Taking a Crisis Seriously

Two decade-defining crises ago, in the aftermath of September 11, there was a brief period of intense public debate about the ethics of torture. One trope that regrettably recurred in those debates was the ticking time bomb: what if the only way to find and disarm a nuclear device in a major city was to torture one of the terrorists responsible? It turned out that 24 was a poor guidebook for national security policy: the United States tortured prisoners on a vast scale, some of whom were completely innocent victims of mistaken identity, for negligible public benefit, and we are still dealing with the terrible consequences of that terrible decision.

But although its application to torture was a moral and policy catastrophe, the general form of the argument is sometimes valid. In a true national crisis, when time is of the essence, strict adherence to rules is sometimes indefensible. When lives are on the line, either the law should bend to allow swift preventative action, or those charged with enforcing the law should ignore it in service of the greater good.

This isn’t universal. True crises are rare. Some rules, like the rule of law and essential human rights, are so fundamental they must be upheld even in crises. And a rationally structured response is almost always better than throwing the rulebook out the window and choosing anarchy as a strategy. The point is only that sticking to rules just because they are the rules in a true crisis is a failure to take the crisis seriously.

Case in point:

As luck would have it, Dr. Chu had a way to monitor the region. For months, as part of a research project into the flu, she and a team of researchers had been collecting nasal swabs from residents experiencing symptoms throughout the Puget Sound region.

To repurpose the tests for monitoring the coronavirus, they would need the support of state and federal officials. But nearly everywhere Dr. Chu turned, officials repeatedly rejected the idea, interviews and emails show, even as weeks crawled by and outbreaks emerged in countries outside of China, where the infection began.

It appears there were two objections. First, there was a regulatory game of buck-passing over which laboratories could perform coronavirus tests:

But there was a hitch: The flu project primarily used research laboratories, not clinical ones, and its coronavirus test was not approved by the Food and Drug Administration. And so the group was not certified to provide test results to anyone outside of their own investigators. They began discussions with state, C.D.C. and F.D.A. officials to figure out a solution, according to emails and interviews. …

C.D.C. officials repeatedly said it would not be possible. “If you want to use your test as a screening tool, you would have to check with F.D.A.,” Gayle Langley, an officer at the C.D.C.’s National Center for Immunization and Respiratory Disease, wrote back in an email on Feb. 16. But the F.D.A. could not offer the approval because the lab was not certified as a clinical laboratory under regulations established by the Centers for Medicare & Medicaid Services, a process that could take months.

This reverse turf war between CDC, FDA, and CMS delayed testing for two weeks, until the Seattle Flu Study simply went ahead and started testing without government approval of the test. Dr. Chu and her colleagues took the crisis seriously; the government agencies whose job it is to take public health crises seriously did not.

The second problem was an issue of research ethics:

On a phone call the day after the C.D.C. and F.D.A. had told Dr. Chu to stop, officials relented, but only partially, the researchers recalled. They would allow the study’s laboratories to test cases and report the results only in future samples. They would need to use a new consent form that explicitly mentioned that results of the coronavirus tests might be shared with the local health department.

They were not to test the thousands of samples that had already been collected. …

On March 2, the Seattle Flu Study’s institutional review board at the University of Washington determined that it would be unethical for the researchers not to test and report the results in a public health emergency, Dr. Starita said. Since then, her laboratory has found and reported numerous additional cases, all of which have been confirmed.

Credit is due to the UW IRB for correctly recognizing the ethics of the situation. Where the federal regulators thought that the interests of the patients who had provided samples prohibited repurposing them to track the spread of coronavirus, the IRB saw that testing the samples for coronavirus was not just ethically allowed but ethically required. But it should not have taken until March to m