Participation in clinical trial is FMLA-protected, DOL says

On November 8, 2024, the Department of Labor (DOL) issued an opinion letter addressing an interesting question under the Family and Medical Leave Act (FMLA): Can an employee take FMLA leave to participate in a clinical trial for experimental treatment? In grappling with this question, the DOL’s opinion dissects two noteworthy issues for employers: (1) Whether treatment received through voluntary participation in a clinical study can be covered by the FMLA; and (2) Whether an individual receiving purposely ineffective treatment—i.e., a placebo—can still qualify for FMLA leave.

Unpacking the regulations

In short, the answer to both questions is yes. To reach this conclusion, the DOL unpacked the regulations piece by piece. As a starting point, the employee requesting to take FMLA leave must have a “serious health condition,” which is an illness, injury, impairment, or physical or mental condition that involves either “inpatient care in a hospital, hospice, or residential medical care facility” or “continuing treatment by a health care provider.” A situation involving “inpatient care” is usually easy for employers to identify for FMLA purposes. However, the “continuing treatment” prong of this test can be more difficult to decipher.