklist at a large academic medical system (Cleveland Clinic). The specific aims of this project are as follows: (1) to improve the quality of ethics consultations (...) by providing reminders to ethics consultants about process steps that are important for most patient-centered ethics consultations, (2) to create consistency in the ethics consultation process across the medical system, and (3) to establish an effective educational tool for trainers and trainees in clinical ethics consultation. The checklist was developed after a thorough literature review and an iterative process of revising and testing by a group of experienced ethics consultants. To pilot test the checklist, it was distributed to 46 ethics consultants. After a six-month pilot period in which ethics professionals used the checklist during their clinical activities, a survey was distributed to all of those who used the checklist. The 10-item survey examined consultants’ perceptions regarding the three aims listed above. Of the 25 survey respondents, 11 self-reported as experts in ethics consultation, nine perceived themselves to have mid-level expertise, and five self-reported as novices. The majority (68 percent) of all respondents, regardless of expertise, believed that the checklist could be a “helpful” or “very helpful” tool in the consultation process generally. Novices were more likely than experts to believe that the checklist would be useful in conducting consultations. The limitations of this study include: reduced generalizability given that this project was conducted at one medical system, utilized a small sample size, and used self-reported quality outcome measures. Despite these limitations, to the authors’ knowledge this is the first investigatation of the use of a checklist systematically to improve quality in ethics consultation. Importantly, our findings shed light on ways this checklist can be used to improve ethics consultation, including its use as an educational tool. The authors hope to test the checklist with consultants in other healthcare systems to explore its usefulness in different healthcare environments. (shrink)

Ontology, since Aristotle, has been conceived as a sort of highly general physics, a science of the types of entities in reality, of the objects, properties, categories and relations which make up the world. At the same time ontology has been for some two thousand years a speculative enterprise. It has rested methodologically on introspection and on the construction and analysis of elaborate world-models and of abstract formal-ontological theories. In the work of Quine and others this ontological theorizing in abstract (...) fashion about the world was supplemented by the study, based on the use of logical methods, of the ontological commitments or presuppositions embodied in scientific theories. In recent years both types of ontological study have found application in the world of information systems, for example in the construction of frameworks for knowledge representation and in database design and translation. As ontology is in this way drawn closer to the domain of real-world applications, the question arises as to whether it is possible to use empirical methods in studying ontological theories. More specifically: can we use empirical methods to test the ontological theories embodied in human cognition? We set forth the outlines of a framework for the formulation and testing of such theories as they relate to the specific domain of geographic objects and categories. (shrink)