Can employees use FMLA leave to participate in clinical trials for their serious health conditions? Of course, they can—how is this even a question?In a recent opinion letter, the Department of Labor confirmed what feels like common sense: treatment provided during a clinical trial counts as treatment for a "serious health condition" under the FMLA. If an employee is eligible for FMLA leave and the trial addresses their condition, the statute covers their absences—end of story. It doesn't matter if the treatment is experimental, uses a placebo, or hasn't yet proven effective.
The FMLA was designed to protect employees dealing with serious medical issues, and its definition of "treatment" is intentionally broad. It spans everything from prescription medications to therapies involving specialized equipment. Clinical trials easily fit this definition. The fact that anyone doubted this—or needed the DOL to say it outright—is surprising. Employers questioning this are either overthinking it or, let's be honest, looking for loopholes to deny FMLA leave and/or fire someone suffering from a serious health condition.
The DOL even provided examples, just in case you need them:
🏥 Janelle, who has sarcoidosis, can take FMLA leave for her clinical trial treatments and recovery, even if her treatment plan evolves.
🏥 Bernard, undergoing chemotherapy, can take leave for both the trial and recovery—even if he's unsure whether he's receiving an experimental drug or placebo.
The takeaway? Employers can't second-guess an employee's treatment plan or claim clinical trials don't qualify under the FMLA. The law is clear: if it involves a serious health condition, it's covered. No one should have to choose between keeping their job and accessing potentially life-saving medical care.
This opinion letter is a win for employees, ensuring equitable access to clinical trials. And for employers? It's a simple reminder: comply with the law and support your team's health.