Media contact: Les Lang (919) 966-9366, firstname.lastname@example.org
Wednesday, Jan. 18, 2012
CHAPEL HILL – Many of the drugs entering the market today have been tested and refined through trials in developing countries. Although conducting science abroad can have both scientific and societal benefits, this growing trend also poses challenges for ensuring research is conducted ethically and responsibly.
University of North Carolina at Chapel Hill researchers are working to promote ethics in biomedical research, public health activities and medical practice through two projects in Africa. The projects, funded by the Fogarty International Center of the National Institutes of Health, are part of a broad effort to build bioethics capacity in developing countries.
“When it comes to global health research, neither the science nor the ethics should be a one-way street,” said Stuart Rennie, PhD, who is co-principal investigator for one of the UNC projects. “People in developing countries should be involved in this conversation, as well.” Rennie is research assistant professor in the department of social medicine and co-chair of the UNC Behavioral Institutional Review Board.
Since 2004, Rennie and others have worked with local institutions in the Democratic Republic of the Congo, the Republic of Congo, Burundi and Madagascar to lead workshops and training sessions in research ethics, establish bioethics programs at two universities and increase public awareness of research ethics in local communities. A project in South Africa launched earlier this year.
An Increased Threat of Exploitation
The impetus for the projects stems from concerns that research conducted in developing countries often falls short of the ethical standards that would be required in the developed world. “We’ve outsourced a lot of research to these countries, just like we’ve outsourced making shoes or clothes,” said Rennie. “Over the last 10-15 years, there’s been a kind of explosive growth in research taking place in developing countries, and that’s not always been because we’re very interested in developing drugs for those countries or health interventions for those countries. Part of it, at least, is driven by the fact that it’s cheaper to run studies in those countries, and it’s easier to get people to participate in studies.”
There are some valid scientific reasons for conducting biomedical research in developing countries. For example, it makes sense to test drugs or public health interventions in the populations they are designed to benefit. Also, it is often desirable to enroll research subjects who are “drug naïve”—not already taking medications that would potentially muddy study results—and such people are easier to find in developing countries.
On the other hand, people in poorer countries can be vulnerable to exploitation in ways people in wealthier countries are not, and regulations for protecting research participants are often more lax, said Rennie.
In most studies, a new drug or approach is compared against the best existing treatment, or “standard of care.” One vexing question for researchers is whether “standard of care” should be defined as the best treatment available in developed countries where the research originates, or in the countries where the research is being conducted. “It’s really problematic what the standard of care should be in clinical trials,” said Rennie.
For example, in controversial HIV prevention trials conducted in Africa in the 1990s, some HIV-positive pregnant women were given a placebo instead of a long course of antiretrovirals, which at that point was considered the standard of care for preventing mother-to-child HIV transmission in the developed world. Critics argued the women should have received the long course of antiretrovirals instead of a placebo, even though that “standard” treatment was beyond the reach of most Africans.
“Another persistent issue is informed consent—both the ‘informed’ part and the ‘consent’ part,” said Rennie. People who otherwise have little or no access to health care may join a study simply to receive medical care, without fully understanding that they are participating in a research study and that they may, for example, receive only a placebo. Participants also may feel compelled to remain in a study once they are in it.
“The ideal of people being free and informed in joining these studies takes a beating in developing countries,” said Rennie.
Building Capacity for Bioethics
The UNC team has taken a multi-pronged approach to help their African colleagues integrate ethics considerations into research and public health efforts. The projects’ focus, said Rennie, is on “trying to make an impact on institutions, so that whatever impact you make is sustained into the future.”
One goal is to educate people who can take positions of leadership and influence the research culture. For example, the UNC team helped develop a master’s level degree program in bioethics in Kinshasa, Democratic Republic of the Congo. A similar program, targeting mid-level professionals, is being implemented in South Africa. “At the end, [trainees] return to their institutions and they’re expected to build capacity for research ethics committees, publish in bioethics and teach about it,” said Rennie.
In addition, the team has helped two local universities develop bioethics units, at the Kinshasa School of Public Health (in the Democratic Republic of the Congo) and at Institut National de Sante Publique et Communautaire (in Madagascar). These units create bioethics courses for students and faculty, conduct public outreach activities and provide a physical symbol of the institutions’ commitment to responsible research. More than 400 students have now been exposed to resulting bioethics curricula. The team has also provided training to create or bolster institutional research review boards.
The team takes an integrated approach to building bioethics capacity in the practice of research, public health and medicine. “We don’t think that these things can stand alone,” said Rennie. “We tend to look at it more holistically—we don’t think that you can have a research ethics culture where there’s not much of a medical ethics culture.”
The dividends are paying off, and the researchers are seeing evidence of a growing culture of bioethics. “Every time we go, we’re struck by how much the local people think that these activities are relevant and that they want them to go on,” said Rennie. “They feel that they’re needed—that there isn’t enough of it. Usually the complaint is, ‘Why only so many trainees?’ or ‘Why only so many sites?’ We need this much more than your project can give.”
In addition to Rennie, UNC faculty members involved in the projects include co-principal investigator Frieda Behets, PhD, Professor of epidemiology at the Gillings School of Global Public Health and Eric Juengst, PhD, director of the UNC Center for Bioethics. Dr. Laurent Ravez and the Interdisciplinary Center for Law, Ethics and Health Sciences (Namur, Belgium) are UNC’s European partners in these projects. There are 22 bioethics projects funded around the world under NIH Fogarty International Center grants.
Click here to read a related article from Project Manager Bavon Mupenda, MPH, of the UNC Fogarty Bioethics Research Capacity Building Project in Kinshasa, Democratic Republic of the Congo.