title: Ethical and regulatory issues related to pregnancy registries and their outcomes.
abstract: Pregnancy registries should be devised so that the interests of science, society, and the individual are all considered. For example, there may be ethical issues that relate to how women are chosen to participate in the registry and how informed consent is obtained. In most cases, consent is required for both the mother and the infant. Some institutional review boards will require that consent be obtained by someone other than the woman's physician. Once data are obtained, there may be an issue as to when results should be released. Options are to release data when there is the first indication of a concerning finding, thereby potentially preventing exposure in the largest number of women, versus waiting until the finding is absolutely confirmed. In a related issue, there are questions of when and how regulatory agencies should change labeling based on findings.
authors.affiliation: New York University, New York, NY 10016, USA. Jacqueline.French@comcast.net
authors.forename: Jacqueline A
authors.initials: JA
authors.lastname: French
authors.forename: Kimford
authors.initials: K
authors.lastname: Meador
authors.forename: Avital
authors.initials: A
authors.lastname: Cnaan
authors.forename: Frank
authors.initials: F
authors.lastname: Gilliam
authors.forename: Jill
authors.initials: J
authors.lastname: Conway
authors.forename: Richardae
authors.initials: R
authors.lastname: Araojo
authors.forename: Karen
authors.initials: K
authors.lastname: Feibus
mesh_terms: D003625:Data Collection / Q000941:ethics / Q000331:legislation & jurisprudence; D005260:Female; D006801:Humans; D033181:Information Dissemination / Q000941:ethics; D007258:Informed Consent / Q000941:ethics* / Q000331:legislation & jurisprudence; D011247:Pregnancy / Q000941:ethics*; D011256:Pregnancy Outcome; D012042:Registries / Q000941:ethics*