A little reminder of why we have IRBs. Did I mention it is still Black History Month?

Reputable citizen-journalist Comradde PhysioProffe has been investigating the doings of a citizen science project, ubiome. Melissa of The Boundary Layer blog has nicely explicated the concerns about citizen science that uses human subjects.

And this brings me to what I believe to be the potentially dubious ethics of this citizen science project. One of the first questions I ask when I see any scientific project involving collecting data from humans is, “What institutional review board (IRB) is monitoring this project?” An IRB is a group that is specifically charged with protecting the rights of human research participants. The legal framework that dictates the necessary use of an IRB for any project receiving federal funding or affiliated with an investigational new drug application stems from the major abuses perpetrated by Nazi physicians during Word War II and scientists and physicians affiliated with the Tuskegee experiments. The work that I have conducted while affiliated with universities and with pharmaceutical companies has all been overseen by an IRB. I will certainly concede to all of you that the IRB process is not perfect, but I do believe that it is a necessary and largely beneficial process.

My immediate thought was about those citizen scientist, crowd-funded projects that might happen to want to work with vertebrate animals.

I wonder how this would be received:

“We’ve given extensive thought to our use of stray cats for invasive electrophysiology experiments in our crowd funded garage startup neuroscience lab. We even thought really hard about IACUC approvals and look forward to an open dialog as we move forward with our recordings. Luckily, the cats supply consent when they enter the garage in search of the can of tuna we open every morning at 6am.”

Anyway, in citizen-journalist PhysioProffe's investigations he has linked up with an amazing citizen-IRB-enthusiast. A sample from this latter's recent guest post on the former's blog blogge.

Then in 1972, a scandal erupted over the Tuskegee syphilis experiment. This study, started in 1932 by the US Public Health Service, recruited 600 poor African-American tenant farmers in Macon County, Alabama: 201 of them were healthy and 399 had syphilis, which at the time was incurable. The purpose of the study was to try out treatments on what even the US government admitted to be a powerless, desperate demographic. Neither the men nor their partners were told that they had a terminal STD; instead, the sick men were told they had “bad blood” — a folk term with no basis in science — and that they would get free medical care for themselves and their families, plus burial insurance (i.e., a grave plot, casket and funeral), for helping to find a cure.

When penicillin was discovered, and found in 1947 to be a total cure for syphilis, the focus of the study changed from trying to find a cure to documenting the progress of the disease from its early stages through termination. The men and their partners were not given penicillin, as that would interfere with the new purpose: instead, the government watched them die a slow, horrific death as they developed tumors and the spirochete destroyed their brains and central nervous system. Those who wanted out of the study, or who had heard of this new miracle drug and wanted it, were told that dropping out meant paying back the cost of decades of medical care, a sum that was far beyond anything a sharecropper could come up with.

CDC: U.S. Public Health Service Syphilis Study at Tuskegee
NPR: Remembering Tuskegee
PubMed: Syphilitic Gumma

31 responses so far

  • Ola says:

    Kudos to you both. And here I was thinkin' CPP was only good for swearing and good pasta recipes!

  • Boundary Layer says:

    What about me??? These guys are totally riding my coat tails!!

  • drugmonkey says:

    You got first billing, BL!

  • Beaker says:

    IRB review is like airport security checks. The vast majority of us don't intend to hijack planes, but we put up with invasive searches in order to fly. The ubiome project sounds like good science, with no malicious intent. Nevertheless, IRB review is the price we pay to ensure ethical credibility while pursuing fascinating research. Even one modern Tuskegee incident would ruin it for everybody else.

  • whimple says:

    All the potential IRB preventable abuses that could ever occur are small change compared to damage that could be inflicted by the idiots reengineering the flu virus to be extra lethal. I'm inclined to give ubiome a pass on this one. Don't sweat the small stuff.

  • drugmonkey says:

    The entire point is that those who are doing the work are too conflicted to decide what is "small stuff" and what is not. Do you really think the people doing Tuskegee thought they were doing wrong and went ahead anyway? Or do you think perhaps they, at best, had people like you advocating that they not sweat the small stuff?

  • bsci says:

    @Beaker and @whimple, go read the linked post: http://boundarylayerphysiology.com/2013/02/17/why-im-worried-about-ethical-shenanigans-in-the-citizen-science-movement/
    This isn't just about asking ubiome to run their well designed science through an IRB formality. In their current format they are guarantee to collect a biased sample by charging $1337 from most participants. They only give you the full consenting form after you pay them money and have a kit delivered to you. We don't know what is on the full consent form, but the website mentions nothing about how your samples might be used and who might profit from them. Data privacy is fuzzy. Risks of finding out the results are unmentioned. Consenting of children or who has the right to collect samples from other people is unmentioned.

    These are all addressable, but, in the current incarnation of ubiome, some of these gaps are clear ethical lapses that limit the utility of the data and might hurt people. This goes beyond sweating small stuff.

  • drugmonkey says:

    Apparently ubiome has been persuaded to do the right thing by the observations of Boundary Layer.

    http://boundarylayerphysiology.com/2013/02/17/why-im-worried-about-ethical-shenanigans-in-the-citizen-science-movement/#comment-112

    A win for the open peer review process...I guess?

  • Jonathan says:

    I suggested at AAAS last weekend that the citizen science movement had arisen as a response (by its advocates) to the scleroses of the current process. I think one of the copanelists took this for an endorsement as she seemed rather cross. I enjoyed the denouncement of neoliberalism in science that followed from an audience member rambling through one of those six-part questatments that makes everyone else groan and roll their eyes.

  • drugmonkey says:

    An earlier example of crowd funded science seeking IRB approval first http://scientopia.org/blogs/drugmonkey/2008/10/14/clinical-mdma-brief-14-oct-2008/

  • whimple says:

    Sure, the righteous indignation is fun, and pointing out the "ethical lapses" of others helps make the case that one's own ethics are superior, which also gives a warm fuzzy feeling.

    bsci: These are all addressable, but, in the current incarnation of ubiome, some of these gaps are clear ethical lapses that limit the utility of the data and might hurt people. This goes beyond sweating small stuff.

    When you say "these are all addressable" that means we are talking small stuff. Your primary complaint seems to be about a violation of process (which is legitimate), rather than genuine fear that having looked at the study design, they really "might hurt people" (which would justify the dramatic nature of the discussion). You will of course know (I hope) that "hurting people" is not a deal breaker in human subjects research and that there is no such thing as completely risk-free human subjects research.

  • DrugMonkey says:

    No, "easily addressable" is not by any means suggesting it is small stuff. Nice leap though.

  • I agree. None of these are small things and would have been addressed by an IRB, preventing them from such apparent lapses.

  • Isabel says:

    "CPP was only good for swearing"

    Yeah, when he publicly complained of the group of traumatized, mourning eight-year-olds from Newtown "could those fuckin kids be any goddamn whiter" ya'll just chuckled and said "there's old CPP sswearing again. What a card!"

    Goddess save us from "citizen journalists"

    I suspect CPP would approve of the experiments if the subjects were white people, say some lower class rednecks? This might push along his goal of a country that can finally make progress because whites are no longer a majority.

  • Isabel says:

    Should have made clear, I was referring to the Tuskegee experiments being discussed here, not thew ones he is discussing over at his blog.

  • drugmonkey says:

    right on cue, Isabel, right on cue. Unfortunately I couldn't get PP or Isis to take my bet, guess they were right it was a sucker's wager.

  • bsci says:

    @whimple, Addressable doesn't mean small. It means that they are doing things wrong that can hurt people, but it won't be hard to change what they're doing wrong.

    Having some participate in research without knowing the risks can hurt people. What if the data is more public than someone realized or they didn't have someone who knows what they were doing make sure the data were HIPAA compliant? What if, after spending the money for the kit, they felt pressured to sign a long consent form without understanding it? (For that matter, I'm not sure a consent for is even legal if a researcher isn't present to answer questions and witness that the volunteer understands the consenting process)

    The chances of harm are well documented in multiple posts. What if information is found that questions who is a biological parent? What if someone discovers a probabilistic health risk, but isn't connected or can't afford a medical specialist who can explain what that risk means resulting in unnecessary testing? What if information is found that affects a person's ability to get health insurance (I think this was legally addressed in the USA for human DNA, but I'm not sure about the biome)

    Like I said, creating a well designed consent process and oversight to make sure data is appropriately stored and distributed is very addressable, but that doesn't mean these are minor issues.

  • Isabel says:

    [DM edit- While I normally extend great latitude in the comment threads, your (Isabel's) continued pursuit of a single issue grows tiresome. I may or may not tolerate it in the future but for the moment, knock it off. If you have comments that are on task, Isabel, feel free to contribute.]

  • zb says:

    Ignoring the question of which research IRB's are absolutely vital in and which they might be useful and which they might be kind of nice and which they might be less than useful, there's not a lot of pressure that can be applied here.

    PLoS can maintain the IRB standards of science. I think they should, if they want scientists who are regulated by IRBs to publish there, and I think they do, since most scientists are not at internet startups or crowdsourced independent research ventures, but are at grant-funded institutions. But what happens when they tell 23andme that standard? My guess is in most cases they would just choose to not publish in PLoS. 23andme can release "technical reports" on its web site, and get the same publicity they currently desire. Then, they have to follow rules of internet privacy (like Google) and not local IRBs.

    The levers to enforce IRBs are grant-funding, institutional policy, and peer reviw/publication. None of them are very effective against private entities (for this kind of human subjects, and probably, for much invertebrate stuff). For invasive human research & invasive vertebrate reserach, laws that otherwise protect humans and other vertebrates would probably come into play.

    Anyoone else remember the report about a French reality show that tried to replicate Milgram experiments? And, in a much sofer vein, Rosalind Wiseman (anti-bullying activist) created bullying experiments with Dateline in which children were deceived. I'm guessing the experiment wouldn't have been approved by any IRB I'm familiar with (or, if they were, would have required a very large amount of red tap). But, journalists and reality shows are ungoverned and can do the same thing, freely.

    I don't think we can stop this kind of work, though we can stop it from being peer-reviewed.

  • Gruffi_Gummi says:

    "instead, the government watched them die a slow, horrific death"

    Isn't this the same benevolent government that you, liberals, love so much?

  • drugmonkey says:

    No. Next question?

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