The Department of Labor's (DOL) Wage and Hour Division has issued guidance clarifying that an employee's participation in a clinical trial can be considered "treatment" under the Family and Medical Leave Act (FMLA) if it addresses the employee's own serious health condition and all other FMLA eligibility requirements are met. This clarification is significant as it addresses the increasing prevalence of clinical trials as a treatment option for various conditions.
The DOL's opinion addresses scenarios where employees seek FMLA leave to participate in clinical trials. The department specifically 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." This acknowledgment is crucial, considering the experimental nature of many clinical trials.
This guidance emphasizes that employers should give significant consideration to FMLA requests from employees seeking to participate in clinical trials. According to the DOL, 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.
It is important to note that this opinion is specific to situations where the clinical trial addresses the employee's own serious health condition. The DOL has not yet addressed whether FMLA coverage would extend to leave requests related to clinical trials not involving the employee's own health, such as participation as a healthy volunteer. Further clarification on this point may be needed in the future as clinical trial participation continues to evolve.
