21 CFR Part 50 Exceptions From Informed Consent Flashcards
1
Q
What Subpart in this part lists exceptions from informed consent?
A
Subpart B
2
Q
List the types of exceptions from informed consent.
A
1) Exception from informed consent requirements for minimal risk clinical investigations
2) Exception from general requirements (an individual in a life-threatening situation needing the test article and Presidential waiver for military)
3) Exception from informed consent requirements for emergency research
3
Q
What section of the CFR addresses exception from general requirements (individual in life-threatening situation and military)?
A
21 CFR Part 50.23 in Subpart B
4
Q
What section of CFR addresses exception from informed consent requirements for emergency research?
A
21 CFR 50.24 (Subpart B)
