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Results for “Helsinki Declaration”

Search indexed PubMed citations on genomics, clinical trials, systematic reviews and public health. Explore titles, authors and supplied subject terms, then open the PubMed record.

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At least 667 records · Page 37Linked to original sources
PubMed1996

Informed consent in human experimentation before the Nuremberg code.

The issue of ethics with respect to medical experimentation in Germany during the 1930s and 1940s was crucial at the Nuremberg trials and related trials of doctors and public health officials. Those involved in horrible crimes attempted to excuse themselves by arguing that there were no explicit rules governing medical research on human beings in Germany during the period and that research practices in Germany were not different from those in allied countries. In this context the Nuremberg code of 1947 is generally regarded as the first document to set out ethical regulations in human experimentation based on informed consent. New research, however, indicates that ethical issues of informed consent in guidelines for human experimentation were recognised as early as the nineteenth century. These guidelines shed light on the still contentious issue of when the concepts of autonomy, informed consent, and therapeutic and non-therapeutic research first emerged. This issue assumes renewed importance in the context of current attempts to assess liability and responsibility for the abuse of people in various experiments conducted since the second world war in the United States, Canada, Russia, and other nations.

Codes of Ethics↗
PubMed1996

Nuremberg lamentation: for the forgotten victims of medical science.

Fifty years after the Nuremberg medical trial there remain many unanswered questions about the role of the German medical profession during the Third Reich. Other than the question of human experimentation, important ethical challenges arising from medicine in Nazi Germany which have continuing relevance were not addressed at Nuremberg. The underlying moral question is that of the exercise of professional power and its impact on vulnerable people seeking medical care. Sensitisation to the obligations of professional power may be achieved by an annual commemoration and lament to the memory of the victims of medical abuse which would serve as a recurring reminder of the physician's vulnerability and fallibility.

Codes of Ethics↗
PubMed1999

Acres of Skin.

Explore the source record for details and available documents.

Attitude↗
PubMedDate not supplied

The Lugano statements on controlled clinical trials.

During a consensus conference in Lugano, Switzerland, 175 statements on controlled clinical trials were drafted by 47 representatives from academia, governmental registration agencies and industry in nine countries. Their opinion on these statements was similar to that of 47 'matched pairs' who did not attend the conference. Thus, the opinion of participants and non-participants appears to reflect the general opinion of those currently involved in designing, conducting and analysing controlled clinical trials. The Lugano statements give answers to the following questions: Is the controlled clinical trial in a crisis? What is the motivation to perform controlled clinical trials? Is it possible for a physician participating in a controlled clinical trial to act in the patient's best interest? Is it possible to obtain truly informed consent in a controlled clinical trial? When is it ethical to withhold active treatment in a controlled clinical trial? What are the controversial issues in the design of a good controlled clinical trial? Is there a double standard with respect to efficacy and adverse drug reactions in controlled clinical trials? What are the alternatives to controlled clinical trials and when should they be performed? How can sponsor bias be minimized? How should an ethics committee decide whether a controlled clinical trial is ethical? Should registration agencies become directly involved in the planning and conduct of controlled clinical trials? Do the declarations of Tokyo and Helsinki facilitate the conduct of ethically valid controlled clinical trials? Is it possible to create an international standard for the conduct and regulation of controlled clinical trials? Why do messages from controlled clinical trials filter into medicine so slowly? Is it possible to bridge the gap between controlled clinical trials and clinical reality? What are the costs of doing and not doing controlled clinical trials? When should drug companies decide to start a trial programme with a specific compound? Is there public hostility against controlled clinical trials? If so, how can it be reduced? The respondents almost unanimously felt that controlled clinical trials are a must: the public must be told that progress in medicine depends on controlled clinical trials, that patients often benefit from participating in them and that the alternative, practising in the face of constant uncertainty, is worse than the possible disadvantages related to the conduct of the trial.

Clinical Trials as Topic↗
PubMed1998

A theory of international bioethics: the negotiable and the non-negotiable.

The preceding article in this issue of the Kennedy Institute of Ethics Journal presents the argument that "moral fundamentalism," the position that international bioethics rests on "basic" or "fundamental" moral prinicples that are universally accepted in all eras and cultures, collapses under a variety of multicultural and postmodern critiques. The present article looks to the contractarian tradition of Hobbes and Locke -- as reinterpreted by David Gauthier, Robert Nozick, and John Rawls -- for an alternative justification for international bioethics. Drawing on the central themes of this tradition, it is argued that international bioethics can be rationally reconstructed as a negotiated moral order that respects culturally and individually defined areas of nonnegotiability. Further, the theory of a negotiated moral order is consistent with traditional ideals about human rights, is flexible enough to absorb the genuine insights of multiculturalism and postmodernism, and yet is strong enough to justify transcultural and transtemporal moral judgments, including the condemnation of the Nazi doctors at Nuremberg. This theory also is consistent with the history of the ethics of human subjects experimentation and offers insights into current controversies such as the controversy over changing the consent rule for experiments in emergency medicine and the controversy over exempting certain clinical trials of inexpensive treatments for preventing the perinatal transmission of AIDS from the ethical standards of the sponsoring country.

Bioethics↗