Un llamado ético a la inclusión de mujeres embarazadas en investigación: Reflexiones del Foro Global de Bioética en Investigación

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Abstract

The Global Forum on Bioethics in Research (GFBR) met on November 3 and 4 in Buenos Aires, Argentina with the purpose of discussing the ethics of research with pregnant women. The GBRF is a global platform that brings together key actors with the purpose of promoting research conducted in an ethical way, strengthening health research ethics–particularly in low- and medium-income countries–and promoting collaboration between the countries in the north and the south.a Some of the participants of the GFBR attending from Latin America include ethicists, researchers, ethics committee members and representatives of health authorities from Argentina, Brazil, Chile, Colombia, Ecuador, El Salvador, Guatemala, Honduras, Panama, Peru, Nicaragua and Dominican Republic. A legitimate concern about the protection of pregnant women and their embryos or fetuses has led most of the countries in the region to restrict studies with pregnant women exclusively to those that are about pregnancy, and to require the systematic exclusion of pregnant women and women who get pregnant from the rest of studies. Certainly, throughout the history of research ethics it has been mistakenly believed that protecting a population is synonymous with excluding that population from studies. It is now known that proceeding in this way implies exposing the very population we want to protect to larger risks. Pregnancy implies substantial physiological changes that significantly influence the way the body metabolizes medications. However, by avoiding conducting research with pregnant women, the necessary scientific evidence to inform decisions on preventive treatments and interventions with effective and safe dosage for them and their embryos or fetuses has not been produced. As an illustration, in 2001 there were barely a dozen medications approved for use during pregnancy in the United States1 , and in 2011 the Food and Drug Administration (FDA) approved, for the first time in 15 years, a medication to be used during pregnancy.2 As a result, pregnant women’s health is jeopardized every time we provide them health care. Pregnant women get sick and sick women get pregnant, and it is not known if the medications they are prescribed are efficacious or even safe for them and their embryos or fetuses.

Description

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Citation

Saenz, Carla et al. “Un llamado ético a la inclusión de mujeres embarazadas en investigación: Reflexiones del Foro Global de Bioética en Investigación” [An ethics call to include pregnant women in research: Reflections from the Global Forum on Bioethics in Research]. Revista panamericana de salud publica = Pan American journal of public health vol. 41 (2017): e13. doi:10.26633/RPSP.2017.13

Keywords

Bioethics, health research, pregnant women, Global Health

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