HHS Requirements for Use of Human Subjects in Research

Legislative Process Framework : HHS Requirements for Use of Human Subjects in Research

HHS Requirements for Inclusion

Informed Consent When Women Are Research Subjects

Subpart B also includes a number of clarifications regarding informed consent:

• Consent only of the woman or her legally authorized representative is required if:
• The research is intended to benefit solely the woman, or both the woman and her fetus; or
• The research has no prospect of direct benefit for the woman or the fetus, when risk to the fetus is no greater than minimal and the purpose of the research is to develop important biomedical knowledge that cannot be obtained by other means.
• Paternal consent is not required when the research is aimed solely to benefit the pregnant woman, or when the research is intended to benefit both the pregnant woman and her fetus.
• Paternal consent is required if the research is intended to benefit solely the fetus, unless the father is unable to consent due to unavailability, incompetence, or temporary incapacity, or the pregnancy resulted from rape or incest. Researchers and institutional review boards will need to ascertain whether the research is intended to benefit the woman, both the woman and her fetus, or solely the fetus. Institutions will be able to consider whether proposed research involving pregnant women, fetuses, and neonates falls within one of the exemptions to the human subjects protection regulations provided under Subpart A. Institutional review boards may consider whether waiver of informed consent, or waiver of documentation of informed consent, is appropriate.