HB5405 EngrossedLRB103 37925 CES 68057 b

1    AN ACT concerning State government.
 
2    Be it enacted by the People of the State of Illinois,
3represented in the General Assembly:
 
4    Section 5. The Department of Public Health Powers and
5Duties Law of the Civil Administrative Code of Illinois is
6amended 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"
10or "underrepresented demographic group" means a community or
11demographic group that is more likely to be historically
12marginalized and less likely to be included in research and
13clinical trials represented by race, ethnicity, sex, sexual
14orientation, socioeconomic status, age, and geographic
15location.
16    (b) The Department of Public Health shall adopt rules
17requiring any State entity or hospital that receives funding
18from the National Institutes of Health for the purpose of
19conducting 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
21Illinois Cancer Center, with academic organizations,
22community-based organizations, and other relevant research
23organizations, shall analyze and provide recommendations on
24the 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
12General Assembly the results of the analysis required under
13this subsection and any recommendations to increase diversity
14and reduce barriers for participants in clinical trials.
15    (d) The Department shall review the most recent guidance
16on race and ethnicity data collection in clinical trials
17published by the United States Food and Drug Administration
18and establish, using existing infrastructure and tools, a
19program to encourage participation in clinical trials of drugs
20and medical devices by persons who are members of demographic
21groups that are underrepresented in such clinical trials. The
22program 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,
19including, without limitation, the Federal Government, to fund
20the requirements of this Section.