Regulations on the issue of using human subjects in research were first explored in the 20th century. The Nuremberg trials took place between 1945 and 1946 to judge Nazi leaders, scientists and doctors for their use of humans in research, especially in prisoners (Shamoo and Resnik, 2009). From these trials arose the Nuremberg Code, which was the first international regulation regarding human subjects used in research. The Nuremberg Code emphasized the need for a valid protocol and informed consent for experiments with social value, as well as minimization of harms and risks for the subjects (Shamoo and Resnik, 2009).
The first major regulation in the US was the National Research Act that was set forth in 1974 (Shamoo and Resnik, 2009). 45 CFR 46, part of that Act, is known as the Common Rule. The Common Rule is still used to regulate research with human subjects in the US, and has been adopted by the University of Maryland (http://www.umresearch.umd.edu/RCR/humansubjects.html). The Common Rule established that research using human subjects must have a proto...
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...ation. Along the same lines, I would also ask what the mechanism of action for this drug is. I would like to ask what the protocol of the study is, how and when the medicine is administered, and the timeline of the study. I would ask who I can contact if I have any questions about the study or if I was having side effects and how to get in touch with this person. I would also ask if I could withdraw from the study if I changed my mind.
Shamoo AE and Resnik DB. 2009. Responsible Conduct of Research. Second Edition. Oxford University Press: New York, NY.
University of Maryland Division of Research. 2011. Responsible Conduct of Research: Human Subjects Research. Available from: http://www.umresearch.umd.edu/RCR/humansubjects.html
University of Maryland Institutional Review Board. n.d. HIPAA. Available from: http://www.umresearch.umd.edu/IRB/hipaa.html
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