Reading Between the Lines: What Do (and Should) Worldwide Research Ethics Guidelines Really Say to Pregnant Women? [1G]

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Abstract

INTRODUCTION:

For many years, pregnant women have been inappropriately excluded from clinical trials, resulting in a vacuum of clinical knowledge that unfairly disadvantages them. There is no other population for which such an abyss of knowledge exists, or would be considered acceptable. Surprisingly, this antiquated practice is supported by several research ethics guidelines worldwide. While these guidelines currently support this practice, there is a plethora of ethics literature calling for change. I have previously published a review of worldwide research ethics guidelines and how they address pregnancy; the next step towards change is to make suggestions for how a ethically sound guideline should be developed.

METHODS:

An extensive review of national and international research ethics guidelines was performed. All guidelines available online or in text, available or translated into English or French were reviewed to determine whether they specifically addressed pregnancy. If they did, they were then subcategorized as restrictive, permissive with conditions and permissive.

RESULTS:

Twenty two National Guidelines and five International Guidelines were reviewed. Important ethical concepts such as appropriate inclusion, consent and appropriate conditions of exclusion were identified. A summary of important concepts were then compiled to ultimately propose criteria for how research ethics guidelines should (and should not) address pregnancy.

CONCLUSION:

Research ethics guidelines are living documents, and this research conveys important knowledge helpful for these inevitable revisions. It provides baseline ethical knowledge and justifications for those editing these documents (or creating new ones) to use in a move toward comprehensive and ethically defendable guidelines.

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