We Were on a Break! (And Other Protocol Deviations)
What happens when clinical trials go off script—and how IRBs help bring them back on track
The show Friends is about a group of 20 somethings who are living in New York City and just trying to navigate life. For many young adults, there are times when expectations aren’t quite met, and they find themselves going down uncharted territory.
One such time was when Ross and Rachel were infamously “on a break.” For them, miscommunication about a temporary pause in the relationship led to an actual breakup between the couple.
In clinical research, miscommunication can lead to significant consequences. One notable example is when investigators veer from approved research protocols, which leads to protocol deviations. This blog connects common Friends themes to protocol deviations in research.
What is a Protocol Deviation?
Research studies are approved by an institutional review board (IRB), and from the time it’s approved, staff must follow the protocol exactly. Failure to do so results in what is called a protocol deviation.
There are two types of protocol deviations:
- Minor deviations: Missing a lab by one day
- Major deviations: Enrolling ineligible participants
In Friends, Joey’s audition mishaps often reflect the two types of protocol deviations. In season 6 episode 24, he misses an audition because he’s distracted by helping Chandler and Monica. This proves to not be as big of a deal since his agent, Estelle, manages to get him another audition. On the other hand, in season 4, episode 13, his audition for a scientist role highlights his lack of experience, which makes it clear he is out of his depth.
Just like in clinical research, different missteps carry different weight. While some can be quickly corrected, others have serious consequences for data integrity and participant safety. That’s why recognizing and addressing them promptly is as critical in research as it is for Joey’s acting career.
Why Deviations Happen
Even with protocol approval, things happen and it can be quite common for protocol deviations to occur during the course of a study. Reasons may include:
- Protocol misunderstandings
- Time constraints
- Patient safety concerns
- Logistical challenges
Throughout the series, the gang celebrates numerous holidays and birthdays with each other, most notably, Thanksgiving. Many Thanksgiving episodes are chaotic, and Monica usually runs around the kitchen trying to create the perfect meal. In season 6, episode 9, the chaos causes Monica to become distracted, and as a result, she forgets the cranberry sauce – Chandler’s favorite. While this is a more lighthearted and honest mistake, it’s easy to see how chaotic situations can lead to distractions, which ultimately can cause people to forget things.
Similarly to how Monica gets overwhelmed managing Thanksgiving details, research staff also face pressure juggling complex protocols and timelines, which can lead to protocol deviations. Understanding the context behind these mistakes is essential for improving processes and ensuring study integrity.
The Role of the IRB: Keeping the Trial Together
As mentioned earlier, IRBs review and approve all protocols for human subjects research. Once a study is approved, an IRB will continue to monitor the protocol to ensure research staff are sticking to everything outlined in the protocol.
With this in mind, when a deviation occurs, it must be reported to the IRB. The IRB usually has documentation outlining what events must be reported, and when they must be reported. Once something is reported, the IRB will review the event, document it on their end, and if necessary, provide corrective actions so the deviations don’t happen again.
Much like how the IRB serves as a safeguard in clinical trials, the crew is quick to notice when something strays from the norm. In season 6, episode 18 of Friends, Ross questionably begins dating his student, which raises red flags from the rest of the crew. They voice their concerns, ask probing questions and nudge him toward reconsideration.
Similarly to Ross’s friends, an IRB will be there to step in, assess potential risks of deviation, and collaborate on corrective actions so a study is realigned with an ethical protocol.
The Right Way to Take a “Break”
As with everything when the IRB is involved, sites and sponsors must have approval for protocol changes or amendments. The IRB does not operate on an “ask for forgiveness” model, it operates on an “ask for permission” one.
Protocol amendments are necessary when there are updates to the study surrounding patient safety, improved study design, correct errors, or reflect changes in regulatory requirements. The steps to an effective protocol amendment process are:
- Drafted amendment
- Internal review
- Regulatory and ethics submission
- Notification to investigators and sites
- Implementation
- Updating trial registries and reporting
In protocol amendment situations, communication is key. Just like in season 3, episode 15 of Friends when Ross and Rachel agree to a break in their relationship, they don’t specify what a “break” actually means. Because of that, there are severe consequences to their relationship, all of which could have been avoided had they been on the same page in the first place.
Just like Ross and Rachel taught us, proactively communicating expectations and changes to the IRB should be at the top of the investigator’s list for running an effective trial.
Real-World Consequences
When deviations go unreported or are mishandled, there can be severe consequences to a trial. Trial timelines can be delayed, funding could be stalled, reputations could be tarnished or trials could completely halt.
At the end of the day, these deviations are to be taken seriously because there are strict parameters in place to protect participants and preserve data integrity. So while something might not seem like a big deal, in the long run, it could have serious consequences for a trial. This is why it’s paramount to effectively work with an IRB; they are there to protect research, rather than restrict it.
Don’t Just Pivot. Work With Sabai.
As a leading central IRB, we understand how to work with protocol amendments at Sabai. We know protecting participants and maintaining data integrity are paramount to an ethical trial. While we don’t joke around when it comes to this, we understand maintaining a protocol correctly requires more than simply pivoting to what does work.