Bioethics News

Exclusion of Mothers-To-Be From Clinical Studies Unfair and Potentially Harmful

July 18, 2017

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In fact, pregnant women’s vulnerability boils down to the lack of research carried out in this group, and it’s a dilemma that can only be overcome by including mums-to-be in clinical studies, they say.

“Our study once and for all demonstrates that there is no indication that pregnant women are vulnerable because of informed consent, susceptibility to coercion, or vulnerability of the fetus,” they write.

“The only reason why pregnant women are potentially vulnerable in clinical research is to the extent that they are increasingly exposed to higher risks due to a lack of scientific knowledge which might render them vulnerable as research subjects,” they continue.

“Only a joint effort to promote fair inclusion by funding agencies, authorities, researchers, methodologists, pharmacologists, guideline committees and [research ethics committees] can successfully reduce pregnant women’s vulnerability,” they conclude.

In a linked Commentary, Drs Carleigh Krubiner and Ruth Faden, of the Berman Institute for Bioethics at Johns Hopkins University, Baltimore, argue that the designation of pregnant women as ‘vulnerable’ “is inappropriate and disrespectful.”

And rather than protecting them, it has had the opposite effect, and created a great deal of uncertainty and anxiety.

… Read More

Vulnerability of pregnant women in clinical research, Journal of Medical Ethics (2017). DOI: 10.1136/medethics-2016-103955

Commentary: Pregnant women should not be categorised as a ‘vulnerable population’ in biomedical research studies: ending a vicious cycle of ‘vulnerability’ Journal of Medical Ethics (2017). DOI: 10.1136/medethics-2017-104446

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Source: Bioethics Bulletin by the Berman Institute of Bioethics.

The views, opinions and positions expressed by these authors and blogs are theirs and do not necessarily represent that of the Bioethics Research Library and Kennedy Institute of Ethics or Georgetown University.