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Molecules to Medicine

Molecules to Medicine

Demystifying drug development, clinical research, medicine, and the role ethics plays

uBiome: Ethical Lapse or Not?

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Jessica Richman at TEDMED

uBiome’s CEO, Jessica Richman, seems to me to be a great saleswoman who also excels at sounding innocent and playing the misunderstood victim in the ethical controversy surrounding her company. I think this was well illustrated in her recent guest blog in Scientific American with Dr. Zachary Apte, co-founder and Chief Scientific Officer of uBiome. The picture is a little less rosy if you look back at the origins and history of the discussions about her company’s perceived ethical lapses.

I was intending to write about uBiome before this, as I was disturbed by Richman’s appearance at TEDMED. Admittedly, I was already put off by her telling twitter handle of “@venturejessica.” Her hubris was further evidenced by the title of her TEDMED talk, “Could a citizen scientist win a Nobel Prize?” Fortunately, her talk was a bit more restrained, though still touting the potential of her as yet untested product.

Richman and Apte’s recent blog has shown that they seem to have learned little from the heated discussions about uBiome. Their business is part of the UCSF’s Quantitative Biosciences Institute start-up incubator. While they say that lawyers provided by UCSF told them that they did not require Institutional Review Board (IRB) ethics approval–something that “didn’t sound like a great system” to them–proceeding without ethical review seems to reflect a lack of understanding of basic research ethics as well as a desire for expediency over more careful volunteer protections.

Richman and Apte complain that IRBs “are provided free of charge to members of that [academic] institution” but that they would have had to pay “thousands of dollars” for an external IRB review. Welcome to the real world. At the non-academic institution where I did research for ~25 years, there were fees for review. It was accepted as a cost of doing business, an expected start-up investment cost, to cover the administrative costs of the host institution.

uBiome proclaims their innocence because they had not yet processed specimens; they were crowdfunding their project and intending to get IRB approval after that step. But their 2/17/13 e-mail solicitation in Science Citizen Newsletter states “Please sign up to get your friends or your loved ones’ microbiomes sequenced.” Their home page certainly implies benefit: “Dozens of health conditions are correlated with the microbiome — from asthma to diabetes, autism to depression, irritable bowel, Crohn’s, chronic sinusitis, heart disease, and more. We help you investigate your personal microbiome and learn how you correlate with others. For just $89, you can learn what’s in your gut, nose, mouth, skin, genitals — or, sample anything!”

Under “How it Works,” we learn that “Our online survey lets you ask and answer questions about your health, lifestyle, demographics, social connections, and more! Then you can see how you correlate with other people in our dataset.” It then states, “our team will analyze the results to explore scientific research questions such as how the microbiome influences human health and disease.”

Under FAQs, we find: “YES! You can definitely sequence your child, at any age. You will need to give your permission to have the sequencing done. If your child is over the age of 13, they will also need to give their assent (non-binding approval) as well as parental permission.” “You will be able to opt-in to make your data available to the public.”

There is, not surprisingly, a medical disclaimer, “uBiome is not a diagnostic test. However, we can give you valuable information about your microbiome that you can use to learn more about your health.” Then their site notes an upgraded kit, ubiome DELTA ^ FIVE, in which for $1,337 “you can sample all 5 areas at 5 timepoints and see how your microbiome responds to your experiments”…”we hope to provide as useful and actionable data as possible.”

Ethical concerns

uBiome (and specifically @ventureJessica) sounds dismissive of the concerns of various bloggers but fails to either note that they are well-positioned to criticize or to respond directly to the substance of their concerns. For example, DrugMonkey is an NIH-funded researcher, who wrote, “A little reminder of why we have IRBs. Did I mention it is still Black History Month?”
Janet Stemwedel, aka @docfreeride, an Associate Professor of Philosophy at San Jose State University, raised other ethical and practical concerns.
Nick Evans, a bioethicist, writes about dual-use research, which might have both benevolent and harmful applications, and criticizes uBiome as a cautionary tale for citizen science.
DNLee, The Urban Scientist, leant a valuable perspective on the need for self-policing in citizen science.
Melissa Bates, PhD, a scientist in Pediatric Critical Care Medicine at the University of Wisconsin School of Medicine and Public Health, writes about Translational Research at BoundaryLayerPhysiology.com, and is clearly well-versed in research ethics as well as a thoughtful writer. Her criticisms, which mirror mine, included:
“1) Participation in the uBiome project requires the payment of a fee.
[Typically, research participants are not charged for participation, and thus are more free to withdraw consent without any penalties.]
2) There is no clear statement about what will be done with the data or samples.
3) There is no apparent plan for how your identity will be protected.
4) It’s not clear what conflicts [of interest] the major players in the project might have.
5) The benefits you’ll receive are grossly over-stated
6) There is no statement as to what your risks of participation are.
7) Children are included, but it’s not apparent how they are protected.”
I encourage all to read the thoughtful discussion and comments in BoundaryLayer’s ethical shenanigans and final thoughts posts.

IRBs

ComraddePhysioproffe (another NIH-funded researcher) provides great information about IRB ethics and oversight, and uBiome’s IRB compliance (or lack thereof), among other posts.

Kelly Hills (@rocza), a bioethicist, and I co-moderated a session at Scio13 (Science Online) on ethics and citizen science, as part of a track that discussed potential problems with citizen science, including the difficulties obtaining IRB and ethical reviews. Holly Menninger (@DrHolly), I, and others hope to continue that discussion this year. DrHolly made an excellent comment about consent and citizen science. I have participated in two of her studies. In each case, there was a clear consent that could be a model of how things should be done.

Yes, there are problems with some IRBs, whether they are associated with academic institutions or are independent, for profit, enterprises. For example the University of Minnesota’s IRB has failed in its oversight of psychiatric trials there, as I have reviewed in the Markingson case. This included having an IRB chair who stated, shockingly, that the IRB is not responsible for protecting clinical trial subjects. Even the Johns Hopkins’ IRB received scathing criticism for failures of oversight in an asthma study that led to the death of a healthy volunteer, Ellen Roche. The GAO has criticized the workloads of IRBs as being too heavy precluding thorough review. This load on IRBs is well described in Trials and Tribulations. And IRBs are subject to conflicts of interest, as I also noted. I, too, have encountered questions as to whether an IRB approval was necessary for a given project.
But having at least an attempt at ethical and independent review is an important step, as is transparency. If there are flaws in the system, we should attempt to correct them, not ignore any attempt at oversight.

On the one hand, @ventureJessica seems to attempt being head of a naive young citizen start-up; on the other hand, uBiome has used their link to UCSF for PR and to UCSF’s legal team as an excuse for not having an IRB.

What uBiome’s management seems to be missing is that their skirting the rules hurts their image and fosters mistrust and, perhaps more importantly, may hurt the citizen science movement more broadly. Rather than whining about being misunderstood and mischaracterized, they should reflect on these criticisms–most from more experienced researchers–and try to respond. As a start towards openness, I would ask that they post their consent form–or do you only get to see that after you buy a kit? It is not just IRBs that need more transparency, Jessica.

Richman and Apte’s IRB 2.0 is not a novel concept–there has been discussion about how to make IRBs more accessible to those not affiliated with academic institutions. There is likely widespread agreement that we need alternative IRBs and better standards for IRBs.

To return to the original question posed at TEDMED, “Could a citizen scientist win a Nobel Prize?”
Perhaps. But not for this.

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Editor’s note (1/3/14): uBiome received Institutional Review Board (IRB) approval on May 10, 2013.

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The views expressed are those of the author and are not necessarily those of Scientific American.

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