The Ethics of Self-Experimentation

Self-care is a civil right

AI conception of self-care

The term “self-care” gets a bad rap. My AI defines it as:

The ability to care for oneself through awareness, self-control, and self-reliance to achieve, maintain, or promote optimal health and well-being.

That sounds great, but if I follow up with the prompt “are there derisive meanings” I get:

Self-care is sometimes mocked as code for pampering, consumerism, and “treating yourself” (e.g., spa days, expensive products) rather than substantive efforts to improve health or functioning.

I confess that when I free-associate self-care the first thing that comes to mind is Goop. I’m not a subscriber.

The basic problem with the term self-care is the same as the problem with science in general. Science is a strong-link problem, not a weak-link problem. The scientific method gives us a way to identify strong links that don’t break under experimental testing. The trouble is the strong links are often hidden under an immense pile of weak links. It’s the classic “diamonds in a dung heap” formulation that Thomas Jefferson used to describe his efforts to find wisdom in the Bible.

In short, the existence of lots of useless crap in the self-care arena absolutely does not mean that everything in the arena is crap. Careful use of the scientific method can help us sort out the diamonds. By which I mean developing hypotheses that comport with available evidence and then doing experiments that test the hypotheses. Here, Thomas Jefferson missed a diamond. When the Declaration of Independence talked about unalienable Rights, it should have said, “Life, Liberty, and the pursuit of Experiments.”

All this may sound so obvious it doesn’t warrant spelling out, but this week I’ve been wrestling with the fact that an institutional ethics committee rejected a self-care proposal in which I would bring vaccine yeast home from the lab, brew beer with it, and then prick my own finger to see if I developed any antibodies. After the institutional veto, I resorted to setting up a shoestring molecular biology lab at home, re-creating the needed yeast using only my own personal resources, and drinking vaccine beer in the comfort of my kitchen. To my surprise, the ethics committee is now arguing that because the kitchen self-care experiment is scientifically “related” to my official duties it should be viewed as unauthorized human subjects research - a form of misconduct that can be grounds for termination.

The idea that an institution might have the legal authority to veto “work-related” menu planning in an employee’s home kitchen is prima facie ridiculous. How did we get into a situation where an ethics committee thinks this argument sounds even remotely reasonable?

My brother and I struggled mightily with this question when writing up our home vaccine beer projects. We think the answer boils down to a badly written section of a law called the Common Rule. After huge amounts of email and Facetime back-and-forth (my brother and I love to debate) we hammered out Appendix A - which presents our considered layman’s analysis of the Common Rule and the history behind it. I guess Appendix A comes off as a little bit stiff and scattered - you can kind of tell it was written by committee. I’ll reproduce the scholarly text in its entirety in the footer, but up here in the main post I’ll try to briefly summarize my individual view of the controversy in more conversational terms.

For anybody who’s unfamiliar with the concept of an Institutional Review Board (IRB), I recommend Scott Alexander’s epic tale, “My IRB Nightmare.” Even for people who are familiar with IRBs, Alexander’s classic post can help emphasize the point that the nightmare I’m describing here isn’t unique.

The basic idea behind the Common Rule is that if scientists are allowed to do whatever experiments we want then some of us might prioritize our own research interests over the individual best interests of study volunteers. A scary thing is that abuse of study subjects can be accidental - a scientist might simply fail to adequately inform study subjects about risks, leaving subjects poorly equipped to defend their own individual interests. It’s a serviceable description of what happened in the insidious Tuskegee Study of Untreated Syphilis - where scientists quietly withheld penicillin from black men with latent syphilis. The Common Rule addresses a real and very serious problem by applying the entirely reasonable approach of requiring scientists to get a second opinion from a neutral third party (an IRB) on research study designs involving human subjects. An central element of IRB review is to ensure that study subjects know what they’re getting into - meaning their consent to participation in the study is well-informed.

The Common Rule grew out of an earlier analysis called the Belmont Report, which was commissioned in direct response to the Tuskegee Study. The Report establishes a clear distinction between routine individual healthcare and scientific research. Unfortunately, the line is blurry because individual healthcare sometimes uses the tools of scientific research. Here’s how the Report describes the problem:

The distinction between research and [healthcare] practice is blurred partly because both often occur together (as in research designed to evaluate a therapy) and partly because notable departures from standard practice are often called “experimental” when the terms “experimental” and “research” are not carefully defined.

So far, so good. Where stuff hits the fan is with the Common Rule’s un-careful definition of the term “research.”

Research means a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge.

Lawmakers intended for their specialized legal definition of research to reinforce the Belmont Report’s exclusion of individual healthcare from human subjects review, but they evidently failed to appreciate the fact that individual healthcare is often at least somewhat systematic and it sometimes contributes to generalizable knowledge (e.g. the scientific publication of case reports). Lawmakers also failed to foresee that scientists and institutional administrators might intuitively drift back to the dictionary definition of research:

Studious inquiry or examination; especially: investigation or experimentation aimed at the discovery and interpretation of facts, revision of accepted theories or laws in the light of new facts, or practical application of such new or revised theories or laws.

If my doctor did not apply the dictionary definition of research to my individual healthcare I’d find a new doctor, pronto! A consequence of the Common Rule’s sloppy definition of the term research is that many modern institutions have fallen into the groupthink belief that the IRB’s purview includes any form of research that in any way involves human subjects. Employees screwing around with beer on the weekends? You betcha! That’s human subjects research, alright! Watch out, America’s Test Kitchen - the bioethics police may be coming for you next.

When the problem is seen through the individual healthcare lens, it becomes clear that the Common Rule never intended to interfere with self-care. The Common Rule was actually intended to prevent research institutions from interfering with individual medical treatment, including self-care. The groupthink failure to understand the sloppy legal definition of “research” has put us into a situation where ethics committees are making bids to replicate the medical withholding abuse of Tuskegee - instead of their actual charter to prevent it.

It’s important to note that self-care includes well-being. If it makes me happy to drink vaccine beer, prick my own finger, and test my own blood then ethics committees have no business demanding an IRB review to determine what I can or cannot do with my own body. The law allows institutional ethics committees to argue that a given experiment isn’t a scientifically useful way to spend institutional resources, but it’s unethical (and arguably illegal) for them to demand veto authority over individual healthcare activities.

An additional risk is that bioethics authoritarianism can needlessly inhibit scientific progress. That’s immoral too.

I believe it’s my civic duty to tell bioethicists to butt out of my self-care. Even if it means they try to fire me [1].

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Song of the day:

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[1] There’s a special place in my heart for Sister Sally Butler: “This is my church. If they don’t like it, they should leave. I’m not going to leave just because of the hierarchy,” Butler says. “But if I stay, I have to try to clean house.”

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Appendix A: Self-experimentation does not meet the specialized legal definition of human subjects research

A federal law known as the Common Rule requires that research involving human subjects be pre-approved by an Institutional Review Board (IRB). Although a plain language analysis might intuitively suggest that the current study is a research project that involves a human, it is important to be aware that the Common Rule uses highly specialized definitions of the terms “human subjects” and “research.” In this Appendix, I argue that self-experimentation does not meet these definitions.

The Common Rule was established as a response to instances in which investigators abused research subjects by performing procedures without consent (such as in the Nazi atrocities) or by withholding information and treatments (such as in the Tuskegee Study). Common Rule section 45 C.F.R. § 46.102(e)(1) defines the term “human subject” based on a relationship between a living individual and an investigator conducting research.

(1) Human subject means a living individual about whom an investigator (whether professional or student) conducting research:

(i) Obtains information or biospecimens through intervention or interaction with the individual, and uses, studies, or analyzes the information or biospecimens; or

(ii) Obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens.

When one individual investigates his own body, there is no potential for an abusive investigator-subject relationship. There is a legal rule known as the absurdity doctrine, which states that a statute is not being interpreted correctly if the interpretation defies common sense. Since it is impossible for a self-experimentor to fail to obtain his own consent, the idea that the Common Rule regulates self-experimentation fails the absurdity doctrine. A single investigator cannot be his own subject any more than he could marry himself or sign as both promisor and promisee in a legal contract.

We can gain further insight into legislative intent by considering the Belmont Report (NCPHSB, 1979), which served as the ethical foundation for the Common Rule. A key principle enunciated in the Report is Respect for Persons:

To respect autonomy is to give weight to autonomous persons’ considered opinions and choices while refraining from obstructing their actions unless they are clearly detrimental to others. To show lack of respect for an autonomous agent is to repudiate that person’s considered judgments, to deny an individual the freedom to act on those considered judgments, or to withhold information necessary to make a considered judgment, when there are no compelling reasons to do so.

IRB disapproval of self-experiments would be a violation of this principle, because it would obstruct the self-experimentor’s actions even though those actions are not clearly detrimental to others. The fact that regulation of self-experiments violates core ethical principles the Common Rule is based on provides further evidence that self-experimentors do not meet the legal definition of human subjects.

Even if one were to accept the proposition that investigators can serve as their own subjects, self-experimentation in pursuit of individual healthcare would still fail to meet the legal definition of the term “research.” The Belmont Report describes individual healthcare practices as:

designed solely to enhance the well-being of an individual patient or client and that have a reasonable expectation of success.

The distinction between healthcare and research is based on whether the treatment (or lack of treatment) is based solely on what is best for a particular individual’s health. If a self-experimentor would have given themselves the treatment for their own health or well-being anyway, then the activity qualifies as healthcare practice, not research. It’s important to note that a self-experimenter is better positioned to judge what serves his own health and well-being than any third party.

The Belmont Report explicitly acknowledges that experimental procedures can be an integral part of personal healthcare:

When a clinician departs in a significant way from standard or accepted practice, the innovation does not, in and of itself, constitute research.

The Report, and the Common Rule law that sprang from it, do not demand institutional review of individual healthcare activities, even in cases where a healthcare practitioner makes use of the scientific method. This makes sense, from the standpoint that institutionalized interference with personal healthcare activities is one of the problems the Common Rule was designed to solve.

The purpose of this study is to investigate the effect of a food-grade bioengineered BKV yeast product on my own well-being and to investigate the effect of the food on the structure and function of my immune system. Although the study does not investigate disease, it is conceivable that immune-mediated suppression of non-pathological BKV infection could have general health effects, such as improved feelings of well-being or maintenance of the healthy structure and function of my urinary tract (the primary site of common asymptomatic BKV infection). I also hope that eating BKV VP1 yeast might support general innate immune responses that could promote my well-being (Zhang et al., 2026). Pursuit of these possible immune system structure-function benefits serves my individual health interests.

When designing the study protocol, I anticipated that the experiments might be publishable. I do not view this as a valid standard for triggering IRB review, because neither the Belmont Report nor the Common Rule mention publication as a defining factor in the distinction between healthcare practice and research. Publication cannot serve as a bright line standard because physicians often publish case reports about individuals they’ve treated as part of normal healthcare practice without IRB review.

In summary, self-experiments designed to support my own well-being fail to meet the legal definition of human subjects research on multiple counts. This supports the common sense view that I am not required to request IRB permission to pursue my personal healthcare goals using my own resources in my free time.