November 22nd, 2024 New FMLA Guidance Empowers Patients to Participate in Clinical Trials For patients battling chronic illnesses or rare conditions, clinical trials are a chance to access potentially life-saving treatments and contribute to advancing medical research. However, finding the time and resources to participate in clinical trials is often a significant hurdle. In a groundbreaking new move, the U.S. Department of Labor (DOL) recently issued new guidance affirming that the Family and Medical Leave Act (FMLA) can cover absences for clinical trial participation, regardless of whether the treatment is experimental or involves placebos. This is excellent news for patients seeking treatment options, as it allows them to pursue advanced therapies without risking their job security. In fact, employers cannot ask about the effectiveness of a treatment, the medications prescribed, or the treatment plan when reviewing FMLA eligibility. The Facts Behind the DOL Guidance The DOL’s opinion letter states that FMLA leave can extend to clinical trial participation if the trial meets certain criteria. Here are the key takeaways from this new guidance: Eligibility Requirements To qualify for FMLA leave, the clinical trial must involve the patient’s treatment for a serious health condition. A healthcare provider must recommend or refer the patient to participate in the trial as part of their care plan. Legal Framework The FMLA allows eligible employees up to 12 weeks of unpaid, job-protected leave annually for serious health conditions. The new interpretation broadens the scope, ensuring that patients can use this leave for clinical trial visits, tests, or treatments related to their condition. Support for Caregivers In addition to covering patients, caregivers who support a family member during a clinical trial may also qualify for FMLA leave under the Act’s “caregiver” provisions. Employer Considerations Employers should review their FMLA policies to ensure compliance with this expanded interpretation. Proper documentation from a healthcare provider will still be required to validate the leave. Why It Matters Clinical trials often require frequent visits to healthcare facilities, disrupting work schedules. With this new guidance, employees no longer have to choose between their health or their loved one’s health and livelihood. A Step Forward for Patients and Research This development is a significant step forward in supporting patients seeking innovative treatment options, as fear of job loss is often a large psychological burden for patients considering clinical trial participation. By reducing the logistical and financial barriers to participating in clinical trials, the DOL’s guidance opens doors for more diverse and inclusive participation in research. Sponsors, Sites, and CROs can further foster involvement by partnering with a company that truly understands patient recruitment and consent and pairs their solutions with patient companions to assist patient engagement and education. In turn, this guidance will benefit the broader medical community by accelerating the discovery of new therapies and ensuring they are tested across a wide spectrum of populations.
For patients battling chronic illnesses or rare conditions, clinical trials are a chance to access potentially life-saving treatments and contribute to advancing medical research. However, finding the time and resources to participate in clinical trials is often a significant hurdle. In a groundbreaking new move, the U.S. Department of Labor (DOL) recently issued new guidance affirming that the Family and Medical Leave Act (FMLA) can cover absences for clinical trial participation, regardless of whether the treatment is experimental or involves placebos. This is excellent news for patients seeking treatment options, as it allows them to pursue advanced therapies without risking their job security. In fact, employers cannot ask about the effectiveness of a treatment, the medications prescribed, or the treatment plan when reviewing FMLA eligibility. The Facts Behind the DOL Guidance The DOL’s opinion letter states that FMLA leave can extend to clinical trial participation if the trial meets certain criteria. Here are the key takeaways from this new guidance: Eligibility Requirements To qualify for FMLA leave, the clinical trial must involve the patient’s treatment for a serious health condition. A healthcare provider must recommend or refer the patient to participate in the trial as part of their care plan. Legal Framework The FMLA allows eligible employees up to 12 weeks of unpaid, job-protected leave annually for serious health conditions. The new interpretation broadens the scope, ensuring that patients can use this leave for clinical trial visits, tests, or treatments related to their condition. Support for Caregivers In addition to covering patients, caregivers who support a family member during a clinical trial may also qualify for FMLA leave under the Act’s “caregiver” provisions. Employer Considerations Employers should review their FMLA policies to ensure compliance with this expanded interpretation. Proper documentation from a healthcare provider will still be required to validate the leave. Why It Matters Clinical trials often require frequent visits to healthcare facilities, disrupting work schedules. With this new guidance, employees no longer have to choose between their health or their loved one’s health and livelihood. A Step Forward for Patients and Research This development is a significant step forward in supporting patients seeking innovative treatment options, as fear of job loss is often a large psychological burden for patients considering clinical trial participation. By reducing the logistical and financial barriers to participating in clinical trials, the DOL’s guidance opens doors for more diverse and inclusive participation in research. Sponsors, Sites, and CROs can further foster involvement by partnering with a company that truly understands patient recruitment and consent and pairs their solutions with patient companions to assist patient engagement and education. In turn, this guidance will benefit the broader medical community by accelerating the discovery of new therapies and ensuring they are tested across a wide spectrum of populations.
