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New international ethical guidelines for research involving human subjects

Article Abstract:

The Council of International Organizations of Medical Sciences and the World Health Organization revised their ethical guidelines for medical research involving human participants in Mar 1993. These guidelines were originally published in 1982 and concentrate on research in developed countries. The revised guidelines attempt to adhere to the principles of the 1964 Declaration of Helsinki. The Declaration of Helsinki adapted the principles of the Nuremberg code to better fit the realities of medical research. The revised guidelines contain 15 statements with detailed commentaries. One guideline specifies that the same ethical principles should apply to research carried out in developing countries by industrialized nations. Participants in developing countries should also receive detailed information on the potential risks and benefits of participation in a study.

Author: Levine, Robert J.
Publisher: American College of Physicians
Publication Name: Annals of Internal Medicine
Subject: Health
ISSN: 0003-4819
Year: 1993
Laws, regulations and rules, World Health Organization

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Minimizing risk in clinical research

Article Abstract:

Medical researchers should follow the highest ethical standards when conducting clinical trials involving human subjects. There is no way to completely eliminate risk to the participating subjects, but it should be possible to minimize it. Institutional review boards should be renamed ethics review boards and informed consent should be strengthened.

Author: Federman, Daniel D.
Publisher: American College of Physicians
Publication Name: Annals of Internal Medicine
Subject: Health
ISSN: 0003-4819
Year: 2003
Public affairs, Ethics

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Institutional review boards: a crisis in confidence

Article Abstract:

Institutional review boards should focus their attention on the details that are important and delegate non-essential details to some other group. These boards were developed to ensure that clinical trials carried out by the institution are done in an ethical manner.

Author: Levine, Robert J.
Publisher: American College of Physicians
Publication Name: Annals of Internal Medicine
Subject: Health
ISSN: 0003-4819
Year: 2001
Management, Universities and colleges, College administration

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Subjects list: Editorial, Clinical trials, Ethical aspects, Human experimentation in medicine, Human medical experimentation
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