November 08, 2024
FMLA Wiles – Clinical Trials?
An employee has cancer and is voluntarily participating in a clinical trial for a new drug intended to help patients manage side effects from chemotherapy. The employee otherwise meets the FMLA eligibility criteria – has worked for you for at least 12 months; 1,250 hours in the immediately preceding months; and works at a location that employs at least 50 employees at or within 75 miles. In the clinical trial, the employee does not know whether he has been prescribed the new drug or a placebo. May the employee use FMLA leave intermittently for time spent participating in the clinical trial? What about recovery time, if any?
Today, the U.S. Department of Labor (DOL) issued an opinion letter explaining why their answer is, “Yes.”
- the fact that treatment is considered optional, voluntary, or elective—as may
generally be the case with clinical trial participation—is not a factor in the determination of whether an employee may take FMLA leave to receive treatment. - it is not relevant whether a course of treatment is new, experimental, a placebo, or proven to meet certain criteria for efficacy.
Practical application. The DOL points out that it is not the employer’s role to assess whether a medical procedure is voluntary, medically necessary, or will be successful. However, “[t]hrough the appropriate certification process…an employer may verify that an employee has a serious health condition that involves treatment.”
