Question

For an IRB review to be required, clinical research must be: A. Federally funded. B. Involve a product regulated by the FDA. C. Fall under local institutional rules requiring IRB approval. D. Any or all of the above A, B or C.

Answer 1

Answer:

Option D

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Answer 2

An IRB (Institutional Review Board) review is required for clinical research when the research meets any of the criteria A, B or C.

An IRB (Institutional Review Board) review is required for clinical research when the research meets any of the criteria A, B or C.(D) Any or all of the above A, B or C.

• A. Federally funded: Research that is funded by federal agencies such as the National Institutes of Health (NIH) or the Department of Defense (DOD) must be reviewed by an IRB.
• B. Involve a product regulated by the FDA: Research that involves drugs, biologics, medical devices, or other products regulated by the Food and Drug Administration (FDA) must be reviewed by an IRB
• C. Fall under local institutional rules requiring IRB approval: Many institutions have their own policies and guidelines that require IRB review for certain types of research, even if they are not federally funded or involve a product regulated by the FDA.
• Therefore, all clinical research that meets any of the above criteria A, B or C will require an IRB review.

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