State of Illinois
92nd General Assembly

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 1        AN ACT in relation to health.

 2        Be it enacted by the People of  the  State  of  Illinois,
 3    represented in the General Assembly:

 4        Section  1.  Short  title.  This  Act may be cited as the
 5    Inclusion of Women and Minorities in Clinical Research Act.

 6        Section 5.  Definitions. In this Act:
 7        "Grantee"  means  any  qualified  public,   private,   or
 8    not-for-profit  agency  or  individual,  including,  but  not
 9    limited  to,  a  college,  university,  hospital, laboratory,
10    research  institution,  local  health  department,  voluntary
11    health agency, health maintenance organization,  corporation,
12    student,   fellow,   or   entrepreneur,  conducting  clinical
13    research  using  State  funds.  A  grantee  may  also  be   a
14    corporation  that  is  headquartered  in  Illinois  and  that
15    conducts research using State funds.
16        "Minority  group"  is  defined  as  in  the 2000 National
17    Institutes of Health guidelines.
18        "Project of clinical research" includes a clinical trial.

19        Section 10.  Inclusion of women and minorities. Except as
20    provided in Section 15 or 30, in conducting or  supporting  a
21    project  of  clinical  research, a grantee must do all of the
22    following:
23             (1)  Ensure that women, including, but  not  limited
24        to,  women  over  the  age  of  40 years, are included as
25        subjects in each research project.
26             (2)  Ensure that  members  of  minority  groups  are
27        included as subjects in each research project.
28             (3)  Conduct  or  support  outreach programs for the
29        recruitment of women and members of  minority  groups  as
30        subjects in projects of clinical research.
                            -2-                LRB9212287DJgc
 1        Section  15.  Exceptions. The requirements established in
 2    Sections 10 and 25 regarding women and  members  of  minority
 3    groups  do not apply to a project of clinical research if the
 4    inclusion of women and members of minority groups as subjects
 5    in the project is inappropriate  because  of  either  of  the
 6    following:
 7             (1)  The health and safety of the subjects.
 8             (2)  The purpose of the research.

 9        Section  20.  Manner  of  conducting trial. In a clinical
10    trial in which women or members of minority  groups  will  be
11    included  as subjects as required under Section 10, a grantee
12    must ensure that the trial is designed and carried out  in  a
13    manner  sufficient to provide for a valid analysis of whether
14    the variables being studied in  the  trial  affect  women  or
15    members  of  minority groups, as the case may be, differently
16    than other subjects in the trial.

17        Section 25.  Grantee bound by terms of Act. In any grant,
18    or in any contract by a grantee under a grant, the grantee or
19    contracting party must acknowledge, agree to, and be bound by
20    the terms of this Act.

21        Section  30.  Grantee's  compliance  with  2000  National
22    Institutes  of  Health  guidelines.  If  a  grantee   is   in
23    compliance  with  the  2000  National  Institutes  of  Health
24    guidelines,  the  grantee shall be deemed to be in compliance
25    with this Act.

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