Parent–Child Roles in Decision Making About Medical Research

Our objective is to understand how parents and children perceive their roles in decision making about research participation. Forty-five children (ages 4–15 years) with or without a chronic condition and 21 parents were the participants. A semistructured interview assessed perceptions of up to 4 hypothetical research scenarios with varying levels of risk, benefit, and complexity. Children were also administered the Peabody Picture Vocabulary Test, Third Edition, to assess verbal ability, as a proxy for the child's cognitive development. The audiotaped interviews were transcribed and analyzed for themes related to parent and child decision-making roles. Both parents and children varied in their perceptions of decision-making roles. Child perceptions of parental influence on decision making as knowledge-based increased with cognitive development, whereas perceptions of parental influence as power-based decreased. Both children and parents commented that they would collaborate with each other when making decisions. Collaborative decision making appeared to increase with cognitive development. These findings suggest that approaches to child assent and parent permission should consider the parent–child relationship and how children and families typically make decisions. Future research is necessary to explain variation in the process of research decision making across children and families, explore the role of collaboration on children's decision-making skills, and understand developmental trajectories and mechanisms related to research decision making.     

The Ethical Inclusion of Children With Psychotic Disorders in Research: Recommendations for an Educative,Multimodal Assent Process

This article addresses the issue of properly assenting children with psychotic disorders to participate in clinical research. Due to the protective concerns with such a vulnerable population, additional precautions are necessary to ensure that youth with psychotic disorders assent to research with an appropriate level of understanding regarding study procedures. Current literature suggests that positive/negative symptoms and minor cognitive deficits do not interfere with the ability to comprehend study-related information for adults with psychosis if the study information is presented through an educative process. Similarly, youth benefit from repeated presentation of procedures and periodic assessment of their comprehension. An integrated educative process is proposed that emphasizes the importance of an interactive consent through repetition and participant/investigator feedback.     

Child Assent and Parental Permission in Pediatric Research

Since children are considered incapable ofgiving informed consent to participate inresearch, regulations require that bothparental permission and the assent of thepotential child subject be obtained. Assent andpermission are uniquely bound together, eachserving a different purpose. Parentalpermission protects the child from assumingunreasonable risks. Assent demonstrates respectfor the child and his developing autonomy. Inorder to give meaningful assent, the child mustunderstand that procedures will be performed,voluntarily choose to undergo the procedures,and communicate this choice. Understanding theelements of informed consent has been theparadigm for assessing capacity to give assent.This method leaves the youngest, leastcognitively mature children vulnerable towaiver of assent and forced researchparticipation. Voluntariness can also becompromised by the influence of authorityfigures who can exert undue influence andcoerce children to participate in research. This paper discusses factors that may influencethe decision to give assent/permission,potential parent-child conflict in theassent/permission process and how it isresolved, and potential parental undueinfluence on research participation. Theseissues are illustrated with quotations drawnfrom a larger qualitative study of parentalpermission and child assent (data notpresented). We suggest a developmentalapproach, viewing assent as a continuum rangingfrom mere affirmation in the youngest childrento the equivalent of the informed consentprocess in the mature adolescent.     

The Default Position: Optimizing Pediatric Participation in Medical Decision Making

Inclusion of children in medical decision making, to the extent of their ability and interest in doing so, should be the default position, ensuring that children are routinely given a voice. However, optimizing the involvement of children in their health care decisions remains challenging for clinicians. Missing from the literature is a stepwise approach to assessing when and how a child should be included in medical decision making. We propose a systematic approach for doing so, and we apply this approach in a discussion of two challenging clinical cases. The approach is informed by a literature review, and is anchored by case studies of teenagers' refusal of clinical care, regulatory requirements for research assent, and the accepted approach to involving cognitively impaired adults in medical decisions.     

Toward a further understanding of the intuitive personologists: Some critical evidence on the diabolical quality of subjective psychometrics

Despite significant advances over the past three decades in our understanding of the implicit dangers in ad hoc psychometric procedures, some important questions remain, particularly as regards the nature of the underlying reasoning process by which subjectively meaningful theoretical impressions are formulated and expressed. The present article seeks to address this issue, with particular attention being given to the distinction between demonstrative and dialectical reasoning. Evidence is offered to show that, at least under certain conditions, intuitive psychometricians formulate and express theoretical impressions on the basis of a reasoning process that is essentially dialectical in nature. Some major implications of this point of view for the study of personality theory are discussed. The limitations of the evidence presented, and the need for further research, are forgone.     

Toward a further understanding of the intuitive personologist: Some preliminary evidence for the dialectical quality of subjective personality impressions

Despite significant advances over the past three decades in our understanding of the implicit personality theorist, some important questions remain, particularly as regards the nature of the underlying reasoning process by which subjectively meaningful personality impressions are formulated and expressed. The present article seeks to address this issue, with particular attention being given to the distinction between demonstrative and dialectical reasoning. Preliminary empirical evidence is offered to suggest that, at least under certain conditions, lay persons formulate and express subjective personality impressions on the basis of a reasoning process that is essentially dialectical in nature. Some major implications of this point of view for the study of the intuitive personologist are discussed. The limitations of the evidence presented, and the need for further research are also noted.     

Toward a causal realist account of causal understanding

Within a limited domain, humans can perceive causal relations directly. The term causal realism is used to denote this psychological hypothesis. The domain of causal realism is in actions upon objects and haptic perception of the effects of those actions: When we act upon an object we cannot be mistaken about the fact that we are acting upon it and perceive the causal relation directly through mechanoreceptors. Experiences of actions upon objects give rise to causal knowledge that can be used in the interpretation of perceptual input. Phenomenal causality, the occurrence of causal impressions in visual perception, is a product of the application of acquired causal knowledge in the automatic perceptual interpretation of appropriate stimuli. Causal realism could constitute the foundation on which all causal perception, judgment, inference, attribution, and knowledge develop.     

Psychology of the Informed Consent Process: A Commentary on Three Recent Articles

In conducting research on humans, respect for human dignity requires investigators to obtain informed consent. Institutional pressures, however, often reduce the informed consent form to a signature on a document. Unfortunately, people often do not read or understand these documents. In the present effort, we argue that the key problem here arises because investigators often do not take into account the psychology of participants. Based on 3 articles, we argue that informed consent requires investigators to help participants “make sense” of a study, and its implications, for both themselves and others. Informed consent procedures that might encourage participant sensemaking are discussed.     

Toward a decolonial global ethics

This paper argues that decolonial theory can offer a distinctive and valuable ethical lens. Decolonial perspectives give rise to an ethics that is fundamentally global but distinct from, and critical of, moral cosmopolitanism. Decolonial ethics shares with cosmopolitanism a refusal to circumscribe normative commitments on the basis of existing political and cultural boundaries. It differs from cosmopolitanism, though, by virtue of its rejection of the individualism and universalism of cosmopolitan thought. Where cosmopolitan approaches tend to articulate abstract principles developed from within a particular Western tradition, decolonial approaches reject abstract global designs in favour of inter-cultural dialogue amongst multiple people(s), including peoples who deem collective and non-human entities to be of fundamental moral importance. In addition, decolonial global ethics rejects universality in favour of ‘pluriversality’.     

A Goodness-of-Fit Approach to Informed Consent for Pediatric Intervention Research

As children and adolescents receive increased research attention, ethical issues related to obtaining informed consent for pediatric intervention research have come into greater focus. In this article, we conceptualize parent permission and child assent within a goodness-of-fit framework that encourages investigators to create consent procedures “fitted” to the research context, the child's cognitive and emotional maturity, and the family system. Drawing on relevant literature and a hypothetical case example, we highlight four factors investigators may consider when constructing consent procedures that best reflect participants' rights, concerns, and well-being: (a) the child's current assent capacity and the likely impact of study information on the child's mental and physical development, (b) parents' understanding of their child's treatment needs and distinctions between treatment and clinical trials research, (c) the family's history of shared decision making, and (d) the child's strivings for autonomy within the context of their parents' duty to make decisions in the child's best interest.     

Informed consent as a prescription calling for debate between analysts and researchers(1)

This article is a review of the international scientific literature on informed consent and its use in some of the constituent organizations of the International Psychoanalytical Association (IPA). Because psychoanalysis comprises a theory based on practice, the dearth of clinical material for study, training and research purposes is a serious problem for analysts. Supervisions, presentations at scientific societies and congresses, publications and teaching material involve patients to an extent that goes beyond the work done in their sessions. Should consent be requested in these cases? This contribution addresses controversial and long‐standing issues such as informed consent and confidentiality, audio recording of treatments, knowledge production, the ambivalence of participating subjects over time and the perspective of analysts and patients respectively. The authors consider the various alternative approaches available for the handling of these ethical dilemmas without losing sight of the patient’s dignity and personal rights, while also taking account of the position of the analyst.     

Software informed consent: Docete emptorem, not caveat emptor

Should software be sold “as is”, totally guaranteed, or something else? This paper suggests that “informed consent”, used extensively in medical ethics, is an appropriate way to envision the buyer/developer relationship when software is sold. We review why the technical difficulties preclude delivering perfect software, but allow statistical predictions about reliability. Then we borrow principles refined by medical ethics and apply them to computer professionals.     

Ethical Dimension of Paediatric Cochlear Implantation

In congenitally or prelingually deaf childrencochlear implantation is open to seriousethical challenge. The ethical dimension ofthis technology is closely related to both asocial standard of quality of life and to theuncertainty of the overall results of cochlearimplantation. Uncertainty with regards theacquisition of oral communicative skills.However, in the western world, available datasuggest that deafness is associated with thelowest educational level and the lowest familyincome. Notwithstanding the existence of aDeaf-World, deafness should be considered as ahandicap. Therefore, society should provide themeans for the fulfilment of a deaf child'sspecific needs.For the time being there is no definitiveanswer with regard the best way to rehabilitatea particular deaf child. Therefore,communitarian values may be acceptable. If thedeaf child parents' decide not to implant,their decision should be respected. Guardiansare entitled to determine which standard ofbest interest to use in a specificcircumstance. They are the proper judges ofwhat (re)habilitation process is best for theirdeaf child. However, most deaf children areborn to two hearing parents. Probably, theywill not be acculturated in the Deaf-World. Itfollows that cochlear implantation is awelcomed (re)habilitation technology.If auditory (re)habilitation will in the futureprovide the necessary communicative skills, inparticular oral language acquisition, customs,values and attitudes of the hearing worldshould be regarded as necessary to accomplish adeaf child's right to an open future. Ifcochlear implantation technology will provideall deaf children with the capacity to developacceptable oral communicative skills –whatever the hearing status of the family andthe cultural environment – then auditory(re)habilitation will be an ethical imperative.     

Neuropsychological Functioning and Recall of Research Consent Information Among Drug Court Clients

Evidence suggests that research participants often fail to recall much of the information provided during the informed consent process. This study was conducted to determine the proportion of consent information recalled by drug court participants following a structured informed consent procedure and the neuropsychological factors that were related to recall. Eighty-five participants completed a standard informed consent procedure to participate in an ongoing research study, followed by a 17-item consent quiz and a brief neuropsychological battery 2 weeks later. Participants performed within the normal range on most of the neuropsychological measures, although roughly one third showed deficits on measures of executive functioning. Participants failed to recall over 65% of the consent information within 2 weeks of entering the study, and their recall was significantly correlated with verbal IQ, drug problem severity, reading ability, memory, and attention. These factors may be useful in determining whether research participants require enhanced consent procedures.     

Navigating Moral Struggle: Toward a Social Model of Exemplarity

Exemplars have the power to help people navigate various levels of moral struggle, from the relatively straightforward problem of lacking motivation to the much deeper problem of failing to see the moral realities that surround us. But there are also serious moral risks in the appeal to exemplars: we romanticize them, we make use of them in authoritarian ways, and we tend to forget how our choice of exemplars is conditioned by oppressive cultural formations. I argue that we need to develop a social model of exemplarity, attuned to social contexts of our exemplars themselves as well as the social processes of constructing and appealing to exemplars. More particularly, I argue that we need to develop space for thinking about exemplary groups, not just exemplary individuals, in order to develop the strengths and avoid the weaknesses in exemplarist moral theories.     

Toward a better understanding of loneliness in community-dwelling older adults

The purpose of this interpretive phenomenological study was to explore the meaning of loneliness in community-dwelling older adults and to understand their daily practices in coping with loneliness. The sample consisted of 8 women and 4 men. Interviews were conducted with the 12 participants utilizing several tools, including 3 separate interview guides and the UCLA Loneliness Scale, Version 3 (Russell, 1996). A critical finding was that many participants experienced loneliness as a result of disrupted meaningful engagement, due to age-related changes, as well as other losses, including death of spouse, retirement, and giving up the car. Two paradigm cases and themes representing the loneliness and coping experience emerged. Participant coping practices with loneliness included reaching out to others, helping those in need, and seeking companionship with pets. Many older adults are at risk for loneliness because of declining health and other age-related losses that prevent them from remaining engaged in meaningful relationships. Health care professionals can screen for loneliness to identify those at risk and can intervene to help older adults maintain connections. Recommendations for those caring for lonely older adults include active listening, vision and hearing screenings, transportation needs, pet therapy, volunteering, and engagement in social activities.     

基因研究中的知情同意之惑

知情同意作为生命伦理的重要原则,在基因研究中同样占据重要的地位,由于基因研究中知情同意的异质性,在基因研究中面临着诸如如何理解其知情同意的异质性、群体知情同意、基因知情与基因隐私、利益冲突等问题.通过分析基因研究中知情同意的特殊性,综合国内外此领域的已有研究,运用理论联系实际的方法,得出结论认为,只有正确区分基因知情与基因隐私的权利主体,用伦理规范来解决利益冲突,在发展中不断完善知情同意,才能够取得科技与伦理的共赢.     

探讨和完善生物医学期刊来稿中的伦理学问题

生物医学期刊来稿中最常见的伦理学问题就是受试者“知情同意”的问题。生物医学期刊通过提高编辑人员素质、加强医学伦理学宣传教育、对来稿严格把关以及协助科研机构建立和完善伦理学审查委员会,不断探讨和完善来稿中的伦理学问题,这不仅是对受试者负责,而且有利于医学科研人员素质的提高,有利于生物医学研究健康、有序的发展。