| > Like, why should we conclude that we need that sort of consent to administer a questionnaire for experimental purposes (i.e.: gaining generally useful knowledge), but that there are no substantial issues of consent when it’s for diagnostic purposes (i.e.: gaining information about that particular patient) instead? 1. Researcher incentives. Data => publications => prestige. If the procedure actually contains some inherent risk (e.g., a surgery) then this mismatch between the priorities of the physician and the priorities of the researcher matters. Even (actually, especially!!!) if the physician and the researcher are the same person. 2. Publication. De-anonymization is a real risk even if you're careful to only talk about patient # N in the publication. 3. Patient preference. Just because I allow my hosting provider to access my servers for the purpose of maintenance doesn't mean I'm OK with them accessing my servers for the purpose of surveillance or to read my personal emails. Purpose matters. Some patients won't want data about them used in the context of a scientific study. Patients should and do have the right to insist on that preference. Frankly, the presumption otherwise is exactly why IRBs exist. This story sounds stupid because -- aside from de-anonymization or data leaks -- there are actually no substantive risks associated with this study. Change "questionnaire" to "open heart surgery" and all of this process starts to make a lot more sense. FWIW I'm not saying IRB's aren't completely overbearing when it comes to benign studies. They totally are. But that doesn't mean these processes aren't well-justified in other circumstances. (Also, a lot of this pain is completely avoidable if you learn and follow the rules, which isn't actually nearly as hard as this post makes it out to be IME.) |