uBiome has posted a public statement concerning IRB review and approval of their human studies research on their third-party Web site from which they have–as viewed by some who have considered the situation–already been recruiting and enlisting study participants from whom they have already received > $300,000 in participation fees:
Does uBiome have an Institutional Review Board?
Balancing the needs of open access while maintaining your safety and privacy is very important. To achieve this end, we are working with an independent Institutional Review Board (IRB) to provide ethical oversight. We will provide complete details when this process is complete.
Isn’t IRB oversight required before a study can begin?
IRB oversight is used to make sure a study is ethically sound before it begins. Our IRB will be completed before any kits are sent out and before any consent forms are signed. We will release our consent forms when we have final IRB approval.
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. That said, we are doing full Board review to insure that every aspect of the project is ethically safe and sound.
If uBiome accepted any federal funding or was a university research laboratory instead of a citizen science startup, the IRB review would indeed be mandatory. As it is, this review should only strengthen uBiome as a research study and as a community.
I will leave it to the reader, and particularly any experts on IRB compliance, whether their argument that they are exempt from IRB oversight and, in particular, the following syllogism hold any water:
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.
Here are some of my own thoughts on this argument (some of which have already been fleshed out and documented in my earlier blogge post):
(1) Their own Web site and their third-party “crowd-funding” site make it very clear that one of the main purposes–perhaps the primary purpose, on a reasonable reading–of their project and one of the major benefits to the participants they have already been recruiting is the aggregation and statistical analysis of the individual results so as to contribute novel information to the scientific understanding of the relationship between the human microbiome and human health/disease.
(2) My understanding is that the meta-analysis exemption applies solely to de-identified data obtained from other already-performed human subjects studies that themselves have been performed subject to appropriate IRB oversight, and that this exemption cannot possibly be applicable to a situation where the directors of a study collect human tissue/fluid samples, perform a biological analysis, and claim its “primary purpose” is a service to the participants, and that their subsequent aggregation and statistical analysis of the data that they collected is nothing but a meta-analysis.
I will also note that the following statement from one of the uBiome principals, Jessica, in her comment on my previous blogge post on this subject in which she points to their newly published IRB verbiage is pretty fucken hilarious, considering the bizarrely belligerent and legally threatening tone that was taken by the signatories Jessica, Zac, and Will in the e-mail to me I referred to earlier in which they “requested” that I not quote from any of their e-mails to me:
I appreciate the dialog here on this blog. Although I think the tone of the original blog post is unnecessarily combative, we are glad for the focus on ethical oversight, and share the goal that citizen science be conducted in a thoughtful, privacy-aware, and ethical manner.