Must you allow an employee to take FMLA leave when she says she’s joining a clinical trial?
In a recent opinion letter dated November 8, 2024, the Wage and Hour Division of the federal Department of Labor (DOL) responded to a request for an opinion on whether an employee may use leave under the FMLA for the treatment of a serious health condition when the treatment is provided through a clinical trial.
In its opinion letter, the DOL said that so long as all other FMLA eligibility requirements are met, an employee can use FMLA leave to participate in a clinical trial for the treatment of a serious health condition.
It’s important to note here that the DOL’s opinion is based on the circumstances presented. While this opinion is important, opinion letters aren’t necessarily precedential, and the DOL recognizes that different facts could lead to a different conclusion.
A Quick FMLA Recap
As I’m sure you know, the FMLA provides covered employees with job-protected leave for qualifying family and medical reasons. It allows covered employees take up to 12 work weeks of leave within a 12-month period due to their own serious health condition. As part of the criteria, the employee must work at a location where the employer has at least 50 employees within 75 miles.
A serious health condition is an illness, injury, impairment, or physical or mental condition that involves inpatient care or continuing treatment by a medical provider.
The New DOL Opinion Letter
The DOL’s opinion letter discusses the law’s broad definition of treatment and specifically mentions that the broad definition doesn’t suggest that the treatment can’t be experimental or that the treatment must “meet a certain level of efficacy.”
It goes on to explain that the fact a treatment is voluntary or elective – as is generally the case with clinical trials – is irrelevant to whether the employee may use FMLA leave to receive treatment. Again, the DOL isn’t concerned about the efficacy of the treatment, that is, the likely rate of success of the treatment. Indeed, the chances of it curing or effectively treating the employee’s health condition is irrelevant.
What Does This Mean For Your Company?
First, the opinion letter means that you should now be more cautious when an employee asks to use FMLA leave to participate in a clinical trial. However, the DOL doesn’t explicitly state that an otherwise healthy employee can use FMLA leave to voluntarily participate in a clinical trial that isn’t related to the treatment of a serious health condition.
As an employer, you don’t have to automatically grant an employee’s FMLA leave simply because they’ve chosen to participate in a clinical trial.
Further, you still may request certain information from your employee to verify that she has a serious health condition that involves treatment. Under the law, you may require a medical certification from a provider that details:
- The approximate date the serious health condition started and its probable duration;
- A statement or description of medical facts on which FMLA leave is requested;
- Information sufficient to establish that the employee can’t perform the essential functions of the job; and
- Other information related to an employee’s request for leave on an intermittent or reduced schedule basis.
But you can’t require the employee disclose any specific details about their medication or treatment plan. So use discretion when discussing leave with your employee. Even though it can feel frustrating, the general approach of using sensitivity and discretion makes sense all the time for many different reasons.
If you have questions about FMLA or any other leave, let us know. We’re always happy to help.
