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EN
The eighteenth century was the time of the big changes in Spain. At the beginning of the century the country was weak from political and economic point of view. Foreign travellers emphasized that Spain was depopulated and destroyed. „The age of reforms” started with the reign of Philip V. His successor Ferdinand VI continued the reconstruction. The main reforms were done during the reign of Charles III. He was the outstanding administrator in Spanish history. For American diplomats who came to Europe during the war of Independence Spain was very often the first point of their travels. America had great expectations of Spain, including large - scale aid and even an alliance. Seeing that the Congress decided to send a minister plenipotentiary to Spain in September 1779. This minister was John Jay. He was the most able and distinguished man whom the Congress could spare for this important mission. The article is based on John and Sarah Jay correspondence and it documents their adventures on the voyage to Spain in 1779. Then it shows the Jays’ opinions on Spanish everday life which they made during their stay in this country. John and Sarah Jay left America in October 1779 on the ship „Confederacy” . The stormy voyage was described in the letters of Sarah Jay too her mother because John Jay himself was too seasick to attend to formal correspondence. When the Jays’ arrived at Cadiz in February 1780 no one welcomed them. John Jay was accorded no offical status by the Spanish court. In March having sent William Carmichael (John Jay’s secretary) ahead, the Jays along set out for Madrid, four hundred miles away. The route to Madrid took them through Andalusia, La Mancha and Castile. As travellers, John and Sarah Jay brought their own food, they ate it with their own utensils, and they carried their own beds. They reached the capital in April 1780. Although the Jays rented the house in Madrid, John Jay was soon engaged in following the court form country seat to country seat. King Charles III moved very often from his winter capitol of El Pardo to Aranjuez and then to the north at the two sites of El Escorial and San Ildefonso. Moving the court from one palace to another made Spain one of the most expensive diplomatic establishment in Europe. That is why Sarah Jay stayed in Madrid most the time. Generally financial problems made their stay in Spain very difficult although John Jay was supported by Benjamin Franklin from Paris. To make matters worse from the beginning Jay’s mission was a hoples one. He had lowly status at the court and he felt lonely. He showed his discontent quite often in his letters. To sum up in the correspondence, John and Sarah Jay did not put a lot of attention to everyday life in Spain. There are a few letters where we can find fascinating descriptions of their ocean voyage, broken by near-disaster and the interlude a t Martinique, and then their arrived in Cadiz and their difficult overland journey to Madrid and the Spanish court.
EN
Abigail Adams played a unique role in the years leading up to the declaration of American independence. She was a highly intelligent person with a forceful and a colourful personality. She was the only woman in American history to be the wife of one president and the mother of another. When Abigail Adams married John Adams in 1764, she did not expect that her life would be changed by the Revolution. Her expectations of marriage were those established by the model of her parents and grandparents. She was prepared to assume domestic responsibilities and to be supported by and dependent her husband. The American Revolution changed her life. While John Adams went to sit with the Continental Congress in Philadelphia, Abigail Adams was ready to take charge at home. Writing to her absent husband Abigail Adams recounted the battles that were sweeping the countyside. She described the apalling life conditions during the war. Later Abigail Adams managed the household and the family finances successfully. She sold or traded different items which John Adams had sent her from Europe. Abigail Adams was interested in women’s rights. She belived that women were as intelligent as men. Finally Abigail Adams fullfield a man’s role but she was no feminist. She belived that women were domestic, that their primary functions were within the home as wife and mother.
EN
The authors of the paper carry out a preliminary assessment of the new regulation on clinical trials of medical devices in the context of software based on intelligent algorithms (so-called AI systems). The primary source of law here is the EU Medical Device Regulation (MDR). The study highlights the need to take into account the regulations on artificial intelligence systems when conducting clinical trials. It is justified by their close relationship with the EU provisions on medical devices. The main difficulty in making a legal and ethical assessment of new solutions used in medical devices is the application of various, sometimes divergent, regulations in the field of new technologies and medical law. The study contains preliminary, necessarily balanced and careful, bearing in mind the need to protect patients - research participants (and other people), conclusions on the application of the above provisions in the conduct of clinical trials.
PL
Autorzy przeprowadzają wstępną ocenę nowej regulacji o badaniach klinicznych wyrobów medycznych w kontekście oprogramowania opartego na inteligentnych algorytmach (tzw. systemów AI). Podstawowym źródłem prawa jest unijne rozporządzenie o wyrobach medycznych (Medical Device Regulation). W opracowaniu zwrócono uwagę na potrzebę uwzględnienia regulacji dotyczących systemów sztucznej inteligencji przy prowadzeniu badań klinicznych. Jest to uzasadnione ich ścisłym związkiem z przepisami unijnymi o wyrobach medycznych. Podstawową trudność przy dokonaniu oceny prawnej oraz etycznej nowych rozwiązań stosowanych w wyrobach medycznych sprawia zastosowanie różnych, czasem rozbieżnych przepisów z dziedziny nowych technologii oraz prawa medycznego. Opracowanie zawiera wstępne, z konieczności zbalansowane i ostrożne, z uwagi na potrzebę ochrony pacjentów – uczestników badań (oraz innych osób), wnioski w zakresie stosowania powyższych przepisów podczas prowadzenia badań klinicznych.
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