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

NOTE: For additional amemendments please see the Bill Drafting List

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Bill Title: DIVERSITY IN CLINICAL TRIALS

Status: 2024-08-09 - Public Act . . . . . . . . . 103-0860 [HB5405 Detail]

Download: Illinois-2023-HB5405-Senate_Amendment_001.html

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Sen. Julie A. Morrison

Filed: 5/7/2024

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AMENDMENT TO HOUSE BILL 5405
AMENDMENT NO. ______. Amend House Bill 5405 by replacing
everything after the enacting clause with the following:
"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) Any State entity or hospital that receives funding

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from the National Institutes of Health for the purpose of
conducting clinical trials of drugs or medical devices is
required 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:
(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.

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(c) The Department, through voluntary reporting from
research institutions and in consultation with community-based
organizations and other stakeholders as appropriate and
available, shall analyze and provide recommendations on the
following:
(1) the demographic groups and populations that are
currently represented and underrepresented in clinical
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, 2026, the Department shall issue a report and
post on its website 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 an
Internet website that:

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