Employees may take FMLA leave for clinical trials

On November 8, the U.S. Department of Labor (DOL) published an opinion letter saying that employees who meet the eligibility criteria may take time off under the Family and Medical Leave Act (FMLA) for a serious health condition where treatment is part of a clinical trial.

Serious health condition

The FMLA defines a serious health condition as an illness, injury, or any physical or mental condition that needs inpatient care or continuing treatment by a health care provider.

The FMLA defines "continuing treatment" very broadly. It can include things like taking prescribed medicine or using special medical equipment.

Clinical trials

Clinical trials often involve prescribed medicine or other major treatments. It doesn't matter if they are experimental or use placebos (fake treatments). The rules don't require the treatment to work a certain way or get a certain result.

In 1995, when the FMLA rules were written, the DOL said they chose a broad definition of "continuing treatment" because they didn't want employers to question a doctor's advice on treatment. Whether the treatment is optional, voluntary, or elective doesn't matter. This is often the case with clinical trials.

If, for example, Joe Employee has cancer and is part of a clinical trial for a new drug to help with side effects from chemotherapy, Joe may use FMLA leave for the time spent getting chemotherapy and being part of the trial, including recovery time.