The voices of children and young people have been largely neglected in discussions of the extent to which the internet takes into account their needs and concerns. This paper aims to highlight young people’s lived experiences of being online.

The concepts of placebos and placebo effects refer to extremely diverse phenomena. I recommend dissolving the concepts of placebos and placebo effects into loosely related groups of specific mechanisms, including (potentially among others) expectation-fulfillment, classical conditioning, and attentional-somatic feedback loops. If this approach is on the right track, it has three main implications for the ethics of informed consent. First, because of the expectation-fulfillment mechanism, the process of informing cannot be considered independently from the potential effects of treatment. Obtaining informed (...) consent influences the effects of treatment. This provides support for the authorized concealment and authorized deception paradigms, and perhaps even for outright deceptive placebo use. Second, doctors may easily fail to consider the potential benefits of conditioning, leading them to misjudge the trade-off between beneficence and autonomy. Third, how attentional-somatic feedback loops play out depends not only on the content of the informing process but also on its framing. This suggests a role for libertarian paternalism in clinical practice. (shrink)

Governments are increasingly making use of field experiments to evaluate policy interventions in the spheres of education, public health and welfare. However, the research ethics literature is largely focused on the clinical context, leaving investigators, institutional review boards and government agencies with few resources to draw on to address the ethical questions they face regarding such experiments. In this article, we aim to help address this problem, investigating the conditions under which informed consent is required for ethical policy research conducted (...) or authorized by government. We argue that investigators need not secure participants' informed consent when conducting government policy experiments if: the government institution conducting or authorizing the experiment possesses a right to rule over the spheres of policy targeted by the research; and data collection does not involve the violation of participants' autonomy rights. (shrink)

The predominant view is that a study using health data is observational research and should require individual consent unless it can be shown that gaining consent is impractical. But recent arguments have been made that citizens have an ethical obligation to share their health information for research purposes. In our view, this obligation is sufficient ground to expand the circumstances where secondary use research with identifiable health information is permitted without explicit subject consent. As such, for some studies the Institutional (...) Review Board/Research Ethics Committee review process should not assess the practicality of gaining consent for data use. Instead the review process should focus on assessing the public good of the research, public engagement and transparency. (shrink)

I. EXECUTIVE SUMMARY The MRCT Center Post-trial Responsibilities: Continued Access to an Investigational Medicine Framework outlines a case-based, principled, stakeholder approach to evaluate and guide ethical responsibilities to provide continued access to an investigational medicine at the conclusion of a patient’s participation in a clinical trial. The Post-trial Responsibilities (PTR) Framework includes this Guidance Document as well as the accompanying Toolkit. A 41-member international multi-stakeholder Workgroup convened by the Multi-Regional Clinical Trials Center of Brigham and Women’s Hospital and Harvard University (...) (MRCT Center) developed this Guidance and Toolkit. Project Motivation A number of international organizations have discussed the responsibilities stakeholders have to provide continued access to investigational medicines. The World Medical Association, for example, addressed post-trial access to medicines in Paragraph 34 of the Declaration of Helsinki (WMA, 2013): “In advance of a clinical trial, sponsors, researchers and host country governments should make provisions for post-trial access for all participants who still need an intervention identified as beneficial in the trial. This information must also be disclosed to participants during the informed consent process.” This paragraph and other international guidance documents converge on several consensus points: • Post-trial access (hereafter referred to as “continued access” in this Framework [for terminology clarification – see definitions]) is the responsibility of sponsors, researchers, and host country governments; • The plan for continued access should be determined before the trial begins, and before any individual gives their informed consent; • The protocol should delineate continued access plans; and • The plan should be transparent to potential participants and explained during the informed consent process. -/- However, there is no guidance on how to fulfill these responsibilities (i.e., linking specific responsibilities with specific stakeholders, conditions, and duration). To fill this gap, the MRCT Center convened a working group in September of 2014 to develop a framework to guide stakeholders with identified responsibilities. This resultant Framework sets forth applicable principles, approaches, recommendations and ethical rationales for PTR regarding continued access to investigational medicines for research participants. (shrink)

The goal of this article is to present a first list of ethical concerns that may arise from research and personal use of virtual reality (VR) and related technology, and to offer concrete recommendations for minimizing those risks. Many of the recommendations call for focused research initiatives. In the first part of the article, we discuss the relevant evidence from psychology that motivates our concerns. In Section “Plasticity in the Human Mind,” we cover some of the main results suggesting that (...) one’s environment can influence one’s psychological states, as well as recent work on inducing illusions of embodiment. Then, in Section “Illusions of Embodiment and Their Lasting Effect,” we go on to discuss recent evidence indicating that immersion in VR can have psychological effects that last after leaving the virtual environment. In the second part of the article, we turn to the risks and recommendations. We begin, in Section “The Research Ethics of VR,” with the research ethics of VR, covering six main topics: the limits of experimental environments, informed consent, clinical risks, dual-use, online research, and a general point about the limitations of a code of conduct for research. Then, in Section “Risks for Individuals and Society,” we turn to the risks of VR for the general public, covering four main topics: long-term immersion, neglect of the social and physical environment, risky content, and privacy. We offer concrete recommendations for each of these 10 topics, summarized in Table 1. (shrink)

Most medical research and a substantial amount of non-medical research, especially that involving human participants, is governed by some kind of research ethics committee (REC) following the recommendations of the Declaration of Helsinki for the protection of human participants. The role of RECs is usually seen as twofold: firstly, to make some kind of calculation of the risks and benefits of the proposed research, and secondly, to ensure that participants give informed consent. The extent to which the role of the (...) REC includes the former is not uncontroversial. Indeed, the most prevalent debate on the role of RECs sees liberals and strong paternalists arguing over the importance of informed consent given by competent agents versus the significance of making benevolent decisions on behalf of others. On the one hand, liberals argue for the rights of competent adults to decide for themselves the kinds and extents of risks to which they wish to expose themselves. On the other hand, proponents of strong paternalism raise concerns about the likelihood of participants being able to truly understand the complex data involved in research. They support a role for RECs in which they exercise duties of benevolence towards patients and participants by limiting the extent to which they can be exposed to significant, permanent and irreversible harms. In this paper, we will argue that when it comes to decisions about risk it is neither possible nor desirable for RECs to adopt either role. (shrink)

In the American medical system, patients do not know the final price of treatment until long after the treatment is given, at which point it is too late to say “no.” I argue that without price disclosure many, perhaps all, tokens of consent in clinical medicine fall below the standard of valid, informed consent. This is a sweeping and broad thesis. The reason for this thesis is surprisingly simple: medical services rarely have prices attached to them that are known to (...) the patient prior to treatment. Yet, for many patients, knowledge of the price is relevant to whether they would give consent. If informed consent requires that patients know all information about their treatment that is relevant to their decision, then consent to a medical intervention in the absence of the price is not informed consent. (shrink)

Purpose: The method of diagnosing diabetic retinopathy (DR) through artificial intelligence (AI)-based systems has been commercially available since 2018. This introduces new ethical challenges with regard to obtaining informed consent from patients. The purpose of this work is to develop a checklist of items to be disclosed when diagnosing DR with AI systems in a primary care setting. -/- Methods: Two systematic literature searches were conducted in PubMed and Web of Science databases: a narrow search focusing on DR and a (...) broad search on general issues of AI-based diagnosis. An ethics content analysis was conducted inductively to extract two features of included publications: (1) novel information content for AI-aided diagnosis and (2) the ethical justification for its disclosure. -/- Results: The narrow search yielded n = 537 records of which n = 4 met the inclusion criteria. The information process was scarcely addressed for primary care setting. The broad search yielded n = 60 records of which n = 11 were included. In total, eight novel elements were identified to be included in the information process for ethical reasons, all of which stem from the technical specifics of medical AI. -/- Conclusions: Implications for the general practitioner are two-fold: First, doctors need to be better informed about the ethical implications of novel technologies and must understand them to properly inform patients. Second, patient's overconfidence or fears can be countered by communicating the risks, limitations, and potential benefits of diagnostic AI systems. If patients accept and are aware of the limitations of AI-aided diagnosis, they increase their chances of being diagnosed and treated in time. (shrink)

Background: The internationalization of clinical studies requires a shared understanding of the fundamental ethical values guiding clinical studies. It is important that these values are not only embraced at the legal level but also adopted by clinicians themselves during clinical studies. Objective: Our goal is to provide an insight on how clinicians in Germany and Poland perceive and identify the different ethical issues regarding informed consent in clinical studies. Methods: To gain an understanding of how clinicians view clinical studies in (...) the countries they work in, we carried out semi-structured problem-centered interviews per telephone in Poland (n = 6) and Germany (n = 6). Our interviewees concentrated on three main topics: an appraisal of the normative framework, challenges in the information process and the protection of all participants in clinical studies. Results: Clinicians generally supported the normative framework, even though they considered it quite complex. In the two study countries, a widely noted dilemma in the information process was whether to overburden participants with extensive information or risking leaving out important facts. Clinicians were ready to exclude larger population groups from participating in clinical studies when the information process could not be carried out with standard procedures or when their inclusion was ethically sensitive. Conclusion: Clinicians need to gain a better understanding of the consequences of excluding larger population groups form participating in clinical studies. They should seek assistance in improving the information process for the inclusion of underrepresented groups in clinical studies. (shrink)

Discussions of patient-centred care and patient autonomy in bioethics have tended to focus on the decision-making context and the process of obtaining informed consent, leaving open the question of how patients ought to be counselled in the daily maintenance of their health and management of chronic disease. Patient activation is an increasingly prominent counselling approach and measurement tool that aims to improve patients’ confidence and skills in managing their own health conditions. The strategy, which has received little conceptual or ethical (...) analysis, raises important questions about how clinicians ought to foster confidence and a sense of control in their patients without exposing them to blame, stigma and other harms. In this paper, we describe patient activation, discuss its relationship to personal responsibility, autonomy and health disparities, and make recommendations regarding its use and measurement. (shrink)

Disputes at the intersection of national security, surveillance, civil liberties, and transparency are nothing new, but they have become a particularly prominent part of public discourse in the years since the attacks on the World Trade Center in September 2001. This is in part due to the dramatic nature of those attacks, in part based on significant legal developments after the attacks (classifying persons as “enemy combatants” outside the scope of traditional Geneva protections, legal memos by White House counsel providing (...) rationale for torture, the USA Patriot Act), and in part because of the rapid development of communications and computing technologies that enable both greater connectivity among people and the greater ability to collect information about those connections. -/- One important way in which these questions intersect is in the controversy surrounding bulk collection of telephone metadata by the U.S. National Security Agency. The bulk metadata program (the “metadata program” or “program”) involved court orders under section 215 of the USA Patriot Act requiring telecommunications companies to provide records about all calls the companies handled and the creation of database that the NSA could search. The program was revealed to the general public in June 2013 as part of the large document leak by Edward Snowden, a former contractor for the NSA. -/- A fair amount has been written about section 215 and the bulk metadata program. Much of the commentary has focused on three discrete issues. First is whether the program is legal; that is, does the program comport with the language of the statute and is it consistent with Fourth Amendment protections against unreasonable searches and seizures? Second is whether the program infringes privacy rights; that is, does bulk metadata collection diminish individual privacy in a way that rises to the level that it infringes persons’ rights to privacy? Third is whether the secrecy of the program is inconsistent with democratic accountability. After all, people in the general public only became aware of the metadata program via the Snowden leaks; absent those leaks, there would have not likely been the sort of political backlash and investigation necessary to provide some kind of accountability. -/- In this chapter I argue that we need to look at these not as discrete questions, but as intersecting ones. The metadata program is not simply a legal problem (though it is one); it is not simply a privacy problem (though it is one); and it is not simply a secrecy problem (though it is one). Instead, the importance of the metadata program is the way in which these problems intersect and reinforce one another. Specifically, I will argue that the intersection of the questions undermines the value of rights, and that this is a deeper and more far-reaching moral problem than each of the component questions. (shrink)

Contrary to intuitions that human beings are free to think and act with “buck-stopping” freedom, philosophers since Holbach and Hume have argued that universal causation makes free will nonsensical. Contemporary neuroscience has strengthened their case and begun to reveal subtle and counterintuitive mechanisms in the processes of conscious agency. Although some fear that determinism undermines moral responsibility, the opposite is true: free will, if it existed, would undermine coherent systems of justice. Moreover, deterministic views of human choice clarify the conditions (...) in which we ought to protect people from themselves, for example when they cannot give informed consent to medical procedures. Some of the most unresolved questions in this domain are just now emerging; they include robot ethics and the responsibilities of groups. We propose a philosophical and scientific research program to apply complex systems science to these problems. (shrink)

Discussions of sexual ethics often focus on the wrong of treating another as a mere object instead of as a person worthy of respect. On this view, the task of sexual ethics becomes putting the other’s subjectivity above their status as erotic object so as to avoid the harms of objectification. Ward and Anderson argue that such a view disregards the crucial, moral role that erotic objecthood plays in sexual encounters. Important moral features of intimacy are disclosed through the experience (...) of being an erotic object for another, as well as in perceiving another as an erotic object. Drawing on phenomenology, especially the insights of Simone de Beauvoir, Ward and Anderson argue that erotic encounters are shaped by the human condition of ambiguity, where being an object for others is intertwined with bodily agency. Because sexual agency is complex in this way, theories of sexual ethics and responsibility must widen their focus beyond transparent communication and authoritative expressions of will. (shrink)

Trials with highly unfavourable risk–benefit ratios for participants, like HIV cure trials, raise questions about the quality of the consent of research participants. Why, it may be asked, would a person with HIV who is doing well on antiretroviral therapy be willing to jeopardise his health by enrolling in such a trial? We distinguish three concerns: first, how information is communicated to potential participants; second, participants’ motivations for enrolling in potentially high risk research with no prospect of direct benefit; and (...) third, participants’ understanding of the details of the trials in which they enrol. We argue that the communication concern is relevant to the validity of informed consent and the quality of decision making, that the motivation concern does not identify a genuine problem with either the validity of consent or the quality of decision making and that the understanding concern may not be relevant to the validity of consent but is relevant to the quality of decision making. In doing so, we derive guidance points for researchers recruiting and enrolling participants into their HIV cure trials, as well as the research ethics committees reviewing proposed studies. (shrink)

One interesting aspect of the Hwang-case has been the way in which this affair was assessed by academic journals such as Nature. Initially, Hwang’s success was regarded as evidence for the detrimental effects of research ethics, slowing down the pace of research in Western countries. Eventually, however, Hwang’s debacle was seen as evidence for the importance of ethics in the life sciences. Ironically, it was concluded that the West maintains its prominence in science (as a global endeavour) precisely because it (...) has its ethics in place. Bioethics was now seen as an indispensable part of quality control. In this article, I will claim that the Hwang case rather reveals that there is no reason for complacency and that there are substantial challenges awaiting us. They have to do with major transformations in the way knowledge is produced and research in the life sciences is conducted (such as the increase in pace and scale, globalisation and the growing importance of ICT and bioinformation). These transformations call for a different kind of bioethics. The focus must shift from duties of autonomous researchers concerning visible research subjects (“micro-ethics”) to responsibilities of institutionalised research networks in managing and processing large amounts of bioinformation (“macro-ethics”). Concepts such as transparency, reliability and benefit-sharing will become more important than concepts such as informed consent. Basically, it is a resurgence of the tension between the Kantian and the Hegelian view of ethics. The contours of macro-ethics will be elaborated notably as it is emerging in bioethical debates over biobanking and genetic databanks. (shrink)

Unlike its friendly cousin the placebo effect, the nocebo effect (the effect of expecting a negative outcome) has been almost ignored. Epistemic and ethical confusions related to its existence have gone all but unnoticed. Contrary to what is often asserted, adverse events following from taking placebo interventions are not necessarily nocebo effects; they could have arisen due to natural history. Meanwhile, ethical informed consent (in clinical trials and clinical practice) has centred almost exclusively on the need to inform patients about (...) intervention risks with patients to preserve their autonomy. Researchers have failed to consider the harm caused by the way in which the information is conveyed. In this paper, I argue that the magnitude of nocebo effects must be measured using control groups consisting of untreated patients. And, because the nocebo effect can produce harm, the principle of non-maleficence must be taken into account alongside autonomy when obtaining (ethical) informed consent and communicating intervention risks with patients. (shrink)

Definition of the problem The umbrella term “explicability” refers to the reduction of opacity of artificial intelligence (AI) systems. These efforts are challenging for medical AI applications because higher accuracy often comes at the cost of increased opacity. This entails ethical tensions because physicians and patients desire to trace how results are produced without compromising the performance of AI systems. The centrality of explicability within the informed consent process for medical AI systems compels an ethical reflection on the trade-offs. Which (...) levels of explicability are needed to obtain informed consent when utilizing medical AI? Arguments We proceed in five steps: First, we map the terms commonly associated with explicability as described in the ethics and computer science literature, i.e., disclosure, intelligibility, interpretability, and explainability. Second, we conduct a conceptual analysis of the ethical requirements for explicability when it comes to informed consent. Third, we distinguish hurdles for explicability in terms of epistemic and explanatory opacity. Fourth, this then allows to conclude the level of explicability physicians must reach and what patients can expect. In a final step, we show how the identified levels of explicability can technically be met from the perspective of computer science. Throughout our work, we take diagnostic AI systems in radiology as an example. Conclusion We determined four levels of explicability that need to be distinguished for ethically defensible informed consent processes and showed how developers of medical AI can technically meet these requirements. (shrink)

Informed consent has become the most obvious instantiation of patient autonomy in contemporary medicine, though as a practice it does not encompass all spheres of medicine. While diagnostic radiological procedures carry some risk due to the use of radiation, there is no standardized practice of informed consent in the United States. The authors describe the ethical justification of informed consent, the legal background surrounding it, and a brief history of radiology and radiological protection. They ultimately argue that informed consent should (...) become a common practice in computed tomography given the risks involved due to radiation exposure, especially considering the overuse of this technology, since it respects patient autonomy. (shrink)

The current ethical and regulatory framework for research is often charged with burdening investigators and impeding socially valuable research. To address these concerns, a growing number of research ethicists argue that informed consent should be adapted to the risks of research participation. This would require less rigorous consent standards in low-risk research than in high-risk research. However, the current discussion is restricted to cases of research in which the risks of research participation are outweighed by the potential clinical benefits for (...) the individual research participant. Furthermore, current proposals do not address the worry that risk-adapted informed consent may result in enrolling participants into research without their autonomous authorization. In this paper, we show how the standard view of informed consent – consent as autonomous authorization – can be adapted to risk even when the research does not have a favourable risk-benefit profile for the participant. Our argument has two important implications: first, it implies that current and proposed consent standards are not adequately calibrated to risk and, second, that consent standards also need to be adapted to factors other than risk. (shrink)

Vaccination against various diseases has been widely practised for more than a century and on a more limited scale its use in a variety of forms stretches back far longer. During earlier eras disease spread more slowly along shipping lanes on water and traditional transport routes on land. Today, in an era of air transport, contagion spreads far more rapidly. Travelling far more rapidly (indeed instantaneously) is the spread of misinformation that hinders vaccination which can, in the instance of Covid-19, (...) reduce disease impacts, including rates of severe illness and death. This paper explores the ethical issue of informed consent in the context of the contest between personal choice and the greater public welfare. It also makes reference to a number of low, middle and high income countries where vaccine hesitance, and to a lesser extent refusal, has been fed by misinformation on a scale not previously observed but made possible by the proliferation of modern technology. This campaign of ignorance has further undermined trust in governmental health bodies and their attempts to implement quarantine and other measures such as vaccination that had already been damaged by early variations and vacillation in governmental approaches around the globe due in part to a reluctance by some governments to take actions that would have economic repercussions but also by the necessary evolution of their approaches as more became known about the disease and its variants. The paper examines the historical background and the current situation and finds that more must be done to restore or increase trust levels between citizens and governmental authorities, including the dissemination of high quality accurate information in a form relevant to readers/viewers. While potential side-effects of vaccines must be disclosed to ensure informed consent, their incidence should also be clearly communicated (e.g., in vaccine information statements) so that clients/patients are aware that a risk is 1 in 100 or 1in 1000 or 1 in 2 million etc. Governments are urged to learn from their experience and better prepare for inevitable future pandemics to minimise vaccine hesitancy and refusal and maximise its acceptance where evidence is overwhelming as to the benefit to the community. Informed consent is part of the context of efforts to use vaccination to contain or eradicate any disease. Nevertheless, while better information for clients/patients/consumers may reduce vaccine hesitancy/refusal, it is unlikely that it would but eliminate the need for mandating vaccination in some circumstances for the benefit of the broader community, although strict quarantine of those reluctant to accept it is an alternative but one not generally accepted by those reluctant to be vaccinated. The information war is one that needs to be won to increase the voluntary uptake of vaccination in the context of voluntary informed consent. (shrink)

Biomarker-based predictive tests for subjectively asymptomatic Alzheimer’s disease (AD) are utilized in research today. Novel applications of artificial intelligence (AI) promise to predict the onset of AD several years in advance without determining biomarker thresholds. Until now, little attention has been paid to the new ethical challenges that AI brings to the early diagnosis in asymptomatic individuals, beyond contributing to research purposes, when we still lack adequate treatment. The aim of this paper is to explore the ethical arguments put forward (...) for AI aided AD prediction in subjectively asymptomatic individuals and their ethical implications. The ethical assessment is based on a systematic literature search. Thematic analysis was conducted inductively of 18 included publications. The ethical framework includes the principles of autonomy, beneficence, non-maleficence, and justice. Reasons for offering predictive tests to asymptomatic individuals are the right to know, a positive balance of the risk-benefit assessment, and the opportunity for future planning. Reasons against are the lack of disease modifying treatment, the accuracy and explicability of AI aided prediction, the right not to know, and threats to social rights. We conclude that there are serious ethical concerns in offering early diagnosis to asymptomatic individuals and the issues raised by the application of AI add to the already known issues. Nevertheless, pre-symptomatic testing should only be offered on request to avoid inflicted harm. We recommend developing training for physicians in communicating AI aided prediction. (shrink)

Mindfulness exercises are presented as being compatible with almost any spiritual, religious or philosophical beliefs. In this paper, we argue that they in fact involve imagining and conceptualising rather striking and controversial claims about the self, and the self’s relationship to thoughts and feelings. For this reason, practising mindfulness exercises is likely to be in tension with many people’s core beliefs and values, a tension that should be treated as a downside of therapeutic interventions involving mindfulness exercises, not unlike a (...) side effect. Clients ought to be informed of these metaphysical aspects of the exercises, and mental health providers ought to take them into account in assessing which course of treatment to recommend. Given these concerns, the casual way in which mindfulness exercises are presently distributed by mental health providers to the general public is inappropriate. (shrink)

ABSTRACT: One important criticism of algorithmic systems is that they lack transparency. Such systems can be opaque because they are complex, protected by patent or trade secret, or deliberately obscure. In the EU, there is a debate about whether the General Data Protection Regulation (GDPR) contains a “right to explanation,” and if so what such a right entails. Our task in this chapter is to address this informational component of algorithmic systems. We argue that information access is integral for respecting (...) autonomy, and transparency policies should be tailored to advance autonomy. -/- To make this argument we distinguish two facets of agency (i.e., capacity to act). The first is practical agency, or the ability to act effectively according to one’s values. The second is what we call cognitive agency, which is the ability to exercise what Pamela Hieronymi calls “evaluative control” (i.e., the ability to control our affective states, such as beliefs, desires, and attitudes). We argue that respecting autonomy requires providing persons sufficient information to exercise evaluative control and properly interpret the world and one’s place in it. We draw this distinction out by considering algorithmic systems used in background checks, and we apply the view to key cases involving risk assessment in criminal justice decisions and K-12 teacher evaluation. -/- The link below is to an open access version of the chapter. (shrink)

This paper aims to outline the foundations for an ethics of digital touch. Digital touch refers to hardware and software technologies, often collectively referred to as ‘haptics’, that provide somatic sensations including touch and kinaesthesis, either as a stand-alone interface to users, or as part of a wider immersive experience. Digital touch has particular promise in application areas such as communication, affective computing, medicine, and education. However, as with all emerging technologies, potential value needs to be considered against potential risk. (...) We therefore identify some areas where digital touch raises ethical concerns, and we identify why these concerns arise, based on the distinctive physiological and functional properties of the human somatosensory system. Most scientific research in digital touch has focused on user interaction with external objects (active touch). However, the most pressing ethical concerns with digital touch technologies arise when users are being passively touched. Our analysis identifies several important questions about control, transparency, and epistemic procedure in digital touch scenarios. First, human somatosensation is “always on”, and many digital touch technologies take advantage of this (e.g., alerting systems). As a result, digital touch technologies can undermine individuals’ sensory autonomy (i.e., the right to choose what sensations one experiences). Second, users may reasonably want to know who or what is touching them, and for what purpose. Consent for digital touch will therefore need to be carefully and transparently transacted. Third, because touch gives us a special, direct experience of interacting with our physical environment, digital touch technologies that manipulate this interaction could potentially provide a major epistemic challenge, by changing a user’s basic understanding of reality and their relation to it. Informed by this discussion, we conclude by suggesting a basis for an ethical design framework for digital touch systems. (shrink)

Background Retraction is a mechanism for alerting readers to unreliable material and other problems in the published scientific and scholarly record. Retracted publications generally remain visible and searchable, but the intention of retraction is to mark them as “removed” from the citable record of scholarship. However, in practice, some retracted articles continue to be treated by researchers and the public as valid content as they are often unaware of the retraction. Research over the past decade has identified a number of (...) factors contributing to the unintentional spread of retracted research. The goal of the Reducing the Inadvertent Spread of Retracted Science: Shaping a Research and Implementation Agenda (RISRS) project was to develop an actionable agenda for reducing the inadvertent spread of retracted science. This included identifying how retraction status could be more thoroughly disseminated, and determining what actions are feasible and relevant for particular stakeholders who play a role in the distribution of knowledge. -/- Methods These recommendations were developed as part of a year-long process that included a scoping review of empirical literature and successive rounds of stakeholder consultation, culminating in a three-part online workshop that brought together a diverse body of 65 stakeholders in October–November 2020 to engage in collaborative problem solving and dialogue. Stakeholders held roles such as publishers, editors, researchers, librarians, standards developers, funding program officers, and technologists and worked for institutions such as universities, governmental agencies, funding organizations, publishing houses, libraries, standards organizations, and technology providers. Workshop discussions were seeded by materials derived from stakeholder interviews (N = 47) and short original discussion pieces contributed by stakeholders. The online workshop resulted in a set of recommendations to address the complexities of retracted research throughout the scholarly communications ecosystem. -/- Results The RISRS recommendations are: (1) Develop a systematic cross-industry approach to ensure the public availability of consistent, standardized, interoperable, and timely information about retractions; (2) Recommend a taxonomy of retraction categories/classifications and corresponding retraction metadata that can be adopted by all stakeholders; (3) Develop best practices for coordinating the retraction process to enable timely, fair, unbiased outcomes; and (4) Educate stakeholders about pre- and post-publication stewardship, including retraction and correction of the scholarly record. -/- Conclusions Our stakeholder engagement study led to 4 recommendations to address inadvertent citation of retracted research, and formation of a working group to develop the Communication of Retractions, Removals, and Expressions of Concern (CORREC) Recommended Practice. Further work will be needed to determine how well retractions are currently documented, how retraction of code and datasets impacts related publications, and to identify if retraction metadata (fails to) propagate. Outcomes of all this work should lead to ensuring retracted papers are never cited without awareness of the retraction, and that, in public fora outside of science, retracted papers are not treated as valid scientific outputs. (shrink)

Several authors have recently argued that psychotherapy, as it is commonly practiced, is deceptive and undermines patients’ ability to give informed consent to treatment. This ‘deception’ claim is based on the findings that some, and possibly most, of the ameliorative effects in psychotherapeutic interventions are mediated by therapeutic common factors shared by successful treatments, rather than because of theory-specific techniques. These findings have led to claims that psychotherapy is, at least partly, likely a placebo, and that practitioners of psychotherapy have (...) a duty to ‘go open’ to patients about the role of common factors in therapy ; to not ‘go open’ is supposed to unjustly restrict patients’ autonomy. This paper makes two related arguments against the ‘go open’ claim. While therapies ought to provide patients with sufficient information to make informed treatment decisions, informed consent does not require that practitioners ‘go open’ about therapeutic common factors in psychotherapy, and clarity about the mechanisms of change in psychotherapy shows us that the common-factors findings are consistent with, rather than undermining of, the truth of many theory-specific forms of psychotherapy; psychotherapy, as it is commonly practiced, is not deceptive and is not a placebo. The call to ‘go open’ should be resisted and may have serious detrimental effects on patients via the dissemination of a false view about how therapy works. (shrink)

It is widely agreed that the view of informed consent found in the regulations and guidelines struggles to keep pace with the ever-advancing enterprise of human subjects research. Over the last 10 years, there have been serious attempts to rethink informed consent so that it conforms to our considered judgments about cases where we are confident valid consent has been given. These arguments are influenced by an argument from Gopal Sreenivasan, which apparently shows that a potential participant9s consent to research (...) participation can be perfectly valid even if she fails to understand the risk-benefit profile of the study. I argue that Sreenivasan9s argument fails. The set of clinical trials that is supposed to be ethical in the face of this kind of ignorance is empty. However, I argue that his argument is nonetheless instructive in allowing us to identify three important but neglected areas for future conceptual research on informed consent. I close by arguing that research on these identified questions promises to yield a defensible view of consent, lessen the burden of ambiguity on researchers attempting to obtain consent to research participation, and facilitate socially valuable research. (shrink)

Florence Ashley has argued that requiring patients with gender dysphoria to undergo an assessment and referral from a mental health professional before undergoing hormone replacement therapy is unethical and may represent an unconscious hostility towards transgender people. We respond, first, by showing that Ashley has conflated the self-reporting of symptoms with self-diagnosis, and that this is not consistent with the standard model of informed consent to medical treatment. Second, we note that the model of informed consent involved in cosmetic surgery (...) resembles the model Ashley defends, and that psychological assessment and referral is recognised as an important aspect of such a model. Third, we suggest that the increased prevalence of psychiatric morbidity in the transgender population arguably supports the requirement of assessment and referral from a mental health professional prior to undergoing HRT. (shrink)

Since the Nuremberg Code and the first Declaration of Helsinki, globally there has been increasing adoption and adherence to procedures for ensuring that human subjects in research are as well informed as possible of the study’s reasons and risks and voluntarily consent to serving as subject. To do otherwise is essentially viewed as violation of the human research subject’s legal and moral rights. However, with the recent philosophical concerns about responsible robotics, the limits and ambiguities of research-subjects ethical codes become (...) apparent on the matter of constructing automata that maximally resemble human beings (as defined hereunder). In this case, the automata themselves, as products of research and development, are in the very process of their construction subjects of research and development. However, such research faces a paradox: The subjects cannot give their informed consent to this research for their own development, although their consent would be needed for the research. According to ethical codes, this research would be unethical. The article then explores whether the background concepts giving rise to this paradox could be reframed in order to allow such research to proceed ethically. (shrink)

In this paper, we illustrate some serious difficulties involved in conveying information about uncertain risks and securing informed consent for risky interventions in a clinical setting. We argue that in order to secure informed consent for a medical intervention, physicians often need to do more than report a bare, numerical probability value. When probabilities are given, securing informed consent generally requires communicating how probability expressions are to be interpreted and communicating something about the quality and quantity of the evidence for (...) the probabilities reported. Patients may also require guidance on how probability claims may or may not be relevant to their decisions, and physicians should be ready to help patients understand these issues. (shrink)

In ‘Psychotherapy, Placebos and Informed Consent’, I argued that the minimal standard for informed consent in psychotherapy requires that ‘patients understand that there is currently no consensus about the mechanisms of change in psychotherapy, and that the therapy on offer…is based on disputed theoretical foundations’, and that the dissemination of this information is compatible with the delivery of many theory-specific forms of psychotherapy (including cognitive behavioural therapy [CBT]). I also argued that the minimal requirements for informed consent do not include (...) information about the role of therapeutic common factors in healing (e.g., expectancy effects and therapist effects); practitioners may discuss the common factors with patients, but they are not part of the ‘core set’ of information necessary to obtain informed consent. In a recent reply, Charlotte Blease criticises these two arguments by claiming they are not supported by empirical findings about the therapeutic common factors. Blease’s response is based on serious misunderstandings of both CBT and what the common factor findings actually find. Nevertheless, addressing the reasons for these misunderstandings is instructive and gives us an opportunity to clarify what, exactly, needs to be explained to patients in order to obtain informed consent for psychotherapy. (shrink)

Vaccination against various diseases has been widely practised for more than a century and on a more limited scale its use in a variety of forms stretches back far longer. During earlier eras disease spread more slowly along shipping lanes on water and traditional transport routes on land. Today, in an era of air transport, contagion spreads far more rapidly. Travelling far more rapidly (indeed instantaneously) is the spread of misinformation that hinders vaccination which can, in the instance of Covid-19, (...) reduce disease impacts, including rates of severe illness and death. This paper explores the ethical issue of informed consent in the context of the contest between personal choice and the greater public welfare. It also makes reference to a number of low, middle and high income countries where vaccine hesitance, and to a lesser extent refusal, has been fed by misinformation on a scale not previously observed but made possible by the proliferation of modern technology. This campaign of ignorance has further undermined trust in governmental health bodies and their attempts to implement quarantine and other measures such as vaccination that had already been damaged by early variations and vacillation in governmental approaches around the globe due in part to a reluctance by some governments to take actions that would have economic repercussions but also by the necessary evolution of their approaches as more became known about the disease and its variants. The paper examines the historical background and the current situation and finds that more must be done to restore or increase trust levels between citizens and governmental authorities, including the dissemination of high quality accurate information in a form relevant to readers/viewers. While potential side-effects of vaccines must be disclosed to ensure informed consent, their incidence should also be clearly communicated (e.g., in vaccine information statements) so that clients/patients are aware that a risk is 1 in 100 or 1in 1000 or 1 in 2 million etc. Governments are urged to learn from their experience and better prepare for inevitable future pandemics to minimise vaccine hesitancy and refusal and maximise its acceptance where evidence is overwhelming as to the benefit to the community. Informed consent is part of the context of efforts to use vaccination to contain or eradicate any disease. Nevertheless, while better information for clients/patients/consumers may reduce vaccine hesitancy/refusal, it is unlikely that it would but eliminate the need for mandating vaccination in some circumstances for the benefit of the broader community, although strict quarantine of those reluctant to accept it is an alternative but one not generally accepted by those reluctant to be vaccinated. The information war is one that needs to be won to increase the voluntary uptake of vaccination in the context of voluntary informed consent. (shrink)

The Adverse Outcome Pathway (AOP) concept is a knowledge assembly and communication tool to facilitate the transparent translation of mechanistic information into outcomes meaningful to the regulatory assessment of chemicals. The AOP framework and associated knowledgebases (KBs) have received significant attention and use in the regulatory toxicology community. However, it is increasingly apparent that the potential stakeholder community for the AOP concept and AOP KBs is broader than scientists and regulators directly involved in chemical safety assessment. In this paper we (...) identify and describe those stakeholders who currently—or in the future—could benefit from the application of the AOP framework and knowledge to specific problems. We also summarize the challenges faced in implementing pathway-based approaches such as the AOP framework in biological sciences, and provide a series of recommendations to meet critical needs to ensure further progression of the framework as a useful, sustainable and dependable tool supporting assessments of both human health and the environment. Although the AOP concept has the potential to significantly impact the organization and interpretation of biological information in a variety of disciplines/applications, this promise can only be fully realized through the active engagement of, and input from multiple stakeholders, requiring multi-pronged substantive long-term planning and strategies. (shrink)

The public constitutes a major stakeholder in the debate about, and resolution of privacy and ethical The public constitutes a major stakeholder in the debate about, and resolution of privacy and ethical about Big Data research seriously and how to communicate messages designed to build trust in specific big data projects and the institution of science in general. This chapter explores the implications of various examples of engaging the public in online activities such as Wikipedia that contrast with “Notice and (...) Consent” forms and offers models for scientists to consider when approaching their potential subjects in research. Drawing from Lessig, Code and Other Laws of Cyberspace, the chapter suggests that four main regulators drive the shape of online activity: Code (or Architecture), Laws, Markets, and Norms. Specifically, scientists should adopt best practices in protecting computerized Big Data (Code), remain completely transparent about their data management practices (Law), make smart choices when deploying digital solutions that place a premium on information protection (Market), and, critically, portray themselves to the public as seriously concerned with protecting the privacy of persons and security of data (Norms). The community of Big Data users and collectors should remember that such data are not just “out there” somewhere but are the intimate details of the lives of real persons who have just as deep an interest in protecting their privacy as they do in the good work that is conducted with such data. (shrink)

The paper investigates the ethics of information transparency (henceforth transparency). It argues that transparency is not an ethical principle in itself but a pro-ethical condition for enabling or impairing other ethical practices or principles. A new definition of transparency is offered in order to take into account the dynamics of information production and the differences between data and information. It is then argued that the proposed definition provides a better understanding of what sort of information should be disclosed and what (...) sort of information should be used in order to implement and make effective the ethical practices and principles to which an organisation is committed. The concepts of “heterogeneous organisation” and “autonomous computational artefact” are further defined in order to clarify the ethical implications of the technology used in implementing information transparency. It is argued that explicit ethical designs, which describe how ethical principles are embedded into the practice of software design, would represent valuable information that could be disclosed by organisations in order to support their ethical standing. (shrink)

Background: Biomedical research nowadays is increasingly carried out in multinational and multicenter settings. Due to disparate national regulations on various ethical aspects, such as informed consent, there is the risk of ethical compromises when involving human subjects in research. Although the Declaration of Helsinki is the point of reference for ethical conduct of research on humans, national normative requirements may diverge from its provisions. The aim of this research is to examine requirements on informed consent in biomedical research in Germany, (...) Poland, and Russia to determine how each national regulatory framework relates to the provisions of the Declaration of Helsinki. Methods: For this analysis, we conducted a search of the legal databases “Gesetze im Internet” for Germany, “Internetowy System Aktow Prawnych” for Poland, and “ГAPAHT – Garant” for Russia. The search was complemented by a review of secondary literature contained in the databases Google Scholar, PubMed, Polish National Library, and eLibrary ru. We have identified 21 normative regulations containing provisions on informed consent in clinical research in all three countries. The content of these documents was systematically categorized and analyzed. Results: The normative framework in all three countries shows a strong commitment towards the core ethical principles of research envisaged in the Declaration of Helsinki. Nevertheless, provisions on informed consent vary between these three countries. The differences range from the method and language in which information should be provided, through the amount of information required to be disclosed, to the form of documenting consent or withdrawal. In the case of research on vulnerable groups, these differences are particularly visible. Conclusions: The identified differences can negatively impact the ethical conduct of international clinical studies. Attention needs to be paid that flexibilities within national regulations are not misused to undermine the protection of research subjects. Achieving global or regional legislative harmonization might prove impossible. Such lack of legal consensus reinforces the significance of the international ethical agreements. (shrink)

-/- Policy regulations of ethically controversial genetic technologies should, on the one hand, be based on ethical principles. On the other hand, they should be socially acceptable to ensure implementation. In addition, they should align with ethical theory. Yet to date we lack a reliable and valid scale to measure the relevant ethical judgements in laypeople. We target this lacuna. -/- We developed a scale based on ethical principles to elicit lay judgments: the Genetic Technologies Questionnaire (GTQ). In two pilot (...) studies and a pre-registered main study, we validated the scale in a representative sample of the US population. -/- The final version of the scale contains 20 items but remains highly reliable even when reduced to five. It also predicts behaviour; for example, ethical judgments as measured by the GTQ predicted hypothetical donations and grocery shopping. In addition, the GTQ may be of interest to policymakers and ethicists because it reveals coherent and ethically justified judgments in laypeople. For instance, the GTQ indicates that ethical judgments are sensitive to possible benefits and harms (in line with utilitarian ethics), but also to ethical principles such as the value of consent-autonomy. -/- In conclusion, the GTQ can be recommended for research in both experimental psychology and applied ethics, as well as a tool for ethically and empirically informed policymaking. (shrink)

Research ethics committees and institutional review boards spend considerable time developing, scrutinising, and revising specific consent processes and materials for survey-based studies conducted on crowdsourcing and online recruitment platforms such as MTurk and Prolific. However, there is evidence to suggest that many users of ICT services do not read the information provided as part of the consent process and they habitually provide or refuse their consent without adequate reflection. In principle, these practices call into question the validity of their consent. (...) In this paper we argue that although the ‘no read problem’ and the routinisation of consent may apply to research participants’ consent practices for studies on crowdsourcing platforms, this is not a serious problem. Furthermore, given that the informational requirements for informed consent in these contexts are minimal, we argue that these participants are, nevertheless, sufficiently informed to give valid consent. We conclude that research ethics committees and institutional review boards should only agonise over the precise details of the informed consent process and materials in those rare cases where appreciable risks to research participants need to be managed. (shrink)

Scientists who engage in science and the scientific endeavor should seek truth with conviction of morals and commitment to ethics. While the number of publications continues to increase, the number of retractions has increased at a faster rate. Journals publish fraudulent research papers despite claims of peer review and adherence to publishing ethics. Nevertheless, appropriate ethical peer review will remain a gatekeeper when selecting research manuscripts in scholarly publishing and approving research applications for grant funding. However, this peer review must (...) become more open, fair, transparent, equitable, and just with new recommendations and guidelines for reproducible and accountable reviews that support and promote fair citation and citational justice. We should engineer this new peer-review process with modern informatics technology and information science to provide and defend better safeguards for truth and integrity, to clarify and maintain the provenance of information and ideas, and to rebuild and restore trust in scholarly research institutions. Indeed, this new approach will be necessary in the current post-truth era to counter the ease and speed with which mis-information, dis-information, anti-information, caco-information, and mal-information spread through the internet, web, news, and social media. The most important question for application of new peer-review methods to these information wars should be ‘Who does what when?’ in support of reproducible and accountable reviews. Who refers to the authors, reviewers, editors, and publishers as participants in the review process. What refers to disclosure of the participants' identities, the material content of author manuscripts and reviewer commentaries, and other communications between authors and reviewers. When refers to tracking the sequential points in time for which disclosure of whose identity, which content, and which communication at which step of the peer-review process for which audience of readers and reviewers. We believe that quality peer review, and peer review of peer review, must be motivated and maintained by elevating their status and prestige to an art and a science. Both peer review itself and peer review analyses of peer reviews should be incentivised by publishing peer reviews as citable references separately from the research report reviewed while crossreferenced and crosslinked to the report reviewed. (shrink)

Medical ethicists conventionally assume that the requirement to employ informed consent procedures is grounded in autonomy. It seems intuitively plausible that providing information to an agent promotes his autonomy by better allowing him to steer his life. However, James Taylor questions this view, arguing that any notion of autonomy that grounds a requirement to inform agents turns out to be unrealistic and self-defeating. Taylor thus contends that we are mistaken about the real theoretical grounds for informed consent procedures. Through analysing (...) Taylor's arguments and showing that they do not stand up to scrutiny, it is possible to defend the view that autonomy is a plausible theoretical basis for informed consent, and to enhance our understanding of the relationship between autonomy and informed consent. (shrink)

In “Informed Consent: What Must be Disclosed and What Must be Understood?”, we reject a dogma at the heart of research ethics. We demonstrate that the constitutive claim...

Armed conflict in Darfur, west Sudan since 2003 has led to the influx of about 100 international humanitarian UN and non-governmental organizations to help the affected population. Many of their humanitarian i...

When agents insert technological systems into their decision-making processes, they can obscure moral responsibility for the results. This can give rise to a distinct moral wrong, which we call “agency laundering.” At root, agency laundering involves obfuscating one’s moral responsibility by enlisting a technology or process to take some action and letting it forestall others from demanding an account for bad outcomes that result. We argue that the concept of agency laundering helps in understanding important moral problems in a number (...) of recent cases involving automated, or algorithmic, decision-systems. We apply our conception of agency laundering to a series of examples, including Facebook’s automated advertising suggestions, Uber’s driver interfaces, algorithmic evaluation of K-12 teachers, and risk assessment in criminal sentencing. We distinguish agency laundering from several other critiques of information technology, including the so-called “responsibility gap,” “bias laundering,” and masking. (shrink)

Weighing competing obligations and achieving the “greatest balance” of right over wrong guides an individual, an agency or a country in determining what ought to be done in an ethically challenging situation. Conducting controlled human infection model (CHIM) studies in India is one such situation. The ethical challenge in conducting a CHIM study lies in completing the difficult task of introducing standardised, attenuated strains of micro-organisms into normal healthy volunteers, at the same time ensuring the safety of these healthy individuals (...) from potential and completely informed risks in a fashion that is transparent and accountable. The bar is further raised against the background of already fragile public confidence in biomedical research in India; especially when “deliberate” introduction of microbial agents into healthy individuals is involved, with the larger altruistic objective of gain to society as a whole. -/- This paper discusses the uses of CHIM studies with respect to the larger scientific Indian research enterprise of the 21st century. It further explores etic and emic perspectives in conducting such trials in India and seeks to generate an ethical coherence to the justification for conducting CHIM studies in India. The paper deliberates on ethical issues arising out of conducting CHIM studies and reflects on how developing the capacity for CHIM studies in India is likely to strengthen the health research and development sector in the country. -/- . (shrink)

Anomaly in English law between age of children's permitted consent to treatment and much lower age of criminal responsibility.

Some experts have argued that patients should routinely be told the specific magnitude and absolute probability of potential risks and benefits of screening tests. This position is motivated by the idea that framing risk information in ways that are less precise violates the ethical principle of respect for autonomy and its application in informed consent or shared decisionmaking. In this Perspective, we consider a number of problems with this view that have not been adequately addressed. The most important challenges stem (...) from the danger that patients will misunderstand the information or have irrational responses to it. Any initiative in this area should take such factors into account and should consider carefully how to apply the ethical principles of respect for autonomy and beneficence. (shrink)

Deception of subjects is used frequently in the social sciences. Examples are provided. The ethics of experimental deception are discussed, in particular various maneuvers to solve the problem. The results have implications for the use of deception in the biomedical sciences.

In both popular and scholarly discussions, sexual consent is gaining traction as the central moral consideration in how people should treat one another in sexual encounters. However, while the concept of consent has been indispensable to oppose many forms of sexual violence, consent-based sexual ethics struggle to account for the phenomenological complexity of sexual intimacy and the social and structural pressures that often surround sexual communication and behavior. Feminist structural critique and social research on the prevalence of violation even within (...) consensual sex suggest that consent is insufficient to ground responsibility; a more fundamental orientation toward the value of sexual agency provides a better foundation for sexual ethics. Using feminist critical theory, phenomenology, and black feminist thought, this dissertation develops a socially situated and relational notion of sexual agency and diagnoses how such agency is neglected in prevailing discussions of consent in moral philosophy and legal theory. I argue that the ethical question of responsibility to another in a sexual encounter—apart from juridical considerations—should be reframed around the value of each person’s socially situated practices of agency. Preceding and extending beyond the obligation to gain valid consent for an action, responsibility demands adapting one’s intentions and behaviors in response to the wider range of another’s communicative expressions of agency. However, communicative expressions can be ambiguous or overdetermined by social context and cultural norms; they often offer only provisional traces of agency. To address this inherent uncertainty in intimacy, I propose drawing on insights from Emmanuel Levinas about the dynamic, open-ended nature of relationality, responsibility, and communication. Responsibility toward another does not depend on securing certainty about their “yes” or “no,” but requires responding continuously under conditions of uncertainty and ambiguity, adapting behaviors and intentions to make room for another’s agency despite its opacity. (shrink)

Recent evidence shows significant potential for therapies involving psychedelic substances such as psilocybin and MDMA to improve clinical outcomes for patients experiencing various mental disorders. However, research to date focuses almost exclusively on adults. I argue that adolescents should be included in research into psychedelic therapies. First, I demonstrate the pressing need for novel interventions to address the growing mental health burden of adolescents, and I draw on empirical evidence to show that research into psychedelic therapies presents an opportunity to (...) address this shortfall. Secondly, I argue that psychedelics pose low risk to young patients, particularly relative to existing psychiatric medications. I then address two major concerns specific to adolescent contexts. First, I address the risks of using psychedelic substances at earlier stages of physiological and cognitive development. I note that the lack of understanding of the risks underscores the need for including adolescents in research. I then address the added complexity of consent in the adolescent context. I highlight some additional concerns that should be addressed in an “enhanced” informed consent process for adolescents and defend the view that capable adolescents should be able to consent to psychedelic interventions. I ultimately hold that including adolescents in emerging psychedelic research has the potential to substantiate innovative treatments that could improve their clinical outcomes, long-term mental health and quality of life. (shrink)