In the lion's den? Experiences of interaction with research ethics committees

Research ethics review is an important process, designed to protect participants in medical research. However, it is increasingly criticised for failing to meet its aims. Here, two researchers reflect on their experiences of applying for ethical approval of observational research in clinical settings. They highlight some problems faced by reviewers and researchers and propose a two-stage ethical review process that would alert researchers to the committee's concerns and allow them to give a more considered response

Tensions between policy and practice: A qualitative analysis of decisions regarding compulsory admission to psychiatric hospital.

The use of detention for psychiatric treatment is widespread and sometimes necessary. International human rights law requires a legal framework to safeguard the rights to liberty and personal integrity by preventing arbitrary detention. However, research suggests that extra-legal factors may influence decisions to detain. This article presents observational and interview data to describe how decisions to detain are made in practice in one jurisdiction (England and Wales) where a tension between policy and practice has been described. The analysis shows that practitioners mould the law into 'practical criteria' that appear to form a set of operational criteria for identifying cases to which the principle of soft paternalism may be applied. Most practitioners also appear willing, albeit often reluctantly, to depart from their usual reliance on the principle of soft paternalism and authorise detention of people with the capacity to refuse treatment, in order to prevent serious harm. We propose a potential resolution for the tension between policy and practice: two separate legal frameworks to authorise detention, one with a suitable test of capacity, used to enact soft paternalism, and the other to provide legal justification for detention for psychiatric treatment of the small number of people who retain decision-making capacity but nonetheless choose to place others at risk by refusing treatment. This separation of detention powers into two systems, according to the principle that justifies the use of detention would be intellectually coherent, consistent with human rights instruments and, being consistent with the apparent moral sentiments of practitioners, less prone to idiosyncratic interpretations in practice.This study was conducted by EF as a PhD student in the Cambridge Intellectual and Developmental Disabilities Research Group, Department of Psychiatry, University of Cambridge, funded by a Wellcome Trust PhD Studentship in Biomedical Ethics. AJH and ICHC supervised the work, and MR contributed social science expertise to the working group. Cambridgeshire and Peterborough NHS Foundation Trust sponsored the project as a service evaluation study and we thank the participations for their co-operation. The findings, and suggestions for practice, have been fed back to the Trust through internal clinical governance processes. During the preparation of this paper, ICHC and AJH were supported by the NIHR's Collaboration for Leadership in Applied Health Research and Care (CLAHRC) East of England at Cambridgeshire and Peterborough NHS Foundation Trust. The views expressed are those of the authors and not necessarily those of the NHS, the NIHR or the Department of Health.This is the author accepted manuscript. It is currently under an indefinite embargo pending publication by Elsevier

Planning for an uncertain future in progressive neurological disease: a qualitative study of patient and family decision-making with a focus on eating and drinking

Abstract Background Dysphagia and other eating and drinking difficulties are common in progressive neurological diseases. Mealtimes can become a major source of difficulty and anxiety for patients and their families. Decisions about eating, drinking and care can become challenging as disease progresses, and the person in question loses the capacity to participate in decisions about their own care. We sought to investigate how patients and their family members make decisions about their future care as their condition deteriorates, with a particular focus on mealtimes, eating and drinking. Methods Longitudinal qualitative in-depth interviews were undertaken with patients and their family members (N = 29) across a range of disease groups, including: dementia, Parkinson’s Disease, Huntington’s Disease, Progressive Supranuclear Palsy, Motor Neurone Disease, Multiple Sclerosis. Patients had varying degrees of eating and drinking difficulties, and levels of decision-making capacity. Interviews were ‘participant led’ and undertaken in the patients’ own homes or a place of their choosing. Follow-up interviews were three months to one year later depending upon disease trajectory. Interviews were audio recorded and analysed in NVivo using a Thematic Analysis approach. Results Twenty-nine participants were interviewed between 2015 and 2017. Two key themes emerged from the analysis: 1) Health Literacy: the extent to which patients and relatives appeared to know about the condition and its treatment. Patients and their family members varied in their ability to speak and communicate about their condition and prognosis. 2) Planning style: the extent to which participants appeared to value involvement in advance care-planning. Patients and their family members varied in the way in which they made decisions: some preferred to ‘take each day as it comes’, while others wished to plan extensively for the future. Conclusions Issues with eating and drinking are often overlooked. Clinicians need to understand both the patient’s level of health literacy and their style of planning before communicating with patients and their families about these sensitive issues

Restrictive practice in the care of people with Prader Willi Syndrome - a review of literature

Most people with Prader-Willi Syndrome (PWS) aspire to live independently. However, their condition means they never feel full, so they always want to eat. They can also tolerate much larger amounts of food in their stomach than people without PWS can and are therefore at increased risk of life-threatening gastric rupture. If access to food is not restricted they are at risk of rapid deterioration of health, increased safety risk and premature death. Parents, carers and authorities struggle with the tension between maximising individual choice and control, satisfying carers duty of care and providing a safe workplace for support workers. There is a need for clear, justifiable, evidence-based guidelines for the care of adults with PWS, which are consistent with international human rights law and are possible to implement in a variety of settings around the world. The ‘Choice and Control’ project aims to produce such guidelines. As part of this project, we are undertaking a review of law regarding restrictive practices for people with PWS in multiple jurisdictions. We will present our findings and discuss how they relate to the development of guidelines on restriction of access to food

Healthcare leadership and applied philosophy: An essential resource

As healthcare leaders, we are constantly in search of a better way to do our important work and practice our profession. We seek out seminars, conferences, workshops, books, and articles to improve our effectiveness and promote the wellness of our staff, patients, and organizations. We examine what is going on in our organizations, measure outcomes, and strive for continuous improvement and efficiency. Why might this be a cause for concern? Surely efficient, well-managed hospitals must be good for their patients, staff, and (in a publicly funded health system) society in general. However, the road to hell is paved with good intentions. The drive for improvement can create unintended consequences that, in the context of healthcare provision, may be criticized as unethical, may distort clinical priorities and has even led to tragedy for individual patients and their families including, in one well-documented example from the United Kingdom, the deaths of up to 1200 patients in one hospital. In this article, we briefly review some of the risks and benefits of using goals and metrics to improve healthcare and introduce some tools to help healthcare leaders develop processes and cultures that help, not harm patients. These tools come from an unexpected source—philosophy

A scoping review of case law relating to support and treatment for people with Prader-Willi Syndrome.

BACKGROUND: Prader-Willi Syndrome (PWS) is a complex multisystem genetic disorder associated with several challenges for people with PWS themselves, and for their families and care givers. Support around access to food is a particular issue due to impaired satiety and, because of this, people with PWS eat excessive amounts of food (hyperphagia). Together with other aspects of the PWS phenotype including, in many cases, a reduced sensitivity to pain, hyperphagia results in life-threatening obesity and life-shortening complications for some people with PWS. Restrictions to liberty and/or access to food raise important legal and ethical considerations in the clinical management of children and adults with PWS. Particularly where disagreements arise and, in the absence of comprehensive guidance for care providers, the courts may be called upon to resolve these difficult issues. AIMS: 1) To review case-law from English-speaking common law jurisdictions concerning support arrangements for people with PWS with a view to identifying issues that have required the intervention of the courts. 2) To identify principles on which to base clinical guidelines relating to the issues identified, ensuring that such guidelines are consistent with ethical and human rights imperatives. METHODS: Westlaw, Westlaw AU, and Lexis Nexis were searched for case law concerning the treatment or support of a person with PWS. RESULTS: Fifteen cases from jurisdictions in Australia, New Zealand, Canada, the United Kingdom and the United States of America met inclusion criteria. Areas requiring judicial decision making included a) detention in psychiatric hospital; b) support in least restrictive environments c) eligibility for support services; d) guardianship; e) access to special education. Judicial decisions are discussed in the context of the United Nations' Convention on the Rights of Persons with Disabilities

Planning for an uncertain future in progressive neurological disease: a qualitative study of patient and family decision-making with a focus on eating and drinking

Abstract Background Dysphagia and other eating and drinking difficulties are common in progressive neurological diseases. Mealtimes can become a major source of difficulty and anxiety for patients and their families. Decisions about eating, drinking and care can become challenging as disease progresses, and the person in question loses the capacity to participate in decisions about their own care. We sought to investigate how patients and their family members make decisions about their future care as their condition deteriorates, with a particular focus on mealtimes, eating and drinking. Methods Longitudinal qualitative in-depth interviews were undertaken with patients and their family members (N = 29) across a range of disease groups, including: dementia, Parkinson’s Disease, Huntington’s Disease, Progressive Supranuclear Palsy, Motor Neurone Disease, Multiple Sclerosis. Patients had varying degrees of eating and drinking difficulties, and levels of decision-making capacity. Interviews were ‘participant led’ and undertaken in the patients’ own homes or a place of their choosing. Follow-up interviews were three months to one year later depending upon disease trajectory. Interviews were audio recorded and analysed in NVivo using a Thematic Analysis approach. Results Twenty-nine participants were interviewed between 2015 and 2017. Two key themes emerged from the analysis: 1) Health Literacy: the extent to which patients and relatives appeared to know about the condition and its treatment. Patients and their family members varied in their ability to speak and communicate about their condition and prognosis. 2) Planning style: the extent to which participants appeared to value involvement in advance care-planning. Patients and their family members varied in the way in which they made decisions: some preferred to ‘take each day as it comes’, while others wished to plan extensively for the future. Conclusions Issues with eating and drinking are often overlooked. Clinicians need to understand both the patient’s level of health literacy and their style of planning before communicating with patients and their families about these sensitive issues

Articulating future directions of law reform for compulsory mental health admission and treatment in Hong Kong

This article explores and outlines four possible pathways for law reform in the area of compulsory mental health admission and treatment in Hong Kong: the (i) abolition, (ii) risk of harm, (iii) mental capacity and (iv) consensus pathways. The discussion of each pathway takes into account local challenges in implementation, as well as Hong Kong’s international commitments for the protection of rights. In outlining these pathways for reform, the authors intend to also provide a blueprint for regulatory change in other jurisdictions that are in the process of reforming their mental health laws