In August of 2023, the Foundation for Sarcoidosis Research (FSR) submitted a Request for Opinion Letter on Clinical Trials and the Family and Medical Leave Act (FMLA) with the U.S. Department of Labor (DOL).

On November 8, 2024, FSR received a letter of clarification from the DOL that ensures employee access to FMLA benefits when participating in clinical trials.

In connection with its research goals, FSR built a comprehensive national campaign called, Ignore No More: Advance Clinical Trials for Equity (ACTeNow!), to better understand barriers for patients to enroll in clinical trials and research related to sarcoidosis treatment. Key components of this campaign included a national IRB-approved survey of African Americans living with sarcoidosis with over 400 respondents, a Key Opinion Thought Leadership Workshop, and a Patient Focus Group to identify barriers and propose strategies to increase opportunity for Black Americans’ participation in clinical trials. This resulted in a Congressional Briefing and white paper highlighting the survey results and recommendations for next steps.

FSR’s survey and focus group discussions revealed that a significant barrier to patients participating in clinical trials relates to concerns about receiving time off from working, including concerns that they are not able to take a leave of absence from work for their participation in clinical trials without risk to pay, job assignments, promotions, training, and access to fringe benefits (such as leave and health insurance).

FMLA provides the primary mechanism under which many employees across the U.S. are entitled to a job-protected leave of absence to address time off to care for an individual’s or a family member’s serious health condition. Although not all employers are covered by the FMLA, the FMLA is often used as guidance for state laws providing similar types of leave opportunities for employees. In addition to providing 12 weeks of unpaid leave for care related to a serious health condition, the FMLA provides security for those taking time off from work to receive treatment for a condition, in that they are generally permitted to maintain terms of employment, including group health coverage, and be reinstated to the same or substantially similar job following FMLA leave. For those seeking to support the development of new treatments, particularly those suffering from the effects of a serious health condition, job security and maintenance of health insurance coverage can be of paramount importance. FSR, in partnership with lawyers, identified that these barriers stemmed from the lack of clarity on whether or not the concept of “therapeutic benefit and treatment” extends to clinical access to clinical trials.

In the November 8, 2024 letter in direct response to FSR, the DOL clarified that:

• Employees who meet all other requirements of FMLA may access FMLA benefits for participation in clinical trials or the clinical trials of those for whom they serve in a caregiver role.
• The term “treatment” includes clinical trials and treatments that may or may not be effective regardless of whether it is new, experimental, or a placebo.
• As long as this is part of the support and management of a serious illness and is not an elective procedure such as plastic surgery, it does not matter that the patient’s participation is “voluntary”.
• Employers may still require appropriate documentation before issuing access to the leave as laid out in the FMLA, but will not require that they indicate if they are on therapy or placebo, as this will not likely be revealed until after the time at which the requested leave time would expire.
• Employers may only verify that an employee has serious health conditions requiring treatment by a provider when responding to the leave request.

“We are grateful to the Department of Labor for this thoughtful and important clarification. No doubt this will have a tremendous impact at the national level for clinical trial enrollment and participation for all diseases.  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,” says Mary McGowan, CEO of FSR.

In May 2024, FSR formed the Coalition for Clinical Trial Equity, a coalition of 27 advocacy organizations, medical societies, academic researchers, and bioethicists who will work collaboratively to increase awareness and support for equitable access to clinical trials. Anyone interested in joining these efforts can reach out directly to FSR.