Discussion

Abstract

The opinion statement on Ethical Considerations in Research Involving Pregnant Women issued by the Committee on Ethics of the American College of Obstetricians and Gynecologists (ACOG) is intended to provide guidelines that affirm the need for human subjects research as well as the obligation of those who conduct or review research to use extreme care in evaluating the potential effects of research on pregnant women and their fetuses. The resulting recommendations are based on a presumption of inclusion of pregnant women in research (with some exceptions) as opposed to a presumption of exclusion. This is a departure from what has historically been the federal policy governing research with pregnant women, and issuance of these recommendations comes at a time when the Department of Health and Human Services is in the process of revising its regulations on research with pregnant women. It gives us the opportunity to review the question of when research with any human subjects is ethically justifiable and to consider whether or why pregnant women should be treated differently from other competent human subjects. It is our contention that the principles governing research with human subjects remain the same, regardless of whether pregnant women are included as subjects. Inclusion of pregnant women as subjects raises questions regarding the implementation of those principles in different circumstances, rather than creating a need for new or special principles. It will primarily affect the nature and scope of information regarding the risks and benefits to the woman or the fetus that is needed to determine whether the research is ethically justifiable and on the scope of information that must be communicated to potential subjects as part of informed consent. Research with human subjects is justifiable only if it can be reasonably © 1999 by the Jacobs Institute of Women’s Health Published by Elsevier Science Inc. 1049-3867/99/$20.00 PII S1049-3867(99)00012-2