On Internalizing the Ethical Standards of Scientific Research

Jul 24 2013 Published by under Academics, Science Ethics

There is an entry up on the Scientific American Blog Network's Guest Blog by two of the principals of μBiome. In Crowdfunding and IRBs: The Case of uBiome Jessica Richman and Zachary Apte address prior criticism of their approach to the treatment of human subjects. In particular, the criticism over their failure to obtain approval from an Institutional Review Board (IRB) prior to enrolling subjects in their study.

In February, there were several posts about the ethics of this choice from a variety 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 appreciate the comments, suggestions and criticisms that were made. Some of the posts threw us off quite a bit as they seemed to be personal attacks rather than reasoned criticisms of our approach.

If you follow the linked blog posts, you will find that when Richman and/or Apte engaged with the arguments, they took a wounded tone. This is a stance they continue.

We thought it was a bit… much, shall we say, to compare us to the Nazis (yes, that happened, read the posts) or to the Tuskegee Experiment because we funded our project without first paying thousands of dollars for IRB approval for a project that had not (and might never have) happened.

I was one of the ones who brought up the Tuskegee Syphilis Experiment. Naturally, this was by way of making an illustrative example of why we have modern oversight of research experiments. I did not anticipate that any of the research planned by the uBiome folks would border on this sort of horrible mistreatment of research subjects. Not at all. And mentioning that older history does not so accuse them either.

PhysioProf made this point very well.

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.

This is a critical reason why scientists using human or animal subjects need to adhere to the oversight/protection mechanisms. The second critical reason is that the people doing the research are biased. Again, it is not the case that one thinks all scientists are setting out to do horrible Mengele type stuff in pursuit of their obsessions. No. It is that we all are subject to subtle influences on our thinking. And we, as humans, have a very well documented propensity to see things our own way, so to speak. Even when we think we are being totally objective and/or professional. By the very nature of this, we are unable to see for ourselves where we are going astray.

Thus, external oversight and review provides a needed check on our own inevitable bias.

We can all grumble about our battles with IRBs (and Institutional Animal Care and Use Committees for animal subject research). The process is far from perfect so a little bit of criticism is to be expected.

Nevertheless I argue that we should all embrace the oversight process unreservedly and enthusiastically. We should be proud, in fact, that we conduct our research under such professional rules. And we should not operate grudgingly, ever seeking to evade or bypass the IRB/IACUC process.

Richman and Apte of μBiome need to take this final step in understanding. They are not quite there yet:

Before we started our crowdfunding campaign, we consulted with our advisors at QB3, the startup incubator at UCSF, and the lawyers they provided us. We were informed (correctly) that IRBs are only required for federally funded projects, clinical trials, and those who seek publication in peer-reviewed journals. That’s right — projects that don’t want federal money, FDA approval, or to publish in traditional journals require no ethical review at all as far as we know.

Well, that is just plain wrong. Being a professional scientist is what "requires" us to seek oversight of our experiments. I believe I've used the example in the past of someone like me buying a few operant chambers out of University Surplus, setting them up in my garage and buying some rats from the local pet store. I could do this. I could do this without violating any laws. I could dose them* with all sorts of legally-obtainable substances, very likely. Sure, no legitimate journal would take my manuscript but heck, aren't we in an era where the open access wackaloons are advocating self-publishing everything on blogs? I could do that. Or, more perniciously, this could be my little pilot study incubator. Once I figured I was on to something, then I could put the protocols through my local IACUC and do the "real" study and nobody would be the wiser.

Nobody except me, that is. And this is why such a thing is never going to happen. Because I know it is a violation of my professional obligations as I see them.

Back to Richman and Apte's excuse making:

Although we are incubated in the UCSF QB3 Garage, we were told that we could not use UCSF’s IRB process and that we would have to pay thousands of dollars for an external IRB. We didn’t think it made sense (and in fact, we had no money) to pay thousands of dollars on the off chance that our crowdfunding campaign was a success.

and whining

We are happy to say that we have completed IRB review and that our protocol has been approved. The process was extremely time-consuming, and expensive. We went back and forth for months to finally receive approval, exchanging literally hundreds of pages of documents. We spent hundreds of hours on the project.

First, whatever the UCSF QB3 Garage is, it was screwing up if it never considered such issues. Second, crying poverty is no excuse. None whatsoever. Do we really have to examine how many evils could be covered under "we couldn't afford it"? Admittedly, this is a problem for this whole idea of crowd-funded science but..so what? Solve it. Just like they** had to solve the mechanisms for soliciting the donations in the first place. Third....yeah. Doing things ethically does require some effort. Just like conducting experiments and raising the funds to support them requires effort. Stop with the whining already!

The authors then go on in a slightly defensive tone about the fact they had to resort to a commercial IRB. I understand this and have heard the criticisms of such Pay-for-IRB-oversight entities. From my perspective this is much, much lesser of a concern. The absolute key is to obtain some oversight that is independent of the research team. That is first-principles stuff to my view. They also attempt to launch a discussion of whether novel approaches to IRB oversight and approvals need to be created to deal with citizen-science and crowd-funded projects. I congratulate them on this and totally agree that it needs to be discussed amongst that community.

What I do not appreciate is their excuse making. Admitting their error and seeking to generate new structures which satisfy the goal of independent oversight for citizen-science in the future is great. But all the prior whinging and excuse making, combined with the hairsplitting over legal requirements, severely undercuts progress. That aspect of their argument is telling their community that the traditional institutional approaches do not apply to them.

This is wrong.

UPDATE: Read uBiome is determined to be a cautionary tale for citizen science over at thebrokenspoke blog.
__
*orally. not sure civilians can get a legal syringe needle anywhere.

**(the global crowdfund 'they')

Additional Reading:

Animals in Research: The conversation begins
Animals in Research: IACUC Oversight

Animals in Research: Guide for the Care and Use of Laboratory Animals

Animals in Research: Mice and Rats and Pigeons...Oh My!
Virtual IACUC: Reduction vs. Refinement
Animals in Research: Unnecessary Duplication

34 responses so far

  • odyssey says:

    And we should not operate grudgingly, ever seeking to evade or bypass the IRB/IACUC process.

    I'd like to have this tattooed on the foreheads of some colleagues...

  • Caroline Abbott says:

    "The process was extremely time-consuming, and expensive. We went back and forth for months to finally receive approval, exchanging literally hundreds of pages of documents. We spent hundreds of hours on the project."

    I sit on an IRB. The process can be long and arduous, but if so it is because there are deficits in the proposal, consent documents and process, or other relevant materials. Sometimes the hypothesis is not clear, the objectives are not clearly related; sometimes the problems are big, sometimes relatively minor. I've seen submissions that are unwittingly racially or economically biased, proposals that were potentially damaging to participants, consent forms that promised non-existent benefits or hid risks.

    That Richman and Apte's proposed study required so much attention, time, and revision is pretty good evidence of the need for IRB oversight.

  • Is there something about being an open science crowd funding enthusiast that also makes these people the whiniest motherfuckers on earth? Between these sniveling dippeshittes and Perlsatin, they've got a fucken locke on the shitte.

  • DrugMonkey says:

    Caroline-

    Yeah everybody has a learning curve on this stuff. I would hesitate to view it as evidence that there was anything additionally wrong with their approaches just b/c of the back and forth.

  • DrugMonkey says:

    CPP-

    Too much time spent with like-minds telling each other how great they are? So when they hit their first bout of substantive and constructive critique it destroys their self-image?

  • Gary says:

    What is so special about the human being that would except it from experimentation?
    Who decided other life forms are more acceptable? Since when was it ever OK to consider ourselves above other life forms we use for experiments?

    That research is open and shared is most relevant.

  • DrugMonkey says:

    Humans are not "excepted " from experiments. This is kind of the underlying point here

  • Burger says:

    There was a research institute in New York, the MSRCNY, which used one of the pay to play IRBs in order to get a clinical trial started to treat MS by injecting stem cells into the CSF of patients. They advertised heavily with exclamatory press releases and glowing praise of the PI & benefits of the therapy. They advertised that they could cure MS within the next few years, if only they could get approval to start the trials. They thought they were exempt from FDA approval because they considered injecting stem cells into the CSF to be a SCAM (supplemental, complementary, alternative medicine), which FDA hasn't authority over (congressionally mandated impotence); however, before initiating the clinical trial, the FDA stopped the trial, considering the treatment an IND. I have a family member with MS who was told to seek this therapy (and possible donate to the cause). I told said family member -- "run & don't look back if they promise a cure," and sent copies of the MSRCNY's FDA warning letters for perusal. Since the FDA investigations started and the MSRCNY have failed to get NIH grants renewed, they've undergone a PR makeover and changed their name. This whole shenanigans (anecdotal, yes) makes me suspicious of pay to play IRBs.

    *Civilians & syringes. I'm pretty sure some patients are trained to self inject medication for certain chronic conditions. Needle exchange programs exist to prevent the spread of infectious diseases in IDU population.

  • @TellDrtell says:

    Syringes and needles are pretty easy for lay people to buy from many sources. That certainly wouldn't impede your hypothetical ethically-questionable pilot study plan.

  • DrugMonkey says:

    I'm not sure getting my hands on syringe needles as a civilian by some stratagem is the same as legal possession.

    (And can I just say, as someone who has had to pill a pet cat......grrrr)

  • Grumble says:

    "Second, crying poverty is no excuse. None whatsoever."

    Dude. If there was no money to pay for IRB review, there was no money for expensive human subjects experiments and hence no risk of Tuskegee-esque consequences.

    I don't know how it works with human subjects experiments, but I'm not required by anyone (my college or the NIH) to submit an animal protocol before I submit a grant. Sure, I have to have an approved protocol before NIH will give me the money - but I certainly wouldn't bother submitting a protocol until I have some indication that the grant is likely to be funded.

    Why should this be any different for crowdsourced experiments? Ask for money first, get the money, then ask for IACUC or human subjects approval, then do the experiments.

  • bsci says:

    @Grumble, Volunteer recruitment is considered part of conducting an experiment. You can't start recruiting volunteers or even advertising to recruit volunteers without IRB approval. Ethical recruitment is a critical part of the informed consent process. uBiome merged fund raising with volunteer recruitment by essentially saying people get to participate in the study by giving them money.

    Similarly, you probably don't need an animal protocol to submit a grant, but, if you want to include some pilot data in the grant proposal, I assume that data was collected under a protocol.

  • @TellDrtell says:

    Yes, legally the needles and syringes can be obtained easily.

    (and having become a veterinarian and pilled too many cats for my taste, I feel your pain on that one)

  • Being a professional scientist is what "requires" us to seek oversight of our experiments

    Oh please. If it wasn't legal requirement for Federal funding, neither you nor anyone else would bother. Yes, you can argue that the requirement is a good thing, but let's not kid ourselves that it would be something anyone would do out of their own free will.

  • DrugMonkey says:

    Don't use your own lack of an intrinsic ethical compass to speak for anyone else JB.

  • You know what would really demonstrate your devotion to non-legally required IRB approvals? You could dedicate your spare time to doing the paperwork for crowd-funded IRBs. After all, doing this non-legally required additional paperwork would make you even more ethical because there would be no legal requirement tainting your "ethical compass" -- it would be purely ethical!

    Plus, it would be putting your words into action. Otherwise one might suspect that the *real* reason for you and others are griping about uBiome and other crowdsourced projects is not because of any serious ethical concerns but because you just don't like the newfangled idea and hope that by spreading FUD about their lack of IRB approvals (despite the lack of any such requirement at present), you'll make similar projects infeasible in the future.

  • drugmonkey says:

    one might suspect that the *real* reason for you and others are griping about uBiome and other crowdsourced projects is not because of any serious ethical concerns

    Again, you are erroneously pasting your own lack of ethical compass for such matters on to other people. My "real reasons" are just as I have expressed them. You are looking for something else simply because you do not agree with me that there is a problem here. One might suspect (as you put it) that your real reason ( as you put it) is that you are starting to feel a tingle of shame at your own lack of ethical grounding in this matter.

    You could dedicate your spare time to doing the paperwork for crowd-funded IRBs.

    What makes you think I want to encourage these people at all? Rather a leap isn't it?

  • Why *wouldn't* you want to encourage them? Crowdsourcing is an exciting new way of doing science, even if I probably wouldn't organize a project that way myself. I agree with much of what you say on this blog, but this and your bizarre opposition to self-archiving "because of contracts with the publishers" baffles me. Ethics is about doing the right thing to the most number of people. It doesn't have anything to do with contracts or paperwork.

  • DrugMonkey says:

    IRB oversight is not mere "paperwork". It is about doing the right thing for the people you intend to use as research subjects. Why is this so difficult to grasp?

    If by "the most number of people" you mean that we can treat dozens anyway we like b/c the knowledge will benefit tens of thousands then you are quite wrong. Despicably so.

  • What is particularly difficult to grasp in this case is what plausible harm you think the ubiome people were in danger of committing and how the research is now made more ethical by having them waste time and money filing an IRB despite not being required to.

    Secondly, if the real reason for IRBs really was about ethics (rather than the more prosaic purpose of having a paper trail to help in legal cases -- "See! This experiment was approved in review!"), why does every institution have their own system (are ethics that local?), and why are the rules generally not made public? (are they afraid the public would have different opinions as to what is ethical?).

  • (And can I just say, as someone who has had to pill a pet cat......grrrr)

    I am fucken awesome at pilling PhysioCatte! When I open the pill bottle, he comes running over and lets me grab him, pry his mouth open, and toss the pill into his throat. Once he swallows it, he then sits down next to me and starts purring.

  • drugmonkey says:

    why does every institution have their own system (are ethics that local?),
    not really, there is training, there is communication between IRBs, etc. They do not all stand alone.

    and why are the rules generally not made public?
    dunno what "rules" you mean but if you google, you can find a lot of documentation on IRB functions, procedures and rationales for their decisions.

    what plausible harm you think the ubiome people were in danger of committing
    giving information that would lead people to take steps with respect to their health that may be illadvised is an obvious problem. accidental release of personal data to the public is another easy one.

  • Grumble says:

    I guess the problem is that no one has an "ethical compass" as rarified as DM's, who apparently craps particularly fragrant compasses.

  • DrugMonkey says:

    No, I'm just a regular dude. Why are you so sure you and JB aren't below the mean?

  • dunno what "rules" you mean but if you google, you can find a lot of documentation on IRB functions, procedures and rationales for their decisions.

    As the linked SA blog posting notes, IRB protocols are *not* public -- you can find bits and pieces here and there, but the public *cannot* just download an complete protocol from an institution and implement it themselves freely. This doesn't seem ethical to me at all.

    giving information that would lead people to take steps with respect to their health that may be illadvised is an obvious problem

    This reminds me of the (thankfully) failed attempt several years ago by physicians to shut down public genomics services on the grounds that only they should be able to look at raw data. A similar argument was common by the closed-publishers near the beginning of the Open Access movement ("We can't have the public reading medical papers! They wouldn't interpret them correctly!") The idea that the public shouldn't have access to information they want that they paid for (either directly or indirectly through taxes leading to grants being funded) is what is unethical.

    accidental release of personal data to the public is another easy one.
    This at least is a semi-valid concern, but it isn't clear how *accidental* release (as opposed to "we plan to sell your data to Merck") is really a matter of ethics.

  • Informed consent to personal genomics/microbiomics studies requires a full understanding on the part of the human subjects that it isn't necessarily all just "GEE WHIZ! NEATO! SCIENZ!", but that they might become aware of facts about their genome/microbiome that are extraordinarily disturbing and/or life-altering. For example, you might find out that you have an incurable horrible degenerative disease, or that you aren't genetically related to people you thought you were, or that you are harboring microbes that make you highly susceptible to horrible illness, obesity, etc. Part of IRB review involves insuring that these sorts of possibilities are comprehensively explained to potential subjects.

  • Or you could just stop and maybe consider that the people signing up for these tests are probably not as stupid as implied and have thought about all these things *already*. This paternalistic idea that the public needs to be protected from knowledge reminds me of the medieval church and its prohibition against translating the bible into modern languages. And what does it really have to do with ethics anyway? Seems like a case of "mission creep".

  • DrugMonkey says:

    One of the major goals of IRB policy is to make sure subjects are *informed*, JB. Not to prevent them from knowledge but to make sure they are as aware of as much as possible. I am uncertain as to how you have managed to twist this into your paranoia about protection *from* knowledge.

  • commentariette says:

    Crowdfunding and open access will eventually lead to much better ethical standards than the very closed, bureaucratic IRB process, which is mostly about CYA paperwork, academic power games, and feeding the administrative beast. In itself, it has very little to do with ethics - it's a nod to the forms. Like attending church, it may or may not have anything to do with a commitment to trying to understand and do good.

    Crowdfunding inherently involves people thinking about what activities they want to support and whether the results meet their expectations. Their choices will more genuinely reflect society's sense of priorities and ethics than any closed university IRB can. Naturally, it will take time for mechanisms and conventions to develop (just as it did for IRB's) and there will certainly be missteps along the way (just as there were and still are for IRBs).

    But I think that to stand conservatively athwart history yelling 'Stop! research must be blessed by university IRBs (led by DM's infallible ethical compass) -- all else is barbarism ' is probably pointless.

    I think it's natural for a small, closed community like academia to end up focusing too much on their rituals (proposals, IRB, publication, tenure) as the source of morality or ethics. But it's not so healthy and it's good that technology enables more open models.

  • DrugMonkey says:

    Where did I say it had to be "university" IRB?

  • Burger says:

    I think there is some confusion regarding IRB "process" and IRB "protocols." The protocols refer to what's being done ... a lengthy (possibly hundreds of pages) detailed step-by-step description of an individual research project. Those aren't public. But they aren't secret either .... someone had to write them, had help writing them, the IRB has a record of them, the IRB members all read them (and discussed them openly in a meeting, the investigator's department chair had to sign off it and kept a record of it in the Dean's office, and the funding agency has assurances that this is all being done, and the protocols are likely subject to FOIA requests as are the IRB meeting minutes where it was discussed. The process is transparent ... you can go to any university's IRB and see exactly what the process is. You can read the federal register to see what the federal policies are regarding IRBs. I am highly skeptical of crowd sourcing scienzy woo and of anyone who complains of an IRB. If you think of the IRB process as a "CYA" exercise -- you speak for yourself and yourself alone. Everyone I know takes it seriously.

  • John says:

    You wrote:

    No. It is that we all are subject to subtle influences on our thinking. And we, as humans, have a very well documented propensity to see things our own way, so to speak. Even when we think we are being totally objective and/or professional. By the very nature of this, we are unable to see for ourselves where we are going astray.

    For me, this is the singular most important point of your piece. All too often more harm is done by the activist/advocate who genuinely believes they are doing righteous work and are totally unaware of the fact that they are corrupted by their own biases.

    Crusaders who think they are all-knowing or truly believe they are pure of intention and without bias can cause a lot of problems in all facets of society.

  • Zee says:

    Just a heads up that you got linked to from a major news blog about the ethical overview of crowd-funded science...

    http://dish.andrewsullivan.com/2013/08/09/can-scientists-make-it-alone-ctd/

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