Under the Common Rule (45 CFR 46), which condition must be met for an IRB to waive the requirement for written informed consent documentation?
-
A
The research involves no more than minimal risk and the waiver will not adversely affect subjects' rights
-
B
The PI holds a federal research grant exceeding $500,000
-
C
All subjects are adults with full decision-making capacity
-
D
The study is conducted at a single site with fewer than 50 participants