> Why not just produce the drug and let people take it (who know the above risks)? Because terrible things have been conducted in the name of research [1,2,3]

> Why not just produce the drug and let people take it (who know the above risks)? Because terrible things have been conducted in the name of research [1,2,3] which made humanity decide to form IRB and consider the actual impact on the participant. While you open up the "who know the above risks", what about child/prisoners/mentally disabled people? In current research, these are protected groups specifically because they can't really make these decisions for themselves. Furthermore, we don't know the longer term effects of things. Quaker didn't know radioactive oatmeal to track nutrient absorption in orphans would be harmful [3] and even made the case that "at least we were feeding them". Yes, again they are a protected group, but what if, say, this drug had the statistics you presented, but then 10-20 years later it was discovered that it gradually caused dementia? Simply saying "they knew the risks" is not enough. In the end, human experimentation is a tricky gray area BECAUSE of the possibilities for misconduct. Someone could be coerced into doing something they didn't need/want to. This is both the annoyance and best thing about IRB. Yes, its annoying that I can't just experiment my novel teaching approach on a subset of students without their consent AND IRB approval, but it is ensuring that my control is getting equal learning opportunities AND my experimental is negatively learning. [1] https://en.wikipedia.org/wiki/Unit_731 https://en.wikipedia.org/wiki/Unit_731 [2] https://en.wikipedia.org/wiki/Unethical_human_experimentation#Nazi_Germany https://en.wikipedia.org/wiki/Unethical_human_experimentatio... [3] https://www.nytimes.com/1998/01/01/us/settlement-reached-in-suit-over-radioactive-oatmeal-experiment.html https://www.nytimes.com/1998/01/01/us/settlement-reached-in-...