RESUMEN
BACKGROUND: The current law on anonymization sets the same standard across all situations, which poses a problem for biomedical research. OBJECTIVE: We propose a matrix for setting different standards, which is responsive to context and public expectations. METHODS: The law and ethics applicable to anonymization were reviewed in a scoping study. Social science on public attitudes and research on technical methods of anonymization were applied to formulate a matrix. RESULTS: The matrix adjusts anonymization standards according to the sensitivity of the data and the safety of the place, people, and projects involved. CONCLUSIONS: The matrix offers a tool with context-specific standards for anonymization in data research.
RESUMEN
The EU offers a suitable milieu for the comparison and harmonisation of healthcare across different languages, cultures, and jurisdictions (albeit with a supranational legal framework), which could provide improvements in healthcare standards across the bloc. There are specific ethico-legal issues with the use of data in healthcare research that mandate a different approach from other forms of research. The use of healthcare data over a long period of time is similar to the use of tissue in biobanks. There is a low risk to subjects but it is impossible to gain specific informed consent given the future possibilities for research. Large amounts of data on a subject present a finite risk of re-identification. Consequently, there is a balancing act between this risk and retaining sufficient utility of the data. Anonymising methods need to take into account the circumstances of data sharing to enable an appropriate balance in all cases. There are ethical and policy advantages to exceeding the legal requirements and thereby securing the social licence for research. This process would require the examination and comparison of data protection laws across the trading bloc to produce an ethico-legal framework compatible with the requirements of all member states. Seven EU jurisdictions are given consideration in this critique.
Asunto(s)
Confidencialidad , Recolección de Datos/ética , Investigación sobre Servicios de Salud/ética , Difusión de la Información/ética , Consentimiento Informado , Registros Médicos , Privacidad , Seguridad Computacional , Recolección de Datos/legislación & jurisprudencia , Ética en Investigación , Unión Europea , Investigación sobre Servicios de Salud/legislación & jurisprudencia , Humanos , Difusión de la Información/legislación & jurisprudencia , Cooperación Internacional , Control Social FormalRESUMEN
BACKGROUND: The enactment of the General Data Protection Regulation (GDPR) will impact on European data science. Particular concerns relating to consent requirements that would severely restrict medical data research have been raised. OBJECTIVE: Our objective is to explain the changes in data protection laws that apply to medical research and to discuss their potential impact. METHODS: Analysis of ethicolegal requirements imposed by the GDPR. RESULTS: The GDPR makes the classification of pseudonymised data as personal data clearer, although it has not been entirely resolved. Biomedical research on personal data where consent has not been obtained must be of substantial public interest. CONCLUSIONS: The GDPR introduces protections for data subjects that aim for consistency across the EU. The proposed changes will make little impact on biomedical data research.
Asunto(s)
Investigación Biomédica/métodos , Seguridad Computacional , Informática/métodos , Proyectos de Investigación , Investigación Biomédica/ética , Humanos , Informática/normasRESUMEN
Sleep experts are called to assist the jury in deciding the mental state of the accused at the time of their alleged criminal behaviour. This task is difficult as the literature on many sleep disorders, particularly sleepwalking and other parasomnias, is still largely a matter of case reports and case series. The probative value of much of the evidence given is not known. Sleep behaviour in the courts present a number of difficulties which illustrate the dilemmas that face an expert witness faced with ambiguous data and uncertain principles with which to interpret them. Additionally there are substantial policy issues involved which are not always adequately addressed in expert evidence. We outline the role of expert witnesses in such cases.
Asunto(s)
Automatismo/psicología , Testimonio de Experto , Defensa por Insania , Sueño/fisiología , Humanos , Reino UnidoRESUMEN
This review is aimed at summarizing the current state of knowledge regarding parasomnias, which have been implicated in medicolegal cases as well as providing guidance to those working within common-law jurisdictions regarding the technical aspects of the law. Sleepwalking and sexsomnia as a defence are being raised more frequently in criminal cases and there has been public debate on their validity. Unfortunately, expert evidence on forensic sleep disorders continues to be heavily opinion-based with the potential for miscarriages of justice seen in recent highly publicized cases. There is an apparent inertia in research into violent sleep disorders. We review the current state of forensic sleep science in the United Kingdom (UK) and abroad and discuss the need to formulate guidelines based on available evidence. We also highlight the pressing necessity for more research in this area as well as the need to reform the law, which is the subject of a recent Criminal Law Commission report in the United Kingdom. In time, this will facilitate the efficient, proportionate, and just disposal of violence arising from sleep, thus benefitting both society and the individual sufferer.
Asunto(s)
Testimonio de Experto/legislación & jurisprudencia , Parasomnias/diagnóstico , Derecho Penal/legislación & jurisprudencia , Humanos , Responsabilidad Legal , Trastorno de la Conducta del Sueño REM/diagnóstico , Delitos Sexuales/legislación & jurisprudencia , Sonambulismo/diagnóstico , Reino Unido , Violencia/legislación & jurisprudenciaRESUMEN
Automatism is a rarely used defence, but it is particularly used for driving offences because many are strict liability offences. Medical evidence is almost always crucial to argue the defence, and it is important to understand the bars that limit the use of automatism so that the important medical issues can be identified. The issue of prior fault is an important public safeguard to ensure that reasonable precautions are taken to prevent accidents. The total loss of control definition is more problematic, especially with disorders of more gradual onset like hypoglycaemic episodes. In these cases the alternative of 'effective loss of control' would be fairer. This article explores several cases, how the criteria were applied to each, and the types of medical assessment required.