Why is 45 cfr 46 called the common rule

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Reference no: EM133921014

Assignment:

Review 45 CFR 46 (Common Rule) and to 21 CFR 50 (FDA). 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.
  • 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?

Reference no: EM133921014

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