The National Academies of Sciences, Engineering, and Medicine have named JoNell Efantis Potter, Ph.D., APRN, FAAN, a professor of clinical obstetrics, gynecology, and reproductive sciences at the University of Miami Miller School of Medicine, to a new committee. The group will develop a framework to address legal ethical, regulatory, and policy issues for research specific to pregnant and lactating persons.
The committee comes amid concerns over how prescription medicines affect people pregnant and lactating. About four million people in the United States give birth annually, and 70% of them take at least one prescription medication during pregnancy. Yet, “pregnant and lactating persons are often excluded from clinical trials, and often have to make treatment decisions without an adequate understanding of the benefits and risks to themselves and their developing or newborn baby,” the academies said in announcing the new panel.
The ad hoc committee, made up of some dozen members, will research the state of real and perceived liability around research conducted in pregnant and lactating persons, including collecting and analyzing federal and state laws and regulations on liability for that research, the academies said.
Based on its review of that information and other expert and public input, the panel will develop a report with findings, conclusions, and recommendations “for safely and ethically including pregnant and lactating persons in clinical research that substantially mitigates or avoids incurring liability (absent negligence or malfeasance),” according to the academies.
The academies are private, nonprofit groups that conduct research and advise the government on science and technology issues. The National Academy of Sciences was created in 1863, the National Academy of Engineering in 1964, and the National Academy of Medicine in 1970.
Dr. Potter serves as the vice chair of research for the Division of Reproductive Services, and vice chair for faculty affairs and professional development in the Department of Obstetrics, Gynecology and Reproductive Sciences. She serves as chief of the women’s HIV service, one of the largest clinical programs in the United States for women living with HIV/AIDS, and founder of the THRIVE program, a Department of Justice-funded program to provide health care for patients who have been victimized by human trafficking.
Dr. Potter is a member of the University of Miami Faculty Senate and the Medical Faculty Council and serves as vice chair for the Institutional Review Board (Board C). She received both her Ph.D. and M.S. in nursing from the University of Miami and is a fellow in the American Academy of Nursing.