Background: Informed consent is regarded as a contract between autonomous and equal parties and requires the elements of information disclosure, understanding, voluntariness and consent. The validity of informed consent for critically ill patients has been questioned. Little is known about how these patients experience the process of consent.Objective: The aim of this study was to explore critically ill patients’ experience with the principle of informed consent in a clinical trial and their ability to give valid informed consent.Design: 11 stroke patients (...) who had been informed about thrombolytic treatment and had been through the process of deciding whether or not to participate in a thrombolysis trial went through repeated qualitative semistructured interviews.Results: None of the patients had any clear understanding of the purpose of the trial. Neither did they understand the principles of randomisation and voluntariness. Reasons for giving or not giving consent were trust, conceptions of benefits and risks and altruism. Several patients found it immoral to involve patients in the consent procedure and argued that this was the doctors’ responsibility. Others argued that it is a duty to question patients and perceived it as a sign of being treated with respect and dignity. A majority of the patients found the consent process vague and ambiguous.Conclusions: The results indicate that the principle of informed consent from critically ill patients cannot be seen as a contract between equal and autonomous parties. Further studies are needed to explore critically ill patients’ experiences with the process of informed consent. (shrink)

In “Potential Subjects’ Responses to an Ethics Questionnaire in a Phase I Study of Deep-Brain Stimulation in Early Parkinson’s Disease,” Finder, Bliton, Gill, Davis, Konrad, and Charles undertake informed consent research on what they describe as a Phase I trial of deep brain stimulation (DBS) for Parkinson’s disease. We argue that the authors should have more carefully characterized the nature of the DBS study at the start of their clinical study.

Volume 20, Issue 7, July 2020, Page 196-198.

Clinical ethicists encounter the most emotionally eviscerating medical cases possible. They struggle to facilitate resolutions founded on good reasoning embedded in compassionate care. This book fills the considerable gap between current texts and the continuing educational needs of those actually facing complex ethics consultations in hospital settings. 28 richly detailed cases explore the ethical reasoning, professional issues, and the emotional aspects of these impossibly difficult consultations. The cases are grouped together by theme to aid teaching, discussion and professional growth. The (...) cases inform any reader who has a keen interest in the choices made in real-life medical dilemmas as well as the emotional cost to those who work to improve the situations. On a more advanced level, this book should be read by ethics committee members who participate in ethics consultations, individual ethics consultants, clinicians who seek education about complex clinical ethics cases, and bioethics students. (shrink)

PURPOSE: To evaluate the effects of social support on comprehension and recall of consent form information in a study of Parkinson disease patients and their caregivers.DESIGN and METHODS: Comparison of comprehension and recall outcomes among participants who read and signed the consent form accompanied by a family member/friend versus those of participants who read and signed the consent form unaccompanied. Comprehension and recall of consent form information were measured at one week and one month respectively, using Part A of the (...) Quality of Informed Consent Questionnaire .RESULTS: The mean age of the sample of 143 participants was 71 years . Analysis of covariance was used to compare QuIC scores between the intervention group and control group . In the 1-week model, no statistically significant intervention effect was found . However, the intervention status by patient status interaction was statistically significant . In the 1-month model, no statistically significant intervention effect was found . Again, however, the intervention status by patient status interaction was statistically significant . At both time periods, intervention group patients scored higher on the QuIC than did intervention group caregivers, and control group patients scored lower on the QuIC than did control group caregivers.IMPLICATIONS: Social support played a significant role in enhancing comprehension and recall of consent form information among patients. (shrink)

Leeds Teaching Hospitals NHS Trust v Mr & Mrs A & othersThe decision of Dame Butler-Sloss in the case of Leeds Teaching Hospitals NHS Trust v Mr & Mrs A & Others1 has already achieved notoriety. The disturbing facts have received widespread media coverage and fuelled further legal and political debate surrounding the “reproductive revolution”.2 This short paper assesses the context and potential implications of the recent decision and, in particular, the nature and meaning of parenthood and the family.THE CASETwo (...) couples, referred to Mr and Mrs A and Mr and Mrs B, were attending the assisted conception unit at Leeds General Infirmary to receive infertility treatment. Both couples understood that they were participating in a technique called intracytoplasmic sperm injection , a technique which would use the eggs of the wife and the sperm of the husband in each case. Mrs A had consented to her eggs being mixed with her husband’s sperm to create an embryo which would then be implanted in her, hopefully resulting in pregnancy. Mr A had consented to his wife’s treatment. Mr and Mrs B gave their consent to similar IVF procedures, although Mr B had expressly refused to consent to his sperm being used in treating others.Following a mix up at the unit, which Butler-Sloss referred to as “a ‘mistake’ … despite its inadequacy as a description of what occurred”, Mr B’s sperm was injected into Mrs A’s eggs. She became pregnant and later gave birth to healthy twins. The mistake became apparent only on Mrs A’s delivery of twins of mixed race; Mr and Mrs A are both white, Mr and Mrs B both black. DNA testing subsequently established that Mr B was the biological father of the children. He has had no subsequent contact with them and …. (shrink)

Background: Thrombolytic drugs to treat an acute ischaemic stroke reduce the risk of death or major disability. The treatment is, however, also associated with an increased risk of potentially fatal intracranial bleeding. This confronts the patient with the dilemma of whether or not to take a risk of a serious side effect in order to increase the likelihood of a favourable outcome. Objective: To explore acute stroke patients’ perception of risk and willingness to accept risks associated with thrombolytic drug treatment. (...) Design: Eleven patients who had been informed about thrombolytic drug treatment and had been through the process of deciding whether or not to participate in a thrombolytic drug trial went through repeated qualitative, semistructured interviews. Results: Many patients showed a limited perception of the risks connected with thrombolytic drug treatment. Some perceived the risk as not relevant to them and were reluctant to accept that treatment could cause harm. Others seemed to be aware that treatment would mean exposure to risk. The patients’ willingness to take a risk also varied substantially. Several statements revealed ambiguity and confusion about being involved in a decision about treatment. The patients’ reasoning about risk was put into the context of their health-related experiences and life histories. Several patients wanted the doctor to be responsible for the decisions. Conclusion: Acute stroke patients’ difficulties in perceiving and processing information about risk may reduce their ability to be involved in clinical decisions where risks are involved. (shrink)

Objective To study how doctors care for their patients, both medically and as fellow humans, through observing their conduct in patient–doctor encounters. Design Qualitative study in which 101 videotaped consultations were observed and analysed using a Grounded Theory approach, generating explanatory categories through a hermeneutical analysis of the taped consultations. Setting A 500-bed general teaching hospital in Norway. Participants 71 doctors working in clinical non-psychiatric departments and their patients. Results The doctors were concerned about their patients' health and how their (...) medical knowledge could be of service. This medical focus often over-rode other important aspects of the consultations, especially existential elements. The doctors actively directed the focus away from their patients' existential concerns onto medical facts and rarely addressed the personal aspects of a patient's condition, treating them in a biomechanical manner. At the same time, however, the doctors attended to their patients with courteousness, displaying a polite and friendly attitude and emphasising the relationship between them. Conclusions The study suggests that the main failing of patient–doctor encounters is not a lack of courteous manners, but the moral offence patients experience when existential concerns are ignored. Improving doctors' social and communication skills cannot resolve this moral problem, which appears to be intrinsically bound to modern medical practice. Acknowledging this moral offence would, however, be the first step towards minimising the effects thereof. (shrink)

When Did I Begin? investigates the theoretical, moral, and biological issues surrounding the debate over the beginning of human life. With the continuing controversy over the use of in vitro fertilization techniques and experimentation with human embryos, these issues have been forced into the arena of public debate. Following a detailed analysis of the history of the question, Reverend Ford argues that a human individual could not begin before definitive individuation occurs with the appearance of the primitive streak about (...) two weeks after fertilization. This, he argues, is when it becomes finally known whether one or more human individuals are to form from a single egg. Thus, he questions the idea that the fertilized egg itself could be regarded as the beginning of the development of the human individual. The author also differs sharply, however, from those who would delay the beginning of the human person until the brain is formed, or until birth or the onset of conscious states. (shrink)

Category-specific impairments of object recognition and naming are among the most intriguing disorders in neuropsychology, affecting the retrieval of knowledge about either living or nonliving things. They can give us insight into the nature of our representations of objects: Have we evolved different neural systems for recognizing different categories of object? What kinds of knowledge are important for recognizing particular objects? How does visual similarity within a category influence object recognition and representation? What is the nature of our semantic knowledge (...) about different objects? We review the evidence on category-specific impairments, arguing that deficits even for one class of object cannot be accounted for in terms of a single information processing disorder across all patients; problems arise at contrasting loci in different patients. The same apparent pattern of impairment can be produced by damage to different loci. According to a new processing framework for object recognition and naming, the hierarchical interactive theory, we have a hierarchy of highly interactive stored representations. HIT explains the variety of patients in terms of lesions at different levels of processing and different forms of stored knowledge used both for particular tasks and for particular categories of object. Key Words: category-specific deficits; functional imaging; hierarchical models; interactive activation models; neuropsychology; object recognition; perceptual and functional knowledge. (shrink)

The chapters in this book have evolved from talks originally presented at The First International Workshop on Human and Machine Cognition.

Objective: To determine the views of people with multiple sclerosis (MS) and professionals in relation to confidentiality, consent and access to data within a proposed MS register in the UK. Design: Qualitative study using focus groups (10) and interviews (13). Setting: England and Northern Ireland. Participants: 68 people with MS, neurologists, MS nurses, health services management professionals, researchers, representatives from pharmaceutical companies and social care professionals. Results: People with MS expressed open and altruistic views towards the use of their personal (...) information to facilitate service provision and research, placing trust in responsible guardianship and legitimate use of their information. Participant’s proposed that people with MS should be able to select their individual level of involvement in a register using levels of consent. It was agreed that access to the register should be governed by a guardianship committee composed of a range of stakeholders. People with MS did not wish their details to be used by marketing agencies and did not consider this a legitimate use of their data. Whilst participants were positive of the role a register could play in promoting research, participants felt that access to data by pharmaceutical industries should be administered by the guardianship committee. People with MS are concerned should their employers be able to access their personal information. Professionals were more cautious than people with MS in their approach to the use of patient personal data within a register. Conclusions: Whilst all stakeholders were positive of the benefits of an MS register, development of such a resource must incorporate robust data security and guardianship measures in order to ensure that, whilst opportunities are maximised, risks to the privacy of individuals and legal challenges to professionals are avoided. (shrink)

Readable and accessible collection of papers re thinking machines.

IntroductionSymptoms of schizophrenia are closely related to aberrant language comprehension and production. Macroscopic brain changes seen in some patients with schizophrenia are suspected to relate to impaired language production, but this is yet to be reliably characterized. Since heterogeneity in language dysfunctions, as well as brain structure, is suspected in schizophrenia, we aimed to first seek patient subgroups with different neurobiological signatures and then quantify linguistic indices that capture the symptoms of “negative formal thought disorder”.MethodsAtlas-based cortical thickness values of 66 (...) patients with first-episode psychosis and 36 healthy controls were analyzed with hierarchical clustering algorithms to produce neuroanatomical subtypes. We then examined the generated subtypes and investigated the quantitative differences in MRS-based glutamate levels [in the dorsal anterior cingulate cortex ] as well as in three aspects of language production features: fluency, syntactic complexity, and lexical cohesion.ResultsTwo neuroanatomical subtypes among patients were observed, one with near-normal cortical thickness patterns while the other with widespread cortical thinning. Compared to the subgroup of patients with relatively normal cortical thickness patterns, the subgroup with widespread cortical thinning was older, with higher glutamate concentration in dACC and produced speech with reduced mean length of T-units and lower repeats of content words, despite being equally fluent.ConclusionWe characterized a patient subgroup with thinner cortex in first-episode psychosis. This subgroup, identifiable through macroscopic changes, is also distinguishable in terms of neurochemistry and language behavior. This study supports the hypothesis that glutamate-mediated cortical thinning may contribute to a phenotype that is detectable using the tools of computational linguistics in schizophrenia. (shrink)

We summarise and respond to the main points made by the commentators on our target article, which concern: whether structural similarity can play a causal role in normal object identification and in neuropsychological deficits for living things, the nature of our structural knowledge of the world, the relations between sensory and functional knowledge of objects, and the nature of our functional knowledge about living things, whether we need to posit a “core” semantic system, arguments that can be marshalled from evidence (...) on functional imaging, the causal mechanisms by which category differences can emerge in object representations, and the nature of our knowledge about categories other than living and nonliving things. We also highlight points raised in our article that seem to be accepted. (shrink)

Ford, Norman M Throughout history Catholics held the commonly accepted views of the times regarding human reproduction, and these views changed as advances were made in scientific knowledge. Hence, it would be best to begin with Aristotle's views on human reproduction.

Ford, Norman M Doctors and nurses understand the personal dignity of their patients and their natural desire to be healthy and happy. The aged with failing memories or mental impairments are persons whose dignity and moral worth remain intact. They also know patients differ in their personal circumstances, their faith, their stages of life's journey and their attitude to sickness and approach of death. This awareness enables them to adequately perform their valuable professional services from a subject centred perspective (...) as well as from an objective approach based on our shared rational human nature. All this needs to be re-affirmed for patients, especially the aged, those living with post coma unresponsiveness, Alzheimer's disease and any other unconscious state. (shrink)

From the stance of cognitive developmental theories, claims that general g is an entity of the mind are compatible with notions about domain-general development and age-invariant individual differences. Whether executive function is equated with general g or fluid g, research into the mechanisms by which development occurs is essential to elucidate the kinds of environmental inputs that engender effective intervention. (Published Online April 5 2006).

Despite an abundance of academic conferences, clinical ethicists lacked a forum to share innovative practices with peers and to generate solutions to common challenges. Organizers of the first Clinical Ethics Un-Conference developed a working event centered on active participation and problem solving through peer learning, with the goal of improving realworld practice. Registrants included 95 individuals from 64 institutions. Attendees were surveyed immediately after the Un-Conference, and again eight months later. After eight months, 85 percent (n = 33/39) of the (...) survey respondents reported that they found the event “highly impactful” or “some-what impactful” to their clinical practice, and 23 attendees reported that they had implemented ideas or projects inspired by the event. Three sets of best practice guidelines and four white papers were published from the event. As the field of clinical ethics continues to advance and evolve, this working event format offers an innovative, disruptive alternative to a traditional conference format and may serve as a model for future efforts aimed at improving real-world clinical ethics practice. (shrink)