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FMLA for Clinical Trials Participation

FSR receives confirmation from the Department of Labor ensuring patient access to FMLA for participation in clinical trials

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). After a year of advocacy, the launch of a 27-member coalition, and over 40 Capitol Hill visits garnering bi-partisan support, FSR received a letter of clarification from the DOL that ensures employee access to FMLA benefits when participating in clinical trials.

This groundbreaking clarification, sent November 8, 2024, extends job-protected leave to eligible clinical trial participants and their family members, benefiting over 60 million employees nationwide and marking a significant step forward in supporting patient access to life-changing treatments. 

This FMLA benefit: 

  • Extends to participants and family members of participants
  • Can be used without fear of risking:
  • Job assignments
  • Promotions
  • Training opportunities
  • Health insurance
  • Broadens definition of ‘treatment’ to include new, experimental and placebo
  • Can be used even if patient’s participation is ‘voluntary’

 

There are additional criteria that the participant must meet, but that will be discussed with the patient.  

Read more about this monumental confirmation in FSR’s blog and press release

FMLA & Clinical Trials: What Clinicians Need to Know

Click here to view our FMLA Clinician Factsheet

Workplace Support for Clinical Trials: What Patients Need to Know

Click here to view our FMLA Patient Factsheet

Watch the FSR Sarc Fighter Podcast episodes on FMLA Clarification:

Important Links

If you have questions about FMLA in your state or need assistance, you can call the Department of Labor’s toll-free information and helpline, available 8 a.m. to 5 p.m. in your time zone, 1-866-4USWAGE (1-866-487-9243). 

 Learn more about the Coalition to Transform Clinical Trial Engagement

 

The Coalition to Transform Clinical Trial Engagement is a collaborative initiative launched by the Foundation for Sarcoidosis Research (FSR) to address disparities in clinical trial participation, particularly among Black Americans. Our mission is to foster a more inclusive research landscape by dismantling barriers and increasing representation of Black patients in clinical trials. Through collective efforts, we seek to pave the way for more equitable access to clinical trials and ultimately improve health outcomes for Black patients.  

Visit ignorenomore.org for more information on the coalition’s initiatives and how to get involved.  

FSR’s FMLA advocacy was driven by the Ignore No More: ACTe Now! (Advancing Clinical Trials for Equity in Sarcoidosis) Campaign. As part of this campaign, FSR conducted an IRB-approved, anonymous survey for Black and African American patients to share their experiences with sarcoidosis, as well as their knowledge and perspectives on clinical trials and the role they play in advancing treatment. The survey findings identified key barriers to participation, including job-related challenges.

Learn more about the barriers and the ways FSR is addressing them at www.stopsarcoidosis.org/actnow and www.stopsarcoidosis.org/Roadmap2Progress.

In The News

 FSR Receives 2025 RareVoice Award for Federal Advocacy

 

We’re proud to share that the Foundation for Sarcoidosis Research (FSR) has been named a 2025 RareVoice Awards Recipient by the EveryLife Foundation for Rare Diseases, receiving the honor for Federal Advocacy by a Patient or Organization for our efforts securing the U.S. Department of Labor’s FMLA clarification providing job-protected leave for clinical trial participants and their family caregivers.

Watch the video below to meet this year’s awardees.

Read the press release here. 

 

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