Coerced consent in clinical research: study protocol for a randomized controlled trial.

BACKGROUND: Despite the low-risk nature of participation in most clinical anesthesia trials, subject recruitment on the same day as surgery is often restricted due to the concerns of researchers and local research ethics boards that same-day consent may not afford adequate time and opportunity for patients to weigh and make decisions, as well as perceptions of patient vulnerability immediately prior to surgery that could impact the voluntary nature and the rigor of the informed consent process. However, specialties such as anesthesiology, critical care, interventional radiology, and emergency medicine have a varied pattern of practice and patient acquaintance that does not typically afford the luxury of time or, in many cases, advance consent for participation in research. Indeed, the initial encounter between anesthesiologists and patients undergoing elective procedures routinely occurs on the day of surgery. Concerns of coercion related to same-day consent for clinical anesthesia research trials have not been borne out in the literature, and represent a significant obstacle to clinical researchers, as well as to the patients who are denied opportunities for potential benefit through participation in research studies. METHODS: We describe the protocol for a prospective randomized controlled trial examining the voluntariness of patient consent, solicited either in advance of surgery or on the same day, to participate in an anesthesia research study at Women's College Hospital. One hundred fourteen patients scheduled to undergo ambulatory anterior cruciate ligament repair facilitated by general anesthesia with an adductor canal block will be randomized for recruitment either (a) in the pre-operative assessment clinic before the day of surgery or (b) on the day of surgery, to be approached for consent to participate in a fabricated research study of adjunct medications in adductor canal blocks. Regardless of allocation, patients in both groups will receive the same routine standard of care and will complete a post-operative questionnaire to signal perceptions of undue influence in the process of providing informed consent for the fabricated trial. DISCUSSION: This study will inform trial design and practice guidelines surrounding the amount of time patients ought to be afforded in order to make durable decisions to participate (or not) in clinical research studies. This is expected to impact trial recruitment in a variety of clinical settings where researchers have only brief opportunities to interface with patients. TRIAL REGISTRATION: The trial was registered prospectively on the Open Science Framework (OSF), registration #46twc, on 2023-Mar-17.

Strategies to promote treatment compliance: a grounded theory study with relatives of people with a serious mental health condition.

BACKGROUND: Treatment pressures encompass communicative strategies that influence mental healthcare service users' decision-making to increase their compliance with recommended treatment. Persuasion, interpersonal leverage, inducements, and threats have been described as examples of treatment pressures. Research indicates that treatment pressures are exerted not only by mental healthcare professionals but also by relatives. While relatives play a crucial role in their family member's pathway to care, research on the use of treatment pressures by relatives is still scarce. Likewise, little is known about other strategies relatives may use to promote the treatment compliance of their family member with a serious mental health condition. In particular, no study to date has investigated this from the perspective of relatives of people with a serious mental health condition. AIM: The aim of this study was to answer the following research questions: Which types of treatment pressures do relatives use? Which other strategies do relatives use to promote the treatment compliance of their family member with a serious mental health condition? How do treatment pressures relate to these other strategies? METHODS: Eleven semi-structured interviews were conducted with relatives of people with a serious mental health condition in Germany. Participants were approached via relatives' self-help groups and flyers in a local psychiatric hospital. Inclusion criteria were having a family member with a psychiatric diagnosis and the family member having experienced formal coercion. The data were analyzed using grounded theory methodology. RESULTS: Relatives use a variety of strategies to promote the treatment compliance of their family member with a serious mental health condition. These strategies can be categorized into three general approaches: influencing the decision-making of the family member; not leaving the family member with a choice; and changing the social or legal context of the decision-making process. Our results show that the strategies that relatives use to promote their family member's treatment compliance go beyond the treatment pressures thus far described in the literature. CONCLUSION: This qualitative study supports and conceptually expands prior findings that treatment pressures are not only frequently used within mental healthcare services but also by relatives in the home setting. Mental healthcare professionals should acknowledge the difficulties faced and efforts undertaken by relatives in seeking treatment for their family member. At the same time, they should recognize that a service user's consent to treatment may be affected and limited by strategies to promote treatment compliance employed by relatives.

El principio ético de la intervención humana en la responsabilidad civil

Una de las mayores complejidades que se presentan respecto de la responsabilidad civil por daños causados por sistemas de inteligencia artificial viene dada por la dificultad de atribuir la conducta que causa daño a un sujeto particular. Frente a ello, este artículo expone la importancia del principio ético de la intervención humana para la responsabilidad civil, cuya función consiste en constituir la guía para la interpretación y aplicación de sus reglas en los casos en los que, como resultado de una acción u omisión emanada de una decisión, recomendación o predicción realizada por un sistema de inteligencia artificial, se causen daños a las personas.

One of the main challenges associated with regard to civil liability for damages resulting from artificial intelligence systems is the difficulty of attributing the behavior that led to harm to a specific individual. The aim of this article is to highlight the significance of the ethical principle of human intervention for civil liability. This principle serves as a guide for interpreting and applying rules when artificial intelligence systems cause harm to individuals due to actions, decisions, recommendations or predictions.

Uma das maiores complexidades que se apresentam a respeito da responsabilidade civil por danos causados por sistemas de inteligência artificial vem dada pela dificuldade de atribuir a conduta que causa dano a um sujeito particular. Frente a isso, este artigo expõe a importância do princípio ético da intervenção humana para a responsabilidade civil, cuja função consiste em constituir uma orientação para a interpretação e aplicação de suas regras nos casos em que, como resultado de uma ação ou omissão emanada de uma decisão, recomendação ou previsão realizada por um sistema de inteligência artificial, se cause danos às pessoas.

Predictors of Retirement Voluntariness Using Canadian Longitudinal Study on Aging Data.

Objectives: Involuntary exit from the labor force can lead to poor health and well-being outcomes. Therefore, the purpose of this research is to better understand the factors that contribute to perceived retirement voluntariness. Methods: We conducted descriptive and multivariable logistic regression analyses using a sample of recent retirees (n = 2080) from the Canadian Longitudinal Study on Aging (CLSA). Results: More than one-quarter (28%) of older workers perceived their retirement to be involuntary. Among 37 possible predictors, 14 directly predicted retirement voluntariness and many more indirectly predicted retirement voluntariness. Only four direct predictors were common to both women and men, retiring because of organizational restructuring/job elimination; disability, health, or stress; financial possibility; and having wanted to stop working. Discussion: Findings suggest the need for employment support, health promotion, work disability prevention, financial education, and support that is sensitive to the differences between women and men to prevent involuntary retirement.

What's trust got to do with research: why not accountability?

This paper explores the intricate dynamics of trust, power, and vulnerability in the relationship between researchers and study participants/communities in the field of bioethics. The power and knowledge imbalances between researchers and participants create a structural vulnerability for the latter. While trust-building is important between researchers and study participants/communities, the consenting process can be challenging, often burdening participants with power abrogation. Trust can be breached. The paper highlights the contractual nature of the research relationship and argues that trust alone cannot prevent exploitation as power imbalances and vulnerabilities persist. To protect participants, bioethics guidance documents promote accountability and ethical compliance. These documents uphold fairness in the researcher-participant relationship and safeguard the interests of socially vulnerable participants. The paper also highlights the role of shared decision-making and inclusive deliberation with diverse stakeholders and recommends that efforts should be made by researchers to clarify roles and responsibilities, while research regulatory agents should transform the research-participant relationship into a legal-based contract governed by accountability principles. While trust remains important, alternative mechanisms may be needed to ensure ethical research practices and protect the interests of participants and communities. Striking a balance between trust and accountability is crucial in this regard.

Research ethics in practice: An analysis of ethical issues encountered in qualitative health research with mental health service users and relatives.

The ethics review of qualitative health research poses various challenges that are due to a mismatch between the current practice of ethics review and the nature of qualitative methodology. The process of obtaining ethics approval for a study by a research ethics committee before the start of a research study has been described as "procedural ethics" and the identification and handling of ethical issues by researchers during the research process as "ethics in practice." While some authors dispute and other authors defend the use of procedural ethics in relation to qualitative health research, there is general agreement that it needs to be supplemented with ethics in practice. This article aims to provide an illustration of research ethics in practice by reflecting on the ways in which we identified and addressed ethical and methodological issues that arose in the context of an interview study with mental health service users and relatives. We describe the challenges we faced and the solutions we found in relation to the potential vulnerability of research participants, the voluntariness of consent, the increase of participant access and the heterogeneity of the sample, the protection of privacy and internal confidentiality, and the consideration of personal and contextual factors.

A response to Al et al. Trials 2023;24:233.

In their recent paper, Al and colleagues (Trials 2023;24:233) argue that manipulation of the methods of recruitment using well-known techniques in order to increase enrollment can be ethically acceptable. This brief response challenges that notion as an affront to voluntariness and a devolution of the ethics of human subjects research to the "ethics" of the marketplace.

When Treatment Pressures Become Coercive: A Context-Sensitive Model of Informal Coercion in Mental Healthcare.

Treatment pressures are communicative strategies that mental health professionals use to influence the decision-making of mental health service users and improve their adherence to recommended treatment. Szmukler and Appelbaum describe a spectrum of treatment pressures, which encompasses persuasion, interpersonal leverage, offers and threats, arguing that only a particular type of threat amounts to informal coercion. We contend that this account of informal coercion is insufficiently sensitive to context and fails to recognize the fundamental power imbalance in mental healthcare. Based on a set of counterexamples, we argue that what makes a proposal coercive is not whether service users will actually be made worse off if they reject the proposal, but rather whether they have the justified belief that this is the case. Whether this belief is justified depends on the presence of certain contextual factors, such as strong dependency on professionals and the salient possibility of formal coercion.

Tracing app technology: an ethical review in the COVID-19 era and directions for post-COVID-19.

We conducted a systematic literature review on the ethical considerations of the use of contact tracing app technology, which was extensively implemented during the COVID-19 pandemic. The rapid and extensive use of this technology during the COVID-19 pandemic, while benefiting the public well-being by providing information about people's mobility and movements to control the spread of the virus, raised several ethical concerns for the post-COVID-19 era. To investigate these concerns for the post-pandemic situation and provide direction for future events, we analyzed the current ethical frameworks, research, and case studies about the ethical usage of tracing app technology. The results suggest there are seven essential ethical considerations-privacy, security, acceptability, government surveillance, transparency, justice, and voluntariness-in the ethical use of contact tracing technology. In this paper, we explain and discuss these considerations and how they are needed for the ethical usage of this technology. The findings also highlight the importance of developing integrated guidelines and frameworks for implementation of such technology in the post- COVID-19 world. Supplementary Information: The online version contains supplementary material available at 10.1007/s10676-022-09659-6.

Ethical and legal requirements for vaccination against COVID-19.

In the current context, there is an extraordinary interest of states in vaccinating the population to prevent Covid-19. In the Czech Republic, gene mRNA and vector DNA vaccines are approved only with conditional marketing authorization, for which a complete and long-term safety assessment is currently lacking. Vaccines show some potential risks, such as penetration of lipid nanoparticles into surrounding tissues, incorporation of DNA into the host genome, ADE syndrome, development of resistant mutations, myocarditis, pericarditis, and thromboembolic events. Since the level of antibodies after vaccination is soon decreasing, immunity after the disease persists longer, and the disease's fatality rate is very low, especially in adolescents, only voluntary vaccination is ethically acceptable, without any direct or indirect restrictions on the unvaccinated. The conclusion is in line with the principles of medical ethics of nonmaleficence, beneficence, autonomy, and justice.

Telework at times of a pandemic: The role of voluntariness in the perception of disadvantages of telework.

The implications of telework are discussed controversially and research on its positive and negative effects has produced contradictory results. We explore voluntariness of employee telework as a boundary condition which may underpin these contradictory findings. Under normal circumstances, individuals who do more telework should perceive fewer disadvantages. However, during the COVID-19 pandemic, employees could no longer voluntarily choose to telecommute, as many organizations were forced to introduce telework by governmental regulations. In two studies, we examine whether the voluntary nature of telework moderates the association between the amount of telework and perceptions of disadvantage. In Study 1, we collected data before and during the COVID-19 pandemic (N = 327). Results show that pre-pandemic participants (who were more likely to voluntarily choose this form of work) reported fewer disadvantages the more telework they did, but this was not the case for employees during the COVID-19 pandemic. To validate these findings, we measured employees' voluntariness of telework in Study 2 (N = 220). Results support the importance of voluntariness: Individuals who experience a high degree of voluntariness in choosing telework perceive fewer disadvantages the more they telework. However, the amount of telework was not related to reduced perceptions of disadvantages for those who experienced low voluntariness regarding the telecommuting arrangement. Our findings help to understand when telework is related to the perception of disadvantages and they can provide organizations with starting points for practical interventions to reduce the negative effects of telework.

"Voluntary in quotation marks": a conceptual model of psychological pressure in mental healthcare based on a grounded theory analysis of interviews with service users.

BACKGROUND: Psychological pressure refers to communicative strategies used by professionals and informal caregivers to influence the decision-making of service users and improve their adherence to recommended treatment or social rules. This phenomenon is also commonly referred to as informal coercion or treatment pressure. Empirical studies indicated that psychological pressure is common in mental healthcare services. No generally accepted definition of psychological pressure is available to date. A first conceptual analysis of psychological pressure focused on staff communication to promote treatment adherence and distinguished between persuasion, interpersonal leverage, inducements and threats. AIM: The aim of this study was to develop a conceptual model of psychological pressure based on the perspectives of service users. METHODS: Data were collected by means of semi-structured interviews. The sample consisted of 14 mental health service users with a self-reported psychiatric diagnosis and prior experience with coercion in mental healthcare. We used theoretical sampling and contacted participants via mental healthcare services and self-help groups to ensure a variety of attitudes toward the mental healthcare system in the sample. The study was conducted in Germany from October 2019 to January 2020. Data were analyzed according to grounded theory methodology. RESULTS: The study indicated that psychological pressure is used not only to improve service users' adherence to recommended treatment but also to improve their adherence to social rules; that it is exerted not only by mental health professionals but also by relatives and friends; and that the extent to which service users perceive communication as involving psychological pressure depends strongly on contextual factors. Relevant contextual factors were the way of communicating, the quality of the personal relationship, the institutional setting, the material surroundings and the level of convergence between the parties' understanding of mental disorder. CONCLUSIONS: The results of the study highlight the importance of staff communication training and organizational changes for reducing the use of psychological pressure in mental healthcare services.

Voluntary decision-making in addiction: A comprehensive review of existing measurement tools.

The notion of voluntariness, notably the inability to refrain from using an addictive substance, is central to addiction. This review examines different constructs measuring voluntariness in the context of drug addiction. We found 117 articles featuring 123 distinct scales for 11 of the 16 constructs initially searched. Self-efficacy was by far the construct with most scales. Most scales were not specifically developed with samples of people with addictions. From a methodological standpoint, current literature jeopardizes the validity of generalizations about how voluntariness functions and is measured in people with and without a drug addiction. From the standpoint of social psychology, the study of voluntariness remains anchored in an individualistic orientation to the study of cognition and behavior, thus calling for greater crosstalk between psychology subspecialties.

Understanding voluntariness of consent in first-in-human cell therapy trials.

Consensus about contents of voluntariness in informed consent is lacking. Core criteria for voluntary consent are needed to ensure voluntariness. This article outlines the multidimensionality of voluntariness and identifies what could reduce voluntariness, especially in first-in-human clinical trials involving cell therapies. In such trials, truly voluntary consent is especially important because: such trials may involve risk of serious harm, while in case of some diseases, eligible patients often have potentially effective therapeutic alternatives; patients considering participation in high-risk first-in-human trials may feel more desperate and some may be dependent on their caregivers, including those in the family; implanted cells cannot be taken out of the patient's body if the patient wants to withdraw.

Commentary 1: Research with Persons Under Involuntary Commitment-Ethical Issues Surrounding Competence and Voluntariness.

In this case commentary, we analyze ethical concerns that were raised in response to an interview with a woman with bipolar disorder who was under involuntary commitment. We focus on competence and voluntariness as two prerequisites for valid informed consent. We recommend that judgments of competence be based on whether prospective research participants sufficiently possess certain decision-making abilities. Based on this functional approach, we argue that manic symptoms need not undermine competence and that, even if we were to assume that the research participant became incompetent during the interview, this would not invalidate her consent retroactively. It would, however, compromise her ability to revoke her consent. We furthermore show that obtaining additional proxy consent for research participation may compromise the autonomy of service users who are competent to consent. Then we turn to the issue of voluntariness. Arguing that neither the great strength nor the external etiology of a desire compromises voluntariness, we propose that the voluntariness of a decision instead depends on whether the decision-maker endorses it on reflection. The researchers disclosed that prospective research participants' decision about study participation would have no influence on the duration of the commitment or the quality of care. We contend that because of this neither coercion nor undue influence was exerted in the informed consent process. Nevertheless, there is an increased likelihood of perceived coercion and undue influence under conditions of involuntary commitment, and we close by suggesting some safeguards to prevent this.

Addiction and Voluntariness: Five "Challenges" to Address in Moving the Discussion Forward.

The question as to whether people with an addiction have control (and to what extent) over their addiction, and voluntarily decide to use substances is an ongoing source of controversy in the context of research on addiction, health policy and clinical practice. We describe and discuss a set of five challenges for further research into voluntariness (definition[s], measurement and study tools, first person perspectives, contextual understandings, and connections to broader frameworks) based on our own research experiences and those of others.

Exploring Understanding of "Understanding": The Paradigm Case of Biobank Consent Comprehension.

Data documenting poor understanding among research participants and real-time efforts to assess comprehension in large-scale studies are focusing new attention on informed consent comprehension. Within the context of biobanking consent, we previously convened a multidisciplinary panel to reach consensus about what information must be understood for a prospective participant's consent to be considered valid. Subsequently, we presented them with data from another study showing that many U.S. adults would fail to comprehend the information the panel had deemed essential. When asked to evaluate the importance of the information again, panelists' opinions shifted dramatically in the direction of requiring that less information be understood. Follow-up interviews indicated significant uncertainty about defining a threshold of understanding and what should happen when prospective participants are unable to grasp key information. These findings have important implications for urgently needed discussion of whether consent comprehension is an ethical requirement or an ethical aspiration.

Children in Social Research: Do Higher Payments Encourage Participation in Riskier Studies?

The MESSI (Managing Ethical Studies on Sensitive Issues) study used hypothetical scenarios, presented via a brief online survey, to explore whether payment amounts influenced Australian children and young people to participate in social research of different sensitivity. They were more likely to participate in the lower sensitivity study than in the higher at all payment levels (A$200 prize draw, no payment, $30, or $100). Offering payments to children and young people increased the likelihood that they would agree to participate in the studies and, in general, the higher the payments, the higher the likelihood of their participating. No evidence of undue influence was detected: payments can be used to increase the participation of children and young people in research without concerns of undue influence on their behavior in the face of relatively risky research. When considering the level of payment, however, the overriding consideration should be the level of risk to the children and young people.

The Relationship between Autonomy and Adult Mental Capacity in the Law of England and Wales.

Judges in England and Wales tell three apparently contradictory stories about the relationship between autonomy and mental capacity. Sometimes, capacity is autonomy's gatekeeper: those with capacity are autonomous, but those without capacity are not. Sometimes, capacity is necessary for autonomy but insufficient; for voluntariness, freedom from undue external influences, is also required. Finally, sometimes autonomy survives incapacity, and a person without capacity is nevertheless treated as autonomous. These three accounts coexist, so no story of evolution, in which one account comes to replace another, can be told. Similarly, no story of judicial factions is plausible, for judges switch account to suit the facts of a particular case. This article gives examples of all three accounts, traces their recent history, and shows how each serves one or two characteristic purposes. It then shows how they can be combined into a coherent descriptive account of the relationship between autonomy and mental capacity in domestic law.

Supporting the Accommodation of Voluntary and Involuntary Migrants: Humanitarian and Host Society Considerations.

Immigration leads to strong public and political debates in Europe and the Western world more generally. In some of these debates, migrants are described as either having little choice but to migrate (involuntary migrants) or migrating out of their own free choice (voluntary migrants). In two experimental studies among national samples of native Dutch respondents, we examined whether support for the accommodation of newcomers differs for voluntary and involuntary migrants and whether this depends on the relative importance of humanitarian considerations and host society considerations. The findings demonstrate that for people who find the topic of immigration personally important, involuntary, compared to voluntary, migration leads to stronger societal considerations which, in turn, is associated with weaker support for the accommodation of migrants. Additionally, humanitarian considerations are associated with stronger support but especially for participants who do not find the topic of immigration very important.