Response to “Do the EPA Studies Violate Do No Harm & Informed Consent”

by Nancy King, JD

I have just read your August 25 post on the EPA studies. While, I do not know that much about these particular exposure studies, I do know that EPA is taking the inquiry very seriously. I do want to question and clarify some of your discussion, principally with respect to Resnik’s 4th and 5th criteria.

You say: “Criteria 4, that the subject must “receive some benefits, such as medical evaluations” seems like a very light standard. If the medical evaluation were part of the study and data was being used for the study, would it be a benefit? I have always viewed a benefit as something that is aimed to help the subject, not the research. In the IRBs in which I have been involved, this is why receiving a study drug is not considered a benefit because it’s not intended to benefit the subject (but to gather data).”

You’re right that offering what John Lantos has called “inclusion benefits” — everybody gets a perk for joining the study — cannot be weighed against risks of harm to subjects in order to justify risk-bearing research. Nor can you offer more than a “light” benefit in order to balance greater risks of harm. That’s why the only benefits that count in the harm-benefit balance should be direct benefits to society from generalizable knowledge, and in some but not all research, benefits from the intervention under study. That works for phase III randomized clinical trials (RCT) where there is clinical equipoise — and it can reasonably apply to getting the study drug in a phase III RCT that is well-supported by data from earlier phases. But you’re right, it can’t be used outside that final study phase.