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At least 19 recordsLinked to original sources
PubMed2005

Self-experimentation, ethics and efficacy.

Much fundamental progress in medicine and, more broadly, in medical sciences has required or benefited from self-experiments. This review provides a definition of self-experiments in which experimenters themselves are subjects for their research, and it considers the logical steps which such experiments require. Lay, medical and scientific communities are often unaware of the contributions and the full range of outcomes from self-experiments. Hence, some implications for ethics committees are explored.

Autoexperimentation↗
PubMedDate not supplied

Urology and the Nobel Prize.

The Nobel Prize in Physiology or Medicine, first awarded in 1901, was established by Alfred Nobel to acknowledge "those who during the preceding year had conferred the greatest benefit on mankind." Two urologists have achieved this daunting task: Werner Theodore Otto Forssmann (1956) and Charles Brenton Huggins (1966). This article reflects the lives and accomplishments of these men as an inspiration to those who have likewise dedicated themselves to the field of urology.

Autoexperimentation↗
PubMed2004

Self-experimentation as a source of new ideas: ten examples about sleep, mood, health, and weight.

Little is known about how to generate plausible new scientific ideas. So it is noteworthy that 12 years of self-experimentation led to the discovery of several surprising cause-effect relationships and suggested a new theory of weight control, an unusually high rate of new ideas. The cause-effect relationships were: (1) Seeing faces in the morning on television decreased mood in the evening (> 10 hrs later) and improved mood the next day (> 24 hrs later), yet had no detectable effect before that (0-10 hrs later). The effect was strongest if the faces were life-sized and at a conversational distance. Travel across time zones reduced the effect for a few weeks. (2) Standing 8 hours per day reduced early awakening and made sleep more restorative, even though more standing was associated with less sleep. (3) Morning light (1 hr/day) reduced early awakening and made sleep more restorative. (4) Breakfast increased early awakening. (5) Standing and morning light together eliminated colds (upper respiratory tract infections) for more than 5 years. (6) Drinking lots of water, eating low-glycemic-index foods, and eating sushi each caused a modest weight loss. (7) Drinking unflavored fructose water caused a large weight loss that has lasted more than 1 year. While losing weight, hunger was much less than usual. Unflavored sucrose water had a similar effect. The new theory of weight control, which helped discover this effect, assumes that flavors associated with calories raise the body-fat set point: The stronger the association, the greater the increase. Between meals the set point declines. Self-experimentation lasting months or years seems to be a good way to generate plausible new ideas.

Affect↗
PubMed2005

Who goes first?

Explore the source record for details and available documents.

Autoexperimentation↗
PubMed1985

Human experimentation during the International Biomedical Expedition to the Antarctic (IBEA).

An extensive research project is described, during which resentment and hostility were aroused due to the data gathering methods. Those effects disturbed the smooth running of the project and led to subjects withdrawing from some experiments. Although the entire project had many positive features, those that are reported here detracted from its complete success. The negative features should be heeded by others who wish to improve the quality of their experimental work with human beings, otherwise the unintended stress of experimentation might restrict subject participation and disrupt data collection.

Acclimatization↗
PubMedDate not supplied

Self-experimentation.

Except in certain cases of unusual risk, self-experimentation should not be encouraged. It is usually scientifically inadequate for lack of proper controls and sufficient subjects to generate meaningful results. It is also inadequate as an ethical test because even if lay persons are also enrolled, self-experimentation is neither necessary nor sufficient to establish that they may participate. It is not necessary to establish that lay persons may participate because institutional ethics review and informed consent are better ways to determine this. It is not sufficient because the investigator may be more risk accepting or not medically typical. Moreover, because scientific research is now done in teams, self-experimentation may involve undue influence when junior investigators participate as research subjects.

Autoexperimentation↗
PubMed2000

Live attenuated vaccine trials in medically informed volunteers: a special case?

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.

AIDS Vaccines↗
PubMed2000

The case for a new system for oversight of research on human subjects.

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.

Autoexperimentation↗
PubMedDate not supplied

[The Italian contributions to the history of salicylates].

It is well-known that the modern history of salicylates began in 1899 when the compound acetylsalicylic acid was registered and introduced commercially as "aspirin" by the Bayer Company of Germany. As a matter of fact, however, remedies made from willow bark had been used to treat fever and rheumatic complaints at least since 1763, when Edward Stone described their efficacy against malarian fever. A number of Italian scientists made significant contributions during the long period of research leading up to the synthesis of acetylsalicylic acid and its widespread use in rheumatic diseases. In this paper we will review the contributions of some of these researchers, beginning with Bartolomeo Rigatelli, who in 1824 used a willow bark extract as a therapeutic agent, denominating it "salino amarissimo antifebbrile" (very bitter antipyretic salt). In the same year, Francesco Fontana described this natural compound, giving it the name "salicina" (salicin). Two other Italian chemists added considerably to current knowledge of the salicylates: Raffaele Piria in 1838, while working as a research fellow in Paris, extracted the chemical compound salicylic acid, and Cesare Bertagnini in 1855 published a detailed description of the classic adverse event associated with salicylate overdoses--tinnitus--which he studied by deliberately ingesting excessive doses himself. Bertagnini and above all Piria also played conspicuous roles in the history of Italy during the period of the Italian Risorgimento, participating as volunteers in the crucial battle of Curtatone and Montanara during the first Italian War of Independence.

Analgesics, Non-Narcotic↗
PubMed1989

Participation of healthy volunteers in research projects.

Research that involves healthy normal volunteers frequently is performed. This article examines ethical guide-lines for the recruitment of healthy volunteers in research projects. Ethical decisions on projects that are based on patient-volunteers or healthy normal volunteers should balance the risk to the volunteer and the collective benefit to the community. For healthy normal volunteers that risk should be minimal or trivial. Investigators should follow recruitment practices that avoid approaches to persons who are dependent upon them in some way, and should carry the day-to-day ethical responsibility even after institutional ethical approval has been granted. Pilot studies and self-experimentation readily can transgress ethical guide-lines. Compensation for mishaps or injuries that occur during research in which there is no question of negligence (for example, an unforeseeable reaction in a phase-1 drug trial) is an unresolved issue which should be addressed by the research community. It is recommended that action be taken to ensure that healthy volunteers who participate in approved research have redress in the rare event of an accident, whether this is a result of negligence, chance or misadventure. Hospitals/institutions or other bodies that sponsor research should extend their insurance to cover specifically such unforeseeable events in which there may be liability, and to have the facility for a payment of beneficence in the case of accidents in which liability cannot be established.

Australia↗