1. 45 CFR 46.102(l).
2. Oversight on the borderline: quality improvement and pragmatic research;Finkelstein;Clin Trials,2015
3. What the Doctor Didn't Say: The Hidden Truth about Medical Research;Menikoff,2006
4. Determining minimal risk for comparative effectiveness research;Joffe;IRB,2014
5. 45 CFR 46.