The U.S. Department of Labor (DOL) has issued an opinion clarifying that an employee's participation in a clinical trial can be considered 'treatment' under the Family and Medical Leave Act (FMLA), potentially entitling them to protected leave. This guidance addresses whether time spent in a clinical trial meets the FMLA's definition of 'treatment' for a serious health condition.
FMLA and Clinical Trial Participation
In a recent opinion letter, the DOL's Wage and Hour Division responded to an inquiry regarding FMLA coverage for individuals participating in clinical trials. The DOL stated that if all other FMLA eligibility requirements are met, a serious health condition that involves either inpatient care or continuing treatment by a healthcare provider, including voluntary participation in a clinical trial, qualifies the employee to use FMLA leave.
The DOL acknowledged the experimental nature of some clinical trials but emphasized that the FMLA regulations' definition of 'continuing treatment' does not require a clinical trial to meet a certain level of efficacy or achieve specific results. This clarification is significant because it broadens the scope of FMLA coverage to include innovative and potentially life-changing medical research.
Key Considerations for Employers
This opinion specifically addresses situations where an individual seeks FMLA leave to participate in a clinical trial for their own serious health condition. The DOL's guidance leaves open the question of whether the opinion would apply if the requested leave related to a clinical trial not involving the employee's own serious health condition, such as participation as a healthy volunteer.
Employers should carefully consider FMLA requests from employees seeking to participate in clinical trials. Given the DOL's stance, employers may want to consider approving such requests, assuming all other elements of FMLA eligibility are met. This includes verifying that the employee has a serious health condition and meets the service requirements for FMLA leave.
Implications for Patients and Research
This clarification from the DOL could have a positive impact on patient access to clinical trials. By ensuring job protection for those who qualify for FMLA, the DOL may alleviate some of the concerns that potential participants have about taking time off work to participate in research. This could lead to increased enrollment in clinical trials and, ultimately, accelerate the development of new treatments and therapies.
