On 21-04-27 12:56, Charles M. Ess wrote:
What is particularly interesting is that the IRB "had reviewed the study and determined that it was not human research, only to backtrack, adding 'throughout the study, we honestly did not think this is human research, so we did not apply for an IRB approval in the beginning. We apologize for the raised concerns.'"
I find this confusing: who determined human subjects weren't involved, the researchers or the IRB? I *think* the researchers argued they weren't human subjects research to their IRB, and the IRB accepted this and exempted them from review and consent procedures....? Looking at the handy OHRP flow charts, this seems like a big mistake. [a]: https://www.hhs.gov/ohrp/regulations-and-policy/decision-charts-2018/index.h... 1. They were collecting information about living people through intervention, interaction, or that was identifiable private information. And while the disciplinary "carve outs" aren't in the flow chart (e.g., (oral) history, journalism, biography), I've not seen an argument that experimenting on/with a community is precluded. 2. The typical exemptions don't apply (education). ... 13. It sounds like they wanted to make a 45 CFR 46.116(f) claim, that the work was so important yet benign and so they should forgo consent. But I don't think they ever made this argument to their IRB.