Can you use job-protected FMLA leave to participate in medical trials? The Department of Labor says yes.
In a recent opinion letter, the Wage & Hour division of the U.S. Department of Labor (DOL) clarified that employees can use Family and Medical Leave Act (FMLA) leave for treatments in clinical trials. This approach helps safeguard the jobs of employees involved in clinical trials while taking care of their health.
Key Points
The DOL’s opinion letter states that eligible employees can use FMLA leave for medical treatments in clinical trials. This includes experimental treatments and even placebos, as long as they meet other FMLA requirements.
Background: An organization focused on curing a severe, long-term disease had initially requested this clarification from the DOL. They were concerned that taking time off often prevented people from joining clinical trials.
Legal Details: The FMLA allows eligible employees up to 12 workweeks of job-protected, unpaid leave in a 12-month period for specific family and medical reasons. The part of the Act allowing leave for “treatment” leaves the definition broad. It covers medical interventions that might not work for everyone. This means employees can take FMLA leave for clinical trial treatments, even if they are experimental.
Example from the opinion letter:
- Bernard: Bernard is battling cancer. He is part of a clinical trial for a new drug to manage chemotherapy side effects. He can take FMLA leave intermittently for his chemotherapy and clinical trial participation, even if he gets a placebo.
Employer Requirements
As with any leave requests under FMLA, employers can ask for certification to support the need for FMLA leave. However, they can’t inquire into the effectiveness of the treatment or demand specific details about the treatment plan.
For more information on FMLA leave, visit the Wage & Hour FMLA resources. You can also get more info about how it applies to clinical trial participation in the full opinion letter on the DOL website.
At Nextep, we’re here to help you navigate these regulations and ensure compliance. Contact your Nextep HR Business Partner for personalized support and guidance.
