The Department of Labor's (DOL) Wage and Hour Division has issued guidance clarifying that an employee's participation in a clinical trial can be considered 'treatment' under the Family and Medical Leave Act (FMLA), provided it addresses the employee's own serious health condition and all other FMLA eligibility requirements are satisfied. This clarification is significant for both employees seeking leave for clinical trial participation and employers navigating FMLA requests.
The DOL's stance acknowledges the often experimental nature of clinical trials, emphasizing that the FMLA's definition of 'continuing treatment' does not mandate a specific level of efficacy or outcome from the trial. This means that even if a clinical trial is investigating a novel or unproven therapy, an employee may still be eligible for FMLA leave to participate, assuming all other criteria are met.
"The regulatory definition [of 'continuing treatment'] does not contain any requirement that the treatment meet a certain level of efficacy or that it achieves a certain result," the DOL stated in its opinion letter. This statement underscores the DOL's focus on the employee's need for medical care and treatment, rather than the proven effectiveness of the specific treatment modality.
It is important to note that the DOL's opinion is specific to situations where the clinical trial addresses the employee's own serious health condition. The guidance does not explicitly address scenarios where an employee seeks leave to participate in a clinical trial as a healthy volunteer or for a condition not affecting the employee directly. This leaves room for interpretation and potential differences in how such requests are handled.
While DOL opinion letters are fact-specific and not legally binding precedent, they offer valuable insight into the agency's interpretation of the FMLA. Employers should carefully consider FMLA requests related to clinical trial participation, ensuring that all eligibility requirements are met and that the employee's health condition warrants the leave. Denying such requests without proper consideration could lead to legal challenges and potential violations of the FMLA.
