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The AIDS Clinical Trials Group Study 076 of 100 Zidovudine in maternal-infant transmission of HIV had been published in 1994. [10] This was a placebo controlled trial which showed a reduction of nearly 70% in the risk of transmission, and Zidovudine became a de facto standard of care .
In March 1959, Austin Bradford Hill, then director of the UK Medical Research Council's Statistical Research Unit, chaired a Vienna-based CIOMS conference on controlled clinical trials. The proceedings, published in 1960, commented on research ethics, experimental design, and statistical analysis.
An institutional review board (IRB), also known as an independent ethics committee (IEC), ethical review board (ERB), or research ethics board (REB), is a committee at an institution that applies research ethics by reviewing the methods proposed for research involving human subjects, to ensure that the projects are ethical. The main goal of IRB ...
The research began with the selection of 22 subjects from a veterans' orphanage in Iowa. None were told the intent of the research, and they believed that they were to receive speech therapy. The study was trying to induce stuttering in healthy children. The experiment became national news in the San Jose Mercury News in 2001, and a book was ...
The Nuremberg Code became a cornerstone of clinical research and bioethics." [ 17 ] In 1995, Judge Sandra Beckwith ruled in the case In Re Cincinnati Radiation Litigation (874 F. Supp 1995) that the Nuremberg Code may be applied in criminal and civil litigation in the Federal Courts of the United States .
A similar guideline for clinical trials of medical devices is the international standard ISO 14155, which is valid in the European Union as a harmonized standard. These standards for clinical trials are sometimes referred to as ICH-GCP or ISO-GCP to differentiate between the two and the lowest grade of recommendation in clinical guidelines.
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Research ethics is a discipline within the study of applied ethics. Its scope ranges from general scientific integrity and misconduct to the treatment of human and animal subjects. The social responsibilities of scientists and researchers are not traditionally included and are less well defined.