WHD Clarifies Clinical Trial Eligibility Under FMLA

The U.S. Department of Labor’s Wage and Hour Division (WHD) has issued an opinion letter on whether an eligible employee may take Family and Medical Leave Act (FMLA) leave to participate in a clinical trial for their own serious health condition. In the letter, signed by WHD Administrator Jessica Looman, the WHD states that the FMLA does not require treatment for a serious health condition to “meet a certain level of efficacy or achieve a specific result.” The letter noted that such an interpretation aligns with the WHD’s decision to define “treatment” broadly in its rules. The WHD explained that when the FMLA regulations were created in 1995, it chose this broad approach to prevent employers from questioning a health care provider’s judgment about whether a treatment is necessary.

For more guidance on FMLA compliance, SHRM has developed a Managing Family and Medical Leave (FMLA) Toolkit.