How FMLA Leave Supports Equity in Clinical Trials

The Impact on Clinical Research

For clinical research organizations, this decision is a win in addressing a long-standing participation barrier. Recruiting a diverse pool of participants has always been a challenge, with logistical and financial hurdles often deterring those most in need of advanced treatments.

With FMLA leave now clearly applicable, clinical trial sponsors have a stronger case for encouraging participation among working individuals. This is especially significant for trials targeting conditions that disproportionately affect marginalized groups, such as sickle cell disease, diabetes, or certain cancers.

To capitalize on this ruling, sponsors should:

• Collaborate with Employers: Build partnerships with companies to raise awareness about clinical trials and their benefits.
• Target Outreach Efforts: Focus on educating underserved communities about their rights and the potential impact of clinical trials.
• Provide Resources: Work with advocacy organizations to offer guidance on navigating FMLA leave and addressing workplace concerns.

This ruling has the potential to improve clinical trial diversity, leading to more representative data and better health outcomes for all.

Practical Scenarios

The Department of Labor provided illustrative examples to highlight the practical application of this ruling:

• Janelle’s Case: Janelle has sarcoidosis, a chronic autoimmune disease. She decides to participate in a clinical trial testing new treatments for her condition. Janelle can use FMLA leave to attend trial-related appointments and recover from the treatment, even if it involves experimental therapies or changes to her care plan.
• Bernard’s Case: Bernard, a cancer patient, is part of a clinical trial testing a drug to alleviate chemotherapy side effects. Though he doesn’t know whether he’s receiving the drug or a placebo, Bernard can use FMLA leave for chemotherapy sessions, trial participation, and recovery.

These examples emphasize that the nature of the treatment—experimental, voluntary, or involving a placebo—does not diminish an employee’s eligibility for FMLA leave.

The Road Ahead: Equity and Access

While this ruling marks progress, there is still work to be done. Clinical trial sponsors, employers, and policymakers must collaborate to ensure the guidance translates into meaningful action. This includes reducing administrative burdens, improving employee awareness, and addressing broader systemic inequities.

Employers should view this as more than a compliance issue; it is an opportunity to lead in health equity and employee well-being. Similarly, clinical trial sponsors must leverage this decision to reach more diverse populations, breaking down long-standing barriers to participation.

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What are your thoughts on this development? Have you faced challenges navigating FMLA leave for clinical trial participation?

Call to Action

At the Kulkarni Law Firm, P.C. , we navigate the complex intersections of labor law, clinical research, and healthcare compliance. If your organization is facing challenges related to FMLA leave or clinical trial participation, we’re here to help.

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