United States 
Canada (EN) 
México 
France 
Deutschland 
United Kingdom 
Quick Hits
- The DOL’s Wage and Hour Division clarified that participation in a clinical trial can qualify as “treatment” under the FMLA if it involves an employee’s own serious health condition and all other FMLA eligibility requirements are met.
- The Wage and Hour Division, acknowledging the experimental nature of some clinical trials, emphasized that the FMLA regulations’ definition of “continuing treatment” does not require that a clinical trial meet a certain level of efficacy or achieve specific results.
It is important to note that the opinion was responsive to a narrative in which the facts surrounded an individual’s ability to take leave under the FMLA to participate in a clinical trial addressing the individual’s own serious health condition. This leaves the door open to a question of whether the opinion would vary if the requested leave related to a clinical trial not involving an employee’s own serious health condition—for instance, as a healthy volunteer.
The DOL explored the concept of clinical trials at times being “experimental” and decisively noted that “the regulatory definition [of “continuing treatment”] does not contain any requirement that the treatment meet a certain level of efficacy or that it achieves a certain result.”
All opinion letters issued by the DOL are fact-specific to the individual circumstances presented to the department. However, this opinion letter may cause employers to, minimally, give significant consideration to FMLA requests by employees to participate in clinical trials. If a clinical trial is designed to treat an individual’s own serious health condition, the employer may want to consider approval of such a request, assuming all other elements of FMLA eligibility are met.
Ogletree Deakins’ Columbus office and Leaves of Absence/Reasonable Accommodation Practice Group will continue to monitor developments with respect to the Family and Medical Leave Act and will provide updates on the Leaves of Absence blog as additional information becomes available.
Follow and Subscribe
