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In this chapter, we seek to offer a fresh perspective on whether or not doctors should be “licensed to kill”. As that phrase indicates, we metaphorically refer to the adventures of fictional spy James Bond, although we hope, in doing so, that readers will not think that we are belittling the serious topic with which the chapter is concerned. Having surveyed some of the familiar arguments for and against allowing medically-assisted dying, we advance a new proposal, which seeks to strike a compromise between such arguments. Our exploratory model builds on an analogy with armed response police units as they operate in England, and specifically with situations in which such officers are found to have killed someone in the course of their duties. Rather than confer immunity prospectively (as proponents of assisted dying often seek) or deny immunity completely (as opponents insist), our policy would provide a potential retrospective excuse.

BackgroundOutcomes for neonatal intestinal failure (IF) have improved significantly over the past two decades, however, there is no consensus for decision making among UK paediatric subspecialists.ObjectivesThe aim was to describe clinician’s attitudes to decision making in neonatal IF and examine variation between subspecialties.MethodsNeonatologists, paediatric surgeons and gastroenterologists were surveyed electronically. They were asked if they would recommend active or palliative care or allow the parents to decide in several scenarios; or if they considered treatment morally obligatory or impermissible.ResultsOf 147 respondents, 81% of gastroenterologists would recommend active care (34.6% regardless of parental decision) for a term infant with total gut Hirschsprung’s compared with 46% and 33% of surgeons and neonatologists. No gastroenterologist would recommend palliation while 23% of both neonatologists and surgeons would. Similarly, 77% of surgeons and 73% of neonatologists would recommend palliation for a 28-week infant with IF and bilateral parenchymal haemorrhages compared with 27% of gastroenterologists.Prognostic estimates also varied. A term baby with IF was estimated to have a survival of >80% at 5 years by 58% of gastroenterologists compared with 11.5% and 2.7% of surgeons and neonatologists. Only 11.5% of surgeons and 2.6% of neonatologist believed a 26-week preterm with IF would have a 5-year survival >60% compared with 59% of gastroenterologists.ConclusionThere is substantial variation in views about outcomes and management choices both within and between specialties; with gastroenterologists being consistently more positive. This is likely to lead to unjustified variation in counselling and parental choices.

Attempts to conduct systematic reviews of ethical arguments in bioethics are fundamentally misguided. All areas of inquiry need thorough and informative literature reviews, and efforts to bring transparency and systematic methods to bioethics are to be welcomed. Nevertheless, the raw materials of bioethical articles are not suited to methods of systematic review. The eclecticism of philosophy may lead to suspicion of philosophical methods in bioethics. Because bioethics aims to influence medical and scientific practice it is tempting to adopt scientific language and methods. One manifestation is the increasing innovation in, and use of, systematic reviews of ethical arguments in bioethics. Yet bioethics, as a broadly philosophical area of inquiry, is unsuited to systematic review. Bioethical arguments are evaluative, so notions of quality and bias are inapplicable. Bioethical argument is conceptual rather than numerical and the classification of concepts is itself a process of argument that cannot aspire to neutrality. Any ‘systematic review’ of ethical arguments in bioethics thus falls short of that name. Furthermore, labels matter. Although the bioethics research community may find that adopting the language and the outward methods of clinical science offers apparent prospects of credibility, policy influence and funding, we argue that such misdirection carries risks and is unlikely to pay dividends in the long term. Bioethical sources are amenable to the review methods of the social sciences , and it is on these methods that specific methods of bioethics literature review should be built.

Systematic reviews (SR) are very well elaborated and established for synthesizing statistical information, for example of clinical studies, for determining whether a clinical intervention is effective. SRs are also becoming more and more popular in bioethics. However, the established approach of conducting and reporting a SR cannot be transferred to corresponding work on ethically sensible questions directly. This is because the object of investigation is not statistical information, but conceptual or normative information, e.g., ethical norms, principles, arguments or conclusions. There is some evidence that the quality of reporting of SRs on ethics literature could be improved in many regards. Although insufficient reporting is not a problem specific to bioethics, as poor study reports are also very common in SRs in e.g. medicine, authors of such SRs have the possibility to follow a reporting guideline – the well-established statement on Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA). For SRs on ethics literature, the PRISMA Statement can only be partially adopted due to the different type of information searched and analyzed.Thus, an international group of authors with years of experience in conducting and reviewing SRs on ethics literature adapted PRISMA for its application in the field of bioethics (“PRISMA-Ethics”). As methods stemming from qualitative research are often used for analysis and synthesis in SRs on ethics literature, also elements of the ENTREQ Guideline were incorporated in PRISMA-Ethics. The resulting reporting guideline has 22 items and is intended to provide authors of SRs on ethics literature with all information necessary for an adequate reporting of their SRs. It also allows readers, reviewers and journal editors critically evaluating the presented results and conclusions made. In this paper, we explain the rationale and give examples for each item. While we acknowledge heterogeneity on how to conduct a SR on ethics literature, we still maintain that there is a need for general reporting standards for improving transparency, understandability and verifiability of such SRs. We invite authors of SRs on ethics literature to test PRISMA-Ethics and to evaluate its usefulness. We hope for a critical discussion of the guideline and welcome its broad implementation.

Importance Patient-reported outcomes (PROs) can inform healthcare decisions, regulatory decisions, and healthcare policy, and also can be used for audit/benchmarking and to monitor symptoms and provide timely care tailored to individual needs. However, several ethical issues have been raised in relation to PRO use. Objective To develop an international, consensus-based, PRO-specific ethical guidelines for clinical research.Evidence ReviewThe PRO ethics guidelines were developed following the Enhancing Quality and Transparency of Health Research (EQUATOR) Network’s guideline development framework. This included a systematic review of the ethical implications of PROs in clinical research. The databases MEDLINE (Ovid), EMBASE, AMED and CINAHL were searched from inception until May 2020. The keywords ‘patient reported outcome*’ and ‘ethic*’ were used to search the databases. Two reviewers independently conducted title and abstract screening before full-text screening to determine eligibility. The review was supplemented by the SPIRIT-PRO Extension recommendations for trial protocol. Subsequently, a two-round international Delphi process (n=96 participants; May and August 2021) and a consensus meeting (n=25 international participants; October 2021) were held. Prior to voting, consensus meeting participants were provided with a summary of the Delphi process results and information on whether the items aligned with existing ethical guidance.Findings Twenty-three items were considered in the first round of the Delphi process: six relevant candidate items from the systematic review and seventeen additional items drawn from the SPIRIT-PRO Extension. Ninety-six international participants voted on the relevant importance of each item for inclusion in ethical guidelines and twelve additional items were recommended for inclusion in round 2 of the Delphi (35 items in total). Fourteen items were recommended for inclusion at the consensus meeting (n=25 participants). The final wording of the PRO ethical guidelines was agreed by consensus meeting participants with input from six additional individuals. Included items focused on PRO-specific ethical issues relating to research rationale, objectives, eligibility requirements, PRO concepts/domains, PRO assessment schedules, sample size, PRO data monitoring, barriers to PRO completion, participant acceptability and burden, administration of PRO questionnaires for participants who are unable to self-report PRO data, input on PRO strategy by patient partners or members of the public, avoiding missing data and dissemination plans. Conclusions and Relevance The PRO ethics guidelines provide recommendations for ethical issues that should be addressed in PRO clinical research. Addressing ethical issues of PRO clinical research has the potential to ensure high-quality PRO data while minimising participant risk, burden and harm and protecting participant and researcher welfare.