In an opinion letter dated November 8, 2024, the Wage and Hour Division of the U.S. Department of Labor (DOL) responded to a question posed by an organization dedicated to finding a cure for specific diseases.
At issue was the question of whether treatment provided as part of a clinical trial would meet the definition of “treatment” as broadly defined under the Family and Medical Leave Act (FMLA). In providing its opinion, the DOL noted, “When all other FMLA eligibility requirements are met, a serious health condition that involves either inpatient care or continuing treatment by a health care provider, including when such care or treatment involves an individual’s voluntary participation in a clinical trial, qualifies the employee to use FMLA leave.” Quick Hits The DOL’s Wage and Hour Division clarified that participation in a clinical trial can qualify as “treatment” under the FMLA if it involves an employee’s own serious health condition and all other FMLA eligibility requirements are met.
The Wage and Hour Division, acknowledging the experimental nature of some clinical trials, emphasized that the FMLA regulations’ definition of “continuing treatment” does not require that a clinical trial meet a certain level of efficacy or achieve specific results. It is important to note that the opinion was responsive to a narrative in which the facts surrounded an individual’s ability to take leave under the FMLA to participate in a clinical trial addressing.