One of the dominant themes of the symposium from which this collection of articles arose was the ontological status of consent. Is consent a particular state of mind? Is it the signification of that state of mind via a conventionally recognized act? Or, is consent a normative concept that evaluates not only the presence of a state of mind or act, but also the appropriateness of that state of mind or act in the particular circumstances?

A review of U. Mäki (ed.). Fact and Fiction in Economics, Cambridge: Cambridge University Press, 2003. pp. xvi 384. ISBN 0521 00957. As people interested mainly in theory, methodologists and philos...

There is an ongoing debate about the “ontology” of consent. Some argue that it is a mental act, some that it is a “hybrid” of a mental act plus behaviour that signifies that act; others argue that consent is a performative, akin to promising or commanding. Here it is argued that all these views are mistaken—though some more so than others. We begin with the question whether a normatively efficacious act of consent can be completed in (...) the mind alone. Standard objections to this “mentalist” account of consent can be rebutted. Here we identify a much deeper problem for mentalism. Normatively transformative acts of consent change others’ reasons for acting in a distinctive—“robust”—way. Robust reason-changing involves acts aimed at fulfilling a distinctive kind of reflexive and recognition-directed intention. Such acts cannot be coherently performed in the mind alone. Consent is not a mental act, but nor is it the signification of such an act. Acts of consent cannot be “completed” in the mind, and it is a mistake to view consent behaviour as making known a completed act of consent. The robust reason-changing account of consent developed here shares something with the performative theory, but is not saddled with a label whose home is philosophy of language. Certain kinds of performative utterance may change reasons robustly, but not all robust reason-changing involves or requires acts of speech, and consent can be effected by a wide range of behavioural acts. (shrink)

In addition to protecting agents’ autonomy, consent plays a crucial social role: it enables agents to secure partners in valuable interactions that would be prohibitively morally risk otherwise. To do this, consent must be observable: agents must be able to track the facts about whether they have received a consent-based permission. I argue that this morally justifies a consent-practice on which communicating that one consents is sufficient for consent, but also generates robust constraints on what (...) sorts of behaviors can be taken as consent- communicating. (shrink)

The aim of a theoretically ideal process of informed consent is to promote the autonomy of the patient and to limit unethical physician paternalism. However, in practice, the nature of the medical profession requires physicians to act as ontological decision architects—based on the medical knowledge that they acquire through their experience and training, physicians ontologically determine a subset of viable courses of action for their patient. What is observed is not an unethical physician limitation or biasing of the patient (...) towards certain treatment options that violates patient autonomy or consciously undermines informed consent, but rather a more foundational paternalism that is necessarily inherent to the physician–patient relationship. In this article we argue for a recognition of this underlying physician paternalism and posit that this necessary paternalism is not a foil to patient autonomy, but rather a foundational aspect of the duties of the medical professional within the physician–patient relationship. (shrink)

The aim of a theoretically ideal process of informed consent is to promote the autonomy of the patient and to limit unethical physician paternalism. However, in practice, the nature of the medical profession requires physicians to act as ontological decision architects—based on the medical knowledge that they acquire through their experience and training, physicians ontologically determine a subset of viable courses of action for their patient. What is observed is not an unethical physician limitation or biasing of the patient (...) towards certain treatment options that violates patient autonomy or consciously undermines informed consent, but rather a more foundational paternalism that is necessarily inherent to the physician–patient relationship. In this article we argue for a recognition of this underlying physician paternalism and posit that this necessary paternalism is not a foil to patient autonomy, but rather a foundational aspect of the duties of the medical professional within the physician–patient relationship. (shrink)

In this paper I take another look at the view, defended by C. Nino, that we may punish criminals because, by knowingly breaking a law, they have consented to becoming liable to the prescribed punishment. I will first rebut the criticisms usually aimed at this view in the literature, aiming to show that they are inconclusive. They are all efforts to show that criminal offenders in fact do not consent to becoming liable to punishment simply by committing crimes. I (...) then turn to a different line of criticism, which I find more promising. I argue that the moral power of effecting normative changes by consenting reflects the power holder’s value as a person, and show how this idea makes sense of how refusal to recognize that power wrongs a person. I then argue that the “power” of consenting to punishability does not fit that model, and is better explained as reflecting the value of other people, whom the offender has wronged. Hence the power of consenting is not involved in typical cases of wrongdoing. (shrink)

The purpose of this study was to evaluate, revise, and extend the Informed Consent Ontology (ICO) for expressing clinical permissions, including reuse of residual clinical biospecimens and health data. This study followed a formative evaluation design and used a bottom-up modeling approach. Data were collected from the literature on US federal regulations and a study of clinical consent forms. Eleven federal regulations and fifteen permission-sentences from clinical consent forms were iteratively modeled to identify entities and their (...) relationships, followed by community reflection and negotiation based on a series of predetermined evaluation questions. ICO included fifty-two classes and twelve object properties necessary when modeling, demonstrating appropriateness of extending ICO for the clinical domain. Twenty-six additional classes were imported into ICO from other ontologies, and twelve new classes were recommended for development. This work addresses a critical gap in formally representing permissions clinical permissions, including reuse of residual clinical biospecimens and health data. It makes missing content available to the OBO Foundry, enabling use alongside other widely-adopted biomedical ontologies. ICO serves as a machine-interpretable and interoperable tool for responsible reuse of residual clinical biospecimens and health data at scale. (shrink)

The paper begins with a more carefully stated version of ontologically neutral (ON) logic, originally introduced in (Hailperin, 1997). A non-infinitistic semantics which includes a definition of potential infinite validity follows. It is shown, without appeal to the actual infinite, that this notion provides a necessary and sufficient condition for provability in ON logic.

RESUMEN Un atento repaso por la concepción de la violencia chulhaniana en el contexto de las formas tradicionales que han estudiado este fenómeno social permite exponer con mayor detalle y claridad esta propuesta en cuanto a la relación con el otro se refiere. Cuando lo sucedido durante el colonialismo que azotó al mundo en el transcurso de los siglos XVIII y XIX se asumía como las más peligrosas acciones cometidas en procura de la supresión de las características propias de cada (...) uno, en la medida en que los fenómenos de invasión suprimían materialmente la diferencia que poblaba el mundo, apareció la violencia de la positividad como la disposición sistémica que parte de la libertad y el consentimiento individual para, tácitamente, eliminar cualquier tipo de sentido de otredad presente en su constitución. ABSTRACT A careful review of the conception of Chulhanian violence in the context of the traditional forms that have studied this social phenomenon makes it possible to explain in greater detail and clarity this proposal as to the relationship with the other refers. When what happened during colonialism that hit the world during the 18th and 19th centuries was assumed to be the most dangerous actions committed in seeking the suppression of each other's own characteristics to the extent that invasion phenomena materially suppressed the difference that populated the world, the violence of positivity appeared as the systemic disposition that begins with freedom and individual consent to, tacitly, to eliminate any kind of sense of otherness present in its constitution. (shrink)

A longstanding debate regarding the nature of consent has marked a tri-fold division among philosophical and legal theorists according to whether they take consent to be a type of mental state, a form of behaviour, or some hybrid of the two. Theorists on all sides acknowledge that ordinary language cannot serve as a guide to resolving this ontological question, given the polysemy of the word “consent” in ordinary language. Similar observations have been noted about the function of (...) consent in the law and use of the word “consent” in legal contexts. This paper makes a parallel argument regarding consent’s characteristic normative role: roughly, to transform moral prohibitions into permissions. This role is neither unique nor essential to any one particular kind of thing, be it a mental state, form of behaviour, or hybrid of the two—rather, it is played by mental states and behaviour in independent and context-sensitive ways. The upshot is that insofar as we are interested in its normative implications, we ought to adopt a pluralistic approach to consent which gives independent weight to the moral contributions of facts about mental states and facts about behaviour relative to a context. (shrink)

This paper asks whether investigation into the ontology of the extended family can help us to think about and resolve questions concerning the nature of the family’s decision-making authority where organ donation is concerned. Here, “extended family” refers not to the multigenerational family all living at the same time, but to the family extended past its living boundaries to include the dead and the not yet living. How do non-existent members of the family figure into its ontology? Does (...) an answer to this question help to resolve questions about the distribution of authority within the extended family? (shrink)

Arguments involve, at minimum, attempts at presenting something that an audience will take to be a reason. Reasons, once understood, affect an addressee’s beliefs in ways that are in some significant sense outside of their direct voluntary control. Since such changes may impact the well-being, life projects, or sense of self of the addressee, they risk infringing upon their autonomy. We call this the “autonomy worry” of argumentation. In light of this worry, this paper asks whether one ought to seek (...) an addressee’s consent before arguing with them. We first consider the view that arguing of any sort and on any topic requires consent. However, such a view is extreme, and we reject the general requirement of consent because argument contains its own internal permission structure. We find, however, that this permission structure is not always operative, and that consent may nonetheless be morally required in certain kinds of cases. (shrink)

Ontologies describe reality in specific domains in ways that can bridge various disciplines and languages. They allow easier access and integration of information that is collected by different groups. Ontologies are currently used in the biomedical sciences, geography, and law. A Biomedical Ethics Ontology would benefit members of ethics committees who deal with protocols and consent forms spanning numerous fields of inquiry. There already exists the Ontology for Biomedical Investigations (OBI); the proposed BMEO would interoperate with OBI, (...) creating a powerful information tool. We define a domain ontology and begin to construct a BMEO, focused on the process of evaluating human research protocols. Finally, we show how our BMEO can have practical applications for ethics committees. This paper describes ongoing research and a strategy for its broader continuation and cooperation. (shrink)

A very common but untested assumption is that potential children would consent to be exposed to the harms of existence in order to experience its benefits. And so, would-be parents might appeal to the following view: Procreation is all-things-considered permissible, as it is morally acceptable for one to knowingly harm an unconsenting patient if one has good reasons for assuming her hypothetical consent—and procreators can indeed reasonably rely on some notion of hypothetical consent. I argue that this (...) view is in error. My argument appeals to a consent-based version of anti-natalism advanced by Seana Valentine Shiffrin. Anti-natalism is the view that it is always wrong to bring people into existence. While, like Shiffrin, I stop short of advocating a thoroughgoing anti-natalism, I nevertheless argue that procreators cannot appeal to hypothetical consent to justify exposing children to the harms of existence. I end by suggesting a more promising route by which this justification might be achieved. (shrink)

This essay produces a paradigmatic analysis of anti-Blackness from within the history and philosophy of biology in order to explore Frantz Fanon’s concept of ontological resistance. Through developing Sylvia Wynter’s notion of the Darwinian Imaginary alongside an Afropessimist paradigmatic analysis, the paper argues that scientific humanism’s claim that the Black is “the ostensible missing link between rational humans and irrational animals” (Wynter 2003: 266) is a form of metaphysical violence that the Black cannot ontologically resist. This heretical reading of three (...) canonical figures in Western bioscience—Carl Linnaeus, George Cuvier, and Charles Darwin—is an attempt to synthesize Wynter’s demonic ground and Wilderson’s grammatology in order to develop a Black anti-philosophy of science that thinks antagonistically about what it means to be “the missing link” in the chain of Human being. (shrink)

Six people were interviewed about the possibility of becoming posthumous body donors. Interview transcripts were analyzed using interpretative phenomenological analysis. Individual-level analysis suggested a common interest in Personhood Concerns and a common commitment to Enlightenment Values. Investigations of these possible themes across participants resulted in identification of two sample-level themes, each with two subthemes: Autonomy, with subthemes of agency and consent, and Rationality, with subthemes of knowledge/epistemology and materialism/ontology. This paper concentrates on the former. Consent for posthumous (...) body donation was felt to sometimes fall short of adequately identifying donors’ preferences about what happened after consent was given, even with respect to actions for which consent established permission. In turn, paucity of information about donors’ preferences limited others’ ability to act as proxy agents to facilitate donors’ posthumous autonomy. Thus, while consent may curtail violations of people’s autonomy by authorizing actions for which permission has been established, it may fall short of facilitating their autonomy in ways that might be possible with greater knowledge of those people’s desires. Alternative methods of establishing consent are explored that might better-determine people’s desires and thereby improve others’ ability to act as proxy agents for them to facilitate their subsequent (even posthumous) autonomy. (shrink)

In lieu of an abstract, here is a brief excerpt of the content:Convention for Protection of Human Rights and Dignity of the Human Being with Regard to the Application of Biology and Biomedicine: Convention on Human Rights and BiomedicineCouncil of EuropePreambleThe Member States of the Council of Europe, the other States and the European Community signatories hereto,Bearing in mind the Universal Declaration of Human Rights proclaimed by the General Assembly of the United Nations on 10 December 1948;Bearing in mind the (...) Convention for the Protection of Human Rights and Fundamental Freedoms of 4 November 1950;Bearing in mind the European Social Charter of 18 October 1961;Bearing in mind the International Covenant on Civil and Political Rights and the International Covenant on Economic, Social and Cultural Rights of 16 December 1966;Bearing in mind the Convention for the Protection of Individuals with Regard to Automatic Processing of Personal Data of 28 January 1981;Bearing also in mind the Convention on the Rights of the Child of 20 November 1989;Considering that the aim of the Council of Europe is the achievement of a greater unity between its members and that one of the methods by which that aim is to be pursued is the maintenance and further realisation of human rights and fundamental freedoms;Conscious of the accelerating developments in biology and medicine;Convinced of the need to respect the human being both as an individual and as a member of the human species and recognising the importance of ensuring the dignity of the human being; [End Page 277]Conscious that the misuse of biology and medicine may lead to acts endangering human dignity;Affirming that progress in biology and medicine should be used for the benefit of present and future generations;Stressing the need for international co-operation so that all humanity may enjoy the benefits of biology and medicine;Recognising the importance of promoting a public debate on the questions posed by the application of biology and medicine and the responses to be given thereto;Wishing to remind all members of society of their rights and responsibilities;Taking account of the work of the Parliamentary Assembly in this field, including Recommendation 1160 (1991) on the preparation of a Convention on bioethics;Resolving to take such measures as are necessary to safeguard human dignity and the fundamental rights and freedoms of the individual with regard to the application of biology and medicine;Have agreed as follows:Chapter IGeneral provisionsArticle 1. (Purpose and object)Parties to this Convention shall protect the dignity and identity of all human beings and guarantee everyone, without discrimination, respect for their integrity and other rights and fundamental freedoms with regard to the application of biology and medicine.Each Party shall take in its internal law the necessary measures to give effect to the provisions of this Convention.Article 2. (Primacy of the human being)The interests and welfare of the human being shall prevail over the sole interest of society or science.Article 3. (Equitable access to health care)Parties, taking into account health needs and available resources, shall take appropriate measures with a view to providing, within their jurisdiction, equitable access to health care of appropriate quality. [End Page 278]Article 4. (Professional standards)Any intervention in the health field, including research, must be carried out in accordance with relevant professional obligations and standards.Chapter IIConsentArticle 5. (General rule)An intervention in the health field may only be carried out after the person concerned has given free and informed consent to it.This person shall beforehand be given appropriate information as to the purpose and nature of the intervention as well as on its consequences and risks.The person concerned may freely withdraw consent at any time.Article 6. (Protection of persons not able to consent)1. Subject to Articles 17 and 20 below, an intervention may only be carried out on a person who does not have the capacity to consent, for his or her direct benefit.2. Where, according to law, a minor does not have the capacity to consent to an intervention, the intervention may only be carried out with the authorisation of his or her representative or an authority or a person or... (shrink)

Vol. 1. Ars logica seu de forma et materia ratiocinandi -- v. 2. Naturalis philosophiae I. pars. De ente mobili in communi. III. pars. De ente mobili corruptibili -- v. 3. Naturalis philosophiae IV. pars. De ente mobili animato.

The paper addresses severalethical issues in online communication researchin light of digital ontology as well as theepistemological questions raised by theblurring boundary between fact and theory inthis field. The concept of ontology is used ina Heideggerian sense as related to the humancapacity of world construction on the basis ofthe givenness of our being-in-the-world.Ethical dilemmas of Internet research thusarise from the tension between bodily existenceand the proper object of research, i.e., onlineexistence. The following issues are beingconsidered: online identity, online (...) language,online consent and confidentiality. We alsoargue that research ethics in the US followsthe utilitarian tradition, while Europeanresearchers are deontologically oriented. Aguideline of best practice in online researchethics is proposed. (shrink)

Background:Moral courage is defined as courage to act according to one’s own ethical values and principles even at the risk of negative consequences for the individual. In a complex nursing practice, ethical considerations are integral. Moral courage is needed throughout nurses’ career.Aim:To analyse graduating nursing students’ moral courage and the factors associated with it in six European countries.Research design:A cross-sectional design, using a structured questionnaire, as part of a larger international ProCompNurse study. In the questionnaire, moral courage was assessed with (...) a single question (visual analogue scale 0–100), the questionnaire also covered several background variables.Participants and research context:The sample comprised graduating nursing students (n = 1796) from all participating countries. To get a comprehensive view about graduating nursing students’ moral courage, the views of nurse managers (n = 538) and patients (n = 1327) from the same units in which the graduating nursing students practised were also explored, with parallel questionnaires.Ethical considerations:Ethical approvals and research permissions were obtained according to national standards in every country and all participants gave their informed consent.Results:The mean of graduating nursing students’ self-assessed moral courage was 77.8 (standard deviation 17.0; on a 0–100 scale), with statistically significant differences between countries. Higher moral courage was associated with many factors, especially the level of professional competence. The managers assessed the graduating nursing students’ moral courage lower (66.5; standard deviation 18.4) and the patients slightly higher (80.6; standard deviation 19.4) than the graduating nursing students themselves.Discussion and conclusions:In all countries, the graduating nursing students’ moral courage was assessed as rather high, with differences between countries and populations. These differences and associations between moral courage and ethics education require further research. (shrink)

Philosophers of music often appeal to intuition to defend ontological theories of musical works. This practice is worrisome as it is rather unclear just how widely shared are the intuitions that philosophers appeal to. In this paper, I will first offer a brief overview of the debate over the ontology of musical works. I will argue that this debate is driven by a conflict between two seemingly plausible intuitions—the repeatability intuition and the creatability intuition—both of which may be defended (...) on the grounds that they are reflective of our actual musical practices. The problem facing philosophers within this debate is that there is no clear way to determine which of the two conflicting intuitions is more reflective of our musical practices. Finally, I offer discussion of an experimental study that was designed to test participants' intuitions regarding the repeatability of musical works. The evidence presented there suggests that the participants broadly accept the repeatability of musical works, but in a much narrower way than philosophers would likely accept. (shrink)

Voluntariness of consent to research has not been sufficiently explored through empirical research. The aims of this study were to develop a more comprehensive approach to assessing voluntariness and to generate preliminary data on the extent and correlates of limitations on voluntariness. We developed a questionnaire to evaluate subjects’ reported motivations and constraints on voluntariness. 88 subjects in five different areas of clinical research—substance abuse, cancer, HIV, interventional cardiology, and depression—were assessed. Subjects reported a variety of motivations for participation. (...) Offers of financial incentives were common but not influential, pressures from others were rare, and no threats were reported. However, certain financial incentives and—paradoxically—altruistic motivations led some subjects to feel more constrained. Consistent with previous studies, no one pattern of motivation was common to all research subjects. There was little evidence of constrained voluntariness, but some suggestion of areas of concern. Voluntariness appears to be susceptible to systematic empirical investigation. (shrink)

Because climate change can be seen as the blind spot of contemporary philosophy of technology, while the destructive side effects of technological progress are no longer deniable, this article reflects on the role of technologies in the constitution of the (post)Anthropocene world. Our first hypothesis is that humanity is not the primary agent involved in world-production, but concrete technologies. Our second hypothesis is that technological inventions at an ontic level have an ontological impact and constitutes world. As we object to (...) classical philosophers of technology like Ihde and Heidegger, we will sketch the progressive contribution of our conceptuality to understand the role of technology in the Anthropocene world. Our third hypothesis is that technology has emancipatory potential and in this respect, can inaugurate a post-Anthropocene World. We consider these three hypotheses to develop a philosophical account of the ontology of technology beyond an abstract and deterministic understanding. This concept enables us to philosophically reflect on the role of technology in the Anthropocene World in general, and its contribution to the transition to the post-Anthropocene World in particular. (shrink)

This book offers the first English translation of the _Quodlibetal Questions _of William of Ockham —reflections on a variety of topics in logic, ontology, natural philosophy, philosophical psychology, moral theory, and theology by one of the preeminent thinkers of the Middle Ages. It is based on the recent critical edition of Ockham’s theological and philosophical works.

ObjectiveTo present the ethical issues, moral arguments, and reasons found in the ethical literature on organoid models.DesignIn this systematic review of reasons in ethical literature, we selected sources based on predefined criteria: The publication mentions moral reasons or arguments directly relating to the creation and/or use of organoid models in biomedical research; These moral reasons and arguments are significantly addressed, not as mere passing mentions, or comprise a large portion of the body of work; The publication is peer-reviewed and published (...) in an academic article, book, national-level report, working paper, or Ph.D. thesis; The publications collected are in English.AnalysisEach article was read in-depth for identifiable moral reasons, arguments, and concerns. These were then inductively classified and synthesized to create broader categories of reasons, and eventually an overarching conceptual scheme was created.ResultsA total of twenty-three sources were included and analyzed out of an initial 266 collected sources. Five themes of ethical issues and arguments were found: Animal Experimentation; Clinical Applications and Experiments; Commercialization and Consent; Organoid Ontology and Moral Status; and Research Ethics and Research Integrity. These themes are then further broken down into sub-themes and topics. Given the extensive nature of the topics found, we will focus on describing the topics that comprised of more in-depth reasons and arguments rather than few, passing mentions or concerns.ConclusionsThe ethics of organoids requires further deliberation in multiple areas, as much of the discussions are not presented as in-depth arguments. Such sentiments are also echoed throughout the organoid ethics literature. (shrink)

Philosophical work on the concept of consent in the past few decades has got to grips with it as a rich notion. We are increasingly sensitive to consent not as a momentary, atomic, transactional thing, but as a complex idea admitting of various qualities and dimensions. In this paper we note that the recognition of this complexity demands a theoretical framework quite different to those presently extant, and we suggest that the enactive approach is one which offers significant (...) value in this regard. In consonance with arguments made by Laurie Penny about how consent is a continuous and dynamic process, we outline how an enactive approach identifies consent as temporally extended (rather than momentarily transactional), and as affected by the skilfulness of the agents involved, the fitness of community provided resources to negotiate the consensual relationship over time, and the unfolding of circumstances in the situation in which the joint action is taking place. We argue that the value of an enactive perspective on consent is in highlighting these complexities, and providing resources to articulate and theorise them in ways that are not open to other current approaches. (shrink)

Dheensa S, Fenwick A, Lucassen A.‘Is this knowledge mine ….

Cell line immortalisation is a growing component of African genomics research and biobanking. However, little is known about the factors influencing consent to cell line creation and immortalisation in African research settings. We contribute to addressing this gap by exploring three questions in a sample of Xhosa participants recruited for a South African psychiatric genomics study: First, what proportion of participants consented to cell line storage? Second, what were predictors of this consent? Third, what questions were raised by (...) participants during this consent process? 760 Xhose people with schizophrenia and 760 controls were matched to sex, age, level of education and recruitment region. We used descriptive statistics to determine the proportion of participants who consented to cell line creation and immortalization. Logistic regression methods were used to examine the predictors of consent. Reflections from study recruiters were elicited and discussed to identify key questions raised by participants about consent. Approximately 40% of participants consented to cell line storage. The recruiter who sought consent was a strong predictor of participant’s consent. Participants recruited from the South African Eastern Cape, and older participants, were more likely to consent; both these groups were more likely to hold traditional Xhosa values. Neither illness nor education were significant predictors of consent. Key questions raised by participants included two broad themes: clarification of what cell immortalisation means, and issues around individual and community benefit. These findings provide guidance on the proportion of participants likely to consent to cell line immortalisation in genomics research in Africa, and reinforce the important and influential role that study recruiters play during seeking of this consent. Our results reinforce the cultural and contextual factors underpinning consent choices, particularly around sharing and reciprocity. Finally, these results provide support for the growing literature challenging the stigmatizing perception that people with severe mental illness are overly vulnerable as a target group for heath research and specifically genomics studies. (shrink)

The starting point of this article is the observation that the emergence of the Anthropocene rehabilitates the need for philosophical reflections on the ontology of technology. In particular, if technological innovations on an ontic level of beings in the world are created, but these innovations at the same time create the Anthropocene World at an ontological level, this raises the question how World creation has to be understood. We first identify four problems with the traditional concept of creation: the (...) anthropocentric, ontic and outcome orientation of traditional concepts of creation, as well as its orientation of material fabrication. We subsequently develop a progressive concept of World creation with four characteristics that move beyond the traditional conceptuality: a materialistic concept of creation that accounts for the ontogenetic process and the ontic and ontological nature of creation, and is conceptualized as semantic creation of the World in which we live and act. (shrink)

Genomic research—including whole genome sequencing and whole exome sequencing—has a growing presence in contemporary biomedical investigation. The capacity of sequencing techniques to generate results that go beyond the primary aims of the research—historically referred to as “incidental findings”—has generated considerable discussion as to how this information should be handled—that is, whether incidental results should be returned, and if so, which ones.Federal regulations governing most human subjects research in the United States require the disclosure of “the procedures to be followed” in (...) the research as part of the informed consent process. It seems reasonable to assume—and indeed, many commentators have concluded—that genomic investigators will be expected to inform participants about, among other procedures, the prospect that incidental findings will become available and the mechanisms for dealing with them. Investigators, most of whom will not have dealt with these issues before, will face considerable challenges in framing meaningful disclosures for research participants.To help in this task, we undertook to identify the elements that should be included in the informed consent process related to incidental findings. We did this by surveying a large number of genomic researchers (n = 241) and by conducting in‐depth interviews with a smaller number of researchers (n = 28) and genomic research participants (n = 20). Based on these findings, it seems clear to us that routine approaches to informed consent are not likely to be effective in genomic research in which the prospect of incidental findings exists. Ensuring that participants’ decisions are informed and meaningful will require innovative approaches to dealing with the consent issue. We have identified four prototypical models of a consent process for return of incidental findings. (shrink)

Though the realm of biology has long been under the philosophical rule of the mechanistic magisterium, recent years have seen a surprisingly steady rise in the usurping prowess of process ontology. According to its proponents, theoretical advances in the contemporary science of evo-devo have afforded that ontology a particularly powerful claim to the throne: in that increasingly empirically confirmed discipline, emergently autonomous, higher-order entities are the reigning explanantia. If we are to accept the election of evo-devo as our (...) best conceptualisation of the biological realm with metaphysical rigour, must we depose our mechanistic ontology for failing to properly “carve at the joints” of organisms? In this paper, I challenge the legitimacy of that claim: not only can the theoretical benefits offered by a process ontology be had without it, they cannot be sufficiently grounded without the metaphysical underpinning of the very mechanisms which processes purport to replace. The biological realm, I argue, remains one best understood as under the governance of mechanistic principles. (shrink)