What additional requirements apply to research with pregnant women or fetuses?
Under the terms of 45 CFR 46, Subpart B, pregnant women and fetuses are considered to be members of a vulnerable population and therefore entitled to special protections if they participate in research activities. Subpart B defines both the types of permissible research with pregnant women and fetuses, and the safeguards that must be followed. For additional information, review the regulations at:http://www.hhs.gov/ ohrp/humansubjects/guidance/45cfr46.
Under the terms of 45 CFR 46, Subpart B, pregnant women and fetuses are considered to be members of a vulnerable population and therefore entitled to special protections if they participate in research activities. Subpart B defines both the types of permissible research with pregnant women and fetuses, and the safeguards that must be followed. For additional information, review the regulations at: http://www.hhs.gov/ ohrp/humansubjects/guidance/45cfr46.
