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It was not the finest hour for clinical research at this institution. An audit of a melanoma
trial uncovered several deviations from protocol. Suspicions of falsification and fabrication
prompted the IRB to notify the hospital-affiliated Research Integrity Officer.
As IRB Chair, I met with the RIO myself.
We think they just made up a lot of their data.
Well, yeah. All of the subjects' BUN/creatinine numbers are the same here. Plus there's a
subject who apparently dropped out but they kept recording labs for?
There were also the questionable premature deaths of two subjects, and a lawsuit by another
participant's family. An internal investigation was initiated, but that was just the beginning
of the fallout.
Key trial figures were suspended. Namely, the investigator,
and the clinical research coordinator, and the president of the hospital was left to
deal with calls from the media, threats of donors withdrawing millions in research endowments,
and concerns from the hospital counsel over liability
How did this happen? Along the way, there were people involved with this study who didn't
follow protocol, turned a blind eye to misconduct, didn't effectively practice oversight and
falsified or fabricated data.
But you know what? It didn't really happen. I mean, it did, but it didn't. You see, in
this movie, unlike real life, you get to go back in time. You can become an investigator,
a clinical research coordinator, a research assistant, and an Institutional Review Board
Chair.
You get a chance to enter an alternate reality as any of these characters. Walk in their
shoes, experience their lives, and figure out how to make the ethical decisions that
will advance integrity in research. It's up to you to figure out how.