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2022 PRIM&R Annual Conference

Populations Requiring Additional Protections

E03 - “Do Not Take if You Are Pregnant”: Demystifying the Inclusion of Pregnant Participants in Research

Wednesday, December 14, 2022
1:30 PM – 2:30 PM ET
Location: Livestreamed
Livestreaming Session Icon CIP Accredited Human Subjects Research Deep Dive Series
Subpart B places additional restrictions on trials that include pregnant people, and there has been systematic and widespread exclusion of pregnant people from non-obstetric trials. The past several years have clearly demonstrated that this has led to a dangerous information gap. Doctors are placed in a position of prescribing (or not) without sufficient data, and many pregnant people feel unable to assess the risks of deciding to take needed medications and vaccines.

Learning Objectives:

  • Review the history and rationale for protection
  • Investigate two dimensions of the ethical conundrum: 1) the primacy of autonomy for adults with decisional capacity vs. the categorical vulnerability and limitations placed upon “pregnant women”; and 2) the emphasis on justice, and the exclusion of otherwise eligible prospective participants due to pregnancy
  • Consider what equal and fair inclusion would look like
  • Discover areas of flexibility within Part B that can be leveraged to increase opportunities for pregnant participants to join studies, common misconceptions, and how to provide guidance for investigators