In November 2024, the Department of Labor (DOL) issued an advisory opinion confirming the Family Medical Leave Act (FMLA) could be used to allow individuals to participate in clinical trials. Previously, consumers were unclear whether clinical trial participation qualified for FMLA leave as some individuals would receive a placebo rather than medical treatment during clinical trial participation. Aimed Alliance and the Crohn’s and Colitis Foundation previously requested DOL clarify this question. In it’s advisory opinion the DOL provided two examples of when FMLA leave would be appropriate for clinical trial participation:
(1) Janelle has sarcoidosis, an inflammatory autoimmune disease that affects her breathing. Janelle receives treatment for sarcoidosis at least twice a year and, as such, the condition qualifies as a chronic serious health condition under the FMLA. Janelle meets the FMLA eligibility criteria. Janelle is interested in volunteering to participate in a clinical trial for the treatment of sarcoidosis but is concerned that if she changes her current treatment plan the amount of time she needs to take off work may change. Under the FMLA, Janelle may use FMLA leave to receive treatment in the clinical trial and recover from treatment, including if there are changes in treatment or in her response to treatment due to her participation in the clinical trial.
(2) Bernard has cancer and is participating in a clinical trial for a new drug intended to help patients manage side effects from chemotherapy. Bernard meets the FMLA eligibility criteria. In the clinical trial, Bernard does not know whether he has been prescribed the new drug or a placebo. Bernard may use FMLA leave intermittently for time spent receiving chemotherapy and participating in the clinical trial, including recovery time.
Read the advisory opinion here. For more information, read Aimed Alliance’s Know Your Rights resources on FMLA, the ADA, and IBD, available here.
Last Updated on February 7, 2025 by Aimed Alliance
