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. (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. (2) Ensure that members of minority groups are included as subjects in each research project.
3. (3) Conduct or support outreach programs for the recruitment of women and members of minority groups as subjects in projects of clinical research.
4. (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.)