BackgroundInnovations in technology have contributed to rapid changes in the way that modern biomedical research is carried out. Researchers are increasingly required to endorse adaptive and flexible approaches to accommodate these innovations and comply with ethical, legal and regulatory requirements. This paper explores how Dynamic Consent may provide solutions to address challenges encountered when researchers invite individuals to participate in research and follow them up over time in a continuously changing environment.MethodsAn interdisciplinary workshop jointly organised by the University (...) of Oxford and the COST Action CHIP ME gathered clinicians, researchers, ethicists, lawyers, research participants and patient representatives to discuss experiences of using Dynamic Consent, and how such use may facilitate the conduct of specific research tasks. The data collected during the workshop were analysed using a content analysis approach.ResultsDynamic Consent can provide practical, sustainable and future-proof solutions to challenges related to participant recruitment, the attainment of informed consent, participant retention and consent management, and may bring economic efficiencies.ConclusionsDynamic Consent offers opportunities for ongoing communication between researchers and research participants that can positively impact research. Dynamic Consent supports inter-sector, cross-border approaches and large scale data-sharing. Whilst it is relatively easy to set up and maintain, its implementation will require that researchers re-consider their relationship with research participants and adopt new procedures. (shrink)

Background Dynamic consent has been proposed as a process through which participants and patients can gain more control over how their data and samples, donated for biomedical research, are used, resulting in greater trust in researchers. It is also a way to respond to evolving data protection frameworks and new legislation. Others argue that the broad consent currently used in biobank research is ethically robust. Little empirical research with cohort study participants has been published. This research investigated (...) the participants’ opinions of adding a dynamic consent interface to their existing study. Methods Adult participants in the Extended Cohort for E-health, Environment and DNA longitudinal cohort study who are members of the EXCEED Public and Participant Engagement Group were recruited. Four focus groups were conducted and analysed for thematic content. Discussion topics were derived from a review of the current literature on dynamic consent. Results Participants were in favour of many aspects of a dynamic consent interface, such as being able to update their information, add additional data to their records and choose withdrawal options. They were supportive provided it was simple to use and not intrusive. Participants expressed a markedly high level of trust in the study and its investigators and were unanimously happy with their current participation. No strong support was found for adding a dynamic consent interface to EXCEED. Conclusions Trust in the study researchers was the strongest theme found. Openness and good data security were needed to retain their trust. While happy to discuss dynamic consent, participants were satisfied with the current study arrangements. There were indications that changing the study might unnecessarily disturb their trust. This raised the question of whether there are contexts where dynamic consent is more appropriate than others. This study was limited by the small number of participants who were committed to the study and biased towards it. More research is needed to fully understand the potential impact of adding a dynamic consent interface to an existing cohort study. (shrink)

As with many other countries, Malaysia is also developing and promoting biomedical research to increase the understanding of human diseases and possible interventions. To facilitate this development, there is a significant growth of biobanks in the country to ensure continuous collection of biological samples for future research, which contain extremely important personal information and health data of the participants involved. Given the vast amount of samples and data accumulated by biobanks, they can be considered as reservoirs of precious biomedical big (...) data. It is therefore imperative for biobanks to have in place regulatory measures to ensure ethical use of the biomedical big data. Malaysia has yet to introduce specific legislation for the field of biobanking. However, it can be argued that its existing Personal Data Protection Act 2010 has laid down legal principles that can be enforced to protect biomedical big data generated by the biobanks. Consent is a mechanism to enable data subjects to exercise their autonomy by determining how their data can be used and ensure compliance with legal principles. However, there are two main concerns surrounding the current practice of consent in biomedical big data in Malaysia. First, it is uncertain that the current practice would be able to respect the underlying notion of autonomy, and second, it is not in accordance with the legal principles of the PDPA. Scholars have deliberated on different strategies of informed consent, and a more interactive approach has recently been introduced: dynamic consent. It is argued that a dynamic consent approach would be able to address these concerns. (shrink)

In recent years, the principle of informed consent has come under significant pressure with the rise of biobanks and data infrastructures for medical research. Study-specific consent is unfeasible in the context of biobank and data infrastructure research; and while broad consent facilitates research, it has been criticised as being insufficient to secure a truly informed consent. Dynamic consent has been promoted as a promising alternative approach that could help patients and research participants regain control (...) over the use of their biospecimen and health data in medical research. Critical voices have focused mainly on concerns around its implementation; but little has been said about the argument that dynamic consent is morally superior to broad consent as a way to respect people’s individual autonomy. In this paper, we identify two versions of this argument—an information-focused version and a control-focused version—and then argue that both fail to establish the moral superiority of dynamic over broad consent. In particular, we argue that since autonomous choices are a certain species of choices, it is neither obvious that dynamic consent would meaningfully enhance people’s autonomy, nor that it is morally justifiable to act on every kind of consent choice enabled by dynamic consent. (shrink)

Dynamic consent is increasingly recommended for longitudinal and biobanking research; however, the value of investing in such systems is unclear. We undertook a rapid review of the benefits and challenges of implementing dynamic consent by searching five databases (Ovid Medline, Ovid Embase, Scopus, Web of Science, Cumulative Index to Nursing and Allied Health Literature – CINAHL) for articles published up to May 2023 that report on participants’ or researchers’ experience of dynamic consent. From 1611 (...) papers screened, 12 met inclusion criteria. Guided by thematic analysis with an inductive approach, we synthesised 31 benefits and 8 challenges. Benefits included: enhanced participant experience through improved consent management and tailoring; greater participant engagement and retention through increased autonomy, trust and communication; reduced costs and burden and increased accessibility and inclusivity. Participants and researchers also valued additional features that dynamic consent platforms facilitate such as two-way communication and return of research updates. The main challenges included the digital divide and consent fatigue. The papers gave recommendations to mitigate these challenges, for example by supplementing with other communication tools and allowing a broad consent approach, respectively. Overall, dynamic consent was described as a valuable consent approach with many benefits and some surmountable challenges. Most included literature was qualitative, so further research is needed to quantify the impact of dynamic consent on recruitment, retention, and participant experience. Further long-term investigations are necessary to explore whether participants want to and do change their consent over time, as well as the impact of dynamic consent on participant privacy. (shrink)

Should people be involved as active participants in longitudinal medical research, as opposed to remaining passive providers of data and material? We argue in this article that misconceptions of ‘autonomy’ as a kind of feat rather than a right are to blame for much of the confusion surrounding the debate of dynamic versus broad consent. Keeping in mind two foundational facts of human life, freedom and dignity, we elaborate three moral principles – those of autonomy, integrity and authority (...) – to better see what is at stake. Respect for autonomy is to recognize the other's right to decide in matters that are important to them. Respect for integrity is to meet, in one's relationship with the other, their need to navigate the intersection between private and social life. Respect for authority is to empower the other – to help them to cultivate their responsibility as citizens. On our account, to force information onto someone who does not want it is not to respect that person's autonomy, but to violate integrity in the name of empowerment. Empowerment, not respect for autonomy, is the aim that sets patient-centred initiatives employing a dynamic consent model apart from other consent models. Whether this is ultimately morally justified depends on whether empowerment ought to be a goal of medical research, which is questionable. (shrink)

The General Data Protection Regulation imposes, at European level, a need to seek express or explicit consent for the processing of health data. In the framework of biomedical research, some favor the use of express ‘broad’ consent, whereas other maintain, or wish to maintain the use of presumed or implicit consent, often referred to as ‘non-opposition’ in conditions in which such consent is still authorized. In our view, broad consent and presumed consent are likely (...) to prove to be easy solutions in the short term but much less relevant in the long term, for both hospital and patients, if the bioethical objective remains the improvement of patient quality of life and/or survival, regardless of the disease considered. Dynamic consent could be the best way to achieve this objective because only this type of consent could improve hospital transparency and increase patient confidence by allaying certain fears. (shrink)

Dynamic Consent is both a model and a specific web-based tool that enables clear, granular communication and recording of participant consent choices over time. The DC model enables individuals to know and to decide how personal research information is being used and provides a way in which to exercise legal rights provided in privacy and data protection law. The DC tool is flexible and responsive, enabling legal and ethical requirements in research data sharing to be met and (...) for online health information to be maintained. DC has been used in rare diseases and genomics, to enable people to control and express their preferences regarding their own data. However, DC has never been explored in relationship to historical collections of bioscientific and genetic heritage or to contexts involving Aboriginal and Torres Strait Islander people.In response to the growing interest by First Peoples throughout Australia in genetic and genomic research, and the increasing number of invitations from researchers to participate in community health and wellbeing projects, this article examines the legal and ethical attributes and challenges of DC in these contexts. It also explores opportunities for including First Peoples' cultural perspectives, governance, and leadership as a method for defining DC on cultural terms that engage best practice research and data analysis as well as respect for meaningful and longitudinal individual and family participation. (shrink)

Networks for the exchange and/or sharing of genetic data are developing in many countries. We focus here on the situations in the US and France. We highlight some recent and remarkable differences between these two countries concerning the mode of access to, and the storage and use of genetic data, particularly as concerns two-sided markets and dynamic consent or dynamic electronic informed consent. This brief overview suggests that, even though the organization and function of these two-sided (...) markets remain open to criticism, dynamic e-IC should be more widely used, especially in France, if only to determine its real effectiveness. (shrink)

Background Conventional consent practices face ethical challenges in continuously evolving digital health environments due to their static, one-time nature. Dynamic consent offers a promising solution, providing adaptability and flexibility to address these ethical concerns. However, due to the immaturity of the concept and accompanying technology, dynamic consent has not yet been widely used in practice. This study aims to identify the facilitators of and barriers to adopting dynamic consent in real-world scenarios. Methods This (...) scoping review, conducted in December 2022, adhered to the PRISMA Extension for Scoping Reviews guidelines, focusing on dynamic consent within the health domain. A comprehensive search across Web of Science, PubMed, and Scopus yielded 22 selected articles based on predefined inclusion and exclusion criteria. Results The facilitators for the adoption of dynamic consent in digital health ecosystems were the provision of multiple consent modalities, personalized alternatives, continuous communication, and the dissemination of up-to-date information. Nevertheless, several barriers, such as consent fatigue, the digital divide, complexities in system implementation, and privacy and security concerns, needed to be addressed. This study also investigated current technological advancements and suggested considerations for further research aimed at resolving the remaining challenges surrounding dynamic consent. Conclusions Dynamic consent emerges as an ethically advantageous method for digital health ecosystems, driven by its adaptability and support for continuous, two-way communication between data subjects and consumers. Ethical implementation in real-world settings requires the development of a robust technical framework capable of accommodating the diverse needs of stakeholders, thereby ensuring ethical integrity and data privacy in the evolving digital health landscape. (shrink)

Background The principles of dynamic consent are based on the idea of safeguarding the autonomy of individuals by providing them with personalized options to choose from regarding the sharing and utilization of personal health data. To facilitate the widespread introduction of dynamic consent concepts in practice, individuals must perceive these procedures as useful and easy to use. This study examines the user experience of a dynamic consent-based application, in particular focusing on personalized options, and (...) explores whether this approach may be useful in terms of ensuring the autonomy of data subjects in personal health data usage. Methods This study investigated the user experience of MyHealthHub, a dynamic consent-based application, among adults aged 18 years or older living in South Korea. Eight tasks exploring the primary aspects of dynamic consent principles–including providing consent, monitoring consent history, and managing personalized options were provided to participants. Feedback on the experiences of testing MyHealthHub was gathered via multiple-choice and open-ended questionnaire items. Results A total of 30 participants provided dynamic consent through the MyHealthHub application. Most participants successfully completed all the provided tasks without assistance and regarded the personalized options favourably. Concerns about the security and reliability of the digital-based consent system were raised, in contrast to positive responses elicited in other aspects, such as perceived usefulness and ease of use. Conclusions Dynamic consent is an ethically advantageous approach for the sharing and utilization of personal health data. Personalized options have the potential to serve as pragmatic safeguards for the autonomy of individuals in the sharing and utilization of personal health data. Incorporating the principles of dynamic consent into real-world scenarios requires remaining issues, such as the need for powerful authentication mechanisms that bolster privacy and security, to be addressed. This would enhance the trustworthiness of dynamic consent-based applications while preserving their ethical advantages. (shrink)

As the capacity to generate, store, aggregate and combine ever greater volumes and types of data about individuals, behaviours and interactions continues to expand apace, so too does the challenge of ensuring suitable and appropriate governance of that data. In broad terms, the challenge is simple; how to ensure the (public) benefits of data, such as improvements in service delivery or individual and collective well-being, while avoiding harms such as discrimination, injustice or placing undue burdens on individuals and groups. The (...) difficulty, as ever, lies in the details. As Nicol et al 1 observe, informed consent is important but does not replace the need for an appropriate governance framework that covers the wider ecosystem of data generation, use and reuse. Moreover, there is no one universal oversight mechanism for data sharing, but what counts as ‘appropriate’ must take into account the context and purpose of data use. In this regard, the study by Ford et al is an important and valuable contribution to our understanding of the …. (shrink)

This article proposes a specific logic of dynamics for integrative social contracts theory that combines two empirically oriented process extensions strengthening concreteness of Donaldson and Dunfee’s conceptualization, namely international policy regime theory and Tiebout migration. While either would help “dynamize” and “concretize” ISCT, the two combined are even more insightful. Real-world policy regime processes can develop concrete action-guiding norms instantiating hypernorms to guide business decisions. Donaldson and Dunfee placed empirical reliance on expectation of converging parallel evolution of universal principles and (...) authentic local values. ISCT remains vague on how global or local norms can develop and change, for two reasons. First, ISCT does not explain mechanisms for how proposed hypernorms can become actual global norms and also become accepted across extant authentic communities. International policy regime theory explains how hypernorms can become instantiated as global norms expressed in policy regimes. Second, a basic element in ISCT is implied consent positing free exit from voluntary moral communities. Empirically, individuals or businesses may be unable to exit from undesired membership in authentic communities to which they do not consent. The Tiebout migration model provides valuable insights concerning how substantive mobility or its absence improves on the minimum ISCT assumption of implied consent. An integrated logic of ISCT dynamics generates a three-level framework in which instantiated hypernorms and authentic community norms can empirically change, and individuals or businesses can migrate more freely across extant communities. (shrink)

The title of this book Perspectives in Social Contract Theory is appropriate because it is a collection of different approaches to the social contract tradition. This is a rich and long tradition that stretches as far back as Thomas Hobbes, which he developed in a number of his works in political philosophy. The chapters in this book fourteen of them engage with, develop and advance various ideas of this tradition. The fourteen chapters are divided into five parts: PART I: What (...) is Contractualism and Contractarianism?; PART II: Contract, Consent and Equality; PART III: Contractualism of Rawls and Jean-Jacques Rousseau; PART IV: Contractarianism Moral and Dynamic; and PART V: Social Contract Theory and African Tradition. While some of the papers raise and discuss issues in connection with specific aspects of contractarianism and contractualism, namely, Hegel s and Rawls contractualism, the contractarianism of Jean-Jacques Rousseau and David Gauthier, others discuss general issues concerning social contract theory, such as contractarianism as dynamic, the status of consent, equality, and obligations in the social contract tradition. In addition, some papers extend social contract theory to include an African perspective, for example, African social contract in the context of human rights, Ubuntu and social contract theory, social contract and traditional African consensual democracy. (shrink)

Informed consent represents a cornerstone of the endeavours to make health care research ethically acceptable. Based on experience of qualitative research on power dynamics in nursing care in acute psychiatry, we show that the requirement for informed consent may be practised in formalistic ways that legitimize the researcher's activities without taking the patient's changing perception of the situation sufficiently into account. The presentation of three patient case studies illustrates a diversity of issues that the researcher must consider in (...) each situation. We argue for the necessity of researchers to base their judgement on a complex set of competencies. Consciousness of research ethics must be combined with knowledge of the challenges involved in research methodology in qualitative research and familiarity with the therapeutic arena in which the research is being conducted. The article shows that the alternative solution is not simple but must emphasize the researcher's ability to doubt and be based on an awareness of the researcher's fallibility. (shrink)

The degree of autonomy present in the choices made by individuals with an addiction, notably in the context of research, is unclear and debated. Some have argued that addiction, as it is commonly understood, prevents people from having sufficient decision-making capacity or self-control to engage in choices involving substances to which they have an addiction. Others have criticized this position for being too radical and have counter-argued in favour of the full autonomy of people with an addiction. Aligning ourselves with (...) middle-ground positions between these two extremes, we flesh out an account of voluntary action that makes room for finer-grained analyses than the proposed all-or-nothing stances, which rely on a rather static metaphysical understanding of the nature of the voluntariness of action. In contrast, a dynamic concept of voluntary action better accounts for varying levels of voluntariness of the person with an addiction which takes into consideration internal and external determinants of choice. Accordingly, like other components of autonomous choices such as level of information, voluntariness can fluctuate. Therefore, there are important implications for research and clinical ethics in matters of consent, recruitment, and therapeutic approaches. Overall, our proposal is inspired by a pragmatist understanding of voluntary action, notably with respect to how voluntariness is both informed by actions and experiences that shape one's view of the world. (shrink)

While Specific Informed Consent has been the established standard for obtaining consent for medical research for many years, it does not appear suitable for large-scale biobank and health data research. Thus, alternative forms of consent have been suggested, based on a variety of ethical background assumptions. This article identifies five main ethical perspectives at stake. Even though Tiered Consent, Dynamic Consent and Meta Consent are designed to the demands of the self-determination perspective as (...) well as the perspective of research as a public good, they are still also criticized from both perspectives. In addition, criticisms based on concerns of justice, participation and democratic deliberation, and relational concerns have been levelled at each of the models. As all of these perspectives have valid points to make, the task at hand lies in balancing these ethical perspectives. What constitutes an adequate balancing depends on contextual factors. These factors include digital infrastructure and digital literacy, data safety regulation, good scientific and clinical practice, transparent debates on ethically relevant features of research, social inequalities, anti-discrimination laws and practices, trust in health care institutions and recognition of patient preferences, and consensus on unethical research. We argue that the role of context in determining acceptable models of consent puts the ethical importance of models of consent into perspective. Since altering contextual factors can help to live up to the ethical concerns at stake in debates about models of consent, opting for such a shift of focus comes without ethical loss. (shrink)

Organ transplantation from living related donors in Bangladesh first began in October 1982, and became commonplace in 1988. Cornea transplantation from posthumous donors began in 1984 and living related liver and bone marrow donor transplantation began in 2010 and 2014 respectively. The Human Organ Transplantation Act officially came into effect in Bangladesh on 13th April 1999, allowing organ donation from both brain-dead and related living donors for transplantation. Before the legislation, religious leaders issued fatwa, or religious rulings, in favor of (...) organ transplantation. The Act was amended by the Parliament on 8th January, 2018 with the changes coming into effect shortly afterwards on 28th January. However, aside from a few posthumous corneal donations, transplantation of vital organs, such as the kidney, liver, heart, pancreas, and other body parts or organs from deceased donors, has remained absent in Bangladesh. The major question addressed in this article is why the transplantation of vital organs from deceased donors is absent in Bangladesh. In addition to the collection of secondary documents, interviews were conducted with senior transplant physicians, patients and their relatives, and the public, to learn about posthumous organ donation for transplantation. Interviews were also conducted with a medical student and two grief counselors to understand the process of counseling the families and obtaining consent to obtain posthumous cornea donations from brain-dead patients. An interview was conducted with a professional anatomist to understand the processes behind body donation for the purposes of medical study and research. Their narrative reveals that transplant physicians may be reticent to declare brain death as the stipulations of the 1999 act were unclear and vague. This study finds that Bangladeshis have strong family ties and experience anxiety around permitting separating body parts of dead relatives for organ donation for transplantation, or donating the dead body for medical study and research purposes. Posthumous organ donation for transplantation is commonly viewed as a wrong deed from a religious point of view. Religious scholars who have been consulted by the government have approved posthumous organ donation for transplantation on the grounds of necessity to save lives even though violating the human body is generally forbidden in Islam. An assessment of the dynamics of biomedicine, religion and culture leads to the conclusion that barriers to posthumous organ donation for transplantation that are perceived to be religious may actually stem from cultural attitudes. The interplay of faith, belief, religion, social norms, rituals and wider cultural attitudes with biomedicine and posthumous organ donation and transplantation is very complex. Although overcoming the barriers to organ donation for transplantation is challenging, initiation of transplantation of vital organs from deceased donors is necessary within Bangladesh. This will ensure improved healthcare outcomes, prevent poor people from being coerced into selling their organs to rich recipients, and protect the solidarity and progeny of Bangladeshi families. (shrink)

_The turn from traditional paternalism and towards patient autonomy has made informed consent a key concept for medical ethics and health legislation. However, informed consent has been attacked for a wide range of shortcomings, both conceptually and theoretically, as well as practically. Vilhjálmur Árnason has suggested an alternative to informed consent, i.e., to give authorizations. Vilhjálmur 1 has been supported by other researchers, but the authorization approach has not been elaborated in any greater detail or come to (...) widespread use in bioethics. This article describes and discusses Vilhjálmur’s and other scholars’ approach to authorizations and reflects on why this approach deserves more attention than previously given, especially for addressing the extended challenges emerging from biological sciences generating a wide range of person-related biological entities._ _Keywords:_ informed consent, authorization, bioethics, medical ethics, patient autonomy, biobank research, dynamic consent, broad consent, genetic research ethics, ethical challenges in biobanking,, PeRBEs, AI/ML. (shrink)

In longitudinal cohort studies involving large populations over extended periods, informed consent entails numerous urgent challenges. This paper explores challenges regarding informed consent in long‐term, large‐scale longitudinal cohort studies based on the longitudinal and dynamic nature of such research. It analyzes and evaluates widely recognized broad consent and dynamic consent methods, highlighting limitations concerning their ability to adapt to evolving research objectives and participant perspectives. This paper discusses trust‐based informed consent and emphasizes the (...) needs to establish and maintain trust with research participants and to balance information disclosure with respect for participants' autonomy. Informed consent in long‐term studies is an evolving process that must adapt to changing research environments. Based on participant trust, researchers should observe and assess potential research risks. Finally, the paper recommends enhancing institutional credibility, implementing reconsent procedures, and ensuring robust ethical oversight to safeguard participants' rights despite the complexity of modern biomedical research. (shrink)

In a recent article, I argued that Ploug and Holm’s ‘meta-consent’ proposal should be rejected for biobank governance. This was because, although meta-consent is permissible, it is both burdensome and ethically omissible. There is no ethical reason why funders should undertake the additional costs. Ploug and Holm have sought to respond to these arguments. Here, it is noted that not only do they fail to adequately refuse the case against meta-consent, they fail to even engage with the (...) arguments, either misunderstanding them or ignoring them. In their response, Ploug and Holm unwittingly provide the basis of an even stronger case against meta-consent. They argue that broad consent has a built in tendency to expire, while also holding that broad consent should be one of the options available in meta-consent. Meta-consent thus ends up being more like dynamic consent, but, arguably, even more burdensome and costly. (shrink)

Abstract:Vulnerability is an important criterion to assess the ethical justification of the inclusion of participants in research trials. Currently, vulnerability is often understood as an attribute inherent to a participant by nature of a diagnosed condition. Accordingly, a common ethical concern relates to the participant’s decisionmaking capacity and ability to provide free and informed consent. We propose an expanded view of vulnerability that moves beyond a focus on consent and the intrinsic attributes of participants. We offer specific suggestions (...) for how relational aspects and the dynamic features of vulnerability could be more fully captured in current discussions and research practices. (shrink)

Abstract:Vulnerability is an important criterion to assess the ethical justification of the inclusion of participants in research trials. Currently, vulnerability is often understood as an attribute inherent to a participant by nature of a diagnosed condition. Accordingly, a common ethical concern relates to the participant’s decisionmaking capacity and ability to provide free and informed consent. We propose an expanded view of vulnerability that moves beyond a focus on consent and the intrinsic attributes of participants. We offer specific suggestions (...) for how relational aspects and the dynamic features of vulnerability could be more fully captured in current discussions and research practices. (shrink)

As biobank research has become increasingly widespread within biomedical research, study-specific consent to each study, a model derived from research involving traditional interventions on human subjects, has for the sake of feasibility gradually given way to alternative consent models which do not require consent for every new study. Besides broad consent these models include tiered, dynamic, and meta-consent. However, critics have pointed out that it is normally not known at the time of enrolment in (...) what ways samples deposited in a biobank may be used in future research and that, for a consent to be informed, exactly this kind of knowledge is required. Therefore, there is an ongoing debate about the ethical acceptability of going for less than study-specific consent. In light of this debate we address the question of how to best protect participants against relevant risks and violations of autonomy. We apply the central aims of the informed consent process to the unique circumstances of biobank research where samples and data in many cases are stored for long periods of time and reused in subsequent studies. Thereby we are able to formulate a set of criteria focusing both on the risk of informational harm and the potential violation of participants’ values. We compare existing models of consent based on their ability to satisfy the criteria, and we find that the broad consent model offers the best level of protection for participants, although, it suffers from a few important deficiencies with regards to protection against participant value violations and long-term protection of autonomy, if it is applied without qualifications. For this reason, we propose modifications to the current broad consent model, in order to ensure that it provides protection of autonomy and participant values through strong ethical review and continuous communication. We conclude that a modified form of broad consent is ethically superior in biobank research, not only because it is most feasible but primarily because it offers the best available protection against the hazards facing research subjects in this form of research. (shrink)

This paper focuses on the position of consent in prevailing models of hegemony. It is argued that the commonly invoked consent assumption is a weakness in the hegemony construct that demands review. Consent is purportedly a crucial element of the hegemony dynamic, yet is often overlooked in favour of dominance and resistance. To illustrate this, the paper provides a genealogical account of the consent premise as it is formulated in notable models of political hegemony. This (...) reveals a declining interest in the purportedly crucial consent element of the hegemony construct, accompanied by a reductive view of language and discourse. Next, the paper contrasts the collective consent premise with modern notions of individual sexual consent. This highlights the connection between the consent assumption and hegemonic masculinity. It is observed that if hegemony is based on modes of control and the lack of meaningful choice, it is not founded on consensus. Rather, it is postulated that such conditions might aptly be described as a form of tolerance. This concept is outlined here as a means of departure towards theorizing how hegemonic domination might be actualized discursively without the requirement of consent. In this respect, the paper responds to proponents of post-hegemony by arguing that it is not the concept of hegemony that is outmoded, but rather how it is secured. (shrink)

Population-level biomedical research has become crucial to the health system’s ability to improve the health of the population. This form of research raises a number of well-documented ethical concerns, perhaps the most significant of which is the inability of the researcher to obtain fully informed specific consent from participants. Two proposed technical solutions to this problem of consent in large-scale biomedical research that have become increasingly popular are meta-consent and dynamic consent. We critically examine the (...) ethical and practical credentials of these proposals and find them lacking. We suggest that the consent problem is not solved by adopting a technology driven approach grounded in a notion of ‘specific’ consent but by taking seriously the role of research governance in combination with broader conceptions of consent. In our view, these approaches misconstrue the rightful location of authority in the way in which population-level biomedical research activities are structured and organized. We conclude by showing how and why the authority for determining the nature and shape of choice making about participation ought not to lie with individual participants, but rather with the researchers and the research governance process, and that this necessarily leads to the endorsement of a fully articulated broad consent approach. (shrink)

When philosophers consider factors compromising autonomy in consent, they often focus solely on the consent-giver’s agential capacities, overlooking the impact of the consent-receiver’s conduct on the consensual character of the activity. In this paper, I argue that valid consent requires justified trust in the consent-receiver to act only within the scope of consent. I call this the Trust Condition (TC), drawing on Katherine Hawley’s commitment account of trust. TC constitutes a belief that the (...) class='Hi'>consent-receiver is capable and willing to act as we expect from them. If such trust is not warranted, I argue, consent lacks the appropriate normative grounds. After establishing TC, I explore its application in the sexual arena, asserting that due to the non-contractual dimensions of sexual activity — such as the dynamic nature of sexual desires and the absence of external factors effectively binding sexual partners to the terms of consent—trust is warranted in sexual consent by means of care. I define care as a special sensitivity and attention toward the partner’s will and discuss how this approach leads to safer intimate relationships in practice. (shrink)

BackgroundThe advent of learning healthcare systems (LHSs) raises an important implementation challenge concerning how to request and manage consent to support secondary use of data in learning cycles, particularly research activities. Current consent models in Quebec were not established with the context of LHSs in mind and do not support the agility and transparency required to obtain consent from all involved, especially the citizens. Therefore, a new approach to consent is needed. Previous work identified the meta- (...) class='Hi'>consent model as a promising alternative to fulfill the requirements of LHSs, particularly large-scale deployments. We elicited the public’s attitude toward the meta-consent model to evaluate if the model could be understood by the citizens and would be deemed acceptable to prepare for its possible implementation in Quebec.MethodsEight focus groups, with a total of 63 members of the general public from various backgrounds were conducted in Quebec, Canada, in 2019. Explicit attention was given to literacy levels, language spoken at home and rural vs urban settings. We assessed attitudes, concerns and facilitators regarding key components of the meta-consent model: predefined categories to personalized consent requests, a dynamic web-based infrastructure to record meta-consent, and default settings. To analyse the discussions, a thematic content analysis was performed using a qualitative software.ResultsOur findings showed that participants were supportive of this new approach of consent as it promotes transparency and offers autonomy for the management of their health data. Key facilitators were identified to be considered in the implementation of a meta-consent model in the Quebec LHSs: information and transparency, awareness campaigns, development of educational tools, collaboration of front-line healthcare professionals, default settings deemed acceptable by the society as well as close partnerships with recognized and trusted institutions.ConclusionsThis qualitative study reveals the openness of a sample of the Quebec population regarding the meta-consent model for secondary use of health data for research. This first exploratory study conducted with the public is an important step in guiding decision-makers in the next phases of implementing the various strategies to support access and use of health data in Quebec. (shrink)

Background To identify and to summarize challenges related to the informed consent process for research completed during humanitarian emergencies. Methods Using relevant search terms, a search of 5 databases was completed, without language, date, or study type restriction. Studies were screened for inclusion, with eligible studies being those that were relevant to the informed consent process for research studies completed in humanitarian emergencies. A Grounded Theory Analysis was completed to identify themes and subthemes. Results Review identified 30 relevant (...) studies. We identified 11 challenges (lack of trust, therapeutic misconception, reduced capacity, security and privacy concerns, harmful research, power differential, literacy, language/local and cultural context, researcher burden and re-evaluation of ongoing trials) and 7 strategies (engage local research communities, use alternative to standard written consent process, modify traditional process of research ethics board review, dynamic consent, training of research staff, mandating transparency of commercial interests, and mandating reporting of informed consent process in all publications) to confront the challenges. These challenges and strategies were unique to the informed consent process in research conducted during humanitarian emergencies. Conclusions This scoping review identified an evidence-based guide for researchers and research ethics boards to perform ethical informed consent procedures in humanitarian emergencies. Trial Registration This trial was not registered as scoping reviews can not be registered as per updated PROSPERO guidelines. (shrink)

In lieu of an abstract, here is a brief excerpt of the content:Informed Consent and Clinical ResearchRuth Faden (bio)Informed consent is a powerful symbol of the commitment and impact of the new, interdisciplinary field of biomedical ethics that the Kennedy Institute has been so instrumental in developing. In the early years of biomedical ethics, there was considerable discussion about the nature of the doctor-patient relationship, about how it ought to be structured, and about how competing values within that (...) relationship ought to be accommodated. By the 1970s and 1980s, the answer was for all practical purposes in. Biomedical ethics was engaged in a clearly reformist project, in step with the values of the times, to right a wrongful imbalance of power and control between physicians and patients.The agenda was clear—to establish the moral authority of the patient to participate in medical decision making by placing respect for the autonomy of patients on the moral map of the medical community. The chief strategy that biomedical ethics adopted to accomplish this agenda was, of course, informed consent. Theories of autonomous action as well as informed consent were intentionally crafted to advance this reformist agenda.In this paper, I examine how the theory of informed consent has fared in one particular realm of “the clinic” where, arguably, there has been considerable success. This is the realm of clinical research; research at the bedside where the patient is also the subject.I rely heavily on the work of President Clinton’s Advisory Committee on Human Radiation Experiments, which I chaired. The Advisory Committee was established in response to exposés in the press about alleged secret experiments during World War II and the Cold War in which patients had been injected with plutonium without their apparent knowledge or consent. As part of its work, the Advisory Committee undertook an oral history project in which we interviewed eminent physicians about the norms and practices of human research in the 1940s and 1950s.Drawing on these interviews, I argue here for two seemingly inconsistent conclusions. First, that the ethical standards for clinical research have changed dramatically in the last 50 years—particularly with respect to informed consent. Second, that despite these important changes, the human dynamics of clinical research in many respects remain unchanged.How the World of Clinical Research Has ChangedDuring the forties and fifties, duties to obtain informed consent, whether for treatment or for research, were simply not part of the doctor-patient experience. [End Page 356]As one physician told us:In 1945, ‘50, the doctor... was king or queen. It never occurred to a doctor to ask for consent for anything. Doctors weren’t in the habit of telling the patients anything (either). They were in charge and nobody questioned their authority.(Advisory Committee on Human Radiation Experiments 1996, p. 83)This unquestioned authority extended to all decisions about the management of the patient, including whether patients were to receive experimental therapies or otherwise become the subjects of research or experimentation. Physicians were trained to be concerned with risk, and harm, and benefit, in keeping with the Hippocratic tradition. But in most institutions, the permission to try something new and to take unknown risks came, not from the patient, but from the chairman of the department.In part, this broad license reflected the very newness of scientifically grounded medical practice. In the forties and fifties, many potentially therapeutic interventions were newly discovered and in this sense considered experimental, or at least innovative. The level of uncertainty about whether a treatment would work was generally high, whether the treatment was part of a research project or not. Moreover, the formalizing of medical science at the bedside was itself still in its infancy—it was not until 1948 that the first modern clinical trial in which patients were randomized to different treatment and control groups was reported in the literature. Much of the research of this period was informal and unsystematic.Thus, it is not surprising that the physician’s authority to make treatment decisions extended to treatments that were innovative or experimental, regardless of whether these innovative treatments were the subject of formal scientific investigation. What is perhaps more surprising is that physicians often acted the same way—that... (shrink)

Background Previous research on informed consent for research in psychiatric patients has centered on disorders that affect comprehension and appreciation of risks. Little has been written about consent to research in those subjects with Borderline Personality Disorder, a prevalent and disabling condition. Discussion Despite apparently intact cognition and comprehension of risks, a borderline subject may deliberately choose self-harm in order to fulfill abnormal psychological needs, or due to suicidality. Alternatively, such a subject may refuse enrollment due to transference (...) or the desire to harm him or herself. Such phenomena could be precipitated or prevented by the interpersonal dynamics of the informed consent encounter. Summary Caution should be exercised in obtaining informed consent for research from subjects with Borderline Personality Disorder. A literature review and recommendations for future research are discussed. (shrink)

Philosophical work on the concept of consent in the past few decades has got to grips with it as a rich notion. We are increasingly sensitive to consent not as a momentary, atomic, transactional thing, but as a complex idea admitting of various qualities and dimensions. In this paper we note that the recognition of this complexity demands a theoretical framework quite different to those presently extant, and we suggest that the enactive approach is one which offers significant (...) value in this regard. In consonance with arguments made by Laurie Penny about how consent is a continuous and dynamic process, we outline how an enactive approach identifies consent as temporally extended (rather than momentarily transactional), and as affected by the skilfulness of the agents involved, the fitness of community provided resources to negotiate the consensual relationship over time, and the unfolding of circumstances in the situation in which the joint action is taking place. We argue that the value of an enactive perspective on consent is in highlighting these complexities, and providing resources to articulate and theorise them in ways that are not open to other current approaches. (shrink)

Informed consent, a cornerstone of research ethics, ensures participant protection and informed participation, particularly in online settings. Despite its significance, engagement with online consent forms remains low, underscoring the need for improved presentation strategies. This study investigates the impact of interactive elements and diverse presentation formats on the comprehension and engagement of online informed consent documents among a broad demographic beyond the commonly studied student populations. Employing a between-subjects experimental design, we explored six versions of online (...) class='Hi'>consent forms varying in interactivity, readability, and visual formatting to identify optimal strategies for enhancing participant comprehension and engagement. Our findings reveal that interactive formats significantly improve comprehension and perceived readability, highlighting the pivotal role of design in facilitating informed consent. The study also examines the influence of individual differences, such as self-efficacy and trust in science, on the effectiveness of consent forms, providing insights into the nuanced dynamics between participant characteristics and consent form engagement. These results advocate for integrating interactive elements and thoughtful design in consent forms to foster a more informed and engaged participant base. Implications for research ethics, best practices in consent form development, and future research directions are also discussed, emphasizing the need for ongoing innovation in the consent process to adapt to the evolving landscape of online research. This study contributes to the body of knowledge on research ethics by offering evidence-based recommendations for enhancing the informed consent process, ultimately promoting participant-centered research practices. (shrink)

The advent of population-specific genomic research has prompted calls for invention of informed consent protocols that would treat entire social groups as research subjects as well as endow such groups with authority as agents of consent. Critics of such an unconventional ethical norm of group consent fear the rhetorical effects of approaching social groups with offers to participate in dialogues about informed consent. Addressing a specific population as the collective subject of genomic research, on this logic, (...) adds currency to the potentially dangerous public opinion that such a group is bound by genetic ties. The paper considers the problem of group and individual identity within the rhetorical dynamics of the discourse and politics of consent. (shrink)

The development and use of large and dynamic health data repositories designed to support research pose challenges to traditional informed consent models. We used semi-structured interviewing to elicit diverse research stakeholders' views of a model of consent appropriate to participation in initiatives that entail collection, long-term storage, and undetermined future research use of multiple types of health data. We demonstrate that, when considering health data repositories, research stakeholders replace a concept of consent as informed with one (...) in which consent is engaged. In engaged consent, a participant's ongoing relationship with a repository serves as a substitute or adjunct to information exchange at enrollment. We detail research stakeholders' views of the risks of engaged consent and suggest questions for further study about engagement and consent procedures in initiatives that aim to store data for future unspecified research purposes. (shrink)

Obtaining consent for medical treatment in older adults raises a number of complex challenges. Despite being required by ethics and the law, consent for medical treatment is not always validly sought in this population. The dynamic nature of capacity, particularly in individuals who have dementia or other cognitive impairments, adds complexity to obtaining consent. Further challenges arise in ensuring that older people comprehend the medical treatment information provided and that consent is not vitiated by coercion (...) or undue influence. Existing mechanisms to address issues surrounding consent for older adults only address incapacity and raise further challenges. As the ageing population increases, these issues are likely to become more profound, thus action is required to address these challenges. Raising awareness, more education, engaging with people with dementia, and conducting further research would assist in beginning to overcome these challenges. (shrink)

There is a growing movement within contemporary medical ethics to blur the boundaries between clinical medicine and clinical research. Some writers now argue that the research-practice distinction is outdated and the importance of distinguishing between research and medicine is no longer as pressing as it once was or seemed to be. Instead, we are now urged to view the health-care system as a dynamic “learning health-care system” in which research components are embedded within standard clinical care. This essay defends (...) the ethical significance of the research-practice distinction while acknowledging the reality and usefulness of integrated health care. A key claim that this essay advances is that the principle of clinical equipoise, which has largely been rejected by research ethicists, can be reinterpreted and repurposed to help distinguish medical practices that call for more demanding forms of informed consent from those that do not. (shrink)

The #MeToo movement generated a feminist insistence that we “believe women.” But the men accused of assault, harassment, and other violations frequently defended themselves with the insistence that they had always “respected women” – sometimes, going so far as to get numerous women to sign letters swearing that these men had always respected them. This common MeToo defense reveals the core inconsistency – and the core entitlement – at the heart of misogyny and sexual injustice: some women deserve respect. But (...) the duty to respect those women relies on an invisible entitlement to disrespect – indeed, to assault, harass, dominate, or exploit – others. This chapter explores consent’s role within the superstructure of misogyny and sexual injustice, arguing what consent is a key apparatus of white supremacy. It argues that consent has been constructed through dynamics of colonial and racist sexual entitlement, mapping some (white) women as deserving of respect and the right to consent, while marking other women as expendable or disposable within the sexual economy. This means not only that consent is historically constructed as white, but also that whiteness, and in particular, white womanhood, is constructed through consent. Thus, white women’s right to consent – or to refuse – is premised upon the inability of other women to do so. In this way, the right to sexual consent does not disrupt the norm of male sexual entitlement. Consent has always been premised on non-consent, from coloniality and slavery to contemporary porn, which offers a vision of the world without proper consent, so that granting consent to actual women is an exceptional practice, an “act of respect.” By including race and class alongside gender in my analysis of consent, I argue that contemporary feminist visions of sexual justice must do more than defend or ameliorate consent, but develop intersectional interrogations of sexual justice that reckon with the complicities of consent. (shrink)

Rather than as a giving of permission to someone to transgress one’s bodily boundaries, I argue for defining sexual consent as feeling-with one’s sexual partner. Dominant approaches to consent within feminist philosophy have failed to capture the intercorporeal character of erotic consciousness by treating it as a form of giving permission, as is evident in the debate between attitudinal and performative theories of consent. Building on the phenomenology of Maurice Merleau-Ponty, Ann Cahill, Linda Martín Alcoff, and others, (...) I argue that taking consent to be an intercorporeal and dynamic coexistence of desiring bodies opens up new ways of thinking about the role of consent in sexual ethics. I suggest that phenomenology’s theories of embodied consciousness, operative intentionality, and the direct perception of others provide a better groundwork for conceptualizing the role of ambiguity and subtle power dynamics in sexual encounters than attitudinal or performative accounts of consent. I also defend my view against Jonathan Jenkins Ichikawa’s argument for doing away with the concept of consent in sexual ethics due to consent's stubborn and infelicitous presupposition of permission-giving. (shrink)

Although Hannah Arendt is not known as an advocate of nonviolence per se, her analysis of power dynamics within and between groups closely parallels Gandhi’s. The paper shows the extent to which her insights are compatible with Gandhi’s and also defends her against charges that her description of the world is overly normative and unrealistic. Both Arendt and Gandhi insist that nonviolence is the paradigm of power in situations where people freely consent to and engage in concerted action, and (...) both argue that power structures based on violence and coercion will ultimately fail, because the resort to violence implies an inability to gain free consent or cooperation. Any gains from violence are temporary, since agents will express themselves freely as soon as force is withdrawn. Arendt argues that dominating powers know this, and therefore rely on manipulation, propaganda, and outright lies to win people’s consent, an analysis which can be used to explain some current social dynamics. (shrink)

Background Informed consent is often cited as the “cornerstone” of research ethics. Its intent is that participants enter research voluntarily, with an understanding of what their participation entails. Despite agreement on the necessity to obtain informed consent in research, opinions vary on the threshold of disclosure necessary and the best method to obtain consent. We aimed to investigate Australian researchers’ views on, and their experiences with, obtaining informed consent. Methods Semi-structured interviews were conducted with 23 researchers (...) from NSW institutions, working in various fields of research. Interviews were analysed and coded to identify themes. Results Researchers reported that consent involved information disclosure, understanding and a voluntary decision. They emphasised the variability of consent interactions, which were dependent on potential participants’ abilities and interests, study complexity and context. All researchers reported providing written information to potential participants, yet questioned the readability and utility of this information. The majority reported using signed consent forms to ‘operationalise’ consent and reported little awareness of, and lack of support in implementing more dynamic informed consent procedures, such as verbal informed consent, that was fit for the purposes of their studies. Views on Human Research Ethics Committees varied. Some reported inconsistent, arduous inputs on the information form and consent process. Others expressed reliance on HRECs for guidance, viewing them as institutional safeguards. Conclusions This study highlights the importance of transparent relationships, both between researchers and participants, and between researchers and HRECs. Where the relationship with study participants was reported as more robust, researchers felt that they were better able to ensure participants made better, more informed decisions. Where the relationship with HRECs was reported as more robust, researchers were more likely to view them as institutional safeguards, rather than as bureaucratic hindrances. Conscientious and mindful researchers are paramount to ensuring the procedure accommodates individual requirements. This study advocates that when designing ethical informed consent practices, researchers should be integrated as autonomous players with a positive input on the process, rather than, in the worst case, predatory recruiters to be curtailed by information forms and oversight. (shrink)

This paper explores the perspectives of women who have agreed that their umbilical cord blood may be collected for a public ‘cord blood bank’, for use in transplant medicine or research. Drawing on interview data from 27 mothers who agreed to the collection and use of their umbilical cord blood, these choices and the informed consent process are explored. It is shown that the needs of sick children requiring transplants are prominent in narrative accounts of cord blood banking, together (...) with high expectations for future applications of stem cells. Given this dynamic, a concern arises that the complex and multiple uses of tissues and related data might be oversimplified in the consent process. In conclusion, the positive finding of a commitment to mutuality in cord blood banking among these women is underlined, and its implications for the wider debate on cord blood banking are discussed. (shrink)

In lieu of an abstract, here is a brief excerpt of the content:Reviewed by:The Poetics of Consent: Collective Decision Making and the Iliad by David F. ElmerWilliam G. ThalmannDavid F. Elmer. The Poetics of Consent: Collective Decision Making and the Iliad. Baltimore, Md.: Johns Hopkins University Press, 2013. x + 313 pp. Cloth, $55.In this book, David Elmer takes a fresh approach to some large questions that have occupied Homeric scholarship: how and under what conditions the epics took (...) shape, the political dynamics and relations of authority in the society they depict, the relation (if any) of that society to historical Greek society, the nature of performances of the poems and the relations between performer and audience, and, within the Iliad, how human action is related to decisions of the gods and the political and social implications of various characters’ conduct, particularly that of Agamemnon and Achilles. Any one of these questions is usually enough for a full-length study. But, drawing on such recent work as that of Gregory Nagy, Johannes Haubold, and Elton Barker, as well as on speech act theory and Indo-European linguistics, Elmer brings these questions together in a fresh and illuminating examination of the Iliad and its performative context.The basis for his study is the observation that, whereas ainein / -os can have various meanings in and outside Homer (“praise,” “[coded] story”), in the Iliad the compound epainein (the noun does not occur in Homer but he uses it for convenience) is limited to contexts of collective deliberation. There it describes the approving response of the community to a proposal by a leader that normally translates the proposal into action. Such a scenario represents the formation of a speech act; one distinctive feature of the book is that it draws attention away from enunciation to its reception by an audience, which is crucial to the completion of a speech act and especially to its effectiveness in shaping reality. This usage of the verb, Elmer argues in an excellent chapter (2), is a vestige of the importance of speech to the creation and maintenance of social order (a prominent theme of the book) in Indo-European societies. It thus refers to socially efficacious and constructive speech. Conversely, the cognate anainesthai and apēnēs are associated with verbal behavior that is socially destructive.The consent signaled by epainos results from consensus, which (following Egon Flaig) Elmer carefully distinguishes from majority rule, and which, he says in connection with the Thersites episode, seems egalitarian but is consistent with social hierarchy. Scholars have often depicted the role of the people (laos) in Homeric assembly scenes as limited to ratifying decisions actually made by their leaders (basilēes), but Elmer makes a strong case that the people’s epainos is necessary for a proposal to become action. The evidence is negative but telling: the many instances in which epainos does not occur and decisions are either [End Page 281] not made or lead to failure. On the other hand, Elmer might have been more explicit about the relation between the authority of the basilēes and the need for consensus. Is a tension between them one of the fault lines of Iliadic society exposed by the narrative? Is the role of a good leader to see that both are somehow accommodated? At any rate, Elmer’s argument that a basileus cannot set aside the opinion of the community, and in particular that Agamemnon’s rebuff of Chryses, despite the people’s support of him at the beginning of the poem, cannot be taken as the norm is persuasive and welcome.Strangely but significantly, an explicit statement of the norm of epainos comes only late in the poem, at Il. 23.539–42, when the Achaeans “express an epainos” at Achilles’ proposal to award the second-prize mare to Eumelos; this response would have been the basis of his doing so if not for Antilochos’s objection. These lines, Elmer argues, show the need for community approval to enact a proposal. The lines also show the power given to individual dissent in a system of consensus. It is a key point in Elmer’s overall argument that in the episode which shows the norm most clearly... (shrink)

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)

This paper argues that it will be important for new genomic technologies to recognize the limits of traditional approaches to informed consent, so that other-regarding implications of genomic information can be properly contextualized and individual rights respected. Respect for individual autonomy will increasingly require dynamic consideration of the interrelated dimensions of individual and broader community interests, so that the interests of one do not undermine fundamental interests of the other. In this, protection of individual rights will be a (...) complex interplay between individual and community concerns. (shrink)

In their fine overview of supported decision making for persons with dynamic cognitive and functional impairments “at the margins of autonomy,” Peterson, Karlawish, and Largent query whether...

Background: Informed consent (IC) is an ethical and legal obligation protected by constitutional rights to bodily integrity, well-being, and privacy in South Africa. The National Health Act 2003 codified IC regulations, requiring that all healthcare professionals inform patients about diagnosis, risks, benefits, options, and refusal rights while factoring in patients’ language and literacy levels. Objectives: This study’s primary aim was to determine the extent of South African professional/staff nurses’ compliance with current IC regulations and ascertain socio-cultural impediments impacting proper (...) IC practice. Methods: A cross-sectional survey using semi-structured questionnaires was used to evaluate knowledge and practice of IC among nurses in KwaZulu-Natal province. Data were analyzed using SPSS, v.21. Descriptive statistics, chi-squared tests, and content analysis were used to compare nursing domains. Results: Three hundred fifty-five (355) nurses, 92% females, with 1 to 41 years of professional experience, completed this study. Information disclosed by nurses to patients included diagnosis (77%), treatment benefits (71%), risks (69%), recommendations (65%), risks of refusal (80%), and right of refusal (67%). Nurses (80%) felt information disclosure was adequate, while 85% reported that patients understood disclosed information. Conclusions: Nurses practicing in local public hospitals had moderate knowledge of IC regulations. Practical implementation appeared deficient. Barriers to IC included language, workload, time constraints, lack of interpreters, and skewed gender norms in the nursing profession. Nurses require continuing professional education in healthcare law and ethics, a “corps of trained interpreters”, and gender transformation in the nursing profession to improve IC practice and overall quality of healthcare service delivery in South Africa. (shrink)

The social impacts of computer technology are often glorified in public discourse, but there is growing concern about its actual effects on society. In this article, we ask: how does “consent” as an analytical framework make visible the social dynamics and power relations in the capture, extraction, and labor of data science knowledge production? We hypothesize that a form of boundary violation in data science workplaces—gender harassment—may correlate with the ways humans’ lived experiences are extracted to produce Big Data. (...) The concept of consent offers a useful way to draw comparisons between gender relations in data science and the means by which machines are trained to learn and reason. Inspired by how Big Tech leaders describe unsupervised machine learning, and the co-optation of “revolutionary” rhetoric they use to do so, we introduce a concept we call “techniques of invisibility.” Techniques of invisibility are the ways in which an extreme imbalance between exposure and opacity, demarcated along fault lines of power, are fabricated and maintained, closing down the possibility for bidirectional transparency in the production and applications of algorithms. Further, techniques of invisibility, which we group into two categories—epistemic injustice and the Brotherhood—include acts of subjection by powerful actors in data science designed to quell resistance to exploitative relations. These techniques may be useful in making further connections between epistemic violence, sexism, and surveillance, sussing out persistent boundary violations in data science to render the social in data science visible, and open to scrutiny and debate. (shrink)