Sen. Julie A. Morrison

Filed: 5/7/2024

 

 


 

 


 
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1
AMENDMENT TO HOUSE BILL 5405

2    AMENDMENT NO. ______. Amend House Bill 5405 by replacing
3everything after the enacting clause with the following:
 
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

 

 

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1from the National Institutes of Health for the purpose of
2conducting clinical trials of drugs or medical devices is
3required 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
2research institutions and in consultation with community-based
3organizations and other stakeholders as appropriate and
4available, shall analyze and provide recommendations on the
5following:
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
19post on its website the results of the analysis required under
20this subsection and any recommendations to increase diversity
21and reduce barriers for participants in clinical trials.
22    (d) The Department shall review the most recent guidance
23on race and ethnicity data collection in clinical trials
24published by the United States Food and Drug Administration
25and establish, using existing infrastructure and tools an
26Internet 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,
13including, without limitation, the Federal Government, to fund
14the requirements of this Section.".