uBiome claims that they are exempt from IRB review because their “primary purpose” is to provide a service to private parties for a fee, and that their subsequent analysis of the data collected is an incidental “meta-analysis”:
However, IRB approval is not required for us to provide our primary service of microbiome compositional analysis and interpretation for private parties. Thus, our sample collection is part of a service and our research study is a meta-analysis of de-identified data, which is technically exempt from IRB.
This is disingenuous post hoc rationalization of their failure to obtain up-front IRB review of their human subjects research project before recruiting and enlisting study participants:
H+: You are looking for funding via Indiegogo. Can you tell me a bit about the project you are looking to fund specifically and describe what funders will receive? Why did you choose Indiegogo over other services, i.e. Kickstarter?
Jessica: We are looking to crowdfund our citizen science project at www.indiegogo.com/ubiome. For $79, you can sequence your GI tract; for $235, you can sequence the GI tract three times; for $272 you can sequence all five sites: mouth, ears, nose, GI tract, and genitals. Here’s how it works: You pledge and we send you a sample kit. You swipe the sample brush across the corresponding sample site. The cells are lysed in solution and sent to our laboratory for processing. Once we’ve sequenced your sample, we’ll send a login to our website where you can visualize and understand your data. As a uBiome community member you find out about our latest discoveries first, participate in ongoing citizen science projects, and suggest new questions that we can address together. We chose Indiegogo because they are international, flexible and have great customer service. However, we hope that a lot more citizen science projects will come online, on any platform.
[Emphasis added.] In case it wasn’t obvious enough already, these public statements by Jessica Richman, a uBiome principal, make it absolutely clear that a primary purpose of the uBiome project is scientific research inquiry, and is far from incidental. And also, the claim that study participants are not recruited or enlisted until the kits are used to collect tissue/fluid samples and returned is also a load of horseshit: note all the uses in this public statement of “you” to refer to the same person paying the fee, receiving the kit, sending in the tissue/fluid samples, and thereby contributing thir microbiome sequences to uBiome’s “discoveries”.