Whose Business Is It If You Want a Bee To Sting Your Penis? Should IRBs Be Policing Self-Experimentation?

by Michelle Meyer, Bioethics Program Faculty.

You might think that the answer to the titular question is pretty obvious. Obviously, it’s your business, and yours alone if you want to induce a bee to sting your penis? Right? I mean, sure, maybe it would be considerate to discuss the potential ramifications of this activity with your partner. And you might want to consider the welfare of the bee. But other than that, whose business could it possibly be?

Well, it turns out that, depending on who you are and why you want to induce a bee sting to your penis, the answer may be: a committee of your peers. As academics whose research involves other human beings know, what others can do freely, they often require permission to do. When you study humans and your research is funded by the federal government, before you can conduct your study — in fact, before you can even recruit a single subject for it — you must submit all of your research plans to your institution’s Institutional Review Board (IRB) for ethics review. Indeed, you must do this even if your research is not federally funded but you work at a college or university that receives federal research grants and is among the 75-90% of such institutions that has promised the federal government that it will require IRB review of all the human subjects research that its students and faculty conduct.

IRBs are designed to provide a neutral, third-party review of research in large part in order to counteract the built-in conflict of interest that researchers have. The IRB system has lots of flaws, but the basic idea is sound. Researchers have lots of reasons for studying other humans, among them scientific curiosity, financial rewards, the pressures and prospects of tenure and promotion, and the desire for fame (or what passes for fame in the small pond of academe, anyway). In pursuing these benefits for society and for themselves, however, they usually impose risks and costs on their subjects (or participants, as they are now most frequently called). Investigators have lots of reasons to proceed with a study, and to characterize it as not-very-risky to people that the investigator needs to agree to participate.

But only academic researchers (and drug and device manufacturers) are subject to IRB review, and ironically, only when their motive in engaging in an activity is to learn something useful and generalizable. And so journalists, for instance, can ask potentially traumatizing questions to children without having to ask whether the risk to children of interviewing them is justified by the expected knowledge to be gained; academics, by contrast, have to get permission from their institution’s IRB first (and often that permission never comes).

So, too, it turns out, with potentially traumatizing yourself — at least if you’re an academic who’s trying to induce a bee to sting your penis in order to produce generalizable knowledge, rather than for some, um, other purpose.

Yesterday, science writer Ed Yong reported a fascinating self-experiment conducted by Michael Smith, a Cornell graduate student in the Department of Neurobiology and Behavior who studies the behavior and evolution of honeybees. As Ed explains, when, while doing his other research, a honeybee flew up Smith’s shorts and stung his testicles, Smith was surprised to find that it didn’t hurt as much as he expected. He began to wonder which body parts would really smart if they were stung by a bee and was again surprised to learn that this was a gap in the literature. So he decided to conduct an experiment on himself. (In addition to writing about the science of bee stings to the human penis, Ed is also your go-to guy for bat fellatio and cunnilingus, the spiky penises of beetles and spiders, and coral orgies.)

As Ed notes, Smith explains in his recently published paper reporting the results of his experiment, Honey bee sting pain index by body location, that

Cornell University’s Human Research Protection Program does not have a policy regarding researcher self-experimentation, so this research was not subject to review from their offices. The methods do not conflict with the Helsinki Declaration of 1975, revised in 1983. The author was the only person stung, was aware of all associated risks therein, gave his consent, and is aware that these results will be made public.

As Ed says, Smith’s paper is “deadpan gold.” But on this point, it’s also wrong.

Most obviously, were Cornell to lack a specific policy about self-experimentation, that would not mean that it possesses a policy exempting self-experimentation from IRB review. As Cornell’s Office of Research Integrity and Assurance correctly notes, although

[f]ederal regulations are silent on the matter of researchers who want to participate in their own studies. . . . , the regulations do not distinguish between self-experimentation and research on people who are recruited for a specific project.

And in fact Cornell, like many other institutions (including Johns Hopkins, the University of Wisconsin-Madison, and Georgia Tech), does have a policy (last updated in October of 2013) requiring researchers to obtain IRB approval before experimenting on themselves:

As part of its commitment to the protection of the rights and welfare of individuals participating in research, Cornell’s Human Research Protection Program requires investigators who wish to act as participants in their own studies to submit for review and approval following standard procedures outline in the IRB policies.

Though investigator self-experimentation may not raise the conventional ethical concerns outlined in the Belmont Report, all human research projects should undergo ethical review to assure the safety of people involved and the integrity of the research at the university. While researchers may be aware of the risks of self-experimentation, they may also be more willing to accept risks that are ill-advised. Application for review with the IRB office allows a neutral third party to raise concerns and/or propose measures to promote the welfare of researchers.

According to his paper, Smith’s research “is based on work supported by a United States National Science Foundation (NSF) Graduate Research Fellowship.” But even if it weren’t federally funded, it wouldn’t matter. Cornell filed a FederalWide Assurance (FWA) with DHHS’s Office for Human Research Protections (OHRP) promising to apply the same federal regulations to all human subjects research, regardless of funding (see #5 here).

Of course, to come within the IRB’s jurisdiction, an activity not only has to involve human subjects; it also has to constitute “research” — “a systematic investigation . . . designed to develop or contribute to generalizable knowledge.” Did Smith’s bee sting adventure fit the bill? Here’s Ed again:

Smith was methodical. He collected bees by grabbing their wings “haphazardly with forceps” and pressing them against the body part of choice. He left the stinger there for a full minute before removing it, and then rated his pain on a scale of 1 to 10. . . . He administered five stings a day, always between 9 and 10am, and always starting and ending with “test stings” on his forearm to calibrate the ratings. He kept this up for 38 days, stinging himself three times each on 25 different body parts.

Sounds systematic to me. What about “designed to contribute to generalized knowledge”? Ed again:

Now, clearly, these data are very subjective, and they all come from one person. Smith is clear that his anatomy of pain can’t be generalised to everyone else. “If someone else did this, they’d probably have different locations that they felt were worst”, he says, although from talking to his colleagues, he feels that the rough shape of the map would be similar. “I didn’t see a lot of merit in repeating this with more subjects,” he says.

But Smith’s pain map being identical to everyone else’s is hardly the only way that his experiment could lead to generalizable knowledge. And anyway, “generalizable knowledge” is a notoriously fuzzy concept in IRB review. In determining whether an activity will contribute to generalizable knowledge, Cornell’s IRB, like many, uses the proxy of asking whether it will “be used in a publication, presentation, or achievement of a degree.” Smith’s study pretty clearly passes that test.

My point in noting Smith’s error about his institution’s IRB policy is not to cause trouble for him or to impugn his character. To the contrary, I think requiring IRB review for all self-experimentation is absurd. And it’s worth highlighting absurd laws and policies.

But maybe Cornell has a point when it notes that researchers “may . . . be more willing to accept risks that are ill-advised.” In discussing the list of body parts that he tested, Smith told Ed that he “had originally had the eye on the list, but when I talked to [my advisor], he was concerned that I go blind. I wanted to keep my eyes.”

But it’s not surprising that researchers might pose undue risks to themselves or make other unwise decisions. All of us have the potential to do that. And there are a variety of mechanisms for trying to reduce the chances that people will take bad risks. A faculty advisor who pressures a graduate student to engage in risky self-experimentation might be disincentivized from doing so by faculty guidelines or disciplinary procedures, for instance.

The question isn’t whether or not to try to deter unduly risky behavior by scientists who self-experiment; it’s whether this goal requires subjecting every instance of self-experimentation, no matter how risky, to mandatory, prospective review by a committee. It’s one thing to require a neutral third party to examine a protocol when there are information asymmetries between investigator and subject, and when the protocol’s risks are externalized onto subjects who may not share much or any of the expected benefits. Mandatory review of self-experimentation takes IRB paternalism to a whole other level.

What do you think?

(Incidentally, the penis shaft turns out not to be the most painful place in which one can be stung (and as suggested above, the testicle wasn’t even close). Check out Smith’s paper or Ed’s post on it to see which two body parts won that particular contest.)

[This blog posting originally appeared in edited form on The Faculty Lounge on April 3, 2014. The contents of this blog are solely the responsibility of the author alone and do not represent the views of the Bioethics Program or Union Graduate College.]

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