Overview of New Guidance
The U.S. Department of Labor (DOL) issued an opinion letter on November 8, 2024, clarifying that employees may use Family and Medical Leave Act (FMLA) leave for treatment received as part of clinical trials. This update significantly broadens the scope of FMLA leave, including medical interventions in clinical trials, even if treatments are experimental or involve placebos.
This guidance is expected to impact employers by providing clarity on FMLA eligibility criteria and ensuring employees can prioritize participation in clinical trials without risking their job security.
Key Highlights from the DOL Opinion Letter
FMLA Eligibility for Clinical Trials
Employees meeting FMLA eligibility criteria can use leave for serious health conditions treated through clinical trials. The treatments may include:
- Experimental drugs or therapies.
- Placebos administered as part of the trial.
- Recovery time after participating in the trial.
Examples provided by the DOL include:
- Janelle’s Case: Janelle, diagnosed with sarcoidosis, participates in a clinical trial for her condition. FMLA allows her to take leave for trial treatments and recovery.
- Bernard’s Case: Bernard, undergoing chemotherapy, joins a clinical trial for a drug managing chemotherapy side effects. He can take intermittent leave for trial participation and recovery.
Definition of Treatment
Under FMLA, “treatment” is defined broadly to include interventions regardless of their effectiveness or experimental status. Voluntary or elective participation in clinical trials does not disqualify an employee from FMLA eligibility. However, treatments unrelated to serious health conditions, such as elective cosmetic procedures, remain excluded.
Caring for Family Members
FMLA leave extends to employees caring for family members with serious health conditions undergoing clinical trial treatments. Military caregiver leave provisions also apply when covered service members participate in clinical trials.
Employer Responsibilities
Employers must:
- Avoid inquiries into the efficacy or specifics of treatment plans.
- Continue following standard FMLA certification processes to verify the existence of a serious health condition requiring treatment by a healthcare provider.
State Leave Laws
State-level family and medical leave programs often align with FMLA definitions. Employers should review state laws to ensure compliance, as these laws may also provide leave for clinical trial participation.
Implications for Employers
Broadening Access to Leave
The DOL’s letter confirms that FMLA’s intent is to support employees facing serious health conditions, emphasizing that the experimental nature of treatments does not diminish their validity under the law.
Confidentiality in Documentation
While employers may request medical certifications, they cannot require employees to disclose whether treatments are part of a clinical trial. This maintains employee privacy while ensuring compliance with FMLA requirements.
Encouraging Clinical Trial Participation
The guidance eliminates a significant barrier to clinical trial participation by assuring employees that they can take necessary leave without jeopardizing their employment. Third-party studies have shown that participation in clinical trials often improves treatment outcomes for serious health conditions (source: National Institutes of Health).
Conclusion
The November 2024 opinion letter from the DOL underscores the importance of inclusive leave policies, ensuring that employees can access critical treatments through clinical trials. Employers should update their FMLA policies to reflect this guidance, enabling employees to make informed decisions about their health care.
For more information on FMLA leave and clinical trials, employers and employees can refer to resources from the U.S. Department of Labor and state labor departments.