Increasingly, conducting research with pregnant women has been recognized as ethically imperative – if enduringly complex. Numerous barriers to including pregnant women in biomedical research have resulted in profound & consequential evidence gaps regarding safe & effective use of medications in pregnancy. Without timely pregnancy-specific data, pregnant women may be dosed inappropriately, given drugs with unacceptable risks to the woman or fetus, denied access to beneficial & potentially lifesaving drugs, & left with deep uncertainty about medical decisions. In an effort to make progress on these challenges, Dr. Lyerly led the PHASES (Pregnancy & HIV/AIDS Seeking Equitable Study) Project, an NIH-funded effort to clear a pathway forward for generating pregnancy-specific evidence in the international context of HIV/co-infections.
Dr. Lyerly presents ethics guidance developed by the project, describing:
The process of guidance development
An ethical framework grounding research with pregnant women
12 concrete recommendations aimed at securing better evidence on safely & effectively treating women living with or at risk for HIV/co-infections
Lessons learned for ethically advancing research with pregnant women in the range of disease contexts