FMLA2024-1-A — Whether an employee may use FMLA leave for treatment provided in a clinical trial

U.S. Department of Labor Wage and Hour Division
Washington, DC 20210

FMLA2024-01-A
November 8, 2024
Dear Name*:
This letter responds to your request for an opinion concerning whether an employee may use
leave under the Family and Medical Leave Act (FMLA) for the treatment of a serious health
condition when treatment is provided as part of a clinical trial. We conclude that, under the
circumstances outlined below, this is a permissible use of FMLA leave. As discussed below,
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.
This opinion is based exclusively on the facts you have presented. You represent that you do
not seek this opinion for any party that the Wage and Hour Division (WHD) is currently
investigating or for any litigation that commenced prior to your request.
BACKGROUND
Your request for an opinion is on behalf of an organization dedicated to finding a cure for a
disease that can be long-term and severe, and to improving care for affected individuals
through research, education, and support. According to the National Institutes of Health
(NIH), a clinical trial 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.”
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Patient participation in clinical trials, you explain, is “a critical
component” of your research goals.
You write that when your organization surveyed African Americans to increase their
participation in clinical trials, you learned that concern about taking time off work is a
“significant barrier” to participation. You ask for confirmation that FMLA leave is available
for those participating in such trials “regardless of whether the individual receives the
applicable experimental treatment.” “[C]larifying access,” you note, “is a critical aspect to
ensuring equitable access to clinical trials since underserved and under-resourced patients face
the most significant risks from job or benefit loss.”
Your request appears to be focused on an individual’s ability to take FMLA leave to

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National Institutes of Health, NIH Clinical Research Trials and You,
https://www.nih.gov/health-information/nih-clinical-research-trials-you/glossary-common-
terms#clinicaltrial (last reviewed July 2, 2024).

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participate in a clinical trial addressing their own serious health condition, so this letter
addresses that scenario.
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See 29 U.S.C. § 2612(a)(1)(D).
GENERAL LEGAL PRINCIPLES AND ANALYSIS
The FMLA provides eligible employees of covered employers with job-protected leave for
qualifying family and medical reasons and requires continuation of their group health benefits
under the same conditions as if they had not taken leave. Eligible employees may take up to
12 workweeks of leave in a 12-month period due to their own serious health condition. FMLA
leave may be unpaid or used at the same time as employer-provided paid leave. Employees
must be restored to the same or a virtually identical position when they return to work after
FMLA leave. Employees have the right to take FMLA leave all at once, or, when medically
necessary, in separate blocks of time or by reducing the time they work each day or week.
Among other qualifying reasons for leave, an eligible employee has the right to use FMLA
leave “[b] ecause of a serious health condition that makes the employee unable to perform the
functions of the position of such employee.” 29 U.S.C. § 2612(a)(1)(D). Where an individual
seeks FMLA leave due to incapacity from a serious health condition, the FMLA regulations
specify that “[t]he term incapacity means inability to work, attend school or perform other
regular daily activities due to the serious health condition, treatment therefore, or recovery
therefrom[,]” and that “[a]n employee who must be absent from work to receive medical
treatment for a serious health condition is considered to be unable to perform the essential
functions of the position during the absence for treatment.” 29 C.F.R. §§ 825.113(b) ,
825.123(a).
The FMLA defines a serious health condition as an illness, injury, impairment, or physical or
mental condition that involves either “inpatient care in a hospital, hospice, or residential
medical care facility[,]” or “continuing treatment by a health care provider.” 29 U.S.C. §
2611(11). A serious health condition involving “continuing treatment by a health care
provider” includes health conditions involving “incapacity and treatment,” “pregnancy or
prenatal care,” “chronic conditions,” “permanent or long-term conditions,” and “conditions
requiring multiple treatments.” 29 C.F.R. § 825.115. The regulations specify the
requirements to satisfy each of these categories. Id.
The regulations further provide that “[t]he term ‘treatment’ includes (but is not limited to)
examinations to determine if a serious health condition exists and evaluations of the
condition[,]” and that a “regimen of continuing treatment includes, for example, a course of
prescription medication (e.g., an antibiotic) or therapy requiring special equipment to resolve
or alleviate the health condition (e.g., oxygen).” 29 C.F.R. § 825.113(c). In contrast,
treatment does not include routine physical examinations, and a regimen of continuing

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Where the relevant requirements are otherwise satisfied, this analysis is also applicable to
the taking of FMLA leave to care for a family member with a serious health condition, see 29
U.S.C. § 2612(a)(1)(C), and to the taking of FMLA military caregiver leave to care for a
covered servicemember, see id. § 2612(a)(1)(3), where the person being cared for is
participating in a clinical trial.

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treatment does not include, standing alone, the taking of over-the-counter medications or
activities such as bed rest that can be initiated without a visit to a health care provider. Id.
An employee may be required by an employer to submit a certification (as set out in 29
C.F.R. §§ 825.102 and 825.125) to support the need for FMLA leave for the employee’s own
serious health condition. The employer may require the certification to include “whether
medication has been prescribed, any referrals for evaluation or treatment (physical therapy,
for example) or any other regimen of continuing treatment” and, for intermittent or reduced
schedule leave for planned medical treatment, “information sufficient to establish the medical
necessity for such intermittent or reduced schedule leave and an estimate of the dates and
duration of such treatments and any periods of recovery.” Id. §§ 825.306(a)(3),
825.306(a)(6).
OPINION
Eligible employees may take FMLA leave for the treatment of a serious health condition
when treatment is part of a clinical trial.
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The FMLA regulations define “continuing treatment” very broadly, establishing only the
general principles that a regimen of continuing treatment includes, for example, prescription
medication or therapy requiring the use of specialized equipment, but not, ordinarily, routine
physical examinations, or over-the-counter medications “that can be initiated without a visit to
a health care provider.” 29 C.F.R. § 825.113(c). The medical interventions generally
involved in clinical trials are similar to the former examples, often involving prescription
medication, equipment, or other significant interventions. That such interventions may be
experimental (or involve the use of placebos) does not suggest otherwise, as the regulatory
definition does not contain any requirement that the treatment meet a certain level of efficacy
or that it achieves a certain result.
This interpretation is consistent with the Department’s deliberate choice to broadly define
“treatment” in its regulations at 29 C.F.R. § 825.113. In 1995, in implementing the FMLA
regulations, the Department explained that it chose a broad definition because it “ did not wish
to encourage employers to second-guess a health care provider’s judgment that a treatment is
advisable (e.g. orthoscopic knee surgery on an out-patient basis) by questioning whether it is
‘necessary.’” 60 Fed. Reg. 2180, 2192, 2195 (Jan. 6, 1995). Previously, the Department had
considered prohibiting the taking of leave for “voluntary” treatments that were not “medically
necessary,” but it ultimately determined that the term “voluntary” was “ inappropriate because
all treatments and surgery are voluntary.” Id. at 2195. Instead, the Department chose to make
a specific exclusion solely for certain types of routine cosmetic treatments, and here too,
included exceptions where such treatment is for a serious health condition (e.g., there is
inpatient care, complications develop, or the treatment involves restorative dental or plastic
surgery after an injury or removal of cancerous growths). Id; 29 C.F.R. § 825.113(d).

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This opinion presumes that the employee is eligible for FMLA leave and is seeking leave for
a qualifying serious health condition, and that other general requirements for use of FMLA
leave have been satisfied.

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Accordingly, the fact that treatment is considered optional, voluntary, or elective—as may
generally be the case with clinical trial participation—is not a factor in the determination of
whether an employee may take FMLA leave to receive treatment.
Similarly, it is the
Department’s determination that it is also not relevant whether a course of treatment is new,
experimental, a placebo, or proven to meet certain criteria for efficacy.
The FMLA and the implementing regulations neither require nor permit an employer to
inquire into the effectiveness of a particular treatment for purposes of determining whether an
employee may take FMLA leave to receive that treatment. Through the appropriate
certification process, and only in response to an employee’s leave request and consistent with
regulatory guidelines, an employer may verify that an employee has a serious health condition
that involves treatment. The FMLA regulations set forth the precise scope of the information
that employers may request and that employees must provide. 29 C.F.R. § 825.306. Those
regulations do not require an employee to disclose specific details about prescribed
medication or their precise treatment plan.
The above principles may be illustrated by the following 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.
In summary, treatment for a serious health condition that is rendered as part of a clinical trial
can be a qualifying reason for FMLA leave.
This opinion is based exclusively on the facts and circumstances described in your request
and is given based on your representation, express or implied, that you have provided a full
and fair description of all the facts and circumstances that would be pertinent to our
consideration of the question presented. Existence of any other factual or historical
background not contained in your letter might require a conclusion different from the one
expressed herein.
We trust that this letter is responsive to your inquiry.

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Sincerely,

Jessica Looman
Administrator
*Note: The actual name(s) was removed to protect privacy in accordance with 5 U.S.C.
§ 552(b).