Early stage gene therapy clinical trials, which are recruiting patients from low- and middle-income countries may not be ethically viable, bioethicists at Carnegie Mellon and McGill universities have revealed.
Their commentary, published in the journal The Lancet, says that such interventions might be promising, but they may also largely unknown in humans.
"There are many reasons why researchers might look to the developing world for research subjects," said Alex John London, lead author of 'Justice in Translation: From Bench to Bedside in the Developing World' and director of Carnegie Mellon's Center for the Advancement of Applied Ethics and Political Philosophy.
"But serious ethical issues can arise when research relies on the deprivations experienced by people living in developing countries to advance research that is not responsive to the urgent health needs of their communities," he added.
One major reason for the recruitment of subjects from developing countries, according to the researchers, lies in the fact that diseases like malaria are much more common in such countries.
Along with his co-author Jonathan Kimmelman, an assistant professor in McGill's Biomedical Ethics Unit, London urges organizations that that sponsor research in low- and middle-income countries to ensure that they are addressing urgent health needs of such countries.
The researchers believe that this fulfilling this requirement represents an important step toward unlocking the substantial promise of innovative research like gene therapy for populations that often experience staggering health needs.
"Our goal is not to curtail research in low and middle-income countries. It is to make sure that project sponsors give careful consideration to relationship between a particular research study and the needs of the communities from which study participants are drawn," said London, who is also an associate professor of philosophy at Carnegie Mellon.