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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.”