HB5405 EnrolledLRB103 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) Any State entity or hospital that receives funding
17from the National Institutes of Health for the purpose of
18conducting clinical trials of drugs or medical devices is
19required 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, through voluntary reporting from
21research institutions and in consultation with community-based
22organizations and other stakeholders as appropriate and
23available, shall analyze and provide recommendations on the
24following:
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, 2026, the Department shall issue a report and
12post on its website 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 an
19Internet website that:
20        (1) provides information concerning methods recognized
21    by the United States Food and Drug Administration for
22    identifying and recruiting persons who are members of
23    underrepresented demographic groups to participate in
24    clinical trials; and
25        (2) contains links to Internet websites maintained by
26    medical facilities, health authorities and other local

 

 

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1    governmental entities, nonprofit organizations, and
2    scientific investigators and institutions that are
3    performing research relating to drugs or medical devices
4    in this State.
5    The Department may apply for grants from any source,
6including, without limitation, the Federal Government, to fund
7the requirements of this Section.