What happened?

On November 8, 2024, the Department of Labor (DOL) issued an opinion letter stating that the department believes that employees can use the Family and Medical Leave Act (FMLA) to participate in a clinical trial to treat a serious health condition.

Overview:

The U.S. Department of Labor (DOL) clarified that employees can use FMLA leave to participate in clinical trials for serious health conditions, marking a significant development.

• Employers should update their FMLA policies, train HR personnel, and ensure clear communication with employees about this provision.
• An opinion letter from the DOL serves as official guidance, representing the agency’s interpretation of how laws should be applied in specific situations and providing employers with direction on compliance.

Additional Details

• Eligibility: Employees can use FMLA leave for clinical trials if the trials involve treatment for a serious health condition.
• Voluntary Participation: The treatment’s voluntary nature or experimental status does not affect FMLA eligibility.
• Certification: Employers may require certification but cannot inquire into the effectiveness of the treatment.
• Responsibilities: Employers must allow FMLA leave for clinical trials and restore employees to their positions afterward.
• Actions for Employers: Employers should update policies to include clinical trial participation as a qualifying reason for FMLA leave and train HR personnel to understand and comply with the new guidelines.
• Consequences of Non-Compliance: Failing to comply with these guidelines can expose employers to FMLA liability, including legal action and penalties.

Source References

• DOL Opinion Letter for FMLA Clinical Trials

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