Can research subject to subpart b and that includes pregnant women as subjects be exempt from the regulations, per 45 cfr 46, if all of the conditions of the exemption are met?.

Respuesta :

There are different kinds of research. YES, research subject to subpart b and that includes pregnant women as subjects be exempt from the regulations, per 45 cfr 46, if all of the conditions of the exemption are met.

Can research subject to Subpart B and includes pregnant women as subjects exempt?

Note that the law for non-exempt human subjects as research subject to 45 CFR 46, Subpart B are the ones that involves the use of pregnant women, human fetuses, or neonates.

Some other basic requirements of Subpart A as shown in C is that Research that pertains to the use of viable neonates may be conducted only in line with the conditions of 45 CFR 46.205(d).

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