The decision to initiate invasive, first-in-human trials involving Parkinson’s disease presents a vexing ethical challenge. Such studies present significant surgical risks, and high degrees of uncertainty about intervention risks and biological effects. We argue that maintaining a favorable riskbenefit balance in such circumstances requires a higher than usual degree of confidence that protocols will lead to significant direct and/or social benefits. One critical way of promoting such confidence is through the application of stringent evidentiary standards for preclinical studies. We close (...) with a series of recommendations for strengthening the internal and external validity of preclinical studies, reducing their tendency toward optimism and publication biases, and improving the knowledge base used to design and evaluate preclinical studies. (shrink)

The aim of this paper is to discuss a key question in the history and philosophy of medicine, namely how scholars should treat the practices and experimental hypotheses of modern life science laboratories. The paper seeks to introduce some prominent historiographical methods and theoretical approaches associated with biomedical research. Although medical scientists need no convincing that experimentation has a significant function in their laboratory work, historians, philosophers, and sociologists long neglected its importance when examining changes in medical theories or progress (...) in scientific knowledge. The reason appears to have been the academic influence of the then dominant tradition in the history of ideas, but was also due to a misconception of what could usefully be termed the view on “historical ontology.” During the last two decades, there have been many books and research articles that have turned towards the subject, so that the study of experimental practice has become a major trend in the contemporary history and philosophy of medicine. A closer look at the issue of laboratory research shows that concepts in medicine and the life sciences cannot be understood as historically constant, free-standing ideas, but have to be regarded as dependent on local research settings. They often carry particular “social memories” with them and thus acquire important ethical implications. (shrink)

The aim of this paper is to discuss a key question in the history and philosophy of medicine, namely how scholars should treat the practices and experimental hypotheses of modern life science laboratories. The paper seeks to introduce some prominent historiographical methods and theoretical approaches associated with biomedical research. Although medical scientists need no convincing that experimentation has a significant function in their laboratory work, historians, philosophers, and sociologists long neglected its importance when examining changes in medical theories or progress (...) in scientific knowledge. The reason appears to have been the academic influence of the then dominant tradition in the history of ideas, but was also due to a misconception of what could usefully be termed the view on “historical ontology.” During the last two decades, there have been many books and research articles that have turned towards the subject, so that the study of experimental practice has become a major trend in the contemporary history and philosophy of medicine. A closer look at the issue of laboratory research shows that concepts in medicine and the life sciences cannot be understood as historically constant, free-standing ideas, but have to be regarded as dependent on local research settings. They often carry particular “social memories” with them and thus acquire important ethical implications. (shrink)

This paper focuses on the make-up of different cultures in experimental neurology, neuroanatomy, and clinical psychiatry. These cultures served as important research bases for early regenerative concepts and projects in the area of neurology and psychiatry at the beginning of the 20th century. Nevertheless, the developments in brain research and clinical neurology cannot be regarded to be isolated from broader societal developments, as the discourses on social de- and regeneration, neurasthenia, nerve-weakness and experiences of the brain-injured after WWI show. Societal (...) and cultural developments directly influenced researchers’ conceptualisation, scientific ideas, and even their experimental and clinical orientation. They directly reflect which scientific problems the neuroscientists felt inclined to address and what areas they began to leave aside. Using the concept of socio-technical experiments, it is demonstrated that research methodologies in neuronal de- and regeneration studies were not simply a product of recent advances in the scientific differentiation of somatic neurology or brain-psychiatry. Moreover, they resulted in important interdisciplinary attempts which emerged from great collaborative work including neuroscientists from various areas of investigation in both basic and clinical contexts. (shrink)