Baltimore -- Throughout Africa, the number of people participating in health research is on the rise, yet surprisingly little is known about how research ethics committees – the critically important, independent review groups charged with protecting human subjects and reviewing protocols – actually operate. In a new case study published in the January 2007 issue of PLoS Medicine, researchers from the Johns Hopkins Berman Institute of Bioethics and the Johns Hopkins Bloomberg School of Public Health aim to change that.
"Research ethics committees are designed to be third-party, independent review bodies to protect the welfare of research participants. But how are they set up in Africa? How do they operate? Some committees are hesitant to be too critical of studies, because in some African communities, a clinical study may bring jobs, medicines, or prestige," said principal investigator Nancy Kass, ScD, deputy director for public health at the Johns Hopkins Berman Institute of Bioethics and the Phoebe R. Berman Professor of Bioethics and Public Health at the Johns Hopkins Bloomberg School of Public Health.
"Our case study closely examined how these committees function in Africa. The results can now help us better understand some very real, on-the-ground challenges they face," said Adnan A. Hyder, MD, MPH, PhD, core faculty of the Johns Hopkins Berman Institute of Bioethics and Assistant Professor at the Johns Hopkins Bloomberg School of Public Health. Nancy Kass and Adnan Hyder also direct the Johns Hopkins-Fogarty International Research Ethics Training Program for Africa.
The latest case study from Nancy Kass and Adnan Hyder included the active collaboration of nearly a dozen African researchers. The history and operational structure of 12 research ethics committees in nine African countries were examined. Key findings of the new report include:
While acknowledging that much more needs to be done, the case study's authors say they were encouraged to learn that research ethics review in some parts of Africa is becoming more routine. This may be partly explained by the increasing number of African investigators submitting articles to international journals that require the approval of a local research ethics committee as a condition of publication. The case study suggests that national policies across Africa are needed to mandate the creation and monitoring of research ethics committees during a time when health research on humans is increasing. The authors suggest this is more likely to occur when international funders, aid agencies, and journals require it.
"Research ethics committees are expensive, so some countries will not create them until they are told to do so," said Nancy Kass. "Until that happens, this report should help researchers working in Africa better understand the landscape of ethics review there. And while it doesn't represent all African research ethics committees, the report can also help large funders better manage resources for capacity development on a continent where health research is critical."
A recent report from the World Health Organization's Africa Regional Office found that 36 percent of its member countries did not have research ethics committees.
About the Report:
The Johns Hopkins case study examined research ethics committees in the Democratic Republic of the Congo, Ghana, Kenya, Nigeria, South Africa, Sudan, Tanzania, Zambia, and Zimbabwe. The case study was the result of collaboration with participants from the Johns Hopkins-Fogarty African Bioethics Training program, funded by the Fogarty International Center, National Institutes of Health. The Johns Hopkins-Fogarty African BioethicsTraining Program began in 2000. The report is available at http://www.plos.org/press/plme-04-01-kass.pdf
About the Johns Hopkins Berman Institute of Bioethics:
One of the largest centers of its kind in the world, the Johns Hopkins Berman Institute of Bioethics is the home for collaborative scholarship and teaching on the ethics of clinical practice, public health, and biomedical science at Johns Hopkins University. Since 1995, the Institute has worked with governmental agencies, non-governmental organizations, and private sector organizations to address and resolve ethical issues. Institute faculty represent such disciplines as medicine, nursing, law, philosophy, public health, and the social sciences. Their works helps anticipate and inform debates on complex moral challenges; discerns ethically acceptable alternatives in medical, scientific, and public health policy; and helps to prepare the next generation of bioethicists. More information is available at www.bioethicsinstitute.org .
PLOS Medicine