In 2012, ten University of Chicago students studying abroad were hiking together in Punnai, India, when lightning struck. No one was seriously hurt, but everyone felt electricity jolt from the wet ground through their legs.

The following summer, one of the ten happened to intern at a company developing a novel, non-invasive device to measure nerve conduction. She wondered whether the singular event of a lightning strike could alter nerve conduction. Perfectly positioned to tackle this interesting question, the student asked me to mentor a project to test the students, nearly all of whom would be back on campus. I readily agreed.

We got to work seeking Institutional Review Board (IRB) approval for our research protocol. At institutions receiving federal research funding, IRB approval is required of any human-subject scientific research destined for journal publication. The idea is to treat subjects ethically, not to prevent science.

Yet two months later, the project and our enthusiasm for it lay dead—slain by the Byzantine process of IRB approval.

IRBs should of course minimize risk to human research participants. But they also should support research nimbly and expansively. That’s not happening.

Profound constitutional, political, and conflict of interest problems with IRB review have been beautifully articulated by many scholars (e,g., Hamburger 2016, Dreger 2015, Hehman and Salmon 2024). Less frequently covered are the ways that IRBs impede science and underestimate people’s interest in being the subject of research that yields no diagnostic or treatment benefit.

Consider the cases of two individuals with extraordinarily rare conditions—two people with whom I’ve had the incredible luck to collaborate.

Not only is Kim one-of-a-kind today, but she will be so for all time.

Since birth, Kim has never sensed touch, temperature, pain, itch, the position of her body parts (proprioception), or taste. After years of working together, we have learned that, rather than arising from one of her parents, Kim’s genetic condition came about de novo in an embryonic cell. That mutation was passed down to the mutated cell’s progeny cells. Meanwhile, all other cells in the embryo that became Kim and those cells’ progeny did not carry the mutation. That makes Kim a unique mosaic of mutated and un-mutated cells. Not only is Kim one-of-a-kind today, but she will be so for all time.

After a viral infection at age 19, Ian found himself unable to sense touch or experience proprioception below the neck (Cole 1991, 2016). Ian is one of about a dozen people who have experienced a similar sensory loss. Among them, he is the only one who taught himself to stand, walk, gesture, and carry on without proprioception. That makes Ian one-of-a-dozen or one-of-a-kind, depending on your lumper-splitter bent.

Enter the IRB.

IRBs are charged with, “when appropriate, [ensuring] there are adequate provisions to protect the privacy of subjects and to maintain the confidentiality of data.” The details of how to do this are left up to each institution’s board. Consistency is not a strong suit of IRB regulation. Some require that researchers completely de-identify research participants by calling them AA, BB, CC, and so on. Others are okay with using subjects’ initials.

Because I work with researchers from other institutions, our work is sometimes governed by multiple boards. One of the IRBs that we used to study Kim was from an institution where the “AA” route was required. Asked how she felt about this “protection” of her, here’s how she responded:

“It is my desire to be identified by my first name, Kim, in research papers about my neurological condition. I want the world to know my unique story and all that I have experienced. The only way to accomplish this goal is to identify myself. I have made this decision on my own after careful consideration and with no undue influence from any research team member. I am fully cognizant of and comfortable with any associated risks.”

I laughed, recognizing the wording for the legalese that it was. Worthy of Kim-the-lawyer’s training and skills.

Armed with what I saw as a beautifully articulate appeal, we went back to the IRB. No go. The IRB reiterated that Kim would have to be “AA,” not Kim, in any publication covering the work that had been conducted at that institution.

Reflecting the full absurdity of this situation, my parent IRB is fine with Kim being Kim. Thus, sometime in the future, when all articles involving our collaboration are published, the publication on AA will refer to other publications that honor Kim’s request to call her by name.

For Ian, the situation is even more ridiculous.

Anyone who has read either of Jonathan Cole’s books on Ian (Pride and a Daily Marathon, MIT Press, 1991; Losing Touch, Oxford University Press, 2016) or seen the 1997 BBC documentary The Man Who Lost His Body knows about Ian Waterman. Jonathan drafted Pride using “IW,” a form of initializing common in the biomedical literature. The manuscript’s editor suggested naming Ian and, as Ian was amenable, the switch was made. From that time forward, it became patently absurd to anonymize Ian elsewhere.

A beneficent motivation does not mitigate the infantilization and disenfranchisement inherent to the “protection.”

What emerges from these stories is a lot of happenstance and no principle. Actual ethics have been lost to ethics performance. Surely a research participant’s wishes should be relevant to how we treat them. Surely it is appropriate to put aside a requirement for privacy if the subject desires to be known. Dictating privacy for a person who wants to be seen is sheer hubris, even if well-intentioned.

“The disability paradox” is the term given to the phenomenon whereby a person with disability has a higher quality of life—close to control values on average—than people without the disability estimate it to be. IRB members appear to be suffering from this as they worry about, perhaps even pity, and ultimately commit to “protecting” ill and disabled people participating in human research, whether they desire such protection or in fact actively reject it. A beneficent motivation does not mitigate the infantilization and disenfranchisement inherent to the “protection.”

Notably, IRBs extend their mandate of purportedly protecting people to protecting the “data” collected from those people. Chief among the concerns are that data (1) not be released to people outside of the study team and (2) be either destroyed or de-identified once the study is completed. While these goals appear reasonable on the surface, they reflect a narrow philosophy: data serve a particular purpose to be accomplished by a particular group of scientists.

But data from rare individuals should not belong to any one research team or to any one era. Others now and in the future may come up with novel questions or innovative methods. It is to everyone’s advantage that those questions be addressed and those methods be utilized. The IRB’s philosophy of tightly demarcated data usage is incompatible with the benefits to society that accrue from knowing and seeing individuals with ultra unusual conditions, who, by the way, want to be seen. Not just today but for the long term.

To this end, my colleagues and I have sought to create a sustainable, accessible archive of original data collected from Kim and Ian with the ultimate aim of extending this database to other individuals with rare conditions. It remains to be seen whether the censorious IRB attitudes toward research participants and the data collected from them will ultimately obstruct our efforts.

I still regret that we will never know whether lightning subtly alters nerve function. We missed a serendipitous chance to answer an interesting question and to stoke the development of a budding scientist. And for what? Nothing valuable was gained—no privacy, no consistency, no benefit to science, and certainly no respect for all the Kims and Ians out there.

The author thanks Kim, Jonathan Cole, and Baddr Shakhsheer for their comments on this essay’s manuscript.

Article Image “66 Degrees,” self portrait by Riva Lehrer (used with permission).