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Caroline Whitbeck Elmer G. Beamer-Hubert H. Schneider Emerita Professor in Ethics Case Western Reserve University Case Western Reserve University More Posts
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Reading Questions for Federal Regulations for Human Subjects Research

Added09/09/2006

Reading questions to help bring out the key issues in the explanation of the general guidelines and federal regulations for human subjects research.

Federal Regulations for Human Subject Research, Part I

These reading questions are to help bring out the key issues as they are discussed in the explanation of the general guidelines and federal regulations for human subjects research.

  1. What criteria determines if research is "human subject research"? List at least two.
  2. What are the categories that determine if a research protocol qualifies for IRB protocol exemption under minimal risk?
  3. What are the categories that determine if a research protocol is eligible for IRB expedited review?
  4. Under what circumstances would a research protocol with human subjects be submitted to the IRB for full review?

Return to Federal Regulations for Human Subjects Research, Part I page

Federal Regulations for Human Subjects Research, Part II

These reading questions are to help bring out the key issues as they are discussed in the explanation of the general guidelines and federal regulations for human subjects research.

  1. How do the federal regulations assure that the principle of justice is reflected in research protocols?
  2. What are the regulations governing inclusion/exclusion that NIH funded research should also consider?
  3. What is the principle of beneficence and how does it apply to risk/benefit assessment?
  4. What are the components of informed consent and how is it implemented in a research protocol?
  5. What criteria are necessary in order to apply for an informed consent waiver from the IRB?

Return to Federal Regulations for Human Subjects Research, Part II page

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Contributor(s) Caroline Whitbeck
Notes Caroline Whitbeck introduced methods and modules for discussing numerous issues in responsible conduct of research at a Sigma Xi Forum in 2000. Partial funding for the development of this material came from an NIH grant. You can find the entire sequence on the OEC at http://www.onlineethics.org/Resources/TeachingTools/Modules/19237.aspx. Some information in these historical modules may be out-of-date; for instance, there may be a new edition of the professional society’s code that is referred to in an item. If you have suggestions for updates, please contact the OEC.
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Year 2000
Cite this page: "Reading Questions for Federal Regulations for Human Subjects Research" Online Ethics Center for Engineering 9/9/2006 OEC Accessed: Tuesday, December 6, 2016 <www.onlineethics.org/Resources/TeachingTools/Modules/19237/resethpages/fedreadq.aspx>