Granting FMLA Leave for Clinical Trials: Five Key Points from the DOL’s New Guidance for Employers

TakeawaysEmployees who meet all other FMLA requirements may take FMLA leave for clinical trial treatment of a serious health condition, regardless of whether the treatment is experimental or involves placebos.Employers may not ask about the effectiveness of a treatment, the specific medications prescribed, or the detailed treatment plan when determining if an employee is eligible to take FMLA leave.LinkFMLA2024-01-AArticleThe U.S. Department of Labor’s Wage and Hour Division issued an opinion letter on Nov. 8, 2024, affirming that employees may use Family and Medical Leave Act (FMLA) leave when participating in clinical trials. This is significant guidance for employers, as it clarifies the scope of permitted uses of FMLA leave to include medical interventions provided as part of clinical trials, regardless of whether the treatment is experimental or involves placebos. The DOL provides two useful examples:Janelle has sarcoidosis, an inflammatory autoimmune disease that... Read the complete article here... Jackson Lewis P.C. © 2024

Takeaways Employees who meet all other FMLA requirements may take FMLA leave for clinical trial treatment of a serious health condition, regardless of whether the treatment is experimental or involves placebos. Employers may not ask about the effectiveness of a treatment, the specific medications prescribed, or the detailed treatment plan when determining if an employee is eligible to take FMLA leave. Link FMLA2024-01-A Article The U.

S. Department of Labor’s Wage and Hour Division issued an opinion letter on Nov. 8, 2024, affirming that employees may use Family and Medical Leave Act (FMLA) leave when participating in clinical trials.

This is significant guidance for employers, as it clarifies the scope of permitted uses of FMLA leave to include medical interventions provided as part of clinical trials, regardless of whether the treatment is experimental or involves placebos. The DOL provides two useful examples: Highlights from the DOL’s opinion letter include: State Leave Laws The new opinion letter may also affect state leave entitlements. Many state family and medical leave insurance programs, for example, mirror FMLA’s definition of “serious health condition” or “treatment” for purposes of eligibility for leave.

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