Policy for Inclusion of Women and Racial and Ethnic Minorities In Research

This policy addresses CDC’s commitment to protecting the health of all people regardless of their age, sex, race, ethnicity, national origin, religion, sexual orientation, socioeconomic status, or other characteristics. This policy updates the guidelines on the inclusion of women and minorities and their subpopulations in research involving human subjects which is supported or conducted by CDC.

This policy applies to all CDC-conducted or CDC-supported research involving human subjects, including research that is otherwise exempt in accordance with Sections 101(b) of Title 45, Code of Federal Regulations (C.F.R) Part 46, HHS Policy for the Protection of Human Subjects.

It is the policy of CDC that women of childbearing potential should not be routinely or arbitrarily excluded from participation. However, ethical issues must be considered for inclusion and exclusion. HHS regulations at 45 C.F.R. Part 46 Subpart B extend additional protections for pregnant women, human fetuses and neonates involved in research. These regulations must be considered when research may involve pregnant women. Information conveying adverse differences in outcome or risk profiles for pregnant women and fetuses is a valid reason for exclusion.