Rio Salado Community College The Common Rule Discussion
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Description
- Using the list of Resources posted for you in “Links and Tools.” Review the links to 45 CFR 46 (Common Rule) and to 21 CFR 50 (FDA). Take time to look at both titles and then do a little research on each to answer the following questions:
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- Why is 45 CFR 46 called the “Common Rule”? Identify and explain two (2) reasons. (10 points)
- What is the difference between the two titles – in other words, why do we have 2 sets of regulations? Have changes in the revised Common Rule requirements impacted the differences in the regulations? If so, how? (10 points)
Resources
- Textbook Mazer: Read Chapter(s) 1-2: Mazur, Dennis J., (2007) Evaluating the Science and Ethics of Research on Humans: A guide for IRB members
- Belmont Report: Ethical principles and guidelines for the protection of human subjects of research
- A Shared Responsibility for Protecting Human Subjects – Steven Peckman
- Nuremburg Code (Links to an external site.)
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