Bill Text: IL HB5405 | 2023-2024 | 103rd General Assembly | Engrossed

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Bill Title: Amends the Department of Public Health Powers and Duties Law of the Civil Administrative Code of Illinois. Sets forth requirements for any State entity or hospital that receives funding from the National Institutes of Health to conduct clinical trials of drugs or medical devices. Provides that the Department of Public Health, in consultation with relevant research organizations, shall analyze and provide recommendations on: (i) the demographic groups and populations that are currently represented and underrepresented in clinical trials in the State, including representation of groups based on their geographic location; (ii) the barriers that prevent persons who are members of underrepresented demographic groups from participating in clinical trials in the State, including barriers related to transportation; and (iii) approaches for how clinical trials can successfully partner with others to provide outreach to underrepresented communities. Provides that the Department shall report to the General Assembly on the results of the study by July 1, 2025. Sets forth definitions of underrepresented community and underrepresented demographic group. Provides that the Department shall review guidance published by the United States Food and Drug Administration and use existing infrastructure to encourage participation in clinical trials of drugs and medical devices by persons who are members of underrepresented demographic groups. Authorizes the Department to apply for any grants related to the encouragement of underrepresented demographic groups related to the United Food and Drug Administration's guidance.

Spectrum: Partisan Bill (Democrat 12-0)

Status: (Engrossed) 2024-05-09 - Placed on Calendar Order of 3rd Reading [HB5405 Detail]

Download: Illinois-2023-HB5405-Engrossed.html

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AN ACT concerning State government.
Be it enacted by the People of the State of Illinois,
represented in the General Assembly:
Section 5. The Department of Public Health Powers and
Duties Law of the Civil Administrative Code of Illinois is
amended by adding Section 2310-730 as follows:
(20 ILCS 2310/2310-730 new)
Sec. 2310-730. Diversity in clinical trials.
(a) As used in this Section, "underrepresented community"
or "underrepresented demographic group" means a community or
demographic group that is more likely to be historically
marginalized and less likely to be included in research and
clinical trials represented by race, ethnicity, sex, sexual
orientation, socioeconomic status, age, and geographic
location.
(b) The Department of Public Health shall adopt rules
requiring any State entity or hospital that receives funding
from the National Institutes of Health for the purpose of
conducting clinical trials of drugs or medical devices to:
(1) adopt a policy that will result in the
identification and recruitment of persons who are members
of underrepresented demographic groups to participate in
the clinical trials and that:

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(A) includes specific strategies for trial
enrollment and retention of diverse participants,
including, but not limited to, site location and
access, sustained community engagement, and reducing
burdens due to trial design or conduct, as
appropriate; and
(B) uses strategies recommended by the United
States Food and Drug Administration to identify and
recruit those persons to participate in the clinical
trials;
(2) provide information to trial participants in
languages other than English in accordance with current
federal requirements;
(3) provide translation services or bilingual staff
for trial recruitment and consent processes;
(4) provide culturally specific recruitment materials
alongside general enrollment materials; and
(5) provide remote consent options when not prohibited
by the granting entity or federal regulations.
(c) The Department, in consultation the University of
Illinois Cancer Center, with academic organizations,
community-based organizations, and other relevant research
organizations, shall analyze and provide recommendations on
the following:
(1) the demographic groups and populations that are
currently represented and underrepresented in clinical

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trials in Illinois, including representation of groups
based on their geographic location;
(2) the barriers that prevent persons who are members
of underrepresented demographic groups from participating
in clinical trials in Illinois, including barriers related
to transportation; and
(3) approaches for how clinical trials can
successfully partner with community-based organizations
and others to provide outreach to underrepresented
communities.
By July 1, 2025, the Department shall report to the
General Assembly the results of the analysis required under
this subsection and any recommendations to increase diversity
and reduce barriers for participants in clinical trials.
(d) The Department shall review the most recent guidance
on race and ethnicity data collection in clinical trials
published by the United States Food and Drug Administration
and establish, using existing infrastructure and tools, a
program to encourage participation in clinical trials of drugs
and medical devices by persons who are members of demographic
groups that are underrepresented in such clinical trials. The
program must include, without limitation:
(1) collaboration with medical facilities, health
authorities and other local governmental entities,
nonprofit organizations, and scientific investigators and
institutions that are performing research relating to

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