Chapter 3. DIYbio and Human Subjects Research

Michael Scroggins

In what follows, I am going to float a thought balloon: DIYbio laboratories should think through their relationships with Title 45 Code of Federal Regulations Part 46, informally known as the "Common Rule", which establishes the existence of institutional review boards (IRBs) for research involving human subjects. I think there are two related reasons for doing so.

First, DIYbio is quickly pushing into research involving human subjects. The GETit Project and the Immunity Project point to medical clinical research as an emerging direction for DIYbio research, and certainly there are others in the planning stage. This is not surprising, given that biology is an unusually broad discipline and DIYbio is more than just an amateur version of synthetic biology, even though it is often portrayed as such.

But medical and clinical research is a field with a long and complicated history that warrants caution. Scientists have experimented on themselves and those close to them since time immemorial. Jonas Salk, for instance, first tested his polio vaccine on himself, then on his family, then on children at the Watson Home for Crippled Children in Sewickley, PA, then on residents of Sewickley, and then on a few traveling friends and family members. Beginning with his own body, Salk’s vaccine spread outward in an ever-expanding circle.

In contrast to Salk’s success, Stubbins Ffirth, an 18th-century medical apprentice, was convinced that yellow fever was not a contagious disease but rather the result of hot weather and bad temper. He "proved" his point by consuming bodily fluids produced by yellow fever patients. Luckily for Ffirth, the fluids came from patients who were no longer contagious and Ffirth survived his ill-considered experiment.[1] Unsurprisingly, Ffirth was unable to convince others to join in his experiment, leaving his a lonely circle. But, experimentation on the self and those physically and emotionally close remains at least a constant possibility, if not normal practice. Even the BioCurious motto, "Experiment with Friends," points to the ubiquity of this idea.

But there is a power discrepancy at work here. Salk and his colleagues may have understood the risks of his polio vaccine (though it is certain that Ffirth did not understand the risks of eating infected vomit), but it is less likely that Salk’s family understood the risks and even less certain that the children at the Watson Home or their parents understood the risks. An IRB, in the broadest sense, is intended to protect both Ffirth from himself and Salk’s family and the children of the Watson Home from Salk’s enthusiasm by ensuring that everyone involved in biomedical or psychological research is fully informed about the possibility of risks and rewards at each step of the research process.

So, the IRB was established because of very real abuses in the power discrepancy between researcher and researched. The worst abuses were perpetrated by Nazi medical experiments, which led to the Nuremberg Code. But there have been many abuses carried out by otherwise well meaning but overly enthusiastic researchers. The Wikipedia page on unethical human experimentation in the United States is very comprehensive on this point, so I will refer you there instead of recounting the numerous abuses here. But, keep in mind that most of the experimenters listed set out with the best of intentions.

For-Profit IRBs

Second, the recent rise of for-profit IRBs to prominence has undercut the ethical purpose of the IRB in two ways: first, by allowing IRB shopping, and second, by creating a market incentive to green-light research that would not otherwise pass. If one IRB rejects a study for being too risky, then it is a simple matter of paying another company to review the proposal until one that will green-light the project is found. The problems with for-profit IRBs have been written about in both PLOS and The Lancet, in addition to the popular press. Unlike institutional IRBs, for-profit boards have no oversight, and conflicts of interest involving IRB members and companies sponsoring the research before the IRB can be hidden behind the corporate veil.

The problems with for-profit IRBs were exposed by a US Government Accountability Office (GAO) sting using the fake drug Adhesiabloc. Briefly, Adhesiabloc was a fake product from a fake company produced by fake researchers. The research proposal was turned down by two for-profit IRBs, but approved by a third—Coast IRB. The fake proposal described a gel to be administered post-surgery into a patient’s abdominal cavity to reduce scarring by absorbing debris left after surgery. Adhesiabloc flew through the IRB process at Coast IRB, but it was not the only fake research approved. Mercifully, Coast IRB was forced to close after the GAO investigation.

If there was ever a process (other than the patent process) that could use openness and transparency, it is the IRB. An open source IRB process is possible and would bring some welcome transparency to an often opaque system. With DIYbio already heading quickly toward human subjects research and the world of for-profit IRBs offering expensive, if not objective, reviews, now is the time for DIYbio laboratories to carefully consider establishing a relationship with the Common Rule.

[1] Stubbins Ffirth, "A Treatise on Malignant Fever: With an Attempt to Prove Its Non-Contagious Nature" (thesis, University of Pennsylvania, 1804).