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,

Zac

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?

Thanks!

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:

Zac:

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.

Thanks,
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.

Your Asshole Media At Work: Truth In Headlines

Here are three different heads on articles explaining how the sicke-fucke America-hating republican party has blocked the nomination of Chuck Hagel as SecDef because this is the kind of “throw sand in the gears” form of governance that their racist misogynist homophobic white christian greedy scumbagge electoral base jizzes over:

G.O.P. Senators Block Vote on Defense Post for Hagel

Democrats decry delay in vote for Hagel as defense chief

Senate Republicans block Hagel nomination – for now

And before you click or mouseover the links, see if you can guess which came from which media outfit.

Fucken Austrofrench Cheese-Eating Fuckebagges

Like anyone gives a single flying fucke about some goddamn austrofrench cheese-eating aristocrat fuckebagge’s motherfucken name???????

In his discussion of suspects in the Piltdown Man mystery, Chris Stringer alludes to the French Jesuit priest, philosopher and palaeontologist Pierre Teilhard de Chardin (Nature 492, 177–179; 2012). The article mistakenly shortens the great man’s compound surname to “de Chardin”. In fact, it should read “Teilhard de Chardin” or just “Teilhard”.

Such aristocratic last names are often misinterpreted in English. One glaring example is the condition known as Tourette’s syndrome, incompletely named after Georges Gilles de la Tourette, who first described it. “Gilles” is part of the compound last name and not a middle name, as is commonly assumed.

From now on, I’m gonna refer to these two fuckewaddes as “Douchebagge de Chardin” and “Fuckenarde de la Tourette”, because fucke you, thatte’s why.

Oh, and the author of this important piece of correspondence to one of the scientific journals of record?

Antoine Louchart, of the Ecole Normale Supérieure de Lyon, Lyons, France.

His official austrofrench name is now Antoine Louchart de la Pissewadde.

Update On Convicted Fraudster Bryan Doreian: The Motherfucker *Did* Pass The Patent Bar

Apparently, convicted fraudster Bryan Doreian *did* pass the patent bar exam, because his name is on this list of individuals published by the USPTO who passed the bar in early 2012, and are hence seeking registration. The purpose of publishing the list is stated as follows:

The following list contains the names of persons seeking for registration to practice before the United States Patent and Trademark Office. Final approval for registration is subject to establishing to the satisfaction of the Director of the Office of Enrollment and Discipline that the person seeking registration is of good moral character and repute. 37 CFR § 11.7 Accordingly, any information tending to affect the eligibility of any of the following persons on moral ethical or other grounds should be furnished to the Director of Enrollment and Discipline on or before June 23, 2012 at the following address: Mail Stop OED United States Patent and Trademark Office P.O. Box 1450 Alexandria VA 22314.

And if you go to the USPTO Web site database of all registered practitioners, and search for people’s names on that early 2012 list, you find that pretty much all of them had since become registered. But Bryan Doreian is *not* in the database. So either someone informed the OED of his lack of “good moral character and repute”, or he disclosed himself to the OED that he is a convicted scientific fraudster (which he would have been obligated to do by the rules governing the application for registration, not that he has proven himself a follower of ethical rules).

So, the final conclusion is that Bryan Doreian *did* pass the USPTO patent bar exam in early 2012. One surmises that the reason he doesn’t tout this on his bar review course Web site is that he didn’t want people looking into the situation, and discovering that he passed the exam but never was successful at becoming registered.

Readers can look within their conscience and decide whether the think it makes sense to absolutely ensure that Bryan Doreian does not slip through the cracks and somehow get registered by mailing a letter to the OED at the following address–Mail Stop OED United States Patent and Trademark Office P.O. Box 1450 Alexandria VA 22314–informing them of his conviction for scientific misconduct involving fabrication of data.

Since this particular kind of failure of good moral character and repute strikes at the very heart of the ethical and legal regime that governs practice before the USPTO as a patent agent/attorney, it seems pretty clear to me that Bryan Doreian should never be permitted to represent inventors before the USPTO.

Jonah Lehrer Is A Greedy Delusional Fuckebagge

What a fucken nuttebagge:

“What I clearly need is a new set of rules, a stricter set of standard operating procedures,” he said. “If I’m lucky enough to write again, then whatever I write will be fully fact-checked and footnoted. Every conversation will be fully taped and transcribed.”

“That is how, one day, I’ll restore a measure of the trust I’ve lost,” he added.

Lehrer used several analogies to make his case. At one point, he likened himself to the FBI, which adopted new failsafes after a case involving fingerprint misidentification revealed systemic problems. He compared his new “standard operating procedures” — a phrase he must have used at least 10 times — to the “forcing functions” that software designers employ to guide users away from accidents.

HAHAHAHAHAH! No, the profession of journalism–as fucked uppe as its mainstream currently is–does not need to implement new standard operating procedures to protect itself and lying craven fuckebagges like Lehrer from their own worst impulses.

Instead, what Lehrer needs is to get a fucken jobbe where his particular personality defects can’t lead to gross professional malfeasance. I’m pretty sure McDonald’s is always hiring.

Convicted Scientific Fraudster Bryan William Doreian Is Running A USPTO Patent Bar Review Course

The Office of Research Integrity just released a notice that Bryan William Doreian has admitted to research misconduct that involved falsifying data. Some of the particular acts that he admitted to included the following:

falsifying the numeric values to fit the hypothesis of the manuscript

multiplying the experimental values by 100 to match the magnitude of the values presented in Figures 21, 6h, and 6i of the Nature Medicine manuscript

claiming that the results represent the rmean of three identical experiments when the three experiments were normalized differently to yield the desired result

This cheatfucke is apparently Founder, President, and Managing Director of his own United States Patent and Trademark Office patent bar exam review course. I wonder if he gets someone else to teach the sections on the USPTO Code of Professional Responsibility for patent practitioners? Like the section that states:

(b) A practitioner shall not:

***

(4) Engage in conduct involving dishonesty, fraud, deceit, or misrepresentation.

Moby Dicke CHAPTER 12. Biographical.

Queequeg was a native of Rokovoko, an island far away to the West and South. It is not down in any map; true places never are.

When a new-hatched savage running wild about his native woodlands in a grass clout, followed by the nibbling goats, as if he were a green sapling; even then, in Queequeg’s ambitious soul, lurked a strong desire to see something more of Christendom than a specimen whaler or two. His father was a High Chief, a King; his uncle a High Priest; and on the maternal side he boasted aunts who were the wives of unconquerable warriors. There was excellent blood in his veins—royal stuff; though sadly vitiated, I fear, by the cannibal propensity he nourished in his untutored youth.

A Sag Harbor ship visited his father’s bay, and Queequeg sought a passage to Christian lands. But the ship, having her full complement of seamen, spurned his suit; and not all the King his father’s influence could prevail. But Queequeg vowed a vow. Alone in his canoe, he paddled off to a distant strait, which he knew the ship must pass through when she quitted the island. On one side was a coral reef; on the other a low tongue of land, covered with mangrove thickets that grew out into the water. Hiding his canoe, still afloat, among these thickets, with its prow seaward, he sat down in the stern, paddle low in hand; and when the ship was gliding by, like a flash he darted out; gained her side; with one backward dash of his foot capsized and sank his canoe; climbed up the chains; and throwing himself at full length upon the deck, grappled a ring-bolt there, and swore not to let it go, though hacked in pieces.

In vain the captain threatened to throw him overboard; suspended a cutlass over his naked wrists; Queequeg was the son of a King, and Queequeg budged not. Struck by his desperate dauntlessness, and his wild desire to visit Christendom, the captain at last relented, and told him he might make himself at home. But this fine young savage—this sea Prince of Wales, never saw the Captain’s cabin. They put him down among the sailors, and made a whaleman of him. But like Czar Peter content to toil in the shipyards of foreign cities, Queequeg disdained no seeming ignominy, if thereby he might happily gain the power of enlightening his untutored countrymen. For at bottom—so he told me—he was actuated by a profound desire to learn among the Christians, the arts whereby to make his people still happier than they were; and more than that, still better than they were. But, alas! the practices of whalemen soon convinced him that even Christians could be both miserable and wicked; infinitely more so, than all his father’s heathens. Arrived at last in old Sag Harbor; and seeing what the sailors did there; and then going on to Nantucket, and seeing how they spent their wages in that place also, poor Queequeg gave it up for lost. Thought he, it’s a wicked world in all meridians; I’ll die a pagan.

And thus an old idolator at heart, he yet lived among these Christians, wore their clothes, and tried to talk their gibberish. Hence the queer ways about him, though now some time from home.

By hints, I asked him whether he did not propose going back, and having a coronation; since he might now consider his father dead and gone, he being very old and feeble at the last accounts. He answered no, not yet; and added that he was fearful Christianity, or rather Christians, had unfitted him for ascending the pure and undefiled throne of thirty pagan Kings before him. But by and by, he said, he would return,—as soon as he felt himself baptized again. For the nonce, however, he proposed to sail about, and sow his wild oats in all four oceans. They had made a harpooneer of him, and that barbed iron was in lieu of a sceptre now.

I asked him what might be his immediate purpose, touching his future movements. He answered, to go to sea again, in his old vocation. Upon this, I told him that whaling was my own design, and informed him of my intention to sail out of Nantucket, as being the most promising port for an adventurous whaleman to embark from. He at once resolved to accompany me to that island, ship aboard the same vessel, get into the same watch, the same boat, the same mess with me, in short to share my every hap; with both my hands in his, boldly dip into the Potluck of both worlds. To all this I joyously assented; for besides the affection I now felt for Queequeg, he was an experienced harpooneer, and as such, could not fail to be of great usefulness to one, who, like me, was wholly ignorant of the mysteries of whaling, though well acquainted with the sea, as known to merchant seamen.

His story being ended with his pipe’s last dying puff, Queequeg embraced me, pressed his forehead against mine, and blowing out the light, we rolled over from each other, this way and that, and very soon were sleeping.