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Can research subject to Subpart B and that includes pregnant women as subjects be exempt from the regulations, per 4 5 CFR 4 6 ,
Can research subject to Subpart B and that includes pregnant women as subjects be exempt from the regulations, per CFR if all of the conditions of the exemption are met?
No research with pregnant women can never be exempt per CFR
Yes, if there are limits on the blood draw amounts included in the research.
Yes, each of the exemptions in CFR may be applied to research subject to Subpart B
Yes, but only for certain exempt categories per CFR
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