(a) In conducting or supporting a project of clinical research, a grantee shall, except as provided in subdivision (b) or (e), 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 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.
(b) The requirement established in subdivisions (a) and (d) regarding women and members of minority groups shall not apply to a project of clinical research if the inclusion, as subjects in the project, of women and minority groups is inappropriate for either of the following reasons:
(1) With respect to the health and safety of the subjects.
(2) With respect to the purpose of the research.
(c) In the case of any clinical trial in which women or members of minority groups will, under subdivision (a), be included as subjects, a grantee shall 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.
(d) In any grant, or in any contract by a grantee under a grant, the grantee or contracting party shall acknowledge, agree to, and be bound by, the terms of this section.
(e) If a grantee is in compliance with the 1993 National Institutes of Health guidelines, the grantee shall be deemed to be in compliance with this section.
(Added by Stats. 2000, Ch. 250, Sec. 1. Effective January 1, 2001.)
Last modified: October 25, 2018