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 “” 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.


  1. Reverend PJ says

    If I recall my IRB training correctly, if the genetic material they’re collecting is going to be used for any research they need IRB approval. A quick look at their Team members shows a few university folks which would argue that they need IRB approval. Finally, it’s in their interest to have a definitive answer to that question since sequence data can be considered PHI.

  2. Reverend PJ says

    The frustrating thing here is that getting IRB approval for this sort of work is a no-brainer, and being evasive about answering can only damage their credibility.

  3. Boundary Layer says

    Furthermore, an IRB has oversight over PHI collected from human subjects, even if you never enroll people or get their consent. It’s not clear to me, for example, if you donate and then do not give consent, is your money returned? What does the project then do with your PHI? An IRB would provide guidance on this matter.

    I’ll restate from my own post that we are not allowed access to our sponsor’s funds until we can prove that we have human subjects assurances. It’s not clear that this happened in this order with this project. That’s a shame, especially given the claims made on their fundraising site. At my institution all advertising would be subject to the approval of the IRB and they would never have approved of these tactics.

    Bottom line, ethics goes beyond informed consent.

  4. Morgan Price says

    Arguably, if it is optional to participate in the research side of it and you can just pay for sequence, then recruitment starts when they ask someone to join the study. I’m more concerned about whether they are overselling the near-term medical utility.

  5. says

    Furthermore, an IRB has oversight over PHI collected from human subjects, even if you never enroll people or get their consent.

    I didn’t even realize that part, and just went and looked at some example IRB regulations. It looks like you need IRB approval to even collect personally identifiable information from potential research subjects, even if they never end up participating in the study. And there is absolutely zero question whatsoever that PHI has already been obtained from every person who has sent payments to uBiome: names, addresses, etc.

  6. Boundary Layer says

    Morgan, the relationship between investigator and subject is without question on the site. When you donate, you are paying for a kit. There is no mention of a secondary consent process and I find that problematic.

    PP, I frequently conduct screening of participants by phone. My IRB requires that I have a plan to deal with destroying their PHI even if they never sign a consent.

  7. docfreeride says

    Their squirrelly reluctance to let you quote the language of their email to you is … troubling. Maybe not a bright red flag, but at least suggestive that their priority is not so much on protecting their human subjects as on minimizing their own legal exposure.

  8. says

    I’m on the Community Advisory Board for the Seattle HIV Vaccine Trials Unit. While an institutional review board works to cover the ass of the group doing a study, a CAB advocates for the study participants. Any medical research being done without IRB oversight is very, very bad. There are REASONS why IRBs are required under federal law and international treaties.

  9. DrugMonkey says

    Let us remember this is going to extend to all of “citizen science”. Not just IRB either. Biohazards, IACUC are just two obvious issues. EH&S protections anyone? Who is responsible when crowd funded ecology dude gets tetanus? Employee payroll taxes?

    Happy revolution crowdfunders

  10. says

    I’ve pulled my notes together as to why this is important. Far too many links to put into a single post, so those who are interested will have to look things up themselves.

    Nuremberg Code – During the war crimes trials in Nuremberg, the extent of Nazi human experimentation came to light. In response, the Counsel for War Crimes set forth in 1947 a ten-point code to define legitimate medical research. This was used as the basis for the

    Declaration of Helsinki adopted in June, 1964, and revised since, most recently in October, 2008. It is a declaration of ethical principles maintained by the World Medical Association that governs human medical experimentation. It serves as a model for the governing laws of many countries, including the United States. It was the first revision, in 1972, which introduced the idea of an independent committee having oversight of research. This led to the creation in the United States of

    Institutional Review Boards, or IRBs, which became mandated in the US under the National Research Act of 1974. The first revision of the Declaration of Helsinki, and the relatively quick adoption of IRBs in the US, were the result of the horrific

    Tuskegee syphilis experiment, which ran in the US from 1932 to 1972. At the time the study began, there was no cure for syphilis. The Public Health Service recruited 600 African American tenant farmers, 300 with syphilis and 300 without, and told them they would get free health care for themselves and their family if they participated in a study on “bad blood.” Neither they nor their partners were ever told they had a fatal sexually transmitted disease. After penicillin was discovered and found to cure syphilis in 1947, the focus of the study changed — without telling the participants — to track the progress of the disease from initial stages through terminal. Neither the men nor their partners ever got penicillin, as that would disrupt the study. Those who tried to withdraw from the study were told that they would have to first repay the government for decades of medical care they received. Questions about the ethics of the study began to surface in 1966, soon after the adoption of the Declaration of Helsinki and right after passage of the 1966 Freedom of Information Act… probably not coincidentally. The story was broken by the Washington Star on July 25, 1972; the study was formally ended on November 6 of that year.

    Any effort to avoid IRB or any other kind of regulatory oversight should be treated with very deep distrust. Aside from which, my understand of what federal law says tells me that uBiome might very well be in violation of US and world law.

  11. Grumble says

    “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.”

    What if they collected all the samples, ran the analyses they wanted, and posted the methods and results online, all without obtaining IRB approval. Let’s also suppose that, aside from not getting IRB approval, they did an incredibly good job. Would you, as a scientist in their field, just plug your ears and say “NAA NAA NAA I CAN’T HEAR YOU!”??

  12. Sciences Expertz says

    Violation of world law? Are you serious?

    My kid swabbed his cheek for a high school science project petri dish. The whole class did the same thing. Sure hope someone alerts an IRB…those kids might be compiling and analyzing data!

  13. says

    @Sciences Expertz #12 – There is a vast legal difference between someone collecting medical research data of himself, by himself, and someone collecting medical research data on others. The law is pretty clear on this.

  14. says

    @Grumble #11 – Even if they did an incredibly good job, the people who did the research would likely be felons under US and/or international law. Any researcher who used the results would be tainted, probably irreparably.
    However, scientists in the field should be able to recreate the research from scratch within the bounds of the law, and use those results. I believe this sort of thing has happened before, I will try to find some references.

  15. Jessica Richman says

    Hello it’s Jessica from uBiome. I just wanted to point everyone to our new FAQ on this subject on completed indiegogo page at I apologize for the confusion on this so far, but we have of course considered the ethical and legal issues involved. Although IRB approval is not required for us to provide our primary service of microbiome compositional analysis and interpretation for private parties, we have planned to do so once our crowdfunding campaign ended, which occurred two days ago.

    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.

  16. DrugMonkey says


    It is fantastic that the open peer review of your project by The Boundary Layer blog has brought you to do the right thing. I believe that in the end you will recognize the tremendous benefit to your goals of working within the appropriate ethical oversight structures. As one of the biggest science projects crowd funded to date it is an important statement to other crowdfund scientists that this is not mere “red tape” to be avoided.

  17. Sciences Expertz says

    Jessica, it’s a good thing you came to your senses because it would appear that world law was about to come after you something fierce. You are lucky to have so many “experts” who have your best interests at heart. Where would society be without bullying and condescending “input” in the form of bush league blog posts? I suppose that’s why it’s a blog post and not a news article…the standards of journalism are apparently much lower. Why go through the process of contacting the company for comment when you can just fire off some questions to a bucket email address and then let the words fly and make wild accusations and assumptions? Good for you for addressing this thread, but in the future, I would be careful about feeling the need to respond to people whose idea of research is to ctrl+f your website for keywords.

  18. bsci says

    I agree with DrugMoney that it’s better that this discussion is prompting a response that will hopefully be able to clean up the problems and let uBiome contribute to real research. That said, the uBiome FAQ response on IRBs is flawed. The key sentence is “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.”

    As noted other places, volunteer recruitment for research requires an IRB. Much of the uBiome site makes it clear that a key purpose of uBiome is to let people donate their samples for research. Even if it is technically a service, they are clearly doing subject recruitment for the study. As a thought experiment, how many people who have committed to pay $1337 for this service would have done so purely to look at their own biome with no ability to compare it to other biomes in the system? The service/research distinction is a very gray for uBiome’s current model. It’s also worth noting that, if uBiome keeps this stance, then paying for this service lets them use data for research without ANY consent process required. This places them on one ethical extreme of the debates regarding research on tissues collected from clinical procedures (Read “The Imortal life of Henrietta Lacks” for more details on this)

    Also, the key to the research part is that the data are anonymized, but one legal aspect of anonymization according to HIPAA laws is “Any other unique identifying number, characteristic, or code (excluding a random identifier code for the subject that is not related to or derived from any existing identifier).” must be removed. I’m not an expert in this, but if subjects are able to use some code to gain access to their data in the anonymized system, these data are not legally considered anonymous. That doesn’t stop the project, but it means IRB review is required and not merely a good idea.

    The additionally write, “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 noted in several places, any organization that wants to publish in a peer reviewed journal needs IRB review. Claiming this doesn’t apply to a company is not a good starting position for this discussion.

  19. yikes says

    “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.”

    So they are volunteering to undergo IRB review, even though it is not “mandatory” for them? This is an extremely concerning point of view. Citizen science must be subject to the same ethical standards as institutional science. Otherwise, can we just do a privately funded (or crowd-funded) Tuskegee, you know, just out of curiosity? Of course, this would be clearly illegal, but one must consider where the line is drawn, and this is what an IRB is for. DM’s point about biohazards, IACUC, etc. is also right on target.

    Institutions have a huge incentive to comply with scientific ethics rules. I’m not sure how Citizen Science has the same. It is crystal clear from history that the “trust me, I’m doing science!” approach is inadequate.

    I’m glad uBiome is getting full IRB approval, but it should not be a choice.

  20. Sciences Expertz says

    Now we’re making thinly-veiled comparisons of uBiome to Tuskegee? Someone doesn’t have enough to do.

    These aren’t research subjects. There is no drug. There is no study. There IS a private contract and a collection and analysis of data available to clients. There is no need for IRB approval other than to appease folks who have an inflated impression of their own importance.

    My favorite part of this thread is all of the assumptions people are making…they are making a study…they are enrolling patients…they are going to publish. Again….people don’t have enough to do.


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