Is The uBiome Project Performing Human Subjects Research Without IRB Approval? (UPDATED AGAIN)

uBiome is a “crowd-funded” “open science” project with the stated goal of studying the human microbiome. As part of their pursuit of this goal, they solicit payments on the Web, in exchange for sending to the payors kits for the collection of human tissue or bodily fluid samples that are sent back to uBiome:

uBiome uses a number of sampling sites: nose, mouth, ear, GI tract, and genitals. When you fund our project, we send you a sample kit with a swab for each sampling site you funded. You swab the sample site and send the kit back to us.

We use state-of-the-art DNA sequencing to analyze your samples. We send you a link to view your own personal Human Biome profile. We’ll tell you what your microbiome is, what it means, and how you can understand it with the latest scientific research. uBiome provides personal analysis tools and data viewers so that users can anonymously compare their own data with crowd data as well as with the latest scientific research. For example, for your GI tract, uBiome will show you your flora composition, your enterotype, the network of your microbiome, and the diversity of your gut flora. uBiome is HIPAA compliant and will not release personal identifying data or information to anyone.

Sounds like straightforward fee-for-service, not scientific research, so no Institutional Review Board analysis and approval of their human subjects protocols and informed consent are needed, right? Well, no:

The more people that join the uBiome community, the more statistical power we have to investigate connections between the microbiome and human health. For example, with 500 people, we can address questions about relatively common diseases such as diabetes and hypertension. With 2,500, the project can investigate connections to breast cancer. With 10,000 people, we can investigate multiple sclerosis and heart disease. The larger the uBiome community, the more we can learn.

They clearly intend to not solely provide the results of the microbiome sequencing to the people who pay for the service, but rather to use it to perform scientific research: to compile all of the results they obtain from the people who pay for service, and then to compare them across all participants, and–based on the above stated scientific plan–also making correlations to the answers provided by the participants to a medical questionnaire.

IRB review of human subjects research projects such as this is designed to protect the participants in the study from undue physical, psychological, and emotional harm, and to ensure that the benefits of the research outweigh any potential harms. While there may not be any statutory legal requirement to obtain IRB review before performing such a human subjects study if it is not funded by the government, no legitimate scientific journal will publish the results of human subjects research in the absence of prior IRB review, nor would any reputable scientist or physician make use of such results.

Several days ago, the Boundary Layer Physiology blogge scoured both the uBiome Web site as well as the Web site of the third-party that uBiome is using to collect payment from study participants. And nowhere on either of those Web sites was there found any mention IRB review and approval having been secured prior to the study leaders having obtained several hundred thousand dollars in payments from study participants who have agreed to send their tissue and/or bodily fluids to uBiome for the purposes of this study.

When I got wind of this situation, I sent an e-mail containing the following text to the “[email protected]” e-mail address:

Is it true that your uBiome research project is collecting human tissue/fluid/cell samples from participants for the purpose of performing research without obtaining any review or approval from a human studies IRB?

If so, you probably will want to give some thought to whether you ought to have. Independently of the intrinsic ethical issues, no reputable scientific journal is going to publish any of the results of your human research studies in the absence of IRB approval.

In response, I received an e-mail with the “from:” header containing the name “Zachary Apte”, who I think is one of the leaders of the uBiome research project:

That is not true. Best,


I then sent the following e-mail back to this person:

That is good to hear, because your Web site makes no mention whatsoever of IRB approval or the mechanisms you have in place for obtaining appropriate informed consent from your study participants.

Could you please let me know how you obtained IRB approval, and what your process is for obtaining informed consent?


I asked about informed consent, because that is one of the elements of a properly designed human subjects research project that must be present in order to obtain IRB approval. But I never heard anything back.

A day later, I then sent this person the following e-mail:


Do you have IRB approval for your human studies research project? Since you are already soliciting study participants, the expected time for obtaining such approval has passed.

While you may not be under any statutory legal obligation to obtain IRB approval, no reputable scientist or physician is going to have anything to do with human subjects research (or the data that is collected) that was not conducted pursuant to IRB review and approval.

Since there is currently discussion on the Internet concerning your human subjects research project and its conformance with ethical norms of human subjects research, it would be great to receive your clarification of this issue.

Comradde PhysioProffe

As of about 24 hours later, I still haven’t heard anything further.

Maybe the uBiome people have IRB approval for their human subjects research project. But if they do, then it is curious that they haven’t asserted so, either in response to my e-mail questions or on the blogge post at Boundary Layer Physiology where one of the people who is associated with uBiome did respond, albeit without stating whether they do or don’t have IRB approval.

UPDATE: I have heard back from some of the uBiome principals, via an e-mail with three signatories, Jessica, Zac, and Will. While they still have not directly answered my question whether they have already obtained IRB approval for their human studies, they have asserted that they are not collecting human samples without IRB approval, that there is no guarantee that the person who has sent in a payment to pre-purchase the kit will be the person who actually provides a tissue/fluid sample using the kit, and that there will be appropriate legal paperwork included when a study participant associates himself directly with the study and receives the tissue/fluid collection kit.

(Note that I am paraphrasing rather than quoting from this e-mail as a courtesy to the senders at their request. It is not clear to me why they do not want me to quote them rather than paraphrase, but whatever. I think that their project is scientifically interesting and potentially valuable, and I hope they will take this seriously and figure out how to get themselves onto tenable footing vis a vis their pursuit of human subjects research.)

As far as the substance of their assertions, it seems to be that they have not actually commenced any human subjects research, because they have not yet sent out any human tissue/fluid collection kits nor received any human tissue/fluid samples.

Unfortunately, I don’t think this holds water. They are already recruiting participants to their study, because they have coupled the payment of fees to the distribution of the tissue/fluid collection kits. As far as I am aware, if operating within an IRB regime, it is not allowed to recruit participants to a human study prior to obtaining IRB approval. The claim that the kits could be used by someone other than the person paying the fee is a distinction without a difference. They are already recruiting participants, regardless of exactly who those participants are.

UPDATE 2: The need for IRB review has little to do with researchers’ intentions to behave ethically–nowadays it is rare that we are talking about genuinely evil exploitative abusive shitte–but rather that it is surprisingly complicated to actually implement processes, procedures, and protocls that thoroughly safeguard human subjects’ rights and safety, even with the best of intentions. This inquiry has absolutely nothing to so with whether the uBiome people are nice guys who just want to do cool science with the best of intentions. That is irrelevant.

IRBs are there exactly to ensure that earnest scientists with the best of intentions in their hearts are forced to think through all of the possible ramifications of their proposed human subjects research projects in a thorough and systematic manner before they embark on their research. The evidence we are in possession of as of now suggests strongly that uBiome has not done so.