Live attenuated vaccine trials in medically informed volunteers: a special case? (1/7)

A group of activist clinicians have offered to volunteer for clinical trials of live attenuated HIV vaccines. This has provided an important conceptual challenge to medical ethics, and to work on the development of HIV vaccines. In exploring these issues, this article highlights how the HIV field has altered the content as well as the tone of ethical discourse. The balance of expertise and authority between research subjects and triallists is profoundly changed, raising questions about the limits of voluntarism and differing perspectives on risk-benefit analysis. Care is needed to ensure that the novelty of the situation does not confuse the central ethical and scientific issues.  (+info)

The case for a new system for oversight of research on human subjects. (2/7)

The increasing emphasis on evidence-based clinical practice has thrown into sharp focus multiple deficiencies in current systems of ethical review. This paper argues that a complete overhaul of systems for ethical oversight of studies involving human subjects is now required as developments in medical, epidemiological and genetic research have outstripped existing structures for ethical supervision. It shows that many problems are now evident and concludes that sequential and piecemeal amendments to present arrangements are inadequate to address these. At their core present systems of ethical review still rely on the integrity and judgment of individual investigators. One possible alternative is to train and license research investigators, make explicit their responsibilities and have ethics committees devote much more of their time to monitoring research activity in order to detect those infringing the rules.  (+info)

Homeopathic pathogenetic trials produce specific symptoms different from placebo. (3/7)

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The unreasonable effectiveness of my self-experimentation. (4/7)

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N of 1, two contemporary arm, randomised controlled clinical trial for bilateral epicondylitis: a new study design. (5/7)

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Limits on risks for healthy volunteers in biomedical research. (6/7)

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Self-experimentation and its role in medical research. (7/7)

Although experimentation involving human volunteers has attracted intense study, the matter of self-experimentation among medical researchers has received much less attention. Many questions have been answered only in part, or have been left unanswered. How common is this practice? Is it more common among certain nationalities? What have been the predominant medical fields in which self-experimentation has occurred? How dangerous an act has this proved to be? What have been the trends over time? What is the future likely to bring?From the available literature, I identified and analyzed 465 documented instances of this practice, performed over the course of the past 2 centuries. Most instances occurred in the United States. The peak of self-experimentation occurred in the first half of the 20th century. Eight deaths were recorded. A number of the investigators enjoyed successful careers, including the receipt of Nobel Prizes. Although self-experimentation by physicians and other biological scientists appears to be in decline, the courage of those involved and the benefits to society cannot be denied.  (+info)