> It used to be that IRBs required AFFIRMATIVE CONSENT This is (and has always been) waivable in cases (like this one) where either obtaining consent is imprac

> It used to be that IRBs required AFFIRMATIVE CONSENT This is (and has always been) waivable in cases (like this one) where either obtaining consent is impractical (which maybe applies here) OR you are making use of de-identified data (more likely to apply in this case). Affirmative consent still is required in many cases. With health data (the case I know personally), it would not be feasible for me to find five million patients and ask them to participate in my boring study answering a question which wouldn’t interest them. Just mailing each of them a letter to ask would be cost prohibitive! The value of research is frequently non-zero, whereas the risk to the participants is generally zero or extremely low. This is the balance the IRB is trying to strike. And believe me, as someone who has gone through it, I think they err way way WAY too far on the side of being overly cautious!