Heather Draper

Appropriate Methodologies for Empirical Bioethics: It'S All Relative

In this article we distinguish between philosophical bioethics (PB), descriptive policy orientated bioethics (DPOB) and normative policy oriented bioethics (NPOB). We argue that finding an appropriate methodology for combining empirical data and moral theory depends on what the aims of the research endeavour are, and that, for the most part, this combination is only required for NPOB. After briefly discussing the debate around the is/ought problem, and suggesting that both sides of this debate are misunderstanding one another (i.e. one side treats it as a conceptual problem, whilst the other treats it as an empirical claim), we outline and defend a methodological approach to NPOB based on work we have carried out on a project exploring the normative foundations of paternal rights and responsibilities. We suggest that given the prominent role already played by moral intuition in moral theory, one appropriate way to integrate empirical data and philosophical bioethics is to utilize empirically gathered lay intuition as the foundation for ethical reasoning in NPOB. The method we propose involves a modification of a long-established tradition on non-intervention in qualitative data gathering, combined with a form of reflective equilibrium where the demands of theory and data are given equal weight and a pragmatic compromise reached.

Anorexia nervosa and respecting a refusal of life-prolonging therapy: a limited justification.

People who suffer from eating disorders often have to be treated against their will, perhaps by being detained, perhaps by being forced to eat. In this paper it is argued that whilst forcing compliance is generally acceptable, there may be circumstances under which a sufferers refusal of consent to treatment should be respected. This argument will hinge upon whether someone in the grip of an eating disorder can actually make competent decisions about their quality of life. If so, then the decision to refuse therapy may be on a par with other decisions to refuse life-prolonging therapy made by sufferers of debilitating chronic, or acute onset terminal illness. In such cases, palliation might justifiably replace aggressive therapy. The argument will also draw heavily on the distinction between competent refusal of therapy and passive euthanasia, and the distinction between incompetence and irrational decisions. Both distinctions will then be applied to decisions to refuse food. The extent to which sufferers from anorexia nervosa can be categorised as either incompetent or irrational will be examined. It against this background that it will be argued that at least some of those who suffer from eating disorders should have their refusals respected, even if they may die as a result.

Telecare, surveillance, and the welfare state

In Europe, telecare is the use of remote monitoring technology to enable vulnerable people to live independently in their own homes. The technology includes electronic tags and sensors that transmit information about the users location and patterns of behavior in the users home to an external hub, where it can trigger an intervention in an emergency. Telecare users in the United Kingdom sometimes report their unease about being monitored by a “Big Brother,” and the same kind of electronic tags that alert telecare hubs to the movements of someone with dementia who is “wandering” are worn by terrorist suspects who have been placed under house arrest. For these and other reasons, such as ordinary privacy concerns, telecare is sometimes regarded as an objectionable extension of a “surveillance state.” In this article, we defend the use of telecare against the charge that it is Orwellian. In the United States, the conception of telecare primarily as telemedicine, and the fact that it is not typically a government responsibility, make a supposed connection with a surveillance state even more doubtful than in Europe. The main objection, we argue, to telecare is not its intrusiveness, but the danger of its deepening the isolation of those who use it. There are ways of organizing telecare so that the independence and privacy of users are enhanced, but personal isolation may be harder to address. As telecare is a means of reducing the cost of publicly provided social and health care, and the need to reduce public spending is growing, the correlative problem of isolation must be addressed alongside the goal of promoting independence.

Robot carers, ethics, and older people

Abstract This paper offers an ethical framework for the development of robots as home companions that are intended to address the isolation and reduced physical functioning of frail older people with capacity, especially those living alone in a noninstitutional setting. Our ethical framework gives autonomy priority in a list of purposes served by assistive technology in general, and carebots in particular. It first introduces the notion of “presence” and draws a distinction between humanoid multi-function robots and non-humanoid robots to suggest that the former provide a more sophisticated presence than the latter. It then looks at the difference between lower-tech assistive technological support for older people and its benefits, and contrasts these with what robots can offer. This provides some context for the ethical assessment of robotic assistive technology. We then consider what might need to be added to presence to produce care from a companion robot that deals with older people’s reduced functioning and isolation. Finally, we outline and explain our ethical framework. We discuss how it combines sometimes conflicting values that the design of a carebot might incorporate, if informed by an analysis of the different roles that can be served by a companion robot.

Modified mandated choice for organ procurement

Presumed consent to organ donation looks increasingly unlikely to be a palatable option for increasing organ procurement in the UK following the publication of the report into events at Alder Hey and elsewhere. Yet, given that the alternative to increasing the number of cadaveric organs available is either to accept a greater number of live donations, or accept that people will continue to die for the want of an organ, public policy makers remain obliged to consider other means of increasing the procurement rate. In this paper, we meet the main objections to mandated choice (namely that it undermines autonomy and that mandated donation is preferable). We have modified the traditional approach to mandated choice to take into account the force of the objection that mandated donation is preferable, by accepting that people can and do make bad decisions about organ donation and proposing that all accompanying public education and information about cadaveric donation should be directed in favour of donation.

Ignorance is bliss? HIV and moral duties and legal duties to forewarn

In 1997, a court in Cyprus jailed Pavlos Georgiou for fifteen months for knowingly infecting a British woman, Janet Pink, with HIV-1 through unprotected sexual intercourse. Pink met Georgiou in January 1994 whilst on holiday. She discovered that she had contracted the virus from him in October 1994 but continued the relationship until July 1996 when she developed AIDS. She returned to the UK for treatment and reported Georgiou to the Cypriot authorities.1 There have been a number of legal cases involving deliberate transmission of HIV, but most have involved forced exposure to infected bodily fluids for example, rape or biting, and have been dealt with using the existing legislation for rape or assault. While it is often difficult to prove responsibility for transmission in cases of forced exposure to HIV, it is even more contentious in cases like those of Janet Pink where an individual has consented to sex but claims that he/she was not forewarned of his/herpartners HIV-positive status. At present there is no specific criminal offence of having unprotected sexual intercourse without disclosing ones HIV-positive status but a prosecution could possibly be brought under any one of a number of existing offences.2 Perhaps a change of policy needs to be considered. The Home Office has issued a consultation document which outlines a proposal that will allow the criminalisation of intentional transmission of diseases, like HIV, that are likely to cause serious harm. This revised legislation would cover all other potentially fatal diseases (including salmonella and legionnaires disease, for instance) but seems primarily to be targeted at HIV transmission. Should transmission of HIV through consensual sex, without the HIV-positive status of the individual being disclosed, be an offence? This question, and that of whether there is a moral obligation to disclose a positive HIV status prior to having a sexual relationship is the subject of this paper.

Patient-Reported Outcome (PRO) Assessment in Clinical Trials: A Systematic Review of Guidance for Trial Protocol Writers

Background Evidence suggests there are inconsistencies in patient-reported outcome (PRO) assessment and reporting in clinical trials, which may limit the use of these data to inform patient care. For trials with a PRO endpoint, routine inclusion of key PRO information in the protocol may help improve trial conduct and the reporting and appraisal of PRO results; however, it is currently unclear exactly what PRO-specific information should be included. The aim of this review was to summarize the current PRO-specific guidance for clinical trial protocol developers. Methods and Findings We searched the MEDLINE, EMBASE, CINHAL and Cochrane Library databases (inception to February 2013) for PRO-specific guidance regarding trial protocol development. Further guidance documents were identified via Google, Google scholar, requests to members of the UK Clinical Research Collaboration registered clinical trials units and international experts. Two independent investigators undertook title/abstract screening, full text review and data extraction, with a third involved in the event of disagreement. 21,175 citations were screened and 54 met the inclusion criteria. Guidance documents were difficult to access: electronic database searches identified just 8 documents, with the remaining 46 sourced elsewhere (5 from citation tracking, 27 from hand searching, 7 from the grey literature review and 7 from experts). 162 unique PRO-specific protocol recommendations were extracted from included documents. A further 10 PRO recommendations were identified relating to supporting trial documentation. Only 5/162 (3%) recommendations appeared in ≥50% of guidance documents reviewed, indicating a lack of consistency. Conclusions PRO-specific protocol guidelines were difficult to access, lacked consistency and may be challenging to implement in practice. There is a need to develop easily accessible consensus-driven PRO protocol guidance. Guidance should be aimed at ensuring key PRO information is routinely included in appropriate trial protocols, in order to facilitate rigorous collection/reporting of PRO data, to effectively inform patient care.

Women, forced caesareans and antenatal responsibilities.

In the UK in October 1992, Mrs S was forced to have a caesarean section despite her objections to such a procedure on religious grounds. The case once again called into question the obligations of women to the unborn, and also whether one person can be forced to undergo a medical procedure for the benefit of someone else. Re S, like the case of Angela Carder, is often discussed in terms of the conflict between maternal and fetal rights. This paper looks instead at our obligations to save life in general-whether or not we are pregnant- and at the obligations of mothers to their children-whether they are born or unborn. Drawing on Judith Jarvis Thomsons distinction, it argues that minimal decency informs the duties which are owed to strangers, but that parents can be expected to behave as Good Samaritans towards their children. Finally, it is argued that even if mothers are ethically obliged to consent to caesarean sections which will save the lives of their babies, this does not necessarily mean that others are at liberty, or even obliged, to proceed with such operations without their consent.

What potential research participants want to know about research: a systematic review

Objective To establish the empirical evidence base for the information that participants want to know about medical research and to assess how this relates to current guidance from the National Research Ethics Service (NRES). Data sources Medline, Web of Science, Applied Social Sciences Index and Abstracts, Sociological abstracts, Health Management Information Consortium, Cochrane Library, thesis indexs, grey literature databases, reference and cited article lists, key journals, Google Scholar and correspondence with expert authors. Study selection Original research studies published between 1950 and October 2010 that asked potential participants to indicate how much or what types of information they wanted to be told about a research study or asked them to rate the importance of a specific piece of information were included. Study appraisal and synthesis methods Studies were appraised based on the generalisability of results to the UK potential research participant population. A metadata analysis using basic thematic analysis was used to split results from papers into themes based on the sections of information that NRES recommends should be included in a participant information sheet. Results 14 studies were included. Of the 20 pieces of information that NRES recommend should be included in patient information sheets for research pooled proportions could be calculated for seven themes. Results showed that potential participants wanted to be offered information about result dissemination (91% (95% CI 85% to 95%)), investigator conflicts of interest (48% (95% CI 27% to 69%)), the purpose of the study (76% (95% CI 27% to 100%)), voluntariness (39% (95% CI 2% to 100%)), how long the research would last (61% (95% CI 16% to 97%)), potential benefits (57% (95% CI 7% to 98%)) and confidentiality (44% (95% CI 10% to 82%)). The level of detail participants wanted to know was not explored comprehensively in the studies. There was no empirical evidence to support the level of information provision required by participants on the remaining seven items. Conclusions There is limited empirical evidence on what potential participants want to know about research. The existing empirical evidence suggests that individuals may have very different needs and a more tailored evidence-based approach may be necessary.

Systematic evaluation of the patient-reported outcome (PRO) content of clinical trial protocols

Background Qualitative evidence suggests patient-reported outcome (PRO) information is frequently absent from clinical trial protocols, potentially leading to inconsistent PRO data collection and risking bias. Direct evidence regarding PRO trial protocol content is lacking. The aim of this study was to systematically evaluate the PRO-specific content of UK National Institute for Health Research (NIHR) Health Technology Assessment (HTA) programme trial protocols. Methods and Findings We conducted an electronic search of the NIHR HTA programme database (inception to August 2013) for protocols describing a randomised controlled trial including a primary/secondary PRO. Two investigators independently reviewed the content of each protocol, using a specially constructed PRO-specific protocol checklist, alongside the ‘Standard Protocol Items: Recommendations for Interventional Trials’ (SPIRIT) checklist. Disagreements were resolved through discussion with a third investigator. 75 trial protocols were included in the analysis. Protocols included a mean of 32/51 (63%) SPIRIT recommendations (range 16–41, SD 5.62) and 11/33 (33%) PRO-specific items (range 4–18, SD 3.56). Over half (61%) of the PRO items were incomplete. Protocols containing a primary PRO included slightly more PRO checklist items (mean 14/33 (43%)). PRO protocol content was not associated with general protocol completeness; thus, protocols judged as relatively ‘complete’ using SPIRIT were still likely to have omitted a large proportion of PRO checklist items. Conclusions The PRO components of HTA clinical trial protocols require improvement. Information on the PRO rationale/hypothesis, data collection methods, training and management was often absent. This low compliance is unsurprising; evidence shows existing PRO guidance for protocol developers remains difficult to access and lacks consistency. Study findings suggest there are a number of PRO protocol checklist items that are not fully addressed by the current SPIRIT statement. We therefore advocate the development of consensus-based supplementary guidelines, aimed at improving the completeness and quality of PRO content in clinical trial protocols.