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It's hard to tell from either article what's going on. The Science piece you linked provides a bit more detail, but I wouldn't say those details are particularly damning (about half of the audited healthy participants didn't have an approved physical as part of the study, but they did have physicals elsewhere at the institution because they were participating in other studies. The most concerning thing is that 2 women didn't have pregnancy test results confirming they weren't pregnant. Sure, you have to be careful about scientists maintaining ethical practice, but the other side of this is a trend toward research IRBs being focused on legal technicalities in reviewing research. For the most part, whether you're talking about NIH or universities, IRBs tend to focus on legal liability rather than ethics. This sounds like it might be reasonable, but in practice what it means is that IRBs aren't asking "is something really problematic happening here?" but instead "is there anything, even the smallest irrelevant detail, that could be used against us in a legal case?" Usually this means that IRBs are representing the institutions' best interests, rather than those of either the researchers or participants. A related thing came up with social scientists recently, where a bunch of them apparently said "screw this, we've had enough"(https://www.nytimes.com/2017/05/22/science/social-science-re...). The issue wasn't that they don't care about ethics, it's that they are fed up with IRBs treating the risks of asking people about their political attitudes as if they are equal to having a surgical procedure done. It sounds like there was some drift from protocol, which should be scrutinized. But nothing I've read so far suggests that the harm incurred justifies a ban on the use of the research data already collected. Maybe have some external review committee review the situation and make recommendations for changes; maybe indefinitely postpone future data collection by certain personnel, until things can be ironed out. But to ban publication of anything based on existing data? To me this story illustrates two problems with academic research today: the unreasonableness of IRBs, and the corruption of grant politics. |