Maximising the value of research data: developing incentives and changing cultures

The value of sharing research data is widely recognised by the research community and funders are setting in place stronger policy requirements for researchers to share data. But the costs to researchers in sharing their data can be considerable and the incentives are sometimes few and far between. A recent report from the cross-disciplinary Expert Advisory Group on Data Access (EAGDA) highlights the need for a shift in cultures to provide greater support for researchers in sharing data and greater recognition for those who do it well. Dave Carr and Natalie Banner, from the Wellcome Trust, highlight some of the key findings and recommendations emerging from this work

Judging by a Different Standard? Examining the Role of Rationality in Assessments of Mental Capacity

Decision-making capacity is an increasingly important medico-legal concept. The recent Mental Capacity Act employs a cognitive, process-based test of capacity, but in many psychiatric conditions pathological beliefs and values impair capacity even when the decision-making process is logically coherent. In such cases, capacity assessments implicitly rely on normative epistemic and evaluative standards. This raises a worry for the capacity test’s reliability, objectivity and tolerance of differences in beliefs and values. There is currently little conceptual research on capacity and the normative standards underpinning its assessment. This thesis makes an original contribution to research by employing a number of philosophical approaches to map out a conceptual terrain within which questions about the substantive standards of capacity assessment can be framed. Focusing on the nature of epistemic standards and third-person judgements about decision-making, the thesis examines the normative constraints determining what counts as a recognisable reason for a decision. It employs the theoretical apparatus of Davidson’s project of Radical Interpretation to explore the epistemology of interpretation, interrogating the conditions under which intentional attribution and the provision of reason explanations for behaviour are possible. It is contended that beliefs are intrinsically rational and intersubjective, and that judgements of irrationality are only possible against a background of shared belief between interpreter and observed agent. This view is defended against the objection that rationality is too stringent a constraint on belief. A misconception giving rise to this objection is then diagnosed. Drawing an analogy with Wittgenstein’s rule-following considerations, it is submitted that the constitutive normativity of belief need not be codified in order to exert a genuine constraint on intentional behaviour. Rather, the norms of belief ought to be construed as emerging from shared practice. This indicates that normative judgements are disciplined through expertise and experience, rather than adherence to abstract principles. Finally, the implications of these insights for conceptualising and assessing capacity are considered

A Pilot Study of the Early Experience of Consultant Psychiatrists in the Implementation of the Mental Capacity Act 2005: Local Policy and Training, Assessment of Capacity and Determination of Best Interests

The Mental Capacity Act 2005 (MCA) was partially implemented in April 2007 and fully implemented in October 2007 in England and Wales (with the exception of the Deprivation of Liberty Safeguards which were implemented in April 2009). The government estimated that up to 2 million adults in England and Wales may have issues concerning their decision-making capacity (henceforth ‘capacity’), and these will included 840,000 people with dementia, 145,000 people with severe learning disability, 1.2 million people with mild to moderate learning disability and 120,000 people with severe brain injury. Additionally, the prevalence of schizophrenia, mania and serious depression are 1%, 1% and 5% respectively, and some of these individuals may also lack capacity. Moreover, up to 6 million family and unpaid carers are estimated to provide care or treatment for individuals lacking capacity. Furthermore, many other people who do not lack capacity may use aspects of the MCA for future planning

Consensus Statement on Public Involvement and Engagement with Data-Intensive Health Research.

This consensus statement reflects the deliberations of an international group of stakeholders with a range of expertise in public involvement and engagement (PI&E) relating to data-intensive health research. It sets out eight key principles to establish a secure role for PI&E in and with the research community internationally and ensure best practice in its execution. Our aim is to promote culture change and societal benefits through ensuring a socially responsible trajectory for innovations in this field.Peer reviewe

Can procedural and substantive elements of decisionmaking be reconciled in assessments of mental capacity?

Capacity legislation aims to protect individual autonomy and avoid undue paternalism as far as possible, partly through ensuring patients are not deemed to lack capacity because they make an unwise decision. To this end, the law employs a procedural test of capacity that excludes substantive judgments about patients’ decisions. However, clinical intuitions about patients’ capacity to make decisions about their treatment often conflict with a strict reading of the legal criteria for assessing capacity, particularly in psychiatry. In this article I argue that this tension arises because the procedural conception of capacity is inadequate and does not reflect the clinical or legal realities of assessing capacity. I propose that conceptualising capacity as having ‘recognisable reasons’ for a treatment decision provides a practical way of legitimately incorporating both procedural and substantive elements of decision-making into assessments of capacity

Unreasonable reasons: normative judgements in the assessment of mental capacity

The recent Mental Capacity Act (2005) sets out a test for assessing a person's capacity to make treatment choices. In some cases, particularly in psychiatry, it is unclear how the criteria ought to be interpreted and applied by clinicians. In this paper, I argue that this uncertainty arises because the concept of capacity employed in the Act, and the diagnostic tools developed to assist its assessment, overlook the inherent normativity of judgements made about whether a person is using or weighing information in the decision-making process. Patients may fail on this criterion to the extent that they do not appear to be handling the information given in an appropriate way, on account of a mental impairment disrupting the way the decision process ought to proceed. Using case law and clinical examples, I describe some of the normative dimensions along which judgements of incapacity can be made, namely epistemic, evaluative and affective dimensions. Such judgements are complex and the normative standards by which a clinician may determine capacity cannot be reduced to a set of criteria. Rather, in recognizing this normativity, clinicians may better understand how clinical judgements are structured and what kinds of assumption may inform their assessment

'Radical interpretation' and the assessment of decision-making capacity

The assessment of patients' decision-making capacity (DMC) has become an important area of clinical practice, and since it provides the gateway for a consideration of non-consensual treatment, has major ethical implications. Tests of DMC such as under the Mental Capacity Act (2005) for England and Wales aim at supporting autonomy and reducing unwarranted paternalism by being ‘procedural’, focusing on how the person arrived at a treatment decision. In practice, it is difficult, especially in problematic or borderline cases, to avoid a consideration of beliefs and values; that is, of the substantive content of ideas rather than simple ‘cognitive’ or procedural abilities. However, little attention has been paid to how beliefs and values might be assessed in the clinical context and what kind of ‘objectivity’ is possible. We argue that key aspects of Donald Davidson's ideas of ‘Radical Interpretation’ and the ‘Principle of Charity’ provide useful guidance as to how clinicians might approach the question of whether an apparent disturbance in a person's thinking about beliefs or values undermines their DMC. A case example is provided, and a number of implications for clinical practice are discussed

‘Radical Interpretation’ and the Assessment of Decision-Making Capacity

The assessment of patients' decision-making capacity (DMC) has become an important area of clinical practice, and since it provides the gateway for a consideration of non-consensual treatment, has major ethical implications. Tests of DMC such as under the Mental Capacity Act (2005) for England and Wales aim at supporting autonomy and reducing unwarranted paternalism by being ‘procedural’, focusing on how the person arrived at a treatment decision. In practice, it is difficult, especially in problematic or borderline cases, to avoid a consideration of beliefs and values; that is, of the substantive content of ideas rather than simple ‘cognitive’ or procedural abilities. However, little attention has been paid to how beliefs and values might be assessed in the clinical context and what kind of ‘objectivity’ is possible. We argue that key aspects of Donald Davidson's ideas of ‘Radical Interpretation’ and the ‘Principle of Charity’ provide useful guidance as to how clinicians might approach the question of whether an apparent disturbance in a person's thinking about beliefs or values undermines their DMC. A case example is provided, and a number of implications for clinical practice are discussed

Patient narrative: an ‘on-switch’ for evaluating best interests

This article examines how the wishes, feelings, values and beliefs of adults lacking capacity can be evaluated and the extent to which they are given effect in best interests decision-making. One way of fulfilling the clinician’s legal responsibilities to take a patient’s preferences into account is to explicitly link these to the notion of narrative. Narratives provide a compelling grounding and give weight to views and values that may have been informally and consistently expressed in the past. An evaluation of recent case law suggests that the trajectory of a person’s life, their character and personality, and the perspectives of those with whom the patient has valued relationships are given increasing judicial recognition. Attending to the narrative of the patient could lead to a more sophisticated judgement of best interests than an objective ‘balance sheet’ approach would allow and enable greater alignment with the UN Convention on the Rights of Persons with Disabilities

The global forum on bioethics in research meeting, “ethics of research in pregnancy”: emerging consensus themes and outputs

Abstract Research during pregnancy is affected by multiple ethical challenges which have not received sufficient international attention and consideration from the bioethics, clinical, and policymaking communities working together. Unresolved ethical questions about research in pregnancy have significant detrimental impacts on maternal and newborn health, in part because they inhibit an evidence base being developed on the efficacy and safety of medicines and health interventions for pregnant women. These problems are compounded in low- and middle-income country (LMIC) settings due to variability in regulatory provisions, the burden of maternal morbidity and mortality, and many social and cultural conventions that impact on pregnant women’s ability to participate in research. Research in pregnancy was chosen as a topic for the 2016 Global Forum on Bioethics in Research (GFBR) meeting, and its timeliness was all the more apparent given the 2016 Zika outbreak, which has deeply affected the Latin American region. The meeting’s emerging consensus themes and outputs epitomized the core aims of the GFBR—to give voice to LMIC perspectives as a priority in dialogue about global health research ethics and to promote collaboration. In this instance, the GFBR meeting catalyzed a strong, unified drive to push researchers and policymakers to include pregnant women in research by default: given the complex nature of the topic, this is a significant achievement in addressing an important question of social justice