Establishing a global regulatory floor for children's decisions about participation in clinical research.

BACKGROUND: Enrolling children in clinical trials typically requires parental or guardian permission and, when appropriate, child assent. Aligning requirements across jurisdictions would facilitate multisite pediatric trials. Guidance from the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) is the best candidate for a global standard but would benefit from additional specification. METHODS: Ethical analysis of ICH guidance for permission and assent for pediatric trials, with recommendations for clarification. RESULTS: ICH guidance regarding permission and assent would be enhanced by additional detail in the following areas: (1) what information should be provided to parents, guardians, and children considering a trial, and how that information should be provided; (2) the definition of "assent," the criteria for when assent should be required, and the need to include children in discussions even when assent is not mandated; (3) criteria for requiring children's signatures indicating agreement; (4) greater specificity regarding children's right to decline or withdraw; and (5) clarification of when children's wish to decline or withdraw from participation may be overridden and of what the overriding process should entail. CONCLUSION: ICH guidance provides a global standard for decision making regarding children's participation in trials. Several clarifications would facilitate the conduct of multinational pediatric research. IMPACT: Enrolling children in clinical trials requires the permission of a parent/guardian ± the assent of the minor. Differing global regulatory requirements for enrolling children complicate the conduct of multicenter and multinational trials. The authors identify points of ambiguity and/or contradiction in the International Council for Harmonization guidelines and offer recommendations for a common ethical platform for conducting global pediatric research.

Quality/risk management system in radiotherapy: Changes afoot.

The French sanitary and regulatory context in which radiotherapy centres are comprised is evolving. Risk and quality management systems are currently adapting to these evolutions. The French nuclear safety agency (ASN) decision of July 1st 2008 on quality assurance obligations in radiotherapy has reached 10 years of age, and the French high authority of health (HAS) certification system 20 years now. Mandatory tools needed for the improvement of quality and safety in healthcare are now well known. From now on, the focus of healthcare policies is oriented towards evaluation of efficiency of these new organisations designed following ASN and HAS nationwide guidelines.

Challenging misconceptions about clinical ethics support during COVID-19 and beyond: a legal update and future considerations.

The pace of change and, indeed, the sheer number of clinical ethics committees (not to be confused with research ethics committees) has accelerated during the COVID-19 pandemic. Committees were formed to support healthcare professionals and to operationalise, interpret and compensate for gaps in national and professional guidance. But as the role of clinical ethics support becomes more prominent and visible, it becomes ever more important to address gaps in the support structure and misconceptions as to role and remit. The recent case of Great Ormond Street Hospital for Children NHS Foundation Trust v MX, FX and X ([2020] EWHC 1958 (Fam), [21]-[23] and [58]) has highlighted the importance of patient/family representation at clinical ethics committee meetings. The court viewed these meetings as making decisions about such treatment. We argue that this misunderstands the role of ethics support, with treatment decisions remaining with the clinical team and those providing their consent. The considered review by clinical ethics committees of the moral issues surrounding complex treatment decisions is not a matter of determining a single ethical course of action. In this article, we consider current legal understandings of clinical ethics committees, explore current concepts of ethics support and suggest how they may evolve, considering the various mechanisms of the inclusion of patients and their representatives in ethics meetings which is not standard in the UK.

'We try' - how nurses work with patient participation in forensic psychiatric care.

RATIONALE: Patients in secure forensic psychiatric care have reduced autonomy because of the constraints imposed on them by compulsion laws. Thus, it is vital that nurses enable patient participation whenever possible. Patient participation, and it's clinical use in forensic psychiatric care, is an understudied field. AIM: To describe nurses' experiences of their work with patient participation in forensic psychiatric care. METHODS: Managers at different secure forensic psychiatric institutions in the south of Sweden approved the study, and oral consent was retrieved from informants. Interviews guided by a semi-structured interview guide were conducted with nine nurses from five different forensic psychiatric institutions and analysed with content analysis. FINDINGS: Nurses describe diverse understandings and abilities in an inflexible setting. This indicates that what participation is, and how to achieve it, is not the same for nurses as for patients. Moreover, patients have different abilities to participate, and the secure setting in itself is perceived as hindering participatory work. Still, participation is described as a crucial part of work that requires a caring relationship. Furthermore, nurses pronounce potentially excluding attitudes and strategies that may obstruct patient participation for all, and at the same time, they have a belief that improvement is possible. CONCLUSION: Compulsory forensic psychiatric care is a complex care context that requires constant efforts from nurses to balance patients' rights and needs with mandatory care. The very nature of this caring context appears to be a major obstacle when promoting patient participation. Nevertheless, nurses express that they do aim for patient participation, 'they try'. From a patient's perspective, trying is not sufficient and a need for improvement is evident. The results can be of clinical interest in similar secure forensic psychiatric nursing settings, and a point of departure in future development of care striving for increased patient participation for all.

Tailoring a rapid autopsy protocol to explore cancer evolution: a patient collaboration.

Genomic analysis of tissues from rapid autopsy programmes has transformed our understanding of cancer. However, these programmes are not yet established in New Zealand. Our neuroendocrine tumour research group, NETwork!, received a request from a patient wishing to donate tumour tissues post-mortem. This viewpoint article summarises the ethical, logistical and social process undertaken to accept this patient's generous donation, and highlights the scientific and educational value of such a gift.

An examination of organisational policies for healthcare and lifestyle decision-making among Australian aged care providers.

OBJECTIVE: Examine policies of aged care organisations relating to healthcare and lifestyle decision-making. METHODS: Seven aged care organisations submitted policy documents. Policies were analysed using the Australian Law Reform Commission (ALRC) "Decision-Making Principles" as a framework. Senior staff (N = 9) with policy development roles participated in follow-up interviews. RESULTS: The structure and content of policy documents varied significantly between organisations. Most acknowledged the need to support the rights of care recipients in decision-making; however, the nature of this support was often unclear. Interview themes included factors relating to "organisational contexts" "policy development and implementation" and "ethical challenges." An overarching theme among high-performing organisations was "proactive response aimed at pre-empting decision-making dilemmas". We provide recommendations for policy development, including a self-assessment audit tool. CONCLUSION: Aged care provider organisations may need to review policies in the areas of healthcare and lifestyle decision-making to meet current best practice principles.

A Comparative Analysis of the Treatment of Decision-Making by or for Patients with Neurodegenerative Diseases in Four Legal Jurisdictions.

Dementia is associated with the gradual impairment of mental ability. The population of people suffering from dementia is as large as 50 million. Most dementia cases result from various neurodegenerative diseases (NDs) linked by a progressive degeneration of neurons. Among NDs, Alzheimer's disease (AD) is the most frequent cause of dementia and accounts for 60- 80% of cases. Certain pathological changes on the cellular and subcellular level occur even 15 years before the manifestation of clinical symptoms of AD. This first asymptomatic phase of AD is considered a preclinical stage, whereas mild cognitive impairment (MCI) is the symptomatic pre-dementia stage. The third, fully symptomatic phase of AD is dementia due to AD. The presence of specific proteins in the cerebrospinal fluid (CSF) may be considered as a characteristic feature of some NDs. The measurement of their CSF concentrations, together with neuropsychological examination and neuroimaging, may be useful for diagnosing AD. The collection of CSF samples is performed by lumbar puncture, which is a medical procedure that requires obtaining informed consent from patients. While asymptomatic AD patients have full legal capacity, those with dementia require a legal guardian who will represent them. Thus, the objective of this study is to compare the legal systems regulating the legal capacity issue in the USA, U.K. (England and Wales), Germany, and Poland. These countries have been chosen as examples of three different types of legal orders, according to the sources of law, i.e., civil law, common law, and case law.

Shared perioperative decision making: a shift in the doctor-patient paradigm.

The high-risk surgical patient only constitutes approximately 4% of the elective non-cardiac surgical population but contributes to the vast majority of in-hospital deaths following surgery. This, in conjunction with a high morbidity rate, can lead to a perioperative pathway fraught with challenges. It is incredibly difficult to anticipate which complications may arise and the risks involved before surgery. It is for this reason that patients need to be engaged in the decision-making processes regarding their perioperative care involved before major surgery. A combination of good medical practice, medicolegal influences and a governmental drive have begun to result in a shift away from paternalistic medicine to a shared decision-making approach. This article defines shared decision making, explores its benefits and limitations and addresses the relevant legal literature.

Navigating difficult conversations.

Breaking bad news and navigating difficult conversations is challenging and a frequent occurrence in surgical oncology practice. Cancer communication recommendations are guided by ethical principles, legal precedence, and emerging evidence regarding patient preference and efficacy of communication tools. Evidence continues to mount supporting a patient-centered communication approach and a model of shared decision making. Likewise, physician training in effective patient-centered cancer communication continues to evolve.

Role of Patients and Parents in Pediatric Drug Development.

Patient engagement in health care has been an emerging priority in the global effort and move toward the consideration of patients as experts of their own conditions. However, the input of pediatric patients and their families have not been consistently requested nor regarded as valuable when deriving protocols for, as well as assessing the outcomes of, pediatric clinical trials. Extending this mutual collaboration further upstream is important, especially in the area of pediatric drug development where the lack of formalized trials for children and adolescents result in the increased use of off-label prescribing and risk of adverse effects. While recent changes to European and North American legislation contributed to the inclusion of children and youth in pediatric drug development, the lack of systematic guidelines and methodologies in literature serve as barriers for practical application. When combined with the work of external pediatric advocacy and patient advisory groups, the hope is that pediatric patient voices can be brought forward for the future. This article brings together international experts to review current best practices, progress from regulatory agencies, as well as global advocacy efforts to involve patients and families in the pursuit of drug development processes that value the voice of children and youth.

The right to choose treatment-without-treatment: respecting civil rights or an unprecedented manifestation of 'reverse stigma'?

Recently the Norwegian Health Minister ordered the creation of medication-free treatment wards as a result of the lobbying by patients' groups and activists. The idea behind this is that patients should have the right to choose their treatment, but for the first time, with this arrangement, the user/patient does not choose between treatment options; he literally determines by himself what efficacious treatment is. In our opinion this is another step towards a 'reverse stigma' which denies patients the right to be considered as such and eventually kicks them out of the health care system, deprives them of the right for proper treatment and care and instead puts them at the jurisdiction of the much cheaper and ineffective social services.

Supported decision-making from the perspectives of mental health service users, family members supporting them and mental health practitioners.

BACKGROUND: Supporting the decision-making of mental health service users fulfils professional, ethical and moral obligations of mental health practitioners. It may also aid personal recovery. Previous research on the effectiveness of supported decision-making interventions is limited. AIMS: The study aims to explore from several perspectives the barriers and facilitators to supported decision-making in an Australian context. Supported decision-making was considered in terms of interpersonal experiences and legal supported decision-making mechanisms. METHODS: In all, 90 narrative interviews about experiences of supported decision-making were conducted and analysed. Participants were mental health service users who reported diagnoses of schizophrenia, psychosis, bipolar disorder and severe depression; family members supporting them and mental health practitioners, including psychiatrists. The data were analysed thematically across all participants. RESULTS: Negative interpersonal experiences in the mental health care system undermined involvement in decision-making for people with psychiatric diagnoses and family carers. Mental health practitioners noted their own disempowerment in service systems as barriers to good supported decision-making practices. All groups noted the influence of prevailing attitudes towards mental health service users and the associated stigma and discrimination that exist in services and the broader community. They believed that legal supported decision-making mechanisms facilitate the participation of mental health service user and their family supporters in supported decision-making. CONCLUSIONS: Enabling supported decision-making in clinical practice and policy can be facilitated by (1) support for good communication skills and related attitudes and practices among mental health practitioners and removing barriers to their good practice in health and social services and (2) introducing legal supported decision-making mechanisms.

Incorporating the patient experience into regulatory decision making in the USA, Europe, and Canada.

The clinical development of cancer therapeutics is a global undertaking, and incorporation of the patient experience into the clinical decision-making process is of increasing interest to the international regulatory and health policy community. Disease and treatment-related symptoms and their effect on patient function and health-related quality of life are important outcomes to consider. The identification of methods to scientifically assess, analyse, interpret, and present these clinical outcomes requires sustained international collaboration by multiple stakeholders including patients, clinicians, scientists, and policy makers. Several data sources can be considered to capture the patient experience, including patient-reported outcome (PRO) measures, performance measures, wearable devices, and biosensors, as well as the careful collection and analysis of clinical events and supportive care medications. In this Policy Review, we focus on PRO measures and present the perspectives of three international regulatory scientists to identify areas of common ground regarding opportunities to incorporate rigorous PRO data into the regulatory decision-making process.

Do not attempt resuscitation orders in primary care settings.

A Do Not Attempt Resuscitation notice (DNACPR) is an important mechanism for avoiding inappropriate CRP attempts, and protects district nurses and others from allegations of ill treatment or wilful neglect. The DNACPR notice must be discussed with the patient or their relatives, before placed on file ( Tracey v Cambridge Uni Hospital NHS Foundation Trust and others [2014] ; Winspear v City Hospitals Sunderland NHSFT [2015] ). In this article Richard Griffith set out the steps district nurses must take to ensure that a DNACPR notice is lawful.

Researching about us without us: exploring research participation and the politics of disability rights in the context of the Mental Capacity Act 2005.

The right to active participation by disabled people in academic research has been discussed at length in recent years, along with the potential for such research to function as a tool in challenging oppression and pursuing disability rights. Significant ethical, legal and methodological dilemmas arise, however, in circumstances where a disabled person loses the capacity to provide informed consent to such participation. In this article, I consider disability politics and academic research in the context of the Mental Capacity Act (MCA) 2005, which sets out in Anglo-Welsh law the circumstances and requirements for research participation by individuals lacking the capacity to provide informed consent. Drawing on my own perspective on research participation in relation to physical and psychosocial disability, I consider the implications of my potential future loss of capacity (eg, if I were to be in a vegetative or minimally conscious state following an accident) for my right to participate in disability-related research. I examine the barriers to such participation and suggest that partial solutions may be found in the advance decision-making and advance care-planning frameworks of the MCA 2005 and related policy, but that current legislative and policy frameworks nevertheless still curtail my rights with regard to research participation on loss of capacity to consent. In so doing, I seek to provoke debate concerning what this legislative provision means for the disability rights movement, and the possibilities and challenges it presents to the movement's commitment to 'nothing about us without us'.

Adolescents' Right to Participate: Opportunities and Challenges for Health Care Professionals.

BACKGROUND: Health care professionals and patients are partners in health care delivery, and this partnership is critical in the treatment of adolescents. International children's rights law establishes that all children have a right to participate in decisions that affect their lives. Fulfillment of that right is as critical in health care settings as any other area of children's lives. OBJECTIVES: In this article we examine the right to participate under international children's rights law, its relevance to health care settings, and how health care professionals can foster adolescents' participation to fulfill children's rights and improve health care outcomes. FINDINGS: The Convention on the Rights of the Child establishes a legal mandate-where ratified-that adolescents have the right to express their views in health care settings and that such views must be given due consideration. In many health care settings, adolescents are not adequately consulted or have limited opportunities to express their views. A review of research finds that both processes and outcomes can improve when youth participation is cultivated. CONCLUSIONS: Health care providers and organizations have numerous opportunities to cultivate adolescent's participation rights and in doing so improve health care delivery and outcomes. Health care providers and organizations should further develop structures and processes to ensure opportunities for children and adolescents to be heard on matters relevant to their health care and health status. Creating opportunities for adolescents to realize their right to participate means engaging youth at every stage in the process, beginning with the design of such opportunities. It also means addressing all aspects of health care, from the built environment to patient-provider communication to follow-up services, so that the entire process fosters an environment conductive to meaningful participation by adolescents.

Informed consent in randomised controlled trials: development and preliminary evaluation of a measure of Participatory and Informed Consent (PIC).

BACKGROUND: Informed consent (IC) is an ethical and legal prerequisite for trial participation, yet current approaches evaluating participant understanding for IC during recruitment lack consistency. No validated measure has been identified that evaluates participant understanding for IC based on their contributions during consent interactions. This paper outlines the development and formative evaluation of the Participatory and Informed Consent (PIC) measure for application to recorded recruitment appointments. The PIC allows the evaluation of recruiter information provision and evidence of participant understanding. METHODS: Published guidelines for IC were reviewed to identify potential items for inclusion. Seventeen purposively sampled trial recruitment appointments from three diverse trials were reviewed to identify the presence of items relevant to IC. A developmental version of the measure (DevPICv1) was drafted and applied to six further recruitment appointments from three further diverse trials to evaluate feasibility, validity, stability and inter-rater reliability. Findings guided revision of the measure (DevPICv2) which was applied to six further recruitment appointments as above. RESULTS: DevPICv1 assessed recruiter information provision (detail and clarity assessed separately) and participant talk (detail and understanding assessed separately) over 20 parameters (or 23 parameters for three-arm trials). Initial application of the measure to six diverse recruitment appointments demonstrated promising stability and inter-rater reliability but a need to simplify the measure to shorten time for completion. The revised measure (DevPICv2) combined assessment of detail and clarity of recruiter information and detail and evidence of participant understanding into two single scales for application to 22 parameters or 25 parameters for three-arm trials. Application of DevPICv2 to six further diverse recruitment appointments showed considerable improvements in feasibility (e.g. time to complete) with good levels of stability (i.e. test-retest reliability) and inter-rater reliability maintained. CONCLUSIONS: The DevPICv2 provides a measure for application to trial recruitment appointments to evaluate quality of recruiter information provision and evidence of patient understanding and participation during IC discussions. Initial evaluation shows promising feasibility, validity, reliability and ability to discriminate across a range of recruiter practice and evidence of participant understanding. More validation work is needed in new clinical trials to evaluate and refine the measure further.