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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↗
PubMed2003

Experimental human infection with the dog hookworm, Ancylostoma caninum.

OBJECTIVE: To investigate possible routes for human infection by the dog hookworm (Ancylostoma caninum). DESIGN, SETTING AND PARTICIPANT: Relatively small numbers of infective larvae were administered orally and percutaneously to an informed healthy volunteer (J K L) under medical supervision, at intervals between May 1998 and May 1999. MAIN OUTCOME MEASURES: Symptoms; weekly blood eosinophil counts; faecal microscopy. RESULTS: A marked blood eosinophilia followed a single oral exposure to 100 infective larvae, while faecal examination remained negative. Eosinophil counts then declined gradually, although a rapid, spontaneous rise several months later, at the beginning of spring, possibly indicated reactivation of dormant larvae. Blood eosinophil numbers did not rise significantly after percutaneous infection with 200 larvae. A subsequent, smaller, oral inoculum of 20 larvae provoked an eosinophil response similar to that of the first experiment. CONCLUSIONS: Our findings suggest that, following ingestion, some infective larvae of A. caninum develop directly into adult worms in the human gut (as they do in dogs). While the percutaneous route might be the most common means of human exposure to canine hookworm larvae, leading generally to subclinical infection, oral infection may be more likely to provoke symptomatic eosinophilic enteritis.

Abdominal Pain↗
PubMed1982

The investigator as volunteer subject.

It is particularly within the past three decades that increased attention has been focused on human experimentation, both in regard to the scientific design that ensures the greatest chance of success and to conformity to ethical principles that are most likely to receive public approbation. The story of man's experimentation on man dates back to prehistoric times. In the past two centuries, these investigations have been carried out at an increasing level of sophistication. In this saga, the narratives of the auto-experimenters define a special group of investigators, to many of whom the term "heroic" can be applied. When investigators involve themselves as subjects of their research, a situation of informed consent is often assumed to exist. Discussions concerning voluntarism and ethical propriety have been much less voluminous when the investigators have themselves been subjects that when this is not so. It is within the past half century that physiologists particularly have often been auto-experimenters, and Dr. Earl Wood belongs to the best of this illustrious group.

Autoexperimentation↗
PubMedDate not supplied

Research with human subjects.

Ackerman reviews three recent books on moral issues in human research: Who Goes First? The Story of Self-Experimentation in Medicine, by Lawrence K. Altman (Random House; 1987); The Patient as Partner: A Theory of Human-Experimentation Ethics, by Robert M. Veatch (Indiana University Press; 1987); and Ethics and Regulation of Clinical Research, 2d ed., by Robert J. Levine (Urban & Schwarzenberg; 1986).

Altruism↗
PubMed2001

The Nuremberg Code: its history and implications.

The Nuremberg Code is a foundational document in the ethics of medical research and human experimentation; the principle its authors espoused in 1946 have provided the framework for modern codes that address the same issues, and have received little challenge and only slight modification in decades since. By analyzing the Code's tragic genesis and its normative implications, it is possible to understand some of the essence of modern experimental ethics, as well as certain outstanding controversies that still plague medical science.

Autoexperimentation↗
PubMed2003

[Self experimentation and in vitro research will not suffice: a plea for treatment].

Alcoholism in humans is a field in which lots of animal experiments, meaning the deaths of thousands of rats and mice, have been carried out and are still being carried out. The question is whether the results of these experiments can be of any help as far as this very complex human disorder is concerned. To find an answer to this question, 86 scientific papers of the years 1990 to 2000 have been analysed and their findings evaluated using up-to-date literature on the therapy of alcoholism. What was found was that animal testing has not led to an improved therapy.

Alcoholism↗