The Family and Medical Leave Act (FMLA) has long been a cornerstone of employee rights in the United States, providing eligible employees with up to 12 weeks of unpaid, job-protected leave for various family and medical reasons. In an opinion letter dated November 8, the US Department of Labor (DOL) clarified that FMLA leave can also be used for participation in clinical trials, marking a significant development for employees facing serious health conditions.
Understanding FMLA
The FMLA, enacted in 1993, allows eligible employees to take leave for their own serious health condition, to care for a family member with a serious health condition, for the birth or adoption of a child, and for certain demands related to a family member’s military service. To qualify, employees must work for a covered employer, have worked for at least 12 months, and have clocked at least 1,250 hours in the past year.
Clinical trials and FMLA
Clinical trials are research studies that test new medical treatments or interventions in human participants. These trials are crucial for advancing medical knowledge and developing new treatments for various diseases. However, participation in clinical trials often requires significant time commitments, which can be a barrier for many employees.
In a recent opinion letter, the DOL clarified that eligible employees can use FMLA leave to participate in clinical trials if the trial involves treatment for a serious health condition. This decision is based on the broad definition of “treatment” under FMLA regulations, which includes examinations, evaluations, and regimens of continuing treatment.
Key takeaways from the DOL’s clarification
- Broad definition of treatment: The DOL’s interpretation hinges on the broad definition of “treatment” under FMLA. Clinical trials often involve prescription medications, specialized equipment, or other significant interventions, all of which fall under the FMLA’s definition of continuing treatment.
- Voluntary participation: The voluntary nature of clinical trial participation does not affect eligibility for FMLA leave. The DOL emphasized that the decision to participate in a clinical trial is not a factor in determining whether an employee can take FMLA leave.
- Treatment success irrelevant: The effectiveness or experimental status of the treatment in a clinical trial does not impact an employee’s eligibility for FMLA leave. The FMLA prohibits employers from questioning the effectiveness of a treatment when determining leave eligibility.
Implications for employees and employers
This clarification by the DOL is a significant step forward in supporting employees with serious health conditions. It ensures that employees can participate in potentially life-saving clinical trials without the added stress of job insecurity. For employers, this means updating FMLA policies to accommodate leave requests for clinical trial participation and ensuring that HR departments are aware of this provision.
Employers should also be prepared to handle the certification process for FMLA leave related to clinical trials. This involves verifying that the employee has a serious health condition and that the clinical trial involves continuing treatment as defined by the FMLA.
Conclusion
The DOL’s clarification on FMLA leave for clinical trial participation underscores the importance of supporting employees in their health journeys. By allowing FMLA leave for clinical trials, the DOL has expanded the scope of employee rights, ensuring that those battling serious health conditions have the opportunity to access cutting-edge treatments without fear of losing their jobs. This development not only benefits employees but also contributes to the broader goal of advancing medical research and finding new treatments for serious diseases.