Waiving the consent requirement to mitigate bias in observational precision medicine research.

Consent bias is a type of selection bias in biomedical research where those consenting to the research differ systematically from those not consenting. It is particularly relevant in precision medicine research because the complexity of these studies prevents certain subgroups from understanding, trusting, and consenting to the research. Because consent bias distorts research findings and causes inequitable distribution of research benefits, scholars propose two types of schemes to reduce consent bias: reforming existing consent models and removing the consent requirement altogether. This study explores the possibility of waiving consent in observational studies using existing data, because they involve fewer risks to participants than clinical trials if privacy safeguards are strengthened. It suggests that data protection mechanisms such as security enhancement and data protection impact assessment should be conducted to protect data privacy of participants in observational studies without consent.

Deprivation of liberty and the community nurse.

In this month's Policy column, Iwan Dowie discusses the 'deprivation of liberty' - which is used to safeguard patients who may be lacking sufficient mental capacity to manage their own safety. The author, through previous legal cases, shares how the Deprivation of Liberty Safeguards (DoLS)-an amendment to the Mental Capacity Act 2005-came into being, and the importance of community nurses in knowing the DoLS.

Global assessment of the biodiversity safeguards of development banks that finance infrastructure.

Infrastructure development is a major driver of biodiversity loss globally. With upward of US$2.5 trillion in annual investments in infrastructure, the financial sector indirectly drives this biodiversity loss. At the same time, biodiversity safeguards (project-level biodiversity impact mitigation requirements) of infrastructure financiers can help limit this damage. The coverage and harmonization of biodiversity safeguards are important factors in their effectiveness and therefore warrant scrutiny. It is equally important to examine the extent to which these safeguards align with best-practice principles for biodiversity impact mitigation outlined in international policies, such as that of the International Union for Conservation of Nature. We assessed the biodiversity safeguards of public development banks and development finance institutions for coverage, harmonization, and alignment with best practice. We used Institute of New Structural Economics and Agence Française de Développement's global database to identify development banks that invest in high-biodiversity-footprint infrastructure and have over US$500 million in assets. Of the 155 banks, 42% (n = 65) had biodiversity safeguards. Of the existing safeguards, 86% (56 of 65) were harmonized with International Finance Corporation (IFC) Performance Standard 6 (PS6). The IFC PS6 (and by extension the 56 safeguard policies harmonized with it) had high alignment with international best practice in biodiversity impact mitigation, whereas the remaining 8 exhibited partial alignment, incorporating few principles that clarify the conditions for effective biodiversity offsetting. Given their dual role in setting benchmarks and leveraging private finance, infrastructure financiers in development finance need to adopt best-practice biodiversity safeguards if the tide of global biodiversity loss is to be stemmed. The IFC PS6, if strengthened, can act as a useful template for other financier safeguards. The high degree of harmonization among safeguards is promising, pointing to a potential for diffusion of practices.

Evaluación mundial de las salvaguardas para la biodiversidad de los bancos del desarrollo que financian la infraestructura Resumen El desarrollo infraestructural es una de las causas principales de la pérdida mundial de biodiversidad. Con más de US$2.5 billones de inversión anual en la infraestructura, el sector financiero impulsa de forma indirecta esta pérdida. Al mismo tiempo, las salvaguardas para la biodiversidad (los requerimientos para la mitigación del impacto sobre la biodiversidad a nivel proyecto) de los financiadores de la infraestructura pueden ayudar a limitar este daño. La cobertura y armonización de estas salvaguardas son factores importantes en su efectividad y por lo tanto requieren de escrutinio. Es igual de importante examinar en qué medida se ajustan estas salvaguardas con los principios de mejores prácticas para mitigar el impacto sobre la biodiversidad esbozados en las políticas internacionales, como las de la UICN. Analizamos las salvaguardas para la biodiversidad de los bancos del desarrollo público y las instituciones de financiamiento para el desarrollo en cuanto a cobertura, armonización y ajuste con las mejores prácticas. Usamos las bases de datos mundiales del Institute of New Structural Economics y de la Agence Française de Développement para identificar los bancos del desarrollo que invierten en infraestructuras con una gran huella de biodiversidad y que tienen más de US$500 millones en activos. De los 155 bancos, el 42% % (n = 65) tenía salvaguardas para la biodiversidad. De éstas, el 86% (56 de 65) armonizaba con el Estándar de Desempeño 6 (PS6) de la Corporación Financiera Internacional (IFC). El PS6 de la IFC (y por extensión, las 56 salvaguardas que armonizan con él) tuvo un gran ajuste con las mejores prácticas internacionales para la mitigación del impacto sobre la biodiversidad, mientras que las ocho faltantes exhibieron un ajuste parcial, pues incorporaban pocos principios que clarificaban las condiciones de una compensación efectiva de biodiversidad. Ya que los financiadores de la infraestructura tienen un papel doble estableciendo referencias e impulsando el financiamiento privado, también necesitan adoptar las mejores prácticas para salvaguardar la biodiversidad si se desea detener la pérdida de biodiversidad mundial. El PS6 de la IFC, si se fortalece, puede fungir como una plantilla útil para los demás financiadores de las salvaguardas. La gran armonización entre las salvaguardas es prometedora y apunta hacia un potencial de difusión de las prácticas.

Dynamic modelling of the impact of community-based acute mental health services for children and adolescents.

OBJECTIVE: To evaluate the potential impact of the recently announced 'Safeguards' initiative on mental health-related emergency department presentation rates for children and adolescents (0-17 years). This state-funded initiative aims to establish 25 Child and Adolescent Acute Response Teams across New South Wales. METHODS: We estimated the effects of the 'Safeguards' initiative using a state-level dynamic model of child and adolescent acute mental health care. Potential reductions in total numbers of mental health-related emergency department presentations and re-presentations (i.e. presentations within 3 months of an initial presentation) were assessed via a series of simulation experiments in which we systematically varied the total number of Child and Adolescent Acute Response Teams and the mean duration of care per patient. RESULTS: Assuming a mean treatment duration of 6 weeks per patient, 25 Child and Adolescent Acute Response Teams are projected to reduce total numbers of mental health-related emergency department presentations and re-presentations over the period 2022-2031 by 15.0% (95% interval, 12.0-18.2%) and 31.7% (26.2-37.8%), respectively. Increasing the total number of Child and Adolescent Acute Response Teams above 25 has minimal additional impact on projected reductions in numbers of emergency department presentations and re-presentations, provided the mean duration of care is no more than 8 weeks. However, where the mean duration of care is greater than 4 weeks, a decrease in the number of Child and Adolescent Acute Response Teams below 25 reduces the potential effectiveness of the 'Safeguards' initiative significantly. CONCLUSION: Our simulation results indicate that full and timely implementation will be critical if the potentially substantial impact of the 'Safeguards' initiative on demand for hospital-based emergency mental health care is to be realised.

Japan should initiate the discussion on voluntary assisted dying legislation now.

BACKGROUND: No laws or official guidelines govern voluntary assisted dying (VAD) in Japan. A legislative bill on the termination of life-sustaining measures has yet to be sent to deliberations for legislation, due to strong opposition that has prevented it from being submitted to the Diet. However, Japan has recently witnessed several cases involving VAD. MAIN TEXT: Against this backdrop, we argue that Japan should begin discussion on VAD legislation, referring to the Voluntary Assisted Dying Act 2017 (VADA2017), which was established in 2017 in Victoria, Australia. VADA2017 puts in place a wide range of stringent safeguards and is considered worldwide to be the safest and most conservative policy on a physician offering assisted dying based on the patient's premeditated request. We consider what opposing opinions from society would arise in response to the VADA2017. Among these will include arguments against VAD itself, those against the validation of this act, and opinions that oppose even the initiation of the dialogue on VAD. CONCLUSIONS: We conclude that to protect the right to life among those placed in vulnerable positions and, at the same time, to respect decision-making of those who wish for immediate death due to unbearable suffering, the dialogue must immediately begin with that on introducing a policy more conservative than that of the VADA2017, which solidly considers arguments against VAD.

Exploring the Impact of Tensions in Stakeholder Norms on Designing for Value Change: The Case of Biosafety in Industrial Biotechnology.

Synthetic biologists design and engineer organisms for a better and more sustainable future. While the manifold prospects are encouraging, concerns about the uncertain risks of genome editing affect public opinion as well as local regulations. As a consequence, biosafety and associated concepts, such as the Safe-by-design framework and genetic safeguard technologies, have gained notoriety and occupy a central position in the conversation about genetically modified organisms. Yet, as regulatory interest and academic research in genetic safeguard technologies advance, the implementation in industrial biotechnology, a sector that is already employing engineered microorganisms, lags behind. The main goal of this work is to explore the utilization of genetic safeguard technologies for designing biosafety in industrial biotechnology. Based on our results, we posit that biosafety is a case of a changing value, by means of further specification of how to realize biosafety. Our investigation is inspired by the Value Sensitive Design framework, to investigate scientific and technological choices in their appropriate social context. Our findings discuss stakeholder norms for biosafety, reasonings about genetic safeguards, and how these impact the practice of designing for biosafety. We show that tensions between stakeholders occur at the level of norms, and that prior stakeholder alignment is crucial for value specification to happen in practice. Finally, we elaborate in different reasonings about genetic safeguards for biosafety and conclude that, in absence of a common multi-stakeholder effort, the differences in informal biosafety norms and the disparity in biosafety thinking could end up leading to design requirements for compliance instead of for safety.

Public attitudes towards sharing loyalty card data for academic health research: a qualitative study.

BACKGROUND: A growing number of studies show the potential of loyalty card data for use in health research. However, research into public perceptions of using this data is limited. This study aimed to investigate public attitudes towards donating loyalty card data for academic health research, and the safeguards the public would want to see implemented. The way in which participant attitudes varied according to whether loyalty card data would be used for either cancer or COVID-19 research was also examined. METHODS: Participants (N = 40) were recruited via Prolific Academic to take part in semi-structured telephone interviews, with questions focused on data sharing related to either COVID-19 or ovarian/bowel cancer as the proposed health condition to be researched. Content analysis was used to identify sub-themes corresponding to the two a priori themes, attitudes and safeguards. RESULTS: Participant attitudes were found to fall into two categories, either rational or emotional. Under rational, most participants were in favour of sharing loyalty card data. Support of health research was seen as an important reason to donate such data, with loyalty card logs being considered as already within the public domain. With increased understanding of research purpose, participants expressed higher willingness to donate data. Within the emotional category, participants shared fears about revealing location information and of third parties obtaining their data. With regards to safeguards, participants described the importance of anonymisation and the level of data detail; the control, convenience and choice they desired in sharing data; and the need for transparency and data security. The change in hypothetical purpose of the data sharing, from Covid-19 to cancer research, had no impact on participants' decision to donate, although did affect their understanding of how loyalty card data could be used. CONCLUSIONS: Based on interviews with the public, this study contributes recommendations for those researchers and the wider policy community seeking to obtain loyalty card data for health research. Whilst participants were largely in favour of donating loyalty card data for academic health research, information, choice and appropriate safeguards are all exposed as prerequisites upon which decisions are made.

Introducing Robust Statistics in the Uncertainty Quantification of Nuclear Safeguards Measurements.

The monitoring of nuclear safeguards measurements consists of verifying the coherence between the operator declarations and the corresponding inspector measurements on the same nuclear items. Significant deviations may be present in the data, as consequence of problems with the operator and/or inspector measurement systems. However, they could also be the result of data falsification. In both cases, quantitative analysis and statistical outcomes may be negatively affected by their presence unless robust statistical methods are used. This article aims to investigate the benefits deriving from the introduction of robust procedures in the nuclear safeguards context. In particular, we will introduce a robust estimator for the estimation of the uncertainty components of the measurement error model. The analysis will prove the capacity of robust procedures to limit the bias in simulated and empirical contexts to provide more sounding statistical outcomes. For these reasons, the introduction of robust procedures may represent a step forward in the still ongoing development of reliable uncertainty quantification methods for error variance estimation.

How to Legalize Medically Assisted Death in a Free and Democratic Society.

In 2015, the Supreme Court of Canada struck down the criminal law prohibiting physician assisted death in Canada. In 2016, Parliament passed legislation to allow what it called 'medical assistance in dying (MAID).' The authors first describe the arguments the Court used to strike down the law, and then argue that MAID as legalized in Bill C-14 is based on principles that are incompatible with a free and democratic society, prohibits assistance in dying that should be permitted, and makes access to medically-assisted death unnecessarily difficult. They then propose a version of MAID legislation ('Ideal MAID') that gives proponents and opponents of MAID everything they can legitimately want, contend that it is the only way to legalize MAID that is compatible with a free and democratic society, and conclude that it is the way to legalize MAID in Canada and other similarly free and democratic societies.

Embracing the Future: Using Artificial Intelligence in Australian Health Practitioner Regulation.

Artificial intelligence (AI) - computerised technology that imitates aspects of human intelligence - is developing at a rapid pace. It is increasingly used to improve the efficiency and effectiveness of multifarious processes in private industry and public administration. Among the statutory authorities that have begun to explore the potential for AI to assist them are regulators of Australia's health professions. Protection of the public is a chief objective of this area of administrative law. This section considers some possible uses of AI - and particularly its capacities to analyse and draw inferences from data, make predictions and decisions, and automate tasks - that might help regulators achieve this goal. The section also contemplates the implications of AI involvement in the regulation of health practitioners for the rule of law and human rights it protects and recommends measures that might be taken to mitigate risks of their infringement.

T cell engineering for adoptive T cell therapy: safety and receptor avidity.

Since the first bone marrow transplantation, adoptive T cell therapy (ACT) has developed over the last 80 years to a highly efficient and specific therapy for infections and cancer. Genetic engineering of T cells with antigen-specific receptors now provides the possibility of generating highly defined and efficacious T cell products. The high sensitivity of engineered T cells towards their targets, however, also bears the risk of severe off-target toxicities. Therefore, different safety strategies for engineered T cells have been developed that enable removal of the transferred cells in case of adverse events, control of T cell activity or improvement of target selectivity. Receptor avidity is a crucial component in the balance between safety and efficacy of T cell products. In clinical trials, T cells equipped with high avidity T cell receptor (TCR)/chimeric antigen receptor (CAR) have been mostly used so far because of their faster and better response to antigen recognition. However, over-activation can trigger T cell exhaustion/death as well as side effects due to excessive cytokine production. Low avidity T cells, on the other hand, are less susceptible to over-activation and could possess better selectivity in case of tumor antigens shared with healthy tissues, but complete tumor eradication may not be guaranteed. In this review we describe how 'optimal' TCR/CAR affinity can increase the safety/efficacy balance of engineered T cells, and discuss simultaneous or sequential infusion of high and low avidity receptors as further options for efficacious but safe T cell therapy.

Security Techniques for the Electronic Health Records.

The privacy of patients and the security of their information is the most imperative barrier to entry when considering the adoption of electronic health records in the healthcare industry. Considering current legal regulations, this review seeks to analyze and discuss prominent security techniques for healthcare organizations seeking to adopt a secure electronic health records system. Additionally, the researchers sought to establish a foundation for further research for security in the healthcare industry. The researchers utilized the Texas State University Library to gain access to three online databases: PubMed (MEDLINE), CINAHL, and ProQuest Nursing and Allied Health Source. These sources were used to conduct searches on literature concerning security of electronic health records containing several inclusion and exclusion criteria. Researchers collected and analyzed 25 journals and reviews discussing security of electronic health records, 20 of which mentioned specific security methods and techniques. The most frequently mentioned security measures and techniques are categorized into three themes: administrative, physical, and technical safeguards. The sensitive nature of the information contained within electronic health records has prompted the need for advanced security techniques that are able to put these worries at ease. It is imperative for security techniques to cover the vast threats that are present across the three pillars of healthcare.

Reporting deaths to the coroner.

The Chief Coroner has issued new guidance in relation to death where the person is subject to a deprivation of liberty safeguards standard authorisation ( Chief Coroner, 2017 ). In this article, Richard Griffith discusses the impact of the Police and Crime Act 2017, section 178 on the need to report deaths of patients' subject to a deprivation of liberty safeguards standard authorisation to the coroner.

Continuities of Risk in the Era of the Mental Capacity Act.

When compared with the Mental Capacity Act (MCA) 2005, the Mental Health Act (MHA) 1983 seems an outlier. It authorises compulsory treatment of mental disorders on the basis of P's risks. English law, therefore, discriminates between mental and physical disorders. Following the UK's ratification of the Convention on the Rights of Persons with Disabilities (CRPD), the MHA probably also violates international law. Against this backdrop, one might expect that decisions contingent on risk are confined to the MHA and have no relevance elsewhere. This article argues that the opposite is true: risk-based decision-making has colonised MCA processes and plays a key role in determining the nature of P's interaction with health services. These 'continuities' of risk are most notable in the Deprivation of Liberty Safeguards (DOLS), where assessments of risk are implicitly significant for best interests and eligibility determinations. Using governmentality theory as an explanatory model, this article claims that the DOLS can be reconstructed as part of a wider legal apparatus for the regulation of the risks of harm associated with mental disorders. The article also argues that the Law Commission's recent proposals to introduce a new 'protective care' scheme and expand the remit of the MHA hint at a 'rehabilitation' of risk as an integral component of mental health and capacity law. The article concludes that the concept's stigmatising potential, lack of definition, and conflict with the CRPD cast doubt on its capacity to reconcile English mental health law with the era of autonomy, capacity, and non-discrimination.

Would protecting tropical forest fragments provide carbon and biodiversity cobenefits under REDD+?

Tropical forests store vast amounts of carbon and are the most biodiverse terrestrial habitats, yet they are being converted and degraded at alarming rates. Given global shortfalls in the budgets required to prevent carbon and biodiversity loss, we need to seek solutions that simultaneously address both issues. Of particular interest are carbon-based payments under the Reducing Emissions from Deforestation and Forest Degradation (REDD+) mechanism to also conserve biodiversity at no additional cost. One potential is for REDD+ to protect forest fragments, especially within biomes where contiguous forest cover has diminished dramatically, but we require empirical tests of the strength of any carbon and biodiversity cobenefits in such fragmented systems. Using the globally threatened Atlantic Forest landscape, we measured above-ground carbon stocks within forest fragments spanning 13 to 23 442 ha in area and with different degrees of isolation. We related these stocks to tree community structure and to the richness and abundance of endemic and IUCN Red-listed species. We found that increasing fragment size has a positive relationship with above-ground carbon stock and with abundance of IUCN Red-listed species and tree community structure. We also found negative relationships between distance from large forest block and tree community structure, endemic species richness and abundance, and IUCN Red-listed species abundance. These resulted in positive congruence between carbon stocks and Red-listed species, and the abundance and richness of endemic species, demonstrating vital cobenefits. As such, protecting forest fragments in hotspots of biodiversity, particularly larger fragments and those closest to sources, offers important carbon and biodiversity cobenefits. More generally, our results suggest that macroscale models of cobenefits under REDD+ have likely overlooked key benefits at small scales, indicating the necessity to apply models that include finer-grained assessments in fragmented landscapes rather than using averaged coarse-grained cells.

District nursing practice for the death of patients subject to deprivation of liberty safeguards.

The Chief Coroner of England and Wales has issued guidance to coroners on whether the death of a person subject to a deprivation of liberty safeguard should be subject to an inquest. The guidance was issued in response to the tenfold increase in people being made subject to the safeguards since the Supreme Court's decision in Cheshire West and Chester Council v P [2014]. It is the Chief Coroner's view that all deaths where a person is subject to a deprivation of liberty safeguard or Court of Protection welfare order allowing a deprivation of liberty must be investigated by the coroner with an inquest held. This article considers the impact of the Chief Coroner's guidance on district nurse practice. It discusses whether a person subject to a deprivation of liberty safeguard is in state detention and whether an inquest is necessary in every case.

Deprivation of liberty safeguard deaths to be reported to the coroner.

The Chief Coroner has issued guidance that all deaths where a person is subject to a deprivation of liberty safeguard or Court of Protection welfare order allowing a deprivation of liberty must be reported to the coroner and an inquest held. In this article the author considers the impact of the guidance.

Revisiting advance decision making under the Mental Capacity Act 2005: a tale of mixed messages.

Whilst most of the existing literature relating to advance decisions has focused on philosophical questions, this article reflects on the significant legal developments that have occurred since the introduction of the Mental Capacity Act 2005. The article provides a critique of the controversial issues which have emerged within contemporary case law. The focus of the discussion centres on capacity, the interpretation of the safeguards, and the bias towards preservation of life.

New Zealand Mental Health Review Tribunal characteristics and outcomes 1993-2011.

OBJECTIVE: This paper provides a descriptive statistical overview of Mental Health Review Tribunal outcomes from 1992 to 2011. METHOD: A database used by administrators of the Mental Health Review Tribunal to store information on applicants and their hearing outcomes was subjected to basic descriptive analysis. RESULTS: A total of 3117 applications were received, with most applications received from males (n=2039, 65%) of New Zealand European ethnicity and a mean age of 49 years. A similar number of applications were received from inpatient and community patients (35%, 28% respectively). There was only a small percentage (7%) of applicants who were released and the number of applications withdrawn before a hearing took place was high, at 45%. CONCLUSION: The success rates of New Zealand Mental Health Review Tribunal applicants is low compared with some international jurisdictions, while at the same time withdrawals are high, warranting further investigation. Applicants in the community are underrepresented, which is of concern in the context of rising use of community treatment orders. Future research focused on service users' experiences of using the Mental Health Review Tribunal and improvements to the existing data stored on applicants are also suggested.

Legal implications of restrictive physical interventions in people with dementia.

Dementia care environments are now home to thousands of people who have complex mental and physical health needs. Many of these people have lost capacity or have fluctuating capacity to make decisions about their care. There can be times when restrictive physical interventions are necessary to protect a person's wellbeing and to administer required treatment and care. However, nurses working in care settings may not be aware of their rights and liabilities, and those of care staff, when such interventions are used for therapeutic purposes. This article seeks to address areas of uncertainty and clarify the legal responsibilities of care teams by exploring the issues raised through a fictitious case vignette.