Understanding drug exceptional access programs (DEAPs) in Canada, and their associated social and political issues.

Drug exceptional access programs (DEAPs) exist across Canada to address gaps in access to pharmaceuticals. These programs circumvent standard procedures, raising epistemic, economic, social and political issues. This commentary provides insights into these issues by revealing the context and procedures on which these programs depend.

Your robot therapist is not your therapist: understanding the role of AI-powered mental health chatbots.

Artificial intelligence (AI)-powered chatbots have the potential to substantially increase access to affordable and effective mental health services by supplementing the work of clinicians. Their 24/7 availability and accessibility through a mobile phone allow individuals to obtain help whenever and wherever needed, overcoming financial and logistical barriers. Although psychological AI chatbots have the ability to make significant improvements in providing mental health care services, they do not come without ethical and technical challenges. Some major concerns include providing inadequate or harmful support, exploiting vulnerable populations, and potentially producing discriminatory advice due to algorithmic bias. However, it is not always obvious for users to fully understand the nature of the relationship they have with chatbots. There can be significant misunderstandings about the exact purpose of the chatbot, particularly in terms of care expectations, ability to adapt to the particularities of users and responsiveness in terms of the needs and resources/treatments that can be offered. Hence, it is imperative that users are aware of the limited therapeutic relationship they can enjoy when interacting with mental health chatbots. Ignorance or misunderstanding of such limitations or of the role of psychological AI chatbots may lead to a therapeutic misconception (TM) where the user would underestimate the restrictions of such technologies and overestimate their ability to provide actual therapeutic support and guidance. TM raises major ethical concerns that can exacerbate one's mental health contributing to the global mental health crisis. This paper will explore the various ways in which TM can occur particularly through inaccurate marketing of these chatbots, forming a digital therapeutic alliance with them, receiving harmful advice due to bias in the design and algorithm, and the chatbots inability to foster autonomy with patients.

Proposed Principles for International Bioethics Conferencing: Anti-Discriminatory, Global, and Inclusive.

This paper opens a critical conversation about the ethics of international bioethics conferencing and proposes principles that commit to being anti-discriminatory, global, and inclusive. We launch this conversation in the Section, Case Study, with a case example involving the International Association of Bioethics' (IAB's) selection of Qatar to host the 2024 World Congress of Bioethics. IAB's choice of Qatar sparked controversy. We believe it also may reveal deeper issues of Islamophobia in bioethics. The Section, Principles for International Bioethics Conferencing, sets forth and defends proposed principles for international bioethics conferencing. The Section, Applying Principles to Site Selection applies the proposed principles to the case example. The Section, Applying Principles Beyond Site Selection addresses other applications of the proposed principles. The Section, Objections responds to objections. We close (in the Section, Conclusion) by calling for a wider discussion of our proposed principles.One-Sentence Capsule Summary: How should bioethicists navigate the ethics of global bioethics conferencing?

Specific challenges posed by artificial intelligence in research ethics.

Background: The twenty first century is often defined as the era of Artificial Intelligence (AI), which raises many questions regarding its impact on society. It is already significantly changing many practices in different fields. Research ethics (RE) is no exception. Many challenges, including responsibility, privacy, and transparency, are encountered. Research ethics boards (REB) have been established to ensure that ethical practices are adequately followed during research projects. This scoping review aims to bring out the challenges of AI in research ethics and to investigate if REBs are equipped to evaluate them. Methods: Three electronic databases were selected to collect peer-reviewed articles that fit the inclusion criteria (English or French, published between 2016 and 2021, containing AI, RE, and REB). Two instigators independently reviewed each piece by screening with Covidence and then coding with NVivo. Results: From having a total of 657 articles to review, we were left with a final sample of 28 relevant papers for our scoping review. The selected literature described AI in research ethics (i.e., views on current guidelines, key ethical concept and approaches, key issues of the current state of AI-specific RE guidelines) and REBs regarding AI (i.e., their roles, scope and approaches, key practices and processes, limitations and challenges, stakeholder perceptions). However, the literature often described REBs ethical assessment practices of projects in AI research as lacking knowledge and tools. Conclusion: Ethical reflections are taking a step forward while normative guidelines adaptation to AI's reality is still dawdling. This impacts REBs and most stakeholders involved with AI. Indeed, REBs are not equipped enough to adequately evaluate AI research ethics and require standard guidelines to help them do so.

Advertising Alternative Cancer Treatments and Approaches on Meta Social Media Platforms: Content Analysis.

BACKGROUND: Alternative cancer treatment is associated with a greater risk of death than cancer patients undergoing conventional treatments. Anecdotal evidence suggests cancer patients view paid advertisements promoting alternative cancer treatment on social media, but the extent and nature of this advertising remain unknown. This context suggests an urgent need to investigate alternative cancer treatment advertising on social media. OBJECTIVE: This study aimed to systematically analyze the advertising activities of prominent alternative cancer treatment practitioners on Meta platforms, including Facebook, Instagram, Messenger, and Audience Network. We specifically sought to determine (1) whether paid advertising for alternative cancer treatment occurs on Meta social media platforms, (2) the strategies and messages of alternative cancer providers to reach and appeal to prospective patients, and (3) how the efficacy of alternative treatments is portrayed. METHODS: Between December 6, 2021, and December 12, 2021, we collected active advertisements from alternative cancer clinics using the Meta Ad Library. The information collected included identification number, URL, active/inactive status, dates launched/ran, advertiser page name, and a screenshot (image) or recording (video) of the advertisement. We then conducted a content analysis to determine how alternative cancer providers communicate the claimed benefits of their services and evaluated how they portrayed alternative cancer treatment efficacy. RESULTS: We identified 310 paid advertisements from 11 alternative cancer clinics on Meta (Facebook, Instagram, or Messenger) marketing alternative treatment approaches, care, and interventions. Alternative cancer providers appealed to prospective patients through eight strategies: (1) advertiser representation as a legitimate medical provider (n=289, 93.2%); (2) appealing to persons with limited treatments options (n=203, 65.5%); (3) client testimonials (n=168, 54.2%); (4) promoting holistic approaches (n=121, 39%); (5) promoting messages of care (n=81, 26.1%); (6) rhetoric related to science and research (n=72, 23.2%); (7) rhetoric pertaining to the latest technology (n=63, 20.3%); and (8) focusing treatment on cancer origins and cause (n=43, 13.9%). Overall, 25.8% (n=80) of advertisements included a direct statement claiming provider treatment can cure cancer or prolong life. CONCLUSIONS: Our results provide evidence alternative cancer providers are using Meta advertising products to market scientifically unsupported cancer treatments. Advertisements regularly referenced "alternative" and "natural" treatment approaches to cancer. Imagery and text content that emulated evidence-based medical providers created the impression that the offered treatments were effective medical options for cancer. Advertisements exploited the hope of patients with terminal and poor prognoses by sharing testimonials of past patients who allegedly were cured or had their lives prolonged. We recommend that Meta introduce a mandatory, human-led authorization process that is not reliant upon artificial intelligence for medical-related advertisers before giving advertising permissions. Further research should focus on the conflict of interest between social media platforms advertising products and public health.

Ethical Implications of Artificial Intelligence in Population Health and the Public's Role in Its Governance: Perspectives From a Citizen and Expert Panel.

BACKGROUND: Artificial intelligence (AI) systems are widely used in the health care sector. Mainly applied for individualized care, AI is increasingly aimed at population health. This raises important ethical considerations but also calls for responsible governance, considering that this will affect the population. However, the literature points to a lack of citizen participation in the governance of AI in health. Therefore, it is necessary to investigate the governance of the ethical and societal implications of AI in population health. OBJECTIVE: This study aimed to explore the perspectives and attitudes of citizens and experts regarding the ethics of AI in population health, the engagement of citizens in AI governance, and the potential of a digital app to foster citizen engagement. METHODS: We recruited a panel of 21 citizens and experts. Using a web-based survey, we explored their perspectives and attitudes on the ethical issues of AI in population health, the relative role of citizens and other actors in AI governance, and the ways in which citizens can be supported to participate in AI governance through a digital app. The responses of the participants were analyzed quantitatively and qualitatively. RESULTS: According to the participants, AI is perceived to be already present in population health and its benefits are regarded positively, but there is a consensus that AI has substantial societal implications. The participants also showed a high level of agreement toward involving citizens into AI governance. They highlighted the aspects to be considered in the creation of a digital app to foster this involvement. They recognized the importance of creating an app that is both accessible and transparent. CONCLUSIONS: These results offer avenues for the development of a digital app to raise awareness, to survey, and to support citizens' decision-making regarding the ethical, legal, and social issues of AI in population health.

Digital Therapies (DTx) as New Tools within Physicians' Therapeutic Arsenal: Key Observations to Support their Effective and Responsible Development and Use.

In recent years, there has been a swift rise in the development of digital therapies (DTx). As a result of various technological advances and accessibility to patients, it is now possible to develop and offer therapeutic interventions in a digital manner. These take the form of an evidence-based intervention that is administered in digital form to prevent, manage, or treat a medical condition. What makes DTx significantly different from other types of digital applications or services (e.g., wellness applications) is that they are interventions authorised by regulatory agencies for the treatment, like a drug, of a health condition. Yielding actual therapeutic benefits and being at the crossroads of health and digital means that DTx are subject to both the upsides and downsides of both sectors. Thus, it is of particular interest to look at the facilitators and barriers to be foreseen in the development, assessment, and implementation of DTx. In this article, we will present key observations and outline the main challenges that may be faced in the development and integration of DTx into practice. It is certain that DTx can represent an interesting avenue for physicians to bring their prescribing role into the 21st century. We conclude with broad lessons that the emerging field of DTx can learn from decades of drug industry practice to avoid history repeating itself and to fast-track the development and ethical and optimal use of DTx.

What Makes Artificial Intelligence Exceptional in Health Technology Assessment?

The application of artificial intelligence (AI) may revolutionize the healthcare system, leading to enhance efficiency by automatizing routine tasks and decreasing health-related costs, broadening access to healthcare delivery, targeting more precisely patient needs, and assisting clinicians in their decision-making. For these benefits to materialize, governments and health authorities must regulate AI, and conduct appropriate health technology assessment (HTA). Many authors have highlighted that AI health technologies (AIHT) challenge traditional evaluation and regulatory processes. To inform and support HTA organizations and regulators in adapting their processes to AIHTs, we conducted a systematic review of the literature on the challenges posed by AIHTs in HTA and health regulation. Our research question was: What makes artificial intelligence exceptional in HTA? The current body of literature appears to portray AIHTs as being exceptional to HTA. This exceptionalism is expressed along 5 dimensions: 1) AIHT's distinctive features; 2) their systemic impacts on health care and the health sector; 3) the increased expectations towards AI in health; 4) the new ethical, social and legal challenges that arise from deploying AI in the health sector; and 5) the new evaluative constraints that AI poses to HTA. Thus, AIHTs are perceived as exceptional because of their technological characteristics and potential impacts on society at large. As AI implementation by governments and health organizations carries risks of generating new, and amplifying existing, challenges, there are strong arguments for taking into consideration the exceptional aspects of AIHTs, especially as their impacts on the healthcare system will be far greater than that of drugs and medical devices. As AIHTs begin to be increasingly introduced into the health care sector, there is a window of opportunity for HTA agencies and scholars to consider AIHTs' exceptionalism and to work towards only deploying clinically, economically, socially acceptable AIHTs in the health care system.

Chapitre 4. How Artistic Transgressive Posture May Challenge Research Ethics Norms.

Research-creation (RC), an emergent field at the interface of academic research and creative activities, is challenging norms of responsible conduct of research (RCR) as well as research ethics. Striking differences exist between the perspectives of RC practitioners and members of the ethics community. For example, some RC practitioners openly state that they do not care about ethics and RCR regulations, their rationale being that the aim of arts is to transgress rules and so they disagree with having to comply to ethics requirements. Such statements are particularly interesting from a bioethical standpoint and represent a starting point for exploring how RCR can or should apply to RC practices. Using examples stemming from bio art, our aim here is to unravel this apparently conflictual relationship, and to show that it is not necessarily contradictory. We seek to find common grounds and to disarm eventual critiques from both sides when it comes to promoting responsibility in RC.

Genetic testing, insurance discrimination and medical research: what the United States can learn from peer countries.

While genetic testing may be the gateway to the future of medicine, it also poses challenges for individuals, especially in terms of differentiated treatments on the basis of their genetic characteristics. The fear of unwanted disclosure to insurers and the possibility of genetic discrimination can hamper the recruitment of individuals for clinical research that involves genetic testing. Precision medicine initiatives, such as All of Us, are proliferating in the United States. In order to succeed, however, they must ensure that the millions of Americans recruited to share their genetic data are not penalized with regard to life, disability and long-term insurance coverage. In this Perspective, we discuss several initiatives adopted by countries around the world, such as the United Kingdom and France, that better balance the interests of insurers and research subjects, and explain how the United States might learn from them. We call for regulatory and industry leadership to come together to establish a voluntary moratorium on insurance pricing with the aim of protecting research participants.

Conflicts of interest and the (in)dependence of experts advising government on immunization policies.

There has been increasing attention to financial conflicts of interest (COI) in public health research and policy making, with concerns that some decisions are not in the public interest. One notable problematic area is expert advisory committee (EAC). While COI management has focused on disclosure, it could go further and assess experts' degree of (in)dependence with commercial interests. We analyzed COI disclosures of members of Québec's immunization EAC (in Canada) using (In)DepScale, a tool we developed for assessing experts' level of (in)dependence. We found great variability of independence with industry and that companies with the highest vaccine sales were predominantly associated with disclosed COIs. We argue that EACs can use the (In)DepScale to better assess and disclose the COIs that affect their experts. Going forward our scale could help manage risk and select members who are less conflicted to foster a culture of transparency and trust in advisors and policy-makers.

Early-career researchers' views on ethical dimensions of patient engagement in research.

BACKGROUND: Increasing attention and efforts are being put towards engaging patients in health research, and some have even argued that patient engagement in research (PER) is an ethical imperative. Yet there is relatively little empirical data on ethical issues associated with PER. METHODS: A three-round Delphi survey was conducted with a panel of early-career researchers (ECRs) involved in PER. One of the objectives was to examine the ethical dimensions of PER as well as ECRs' self-perceived level of preparedness to conduct PER ethically. The study was conducted among awardees of the Québec SPOR-SUPPORT Unit in Canada, who represent the next generation of researchers involved in PER. Many themes were addressed throughout the study, such as definition, values, patients' roles, expected characteristics of patients, and anticipated challenges (including ethical issues). Open-ended questions were used, and all quantitative data were collected through statements using 7-point Likert scales. RESULTS: Between April and November 2016, 25 ECRs were invited to participate; 18 completed both the first and second rounds, and 16 completed the third round. Panelists consisted of nine women and seven men with various backgrounds (general practitioners and postgraduate students). The majority were between 25 and 44 years old. Panelists' responses showed PER raises important ethical issues: 1) professionalization of patients involved in research (with risks of patients becoming less representative); 2) adequate remuneration of patients; 3) fair recognition of patients' experiential knowledge; and 4) tokenism (engaging patients only for symbolic appeal). While the panelists felt moderately prepared to confront these ethical issues, they reported being uncomfortable applying for an ethics certificate for a PER project. CONCLUSION: If PER is an ethical imperative, it is vital to establish clear ethical standards and to train and support the PER community to identify and resolve ethical issues. Despite their overall readiness to conduct PER, panelists did not feel adequately prepared to address many of these issues. It is not easy for ECRs to reconcile ethical desiderata and logistical imperatives. Additional research should focus on supporting the responsible conduct of PER, which, if not done, can undermine the credibility and feasibility of the entire PER enterprise.