The Kennedy Institute of Ethics received part of a $3.6 million grant from the National Institute of Health to fund a joint study on the ethical concerns with conducting research on pregnant women with HIV in late September.
The grant was awarded to Georgetown and three other universities including the University of North Carolina, Johns Hopkins University and the University of Washington. Georgetown will share the funding with the other institutions.
The study, titled “Pregnancy and HIV/AIDS: Seeking Equitable Study,” is a four-year collaborative project led by Kennedy Institute of Ethics Director Margaret Little, the grant’s co-principal investigator, along with doctors and professors from the other universities.
The four universities first applied for the NIH grant in 2013 and received approval for a one-year project. After further development in 2015, the project was resubmitted and approved for a four-year grant.
Little said that the project aims to identify the perceived challenges of studying HIV in pregnant women, find ethical and legally sound solutions to these hurdles and provide advice to medical researchers.
To accomplish this, the project will conduct research, organize informative workshops and develop concrete guidelines for researchers looking to design trials with pregnant women. The project will reach out to researchers and patients in the United States, Malawi, Botswana and South Africa.
“Our aim is to give concrete guidance on how research can be conducted to ethically high standards and in ways acceptable to the regulations,” Little said.
According to Little, researchers are hesitant to conduct research on treating illnesses that involve pregnant women, despite the fact that pregnant women are at a higher risk of contracting HIV.
“Knowing how to dose medication during pregnancy, given the radically changed metabolism of the pregnant body, and knowing which medications have a proper risk/benefit ratio … is critical,” Little wrote in an email to The Hoya. “Health researchers usually avoid doing clinical research with pregnant women out of concern and confusion about the ethics of it. In fact, regulations allow such research.”
Liza Dawson, the research ethics team leader in the Division of AIDS at the NIH, said that the grant will provide valuable data on pregnant women suffering from AIDS. Pregnant women are at a higher risk of infection and often develop more severe symptoms. “We should be concerned about safety of the mother and the fetus and the ultimate safety of the infant … [but] because of those concerns about safety, there has been a big hesitancy to include pregnant women in studies,” Dawson said. “That’s understandable, but it has created a big problem in that we don’t have the evidence base for treatment of pregnant women.”
According to KIE Director of Communications and Project Development Kelly Heuer, the project grew out of the Second Wave Workshop hosted by Georgetown in April 2009, which focused on the inclusion of pregnant women in medical research.
“When the first group formally convened at Georgetown to examine the tangle of complex issues surrounding research on pregnant women, our sights were set very high,” Heuer said.
The grant was awarded to Georgetown and the other universities by an external panel of academic peer reviewers called a study section, which evaluated the project on its significance, investigators, innovation, approach and environment. NIH bioethics grants are only given twice per year.
Dawson said that the project may extend beyond HIV into providing health care for pregnant women with other diseases.
“I’m optimistic that this project can help us work on these ethical challenges in other areas,” Dawson said. “It’s good to remember that these are everyday issues that we all struggle with, about how to balance different risks and benefits or different actions that may have diverse consequences …. in a complex world.”
Heuer said she is proud of Little and the other project participants for taking on a complex problem that is often ignored.
“Maggie and the other leaders on this project are moving aggressively … to help the women and children who are harmed by our collective societal failure,” Heuer said. “I couldn’t be more proud of … the whole team’s commitment to making strides commensurate with the scope of the problem.”