The U.S. Department of Labor (DOL) recently released an opinion letter clarifying that employees may take Family and Medical Leave Act (FMLA) leave to participate in clinical trials, assuming all other eligibility factors are met.
The DOL reasoned that because the FMLA broadly defines “continuing treatment” and “treatment,” restricting only conditions for which cosmetic treatments are administered, clinical trials would be included.
Treatment under the FMLA includes (but is not limited to) examinations to determine if a serious health condition exists and evaluations of the condition. Additionally, the DOL found that the medical interventions generally involved in clinical trials were comparable to the prescription medication or therapy requiring the use of specialized equipment that constitute “continuing treatment” under FMLA.
Accordingly, employees aren’t barred from taking FMLA leave just because the treatment in the clinical trial is experimental or even if they are provided a placebo in the trial.
What does this mean for employers? Employers should still follow their usual processes under the FMLA and require that employees provide medical certification substantiating the need for leave. Assuming an employee is eligible, the fact that the leave is to participate in a clinical trial should not be a reason to deny FMLA leave.
Employers with questions about FMLA can find more information in this whitepaper and can contact Employers Council for additional assistance.
Jennifer Vold is an attorney for Employers Council.