Consent Model Research Articles

Enabling Demonstrated Consent for Biobanking with Blockchain and Generative AI.

Participation in research is supposed to be voluntary and informed. Yet it is difficult to ensure people are adequately informed about the potential uses of their biological materials when they donate samples for future research. We propose a novel consent framework which we call "demonstrated consent" that leverages blockchain technology and generative AI to address this problem. In a demonstrated consent model, each donated sample is associated with a unique non-fungible token (NFT) on a blockchain, which records in its metadata information about the planned and past uses of the sample in research, and is updated with each use of the sample. This information is accessible to a large language model (LLM) customized to present this information in an understandable and interactive manner. Thus, our model uses blockchain and generative AI technologies to track, make available, and explain information regarding planned and past uses of donated samples.

How does the consent model in Australia’s Privacy Act 1988 (Cth) undermine our human right to privacy?

ABSTRACT Cambridge Analytica was a political consulting business that became known for its use of personal data obtained from social media platform Facebook, to drive election campaigns on behalf of its clients. Their most famous client was the winner of the 2016 US Presidential election. When it was realised that Cambridge Analytica had acquired Australian Facebook users’ data, the Australian privacy regulator started litigation against Facebook to enforce the Privacy Act 1988 (Cth). This article examines how the Facebook litigation and subsequent law reform activities shed light on the central, yet fictitious role of the consent model. A historical and cultural analysis reveals how consent to surrender private information is a symptom of social conditions in which we take it for granted that individuals, rather than business, will bear the costs of poor privacy outcomes. Our collective ‘consent realism’ not only constrains the imagination of policy makers but interferes with a person’s autonomy in forming and developing opinions. However, a right to privacy can be more viably re-asserted, at least in response to the Cambridge Analytica incident, within the framework of Australia’s implied freedom of political communication. Consent realism can thus potentially be overcome in favour of human rights principles.

Hell yes? Enthusiastic consent as a legal standard for sexual consent

Australian laws around sexual consent have recently begun to shift towards ‘yes mean yes’ standards of affirmative consent. This article examines whether Australian laws should go further and adopt ‘enthusiastic yes’ standards of enthusiastic consent. This article begins by explaining enthusiastic consent and highlighting its strengths as a model of consent, before outlining both the practical and conceptual objections to its use within law. Ultimately, this article finds that whilst enthusiastic consent should not be used as a legal standard for sexual consent in Australia, it nonetheless remains a valuable tool for thinking about sexual consent in non-legal areas such as ethics and education.

Implementation of a genotyped African population cohort, with virtual follow-up: A feasibility study in the Western Cape Province, South Africa

Background There is limited knowledge regarding African genetic drivers of disease due to prohibitive costs of large-scale genomic research in Africa. Methods We piloted a cost-effective, scalable virtual genotyped cohort in South Africa, with participant recruitment using a tiered informed consent model and DNA collection by buccal swab. Genotype data was generated using the H3Africa Illumina micro-array, and phenotype data was derived from routine health data of participants. We demonstrated feasibility of nested case control genome wide association studies using these data for phenotypes type 2 diabetes mellitus (T2DM) and severe COVID-19. Results 2267346 variants were analysed in 459 participant samples. 78.6% of SNPs and 74% of samples passed quality control (QC). Principal component analysis showed extensive ancestry admixture in study participants. For 1780 published COVID-19-associated variants, 3 SNPs in the pre-imputation data and 23 SNPS in the imputed data were significantly associated with severe COVID-19 cases compared to controls. For 2755 published T2DM associated variants, 69 SNPs in the pre-imputation data and 419 SNPs in the imputed data were significantly associated with T2DM cases when compared to controls. Conclusions The results shown here are illustrative of what will be possible as the cohort expands in the future. Here we demonstrate the feasibility of this approach, recognising that the findings presented here are preliminary and require further validation once we have a sufficient sample size to improve statistical significance of findings. We implemented a genotyped population cohort with virtual follow up data in a resource-constrained African environment, demonstrating feasibility for scale up and novel health discoveries through nested case-control studies.

Lack of Consent to Sexual Intercourse and the Fault of the Rape Survivor under U.S. Criminal Law

The greatest attention to the lack of consent to sexual intercourse as a mandatory feature of rape is paid under the US criminal law. This issue is closely related to the main changes in US state legislation that have occurred as a result of a departure from the traditional understanding of rape as a crime. There are three approaches to understanding the term «consent» in doctrine and legislation, namely, «no means no», «yes means yes» and a negotiation model. Each model imposes features on the process of establishing the fault of the subject and the rapist’s possible error in consent. Difficulties arise when the subject and the victim are intoxicated. Based on the experience of the United States, recommendations are formulated that are useful for the Russian legislator and law enforcement officer. It is not necessary to consolidate any model of consent to sexual intercourse in the criminal law, as well as to abandon signs of the use of violence, the threat of its use or the use of the helpless state of the victim. It is required to distinguish harassment and overcoming the will of the victim, to assess the silence of the victim, victim’s words and actions, finding out whether the victim’s will was distorted. A woman has the right to withdraw her consent after sexual intercourse starts, in which case, if there are other signs of a crime, the continuation of sexual intercourse against the will of the victim is qualified as rape.

Informed consent in the age of smart technologies

Technology is increasingly being brought into the home care of older people. Digitalization is seen as an enabler for efficient and resource-saving operations. In the use of technology, informed consent is considered an ethical practice and part of a responsible home care service system. The aim of this article is to describe the problem of informed consent in situations where emerging technologies, such as artificial intelligence (AI) and mass data, are used as part of welfare services and home care for older people. The article discusses principles and ways to better integrate informed consent as an ethical practice into a responsible home care service system. A qualitative study was carried out to gather the views of experts in the field of elderly care and ethics. A content analysis of a semi-structured focus group was used to explore perceptions of the changing nature of informed consent. According to our findings, the informed consent model requires updating. The key is to embrace the idea that consent is a living process designed to respect people's autonomous choices and protect them from risk. If the nature of the use of the data collected from individuals changes significantly in the future, the consent should also be updated to reflect this change. This aspect is important because new technologies will change the nature of the collection and use of the data. Mass data collection combines multiple databases so that the resulting data can be used even far from the original purpose or context in which it was collected. Therefore, consent should always be tailored to the context, allowing sufficient time for the person seeking and giving consent to clarify the content of the consent. This process highlights the importance of understanding the agency of the consent giver.

Longitudinal frailty assessment in the prediction of survival among patients with advanced chronic kidney disease: a prospective observational single-centre cohort study

ObjectivesThis study aims to describe the prevalence, characteristics and longitudinal changes in frailty among outpatient chronic kidney disease (CKD) and haemodialysis (HD) populations and their impact on survival.DesignProspective observational cohort...

Public Perspectives on Consent for and Governance of Biobanking in Japan.

Through strengthened biobank governance, broad consent has been widely accepted as a means to replace donors' discretion based on the information of individual research protocols. Trust and other ethical and social notions, such as reciprocity and solidarity, are key concepts that support biobank governance. The types of allowed broad consent are several; however, they remain unclear, and whether these ethical and social notions are associated with public attitudes toward the consent model is not fully understood. This quantitative study examined two hypotheses: narrower and limited broad consent are more accepted by the public, and acceptance rates for broad consent increase with established measures related to biobank governance. This analysis supported both hypotheses, implying that the limited type of broad consent should be considered an important option, and that a specific type of governance is critical in promoting trust, reciprocity, and solidarity between biobanks and the public.

Is Affirmative Consent the Answer? Yes, Sort of, Maybe

Recently, there have been some powerful calls in the media for the law to adopt an affirmative consent model in relation to the law on rape. This article explores this proposal. It argues that while there is much that is attractive about the concept of affirmative consent, it needs considerable unpacking and explanation before it can be accepted. Indeed, if adopted at a simplistic level, it carries considerable dangers. The article presents six ambiguities around what is meant by affirmative consent but concludes with a proposal as to what an appropriate nuanced model of could look like.

Sexual Futures and Creative Practice: Engagements in World-Building

ABSTRACT This paper outlines the inception, process, and key findings of five creative arts workshop held with 28 students in 2022 at Newcastle University. Participants engaged in crafting exercises and semi-structured discussions about sexual ethics grounded in lived experience. Sexual consent and novel models of sexual ethics were discussed, as well as an approach called a pleasure and care-centred ethic of embodied and relational sexual Otherness. Using an iterative form of thematic analysis, four core themes were identified: namely, culture and ethnocentrism, gendered sexual scripts/sexual-gendered scripts, heteronormativity, and pleasure. Analysis of the art objects also yielded findings related to anger, gendered norms, communication, and obligation. This project examined how university students felt about consent as the dominant model of sexual ethics and explored other possibilities using discourse and crafting to engage with lived experience. This article aims to capture these findings while also placing the workshops and its findings in methodological and socio-cultural context.

Developing Informed Consent for Academic Hospital-Based Biobank Modeling: An Experience from Indonesia.

Background: Informed consent (IC) for biobank practice is vital to ensure that sample collection, storage, and utilization are ethical. However, the standard practices in biobanking in upper-middle-income countries such as Indonesia often rely on specific consent, leading to restricted sample use and ethical concerns. This article describes the development of an IC model that meets ethical standards and yet is acceptable for biobanking practice in an Indonesian academic hospital. Method: We conducted a study involving Universitas Gadjah Mada (UGM) Biobank Unit and the UGM Academic Hospital, Yogyakarta, Indonesia, between 2019 and 2021. The IC development process consisted of four stages: (1) conceptualization, (2) preparation, (3) pilot, and (4) evaluation. These activities were part of a more extensive pilot study for an academic hospital-based biobank (Medical Biobank for Research in Indonesia (MBRIO) study). Result: We conceptualized a broad consent model, consisting of an information sheet, comprehension test, agreement sheet, and exit survey. We tested and revised the broad consent document to ensure readability, trained 10 consenting staff (1 surgeon and 9 nurses), and then piloted the IC procedure on 24 patients with elective surgery. The evaluation showed that patients understood the information objectively and subjectively. Consenting staff considered the broad consent model acceptable for the academic hospital setting and suggested improvements to increase the readability of information sheets and have more trained staff for better coordination. Conclusion: The IC development process and model consent are ethically sufficient, acceptable and feasibleto be implemented in academic hospital-based biobanks in Indonesia adjusted to the business processes.

Ethical, Legal, and Practical Concerns Surrounding the Implemention of New Forms of Consent for Health Data Research: Qualitative Interview Study.

In Europe, within the scope of the General Data Protection Regulation, more and more digital infrastructures are created to allow for large-scale access to patients' health data and their use for research. When the research is performed on the basis of patient consent, traditional study-specific consent appears too cumbersome for many researchers. Alternative models of consent are currently being discussed and introduced in different contexts. This study explores stakeholder perspectives on ethical, legal, and practical concerns regarding models of consent for health data research at German university medical centers. Semistructured focus group interviews were conducted with medical researchers at German university medical centers, health IT specialists, data protection officers, and patient representatives. The interviews were analyzed using a software-supported structuring qualitative content analysis. Stakeholders regarded broad consent to be only marginally less laborious to implement and manage than tiered consent. Patient representatives favored specific consent, with tiered consent as a possible alternative. All stakeholders lamented that information material was difficult to understand. Oral information and videos were mentioned as a means of improvement. Patient representatives doubted that researchers had a sufficient degree of data security expertise to act as sole information providers. They were afraid of undue pressure if obtaining health data research consent were part of medical appointments. IT specialists and other stakeholders regarded the withdrawal of consent to be a major challenge and called for digital consent management solutions. On the one hand, the transfer of health data to non-European countries and for-profit organizations is seen as a necessity for research. On the other hand, there are data security concerns with regard to these actors. Research without consent is legally possible under certain conditions but deemed problematic by all stakeholder groups, albeit for differing reasons and to different degrees. More efforts should be made to determine which options of choice should be included in health data research consent. Digital tools could improve patient information and facilitate consent management. A unified and strict regulation for research without consent is required at the national and European Union level. Obtaining consent for health data research should be independent of medical appointments, and additional personnel should be trained in data security to provide information on health data research.

Improving the integration of care for trans adults: ICTA a mixed-methods study.

This research concerns improving the National Health Service health services trans adults need. These include the national specialist Gender Identity Clinics that support people making a medical transition. Not all trans people need to make a medical transition, and transition can take many different paths. Waits to be seen by Gender Identity Clinics are, however, several years long, and there may be significant problems of co-ordination between different aspects of transition-related care, and between transition-related care and general health care. The main objectives were to understand: Which factors make services more or less accessible and acceptable to the variety of trans adults? How initiatives for providing more person-centred and integrated care can be successfully implemented and further improved? An online and paper screening survey was used to gather data on demographics and service use of trans people across the United Kingdom, with 2056 responses. Researchers used survey data to construct five purposive subsamples for individual qualitative interviews, identifying groups of people more likely to experience social exclusion or stigma. There were 65 online interviews. In addition, 23 trans Black people and people of colour attended focus groups. Six case studies were completed: four on initiatives to improve care and two on experiences of particular trans populations. Fifty-five service provider staff and 45 service users were interviewed. The following undermine person-centred co-ordinated care and can lead to experiences of harm: lack of respectful treatment of trans people by general practitioner practices; inadequate funding of services; lack of support during waiting; the extended and challenging nature of Gender Identity Clinic diagnostic assessments, sometimes experienced as adversarial; breakdowns in collaboration between Gender Identity Clinics and general practitioner practices over hormone therapy; lack of National Health Service psychological support for trans people. Case studies indicated ways to improve care, although each has significant unresolved issues: training in trans health care for general practitioners; third-sector peer-support workers for trans people who come to National Health Services; gender services taking a collaborative approach to assessing what people need, clarifying treatment options, benefits and risks; regional general practitioner-led hormone therapy clinics, bringing trans health care into the mainstream; psychology services that support trans people rather than assess them. Some contexts of care and experiences of particular groups of trans people were not addressed sufficiently within the scope of the project. While efforts were made to recruit people subject to multiple forms of stigma, there remained gaps in representation. The findings have significant implications for commissioners and providers of existing National Health Services gender services, including recently established pilot services in primary care. In particular they point to the need for assessments for access to transition care to be more collaborative and culturally aware, implying the value of exploring informed consent models for accessing transition-related care. Further research is needed to investigate how far the findings apply with particular subpopulations. This study is registered as Research Registry, no. 5235. This award was funded by the National Institute for Health and Care Research (NIHR) Health and Social Care Delivery Research programme (NIHR award ref: 17/51/08) and is published in full in Health and Social Care Delivery Research; Vol. 12, No. 28. See the NIHR Funding and Awards website for further award information.

Giving Meaning to Consent at the International Criminal Court and Beyond: A (Qualified) Defence of Consent

ABSTRACT This article examines the concept of consent in the context of rape and sexual violence within the framework of the International Criminal Court (ICC). Lack of consent is not required to be proven in relation to charges of rape in the Rome Statute, an aspect praised by feminist legal scholar Catharine MacKinnon. A significant and contested feature of MacKinnon’s theorisation of rape is her argument that such a standard should also serve as a model for domestic laws. However, it is not clear that the ICC’s current framework regarding consent and the means to address sexual violence is as robust as MacKinnon suggests. Importantly, our analysis of the international experience takes place against a backdrop where in many domestic jurisdictions consent remains firmly entrenched in law reform efforts to address the ubiquity of sexual violence. Drawing primarily on recent law reform examples from Australia, where the trend has been toward affirmative models of consent, we consider how consent is positioned within them. We argue that consent still has a place in measures in both domestic and international jurisdictions aimed at addressing the structural inequalities and power dynamics underpinning sexual violence, MacKinnon’s privileging of the measures in the international jurisdiction notwithstanding.

Affirmative Consent is Not Enough: A Feminist Critique of the NSW Reforms and the Limits of Consent under Patriarchy

ABSTRACT On 1 June 2022, long-awaited reforms to the law of sexual consent came into force in NSW. The central feature of the amendments is the introduction of affirmative consent – a ‘yes means yes’ standard which requires positive communication for sex to be lawful. In the context of national conversation around the prevalence of sexual assault, instituting affirmative consent is an important step – but is it enough? This paper considers the NSW model and introduction of affirmative consent in the context of feminist theory, particularly the arguments raised by Catharine MacKinnon in Toward a Feminist Theory of the State. Engaging with the limits of the consent framework as a product of a liberal, patriarchal system is critical to improving the legal recognition of the spectrum of sexual assault experienced by women.

HAP-FAST: a feasibility study incorporating qualitative, mechanistic and costing sub-studies alongside a randomised pilot trial comparing chest x-ray to low-dose CT scan and empirical antibiotics to antibiotics guided by the BIOFIRE® FILM ARRAY® pneumonia plus panel in adults with suspected non-ventilator-associated hospital-acquired pneumonia

IntroductionNon-ventilator-associated hospital-acquired pneumonia (nv-HAP) is the most common healthcare-associated infection (HCAI), is associated with high mortality and morbidity and places a major burden on healthcare systems. Diagnosis currently relies on...

Artificial Intelligence Needs Data: Challenges Accessing Italian Databases to Train AI

Population biobanks are an increasingly important infrastructure to support research and will be a much-needed resource in the delivery of personalised medicine. Artificial intelligence (AI) systems can process and cross-link very large amounts of data quickly and be used not only for improving research power but also for helping with complex diagnosis and prediction of diseases based on health profiles. AI, therefore, potentially has a critical role to play in personalised medicine, and biobanks can provide a lot of the necessary baseline data related to healthy populations that will enable the development of AI tools. To develop these tools, access to personal data, and in particular, sensitive data, is required. Such data could be accessed from biobanks. Biobanks are a valuable resource for research but accessing and using the data contained within such biobanks raise a host of legal, ethical, and social issues (ELSI). This includes the appropriate consent to manage the collection, storage, use, and sharing of samples and data, and appropriate governance models that provide oversight of secondary use of samples and data. Biobanks have developed new consent models and governance tools to enable access that address some of these ELSI-related issues. In this paper, we consider whether such governance frameworks can enable access to biobank data to develop AI. As Italy has one of the most restrictive regulatory frameworks on the use of genetic data in Europe, we examine the regulatory framework in Italy. We also look at the proposed changes under the European Health Data Space (EHDS). We conclude by arguing that currently, regulatory frameworks are misaligned and unless addressed, accessing data within Italian biobanks to train AI will be severely limited.

Universal germline testing for cancer susceptibility and actionable noncancer disorders among 19,842 patients: Initial findings from the City of Hope INSPIRE study.

10594 Background: Germline testing can be essential for risk stratification and therapeutic decision making. However, guideline-based testing misses ~50% of people with inherited cancer risk. To address this gap, we launched the INSPIRE study, offering universal germline testing (31 non-cancer and 154 cancer genes) to consented patients affected and unaffected with cancer. Methos: In 2020, we initiated a scalable in person/remote consent model without formal pre-test counseling. Consenting patients opted-in for one, both, or neither germline test. Research staff placed orders. Results were reviewed by a genetic counselor. Pathogenic/likely pathogenic (P/LP) and increased risk allele (IRA) results were disclosed by phone and scheduled for a genetic consult. Variant of uncertain significance (VUS)/negative results were disclosed by letter with a genetic consult available on request. Descriptive statistics and chi-squared tests evaluated a priori hypotheses regarding potential factors impacting genetic testing uptake and actionability. Results: We approached 26,920 patients: 22,115 (82%) enrolled, 1,830 (7%) declined, 2,975 (11%) deferred a decision. Consented patients opted for testing for germline cancer (21,871/ 99%), non-cancer (21,731/98%), or neither (160/0.7%). We have returned results to 19,842 patients: mean age 62, 69% female; 72% white, 14% Asian, 5% Black, 9% other; 24% Hispanic. Most patients (15,578) had cancer, 13% with multiple primaries. Among the 19,842 patients, 4,456 (23%) had at least one P/LP/IRA variant; 3,971 (20%) in a cancer risk gene and 589 (3%) in a non-cancer gene. Variant proportion by category was 1,466 (30%) high-penetrance, 847 (18%) moderate-penetrance, 1,127 (23%) low-penetrance, 1,282 (28%) recessive, and 34 (0.7%) preliminary evidence. Penetrance prevalence differed by sex: high penetrance variants were more common in females (33% vs. 27%; p=<0.001) and moderate penetrance variants were more common in males (21% vs. 17%; p=0.003). 16,883 (85%) individuals carry at least one VUS. Conclusions: A scalable model to increase germline genetic testing among unselected cancer and unaffected patients across >20 sites was highly feasible. A significant proportion of patients had actionable findings in cancer and non-cancer genes. Next steps include analyses to establish variant prevalence across groups, a longitudinal assessment of psychological outcomes and an evaluation of the impact of result disclosure on cost, patient care, and outcomes.

Protocol implementation during the COVID-19 pandemic: experiences from a randomized trial of stress ulcer prophylaxis

BackgroundDuring the COVID-19 pandemic, many intensive care units (ICUs) halted research to focus on COVID-19-specific studies.ObjectiveTo describe the conduct of an international randomized trial of stress ulcer prophylaxis (Re-Evaluating the Inhibition of Stress Erosions in the ICU [REVISE]) during the pandemic, addressing enrolment patterns, center engagement, informed consent processes, data collection, a COVID-specific substudy, patient transfers, and data monitoring.MethodsREVISE is a randomized trial among mechanically ventilated patients, comparing pantoprazole 40 mg IV to placebo on the primary efficacy outcome of clinically important upper gastrointestinal bleeding and the primary safety outcome of 90-day mortality. We documented protocol implementation status from March 11th 2020-August 30th 2022.ResultsThe Steering Committee did not change the scientific protocol. From the first enrolment on July 9th 2019 to March 10th 2020 (8 months preceding the pandemic), 267 patients were enrolled in 18 centers. From March 11th 2020-August 30th 2022 (30 months thereafter), 41 new centers joined; 59 were participating by August 30th 2022 which enrolled 2961 patients. During a total of 1235 enrolment-months in the pandemic phase, enrolment paused for 106 (8.6%) months in aggregate (median 3 months, interquartile range 2;6). Protocol implementation involved a shift from the a priori consent model pre-pandemic (188, 58.8%) to the consent to continue model (1615, 54.1%, p < 0.01). In one new center, an opt-out model was approved. The informed consent rate increased slightly (80.7% to 85.0%, p = 0.05). Telephone consent encounters increased (16.6% to 68.2%, p < 0.001). Surge capacity necessitated intra-institutional transfers; receiving centers continued protocol implementation whenever possible. We developed a nested COVID-19 substudy. The Methods Centers continued central statistical monitoring of trial metrics. Site monitoring was initially remote, then in-person when restrictions lifted.ConclusionProtocol implementation adaptations during the pandemic included a shift in the consent model, a sustained high consent rate, and launch of a COVID-19 substudy. Recruitment increased as new centers joined, patient transfers were optimized, and monitoring methods were adapted.

Urological focus on gender affirmation surgery.

Gender affirmation surgery plays an important role in the treatment of gender dysphoria. These procedures play a vital role in aligning individuals' physical characteristics with their gender identity, resulting in improved mental health and overall wellbeing. This article provides an overview of genital gender affirmation surgeries, focusing on the available options and appropriate referral criteria for general practitioners and surgeons. Gender affirmation surgery necessitates a multidisciplinary approach, emphasising patient readiness, clear surgical preferences, hormonal transition and modifiable risk factors. The two primary methods for assessing patient appropriateness, the World Professional Association for Transgender Health (WPATH) guidelines and the informed consent model, are discussed. This article summarises surgical options for both trans-male and trans-female individuals, outlining procedures, benefits and potential complications. Gender affirmation surgery is set to play an increasingly important role in the management of gender dysphoria. By understanding the available options and referral processes, primary care physicians will be able to optimise care for these patients.