Full Text of HB5405 103rd General Assembly
HB5405eng 103RD GENERAL ASSEMBLY | | | HB5405 Engrossed | | LRB103 37925 CES 68057 b |
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| 1 | | AN ACT concerning State government. | 2 | | Be it enacted by the People of the State of Illinois, | 3 | | represented in the General Assembly: | 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: | 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 |
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| 1 | | drugs or medical devices to assist those investigators and | 2 | | institutions in identifying and recruiting persons who are | 3 | | members of underrepresented demographic groups to | 4 | | participate in clinical trials; and | 5 | | (2) the establishment and maintenance of an Internet | 6 | | website that: | 7 | | (A) provides information concerning methods | 8 | | recognized by the United States Food and Drug | 9 | | Administration for identifying and recruiting persons | 10 | | who are members of underrepresented demographic groups | 11 | | to participate in clinical trials; and | 12 | | (B) contains links to Internet websites maintained | 13 | | by medical facilities, health authorities and other | 14 | | local governmental entities, nonprofit organizations, | 15 | | and scientific investigators and institutions that are | 16 | | performing research relating to drugs or medical | 17 | | devices in this State. | 18 | | The Department may apply for grants from any source, | 19 | | including, without limitation, the Federal Government, to fund | 20 | | the requirements of this Section. |
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