HB 5405

Abstract

Amends the Department of Public Health Powers and Duties Law of the Civil Administrative Code of Illinois. Sets forth requirements for any State entity or hospital that receives funding from the National Institutes of Health to conduct clinical trials of drugs or medical devices. Provides that the Department of Public Health, in consultation with relevant research organizations, shall analyze and provide recommendations on: (i) the demographic groups and populations that are currently represented and underrepresented in clinical trials in the State, including representation of groups based on their geographic location; (ii) the barriers that prevent persons who are members of underrepresented demographic groups from participating in clinical trials in the State, including barriers related to transportation; and (iii) approaches for how clinical trials can successfully partner with others to provide outreach to underrepresented communities. Provides that the Department shall report to the General Assembly on the results of the study by July 1, 2025. Sets forth definitions of underrepresented community and underrepresented demographic group. Provides that the Department shall review guidance published by the United States Food and Drug Administration and use existing infrastructure to encourage participation in clinical trials of drugs and medical devices by persons who are members of underrepresented demographic groups. Authorizes the Department to apply for any grants related to the encouragement of underrepresented demographic groups related to the United Food and Drug Administration's guidance. House Floor Amendment No. 1 Requires the policy to include specific strategies for trial enrollment and retention of diverse participants, including, but not limited to, site location and access, sustained community engagement, and reducing burdens due to trial design or conduct, as appropriate (rather than a requirement for investigators who are conducting the clinical trials to collaborate with community-based organizations). Requires a policy to provide information to trial participants in languages other than English in accordance with current federal requirements. Requires the Department of Public Health to consult with the University of Illinois Cancer Center in making recommendations. Makes other changes. Senate Committee Amendment No. 1 Replaces everything after the enacting clause with the provisions of the engrossed bill, and makes the following changes: Removes language requiring the Department of Public Health to adopt rules requiring State entities or hospitals to comply with specified requirements. Provides that the Department shall analyze and provide recommendations on specified information through voluntary reporting from research institutions and in consultation with community-based organizations and other stakeholders as appropriate and available (rather than in consultation with the Illinois Cancer Center, community-based organizations, and other research organizations). Provides that the Department shall issue its report and post the report on its website by July 1, 2026 (rather than reporting to the General Assembly by July 1, 2025). Provides that the Department shall establish an Internet website that provides information concerning methods for identifying and recruiting persons who are members of underrepresented demographic groups to participate in clinical trials and contains links to websites maintained by entities that are performing research relating to drugs or medical devices in the State (rather than establish a program to encourage participation in clinical trials of drugs and medical devices by persons who are members of demographic groups that are underrepresented in clinical trials).