A physician at Setonia Hospital (which is covered by the Common Rule) proposes to photocopy the medical records of the last 50 patients who suffered fatal heart attacks while at the hospital, and then analyze them to determine if the hospital provided appropriate care.
a. Is this research?
b. Assuming it is research, are human subjects involved?
c. Assuming the activity constitutes research with human subjects, would it be eligible for an exemption from IRB review?