Participation in sarcoidosis trials fills criteria for FMLA benefits: FSR
US Department of Labor letter to foundation confirms leave eligibility
Employees in the U.S. who participate in clinical trials — including those testing treatments for sarcoidosis — and workers also caring for trial participants have access to Family and Medical Leave Act (FMLA) benefits.
That’s according to a new letter from the U.S. Department of Labor, sent in response to a clarification request from the Foundation for Sarcoidosis Research (FSR), which has long been leading efforts in the country to increase the representation of Black sarcoidosis patients in clinical trials.
Prior FSR efforts, including a national survey, revealed that a significant barrier to trial participation by Black patients was a concern about getting needed time off work. That led the nonprofit to query the department for further information about FMLA benefits, sparking this letter.
“We are grateful to the Department of Labor for this thoughtful and important clarification,” which “will have a tremendous impact at the national level for clinical trial enrollment and participation for all diseases,” Mary McGowan, CEO of FSR, said in a foundation press release.
The nonprofit in 2022 launched a national campaign dubbed ACTeNow!, for Ignore No More: Advance Clinical Trials for Equity.
“It will be pivotal ensuring equitable access to clinical trials, ensuring corporate America and human resources professionals nationwide understand how experimental treatments and trials align with FMLA regulations, and in empowering patient access to medical leave to pursue all appropriate avenues for the management and development of better therapies of serious chronic illnesses like sarcoidosis,” McGowan said.
In the letter, the Department of Labor noted that those seeking benefits must still meet all other requirements of the FMLA.
Letter sent to Department of Labor sparked by FSR’s Ignore No More campaign
In sarcoidosis, small clumps of inflammatory cells called granulomas form in different tissues and organs, negatively impacting their function. While sarcoidosis can affect people of any race, ethnicity, or sex, Black Americans are 2.5 times more likely to have sarcoidosis than white Americans, studies have shown.
Despite this, however, just 9% of participants in U.S. clinical trials of rare diseases are Black Americans, according to the U.S. Food and Drug Administration.
Those statistics were among the reasons for the FSR’s Ignore No More campaign, and its ensuing national survey of more than 400 Black Americans living with sarcoidosis. A key survey goal was identifying barriers to participating in clinical trials.
Patients reported concerns about being unable to take a leave of absence from work for trial participation without risk to pay, job assignments, and access to benefits, including leave and health insurance.
In the U.S., many employees are entitled to a job-protected leave of absence to address time off to care for their own, or a family member’s, serious health condition. These rights are protected by a labor law known as the FMLA.
The FMLA offers security for those taking time off work to receive treatment for a medical condition. Under the law, covered employees will maintain the terms of employment, including eligibility for healthcare benefits, and be given the same or very similar jobs following FMLA leave.
Although not all employers are subject to the FMLA, the act frequently serves as the basis for state laws that provide similar types of protection, and leave opportunities, for other employees.
Employers can’t inquire into treatment efficacy when granting FMLA benefits
According to the FSR, however, there was a lack of clarity on whether the act’s concept of “therapeutic benefit and treatment” included protecting the rights of employees to participate in clinical trials.
Thus, the FSR reached out to the Department of Labor in August 2023, asking for clarification on this subject. The department’s responding letter, signed by Jessica Looman, an administrator, was received by the nonprofit earlier this month.
The letter’s opinion section specifically states that “eligible employees may take FMLA leave for the treatment of a serious health condition when treatment is part of a clinical trial.” It further notes that “voluntary participation in a clinical trial … qualifies the employee to use FMLA leave.”
“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,” the letter stated.
Eligible employees may take FMLA leave for the treatment of a serious health condition when treatment is part of a clinical trial.
The Department of Labor detailed how employees meeting all FMLA requirements may access the law’s benefits for their own participation in trials — or for participation by family members for whom they serve in a caregiver role.
The term “treatment” covers clinical trials and therapies that may or may not be effective, regardless of whether such treatment is novel, experimental, or a placebo, the letter noted. While trial participation is voluntary, it is eligible for FMLA benefits as long as it is part of the management of a serious disease and is not an elective procedure, per the opinion.
While employers may require some documentation before granting the employee leave in line with the FMLA, employees do not need to disclose if they are receiving the experimental treatment or a placebo, in cases of controlled trials, the letter stated.
According to the FSR, the “letter of clarification from the [Department of Labor] … ensures employee access to FMLA benefits when participating in clinical trials.”
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