Background If trials of therapeutic interventions are to serve society's interests, they must be of high methodological quality and must satisfy moral commitments to human subjects. The authors set out to develop a clinical - trials compendium in which standards for the ethical treatment of human subjects are integrated with standards for research methods. Methods The authors rank-ordered the world's nations and chose the 31 with >700 active trials as of 24 July 2008. Governmental and other authoritative entities of the (...) 31 countries were searched, and 1004 English-language documents containing ethical and/or methodological standards for clinical trials were identified. The authors extracted standards from 144 of those: 50 designated as ‘core’, 39 addressing trials of invasive procedures and a 5% sample of the remainder. As the integrating framework for the standards we developed a coherent taxonomy encompassing all elements of a trial's stages. Findings Review of the 144 documents yielded nearly 15 000 discrete standards. After duplicates were removed, 5903 substantive standards remained, distributed in the taxonomy as follows: initiation, 1401 standards, 8 divisions; design, 1869 standards, 16 divisions; conduct, 1473 standards, 8 divisions; analysing and reporting results, 997 standards, four divisions; and post-trial standards, 168 standards, 5 divisions. Conclusions The overwhelming number of source documents and standards uncovered in this study was not anticipated beforehand and confirms the extraordinary complexity of the clinical trials enterprise. This taxonomy of multinational ethical and methodological standards may help trialists and overseers improve the quality of clinical trials, particularly given the globalisation of clinical research. (shrink)

Originally published in 1948, this book contains an edited version of The Tree of Commonwealth, which was written by Edmund Dudley while imprisoned in the Tower of London in 1509 prior to his execution for treason the following year. Brodie notes any variations between manuscripts and provides a brief biography of Dudley and the impact of his famous text on later monarchs. This book will be of value to anyone with an interest in Tudor history or the history of (...) English statesmanship. (shrink)

This essay is composed of five stories written by practicing physicians about their patients. Each clinical story describes a challenging ethical condition–potential abuse of medical power, gravely ill and probably over-treated newborns, iatrogenic narcotic addiction, deceived dying people. Rather than singling out one ethical conflict to resolve or adjudicate, the authors attempt, through literary methods, to grasp the singular experiences of their patients and to act according to the deep structures of their patients' lives. Examining these five stories with simple (...) literary tools–attention to narrative frames, time, plot, and desire–reveals the mechanisms through which acts of writing and reading contribute to clinical clarity and ethical actions. (shrink)

Family medicine has grown as a specialty from its early days of general practice. It was established as a Board Certified specialty in 1969. This growth and maturation can be traced in the philosophy of family medicine as articulated by Edmund D. Pellegrino, M.D. Long before it was popular to do so, Pellegrino supported the development of family medicine. In this essay I examine the development of Pellegrino's philosophical thought about family practice, and contrast it to other thinkers like Ian (...) McWhinney, Kerr White, Walter Spitzer, Donald Ransom, and Hebert Vandervoort. The arguments focus on whether the goals of family medicine and family practice (possibly two distinct entities) can be articulated, especially considering the definitional problems of family and community. I conclude by echoing Pellegrino's hope that family medicine can contribute a fresh alternative to isolated, individualistic and technological thinking in medicine. (shrink)

It was in December 1868, a little less than fifteen years before his death, that T. H. Green entered into correspondence with the young Henry Scott Holland and R. L. Nettleship on the occasion of the latter's visit to the young Gerard Manley Hopkins, then on the threshold of entering the novitiate of the Society of Jesus. Part of this correspondence is preserved in Stephen Paget's memoir of Scott Holland, and no student of the interpretation of Christianity in the writings (...) and teachings of the British Idealists should neglect either this exchange of letters, or indeed the latter correspondence with Scott Holland in which the young Anglican, on the eve of his own ordination, sought to defend his commitment to his mentor. (shrink)