The following is adapted from the testimony, on 6 June 1984, of Dr T. G. Krontiris before the U.S. House Science and Technology Subcommittee on Investigations and Oversight, on the subject of oncogene research. In a previous report (BioEssays, 1, 3), the testimony of Dr C. J. Sherr, describing the molecular biology of oncogene action was given. Here, Krontiris describes the challenges in applying the new5ndings in diagnosis and therapy.

Machine learning algorithms may radically improve our ability to diagnose and treat disease. For moral, legal, and scientific reasons, it is essential that doctors and patients be able to understand and explain the predictions of these models. Scalable, customisable, and ethical solutions can be achieved by working together with relevant stakeholders, including patients, data scientists, and policy makers.

How physicians approach patients and the problems they present is much influenced by the conceptual models around which their knowledge is organized. In this paper the implications of the biopsychosocial model for the study and care of a patient with an acute myocardial infarction are presented and contrasted with approaches used by adherents of the more traditional biomedical model. CiteULike Connotea Del.icio.us What's this?

Advances in psychopharmacology raise the prospects of enhancing neurocognitive functions of humans by improving attention, memory, or mood. While general ethical reflections on psychopharmacological enhancement have been increasingly published in the last years, ethical criteria characterizing physicians’ role in neurocognitive enhancement and guiding their decision-making still remain highly unclear. Here it will be argued that also in the medical domain the use of cognition-enhancing drugs is not intrinsically unethical and that, in fact, physicians should assume an important role in gating (...) their usage. For finding normative orientation, concepts of disease, normality or medicine will not be helpful since—due to their cryptonormative nature—they rather hamper than allow targeted discussion and decision-making. As an alternative, the common and widely accepted bioethical criteria of beneficence, non-maleficence, autonomy and distributive justice allow a clinically applicable, highly differentiated context- and case-sensitive approach. By embedding decision-making in a participative physician–patient relationship extrinsic objections against neurocognitive enhancement (e.g. invalid perceptions about efficacy, benefit or risk; questionable voluntariness; restrained decision-making capacity) can be curtailed. (shrink)

Once a neural implant has shown some efficacy during initial research trials, it begins to enter the world of clinical application. This culminates when the implant becomes approved for a particular indication. However, the ethical challenges continue as the technology is adopted as a standard of practice. Patient eligibility criteria, as documented by inclusion and exclusion criteria with any new treatment, are not always clearly quantified and defined. These vagaries can result in considerable debate regarding who should or should (...) not proceed with surgery. There is often considerable room for clinical judgment that can result in extension of the treatment to a wider range of patients. The ethical questions that arise in clinical decisionmaking differ significantly from those inherent in engineering design and research development. (shrink)

An important measure of the validity and utility of basic behavioral research is the extent to which it can be applied in real life. Basic research on behavioral momentum and the model unifying choice and resistance to change (Nevin & Grace 1999) has stimulated the development of behavioral technologies aimed at increasing the persistence of adaptive behavior and decreasing maladaptive choices.

Bioethics, Volume 35, Issue 7, Page 623-633, September 2021.

When the language-dominant hemisphere is damaged by a focal lesion, the brain may reorganize the language network through functional and structural changes known as adaptive plasticity. Adaptive plasticity is documented for triggers including ischemic, tumoral, and epileptic focal lesions, with effects in clinical practice. Many questions remain regarding language plasticity. Different lesions may induce different patterns of reorganization depending on pathologic features, location in the brain, and timing of onset. Neuroimaging provides insights into language plasticity due to its non-invasiveness, (...) ability to image the whole brain, and large-scale implementation. This review provides an overview of language plasticity on MRI with insights for patient care. First, we describe the structural and functional language network as depicted by neuroimaging. Second, we explore language reorganization triggered by stroke, brain tumors, and epileptic lesions and analyze applications in clinical diagnosis and treatment planning. By comparing different focal lesions, we investigate determinants of language plasticity including lesion location and timing of onset, longitudinal evolution of reorganization, and the relationship between structural and functional changes. (shrink)

In this article, we critically examine some of the ethical challenges and interpretive difficulties with possible future non-clinical applications of pediatric fMRI with a particular focus on applications in the classroom and the courtroom - two domains in which children come directly in contact with the state. We begin with a general overview of anticipated clinical and non-clinical applications of pediatric fMRI. This is followed by a detailed analysis of a range of ethical challenges and interpretive difficulties (...) that trouble the use of fMRI and are likely to be especially acute with non-clinical uses of the technology. We conclude that knowledge of these challenges and difficulties should influence policy decisions regarding the non-clinical uses of fMRI. Our aim is to encourage the development of future policies prescribing the responsible use of this neuroimaging technology as it develops both within and outside the clinical setting. (shrink)

This book seeks to resolve an issue that has divided psychoanalysts and other scholars of aggression for decades, namely the nature of aggression. The work expands and unifies the Freudian drive-based explanation of aggression into contemporary psychoanalytic theory and practice and brings Freudian theory into the 21st Century.

Stem cells are likely to be used as an alternate source of biological material for neural transplantation to treat Parkinson’s disease in the not too distant future. Among the several ethical criteria that must be fulfilled before proceeding with clinical research, a favourable benefit to risk ratio must be obtained. The potential benefits to the participant and to society are evaluated relative to the risks in an attempt to offer the participants a reasonable choice. Through examination of preclinical studies (...) transplanting stem cells in animals and the transplantation of fetal tissue in patients with Parkinson’s disease, a current set of potential benefits and risks for neural transplantation of stem cells in clinical research of Parkinson’s disease are derived. The potential benefits to research participants undergoing stem cell transplantation are relief of parkinsonian symptoms and decreasing doses of parkinsonian drugs. Transplantation of stem cells as a treatment for Parkinson’s disease may benefit society by providing knowledge that can be used to help determine better treatments in the future. The risks to research participants undergoing stem cell transplantation include tumour formation, inappropriate stem cell migration, immune rejection of transplanted stem cells, haemorrhage during neurosurgery and postoperative infection. Although some of these risks are general to neurosurgical transplantation and may not be reduced for participants, the potential risk of tumour formation and inappropriate stem cell migration must be minimised before obtaining a favourable potential benefit to risk calculus and to provide participants with a reasonable choice before they enrol in clinical studies. (shrink)

Neural cell transplants have been introduced in clinical practice during the last decade with mixed results, encouraged by success with simple animal models. This commentary is a reminder that although the ideas and techniques of transplantation appear simple, the variables involved in host-transplant integration still require further study. The field may benefit from a concerted, multidisciplinary approach.

Current evidence suggests that the efficacy of psychedelic therapy depends, in part, on the character of psychedelic experiences themselves. One pronounced aspect of psychedelic experiences is alterations to the experience of time, including reports of timelessness or transcending time. However, how we should interpret such reports remains unclear, and this lack of clarity has philosophical and clinical implications. For instance, “true” timelessness may be considered antithetical to having any experience at all, and descriptions of experiences involving “timelessness” are known (...) to be diverse and of varying clinical significance. In this article, we utilize a phenomenological approach to the study of temporality to highlight ambiguities in current constructs used to assess psychedelic experiences. In doing so, we advance some preliminary phenomenological accounts of psychedelic therapy’s mechanisms of action, such as psychedelic temporality acting as a kind of counterpoint for depressive temporality. We conclude by outlining how a dedicated phenomenological research program can provide a nuanced map of psychedelic temporality, guiding future research in a manner that addresses both philosophical and clinical ambiguities. (shrink)

Neurotechnologies describe a field of science and engineering in which the nervous system is interfaced with technical devices. Fundamental research is conducted to explore functions of the brain, decipher the neural code and get a better understanding of diseases and disorders. Risk benefit assessment has been well established in all medical disciplines to treat patients best possible while minimizing jeopardizing their lives by the interventions. Is this set of assessment rules sufficient when the brain will be interfaced with a technical (...) system and is this assessment enough? How will these new technologies change personality and society? This article will shortly review different stakeholders’ opinions and their expectation in the field, assembles information the state-of-the art in medical applications of neurotechnological implants and describes and assesses the fundamental technologies that are used to build up these implants starting with essential requirements of technical materials in contact with living tissue. The different paragraphs guide the reader through the main aspects of neurotechnologies and lay a foundation of knowledge to be able to contribute to the discussion in which cases implants will be beneficial and in which cases we should express serious concerns. (shrink)

_Emotional Presence in Psychoanalysis_ provides a detailed look at the intricacies of attaining emotional presence in psychoanalytic work. John Madonna and a distinguished group of contributors draw on both the relational and modern psychoanalytic schools of thought to examine a variety of different problems commonly experienced in achieving emotional resonance between analyst and patient, setting out ways in which such difficulties may be overcome in psychoanalytic treatment, practical clinical settings and in training contexts. A focused review of relevant comparative (...) literature is followed by chapters featuring individual clinical case studies, each illustrating particularly challenging aspects. The uniqueness of this book lays not simply in the espousal of the commonly accepted importance of emotional resonance between analyst and patient; rather it is in the way in which emotional presence is registered by both participants, requiring a working through, which at times can be not only difficult but dangerous. Such efforts involve a theory which enables the lens to understanding, an effective methodology which guides intervention. The book also calls for the art of the analyst to construct with patients meanings which heal, and possess the heart to persist in commitment despite the odds. _Emotional Presence in Psychoanalysis_ is about patients who suffer, struggle, resist and prevail. It offers distinctive, transparently told accounts of analysts who engage with patients, navigating through states of confusion, hatred and more controversial feelings of love. Emotional Presence in Psychoanalysis features highly compelling material written in an accessible and easily understood style. It will be a valuable resource for psychoanalysts and psychoanalytic psychotherapists, psychologists and clinical social workers as well as teachers, trainers and students seeking to understand the power and potential of the analytic process and the resistances to it. (shrink)

This unique book applies concepts from the field of anthropology to clinical settings to result in a powerful and dynamic model/theory of clinical anthropology.

Does work psychodynamics--a sub-discipline of clinical psychology in the field of work sciences--offer a relevant methodological reference to analyze the psychological processes that come into play when a CEO is working? The objective of this article is to propose an answer to this question by going back to a doctoral research, which focused on the clinical analysis of the CEOs' "presentation of self," noted as one aspect of their work. The author's arguments for a clinical approach are (...) presented as well as the later decision to resort to "astute" tactics that, beyond the traditional frameworks of work psychodynamics, were required to have access to the CEOs' presentation of self. Following the presentation of the research's achievements, the article shows that, while methodologically unconventional, the astute tactics proved useful in ushering in new elements of knowledge that otherwise would have remained inaccessible. Notably, the specifics of the intersubjective relationship that was established between the author and each CEO had a major positive impact on the interpretations. To legitimize this clinical approach further, the conclusion draws a few indications on criteria that could be investigated to scientifically validate the qualitative methods and their interpretive results. (shrink)

The European framework surrounding clinical trials on medicinal products for human use is going to change as demonstrated by the large debate at European institutional level. One of the major challenges is to overcome the lack of harmonisation of clinical trial procedures among countries. This aspect is gaining more and more importance, considering the increasing number of multicentre and multinational studies. In this work, the actual European rules governing the Clinical Trial Application have been analysed throughout the (...) different steps including the registration of the trial in the European database; the preparation of documents to be submitted and their contents; the preparation of documents related to the information and consent process; the submission to competent bodies. Specific issues related to paediatric research and trials involving non EU/EEA countries have been addressed as well. Results reveal that the European legislation offers a well defined set of European rules covering different aspects of a Clinical Trial Application. However, these are not suitable to meet the challenges from multicentre and multinational clinical studies. A stronger set of rules, such as is available in a composite European Regulation has been adopted and is expected to harmonise practices and enable sponsors to carry out well conducted trials. But will the new regulation overcome the existing criticisms of Directive 2001/20/EC? (shrink)

The debate on the ethical permissibility of euthanasia in medicine has a corollary in the ethical application of drugs. The overall moral limits of medical treatment apply evenly to the moral acceptability of the pharmacological aspect of the act of euthanasia. The pharmacological aspect of the act is of ethical importance not only for the person requesting an active ending of his or her life, but also for the grieving family. Keywords: effectivity, ideal euthanaticum, patient's/family's interest, pharmacology of euthanasia, routes (...) of application CiteULike Connotea Del.icio.us What's this? (shrink)

The executive board of the Academy for Ethics in Medicine and two AEM working groups formulated standards and recommendations for clinical ethics consultation in 2010, 2011, and 2013. These guidelines comply with the international standards like those set by the American Society for Bioethics and Humanities. There is no empirical data available yet that could indicate whether these standards and recommendations have been implemented in German hospitals. This desideratum is addressed in the present study. We contacted 1.858 German hospitals (...) between September 2013 and January 2014. A follow-up survey was conducted between October 2014 and January 2015. The data of the initial survey and the follow-up survey were merged and evaluated. The statements of the participants were compared with the standards and recommendations. The standards of the AEM concerning the tasks of clinical ethics consultation are employed by a majority of participants of the study. Almost all of these participants document their consultation activities by means of protocols or entries in the patient file. There are deviations from the recommendations of the AEM working groups regarding the drafting of statutes, activity reports, and financial support. The activities of clinical ethics consultation predominantly comply with the standards of the AEM and recommendations for the documentation. The recommendations for evaluation should be improved in practice. This applies particularly for activity reports in order to evaluate the activities. Internal evaluation could take place accordingly. (shrink)

Although clinical ethics consultation has existed for more than 40 years in the USA and Europe, it was not available in Bulgaria until recently. In introducing clinical ethics consultation into our country, the Modular, Ethical, Treatment, Allocation of resources, Process (METAP) methodology has been preferred because of its potential to be used in resource-poor settings and its strong educational function. This paper presents the results of a METAP evaluation in a hospital palliative care ward in the town of (...) Vratsa. The evaluation was based on Beauchamp and Childress’ four principles of biomedical ethics and involves implementation of specific instruments for clinical ethics decision-making. Research tasks emphasised analyses of ethics meetings in the ward. Data were processed by SPSS v.24 using descriptive statistical analysis. Altogether, 32 ethics meetings of an average duration 20.63 min were conducted on cases involving critically ill patients. Most of the participants (86.0%) expressed satisfaction with the ethics process. The principlist approach supported resolution of conflicts between autonomous patients and their relatives, clarified definitions of “medical benefit” and “social good,” and enabled assessments of the risk of unequal treatment. Even as the specific research tasks were achieved, further participant follow-up is necessary to identify any improvement in healthcare personnel’s ethical competence. METAP worked well in end-of-life care settings. Participants experienced several benefits, including improved team communication, better understanding of patient preferences, and confidence in the correctness of decisions. Despite the significant educational potential of METAP, the need for additional and ongoing ethics training of health professionals should not be underestimated. (shrink)

Annotation Since clinical psychologists often have little background in cognitive psychology, and cognitive psychologists often have little training in conducting research with special populations, this book discusses the popularly used cognitive tasks in applied research, including the Stroop, Selective Attention, Implicit Memory, Directed Forgetting, and Autobiographical Memory tasks. For each, the contributors provide the background necessary for readers to ground themselves in the basics and be directed to more detailed information that they might need. The result is a text (...) that will assist researchers from different backgrounds in finding important task-related data. An up-to-date resource on conducting rigorous research. (shrink)

Fully interpreted, Lewis's dynamic systems modeling of emotion encompasses psychological-adaptation thinking and individual and group differences in normal and abnormal behavior. It weakens the categorical perspective in evolutionary psychology and the clinical sciences; and suggests continuity between “normal” or “abnormal” behavior in whatever way this is self and culturally constituted, although culture/linguistic factors and selfhood are neglected. Application of a dynamic systems model could improve formulation of clinical problems.

This text offers a concise explanation of how philosophical concepts underpin much medical activity, and how being aware of this can improve everyday practice. It is not a basic introduction to philosophy, but restricts itself to those aspects that have a direct impact on medical professionals.