The overregulation of science

To the outsider, scientific research might seem like a boring parade of spreadsheets and test-tubes. It isn’t. Research is often hard, repetitive, and slow-moving. But the grueling work in the trenches is punctuated with lightning strikes of brilliance that can be game-changers. These moments must be acted on while the enthusiasm, the opportunity, and the ideas are hot. Carpe Cogitationem!

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Forces that discourage brilliant action and timely investigation of hypotheses are bad for science. One such force is excessive regulation. When rules and regulations are illogical and overly burdensome, their primary effect is to dampen enthusiasm for research and to delay scientific progress. In the realm of medical research with human subjects, the Institutional Review Board (IRB) is often the culprit. To get a sense of the costs of over-regulation by the IRB, it is instructive to look back to episodes that predate the IRB entirely, predate the modern all-encompassing IRB, or were outside the IRB’s purview.

In 1929, in a hospital in Eberswalde, Germany, Werner Forssmann, a medical intern, made an incision in his own arm vein and fed a long catheter up his vein and all the way into his own heart. Such techniques had previously been attempted on animals, but this was the first recorded instance of a catheter being inserted into the heart of a living person. We know that it happened because Forssmann was careful to obtain X-ray evidence of his feat. He was motivated in part by pure scientific curiosity but was also acting with the hope that, once perfected, the method could be used to study the workings of the living heart by taking blood and tissue samples from, and delivering drugs directly to, it.

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Forssmann had been warned by colleagues and supervisors not to attempt the technique on others or on himself. He may have been insubordinate, but he was not acting recklessly. He was familiar with the relevant animal experiments and had good reason to expect that he would succeed. He was confident that his procedure was reasonably safe and important, so he persevered. There were no ethics panels nor any government regulations to satisfy. His audacious—if impatient—experimentation ushered in the field of cardiac catheterization.

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