Background Ethics committees typically apply the common principles of autonomy, nonmaleficence, beneficence and justice to research proposals but with variable weighting and interpretation. This paper reports a comparison of ethical requirements in an international cross-cultural study and discusses their implications. Discussion The study was run concurrently in New Zealand, UK, Israel, Canada and USA and involved testing hypotheses about believability of testimonies regarding alleged child sexual abuse. Ethics committee requirements to conduct this study ranged from nil in Israel to considerable (...) amendments designed to minimise participant harm in New Zealand. Assessment of minimal risk is a complex and unreliable estimation further compounded by insufficient information on probabilities of particular individuals suffering harm. Estimating potential benefits/ risks ratio and protecting participants' autonomy similarly are not straightforward exercises. Summary Safeguarding moral/humane principles should be balanced with promotion of ethical research which does not impede research posing minimal risk to participants. In ensuring that ethical standards are met and research has scientific merit, ethics committees have obligations to participants (to meet their rights and protect them from harm); to society (to ensure good quality research is conducted); and to researchers (to treat their proposals with just consideration and respect). To facilitate meeting all these obligations, the preferable focus should be promotion of ethical research, rather than the prevention of unethical research, which inevitably results in the impediment of researchers from doing their work. How the ethical principles should be applied and balanced requires further consideration. (shrink)

Philosophy has much to offer psychiatry, not least regarding ethical issues, but also issues regarding the mind, identity, values, and volition. This has become only more important as we have witnessed the growth and power of the pharmaceutical industry, accompanied by developments in the neurosciences. However, too few practising psychiatrists are familiar with the literature in this area. -/- The Oxford Handbook of Philosophy and Psychiatry offers the most comprehensive reference resource for this area ever published. It assembles challenging and (...) insightful contributions from key philosophers and others to the interactive fields of philosophy and psychiatry. Each contributions is original, stimulating, thorough, and clearly and engagingly written - with no potentially significant philosophical stone left unturned. Broad in scope, the book includes coverage of several areas of philosophy, including philosophy of mind, science, and ethics. For philosophers and psychiatrists, The Oxford Handbook of Philosophy and Psychiatry is a landmark publication in the field - one that will be of value to both students and researchers in this rapidly growing area. (shrink)

Research Ethics, Volume 18, Issue 1, Page 3-12, January 2022. Consent is one necessary foundation for ethical research and it’s one of the research ethics committee’s major roles to ensure that the consent process meets acceptable standards. Although on Oxford ‘A’ REC we’ve been impressed by the thought and work put into this aspect of research ethics, we’ve continued to have concerns about the suitability and effectiveness of consent processes in supporting decision making, particularly for clinical trials. There’s poor understanding (...) of what people want to help them decide; current processes don’t provide the best grounding for informed consent and there’s inadequate public involvement. We’ve also found a lack of proportionality with researchers failing to adapt consent procedures in proportion to the burdens and consequences of the study. As a result, people are often not best helped to make an informed choice when asked to join a research study. To address these concerns, we considered how we might improve this aspect of research ethics review. Recognising the central importance of the dialogue between the volunteer and researcher, we’ve drawn up a model or flowchart of what we deem good consent practice, proposing consent should be built around four simple steps:Step 1: Introducing the study and the choices: helping the potential participants get an overview of the proposal and introducing the key issues.Step 2: Explaining all the details of the study using the detailed Participant Information Sheet.Step 3: After a gap, if necessary, reviewing and checking understanding.Step 4: Reaching agreement and recording consent.These steps, we believe, could help all involved and this article lays out ways we might improve participant choice while complying with accepted principles and current regulations. (shrink)

How, in this Christian age of belief, can we draw sense from the ritual acts of Christians assembled in worship? Convinced that people shape their meanings from the meanings available to them, Graham Hughes inquires into liturgical constructions of meaning within the larger cultural context of late twentieth-century meaning theory. Major theories of meaning are examined in terms of their contribution or hindrance to this meaning making: analytic philosophy, phenomenology, structuralism and deconstruction. Drawing particularly upon the work of Charles (...) Peirce, Hughes turns to semiotic theory to analyse the construction, transmission and apprehension of meaning within an actual worship service. Finally the book analyses the ways in which various worshipping styles of western Christianity undertake this meaning making. Taking account of late modern values and precepts, this ground-breaking book will appeal to teachers and students of theology, to clergy, and to thoughtful lay Christians. (shrink)

Current profess ional and la y lore ove rlook the ro le of hone sty in develop ing and s ustaining intimate relationships. We w ish to ass ert its importa nce. W e begin b y analyz ing the no tion of intimac y. An intim ate encounter or exchange, we argue, is one in which one verbally or non-verbally privately reveals something about oneself, and does so in a sensitive, trusting way. An intimate relationship is one marked by (...) regular intimate encounters or excha nges. Then, we co nsider two sorts of cases wh ere it is widely thought permissible, if not lauda tory, to lie to one 's intimates. In discrediting these presumably central cases of justified dishonesty, we put forward general considerations requiring hones ty. We e nd by s ugges ting how 'meta honesty'--hone sty about one's own efforts at communication, including one's efforts to be honest--is particularly important in intimate relationships. (shrink)

This paper reports an initiative from the National Research Ethics Service and research ethics committees in the UK to develop a shared ethical debate between committees and to promote standards of ethical review, exploring the problems and practicalities of such an approach.

When research concludes, post-trial access to the trial intervention or standard healthcare can be crucial for participants who are ill such as those in resource-poor countries with inadequate healthcare, British participants testing ‘last-chance drugs’ unavailable on the National Health Service and underinsured US participants. Yet, many researchers are unclear about their obligations regarding the post-trial period, and many research ethics committees do not know what to require of researchers. Consequences include participants who reasonably expect but lack PTA to the trial (...) intervention, unplanned financial liabilities for NHS Trusts forced to fund this, negative press and potential to undermine public trust.1–3,iOne reason for the lack of clarity is controversy over whether and when participants should have access, after the study, to the study intervention. At one extreme is the view that continued access should be ensured when the intervention has benefited the participant or when it has proven safe and effective for the participant population, irrespective of the cost and burden of ensuring continued access. At the other extreme is the view that continued access need never be provided so long as non-availability of the study intervention post-trial was adequately disclosed when participants were invited to participate.6 There is also disagreement about when poststudy access to the study intervention should be considered beneficial for participants. The spectrum ranges from the view that the intervention should be regarded as beneficial for a proposed use only after the …. (shrink)

Resumen Ésta es la primera traducción al español de las guías “Atención después de la investigación: un marco para los comités de ética de investigación del National Health Service (NHS) (borrador versión 8.0)”. El documento afirma que existe una fuerte obligación moral de garantizar que los participantes enfermos de un estudio clínico hagan una transición después del estudio hacia una atención de la salud apropiada. Con “atención de la salud apropiada” se hace referencia al acceso para los participantes a la (...) atención de la salud, proporcionada principalmente por el National Health Service (en adelante NHS), el sistema de salud del Reino Unido, y/o a la intervención en estudio, también llamada producto o tratamiento en investigación. Las guías “Atención después de la investigación” están dirigidas principalmente a los miembros de los 79 comités de ética de investigación del NHS y a quienes presentan sus estudios de investigación ante estos comités. Se trata de un documento borrador muy avanzado, trabajado en numerosas reuniones, durante más de 3 años, que ha sido discutido por participantes de estudios y miembros de la comunidad, miembros y presidentes de comités de ética de investigación del Reino Unido, especialistas internacionales en ética de la investigación, representantes de la industria y otras partes interesadas. La redacción de las guías es producto de la colaboración de Neema Sofaer y Penney Lewis, ambas investigadoras del King’s College London, en el Centre of Medical Law and Ethics del Dickson Poon School of Law, y Hugh Davies, Asesor en Ética de la Investigación de la Health Research Authority (HRA) del NHS. El traductor del presente documento, Ignacio Mastroleo, participó del workshop en la Fundación Brocher (Ginebra, Suiza, diciembre de 2011) donde se revisó el borrador versión 7.0 y contribuyó en la revisión del borrador de la versión 8.0 durante el 2012. -/- Abstract This is the first Spanish translation of the guidelines “Care after research: a framework for NHS RECs (8th draft)”. The document states that there is a strong moral obligation to ensure that participants in a clinical study who are ill transition after the study to appropriate healthcare. The terms "appropriate healthcare" refer to participants’ access to health care, mainly provided by the National Health Service (NHS), the health system in the UK, and/or to the intervention study also named investigational treatment or product. The guides "Care after research" are mainly directed to members of the 79 NHS committees of research ethics (RECs) and to those who submit their research to these committees. This is a very advanced draft document, worked in several meetings, for more than three years, that has been discussed with study participants and community members, members and chairs of RECs in the UK, international specialists in research ethics, industry representatives and other stakeholders. The drafting of the guidelines is the result of the collaboration of Neema Sofaer and Penney Lewis, both researchers at King's College London, at the Centre of Medical Law and Ethics of Dickson Poon School of Law, and Hugh Davies, Research Ethics Advisor of the Health Research Authority (HRA) of the NHS. The translator of this document, Ignacio Mastroleo, attended the workshop at the Brocher Foundation (Geneva, Switzerland, December 2011) where draft version 7.0 was revised and contributed in the revision of draft version 8.0 during 2012. (shrink)

In this introduction to the Section II, the thrust of the component chapters is described. An important strand in the philosophy of psychiatry since its beginnings has been sociopolitical critiques: criticism which aims to improve and humanize psychiatric practice and mental health systems. From this standpoint, the introduction provides an overview of this tradition, including considerations of "postpsychiatry," value commitments in psychiatry, the recovery movement, racism and sexism in the field, and technology.

The editorial introduction sets the stage for the chapter by identifying the roles that concepts and categories play not just in the field of mental health medicine but in the human mind itself. Then, each chapter is summarized or highlighted.

This is not a random collection of essays, but a book on a single theme. Written by separate hands, mainly by literary critics at Cambridge, it was planned as a whole and executed with a common purpose: to produce the first literary study of the English moralists of the seventeenth century to the beginning of the twentieth. The authors share two convictions: they believe that the study of literature demands an understanding of whatever moral philosophy is embodied in it; and (...) they believe that philosophical writings are capable of being tested by the techniques of literary criticism. In this book, such works as Bacon's Advancement of Learning, Hobbes's Leviathan, and Hume's Enquiries are viewed as whole works, not as repositories of philosophical propositions, nor as episodes in the history of English thought. (shrink)

This paper describes the UK Research Ethics Committee’s (REC) preparations and review of the global first SARS-CoV-2 human infection challenge studies. To frame our review, we used the WHO guidance and our UK Health Research Authority ethical review framework. The WHO criteria covered most issues we were concerned about, but we would recommend one further criterion directing RECs to consider alternative research designs. Could research questions be equally well answered by less intrusive studies? The committee met virtually, ensuring broad representation (...) across the UK nations and also ensuring applicants could attend easily. We worked in collaboration with the applicants but while we recognise that such proximity might raise the accusation of ‘collusion’, we made every effort to maintain ‘moral distance’ and all decisions were made by the committee alone. Prior existing processes and policy facilitated training and review but even with this preparation, review took time and this could have hindered a rapid response to the emergency. Review for the various follow-on studies will now be speedier and once the pandemic has subsided, our group could be reconvened in future emergencies. In conclusion, we have tried to make decisions in good faith. We know there is controversy and disagreement and reasonable people may feel we have made the wrong decision. A more detailed analysis, built on the WHO guidance, is provided in online supplemental material. (shrink)

Our understanding of biological processes in humans is often based on examination of analogous processes in other organisms. The nematode worm Caenorhabditis elegans has been a particularly valuable model, leading to Nobel prize winning discoveries in development and genetics. Until recently, however, the worm has not been widely used as a model to study transcription due to the lack of a comprehensive catalogue of its RNA transcripts. A recent study by Chen et al. uses next‐generation sequencing to address this issue, (...) mapping the transcription initiation sites in C. elegans and finding many unexpected similarities between the transcription of enhancers and promoters in the worm and mammalian genomes. As well as providing a valuable resource for researchers in the C. elegans community, these findings raise the possibility of using the worm as a model to investigate some key, current questions about transcriptional regulation that remain technically challenging in more complex organisms. (shrink)

Research consent processes must provide potential participants with the necessary information to help them decide if they wish to join a study. On the Oxford ‘A’ Research Ethics Committee we’ve found that current research proposals mostly provide adequate detail (even if not in an easily comprehensible format), but often fail to support decision making, a view supported by published evidence. In a previous paper, we described how consent might be structured, and here we develop the concept of an Information and (...) Decision Aid (IDA) that can support decision making and be used to guide the dialogue between researcher and potential participant. Our proposal requires limited changes to current processes or paperwork and would provide an easily accessible document for others that the potential participant might approach for advice. It could later be integrated with the Informed Consent Form to ensure all matters of concern to the individual participant have been addressed before consent is formally signed off. (shrink)

Inflammatory mediators have an established role in inducing insulin resistance and promoting hyperglycemia. In turn, hyperglycemia has been argued to drive immune cell dysfunction as a result of mitochondrial dysfunction. Here, the authors review the evidence challenging this view. First, it is pointed out that inflammatory mediators are known to induce altered mitochondrial function. In this regard, critical care patients suffer both an elevated inflammatory tone as well as hyperglycemia, rendering it difficult to distinguish between the effects of inflammation and (...) hyperglycemia. Second, emerging evidence indicates that a decrease in mitochondrial respiration and an increase in reactive oxygen species (ROS) production are not necessarily manifestations of pathology, but adaptations taking shape as the mitochondria is abdicating its adenosine triphosphate (ATP)‐producing function (which is taken over by glycolysis) and instead becomes “retooled” for an immunological role. Collectively, these observations challenge the commonly held belief that acute hyperglycemia induces mitochondrial damage leading to immune cell dysfunction. (shrink)

Introduction Patients require an accurate knowledge about placebos and their possible effects to ensure consent for placebo-controlled clinical trials is adequately informed. However, few previous studies have explored patients’ baseline levels of understanding and knowledge about placebos. The present online survey aimed to assess knowledge about placebos among patients with a history of back pain. Design A 15-item questionnaire was constructed to measure knowledge about placebos. Additional questions assessed sociodemographic characteristics, duration and severity of back pain, and previous experience of (...) receiving placebos. Setting Participants recruited from community settings completed the study online. Results 210 participants completed the questionnaire. 86.7% had back pain in the past 6 months, 44.3% currently had back pain. 4.3% had received a placebo intervention as part of a clinical trial and 68.1% had previously read or heard information about placebos. Overall knowledge of placebos was high, with participants on average answering 12.07 of 15 questions about placebos correctly. However, few participants correctly answered questions about the nocebo effect and the impact of the colour of a placebo pill. Conclusions The findings identified key gaps in knowledge about placebos. The lack of understanding of the nocebo effect in particular has implications for the informed consent of trial participants. Research ethics committees and investigators should prioritise amending informed consent procedures to incorporate the fact that participants in the placebo arm might experience adverse side effects. (shrink)

For over forty years, Leland Ryken has championed and modeled a Christian liberal arts education. His scholarship and commitment to integrating faith with learning in the classroom have influenced thousands of students who have sat under his winsome teaching. Published in honor of Professor Ryken and presented on the occasion of his retirement from Wheaton College, this compilation carries on his legacy of applying a Christian liberal arts education to all areas of life. Five sections explore the background of a (...) Christian liberal arts education, its theological basis, habits and virtues, differing approaches, and ultimate aims. Contributors including Philip Ryken, Jeffry Davis, Duane Litfin, John Walford, Alan Jacobs, and Jim Wilhoit analyze liberal arts as they relate to the disciplines, the Christian faith, and the world. Also included are a transcript of a well-known 1984 chapel talk delivered by Leland Ryken on the student's calling and practical chapters on how to read, write, and speak well. Comprehensive in scope, this substantial volume will be a helpful guide to anyone involved in higher education, as well as to students, pastors, and leaders looking for resources on the importance of faith in learning. - Publisher. (shrink)

This paper reports a European Forum for Good Clinical Practice workshop held in 2011 to consider a research ethics committee training syllabus, subsequent training needs and resources. The syllabus that was developed was divided into four competencies: committee working; scientific method; ethical analysis and the regulatory framework. Appropriate training needs for each, with possible resources, were discussed. Lack of funding for training was reported as a major problem but affordable alternatives were debated. Strengths and weaknesses of this approach were discussed (...) and the resultant proposal will be disseminated through the European Forum for Good Clinical Practice and the research ethics committees of member states. (shrink)

Valid consent requires the potential research participant understands the information provided. We examined current practice in 50 proposed Clinical Trials of Investigational Medicinal Products to determine how this understanding is checked. The majority of the proposals ( n = 44) indicated confirmation of understanding would take place during an interactive conversation between the researcher and potential participant, containing questions to assess and establish understanding. Yet up until now, research design and review have not focussed upon this, concentrating more on written (...) material. We propose ways this interactive conversation can be documented, and the process of checking understanding improved. (shrink)

It is self-evident that medical treatments have improved in recent centuries. Through a historical analysis this article demonstrates that experimental research has underpinned the success of modern medical therapy, but it also shows that there have been examples of unethical research and that these can still be found, even today. Whilst it is crucial that research continues, it is equally important that there is appropriate review. Although the health of research itself is central to our well-being, the community needs to (...) be able to exercise its right to scrutinize such projects, not only to understand what the scientific medical community is undertaking but also to identify research it regards as unfair. In the United Kingdom this is the work of Research Ethics Committees. (shrink)

This section concerns the question of how best to understand the scientific status of mental health care in general and psychiatry in particular. On the assumption that psychiatry is based, in part at least, on natural science, what is the nature or the general shape of that science? Some of the chapters aim at shedding light on component parts of a scientific world view: causation, explanation, natural kinds, models of medicine, etc. Others concern potentially fruitful scientific approaches to mental health (...) care, drawing on brain imaging results, phenomenology, enactivism and what can be learnt from debate of the status of psychoanalysis. One overall lesson is that twenty-first-century psychiatry needs twenty-first-century philosophy of science. (shrink)

This Section examines several moral dilemmas and epistemological aporias in clinical practice and shows how clinicians can benefit from the introduction of philosophical methods and discourse. The authors develop these issues having in mind emblematic mental disorders and typical clinical situations. One important claim shared by the Authors is that a great effort has been made to ground psychiatry on evidence-based science, and to tie it to our growing understanding of the human brain. This is obviously an exceedingly important project, (...) but it would be a mistake to assume that the central questions of psychiatry can be completely resolved through scientific inquiry. Science offers guidance for clinical practice only in light of our concepts and normative judgments. (shrink)

In the editorial introduction the stage is set for the chapters in the section by a brief discussion of the relationship between the disciplines of philosophy and psychiatry. Then each chapter briefly is summarized or highlighted.

A cross-disciplinary discussion of the basis of interpersonal relating is of interest to philosophers and psychiatrists for several reasons. The development of successful clinical practice may depend, at least partly, on having an accurate understanding of the basic character of unimpaired interpersonal relating because such understanding can shed light on the nature and source of its disturbed forms. How we think about the basis of "mind-minding" competencies influences how we think about the prognosis and possible treatment of dysfunctional interpersonal relating. (...) Another reason is that philosophical frameworks influence the way we think about and evaluate possible psychiatric disorders and philosophical discussions may be of direct practical importance to psychiatry given that different theories suggest different potential ways of devising therapies. (shrink)

Care after research is for participants after they have finished the study. Often it is NHS-provided healthcare for the medical condition that the study addresses. Sometimes it includes the study intervention, whether funded and supplied by the study sponsor, NHS or other party. The NHS has the primary responsibility for care after research. However, researchers are responsible at least for explaining and justifying what will happen to participants once they have finished. RECs are responsible for considering the arrangements. There are (...) ethical and practical issues, in particular when participants may wish to continue on the study intervention after the study. There are also various guidelines and legislation. This document presents a framework of questions to help NHS RECs and their applicants. Information on this document’s development is here. (shrink)

The use of prisoners as research participants is controversial. Efforts to protect them in response to past exploitation and abuse have led to strict regulations and reluctance to involve them as participants. Hence, prisoners are routinely denied the opportunity to participate in research. In the absence of comprehensive information regarding prisoners’ current involvement in research, we examined UK prisoners’ involvement through review of research applications to the UK National Research Ethics Service. We found that prisoners have extremely limited access to (...) research participation. This analysis was augmented by a survey of those involved in research and research governance (UK researchers and Research Ethics Committee members). Our results suggest that pragmatic concerns regarding the perceived burden of including prisoners are far more prominent in motivating their exclusion than ethical concerns or knowledge of regulations. While prisoners may remain a vulnerable research population due to constraints upon their liberty and autonomy and the coercive nature of the prison environment, routine exclusion from participation may be disadvantageous. Rigorous ethical oversight and the shift in the prevailing attitude towards the risks and benefits of participation suggest that it may be time for research to be more accessible to prisoners in line with the principle of equivalence in prison healthcare. We suggest the necessary first step in this process is a re-examination of current guidance in the UK and other countries with exclusions. (shrink)