Full Text of HB5405 103rd General Assembly
HB5405sam001 103RD GENERAL ASSEMBLY | Sen. Julie A. Morrison Filed: 5/7/2024 | | 10300HB5405sam001 | | LRB103 37925 LNS 73018 a |
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| 1 | | AMENDMENT TO HOUSE BILL 5405
| 2 | | AMENDMENT NO. ______. Amend House Bill 5405 by replacing | 3 | | everything after the enacting clause with the following: | 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) Any State entity or hospital that receives funding |
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| 1 | | from the National Institutes of Health for the purpose of | 2 | | conducting clinical trials of drugs or medical devices is | 3 | | required to: | 4 | | (1) adopt a policy that will result in the | 5 | | identification and recruitment of persons who are members | 6 | | of underrepresented demographic groups to participate in | 7 | | the clinical trials and that: | 8 | | (A) includes specific strategies for trial | 9 | | enrollment and retention of diverse participants, | 10 | | including, but not limited to, site location and | 11 | | access, sustained community engagement, and reducing | 12 | | burdens due to trial design or conduct, as | 13 | | appropriate; and | 14 | | (B) uses strategies recommended by the United | 15 | | States Food and Drug Administration to identify and | 16 | | recruit those persons to participate in the clinical | 17 | | trials; | 18 | | (2) provide information to trial participants in | 19 | | languages other than English in accordance with current | 20 | | federal requirements; | 21 | | (3) provide translation services or bilingual staff | 22 | | for trial recruitment and consent processes; | 23 | | (4) provide culturally specific recruitment materials | 24 | | alongside general enrollment materials; and | 25 | | (5) provide remote consent options when not prohibited | 26 | | by the granting entity or federal regulations. |
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| 1 | | (c) The Department, through voluntary reporting from | 2 | | research institutions and in consultation with community-based | 3 | | organizations and other stakeholders as appropriate and | 4 | | available, shall analyze and provide recommendations on the | 5 | | following: | 6 | | (1) the demographic groups and populations that are | 7 | | currently represented and underrepresented in clinical | 8 | | trials in Illinois, including representation of groups | 9 | | based on their geographic location; | 10 | | (2) the barriers that prevent persons who are members | 11 | | of underrepresented demographic groups from participating | 12 | | in clinical trials in Illinois, including barriers related | 13 | | to transportation; and | 14 | | (3) approaches for how clinical trials can | 15 | | successfully partner with community-based organizations | 16 | | and others to provide outreach to underrepresented | 17 | | communities. | 18 | | By July 1, 2026, the Department shall issue a report and | 19 | | post on its website the results of the analysis required under | 20 | | this subsection and any recommendations to increase diversity | 21 | | and reduce barriers for participants in clinical trials. | 22 | | (d) The Department shall review the most recent guidance | 23 | | on race and ethnicity data collection in clinical trials | 24 | | published by the United States Food and Drug Administration | 25 | | and establish, using existing infrastructure and tools an | 26 | | Internet website that: |
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| 1 | | (1) provides information concerning methods recognized | 2 | | by the United States Food and Drug Administration for | 3 | | identifying and recruiting persons who are members of | 4 | | underrepresented demographic groups to participate in | 5 | | clinical trials; and | 6 | | (2) contains links to Internet websites maintained by | 7 | | medical facilities, health authorities and other local | 8 | | governmental entities, nonprofit organizations, and | 9 | | scientific investigators and institutions that are | 10 | | performing research relating to drugs or medical devices | 11 | | in this State. | 12 | | The Department may apply for grants from any source, | 13 | | including, without limitation, the Federal Government, to fund | 14 | | the requirements of this Section. ". |
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