Doctor T. E. Woodward's legacy: from typhus to typhoid fever.
(17/30)
Dr. Theodore E. Woodward was one of the early giants of infectious diseases research who set the groundwork for the field. He was the first to evaluate vaccines against typhus, employing volunteers to test the effectiveness of the vaccines. This led to the evaluation of chloramphenicol for the treatment of rickettsial diseases and typhoid fever. Subsequently, he was influential in establishing a unique volunteer unit in Maryland in which a wide range of vaccines were evaluated. (+info)
The three official language versions of the Declaration of Helsinki: what's lost in translation?
(18/30)
BACKGROUND: The Declaration of Helsinki, the World Medical Association's (WMA's) statement of ethical guidelines regarding medical research, is published in the three official languages of the WMA: English, French and Spanish. METHODS: A detailed comparison of the three official language versions was carried out to determine ways in which they differed and ways in which the wording of the three versions might illuminate the interpretation of the document. RESULTS: There were many minor linguistic differences between the three versions. However, in paragraphs 1, 6, 29, 30 and in the note of clarification to paragraph 29, there were differences that could be considered potentially significant in their ethical relevance. INTERPRETATION: Given the global status of the Declaration of Helsinki and the fact that it is translated from its official versions into many other languages for application to the ethical conduct of research, the differences identified are of concern. It would be best if such differences could be eliminated but, at the very least, a commentary to explain any differences that are unavoidable on the basis of language or culture should accompany the Declaration of Helsinki. This evidence further strengthens the case for international surveillance of medical research ethics as has been proposed by the WMA. (+info)
Human subject protection; foreign clinical studies not conducted under an investigational new drug application. Final rule.
(19/30)
The Food and Drug Administration (FDA) is amending its regulations on acceptance of foreign clinical studies not conducted under an investigational new drug application (IND) (non-IND foreign clinical studies) as support for an IND or application for marketing approval for a drug or biological product. The final rule replaces the requirement that these studies be conducted in accordance with ethical principles stated in the Declaration of Helsinki (Declaration) issued by the World Medical Association (WMA), specifically the 1989 version (1989 Declaration), with a requirement that the studies be conducted in accordance with good clinical practice (GCP), including review and approval by an independent ethics committee (IEC). The final rule updates the standards for the acceptance of foreign clinical studies not conducted under an IND and helps ensure the protection of human subjects and the quality and integrity of data obtained from these studies. (+info)
Moral imperialism and multi-centric clinical trials in peripheral countries.
(20/30)
The Helsinki Declaration on Patient Safety in Anesthesiology: a way forward with the European Board and the European Society of Anesthesiology.
(24/30)
Anesthesiology, which includes anaesthesia, perioperative care, intensive care medicine, emergency medicine and pain therapy, is acknowledged as the leading medical specialty in addressing issues of patient safety, but there is still a long way to go. Several factors pose hazards in Anesthesiology, like increasingly older and sicker patients, more complex surgical interventions, more pressure on throughput, as well as new drugs and devices. To better design educational and research strategies to improve patient safety, the European Board of Anesthesiology (EBA) and the European Society of Anesthesiology (ESA) have produced a blueprint for patient safety in Anesthesiology. This document, to be known as the Helsinki Declaration on Patient Safety in Anesthesiology, was endorsed together with the World Health Organization (WHO), the World Federation of Societies of Anesthesiologists (WFSA), and the European Patients' Federation (EPF) at the Euroanaesthesia meeting in Helsinki in June 2010. It was signed by several Presidents of National Anesthesiology Societies as well as other stakeholders. The Helsinki Declaration on Patient Safety in Anesthesiology represents a shared European view of what is necessary to improve patient safety, recommending practical steps that all anesthesiologists can include in their own clinical practice. The Italian Society of Anaesthesia, Analgesia, Reanimation and Intensive Care (SIAARTI) is looking forward to continuing work on "patient safety" issues in Europe, and to cooperating with the ESA in the best interest of European patients. (+info)