DOL Addresses FMLA Leave for Clinical Trial Participation

November 19, 2024

On November 8, 2024, the DOL issued Advisory Opinion FMLA2024-01-A, which addresses whether an employee can take leave under FMLA for treatment of a serious health condition provided as part of a clinical trial.

As background, the inquirer is an organization involved in the treatment and cure of a known disease that uses clinical trials as part of its research goals towards finding a cure. In its research, the organization has found that one barrier to participation in their clinical trials is participants’ beliefs that they cannot take time off from work to participate in the trial. The organization sought clarification from the DOL as to whether participation in the clinical trial would be a qualifying reason for leave for an employee who is otherwise eligible for leave under FMLA.

Under the FMLA, a qualifying reason for leave includes a serious health condition that makes the employee unable to perform functions of their employment. A serious health condition can be an illness, injury, impairment, or condition that involves continuing treatment by a healthcare provider or care at a hospital or treatment facility.

In its opinion, which is based solely on the facts provided by the inquirer, the DOL notes that the term “treatment” applies broadly and the fact that treatment is related to the individual’s voluntary participation in a clinical trial would not impact the applicability of the term. Treatment may include services such as therapy or care requiring specialized equipment, significant intervention, or prescription medication, which are often found in clinical trial participation. The opinion notes that the regulations also do not specify that the treatment meets specific efficacy standards to be considered a qualifying reason for leave.

Similar to other FMLA requests, an employee must still submit certification documents as requested to support the need for continued leave. However, employers are not permitted to inquire as to the effectiveness of the treatment as part of the decision-making process.

The opinion concludes that treatment for a serious health condition that is included as part of a clinical trial can be a qualifying reason for leave under FMLA for an otherwise eligible employee. While matters of FMLA fall into employment law rather than employee benefits, it is important for employers to ensure FMLA is administered correctly and consistently. This opinion letter is a helpful reminder to employers to carefully review the facts of an employee’s specific situation prior to making a determination under FMLA.

Advisory Opinion FMLA2024-01-A