In a November 8, 2024 opinion letter, the U.S. Department of Labor’s (DOL) Wage and Hour Division addressed a question asking whether treatment received in a clinical trial could qualify as “treatment” under the Family and Medical Leave Act (FMLA), which has a broad definition of “treatment.”
The DOL’s response clarified that, when all other FMLA eligibility criteria are met, a serious health condition that requires either inpatient care or continuing treatment from a healthcare provider qualifies an employee for FMLA leave, whether the leave is required to care for the employee’s own serious health condition or a family member’s serious health condition. The opinion emphasized that “treatment” is broadly defined under the FMLA and that it encompasses medical interventions involved in clinical trials, even when experimental or placebo-based, and that the definition of “treatment” does not depend on the trial’s effectiveness or outcome. The fact that the treatment may be considered optional, voluntary, or elective is not a factor in determining whether an employee may take FMLA leave to receive treatment.
Though DOL opinion letters are based on specific facts presented by the requesting party, this letter should be taken into consideration when employees request FMLA leave attributable to participation in a clinical trial. If all other FMLA eligibility requirements are met, an employer may want to approve such a request. Any employer or employee with questions about requests for FMLA leave to participate in a clinical trial is encouraged to contact any of Kenney &Sams’s employment attorneys.
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