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Employment Law Update: Clinical Trials and FMLA Eligibility

As the advancements in medicine grow, so too do the number of clinical trials. Clinical trials for serious medical conditions are nothing new. Recently, the U.S. Department of Labor analyzed whether the Family and Medical Leave Act (FMLA) covers employees taking time off work to participate in a clinical trial for their own serious health condition. On November 8, 2024, the U.S. Department of Labor’s Wage and Hour Division issued an Opinion Letter concluding that based on the facts presented, the FMLA applied to the leave sought by the employee to participate in clinical trials for an employee’s treatment of a serious health condition.

A clinical trial, according to the National Institutes of Health is “a research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes.” The opinion letter originated from an organization dedicated to finding a cure for certain diseases and noting that patient participation in clinical trials is challenging because of individual concerns about taking time off work, which presents a significant barrier to participation in such clinical trials.

The Department of Labor, in its opinion, concluded that the FMLA permits eligible employees to take leave for the treatment of a serious health condition when treatment is part of a clinical trial. Of course, the ability to take leave also requires that the employee is eligible for FMLA leave and is seeking leave for a qualifying serious health condition and that the other general requirements for the use of FMLA have been satisfied.

As the opinion sets out, “continuing treatment” is broadly defined. See 29 C.F.R. § 825.113(c). A clinical trial often involves prescription medications, equipment, and/or other significant interventions. While an intervention under the clinical trial aspect may be experimental and may use placebos, such qualities do not result in the treatment falling outside the FMLA regulations for “continuing treatment.” When an employee has a serious health condition, not routine cosmetic treatments, the use of clinical trials as a method of treatment is irrelevant. Whether the treatment prescribed for the serious health condition is considered optional, voluntary, or elective – as is generally the case for clinical trial participation – does not factor into the determination of whether an employee may take FMLA leave. Moreover, the type of clinical trial and where an employee is placed in the trial are also not factors. Whether the course of treatment is new, experimental, or a placebo, is not a factor in determining FMLA eligibility.

Ultimately, if an employee requests FMLA leave to participate in a clinical trial for the employee’s own serious health condition, an employer should likely view the request as a qualifying reason for FMLA leave. The FMLA does not require or permit an employer to inquire into the effectiveness of a particular treatment when determining FMLA eligibility. An employer must follow the certification process, consistent with the regulations, to verify an employee has a serious health condition that involves treatment. Of course, certain circumstances may result in a different determination, but for all questions related to FMLA leave and other employment matters, Whiteford’s Employment team stands ready to address those questions.

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