Citi Training Complete Questions and Answers

Belmont Report of 1979 3 elements - ANSWER Benevolence Respect for Individual Justice How respect of individual is applied to human research - ANSWER Autonomy -Protection of those with dimished autonomy Informed consent How Benevolence is applied to human research - ANSWER IRB assessment of Risk & Benefits How is justice applied to human research - ANSWER selection of subjects to distribute burden & benefit equitably The Common Rule a.k.a. OHRP definition of Unanticipted Events - ANSWER Events in a study with all three are typically reported to IRB: Unexpected in nature, frequency, or severity Related to study Greater risk of harm Adverse Event - ANSWER ANY unfavorable medical occurance (physical, psychological, social, or behavioral) REGARDLESS of participation in study