Rio Salado Community College The Common Rule Discussion

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Rio Salado Community College


  • 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:
    • 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)


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Discussion Questions
1. Why is 45 CFR 46 called the "Common Rule"? Identify and explain two (2) reasons.
In the analysis of Steve Peckman, Mazur Dennis, the Belmont Report, and the
Nuremberg Code report, numerous justifications can be given for these two titles, the 45 CFR 46
(Common Rule) and the 21 CFR 50 (FDA. First of all, due to the fact that numerous government
departments and agencies have ratified the Federal-Policy for the Protection of Human Subjects,
it is referred to as the "Common Rule." The fundamental policy lays out ...

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