(30 ILCS 785/1) Sec. 1. Short title. This Act may be cited as the Inclusion of Women and Minorities in Clinical Research Act. (Source: P.A. 93-514, eff. 1-1-04.)

(30 ILCS 785/5) Sec. 5. Definitions. In this Act: "Grantee" means any qualified public, private, or not-for-profit agency or individual, including, but not limited to, a college, university, hospital, laboratory, research institution, local health department, voluntary health agency, health maintenance organization, corporation, student, fellow, or entrepreneur, conducting clinical research using State funds. A grantee may also be a corporation that is headquartered in Illinois and that conducts research using State funds. "Minority group" means a group that is a readily identifiable subset of the U.S. population that is distinguished by racial, ethnic, or cultural heritage and that is made up of persons who are any of the following:(1) American Indian or Alaska Native (a person having

origins in any of the original peoples of North and South America, including Central America, and who maintains tribal affiliation or community attachment).

(2) Asian (a person having origins in any of the

original peoples of the Far East, Southeast Asia, or the Indian subcontinent, including, but not limited to, Cambodia, China, India, Japan, Korea, Malaysia, Pakistan, the Philippine Islands, Thailand, and Vietnam).

(3) Black or African American (a person having

origins in any of the black racial groups of Africa). Terms such as "Haitian" or "Negro" can be used in addition to "Black or African American".

(4) Hispanic or Latino (a person of Cuban, Mexican,

Puerto Rican, South or Central American, or other Spanish culture or origin, regardless of race).

(5) Native Hawaiian or Other Pacific Islander (a

person having origins in any of the original peoples of Hawaii, Guam, Samoa, or other Pacific Islands).

"Project of clinical research" includes a clinical trial. (Source: P.A. 97-396, eff. 1-1-12.)

(30 ILCS 785/10) Sec. 10. Inclusion of women and minorities. Except as provided in Section 15 or 30, in conducting or supporting a project of clinical research, a grantee must do all of the following: (1) Ensure that women, including, but not limited to,

women over the age of 40 years, are included as subjects in each research project.

(2) Ensure that members of minority groups are

included as subjects in each research project.

(3) Conduct or support outreach programs for the

recruitment of women and members of minority groups as subjects in projects of clinical research.

(4) Comply with the National Institutes of Health

Guidelines on the Inclusion of Women and Minorities in Clinical Research.

(Source: P.A. 93-514, eff. 1-1-04; 93-787, eff. 1-1-05.)

(30 ILCS 785/15) Sec. 15. Exceptions. The requirements established in Sections 10 and 25 regarding women and members of minority groups do not apply to a project of clinical research if the inclusion of women and members of minority groups as subjects in the project is inappropriate because of either of the following: (1) The health and safety of the subjects. (2) The purpose of the research. (Source: P.A. 93-514, eff. 1-1-04.)

(30 ILCS 785/20) Sec. 20. Manner of conducting trial. In a clinical trial in which women or members of minority groups will be included as subjects as required under Section 10, a grantee must ensure that the trial is designed and carried out in a manner sufficient to provide for a valid analysis of whether the variables being studied in the trial affect women or members of minority groups, as the case may be, differently than other subjects in the trial. (Source: P.A. 93-514, eff. 1-1-04.)

(30 ILCS 785/25) Sec. 25. Grantee bound by terms of Act. In any grant, or in any contract by a grantee under a grant, the grantee or contracting party must acknowledge, agree to, and be bound by the terms of this Act. (Source: P.A. 93-514, eff. 1-1-04.)

(30 ILCS 785/30) Sec. 30. Grantee's compliance with 2000 National Institutes of Health guidelines. If a grantee is in compliance with the 2000 National Institutes of Health guidelines, the grantee shall be deemed to be in compliance with this Act. (Source: P.A. 93-514, eff. 1-1-04.)