A professor at Big State University is writing a biography about Bill Gates and conducting oral histories with all of Bill Gates’ friends, family members, and business acquaintances. The researcher submits the research proposal to the institution’s IRB. What action can he expect by the IRB?
(A) The IRB will not review this study because it does not involve an investigational new device.
(B) The IRB will not review this study because it is not research as defined by the federal regulations.
(C) The IRB will review this study because it includes human subjects and is considered research.
(D) The IRB will not review this study because it does not include human subjects as defined by the federal regulations.

Respuesta :

Answer: The action that he can expect by the IRB: The IRB will not review this study because it is not research as defined by the federal regulations.

Biographers working on research that is particular to the individual, their activities are external of the purview of IRB and do not require review.

Therefore, the correct option in this case is (b).