IRB Chair: 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 notifiy
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. RIO: Well, yeah. All of the subjects’ BUN/creatinine
numbers are the same here. IRB Chair: 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 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 advance integrity in research. It’s up
to you to figure out how.