Pregnant women's presumed inclusion in clinical research called for in HHS proposal.
This article was originally published in The Tan Sheet
Executive Summary
PREGNANT WOMEN's PRESUMED INCLUSION IN CLINICAL RESEARCH is called for by HHS in an advance notice of proposed rulemaking published in the May 20 Federal Register. The proposed rule "institutes a policy of presumed opportunity for inclusion of pregnant women in research in place of one of presumed exclusion," HHS states. In other words, pregnant women should be allowed to be participants in clinical trials unless there are compelling reasons to prevent their inclusion. HHS invites comments on the proposed rule, which modifies 45 CFR 46 Subpart B, until Aug. 18.