¿Cómo afectan la Ley 8/2021 y la ley 6/2022 a la investigación biomédica desarrollada en España? / ¿Com afecten la Llei 8/2021 i la Llei6/2022 a la investigació biomèdica desenvolupada a Espanya? / How do Act 8/2021 and Act 6/2022 affect biomedical research carried out in Spain?

La implementación de la Convención de Derechos de las Personas con Discapacidad obliga a los Estados Partes a realizar reformas legales que afectan a las normas que regulan la participación de las personas con discapacidad en la investigación biomédica clínica, en especial en los ensayos clínicos con medicamentos. En España, se ha tenido que reformar el Código Civil y la Ley General de Derechos de las Personas con Discapacidad para adecuar el ejercicio de la capacidad jurídica y para garantizar la accesibilidad cognitiva. Estas reformas podrían servir como modelo de las reformas que deben implementarse en otros países.(AU)

La implementació de la Convenció dels Drets de les Persones amb Discapacitat obliga als Estats Parts a realitzar reformes legals que afecten les normes que regulen la participació de les persones amb discapacitat en la investigació biomèdica clínica, especialment en els assaigs clínics amb medicaments. A Espanya, s'ha hagut de reformar el Codi Civil i la Llei General de Drets de les Persones amb Discapacitat per adequar l'exercici de la capacitat jurídica i garantir l'accessibilitat cognitiva. Aquestes reformes podrien servir com a model per a les reformes que han d'implementar-se en altres països.(AU)

The implementation of the Convention on the Rights of Persons with Disabilities obliges the States Parties to carry out legal reforms that affect the norms that regulate the participation of persons with disabilities in clinical biomedical research, especially in clinical trials with drugs. In Spain, the Civil Code and the General Act on the Rights of Persons with Disabilities have had to be reformed to adapt the exercise of legal capacity and to guarantee cognitive accessibility. These reforms could serve as a model for reforms to be implemented in other countries.(AU)

Threads of memory: Reviving the ornament of a dead child at the Neolithic village of Ba`ja (Jordan).

In 2018, a well-constructed cist-type grave was discovered at Ba`ja, a Neolithic village (7,400-6,800 BCE) in Southern Jordan. Underneath multiple grave layers, an 8-year-old child was buried in a fetal position. Over 2,500 beads were found on the chest and neck, along with a double perforated stone pendant and a delicately engraved mother-of-pearl ring discovered among the concentration of beads. The first was found behind the neck, and the second on the chest. The meticulous documentation of the bead distribution indicated that the assemblage was a composite ornament that had gradually collapsed, partly due to the burying position. Our aim was to challenge time degradation and to reimagine the initial composition in order to best explore the significance of this symbolic category of material culture, not as mere group of beads, but as an ornamental creation with further aesthetic, artisanal and socioeconomic implications. The reconstruction results exceeded our expectations as it revealed an imposing multi-row necklace of complex structure and attractive design. Through multiple lines of evidence, we suggest that the necklace was created at Ba`ja, although significant parts of beads were made from exotic shells and stones, including fossil amber, an unprecedented material never attested before for this period. The retrieval of such an ornament from life and its attribution to a young dead child highlights the significant social status of this individual. Beyond the symbolic functions related to identity, the necklace is believed to have played a key role in performing the inhumation rituals, understood as a public event gathering families, relatives, and people from other villages. In this sense, the necklace is not seen as belonging completely to the realm of death but rather to the world of the living, materializing a collective memory and shared moments of emotions and social cohesion.

COVID-19, the Immune System, and Organic Disability.

Despite the availability of safe vaccines against SARS-CoV-2, some people will remain vulnerable because they will not be vaccinated. Who are these non-vaccinated people? We can distinguish two groups: (i) persons who cannot be vaccinated for clinical reasons and who, despite having been vaccinated, have not achieved immunity; (ii) persons who voluntarily refuse to get vaccinated. These groups have in common an immune system that will make them vulnerable to COVID-19. The reasons for their vulnerability and the ethical judgment they deserve are different; the solutions offered to them are also different. In the case of those who voluntarily avoid vaccination, States are not compromised to introduce new protective policies. In the case of people who remain involuntarily vulnerable, instead, the response should be articulated on the same rules and principles that inform the social model of disability because they will live with an organic disability.

Amber imitation? Two unusual cases of Pinus resin-coated beads in Iberian Late Prehistory (3rd and 2nd millennia BC).

A group of beads from the artificial cave of La Molina (Lora de Estepa, Sevilla) and Cova del Gegant (Sitges, Barcelona) were made from a biogenic raw material and intentionally covered by a layer of resin. This is the first time this type of treatment has been documented on elements of adornment in the Late Prehistory of the Iberian Peninsula. The composition and nature of the coatings are analysed and the symbolic role of such alterations and imitations of prehistoric adornments is discussed.

El aseguramiento del daño en la Ley 14/2007, de Investigación Biomédica / The insurance of the damage in the Law 14/2007, of Biomedical Research

La realización de procedimientos invasivos en seres humanos que impliquen un riesgo físico o psíquico con fines de investigación, debe contar con un seguro de responsabilidad que compense los posibles daños. La elección del tipo de aseguramiento tiene repercusiones directas tanto en los derechos de las personas que participan como en la calidad ética de la propia investigación. Existen buenas razones basadas en la justicia compensatoria para optar por un sistema de aseguramiento que no sólo obligue a la contratación de un seguro, sino que también establezca un sistema de responsabilidad objetiva en el que se presuponga la relación de causalidad entre la investigación biomédica y los daños que puedan producirse. La obligación de contratar un seguro específico se puede excepcionar cuando sea una investigación que implique un nivel bajo de intervención o un riesgo mínimo siempre que los posibles daños estén cubiertos por un seguro colectivo o individua

The performance of invasive procedures in humans that involve a physical or psychological risk for research purposes, must have a liability insurance that compensates for possible damages. The choice of type of insurance has direct repercussions both on the people rights involved and on the ethical quality of the research itself. There are good reasons based on compensatory justice to opt for an insurance system that not only requires the purchase of insurance but also establishes a system of strict liability in which assumes the causal relationship between biomedical research and damages that may occur. The obligation to contract a specific insurance can be excepted when it is an investigation that implies a low level of intervention or a minimum risk provided that the possible damages are covered by a collective or individual insurance

Participantes indirectos en los ensayos clínicos con medicamentos / Non-direct participantsindrugclinicaltrials

No disponible

No disponible

Impacto de la Ley 14/2007 de Investigación Biomédica en los ensayos clínicos / Impact of Spanish Law 14/2007 of biomedical research on clinical trials

No disponible