The U.S. Department of Labor has issued an opinion letter explaining that eligible employees may take FMLA leave for the treatment of a serious health condition when treatment is part of a clinical trial.
According to the DOL, the term “treatment” is broadly defined under the FMLA to include medical interventions that may or may not be effective in every case. When all other FMLA eligibility requirements are met, a serious health condition that involves either inpatient care or continuing treatment by a health care provider, including when such care or treatment involves an individual’s voluntary participation in a clinical trial, qualifies the employee to use FMLA leave.
The DOL provides several clarifying examples:
- Janelle has sarcoidosis, an inflammatory autoimmune disease that affects her breathing. Janelle receives treatment for sarcoidosis at least twice a year and, as such, the condition qualifies as a chronic serious health condition under the FMLA. Janelle meets the FMLA eligibility criteria. Janelle is interested in volunteering to participate in a clinical trial for the treatment of sarcoidosis but is concerned that if she changes her current treatment plan the amount of time she needs to take off work may change. Under the FMLA, Janelle may use FMLA leave to receive treatment in the clinical trial and recover from treatment, including if there are changes in treatment or in her response to treatment due to her participation in the clinical trial.
- Bernard has cancer and is participating in a clinical trial for a new drug intended to help patients manage side effects from chemotherapy. Bernard meets the FMLA eligibility criteria. In the clinical trial, Bernard does not know whether he has been prescribed the new drug or a placebo. Bernard may use FMLA leave intermittently for time spent receiving chemotherapy and participating in the clinical trial, including recovery time.
Click here to read the opinion letter in full.
