'Your DNA, Your Say': global survey gathering attitudes toward genomics: design, delivery and methods.

Our international study, 'Your DNA, Your Say', uses film and an online cross-sectional survey to gather public attitudes toward the donation, access and sharing of DNA information. We describe the methodological approach used to create an engaging and bespoke survey, suitable for translation into many different languages. We address some of the particular challenges in designing a survey on the subject of genomics. In order to understand the significance of a genomic result, researchers and clinicians alike use external databases containing DNA and medical information from thousands of people. We ask how publics would like their 'anonymous' data to be used (or not to be used) and whether they are concerned by the potential risks of reidentification; the results will be used to inform policy.

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

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.

The definition of mental disorder: evolving but dysfunctional?

Extensive and diverse conceptual work towards developing a definition of 'mental disorder' was motivated by the declassification of homosexuality from the Diagnostic and Statistical Manual in 1973. This highly politicised event was understood as a call for psychiatry to provide assurances against further misclassification on the basis of discrimination or socio-political deviance. Today, if a definition of mental disorder fails to exclude homosexuality, then it fails to provide this safeguard against potential abuses and therefore fails to do an important part of the work it was intended to do. We argue that fact-based definitions of mental disorder, relying on scientific theory, fail to offer a robust definition of mental disorder that excludes homosexuality. Definitions of mental disorder based on values do not fare better: these definitions are silent on questions about the diagnostic status of individuals in oppressive societies and over-inclusive of mental or behavioural states that happen to be negatively valued in the individual's social context. We consider the latest definition proposed for the Diagnostic and Statistical Manual-5 (DSM-5) in light of these observations. We argue that definition fails to improve on these earlier deficiencies. Its inclusion in the manual may offer false reassurance against repetition of past misclassifications. We conclude with a provocation that if candidate definitions of mental disorder are unable to exclude homosexuality, it might perhaps be preferable not to attempt a definition at all.

Mental disorders are not brain disorders.

As advances in neuroscience and genetics reveal complex associations between brain structures, functions and symptoms of mental disorders, there have been calls for psychiatric classifications to be reconfigured, to conceptualize mental disorders as disorders of the brain. In this paper, I argue that this view is mistaken, and that the level at which we identify mental disorders is, and should be, the person, not the brain. This is not to deny physicalism or argue that the mental realm is somehow distinct from the physical, but rather to suggest the things that are going 'wrong' in mental disorder are picked out at the person-level: they are characterized by breaches in epistemic, rational, evaluative, emotional, social and moral norms. However, as our scientific understanding of the brain becomes advanced, what makes an identified neurobiological difference in brain structure or functioning indicative of pathology is its association with these behaviours at the person-level. Instead of collapsing psychiatry into biomedicine, biomedicine may benefit from drawing closer to the expertise of psychiatry, as it is able to accommodate social, psychological and biological explanations while focusing on the person, within their environment.

'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.

Can procedural and substantive elements of decision-making 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.

A pilot study of the early implementation of the Mental Capacity Act 2005 in England and Wales: the experience of consultants in old age psychiatry.

BACKGROUND: The Mental Capacity Act 2005 (MCA) was fully implemented in October 2007 in England and Wales. METHODS: A pilot qualitative study using thematic analysis examined the experience of consultants in old age psychiatry in the early implementation of the MCA using a questionnaire designed to ascertain the experienced difficulties and the positive experiences of implementing the MCA, and its impact on their workload and associated changes in staffing levels. RESULTS: Fifty-two (27%) of the 196 consultants in old age psychiatry returned usable questionnaires. Eleven categories of difficulties and nine categories of positive experiences in the implementation of the MCA were reported. Two-thirds of respondents reported an increase in their workload, but over 90% reported no associated changes in staffing levels. CONCLUSIONS: The factors contributing to the experienced difficulties and positive experiences in the implementation of the MCA require careful identification because strategies to lessen the difficulties and to maintain positive experiences need to be developed. The definitions of restraint and deprivation of liberty used in clinical practice and the overlap between these definitions requires careful study. The workload of clinicians in the context of implementing the MCA requires ongoing monitoring.

The early experience of Old Age Psychiatrists in the application of the Mental Capacity Act 2005: a pilot study.

BACKGROUND: The Mental Capacity Act 2005 (MCA) was fully implemented in October 2007 in England and Wales. METHODS: A pilot questionnaire study examined the experience of consultants in Old Age Psychiatry in the early implementation of the MCA pertaining to local policy and training in the application of the MCA, the assessment of decision-making capacity, the determination of best interests, and the use of the least restrictive option and restraint. RESULTS: Fifty-two (27%) of the 196 consultants in Old Age Psychiatry returned useable questionnaires. Seventy-five percent of them reported that local training on the application of the MCA was available, but less than 50% reported that training was mandatory. The vast majority of assessments of decision-making capacity were conducted by consultants in Old Age Psychiatry. Almost all of them reported using the four-fold specific test of decision-making capacity (DMC) described in the MCA. Restraint was reported to be rarely used. CONCLUSIONS: Consultants in Old Age Psychiatry generally reported using the criteria for the assessment of DMC, the determination of best interests and restraint described in the MCA. The findings highlight concern about the workload of clinicians in implementing the MCA and this requires careful monitoring. Consideration should be given to statutory provision of training in the application of the MCA by all healthcare and social care providers for all their healthcare and social care staff.

The application of the Mental Capacity Act 2005 among geriatric psychiatry patients: a pilot study.

BACKGROUND: The Mental Capacity Act 2005 (MCA) was fully implemented in October 2007 in England and Wales. The experience of clinicians working in Old Age Psychiatry, who are likely to have greater experience in the use of MCA, in the early implementation of the MCA was examined. METHODS: Case-notes of 37 patients in seven different Old Age Psychiatry services in two mental health trusts in west London, who had received at least one assessment of decision-making capacity (DMC) for a specific issue, were examined. A qualitative thematic analysis pertaining to the criteria used for the assessment of DMC, determination of best interests, least restrictive option and unwise decision was used for data analysis. RESULTS: The main findings were: the criteria used for the assessment of DMC and the determination of best interests were those described in the MCA and the accompanying Code of Practice; and clinicians were developing the concepts of least restrictive option and unwise decision with face validity despite the absence of their definitions in the MCA. CONCLUSION: Caution should be exercised in extrapolating the findings of this study, which is confined to two Mental Health Trusts in one geographical area and the speciality of Old Age Psychiatry, to other localities and other specialties. Nevertheless, there was evidence that clinicians were following the basic principles of the MCA correctly.