Consent under Duress
Book
Tom Dougherty
Oxford Academic, 31 December 2024
Abstract
Consent can make actions morally permissible. But consent can lose its moral force when it is given under duress. Understanding how this happens requires answering the question of which types of duress undermine consent. Uncontroversially, severe coercion, like threats of violence, can prevent consent from creating moral permissions. But what about minor duress? Duress from natural causes? Duress from social norms? Duress that is merely apparent to the consent-giver with no objective basis in reality? To answer these questions, Consent under Duress defends an account that follows two key approaches. First, it adopts an expansive approach that broadens the class of misconduct that is constituted by acting on someone’s consent that is given under duress. Second, it adopts a scalar approach that allows that consent can be invalidated to varying degrees, which in turn can track the degrees of the severity of the duress to which the consent-giver is subject. The expansive and scalar approaches work in tandem. Once there is an expansion of the aforementioned class of misconduct, additional theoretical resources are needed to draw moral distinctions within this heterogeneous class. By providing these resources, the scalar approach supplements the expansive approach. Meanwhile, once it is recognized that consent can be partially invalidated by minor duress, it is necessary to expand the class of what constitutes misconduct that is constituted by acting on someone’s consent that is given under duress. By arguing independently for these mutually reinforcing approaches, Consent Under Duress offers a robust defense of their combination.
Scaffolding Informed Consent
Scaffolding Informed Consent
Extended Essay
Dominic Wilkinson, Neil Levy
Journal of Medical Ethics, 20 December 2024
Abstract
The principle of respecting patient autonomy underpins the concept and practice of informed consent. Yet current approaches to consent often ignore the ways in which the exercise of autonomy is deeply epistemically dependent.
In this paper, we draw on philosophical descriptions of autonomy ‘scaffolding’ and apply them to informed consent in medicine. We examine how this relates to other models of the doctor–patient relationship and other theories (eg, the notion of relational autonomy). A focus on scaffolding autonomy reframes the justification for existing ways of supporting decisions. In other cases, it suggests a need to rethink how, when and where professionals obtain consent. It may highlight the benefit of technology for supporting decisions.
Finally, we consider the implications for some high-stakes decisions where autonomy is thought to be critical, for example, termination of pregnancy. We argue that such decisions should not be free from all sources of influence—rather they should be protected from undesired influence.
Excerpt
…In what we might call a socially supported model of decision making, individuals make their decisions with input from others. They seek opinions and advice from family and friends, and information from medical professionals, and then attempt to weigh that information in coming to a decision that reflects their own values and outlook. Such socially supported decisions are very plausibly better for the input of others: a broader range of considerations are brought to bear than the individual could marshal on their own. But the final decision-making reflects cognition that is fully the individual’s own. Properly scaffolded models, however, go beyond socially supported models. On the latter, decision-making reflects cognition that is distributed across agents and across the environment. Scaffolded autonomy draws its inspiration from distributed models of cognition…
“Informed” consent? Ethical considerations for clinicians using therapy-matching platforms
“Informed” consent? Ethical considerations for clinicians using therapy-matching platforms
Colette N. Delawalla, Lorenzo Lorenzo-Luaces
Journal of Consulting and Clinical Psychology, 2024; 92(12)
Abstract
Mental health care in the United States is prohibitively difficult to access. Barriers of entry include a shortage of providers, high cost of services, insufficient insurance coverage, and layers of bureaucracy. This problem of low supply and high demand created a unique environment for capitalist problem solvers to enter the therapeutic market, via “therapy-matching platforms.” Several ethically related Federal Trade Commission (FTC) complaints and independent investigations into these platforms highlight that the forward progress is not without growing pains. This commentary focuses on ensuring proper informed consent when providing services on therapy-matching platforms (e.g., BetterHelp, TalkSpace).
Empowering Patients for Disease Diagnosis and Clinical Treatment: A Smart Contract-Enabled Informed Consent Strategy
Empowering Patients for Disease Diagnosis and Clinical Treatment: A Smart Contract-Enabled Informed Consent Strategy
Md Al Amin, Hemanth Tummala, Rushabh Shah, Indrajit Ray
arXiv, 13 December 2024
Open Access
Abstract
Digital healthcare systems have revolutionized medical services, facilitating provider collaboration, enhancing diagnosis, and optimizing and improving treatments. They deliver superior quality, faster, reliable, and cost-effective services. Researchers are addressing pressing health challenges by integrating information technology, computing resources, and digital health records. However, digitizing healthcare introduces significant risks to patient data privacy and security, with the potential for unauthorized access to protected health information. Although patients can authorize data access through consent, there is a pressing need for mechanisms to ensure such given consent is informed and executed properly and timely. Patients deserve transparency and accountability regarding the access to their data: who access it, when, and under what circumstances. Current healthcare systems, often centralized, leave much to be desired in managing these concerns, leading to numerous security incidents. To address these issues, we propose a system based on blockchain and smart contracts for managing informed consent for accessing health records by the treatment team members, incorporating safeguards to verify that consent processes are correctly executed. Blockchain’s inherent immutability ensures the integrity of consent. Smart contracts automatically execute agreements, enhancing accountability. They provide a robust framework for protecting patient privacy in the digital age. Experimental evaluations show that the proposed approach can be integrated easily with the existing healthcare systems without incurring financial and technological challenges.
Current Calls For Public Consultation
Ethical Guidelines for Research Using Pervasive Data
A Notice by the U.S. National Telecommunications and Information Administration on 12/11/2024
Public comment period that ends 01/15/2025.
SUMMARY:
The National Telecommunications and Information Administration (NTIA) is seeking public input on the potential writing of ethical guidelines for the use of “pervasive data” in research. “Pervasive data” refers to data about people gathered through online services. NTIA will rely on these comments, along with stakeholder engagements, in considering whether to draft and issue non-binding guidelines to assist researchers working with pervasive data. Such guidelines, if warranted, would detail how independent third-party researchers [3] can work with pervasive data while meeting ethical expectations of research and protecting individuals’ privacy and other rights…
The goal of ethical guidelines would be to outline principles and best practices that researchers, research institutions, data intermediaries,[4] and online service providers can choose to follow when involved in research with pervasive data…
Pervasive data can be drawn from global networks and may be analyzed by an international community of researchers. Therefore, it is increasingly important to use a global lens to address ethical issues in pervasive data. Advancements in research using pervasive data may benefit from international collaboration and agreed-upon norms for ethical research and the protection of privacy and other rights…
Risks to data subjects presented by research with pervasive data include reidentification of anonymous user accounts; release or inference of information that can be used to perpetuate a range of privacy and other individual-level harms, including fraud, impersonation, discrimination, reputational harms, and emotional distress; and decreased willingness to post and access information online and engage in the digital economy…
Sample Questions:
- Consent and autonomy are key principles in human subjects research ethics. However, users of online services may be required to divulge certain personal information and/or have no ability to freely make decisions about its use.[44] How should researchers working with pervasive data consider consent and autonomy?
- What, if any, would be an appropriate consent model for research with pervasive data? How and how often should consent occur?
- Are there alternative models to traditional consent that either support autonomy or provide protections for data subjects in cases where autonomy is limited?
- How, if at all, is user autonomy influenced by context, such as the need to use online services for school, work,[45] or socializing?
- What existing ethical frameworks, such as those from professional organizations [64] or government agencies,[65] should be considered when drafting national-level ethical guidelines for research with pervasive data?
- To what extent do existing frameworks apply to the collection and use of pervasive data?
- What modifications of existing frameworks might be necessary to ensure that those frameworks are applicable to the needs of research with pervasive data?
Informed Consent: A Monthly Review
_________________
December 2024 :: Issue 72
In preparing this digest, we monitor a broad range of academic journals and utilize Google Scholar to search articles referencing informed consent or assent. After careful consideration, a selection of these results appear in the digest. We also monitor other research, analysis, guidance and commentary beyond the academic literature globally, including calls for public consultation and symposia/conferences which address consent/assent in whole or in part. We recognize that some of the arguments presented in this edition may be controversial and may warrant closer scrutiny. We have elected to be generous in our inclusion with the goal of presentating of a wholistic landscape of informed consent literature as it is being published. We acknowledge that this scope yields an indicative and not an exhaustive digest product.
Informed Consent: A Monthly Review is a service of the Center for Informed Consent Integrity, a program of the GE2P2 Global Foundation. The Foundation is solely responsible for its content. Comments and suggestions should be directed to:
Editor
Paige Fitzsimmons, MA
Associate Director, Center for Informed Consent Integrity
GE2P2 Global Foundation
paige.fitzsimmons@ge2p2global.org
PDF Version: Center for Informed Consent Integrity – A Monthly Review_December 2024
Spotlight
This month we spotlight the new set of principles supporting ethical human genomic data collection and sharing released by the WHO in late November. In this normative guidance, WHO addresses eight principles [detailed below], many of which touch on consent either directly or indirectly. In particular, the first principle [3.1] presents a number of consent-related recommendations which we highlight here:
3.1. To affirm and value the rights of individuals and communities to make decisions
A commitment to affirm and value the rights and interests of individuals with capacity to make informed decisions about their human genome data throughout the data life cycle. In addition, a commitment to affirm the best interests of, and support for, individuals who do not have the capacity to make decisions for themselves.
The use of human genome data has implications beyond the individual, and the relevant views of family members and communities on collection, access to, use and sharing of these data should be taken into account throughout the data life cycle.
Recommendations: [selected]
:: Informed consent should be as specific and granular as possible in relation to the potential uses (including by for-profit entities and the potential to share the data to train artificial intelligence), benefits and harms possibly resulting from the use of human genome data, the infrastructure hosting the data (including location and access modalities), and this information must be tailored to respect social and cultural contexts.
:: The most appropriate informed consent model (e.g. specific, broad, tiered or dynamic informed consent) depends upon the individual/local context.
:: Informed consent should be supported by governance frameworks and processes, and individuals should be informed of such processes…
:: Individuals, families and communities should have access to clear, transparent, accessible, understandable and ongoing communication about their human genome data collection, access, use and sharing, for those who wish to receive that information. This ongoing communication should, where possible, continue throughout the data life cycle.
:: Individuals and their representative communities should be engaged in the governance and decision-making process regarding collection, access to, use and sharing of human genome data, including the development of appropriate informed consent models and processes.
:: Children, when sufficiently mature to understand what is involved in their participation, should be given the opportunity to affirm the informed consent previously given on their behalf or to withdraw their consent from that point onwards….
Below, we provide excerpts from the WHO media release and the full citation/overview of the guidance document.
WHO releases new principles for ethical human genomic data collection and sharing
20 November 2024
The World Health Organization (WHO) has issued a set of principles for the ethical collection, access, use and sharing of human genomic data. Created with guidance from the WHO Technical Advisory Group on Genomics (TAG-G) and other international experts, these principles establish a global approach to help protect individual rights, promote equity and foster responsible collaboration in genomic research…
“The potential of genomics to revolutionize health and disease understanding can only be realized if human genomic data are collected, accessed and shared responsibly,” says Dr John Reeder, Director of WHO’s Research for Health Department. “This document outlines globally applicable principles designed to guide ethical, legal and equitable use of human genome data, fostering public trust and protecting the rights of individuals and communities. It serves as a call to action, urging all stakeholders to adhere to these principles and ensure the benefits of genomic advancements are accessible to everyone.”
The principles emphasize several core themes:
:: Informed consent and privacy are foundational, with clear guidelines to ensure that individuals understand and agree to how their genomic data will be used. WHO underscores the importance of transparency, requiring that data collection processes are openly communicated and safeguarded against misuse.
:: Another core focus is equity. The principles call for targeted efforts to address disparities in genomic research, especially in low- and middle-income countries (LMICs), and for ensuring that genomic research benefits populations in all their diversity. By prioritizing the inclusion of underrepresented groups, the guidelines aim to promote broader and fairer representation in genomic research and its applications.
:: Recognizing the importance of international collaboration through partnerships across borders and sectors, WHO encourages collaborative efforts between governments, academia and the private sector to maximize the positive impact of genomic research. Responsible data sharing, supported by robust governance structures, is essential for advancing global health while respecting privacy.
:: WHO’s principles also address capacity building in regions with limited genomic infrastructure. By encouraging investment in local expertise and resources, the organization aims to close global disparities in research capacity, making genomic data practices more inclusive and sustainable.
The release of these principles represents a significant step forward in WHO’s mission to promote ethical genomics practices. As the field continues to evolve, these guidelines offer a trusted framework to support genomic research that is equitable, transparent and respectful of individual rights.
Guidance for human genome data collection, access, use and sharing
WHO – Guidance [normative]
20 November 2024 :: 22 pages
Overview
The ethical, legal, and equitable sharing of human genomic data is critical to advancing global health research and ensuring fair access to the benefits of genomics. The WHO’s new document outlines a comprehensive set of globally applicable principles designed to guide stakeholders in the responsible collection, use, and sharing of human genome data. This document serves as a key resource to navigate complex issues surrounding data governance, with the aim of fostering transparency, promoting equity, and safeguarding individual and collective rights. These principles are intended to support the implementation of best practices across diverse settings, thereby enhancing the global capacity for genomic research and its translation into health benefits for all.
Table of Contents [excerpt]
3.0 Principles for human genome collection, access, use and sharing
3.1 To affirm and value the rights of individuals and communities to make decisions
3.2 Social justice
3.3 Solidarity
3.4. Equitable access to and benefit from human genome data
3.5 Collaboration, cooperation and partnership
3.6. Stewardship of human genome data
3.7. Transparency
3.8. Accountability
Glossary [excerpt]
Benefit-sharing refers to profit-sharing agreements, equitable access to diagnostics, therapeutics and technology transfer, as well as capacity-building and -strengthening initiatives. What constitutes a benefit (and the nature of that benefit) is both subjective and context dependent
Human genome data include but is not limited to:
– DNA sequence(s) from the nuclear and mitochondrial genomes.
– Transcriptome (complete set of RNA transcripts).
– Proteome (complete set of proteins produced by an organism, from which the corresponding
– genetic sequences can be inferred)
– Methylome and other epigenetic modifications.
Consent-Related Outcomes in the Alteplase Compared to Tenecteplase Trial
Consent-Related Outcomes in the Alteplase Compared to Tenecteplase Trial
Michel C. Shamy, Brian Dewar, Yan Deschaintre, Nishita Singh, Carol Kenney, Mohammed A. Almekhlafi, Ayoola Ademola, Brian H. Buck, Tolulope T. Sajobi, Luciana Catanese, Kayla D. Sage, Dar Dowlatshahi, Laura C. Gioia, Aleksander Tkach, Richard H. Swartz, Bijoy K. Menon
Neurology, 26 November 2024
Abstract
Background and Objectives
In recent years, researchers have sought to address the challenges of obtaining informed consent for participation in acute stroke trials. We studied outcomes related to the use of deferral of consent in the phase 3 Alteplase Compared to Tenecteplase (AcT) trial.
Methods
As part of our protocol, we captured methods of consent, participant withdrawals, door-to-randomization times, and door-to-needle times. Participants at 3 sites were invited to complete a survey of attitudes regarding consent for AcT and for acute stroke trials generally.
Results
The AcT trial enrolled 1,600 participants from 22 centers across Canada of whom 1,537 were enrolled through deferral of consent (96.0%) and 63 (4.0%) were enrolled by prospective verbal consent followed by written informed consent. Of those enrolled by deferral of consent, 95% (1,454/1,537) consented to ongoing participation. Door-to-randomization times were similar regardless of method of consent, with an overall median of 30 minutes (interquartile range [IQR] 22–42): 29 minutes (IQR 22–42) in the deferral of consent group vs 32 minutes (IQR 25–44) in the prospective consent group (p = 0.1602). Survey respondents overwhelming agreed or strongly agreed with the use of deferral of consent in AcT (86%) and in any acute stroke trial (76%).
Discussion
Deferral of consent was broadly acceptable to participants in the AcT trial as demonstrated by low rates of withdrawal and by survey results. Door-to-randomization times using deferral of consent in AcT were short, although a system of prospective verbal consent used at 1 center took only slightly longer. These results support the importance of innovation around consent for acute stroke trials.
Insights From the Development of a Dynamic Consent Platform for the Australians Together Health Initiative (ATHENA) Program: Interview and Survey Study
Insights From the Development of a Dynamic Consent Platform for the Australians Together Health Initiative (ATHENA) Program: Interview and Survey Study
Eddy Xiong, Carissa Bonner, Amanda King, Zoltan Maxwell Bourne, Mark Morgan, Ximena Tolosa, Tony Stanton, Kim Greaves
JMIR Formative Research, 6 November 2024
Abstract
Background
Dynamic consent has the potential to address many of the issues facing traditional paper-based or electronic consent, including enrolling informed and engaged participants in the decision-making process. The Australians Together Health Initiative (ATHENA) program aims to connect participants across Queensland, Australia, with new research opportunities. At its core is dynamic consent, an interactive and participant-centric digital platform that enables users to view ongoing research activities, update consent preferences, and have ongoing engagement with researchers.
Objective
This study aimed to describe the development of the ATHENA dynamic consent platform within the framework of the ATHENA program, including how the platform was designed, its utilization by participants, and the insights gained.
Methods
One-on-one interviews were undertaken with consumers, followed by a workshop with health care staff to gain insights into the dynamic consent concept. Five problem statements were developed, and solutions were posed, from which a dynamic consent platform was constructed, tested, and used for implementation in a clinical trial. Potential users were randomly recruited from a pre-existing pool of 615 participants in the ATHENA program. Feedback on user platform experience was gained from a survey hosted on the platform.
Results
In the 13 consumer interviews undertaken, participants were positive about dynamic consent, valuing privacy, ease of use, and adequate communication. Motivators for registration were feedback on data usage and its broader community benefits. Problem statements were security, trust and governance, ease of use, communication, control, and need for a scalable platform. Using the newly constructed dynamic consent platform, 99 potential participants were selected, of whom 67 (68%) were successfully recontacted. Of these, 59 (88%) agreed to be sent the platform, 44 (74%) logged on (indicating use), and 22 (57%) registered for the clinical trial. Survey feedback was favorable, with an average positive rating of 78% across all questions, reflecting satisfaction with the clarity, brevity, and flexibility of the platform. Barriers to implementation included technological and health literacy.
Conclusions
This study describes the successful development and testing of a dynamic consent platform that was well-accepted, with users recognizing its advantages over traditional methods of consent regarding flexibility, ease of communication, and participant satisfaction. This information may be useful to other researchers who plan to use dynamic consent in health care research.
Maximising the opportunities in lung cancer screening: uptake of consent to contact for research
Maximising the opportunities in lung cancer screening: uptake of consent to contact for research
T Patrick, SB Naidu, L Anandan, K Desai, V Marshman, P Robinson, S Patel, A Nair, R Thakrar, N Navani, JR Hurst, SM Janes, A Bhamani
BMJ Thorax, 3 November 2024
Abstract
Introduction
Low-Dose CT (LDCT) screening reduces lung cancer mortality. However, the benefits of Lung Cancer Screening (LCS) can be extended, for example, by offering individuals the opportunity to participate in research. We investigated the proportion and characteristics of individuals willing to be approached about research participation in our Targeted Lung Health Check programme.
Methods
In our programme, eligible individuals as assessed in an initial telephone questionnaire proceed to a face-to-face lung health check and LDCT. An additional question for eligible individuals (‘Are you happy to be approached by a member of our research team about participating in research?’) was introduced on 4th December 2023. All individuals subsequently completing a telephone questionnaire up to 20th May 2024 were included in this analysis.
Results
1708/3095 (55.2%) individuals consented to being approached about participating in research. Of these, 1068 (62.5%) were male, 746 (43.7%) were current smokers and 1380 (80.8%) were of white ethnicity. Multivariable binary logistic regression analysis (table 1) showed that the factors associated with an increased likelihood of agreeing to research contact were: personal cancer history (aOR 1.39 (95% confidence interval (CI) 1.15–1.69)) and exposure to asbestos (aOR 1.63 (95%CI 1.34–1.99)). Being Asian (aOR 0.56 (95%CI 0.44–0.72)), having fewer years of formal education (finished education aged 15 or less aOR 0.44 (95%CI 0.33–0.60)) and a self-reported medical history of COPD (aOR 0.83 (95%CI 0.69–0.99) were associated with a reduced likelihood of consenting to research contact.
Discussion
Increasing public participation in research is important and part of the current NHS Long Term Plan.1 The majority of individuals undergoing LCS consented to be approached about research. However, groups already underrepresented in research were less likely to consent. Future studies should focus on increased diversity in research, potential benefits of which include increased public trust, promotion of fairness and improved generalisability of research findings.
Center for Informed Consent Integrity 