A Question of Host Factors in Side Effects of Medication

Author(s): Elysa Koppelman and Caroline Whitbeck

You are doing research to look for side effects of a certain drug. You know that evidence of such side effects shows up in blood. You also know that studies should be designed in a way that exposes subjects to as minimal risk as possible. Given this, you designed a study which looks at blood already being drawn from patients for other purposes.

As your study progresses, you discern that the pattern of both the efficacy of the drug and the incidence of some side effects suggests that they depend on genetic factors in subjects.

How, if at all, would it be ethical for you to look into this possibility?