The presence of the Tuskegee Syphilis Study was palpable at the June 16, 2005, Food and Drug Administration’s Advisory Committee meeting on BiDil, a heart medication from the pharmaceutical company NitroMed that sought approval as the first race-specific drug. So ubiquitous is the restless and unsettled spirit of Tuskegee that it continues to hover over the African American public and the biomedical research/health care provider communities more than three and a half decades after the actual study “died.” No one invoked (...) the word “Tuskegee” in that dimly lit meeting room as BiDil gained the Advisory Committee’s approval. Yet its power was exerted even when it was not named. The FDA Committee’s chairman, Cleveland Clinic cardiology chief Steven Nissen, acknowledged this after the committee met: “We were putting [Tuskegee]…to rest.”. (shrink)

Background Research is fundamental to improving the quality of health care. The need for regulation of research is clear. However, the bureaucratic complexity of research governance has raised concerns that the regulatory mechanisms intended to protect participants now threaten to undermine or stifle the research enterprise, especially as this relates to sensitive topics and hard to reach groups. Discussion Much criticism of research governance has focused on long delays in obtaining ethical approvals, restrictions imposed on study conduct, and the inappropriateness (...) of evaluating qualitative studies within the methodological and risk assessment frameworks applied to biomedical and clinical research. Less attention has been given to the different epistemologies underlying biomedical and qualitative investigation. The bioethical framework underpinning current regulatory structures is fundamentally at odds with the practice of emergent, negotiated micro-ethics required in qualitative research. The complex and shifting nature of real world settings delivers unanticipated ethical issues and (occasionally) genuine dilemmas which go beyond easy or formulaic ‘procedural’ resolution. This is not to say that qualitative studies are ‘unethical’ but that their ethical nature can only be safeguarded through the practice of ‘micro-ethics’ based on the judgement and integrity of researchers in the field. Summary This paper considers the implications of contrasting ethical paradigms for the conduct of qualitative research and the value of ‘empirical ethics’ as a means of liberating qualitative (and other) research from an outmoded and unduly restrictive research governance framework based on abstract prinicipalism, divorced from real world contexts and values. (shrink)

Deep brain stimulation has recently been identified as the “new frontier” in the surgical treatment of major depressive disorder. Powerful memories of the lobotomy era, however, pose a rhetorical challenge to clinical researchers who wish to make a case for its therapeutic future. For DBS advocates, establishing the relationship between these two treatments is not just a matter of telling a history; it also requires crafting persuasive arguments for the lineage of DBS that relate the new psychosurgery in some way (...) to the old. Working from a rhetorical perspective, this article identifies and analyzes three strategies employed by DBS advocates to manage the memory of lobotomy, which it terms evolutionary, genealogical, and semantic. In conclusion, this article suggests that a rhetorical perspective might be brought to bear on the frequent calls for dialogue with regard to psychosurgery, which are meaningless without attention to the persuasive dynamics such dialogue entails. (shrink)