The U.S. Department of Labor (DOL) has issued a clarification that allows employees to access Family and Medical Leave Act (FMLA) benefits when participating in clinical trials. This decision, prompted by a request from the Foundation for Sarcoidosis Research (FSR), ensures that individuals can take job-protected leave for clinical trial participation without risking their employment or health insurance coverage.
Impact on Clinical Trial Access
FSR's advocacy efforts, including a national survey of African Americans with sarcoidosis, revealed that concerns about job security and benefits were significant barriers to clinical trial enrollment. The DOL's clarification addresses these concerns by confirming that FMLA benefits apply to clinical trial participation, regardless of whether the treatment is new, experimental, or a placebo.
Key Points from the DOL Clarification
The DOL's letter, issued on November 8, 2024, provides the following key clarifications:
- Employees meeting FMLA requirements can access benefits for clinical trial participation, whether for themselves or as caregivers.
- The term "treatment" includes clinical trials, regardless of their effectiveness or experimental nature.
- Participation is covered as long as it supports the management of a serious illness and is not an elective procedure.
- Employers can request documentation but cannot require information about whether the employee is receiving therapy or a placebo.
- Employers may only verify that an employee has serious health conditions requiring treatment by a provider when responding to the leave request.
FSR's Role and Future Initiatives
Mary McGowan, CEO of FSR, emphasized the significant impact of this clarification on clinical trial enrollment and equitable access to medical leave. FSR formed the Coalition for Clinical Trial Equity in May 2024, uniting advocacy organizations, medical societies, academic researchers, and bioethicists to promote equitable access to clinical trials.
Sarcoidosis and the Need for Clinical Trials
Sarcoidosis is a rare inflammatory disease characterized by granulomas in various organs. Diagnosing sarcoidosis remains challenging, and treatment options are limited. Clinical trials are crucial for developing better therapies and finding a cure. The DOL's clarification removes a significant barrier to participation, potentially accelerating research and improving outcomes for sarcoidosis patients.
