(Re)Conceptualising 'good' proxy decision-making for research: the implications for proxy consent decision quality.

People who are unable to make decisions about participating in research rely on proxies to make a decision based on their wishes and preferences. However, patients rarely discuss their preferences about research and proxies find it challenging to determine what their wishes would be. While the process of informed consent has traditionally been the focus of research to improve consent decisions, the more conceptually complex area of what constitutes 'good' proxy decision-making for research has remained unexplored. Interventions are needed to improve and support proxy decision-making for research but are hampered by a lack of understanding about what constitutes decision quality in this context. A global increase in conditions associated with cognitive impairment such as dementia has led to an urgent need for more research into these conditions. The COVID-19 pandemic and subsequent necessity to conduct research with large numbers of critically ill patients has made this need even more pressing. Much of the empirical research centres on the desire to improve decision accuracy, despite growing evidence that authenticity is more reflective of the aim of proxy decisions and concerns about the methodological flaws in authenticity-focused studies. Such studies also fail to take account of the impact of decision-making on proxies, or the considerable body of research on improving the quality of healthcare decisions. This paper reports a concept synthesis of the literature that was conducted to develop the first conceptualisation of 'good' proxy decisions about research participation. Elements of decision quality were identified across three stages of decision-making: proxy preparedness for decision-making which includes knowledge and understanding, and values clarification and preference elicitation; the role of uncertainty, decisional conflict, satisfaction and regret in the decision-making process; and preference linked outcomes and their effect. This conceptualisation provides an essential first step towards the future development of interventions to enhance the quality of proxy decision-making and ensure proxy decisions represent patients' values and preferences.

The Impact of Dementia on Oral Health and Dental Care, Part 2: Approaching and Planning Treatment.

Dementia has been described as the biggest health and social care challenge of this century; its impact on dental care cannot be ignored. Dementia affects cognitive ability and decision making, so it is important that oral healthcare professionals are conversant with current mental capacity legislation and issues that may be raised when treatment planning for patients living with the condition. This second article in the series considers the impact of dementia on dental care provision and covers a range of issues which are relevant to both general and specialist practice. These include assessment of capacity, use of different treatment modalities, such as sedation and general anaesthesia, and the factors that may be relevant when deciding to offer treatment or to refer to a secondary care setting for dental treatment. Advanced care planning is detailed to support general dental practitioners considering the longer-term wishes of their patients with an early diagnosis of dementia.

The ethics of risk displacement in research and public policy.

We identify three distinct ethical problems that can arise with risk displacement. Risk displacement is the shifting of extant risk from one or more individuals to other individual(s) such that the reduction of risk to the first group is causally implicated in increasing risk to the second group. These problems are: concentration of risk in inequitable ways; transfer of risk to already vulnerable or disadvantaged populations; and exercise of undue influence over potential research participants. The first two arise in both public policy and research initiatives, whereas the third is a special concern that only applies to research initiatives. We argue that when one or more of these is of high magnitude, then the study or policy intervention may be ethically wrong. Finally, we conclude that although some risk displacement is ethically permissible, researchers and policymakers still have ethical reasons to reduce the magnitude of these problems.

Risk to bystanders in clinical trials: A symposium.

This symposium takes a critical look at the ethics of impact on "bystanders" to clinical research. By that we mean study non-participants who nevertheless are at risk of being affected by the study in some way. This introduction suggests some questions to consider while reading through the symposium contributions, and gives a précis of each.

Objective monitoring of mosquito bednet usage and the ethical challenge of privacy revelations about study bystanders: Ethical analysis.

Clinical trials and public health surveillance of bednet use for malaria prevention involve the ongoing collection of sensitive data from private settings. This article discusses risks to bystanders, who have not consented to participating in surveillance or research, but whose behavior may nevertheless be recorded. In the case of clinical trials, community consultation and consent processes are one well-accepted way to address potential risk to bystanders. I argue that the intrusive monitoring required by some bednet trials may render this type of consent insufficient. In these cases, either bystanders should be enrolled as participants and give consent or less intrusive monitoring methods should be used. Validated monitoring methods should also have relevance for practice beyond use in a clinical trial. Considering the global impact of malaria, applying these methods to public health surveillance would be a practical use. Existing justifications for surveillance without consent, which sometimes result in coercive public health measures, could apply to the case of bednets. Particularly in cases where there is the potential for harm to others, individuals who were not the original subjects of disease reporting are often caught in the surveillance net. Although an argument can be made that malaria meets this bar, considerations of feasibility, sustainability, and trust make intrusive surveillance unsustainable in the case of a daily, lifelong behavior such as bednet use.

Regulating impact on bystanders in clinical trials: An unsettled frontier.

This article informally reviews key research ethics guidelines and regulations, academic scholarship, and research studies and finds wide variety in how they consider risk to bystanders in medical research (namely, non-participants whom studies nevertheless place at risk). Some of these key sources give no or very little consideration to bystanders, while others offer them the utmost protection (greater than they offer study participants). This unsettled frontier would benefit from a deeper investigation of the ethics of protecting research bystanders.

Healthcare professionals' understanding of the legislation governing research involving adults lacking mental capacity in England and Wales: a national survey.

OBJECTIVE: To examine health and social care professionals' understanding of the legislation governing research involving adults lacking mental capacity in England and Wales. METHODS: A cross-sectional online survey was conducted using a series of vignettes. Participants were asked to select the legally authorised decision-maker in each scenario and provide supporting reasons. Responses were compared with existing legal frameworks and analysed according to their level of concordance. RESULTS: One hundred and twenty-seven professionals participated. Levels of discordance between responses and the legal frameworks were high across all five scenarios (76%-82%). Nearly half of the participants (46%) provided responses that were discordant in all scenarios. Only two participants (2%) provided concordant responses across all five scenarios. DISCUSSION: Participants demonstrated a lack of knowledge about the legal frameworks, the locus of authority and the legal basis for decision-making. The findings raise concern about the accessibility of research for those who lack capacity, the ability to conduct research involving such groups and the impact on the evidence base for their care. CONCLUSION: This is the first study to examine health and social care professionals' knowledge and understanding of the dual legal frameworks in the UK. Health and social care professionals' understanding and attitudes towards research involving adults with incapacity may warrant further in-depth exploration. The findings from this survey suggest that greater training and education is required.

Cerebrospinal Fluid Apolipoprotein E Levels in Delirium.

BACKGROUND/AIMS: Delirium and the apolipoprotein E ε4 allele are risk factors for late-onset Alzheimer disease (LOAD), but the connection is unclear. We looked for an association. METHODS: Inpatients with delirium (n = 18) were compared with LOAD outpatients (n = 19), assaying blood and cerebrospinal fluid (CSF) using multiplex ELISA. RESULTS: The patients with delirium had a higher Confusion Assessment Method (CAM) score (5.6 ± 1.2 vs. 0.0 ± 0.0; p < 0.001) and Delirium Index (13.1 ± 4.0 vs. 2.9 ± 1.2; p = 0.001) but a lower Mini-Mental State Examination (MMSE) score (14.3 ± 6.8 vs. 20.8 ± 4.6; p = 0.003). There was a reduction in absolute CSF apolipoprotein E level during delirium (median [interquartile range]: 9.55 µg/mL [5.65-15.05] vs. 16.86 µg/mL [14.82-20.88]; p = 0.016) but no differences in apolipoprotein A1, B, C3, H, and J. There were no differences in blood apolipoprotein levels, and no correlations between blood and CSF apolipoprotein levels. CSF apolipoprotein E correlated negatively with the CAM score (r = -0.354; p = 0.034) and Delirium Index (r = -0.341; p = 0.042) but not with the Acute Physiology and Chronic Health Evaluation (APACHE) index, or the MMSE or Informant Questionnaire on Cognitive Decline in the Elderly (IQCODE). CONCLUSION: Reduced CSF apolipoprotein E levels during delirium may be a mechanistic link between two important risk factors for LOAD.

COMmunication with Families regarding ORgan and Tissue donation after death in intensive care (COMFORT): protocol for an intervention study.

BACKGROUND: Discussing deceased organ donation can be difficult not only for families but for health professionals who initiate and manage the conversations. It is well recognised that the methods of communication and communication skills of health professionals are key influences on decisions made by families regarding organ donation. METHODS: This multicentre study is being performed in nine intensive care units with follow-up conducted by the Organ and Tissue Donation Service in New South Wales (NSW) Australia. The control condition is pre-intervention usual practice for at least six months before each site implements the intervention. The COMFORT intervention consists of six elements: family conversations regarding offers for organ donation to be led by a "designated requester"; family offers for donation are deferred to the designated requester; the offer of donation is separated from the end-of-life discussion that death is inevitable; it takes place within a structured family donation conversation using a "balanced" approach. Designated requesters may be intensivists, critical care nurses or social workers prepared by attending the three-day national "Family Donation Conversation" workshops, and the half-day NSW Simulation Program. The design is pre-post intervention to compare rates of family consent for organ donation six months before and under the intervention. Each ICU crosses from using the control to intervention condition after the site initiation visit. The primary endpoint is the consent rate for deceased organ donation calculated from 140 eligible next of kin families. Secondary endpoints are health professionals' adherence rates to core elements of the intervention; identification of predictors of family donation decision; and the proportion of families who regret their final donation decision at 90 days. DISCUSSION: The pragmatic design of this study may identify 'what works' in usual clinical settings when requesting organ donation in critical care areas, both in terms of changes in practice healthcare professionals are willing and able to adopt, and the effect this may have on desired outcomes. The findings of this study will be indicative of the potential benefits of the intervention and be relevant and transferrable to clinical settings in other states and countries. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry (ANZCTR): ACTRN12613000815763 (24 July 2013). ClinicalTrials.gov: NCT01922310 (14 August 2013) (retrospectively registered).

Feasibility of conducting prospective observational research on critically ill, dying patients in the intensive care unit.

Studying patients during the end of life is important, as it has the potential to lead to improvements in care for the dying. For patients who die after a controlled withdrawal of life-sustaining therapies in the intensive care unit, information about the natural history of death and the process of removing life support has additionally led to advances in practice for deceased organ donation. However, this unique population of severely critically ill and imminently dying patients has been difficult to study, largely due to assumptions made by research teams and ethics boards alike about the logistical difficulties of obtaining consent and completing research procedures before or during the process of withdrawal of life-sustaining therapies. In this paper, we describe the ethics substudy of the first prospective observational research study in Canada to obtain consent and collect clinical data on patients during the process of withdrawal of life-sustaining therapies in the intensive care unit. We describe in detail the process of protocol development, review by five institutional research ethics boards and bedside staff satisfaction with the study. We conclude that prospective research on a critically ill and imminently dying population is feasible and can be conducted in an ethical manner. Further information is needed about the experiences and motivations of families and substitute decision makers who provide consent for research on critically ill intensive care unit patients at the end of life.

Measuring informed consent capacity in an Alzheimer's disease clinical trial.

INTRODUCTION: Accurately and efficiently determining a participant's capacity to consent to research is critically important to protect the rights of patients with Alzheimer's disease (AD). METHODS: Understanding of the informed consent document was assessed in 613 community-dwelling patients with mild-to-moderate AD enrolled in a randomized, placebo-controlled trial. Associations were examined between clinically determined capacity to consent and (1) patient demographics and clinical characteristics and (2) the Informed Consent Questionnaire (ICQ), an objective measurement of a participant's factual understanding and perceived understanding. RESULTS: A total of 453 (74%) participants were determined to have capacity to consent by clinical judgment. ICQ perceived understanding, race, measures of cognitive function, and caregiver time were all significantly associated with the determination of capacity in multivariate analyses. DISCUSSION: We found a significant association between capacity and disease severity level, caregiver time, race, and ICQ perceived understanding.

Ethical implications of Italian legislation on 'epilepsy and driving'.

The laws concerning driving licences and epilepsy in different countries are very diverse with regard to the criteria for issuance or renewal of licences, and also the methods of evaluating fitness. In 2011, a law was issued in Italy implementing the European directives on driving licences, including provisions for mandatory notification that a driver is epileptic. This was established regardless of the European rules that require compulsory notification only of patients. The Federation of Italian Boards of Physicians has made recommendations against mandated physician reporting, resulting in a current confusion between legal and ethical recommendations to medical doctors. The mandatory notification enacted by Italian law raises ethical concerns about disparities in access to care and possible violations of the right to confidentiality of patient information. Moreover, the law discussed here fails to emphasise the importance of physicians ensuring compliance by the patient, by sharing the correct information about the risks associated with illegal driving and by obtaining information from the patient through regular check-ups. An urgent revision of the law is required to implement the duty of the physician to provide information and to ensure that the rule about mandatory notification should be erased in favour of optional self-reporting by epileptics as the preferred way to notify the licensing authority. The implementation of these measures could correct the dichotomy between the law and the ethical recommendations for medical doctors and protect the rights of people with epilepsy as well as those of any other patients whose pathology or impairment could imply a risk to the community.

Consentimento informado e competência em pediatria: opiniões de uma amostra de médicos romenos em treinamento / Informed consent and competence in pediatrics: opinions from a sample of Romanian physicians in training

OBJETIVOS: Analisar o ponto de vista de médicos em treinamento a respeito do consentimento informado como autorização autônoma em pediatria e discutir os efeitos limitantes da norma de competência nesse campo. MÉTODOS: Foi realizado um estudo multi-institucional com 158 residentes de medicina com o intuito de analisar o ponto de vista de médicos em treinamento a respeito do consentimento informado como autorização autônoma em pediatria. A participação no estudo foi voluntária, e os participantes eram provenientes de uma área geográfica limitada (Bucareste e arredores). RESULTADOS: A maioria dos respondentes concordou totalmente que um paciente entre 16 e 18 anos deve tomar decisões médicas informadas sobre qualquer tipo de procedimento (inclusive os referentes a escolhas reprodutivas); enquanto que pacientes entre 14 e 16 anos devem ser autorizados a tomar decisões médicas informadas apenas a respeito de procedimentos menores. A maioria concordou que transplantes de medula óssea devem ser permitidos entre irmãos se aprovados por ambos, enquanto que a maioria não concorda com o transplante de órgãos sólidos. A participação de crianças em estudos clínicos deve ser permitida apenas se a criança concordar. CONCLUSÕES: As respostas obtidas em nosso estudo sobre o consentimento informado aproximam-no mais do sentido de autorização autônoma do que do sentido de autorização efetiva. Portanto, a intuição moral dos participantes é mais bioética e menos jurídica, o que, embora maximize os benefícios do paciente, está associado a um aumento no risco de responsabilidade. No entanto, visto que as gerações mais novas tornam-se cada vez mais precoces, é preciso reavaliar os dogmas tradicionais a respeito da competência.

OBJECTIVES: To assess the views of physicians in training regarding the informed consent as autonomous authorization in pediatrics and to discuss the limiting effects of the competence norm in this field. METHODS: We conducted a multi-institutional survey with 158 medical residents in order to assess the views of physicians in training regarding the informed consent as autonomous authorization in pediatrics. The study was conducted with volunteer participants, from a limited geographical area (Bucharest and surrounding areas). RESULTS: Most respondents strongly agreed that a patient aged 16-18 years should make informed medical decisions regarding any type of procedures (including reproductive choices), whilst those aged 14-16 should be allowed to take informed medical decisions regarding minor procedures only. Most participants agreed that transplant procedures involving bone marrow should be allowed between siblings if they approve, whilst most disagreed allowing solid organ transplantation. The involvement of children in clinical studies should only be allowed if the children agree. CONCLUSIONS: The responses obtained in our study regarding the informed consent put it closer to the autonomic authorization sense than the effective authorization sense. Therefore, respondents' moral intuition is more bioethical and less legal, which, even if maximizing the patient's benefit, is associated with an increased liability risk. However, since the newer generations become more and more precocious, a reanalysis of the classical competence dogmas should be conducted.

O responsável legal é de fato o responsável? Um questionamento ético-legal sobre o termo / Is the legally responsible party indeed responsible?An ethical-legal question on the term

Os autores discutem o significado ético e jurídico da expressão "responsável legal", questionando seus limites. Demonstram que de fato ela não atende satisfatoriamente o que se denomina responsabilidade legal, pois para tanto teria que encontrar amparo nos códigos e normas legais, o que, de fato, não acontece. Assim, a expressão representante legal pode não possibilitar ao profissional, quando de sua utilização respaldo ético e legal normativo a sua atividade profissional.

The authors discuss the legal and ethical meaning of the expression "Third-Party Consent" by questioning its limits. It is indeed shown that it does not satisfactorily meet what is called third-party consent because this would require legal endorsement by legal codes and norms which, in fact does not occur. As such, the expression "third-party consent", whenever used, may not provide the professional with the normative, ethical and legal support needed for professional performance.