David M. Shaw

In this article I argue that vagueness concerning consent to post-mortem organ donation causes considerable harm in several ways. First, the information provided to most people registering as organ donors is very vague in terms of what is actually involved in donation. Second, the vagueness regarding consent to donation increases the distress of families of patients who are potential organ donors, both during and following the discussion about donation. Third, vagueness also increases the chances that the patient's intention to donate will not be fulfilled due to the family's distress. Fourth, the consequent reduction in the number of donated organs leads to avoidable deaths and increased suffering among potential recipients, and distresses them and their families. There are three strategies which could be used to reduce the harmful effects of this vagueness. First, recategorizing the reasons given by families who refuse donation from registered donors would bring greater clarity to donation discussions. Second, people who wish to donate their organs should be encouraged to discuss their wishes in detail with their families, and to consider recording their wishes in other ways. Finally, the consent system for organ donation could be made more detailed, ensuring both that more information is provided to potential donors and that they have more flexibility in how their intentions are indicated; this last strategy, however, could have the disadvantage of discouraging some potential donors from registering.

Institutional review boards (IRBs) have a reputation for impeding research. This reputation is understandable inasmuch as many studies are poorly designed, exploit participants, or do not ask a relevant question , and it is entirely proper that IRBs should reject such proposals. However, IRBs also frequently reject or tamper with perfectly sound and relevant studies in the name of protecting participants from harm, in accordance with the widely accepted message that “clinical research is justified only when participants are protected from excessive risks”. Here, I argue that IRBs should never reject a study because it poses too high a risk to participants, and that their role should be confined to ensuring that risks and any potential benefits are fully explained to potential participants. Everyone should have the right to participate in research without paternalistic decisions about risk being made on their behalf.

Over the last decade, several European countries and the Council of Europe itself have strongly supported the use of advance directives as a means of protecting patients’ autonomy, and adopted specific norms to regulate this matter. However, it remains unclear under which conditions those regulations should apply to people who are placed in correctional settings. The issue is becoming more significant due to the increasing numbers of inmates of old age or at risk of suffering from mental disorders, all of whom might benefit from using advance directives. At the same time, the closed nature of prisons and the disparate power relationships that characterise them mean that great caution must be exercised to prevent care being withdrawn or withheld from inmates who actually want to receive it. This paper explores the issue of prisoners’ advance directives in the European context, starting with the position enshrined in international and European law that prisoners retain all their human rights, except the right to liberty, and are therefore entitled to self-determination regarding health care decisions.

It is clearly unethical for the NHS to tell people that they will die sooner unless they pay for private treatment, and then to tell them that if they pay for private treatment they will have to pay the NHS for its insufficient service. This is all the more true if people in other parts of the country are receiving all the drugs they need for the same condition on the NHS. Patients who discover that the NHS care that they have paid for will not keep them alive should be able to supplement their care privately if they can afford it, without the added burden and insult of being told their independently inadequate NHS care will cease unless they pay for it too. Mired in self-contradiction as it is, the NHS’ "anti-two-tier" policy must change.

Despite the heavy emphasis on consent in the ethical code of the General Dental Council (GDC), it is often overlooked that communication difficulties between patient and dentist can cause problems in maintaining genuine consent during interventions. Inconsistencies in the GDC's Standards for dental professionals and Principles of patient consent guidelines are examined in this article, and it is concluded that more emphasis must be placed on continuous consent as an ongoing process essential to maintaining patients' dignity in dentistry.

In 2006, the Indian Council of Medical Research (ICMR) published its ‘Ethical guidelines for Biomedical Research on human participants’. The intention was to translate international ethical standards into locally and culturally appropriate norms and values to help biomedical researchers in India to conduct ethical research and thereby safeguard the interest of human subjects. Unfortunately, it is apparent that the guideline is not fit for purpose. In addition to problems with the structure and clarity of the guidelines, there are several serious omissions and contradictions in the recommendations. In this paper, we take a close look at the two key chapters and highlight some of the striking flaws in this important document. We conclude that ethics committees and national authorities should not lose sight of international ethical standards while incorporating local reality and cultural and social values, as focusing too much on the local context could compromise the safety of human subjects in biomedical research, particularly in India

In this Current Controversy article, I describe and analyse the imminent move to a system of deemed consent for deceased organ donation in England and similar planned changes in Scotland, in light of evidence from Wales, where the system changed in 2015. Although the media has tended to focus on the potential benefits and ethical issues relating to the main change from an opt-in default to an opt-out one, other defaults will also change, while some will remain the same. Interaction of these other defaults with the principal one raise several ethical issues that may complicate efforts to use deemed consent to increase donation rates. Most significantly, changing the main default will have the effect of changing the default for patients' families, who play a vital role in the consent process.

This paper explores the importance of hope as a determining factor for patients to participate in first-in-human trials for synthetic biology therapies. This paper focuses on different aspects of hope in the context of human health and well-being and explores the varieties of hope expressed by patients. The research findings are based on interview data collected from stable gout and diabetes patients. Three concepts of hope have emerged from the interviews: hope as certainty ; hope as reflective uncertainty ; hope as self-therapy. The purpose of the paper is twofold. First, it aims to underline the significance of hope in patients’ medical decision-making, as well as the beneficence of hope for patients’ well-being, and for progress in research. Second, it shows how philosophical investigations—in particular Descartes—explore the phenomenon of hope and provide medical empirical research with profitable insights and tools.

Nanotechnology, which involves manipulation of matter on a ‘nano’ scale, is considered to be a key enabling technology. Medical applications of nanotechnology are expected to significantly improve disease diagnostic and therapeutic modalities and subsequently reduce health care costs. However, there is no consensus on the definition of nanotechnology or nanomedicine, and this stems from the underlying debate on defining ‘nano’. This paper aims to present the diversity in the definition of nanomedicine and its impact on the translation of basic science research in nanotechnology into clinical applications. We present the insights obtained from exploratory qualitative interviews with 46 stakeholders involved in translational nanomedicine from Europe and North America. The definition of nanomedicine has implications for many aspects of translational research including: fund allocation, patents, drug regulatory review processes and approvals, ethical review processes, clinical trials and public acceptance. Given the interdisciplinary nature of the field and common interest in developing effective clinical applications, it is important to have honest and transparent communication about nanomedicine, its benefits and potential harm. A clear and consistent definition of nanomedicine would significantly facilitate trust among various stakeholders including the general public while minimizing the risk of miscommunication and undue fear of nanotechnology and nanomedicine.

The Ebola epidemic in Western Africa has highlighted issues related to weak health systems, the politics of drug and vaccine development and the need for transparent and ethical criteria for use of scarce local and global resources during public health emergency. In this paper we explore two key themes. First, we argue that independent of any use of experimental drugs or vaccine interventions, simultaneous implementation of proven public health principles, community engagement and culturally sensitive communication are critical as these measures represent the most cost-effective and fair utilization of available resources. Second, we attempt to clarify the ethical issues related to use of scarce experimental drugs or vaccines and explore in detail the most critical ethical question related to Ebola drug or vaccine distribution in the current outbreak: who among those infected or at risk should be prioritized to receive any new experimental drugs or vaccines? We conclude that healthcare workers should be prioritised for these experimental interventions, for a variety of reasons

In this article we explore the ethical issues raised by permitting patients to pay for participation in clinical trials, and discuss whether there are any categorical objections to this practice. We address key considerations concerning payment for participation in trials, including patient autonomy, risk/benefit and justice, taking account of two previous critiques of the ethics of P4. We conclude that such trials could be ethical under certain strict conditions, but only if other potential sources of funding have first been explored or are unavailable.

We analyzed stable patients’ views regarding synthetic biology in general, the medical application of synthetic biology, and their potential participation in trials of synthetic biology in particular. The aim of the study was to find out whether patients’ views and preferences change after receiving more detailed information about synthetic biology and its clinical applications. The qualitative study was carried out with a purposive sample of 36 stable patients, who suffered from diabetes or gout. Interviews were transcribed verbatim, translated and fully anonymized. Thematic analysis was applied in order to examine stable patients’ attitudes towards synthetic biology, its medical application, and their participation in trials. When patients were asked about synthetic biology in general, most of them were anxious that something uncontrollable could be created. After a concrete example of possible future treatment options, patients started to see synthetic biology in a more positive way. Our study constitutes an important first empirical insight into stable patients’ views on synthetic biology and into the kind of fears triggered by the term “synthetic biology.” Our results show that clear and concrete information can change patients’ initial negative feelings towards synthetic biology. Information should thus be transmitted with great accuracy and transparency in order to reduce irrational fears of patients and to minimize the risk that researchers present facts too positively for the purposes of persuading patients to participate in clinical trials. Potential participants need to be adequately informed in order to be able to autonomously decide whether to participate in human subject research involving synthetic biology.

Almost all academics sigh at any mention of the REF. Preparing submissions for the Research Excellence Framework takes up a lot of effort, but is important because the REF determines a department's funding allocation from a finite pot of cash. As such, it is seen as a necessary evil by most staff. However, the REF poses ethical problems in addition to the stress it causes. As it stands, the REF is exacerbating a schism between research and teaching staff, encouraging deceptive attribution of authorship, and failing to give due credit (and cash) to deserving research. As such, the REF needs some serious refereeing.

Switzerland has very detailed laws regulating the use of animals in agriculture, entertainment and science. There are also many Swiss laws governing the genetic modification of animals, protecting human embryos, and criminalising the creation of human/animal chimeras or hybrids. Despite all these regulations, the creation of an animal embryo that will develop a human organ using induced pluripotent stem cells and the subsequent birth of the resulting chimera would actually be permitted by current legislation. While this might appear to be an unhappy accident due to insufficient scientific foresight, I argue here that this loophole should not be closed, as the creation of human organs inside animals will probably be possible within 10 years, and Swiss laws would currently enable the use of this process to save human lives through this allogenic or autologous organ source.

Why devote an issue of an ethics journal to prison medicine? Why conduct ethics research in prisons in the first place? In this editorial, we explain why prison ethics research is vitally important and illustrate our argument by introducing and briefly discussing the fascinating papers in this special issue of the Journal of Bioethical Inquiry.Ethics is often regarded as a theoretical discipline. This is in large part due to ethics’ origin as a type of moral philosophy, which is frequently associated with armchair theorising about principles and virtues and seems to have little connection with the “real world.” However, medical ethics and bioethics are increasingly becoming empirical disciplines. The “empirical turn” in ethics has led to an explosion in field research in ethics that uses the empirical methods of sociology, anthropology, and the health sciences to investigate a variety of ethical issues. The results of such research are often of much more value than purely theoret.

Researchers often refer to “research integrity”, “scientific integrity”, “research misconduct”, “scientific misconduct” and “research ethics”. However, they may use some of these terms interchangeably despite conceptual distinctions. The aim of this paper is to clarify what is signified by several key terms related to research integrity, and to suggest clearer conceptual delineation between them. To accomplish this task, it provides a conceptual analysis based upon definitions and general usage of these phrases and categorization of integrity-breaching behaviours in literature and guidelines, including clarification of the different domains and agents involved. In the first part of the analysis, following some initial clarifications, I explore the distinction between internal and external rules of integrity. In the second part, I explore the distinction between integrity and lack of misconduct, before suggesting a recategorisation of different types of integrity breach. I conclude that greater clarity is needed in the debate on research integrity. Distinguishing between scientific and research integrity, reassessing the relative gravity of different misbehaviours in light of this distinction, and recognising all intentional breaches of integrity as misconduct may help to improve guidelines and education.

Artificial intelligence (AI) based clinical decision support systems (CDSS) are becoming ever more widespread in healthcare and could play an important role in diagnostic and treatment processes. For this reason, AI‐based CDSS has an impact on the doctor–patient relationship, shaping their decisions with its suggestions. We may be on the verge of a paradigm shift, where the doctor–patient relationship is no longer a dual relationship, but a triad. This paper analyses the role of AI‐based CDSS for shared decision‐making to better comprehend its promises and associated ethical issues. Moreover, it investigates how certain AI implementations may instead foster the inappropriate paradigm of paternalism. Understanding how AI relates to doctors and influences doctor–patient communication is essential to promote more ethical medical practice. Both doctors' and patients' autonomy need to be considered in the light of AI.

One of the most fascinating issues in the emerging field of neuroethics is pharmaceutical cognitive enhancement (CE). The three main ethical concerns around CE were identified in a Nature commentary in 2008 as safety, coercion and fairness; debate has largely focused on the potential to help those who are cognitively disabled, and on the issue of “cosmetic neurology”, where people enhance not because of a medical need, but because they want to (as many as 25% of American students already use nootropic cognitive enhancers such as ritalin). However, the potential for CE to improve public health has been neglected. This paper examines the prospect of improving health outcomes through cognitive enhancement among sections of the population where health inequalities are particularly pronounced. I term this enhancement of the public's health through CE “neuroenhancing health”. It holds great promise, but raises several ethical issues. This paper provides an outline of these issues and related philosophical problems. These include the potential effectiveness of CE in reducing health inequalities; issues concerning autonomy and free will; whether moral enhancement might be more effective than cognitive enhancement in reducing health inequalities; and the problem of how to provide such CE, including the issue of whether to provide targeted and universal coverage.

Many families refuse to consent to donation from their deceased relatives or over-rule the consent given before death by the patient, but giving families more information about the potential recipients of organs could reduce refusal rates. In this paper, we analyse arguments for and against doing so, and conclude that this strategy should be attempted. While it would be impractical and possibly unethical to give details of actual potential recipients, generic, realistic information about the people who could benefit from organs should be provided to families before they make a decision about donation or attempt to over-rule it.

The various problems associated with co-authorship of research articles have attracted much attention in recent years. We believe that this growing awareness is a very welcome development. However, we will argue that the particular and increasing importance of authorship and the harmful implications of current practices of research authorship for junior researchers have not been emphasised enough. We will use the case of our own research area to illustrate some of the pitfalls of current publishing practices—in particular, the impact on the evaluation of one’s work in the area of employment or funding. Even where there are explicit guidelines, they are often disregarded. This disregard, which is often exemplified through the inflation of co-authorship in some research areas, may seem benign to some of us; but it is not. Attribution of co-authorship for reasons other than merit in relation to the publication misrepresents the work towards that publication, and generates unfair competition. We make a case for increasing awareness, for transparency and for more explicit guidelines and regulation of research co-authorship within and across research areas. We examine some of the most sensitive areas of concern and their implications for researchers, particularly junior ones, and we suggest several strategies for future action

Emerging biotechnology may soon allow the creation of genetically human organs inside animals, with non-human primates and pigs being the best candidate species. This prospect raises the question of whether creating organs in primates in order to then transplant them into humans would be more acceptable than using them for research. In this paper, we examine the validity of the purported moral distinction between primates and other animals, and analyze the ethical acceptability of using primates to create organs for human use.

This paper examines the legal justification for water fluoridation (WF) in the United Kingdom. While current legislation clearly permits WF, there is a degree of obfuscation concerning whether the practice amounts to medication, and were it to be acknowledged that fluoridated water constitutes a medicine, the legality of the practice would not be so obvious. It is concluded that an accurate and honest interpretation of the law would result in the conclusion that fluoridation does constitute medication, as it seeks to improve health by the addition of a chemical.

In recent years there have been many revelations about ghost authors, who contribute to publications but are not credited, and guest authors, who do not contribute but are credited. Most medical and many other journals adhere to the authorship standards set by the International Committee of Medical Journal Editors (ICMJE), which were designed in part to combat the phenomena of ghost and guest authorship. However, the current criteria set for authorship by the ICMJE have their own problems. This brief paper illustrates these problems with an example, and concludes that the current ICMJE definition of authorship is both illogical and unethical.

Informed consent is at the core of the clinical relationship. With the introduction of machine learning in healthcare, the role of informed consent is challenged. This paper addresses the issue of whether patients must be informed about medical ML applications and asked for consent. It aims to expose the discrepancy between ethical and practical considerations, while arguing that this polarization is a false dichotomy: in reality, ethics is applied to specific contexts and situations. Bridging this gap and considering the whole picture is essential for advancing the debate. In the light of the possible future developments of the situation and the technologies, as well as the benefits that informed consent for ML can bring to shared decision-making, the present analysis concludes that it is necessary to prepare the ground for a possible future requirement of informed consent for medical ML.