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| | HB5405 Engrossed | | LRB103 37925 CES 68057 b |
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| 1 | | AN ACT concerning State government.
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| 2 | | Be it enacted by the People of the State of Illinois, |
| 3 | | represented in the General Assembly:
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| 4 | | Section 5. The Department of Public Health Powers and |
| 5 | | Duties Law of the Civil Administrative Code of Illinois is |
| 6 | | amended by adding Section 2310-730 as follows:
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| 7 | | (20 ILCS 2310/2310-730 new) |
| 8 | | Sec. 2310-730. Diversity in clinical trials. |
| 9 | | (a) As used in this Section, "underrepresented community" |
| 10 | | or "underrepresented demographic group" means a community or |
| 11 | | demographic group that is more likely to be historically |
| 12 | | marginalized and less likely to be included in research and |
| 13 | | clinical trials represented by race, ethnicity, sex, sexual |
| 14 | | orientation, socioeconomic status, age, and geographic |
| 15 | | location. |
| 16 | | (b) The Department of Public Health shall adopt rules |
| 17 | | requiring any State entity or hospital that receives funding |
| 18 | | from the National Institutes of Health for the purpose of |
| 19 | | conducting clinical trials of drugs or medical devices to: |
| 20 | | (1) adopt a policy that will result in the |
| 21 | | identification and recruitment of persons who are members |
| 22 | | of underrepresented demographic groups to participate in |
| 23 | | the clinical trials and that: |
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| 1 | | (A) includes specific strategies for trial |
| 2 | | enrollment and retention of diverse participants, |
| 3 | | including, but not limited to, site location and |
| 4 | | access, sustained community engagement, and reducing |
| 5 | | burdens due to trial design or conduct, as |
| 6 | | appropriate; and |
| 7 | | (B) uses strategies recommended by the United |
| 8 | | States Food and Drug Administration to identify and |
| 9 | | recruit those persons to participate in the clinical |
| 10 | | trials; |
| 11 | | (2) provide information to trial participants in |
| 12 | | languages other than English in accordance with current |
| 13 | | federal requirements; |
| 14 | | (3) provide translation services or bilingual staff |
| 15 | | for trial recruitment and consent processes; |
| 16 | | (4) provide culturally specific recruitment materials |
| 17 | | alongside general enrollment materials; and |
| 18 | | (5) provide remote consent options when not prohibited |
| 19 | | by the granting entity or federal regulations. |
| 20 | | (c) The Department, in consultation the University of |
| 21 | | Illinois Cancer Center, with academic organizations, |
| 22 | | community-based organizations, and other relevant research |
| 23 | | organizations, shall analyze and provide recommendations on |
| 24 | | the following: |
| 25 | | (1) the demographic groups and populations that are |
| 26 | | currently represented and underrepresented in clinical |
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| 1 | | trials in Illinois, including representation of groups |
| 2 | | based on their geographic location; |
| 3 | | (2) the barriers that prevent persons who are members |
| 4 | | of underrepresented demographic groups from participating |
| 5 | | in clinical trials in Illinois, including barriers related |
| 6 | | to transportation; and |
| 7 | | (3) approaches for how clinical trials can |
| 8 | | successfully partner with community-based organizations |
| 9 | | and others to provide outreach to underrepresented |
| 10 | | communities. |
| 11 | | By July 1, 2025, the Department shall report to the |
| 12 | | General Assembly the results of the analysis required under |
| 13 | | this subsection and any recommendations to increase diversity |
| 14 | | and reduce barriers for participants in clinical trials. |
| 15 | | (d) The Department shall review the most recent guidance |
| 16 | | on race and ethnicity data collection in clinical trials |
| 17 | | published by the United States Food and Drug Administration |
| 18 | | and establish, using existing infrastructure and tools, a |
| 19 | | program to encourage participation in clinical trials of drugs |
| 20 | | and medical devices by persons who are members of demographic |
| 21 | | groups that are underrepresented in such clinical trials. The |
| 22 | | program must include, without limitation: |
| 23 | | (1) collaboration with medical facilities, health |
| 24 | | authorities and other local governmental entities, |
| 25 | | nonprofit organizations, and scientific investigators and |
| 26 | | institutions that are performing research relating to |