DOL Says that Employees May Use FMLA Leave to Participate in a Clinical Trial
This month, the U.S. Department of Labor released an opinion letter asserting that employees may use leave under the Family and Medical Leave Act for treatment of a serious health condition as part of a clinical trial. Opinion letters respond to an inquiry to the DOL from an employer or other entity, and represent the DOL’s official position on that particular issue. Other employers may then look to these opinion letters for guidance. In addition to this FMLA opinion letter, the DOL also issued an FLSA opinion letter this month, as discussed elsewhere in this E-Update.
Clinical Trials as Treatment Under the FMLA. As the DOL explains in the FMLA opinion letter, a clinical trial is a research study in which participants with a particular medical issue are assigned to interventions that may include a placebo or other controls rather than the experimental treatment. Assuming that the employee’s medical issue meets the criteria for a serious health condition (i.e. an overnight stay in a hospital or continuing treatment by a health care provider) that makes them unable to perform their job functions, the DOL asserts that they may take FMLA leave for treatment that is part of a clinical trial. This is because the definition of “continuing treatment” is very broad, and “does not contain any requirement that the treatment meet a certain level of efficacy or that it achieves a certain result.” Moreover, the scope of information that an employer may receive as part of the FMLA certification process is limited by regulation, and an employee need not disclose specific details about their precise treatment plan.
To illustrate its point, the DOL offers two 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.
Lessons for Employers. Thus, employers should keep in mind that employees who choose to participate in a clinical trial related to their serious health condition will be entitled to use any available FMLA leave to do so.
