Justin Coffeen on Why Blame-First Sites Underreport

Accountability and blame are not the same thing, and Justin Coffeen says the difference between them decides how much a research site ever finds out about its own problems.

What this episode covers

  • Why an explicit mission removes decision paralysis when two priorities compete
  • Participant safety and data integrity as the two outcomes everything else serves
  • What accountability without blame looks like inside a well-run unit
  • How blame-first site cultures produce underreporting and compounding problems

The reporting culture decides the data

A site where surfacing a deviation reliably results in scrutiny of whoever surfaced it has taught its staff a lesson it did not intend to teach. The deviations do not stop. They stop being reported early, which is the only point at which they are cheap to fix.

Justin Coffeen served in a United States Air Force medical unit from 2017 to 2020, and the model he took from it was not discipline in the abstract. It was the practice of directing the analysis at the system rather than at a person.

That distinction has a measurable effect in research. Teams that treat an honest report as the professional response collect better information, catch patterns earlier, and correct them while the correction is still small.

What an explicit mission does under pressure

Most difficult decisions at a site are not difficult because the answer is unknown. They are difficult because two legitimate priorities are competing and nobody has said out loud which one yields.

Naming participant safety and data integrity as the mission settles that in advance. Coffeen’s point is that a team which has already worked out its hierarchy of priorities does not have to relitigate it at four on a Friday, which is precisely when the question tends to arrive.

The practical test Justin Coffeen applies fits on one line. Watch what happens to the first person at a site who reports something inconvenient, then count how long it takes the second one to speak up.

Transcript

I was in the Air Force for three years. Medical unit. And when I got out, I went into clinical research, which on the surface might look like a pretty significant pivot, but honestly, the more time I spend in research, the more I see the parallels.

Let me start with something that might sound obvious but I don’t think is obvious at all: mission definition. In the military, the mission is explicit. Everyone knows what it is. Every decision gets measured against it. And here’s what that does for you, it removes the ambiguity when you’re under pressure. You don’t have to figure out which thing matters more when two things are competing for your attention. The mission already told you.

In clinical research, I’d argue the mission is patient safety and data integrity. Those two things, together, are the point of everything else we do. The protocols, the regulatory binders, the monitoring visits, the adverse event reporting, all of that machinery exists to serve those two outcomes.

So when I’m in a situation where there’s pressure to let something slide, a deviation that could be handled quietly, an adverse event that could be interpreted as outside the reporting window, whatever it is, I go back to the mission. Is this in the interest of participant safety? Is this in the interest of data integrity? That’s not a philosophical exercise. That’s the operational question.

The other thing the Air Force gave me was a working model of what accountability without blame actually looks like. And I know that sounds counterintuitive, the military has a reputation for punitive accountability. But in a well-run unit, when something goes wrong, the question is what happened in the system and how do we fix it, not who do we hold responsible.

That matters enormously in research, because sites that run on blame-first cultures underreport. People hide problems. Things compound. Sites that make it safe to surface problems honestly get better information and run better studies.

I’m based in Lakewood Ranch, Florida, and I think about these things a lot, how the operational disciplines from military service translate into research practice. Because they genuinely do.