Illinois Code § 5

§ 5.

Findings. The General Assembly finds that: (1) The ability to translate medical findings from research to practice relies largely on robust subject participation and a diverse subject participation pool in clinical trials. (2) Diverse subject participation in clinical trials depends significantly on whether an individual is able to afford ancillary costs, including transportation and lodging, during the course of participation in a clinical trial. (3) A national study conducted in 2015 found that individuals from households with an annual income of less than $50,000 were 30% less likely to participate in clinical trials. (4) Direct and indirect costs, including transportation, lodging, and child-care expenses, prevent eligible individuals from participating in clinical trials according to the National Cancer Institute. (5) The disparities in subject participation in clinical trials threaten the basic ethical underpinning of clinical research, which requires the benefits of the research to be made available equitably among all eligible individuals. (6) While the United States Food and Drug Administration recently confirmed to Congress and provided guidance on its website that reimbursement of direct subject-incurred expenses is not an undue inducement, many organizations, research sponsors, philanthropic individuals, charitable organizations, governmental entities, and other persons still operate under the misconception that such reimbursement is an undue inducement. (7) It is the intent of the General Assembly to enact legislation to further define and establish a clear difference between items considered to be an undue inducement for a subject to participate in a clinical trial and the reimbursement of expenses for participating in a clinical trial. (8) Further clarification of the United States Food and Drug Administration's confirmation and guidance is appropriate and important to improve subject participation in clinical trials, which is the primary intent of this legislation. (Source: P.A. 103-227, eff. 6-30-23.)