Suchergebnisse

This book is the 43rd in a series entitled 'Basic bioethics', and is intended to make work in bioethics accessible to a broad audience. This volume looks at the regulations safeguarding research involving human participants, and explores the legislative framework governing research in the US, in particular the 'Common Rule for the Protection of Human Subjects'. The reason for this focus is that there have been a number of proposed changes (described within the Advanced Notice for Proposed Rulemaking, or ANPRM) which aim to take a risk-based approach to targeting regulatory oversight, as well as modifying regulations to keep pace with research, particularly regarding multi-site trials and the challenges facing research involving use of biological specimens. One of the points made in the introduction is that at the time of writing (late 2013) little progress had been made in terms of this legislative review. Indeed, at the time of writing this review, the process is far from complete. The aim of the book, therefore, is to stimulate dialogue around the proposed changes.

Considers how the legislative framework governing pharmaceuticals can have an impact on patient safety. Discusses key aspects of the healthcare system, the characteristics of a high reliability organisation (HRO), and the role of just culture. Examines the current pharmaceuticals regulatory regime, the impact of criminalising healthcare errors, and how the adoption of a human factors/ergonomics (HFE) approach can improve patient safety.

To ensure that central counterparties ("CCPs") are safe in all market conditions the European Union (EU) has adopted legislation, commonly known as the European Market Infrastructure Regulation ("EMIR") that deal with their organisational requirements including prudential requirements in relations to margins and the waterfall and default funds. It has published in a single Regulation (EU) No 153/2013, the technical standards required to be adopted by all CCPs operating in the EU. EMIR requires a mandatory clearing of certain standardised OTC (i.e. over-the-counter) derivatives transactions through central counterparties. A risk methodology that can meet some of the most challenging technical requirements, such as sensitivity testing, estimating the probability of joint member defaults and reverse stress testing is the Filtered Historical Simulation (FHS). In this study we extend the use of Filtered Historical Simulation in estimating the potential losses the CCP would face from a multiple default. The proposed methodology provides a probabilistic estimation of defaulting of named members, the expected size of losses, i.e. the joint expected shortfall (JES), and confidence intervals around the JES. This in turn provides an estimate of CCPs need of financial resources to absorb multiple defaults. Our methodology is carrying a full re-pricing of all instruments in the portfolio and takes into account positions that expire before the profits and losses (P&L) horizon. Order statistics tell us that estimates on the tails is unreliable. To handle this risk we carry out a bootstrapping of 5,000,000 simulation trials. The bootstrapping of 5,000,000 trials is repeated 5,000 times to generated the density of the JES.

Abstract. Background: Cervical screening helps prevent cervical cancer ( NHS, 2019 ). Women who have experienced sexual assault have lower cervical screening attendance, however, no theory-driven research explores reasons for this. The Health Action Process Approach (HAPA) explains intention and ongoing attendance to health-promoting behaviors. Aims: The HAPA was used to identify and explore how sexual assault impacts cervical screening uptake. Method: An online study of 247 women aged 21–63 explored whether HAPA variables (task, maintenance, and recovery self-efficacy, outcome expectancies, risk perception, action, and coping planning), trauma variables (nature and age of abuse, and level of post-traumatic stress disorder symptoms [PTSD]), and other potentially confounding factors related to cervical screening uptake in women who have experienced sexual assault. Regression and mediation analyses were conducted to explore predictive variables of intention and attendance. Results: Self-efficacy beliefs predicted both intention and attendance of cervical screening. Task self-efficacy predicted intention and mediated relationships between HAPA variables and intention. Maintenance self-efficacy predicted attendance and mediated relationships between HAPA variables and attendance. Trauma variables did not predict more variance in intention or attendance over HAPA variables. Limitations: The cross-sectional nature of the study means causality was not established. Conclusion: Self-efficacy develops an understanding of cervical screening in women with experience of sexual assault, over and above the trauma variables of type of assault and PTSD symptoms. Focusing on self-efficacy to improve cervical screening uptake in women who have experienced sexual assault is considered for clinical implications.