The consequences of the new European reclassification of non-invasive brain stimulation devices and the medical device regulations pose an existential threat to research and treatment: An invited opinion paper.

A significant amount of European basic and clinical neuroscience research includes the use of transcranial magnetic stimulation (TMS) and low intensity transcranial electrical stimulation (tES), mainly transcranial direct current stimulation (tDCS). Two recent changes in the EU regulations, the introduction of the Medical Device Regulation (MDR) (2017/745) and the Annex XVI have caused significant problems and confusions in the brain stimulation field. The negative consequences of the MDR for non-invasive brain stimulation (NIBS) have been largely overlooked and until today, have not been consequently addressed by National Competent Authorities, local ethical committees, politicians and by the scientific communities. In addition, a rushed bureaucratic decision led to seemingly wrong classification of NIBS products without an intended medical purpose into the same risk group III as invasive stimulators. Overregulation is detrimental for any research and for future developments, therefore researchers, clinicians, industry, patient representatives and an ethicist were invited to contribute to this document with the aim of starting a constructive dialogue and enacting positive changes in the regulatory environment.

Systematic review of ethical issues in perinatal mental health research.

BACKGROUND: Maternal mental health during the peripartum period is critically important to the wellbeing of mothers and their infants. Numerous studies and clinical trials have focused on various aspects of interventions and treatments for perinatal mental health from the perspective of researchers and medical health professionals. However, less is known about women's experiences of participating in perinatal mental health research, and the ethical issues that arise. AIM: To systematically review the literature on the ethical issues that emerge from pregnant and/or postpartum women's experiences of taking part in perinatal mental health-related research. METHODS: Systematic review of nine bibliographic databases, from inception to July 2021. Qualitative, quantitative and mixed method studies were included if they reported on ethical issues experienced by perinatal women. Research ethical issues encompassed any issue relating to women's experiences of being offered study information, recruitment, consent, retention and respect for autonomy.Titles, abstracts and full text screening, appraisal of the methodological quality of included studies, and data extraction, were conducted independently by two reviewers. ETHICAL CONSIDERATIONS: Ethical approval was not required for this systematic review. FINDINGS: A total of 9830 unique citations was retrieved. Six studies met the inclusion criteria. Studies were clinically and methodologically heterogenous, and only one was purposively designed to explore women's experiences. The key finding was the establishment of trust between the researcher and participant in all stages of the research process. Findings are presented according to recruitment and consent processes, participation and retention, and study follow-up and completion. CONCLUSION: The establishment of trust between the researcher and perinatal women leads to a dynamic with research ethical implications relevant to all stages of perinatal mental health-related research. Further research on the research ethical issues experienced by perinatal women is required because of the limited literature.

The role of ethical analysis in conducting a health technology assessment of medical treatments for gender dysphoria.

OBJECTIVES: Treatment seeking for gender dysphoria (GD) has increased manifold in western countries. This has led to increased interest on evidence-base of treatments, but also discussions related to human rights, identity politics, gender-related structures, and medicalization. Combining these discourses into coherent health policy is difficult. Health technology assessment (HTA) is the golden standard for assessing whether a medical intervention should be included in a health system. A comprehensive HTA should include medical, safety, and cost-utility perspectives, but often also ethical, societal, organizational, and legal concerns. Still, ethics is often omitted in practice. This paper aims to demonstrate how integrated ethical analysis influenced a HTA of complex and controversial topics like GD. METHODS: A HTA of medical treatments of GD was conducted using integrated ethical analysis based on the EUnetHTA-model. This integrates ethical thinking into the whole HTA, explicitly analyses ethical topics, and balances arguments using several ethical theories. RESULTS: Integrating ethics had a significant impact on the HTA process and recommendations. It influenced how the HTA was planned and executed, emphasized autonomy and justice when creating the recommendations, and helped the workgroup to understand the complexity of combining different stakeholders' discourses. Tensions between scientific evidence, expectations, and values became explicit. CONCLUSIONS: Comprehensive HTA provides an important, integrative approach to considering complex and controversial topics in health systems. HTA emphasizes multidisciplinary and multi-stakeholder approach but simultaneously forces a pragmatic, results-oriented, and evidence-based approach on all argumentation. Ethical analysis can facilitate interactions between stakeholders, bridge different discourses, and help formulate widely acceptable guidelines and policy decisions.

Mapping out the philosophical questions of AI and clinical practice in diagnosing and treating mental disorders.

How to classify the human condition? This is one of the main problems psychiatry has struggled with since the first diagnostic systems. The furore over the recent editions of the diagnostic systems DSM-5 and ICD-11 has evidenced it to still pose a wicked problem. Recent advances in techniques and methods of artificial intelligence and computing power which allows for the analysis of large data sets have been proposed as a possible solution for this and other problems in classification, diagnosing, and treating mental disorders. However, mental disorders contain some specific inherent features, which require critical consideration and analysis. The promises of AI for mental disorders are threatened by the unmeasurable aspects of mental disorders, and for this reason the use of AI may lead to ethically and practically undesirable consequences in its effective processing. We consider such novel and unique questions AI presents for mental health disorders in detail and evaluate potential novel, AI-specific, ethical implications.

Philosophy of too much medicine conference report.

Medical scientists have expressed scepticism about whether philosophy is relevant to medicine. We challenged this in a conference on the topic of "too much medicine" (TMM) held in Oxford in April 2017. The topic of TMM provided an opportunity to bring the two disciplines together because of its history both in philosophy and in medicine. We found that the collaboration between the two disciplines was fruitful when two conditions were met. First, both disciplines had to avoid discipline-specific jargon. Second, each discipline had to engage with the other. Specifically, medical scientists had to engage with some philosophical literature, and philosophers had to "get their hands dirty with data." In this conference report, we provide an overview of our discussions and summarize the other papers in the series.

Addiction, Heroin-Assisted Treatment and the Idea of Abstinence: A reply to Henden.

In our previous article on the question whether heroin addicts are able to give informed consent voluntarily to research on heroin-assisted treatment, we criticized the ongoing bioethical discussion of a flawed conceptualization of heroin addicts' options. As a participant in this discussion, Edmund Henden defends the conceptualization as sufficient for determining whether heroin addicts are able to give informed consent to the research on heroin-assisted treatment voluntarily. This discussion on research on heroin-assisted treatment seems to go astray in several respects. In his reply to our article Henden maintains some of the biases, such as the necessity of abstinence in recovery, that seem to prevail in addiction research on a more general level as well. These biases run the danger of having implausible ethical implications on stakeholders in addiction research and treatment. In our reply to him, we will further clarify and discuss the importance of describing the relevant issues in plausible terms that do justice to the realities of the cases of informed consent in research on heroin-assisted treatment and also raise a wider issue of the ethics of wording as well as of the narrow scope, or 'tunnel vision', in addiction research as currently conducted.

Towards a 'Sociorelational' Approach to Conceptualizing and Managing Addiction.

This article looks at how and why addiction should be understood as a 'sociorelational' (social and relational) disorder, and what this implies on a policy level in terms of the treatment and prevention of addiction. In light of scientific research, we argue that the neurobiological changes that underlie addiction are heavily influenced by sociorelational processes. We thereby advocate for a conceptual approach in which autonomy in addiction is a sociorelational concept, and social environments are considered autonomy undermining or autonomy promoting. We then discuss the various implications this should have on policies.

Scientific and conceptual flaws of coercive treatment models in addiction.

In conceptual debates on addiction, neurobiological research has been used to support the idea that addicted drug users lack control over their addiction-related actions. In some interpretations, this has led to coercive treatment models, in which, the purpose is to 'restore' control. However, neurobiological studies that go beyond what is typically presented in conceptual debates paint a different story. In particular, they indicate that though addiction has neurobiological manifestations that make the addictive behaviour difficult to control, it is possible for individuals to reverse these manifestations through their own efforts. Thus, addicted individuals should not be considered incapable of making choices voluntarily, simply on the basis that addiction has neurobiological manifestations, and coercive treatment models of addiction should be reconsidered in this respect.

Rethinking Informed Consent in Research on Heroin-Assisted Treatment.

Can heroin addicts give consent to research on trials in which heroin is prescribed to them? Analyses of addicts and informed consent have been objects of debate in several articles. Informed consent requires the agent not only to be competent but also to give consent voluntarily. This has been questioned because of alleged features of heroin addiction. Until recently the discussion has focused on heroin addicts' desires for heroin, whether these are irresistible and thus pose a problem for giving consent. Still, in light of empirical evidence, there seems to be a consensus more or less that the problem is not whether the addicts can resist their desire for heroin. A recent article concentrates specifically on heroin addicts' false assumptions of options and voluntariness. We argue that the prevailing framing of the options in this discussion in terms of heroin and access to it is problematic. The way in which the options are typically laid out suggests an assumption that participation in the research is allegedly based on the addicts' views on using the drug. We argue that this way of presenting the options is, first, a mismatch to the studies carried out and, second, symptomatic of potential misconceptions about heroin addiction and addicts. Furthermore, we also suggest that the account of voluntariness needs to be realistic in order for subjects to be able to give consent voluntarily in actual situations, and for medical research to carry out studies on improving outcomes in addiction treatment in an ethical way.