Public Act 103-0860
 
HB5405 EnrolledLRB103 37925 CES 68057 b

    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.

Effective Date: 1/1/2025