The U.S. Department of Labor (DOL) has issued a clarification ensuring that employees can access Family and Medical Leave Act (FMLA) benefits when participating in clinical trials. This decision, prompted by advocacy from the Foundation for Sarcoidosis Research (FSR), addresses a significant barrier to clinical trial enrollment, particularly for patients with sarcoidosis and other serious chronic illnesses.
The DOL's letter, dated November 8, 2024, confirms that FMLA benefits extend to employees (or those in caregiver roles) participating in clinical trials. This includes trials involving new, experimental, or placebo treatments, as long as the participation is part of managing a serious health condition.
Overcoming Barriers to Clinical Trial Participation
FSR's research, including a national survey of African Americans with sarcoidosis, revealed that concerns about job security and access to health insurance were major obstacles to clinical trial participation. Many patients feared losing pay, job assignments, or benefits if they took time off work to participate in trials.
Mary McGowan, CEO of FSR, stated, "We are grateful to the Department of Labor for this thoughtful and important clarification... It will be pivotal ensuring equitable access to clinical trials... 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."
Key Clarifications from the DOL
The DOL's clarification provides several key assurances for employees:
- Employees meeting FMLA requirements can access benefits for clinical trial participation, whether for themselves or as caregivers.
- "Treatment" includes clinical trials, regardless of the treatment's effectiveness or whether it involves a placebo.
- Participation is covered as long as it supports managing a serious illness, even if voluntary.
- Employers can require documentation but cannot demand information on whether the employee is receiving therapy or a placebo.
Impact on Clinical Trial Equity
This ruling is expected to have a significant impact on clinical trial enrollment, particularly for underserved populations. By ensuring job protection and continued access to health insurance, the DOL's clarification removes a major barrier to participation, promoting more equitable access to potentially life-saving treatments.
FSR formed the Coalition for Clinical Trial Equity in May 2024, uniting advocacy groups, medical societies, researchers, and bioethicists to increase awareness and support for equitable clinical trial access. This coalition will likely play a crucial role in disseminating the DOL's clarification and ensuring its effective implementation.
Sarcoidosis: A Disease in Need of Better Treatments
Sarcoidosis is a rare inflammatory disease characterized by granulomas forming in various organs. Diagnosis remains challenging, treatment options are limited, and there is no known cure. The DOL's decision offers hope for advancing sarcoidosis research and improving patient outcomes by facilitating greater participation in clinical trials.
