Quantcast

«

»

Feb 21 2013

uBiome Has Made A Public Statement About IRB Compliance Of Their Human Subjects Research

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.

9 comments

3 pings

Skip to comment form

  1. 1
    Gregory in Seattle

    They “are working with” an IRB, the process is not yet complete, and yet they are still collecting data.

    Wrong order. From an ethical and probably legal point of view, all of the data they collect before the IRB has approved the research is tainted.

  2. 2
    Boundary Layer

    At least we have an answer.

  3. 3
    G Pierce (Was ~G~)

    Intent is important in determining if an activity is research or not. If someone had been doing some activity involving data collection purely for non-research purposes and then later on someone wanted to do a retrospective study of that data, the original activity wouldn’t be human subjects research, but the later data collection would be. Researchers do these retrospective chart reviews all the time and they require requesting a consent and HIPAA waiver from the IRB. (You may be a subject right now!)

    If a researcher requests data from a *completely* de-identified* database like this- http://www3.norc.org/GSS+Website/About+GSS/ that already exists (as opposed to accessing identified data and then de-identifying it as part of the research) , that is still research, but because it is not involving interaction with patients or accessing their identifiable data it is no longer *human* subjects research and thus does not require IRB oversight.

    There is a category human subjects research called “exempt” http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html#46.101 but most institutions still require some sort of review to make the determination that it is exempt. OHRP requires that the person making the determination has adequate expertise in the regulations and they can be pretty tricky.

    Based on above, it seems their intent in collecting the data right now is at least partially for later research and could potentially be considered a research activity. Approval cannot be given retroactively and they may not be able to use this data.

    For more info see- http://www.hhs.gov/ohrp/index.html (And FDA regulations may apply as well)

    *There are very specific rules about this, and de-identified is more than just removing names and SSN or medical record numbers.

  4. 4
    G Pierce (Was ~G~)

    Looking at their site more, it seems they like they are primarily recruiting for research over offering a non-research service. Even study recruitment is not allowed prior to IRB approval.

  5. 5
    fuckesatonne

    “it seems they like they are primarily recruiting for research over offering a non-research service. Even study recruitment is not allowed prior to IRB approval.”

    Clearly they need to be strung up by their toenails by the busybody brigade, with Generale PhysioProffe leading the charge.

  6. 6
    G Pierce (Was ~G~)

    Well, I saw their comment that because they are not federally funded or have federal oversight in any way, they are not subject to the same rules. Technically AFAIK (since I have no experience with that sort of operation) that would be true. However, most reputable journals require IRB approval letters for publication. Somehow I doubt that’s a concern of theirs. :)

    I note they carefully say their test is not diagnosing anything. That’s purposeful I think for legal reasons.

  7. 7
    loquaxe

    Physioproffe Generale of Platinum is right in questioning and raising the voice. No screw with critical matters.

  8. 8
    tv shows

    nice article !

  9. 9
    Kevin Keith

    It’s not clear to me what they are doing and how it is being done, so I have no opinion on the overall validity of their procedure. They do seem somewhat legalistic in addressing it.

    However, regarding exemption from IRB review, there is a rule providing for exemption from review for certain categories of studies. Those categories are those that inherently do not threaten harm to particular human subjects, either because the procedures are innocuous (opinion surveys, etc.), or because the data involved are de-linked from identification with particular individuals, and thus would not violate the privacy of individuals.

    The relevant section of the Code of Federal Regulations is here (45CFR46.101(b)): http://bit.ly/ZvrLmp

    A useful overview is here: http://www.hhs.gov/ohrp/policy/checklists/decisioncharts.html

    One important category for exemption is studies of data which have previously been collected for some other purpose, and are anonymized before use, again so that no individual data source can be identified. The regulations do not require that that data have been collected from a study that was subject to IRB review. (They do not have to be from a scientific study at all. They could be, for instance, tax records, student grades, etc.) It only requires that the individual identifying information be stripped out when the data is copied for analysis.

    However, as you note, the regulations do require that this data be already in existence – not collected for the purpose of the exempt study itself. Again, it is not clear to me just what this outfit is doing, but if they are collecting samples for study purposes, and offering a service to the study subjects in addition as a way to claim the samples were not “really” for research, that is clearly at odds with the regulations. (Once more, I don’t know that that is what they are doing.) If they do legitimately offer a medical or laboratory service, though, it is not illegitimate for them to study the data that inevitably results. There is nothing that says you can’t study your own lab’s data.

    Finally, as they note, as an independent organization they may not technically be subject to IRB review at all. That they are in fact willing to involve an IRB speaks to their sincerity, although the way in which they have gone about it may still be open to question.

    There may be more to be said about this case. But, regarding the strict legal need for IRB review, and the requirement under the regulations for IRB review specifically of studies of this type, it appears to me that there is at least a provisional case to be made in the investigators’ favor.

  1. 10
    A Statement from Ubiome and Some Final Thoughts | The Boundary Layer

    [...] bloggers pondering ethics, including “citizen-journalist” Comradde Physioprof (here and here), Drugmonkey (here), Janet Stemwedel (here), and evidence-minded physician Peter Lipson [...]

  2. 11
    Meet Your Microbes: uBiome Offers New Service « Science-Based Medicine

    [...] can now safely say based on statements left here and at Comradde Physioprof’s blog that uBiome has not received IRB approval for their project, despite having made what I believe to [...]

  3. 12
    On Internalizing the Ethical Standards of Scientific Research | DrugMonkey

    [...] of bloggers. (See links from Boundary Layer Physiology (here, here, here) Comradde Physioprof (here, here, here), Drugmonkey (here), Janet Stemwedel (here), Peter Lipson (here).) We greatly [...]

Leave a Reply

Your email address will not be published. Required fields are marked *

You may use these HTML tags and attributes: <a href="" title=""> <abbr title=""> <acronym title=""> <b> <blockquote cite="" class=""> <cite> <code> <del datetime=""> <em> <i> <q cite=""> <strike> <strong>