Meaningful Consent Research Articles

Understanding contextual expectations for sharing wearables' data: Insights from a vignette study

People are increasingly open to sharing personal data collected by wearables, while concerns have emerged on how companies, governments and organisations process this data. This paper applies Nissenbaum's theory of contextual integrity to explore the perceived appropriateness of information flows linked to wearables. A vignette study was conducted (N = 500) to examine the influence of the type of data shared, its purpose, and the sender, on the appropriateness of different wearables' information flow scenarios. Results revealed a significant impact of information type, sharing purpose, and sender on the perceived appropriateness of data sharing. Notably, data collected for research purposes or to develop new functionalities was deemed most appropriate, while data used for advertising was viewed unfavourably. Further, the user-controlled sharing received higher appropriateness ratings. This research underscores the need for meaningful consent in data sharing and suggests that manufacturers of wearable devices should utilise user agency to supplement information flow automation based on societal and contextual privacy norms.

Video Notice Design to Support Meaningful Consent Online: An Analysis of Social Media Videos About Artificial Intelligence and Privacy

Video Notice Design to Support Meaningful Consent Online: An Analysis of Social Media Videos About Artificial Intelligence and Privacy

The challenges and potential solutions of achieving meaningful consent amongst research participants in northern Thailand: a qualitative study

BackgroundAchieving meaningful consent can be challenging, particularly in contexts of diminished literacy, yet is a vital part of participant protection in global health research.MethodWe explored the challenges and potential solutions of achieving meaningful consent through a qualitative study in a predominantly hill tribe ethnic minority population in northern Thailand, a culturally distinctive population with low literacy. Semi-structured interviews were conducted with 37 respondents who had participated in scrub typhus clinical research, their family members, researchers and other key informants. A thematic analysis was conducted.ResultsOur analysis identified four interrelated themes surrounding participants’ ability to give consent: varying degrees of research understanding, limitations of using informal translators, issues impacting decisions to join research, and voluntariness of consent. Suggestions for achieving more meaningful consent included the use of formal translators and community engagement with research populations.ConclusionsParticipant’s agency in decision making to join research should be supported, but research information needs to be communicated to potential participants in a way that they can understand. We found that improved understanding about the study and its potential benefits and harms goes beyond literacy or translation and requires attention to social and cultural factors.

Terms-we-serve-with: Five dimensions for anticipating and repairing algorithmic harm

Power and information asymmetries between people and digital technology companies are further legitimized through contractual agreements that fail to provide meaningful consent and contestability. In particular, the Terms-of-Service (ToS) agreement, is a contract of adhesion where companies effectively set the terms and conditions of the contract. Whereas, ToS reinforce existing structural inequalities, we seek to enable an intersectional accountability mechanism grounded in the practice of algorithmic reparation. Building on existing critiques of ToS in the context of algorithmic systems, we return to the roots of contract theory by recentering notions of agency and mutual assent. We evolve a multipronged intervention we frame as the Terms-we-Serve-with (TwSw) social, computational, and legal framework. The TwSw is a new social imaginary centered on: (1) co-constitution of user agreements, through participatory mechanisms; (2) addressing friction, leveraging the fields of design justice and critical design in the production and resolution of conflict; (3) enabling refusal mechanisms, reflecting the need for a sufficient level of human oversight and agency including opting out; (4) complaint and algorithmic harms reporting, through a feminist studies lens and open-sourced computational tools; and (5) disclosure-centered mediation, to disclose, acknowledge, and take responsibility for harm, drawing on the field of medical law. We further inform our analysis through an exploratory design workshop with a South African gender-based violence reporting AI startup. We derive practical strategies for communities, technologists, and policy-makers to leverage a relational approach to algorithmic reparation and propose there's a need for a radical restructuring of the “take-it-or-leave-it” ToS agreement.

Touch and consent: towards an ethics of care in intimate performance

Our personal experiences as women working in the performing arts and entertainment sector indicate to us that there is a need for actron-training that includes articulated pedagogical framework and methodological approaches that engage with the performance of intimate content and professional touch. Women’s behaviour and communicative acts are often gendered through socialisation and gender hegemony that at times, are covertly upheld by the culture of a work context. Gender hegemony and perceptions about gender uphold and legitimize practices that do harm, impacting women’s physical, mental and emotional safety. For women actrons, this is exacerbated by expectations of what they should consent to in service of their work, including touch and intimacy. We argue that using a feminist ethic of care as pedagogical framework together with intimacy coordination as resonant methodological approach might offer an approach to actron-training that might further women actrons’ agency in giving meaningful consent with regards to professional touch, whist cultivating a broader imperative of care.

War without Agreement: Thinking through Okeja's Jus ad Bellum Theory

ABSTRACT In a recent article in this journal, Uchena Okeja, inspired by sources in African philosophy and military ethics, argued that war by agreement is the only morally justified war. The present piece is a response to Okeja's contention that agreement is both necessary and sufficient for waging war. Contrasting with Okeja, I contend that agreement is neither necessary nor sufficient for initiating a war. Regarding necessity, I contend that there may be overriding values at risk in a conflict and protecting these values may require engaging in war without agreement. Further, I contend that in cases of self-defense, it is not necessary to have consensus for defending oneself from an attacker. With respect to sufficiency, I uphold that Okeja's perspective fails because his model does not provide just cause, conditions for meaningful consent, or the tools with which to avoid exclusion, elitism, and manipulation in deliberative settings. I conclude that Okeja's arguments are indeed valuable and provide inspirational ideas for how to avoid war, but overall, they do not hold up as a full-fledged theory.

Patient Perspectives and Preferences for Consent in the Digital Health Context: State-of-the-art Literature Review.

The increasing integration of digital health tools into care may result in a greater flow of personal health information (PHI) between patients and providers. Although privacy legislation governs how entities may collect, use, or share PHI, such legislation has not kept pace with digital health innovations, resulting in a lack of guidance on implementing meaningful consent. Understanding patient perspectives when implementing meaningful consent is critical to ensure that it meets their needs. Consent for research in the context of digital health is limited. This state-of-the-art review aimed to understand the current state of research as it relates to patient perspectives on digital health consent. Its objectives were to explore what is known about the patient perspective and experience with digital health consent and provide recommendations on designing and implementing digital health consent based on the findings. A structured literature search was developed and deployed in 4 electronic databases-MEDLINE, IEEE Xplore, Scopus, and Web of Science-for articles published after January 2010. The initial literature search was conducted in March 2021 and updated in March 2022. Articles were eligible for inclusion if they discussed electronic consent or consent, focused on the patient perspective or preference, and were related to digital health or digital PHI. Data were extracted using an extraction template and analyzed using qualitative content analysis. In total, 75 articles were included for analysis. Most studies were published within the last 5 years (58/75, 77%) and conducted in a clinical care context (33/75, 44%) and in the United States (48/75, 64%). Most studies aimed to understand participants' willingness to share PHI (25/75, 33%) and participants' perceived usability and comprehension of an electronic consent notice (25/75, 33%). More than half (40/75, 53%) of the studies did not describe the type of consent model used. The broad open consent model was the most explored (11/75, 15%). Of the 75 studies, 68 (91%) found that participants were willing to provide consent; however, their consent behaviors and preferences were context-dependent. Common patient consent requirements included clear and digestible information detailing who can access PHI, for what purpose their PHI will be used, and how privacy will be ensured. There is growing interest in understanding the patient perspective on digital health consent in the context of providing clinical care. There is evidence suggesting that many patients are willing to consent for various purposes, especially when there is greater transparency on how the PHI is used and oversight mechanisms are in place. Providing this transparency is critical for fostering trust in digital health tools and the innovative uses of data to optimize health and system outcomes.

Pyaar, Promise, Dhoka: Feminist Questions to Law – Commentary on Uday v. State of Karnataka (2003) 4 SCC 46

This commentary is on one ‘promise to marry’ judgment and its feminist re-writing. Promise to marry cases involve a woman agreeing to sexual intercourse with a partner relying on his promise to marry her subsequently. In inter-caste relationships, the offer of promise to marriage as a basis for engaging in sexual intercourse raises complex issues. The impunity of the caste system means that if the promise is not followed through, the woman may not just feel betrayed, but also ‘dishonoured’, socially ostracized, and left with the option of approaching the court alleging rape on grounds of an absence of meaningful consent. The original judgment did not take into consideration this caste hierarchy and rejected the allegation of rape, suggesting that an ‘intelligent, consenting’ woman needed to be aware of the ‘impossibility’ of such marriages. The judgment thereby upheld endogamous caste practices. The feminist rewriting is critical of this perspective and also highlights the absence of any form of compensation to a woman who has been violated of her dignity and social status. Feminist questions on this issue require nuance, taking into consideration the caste-religion-gender intersectionality and at the same time not measuring all acts of betrayal through the vantage point of rape. This commentary proposes certain feminist questions to the law beyond the text and interpretation of existing legal provisions.

Expanding the notion of “benefit”: comparing public, parent, and professional attitudes towards whole genome sequencing in newborns

Whole genome sequencing (WGS) is being considered as a tool to deliver newborn screening (NBS) internationally. Its use would dramatically increase the number of genetic variants identified, presenting a host of ethical, social, and practical considerations. A scoping review was conducted to examine the acceptability of WGS-NBS among parents, the public, and health professionals. Parent/public groups were enthusiastic about WGS-NBS, holding panoramic views of current/future benefits, incorporating family and wider society. While actionable early-onset findings were prioritized, non-actionable and uncertain results were still viewed as empowering. Conversely, professionals preferred selective results disclosure, prioritized by clinical need. They emphasized the need for meaningful consent and protection of the child’s autonomy. All groups outlined the importance of properly considered implementation (e.g. resources, governance) to minimize harms and prevent a reduction in NBS participation. As genomic medicine integrates into healthcare, divergent conceptualizations of “harms” and “benefits” across social groups must be considered.

Foundations for Meaningful Consent in Canada's Digital Health Ecosystem: Retrospective Study.

BackgroundCanadians are increasingly gaining web-based access to digital health services, and they expect to access their data from these services through a central patient access channel. Implementing data sharing between these services will require patient trust that is fostered through meaningful consent and consent management. Understanding user consent requirements and information needs is necessary for developing a trustworthy and transparent consent management system.ObjectiveThe objective of this study is to explore consent management preferences and information needs to support meaningful consent.MethodsA secondary analysis of a national survey was conducted using a retrospective descriptive study design. The 2019 cross-sectional survey used a series of vignettes and consent scenarios to explore Canadians’ privacy perspectives and preferences regarding consent management. Nonparametric tests and logistic regression analyses were conducted to identify the differences and associations between various factors.ResultsOf the 1017 total responses, 716 (70.4%) participants self-identified as potential users. Of the potential users, almost all (672/716, 93.8%) felt that the ability to control their data was important, whereas some (385/716, 53.8%) believed that an all or none control at the data source level was adequate. Most potential users preferred new data sources to be accessible by health care providers (546/716, 76.3%) and delegated parties (389/716, 54.3%) by default. Prior digital health use was associated with greater odds of granting default access when compared with no prior use, with the greatest odds of granting default access to digital health service providers (odds ratio 2.17, 95% CI 1.36-3.46). From a list of 9 information elements found in consent forms, potential users selected an average of 5.64 (SD 2.68) and 5.54 (SD 2.85) items to feel informed in consenting to data access by care partners and commercial digital health service providers, respectively. There was no significant difference in the number of items selected between the 2 scenarios (P>.05); however, there were significant differences (P<.05) in information types that were selected between the scenarios.ConclusionsA majority of survey participants reported that they would register and use a patient access channel and believed that the ability to control data access was important, especially as it pertains to access by those outside their care. These findings suggest that a broad all or none approach based on data source may be accepted; however, approximately one-fifth of potential users were unable to decide. Although vignettes were used to introduce the questions, this study showed that more context is required for potential users to make informed consent decisions. Understanding their information needs will be critical, as these needs vary with the use case, highlighting the importance of prioritizing and tailoring information to enable meaningful consent.

Marriage Without Meaningful Consent and Compromised Agency in Married Life: Evidence From Married Girls in Jharkhand, India

PurposeMarriage without meaningful consent persists in India, yet early marriage programs have rarely addressed consent, and research on the practice and its consequences for married life is limited. This study explores how consent in marriage decisions affects married life, specifically, agency, gender attitudes, spousal communication, contraception, and marital violence outcomes. MethodsA subset of 1991 married girls and young women was drawn from a 2018 state-representative survey of adolescents and youth aged 15–21 years in Jharkhand. We compared outcomes between those in self-arranged marriages (n = 392), those in semi-arranged marriages who were acquainted with their husbands before marriage (n = 612), and those in fully parent-arranged marriages with no premarital contact (n = 995). Logistic regression analyses identify associations between marriage decision-making and outcomes of interest, controlling for confounding sociodemographic factors. ResultsCompared with girls whose marriages were self-arranged, those in both fully parent- and semi-arranged marriages were less likely, respectively, to make household decisions (odds ratios [OR], .37 and .60), hold egalitarian gender role attitudes (OR, .48 and .66), uphold girls' rights (OR, .41 and .48), communicate with their husbands (OR, .48 and .64), and practice contraception (OR, .51 and .67). Those in fully family-arranged marriages also had less freedom of movement (OR, .64) and were less likely to express self-efficacy (OR, .64). Marital violence was unrelated to marriage arrangements. ConclusionsSelf-arranged marriage is associated with more positive outcomes than family-arranged ones, including semi-arranged ones, but marriage arrangements are unrelated with marital violence. Findings reaffirm the need to breakdown prevailing patriarchal norms and promote girls' right to meaningful, “free and full consent”.

Social and structural factors influencing women’s agency regarding female genital mutilation/cutting: an intersectional analysis – a reply to ‘The prosecution of Dawoodi Bohra women’ by Richard Shweder

Countries around the world have passed laws specifically banning female genital mutilation/cutting. Legal restrictions vary as to whether they apply to both girls and adult women or to minors only, and few address a second set of genital cutting procedures known as ‘female genital cosmetic surgeries’. Different legal framings reflect variation in views regarding women’s autonomy and their ability to provide meaningful consent. Social norms theory has drawn attention to the fact that in societies where customary female genital mutilation/cutting is common, women can be under intense pressure to conform lest risking social inclusion, support and possibly marriage prospects. Hence, protectionist measures by the state have been invited. Much less attention has been directed towards the broader circumstances that can shape and constrain women’s autonomy, including economic instability, limited access to resources and services, political marginalisation and discrimination, and global factors such as climate change. In this article, I highlight the promise of intersectional analyses of factors influencing female genital mutilation/cutting and suggest that in moving beyond the problematic distinction of ‘modern’ and ‘traditional’ societies, it is more fruitful to understand the multiple and combined factors that influence women’s empowerment. Drawing on case studies from Senegal, Kenya and the US, I illustrate that the logic to perform female genital mutilation/cutting or to resist engaging in community outreach on female genital mutilation/cutting may not only emanate from community norms, but also include broader conditions that influence people’s ability to cope with precarious livelihoods. A more comprehensive understanding of spheres of influence on women’s choices can be gained by examining how structural, material, social and individual domains overlap in a woman’s life. Programmes that aim to address female genital mutilation/cutting may be enhanced by expanding beyond a focus on legal reform and social norms to also address the broader structural and global factors that influence women’s agency.

Meaningful Digital Consent in Canada: Recommendations from Pan-Canadian Consent Management Workshops.

The digital health landscape is rapidly evolving with regard to how society accesses and interacts with digital information and technologies. With a largely commercial marketplace, there are growing concerns that users are not fully informed about how their data are used. Canadian privacy legislation is currently undergoing modernization to improve the transparency of commercial information handling practices through the introduction of meaningful consent. This paper reports on workshops held across Canada, exploring the implications of meaningful consent in a digital health context. Recommendations focus on measures to promote transparency, improve digital literacy and foster public trust in digital health innovations.

A Blockchain-based platform for data management and sharing

Data management is the collection, processing, storing, and sharing of data. In today's dispensation, data sharing and collaborative data processing is a necessity for multi-partner organizations as it can lead to the discovery of new insight. Shared data is generally for the purpose of marketing, advertising, and other institutional decision-making reasons. A challenge however is that the collected data (mostly about individuals known as data subjects or producers) is disseminated among organizations without meaningful consent from the data subjects. Hence, data subjects are not aware of what is happening to their data regarding use and misuse. Furthermore, data subjects can hardly determine which third-party institutions have access to their data. In this paper, we opined that data should be managed in a manner that can persuade the trust of data subjects. To achieve this, data subjects should have the rights to be informed about details of their data. Thus, this paper proposes a cloud-based data management and sharing platform to enable data subjects to control who can access their data and consent to its collection and usage based on smart contracts. The proposed system leverages blockchain to enforce accountability, provenance, and auditability of all events. We implemented a dynamic consent management prototype on top of Ethereum blockchain to demonstrate the feasibility of the proposed work.

Periods for Profit and the Rise of Menstrual Surveillance

&#x0D; &#x0D; &#x0D; Menstruation is being monetized and surveilled, with the voluntary participation of millions of women. Thousands of downloadable apps promise to help women monitor their periods and manage their fertility. These apps are part of the broader, multi-billion dollar, Femtech industry, which sells technology to help women understand and improve their health. Femtech is marketed with the language of female autonomy and feminist empowerment. Despite this rhetoric, Femtech is part of a broader business strategy of data extraction, in which companies are extracting people’s personal data for profit, typically without their knowledge or meaningful consent. Femtech can oppress menstruators in several ways. Menstruators lose control over their personal data and how it is used. Some of these uses can potentially disadvantage women in the workplace, insurance markets, and credit scoring. In addition, these apps can force users into a gendered binary that does not always comport with their identity. Further, period trackers are sometimes inaccurate, leading to unwanted pregnancies. Additionally, the data is nearly impossible to erase, leading some women to be tracked relentlessly across the web with assumptions about their childbearing and fertility. Despite these harms, there are few legal restraints on menstrual surveillance. American data privacy law largely hinges on the concept of notice and consent, which puts the onus on people to protect their own privacy rather than placing responsibility on the entities that gather and use data. Yet notice and consent is a myth because consumers do not read, cannot comprehend, and have no opportunities to negotiate the terms of privacy policies. Notice and consent is an individualistic approach to data privacy that envisions an atomized person pursing their own self-interest in a competitive marketplace. Menstruators’ needs do not fit this model. Accordingly, this Essay seeks to reconceptualize Femtech within an expanded menstrual justice framework that recognizes the tenets of data feminism. In this vision, Femtech would be an empowering and accurate health tool rather than a data extraction device.&#x0D; &#x0D; &#x0D;

Applying a Digital Health Checklist and Readability Tools to Improve Informed Consent for Digital Health Research.

Background: As research involving human participants increasingly occurs with the aid of digital tools (e.g., mobile apps, wearable and remote pervasive sensors), the consent content and delivery process is changing. Informed consent documents to participate in research are lengthy and difficult for prospective participants to read and understand. As the consent communication will need to include concepts and procedures unique to digital health research, making that information accessible and meaningful to the prospective participant is critical for consent to be informed. This paper describes a methodology that researchers can apply when developing a consent communication for digital health research.Methods: A consent document approved by a US institutional review board was deconstructed into segments that aligned with federal requirements for informed consent. Three researchers independently revised each segment of text with a goal of achieving a readability score between a 6–8th grade level. The team then consulted with an external readability expert well-versed in revising informed consent documents into “plain language.” The resulting text was evaluated using Microsoft Word and Online-Utility accessibility software. The final step involved adding visual images and graphics to complement the text. The Digital Health Checklist consent prototype builder was then used to identify areas where the consent content could be expanded to address four key domains of Access and Usability, Privacy, Risks and Benefits, and Data Management.Results: The approved consent was evaluated at a 12.6 grade reading level, whereas the revised language by our study team received 12.4, 12, and 12.58, respectively. The final consent document synthesized the most readable of the three revised versions and was further revised to include language recommended by the software tool for improving readability, which resulted in a final revised consent readability score of a 9.2 grade level. Moreover, word count was reduced from 6,424 in the original consent to 679 in the rewritten consent form.Conclusion: Utilizing an iterative process to design an accessible informed consent document is a first step in achieving meaningful consent to participate in digital health research. This paper describes how a consent form approved by an institutional review board can be made more accessible to a prospective research participant by improving the document readability score, reducing the word count and assessing alignment with the Digital Health Checklist.

The right to move and the right to exclude: Ilya Somin and ‘foot voting’

The right to move and the right to exclude: Ilya Somin and ‘foot voting’

Should parents be asked to consent for life-saving paediatric interventions?

Informed consent, when given by proxy, has limitations: chiefly, it must be made in the interest of the patient. Here we critique the standard approach to parental consent, as present in Canada and the UK. Parents are often asked for consent, but are not given the authority to refuse medically beneficial treatment in many situations. This prompts the question of whether it is possible for someone to consent if they cannot refuse. We present two alternative and philosophically more consistent frameworks for paediatric proxy consent. The first allows meaningful consent (parents may say 'yes' or 'no' to treatment), provided that parents are medically informed/competent and intend the health and well-being of their child. In the second solution, medical practitioners or the state consent for treatment, with parents only being consulted to help give insight to the child's circumstances. While we contend that either of these two options is superior to the insincerity of the present paradigm, we suggest that the first solution is preferable.

Inclusion of American Indians and Alaskan Natives in Large National Studies: Ethical Considerations and Implications for Biospecimen Collection in the HEALthy Brain and Child Development Study.

This manuscript is the result of an interdisciplinary team approach to examine the ethical and cultural considerations of biospecimen collection among American Indian and Alaskan Native (AIAN) communities for the planned Healthy Brain and Child Development (HBCD) study. We begin by reviewing a brief history of the treatment of AIAN communities by the US government and within research studies. Based in part on this history, we highlight the overlapping and intersecting vulnerabilities of AIAN communities, including historical trauma, poverty, lack of healthcare access, and environmental hazards. After consideration of ethical and legal implications, we introduce our recommendations for biospecimen collection/biobanking with AIAN communities in the context of population-representative, multi-site, national studies. We recommend the following key considerations: (1) authentic partnership development; (2) beneficence to the community; (3) culturally respectful research design; (4) meaningful consent to support enrollment and retention; (5) culturally appropriate data management. Adherence to a culturally aware approach for inclusion of underrepresented communities assures external validity in the national studies and increases likelihood of bidirectional value exchange.

Hydroxychloroquine and COVID-19: critiquing the impact of disease public profile on policy and clinical decision-making

The controversy surrounding the use of hydroxychloroquine (HCQ), an antimalarial drug, for COVID-19 has raised numerous ethical and policy problems. Since the suggestion that HCQ has potential for COVID-19, there...