The Wage and Hour Division of the U.S. Department of Labor (DOL) has issued an opinion letter clarifying that an employee's participation in a clinical trial can be considered "treatment" under the Family and Medical Leave Act (FMLA) under certain conditions. This clarification addresses whether time off for clinical trial participation related to a serious health condition is protected under federal law.
The DOL's opinion, issued on November 8, 2024, responds to an inquiry regarding the applicability of FMLA to employees participating in clinical trials. The DOL stated, "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."
Key Considerations for Employers
The DOL's guidance emphasizes that the FMLA regulations do not require a clinical trial to meet a specific efficacy level or achieve particular results to qualify as "continuing treatment." The department acknowledged the often experimental nature of clinical trials but affirmed their potential to constitute legitimate medical treatment under the FMLA.
It is important to note that the opinion specifically addresses situations where an employee seeks leave to participate in a clinical trial for their own serious health condition. The DOL has not yet addressed whether FMLA coverage extends to employees seeking leave to participate in clinical trials as healthy volunteers or for the health conditions of family members.
Implications for FMLA Requests
This opinion letter suggests that employers should carefully consider FMLA requests from employees seeking to participate in clinical trials. If the clinical trial is designed to treat the employee's own serious health condition, and all other FMLA eligibility requirements are met, the employer may want to consider approving the request.
