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This session will address the following topics and related changes in the pending updated HRPP policies:

Reasons for enrolling pregnant women in clinical trials
Circumstances under which pregnant women may be enrolled in human subjects research (HSR)
What to do when a woman becomes pregnant while participating in a protocol not originally reviewed under regulations governing research involving pregnant women
Circumstances when prisoners may be enrolled in HSR and PI responsibilities if a participant becomes incarcerated while on study
Identifying and determining the appropriateness of the legally authorized representative for potential participants who lack capacity to provide informed consent for participation in HSR
Temporary versus permanent loss of capacity to provide informed consent for participation in HSR

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This session will address the following topics and related changes in the pending updated HRPP policies:

Reasons for enrolling pregnant women in clinical trials
Circumstances under which pregnant women may be enrolled in human subjects research (HSR)
What to do when a woman becomes pregnant while participating in a protocol not originally reviewed under regulations governing research involving pregnant women
Circumstances when prisoners may be enrolled in HSR and PI responsibilities if a participant becomes incarcerated while on study
Identifying and determining the appropriateness of the legally authorized representative for potential participants who lack capacity to provide informed consent for participation in HSR
Temporary versus permanent loss of capacity to provide informed consent for participation in HSR

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This session will address the following topics and related changes in the pending updated HRPP policies:

Reasons for enrolling pregnant women in clinical trials
Circumstances under which pregnant women may be enrolled in human subjects research (HSR)
What to do when a woman becomes pregnant while participating in a protocol not originally reviewed under regulations governing research involving pregnant women
Circumstances when prisoners may be enrolled in HSR and PI responsibilities if a participant becomes incarcerated while on study
Identifying and determining the appropriateness of the legally authorized representative for potential participants who lack capacity to provide informed consent for participation in HSR
Temporary versus permanent loss of capacity to provide informed consent for participation in HSR

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