On Internalizing the Ethical Standards of Scientific Research

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.
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*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