On the ethicical approval of RCTs

From Nicolas A. Christakis:

Incidentally, another thing that’s fascinating to me is that, there’s a very funny saying when it comes to the ethical review of science, or an anecdote, which is that if a doctor wakes up in the morning and decides that, for the next 100 patients with cancer that he or she sees that have this condition, he’s going to treat them all with this new drug because he thinks that drug works, he can do that. He doesn’t need to get anyone’s permission. He can use any drug “off-label” he wants when, in his judgment, it is helpful to the patient. He’ll talk to the patient. He needs to get the patient’s consent. He can’t administer the drug without the patient knowing. But, he can say to the patient, “I recommend that you do this,” and he can make this recommendation to every one of the next 100 patients he sees.

If, on the other hand, the doctor is more humble, and more judicious, and says “you know, I’m not sure that this drug works, I’m going to only give it to half of the next 100 patients I see,” then he needs to get IRB approval, because that’s research. So even though he’s giving it to fewer patients, now there’s more review.

It would be interesting to think of the off-label analogues in development. You could argue that a lot of new government policy is essentially off-label.

Hat tip to Marginal Revolutio

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