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| Public Act 103-0860 | ||||
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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) 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 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. | ||
(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: | ||
(1) provides information concerning methods recognized | ||
by the United States Food and Drug Administration for | ||
identifying and recruiting persons who are members of | ||
underrepresented demographic groups to participate in | ||
clinical trials; and | ||
(2) contains links to Internet websites maintained by | ||
medical facilities, health authorities and other local | ||
governmental entities, nonprofit organizations, and | ||
scientific investigators and institutions that are | ||
performing research relating to drugs or medical devices | ||
in this State. | ||
The Department may apply for grants from any source, | ||
including, without limitation, the Federal Government, to fund | ||
the requirements of this Section. | ||