Contact: Ed Bodensiek, Johns Hopkins Berman Institute of Bioethics, Office of Communications, 410-516-8523, ebodensiek@jhu.edu

BALTIMORE, Jan. 23 /Standard Newswire/ -- 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.

Kass and Hyder also direct the Johns Hopkins-Fogarty International Research Ethics Training Program for Africa. The latest case study from Kass and 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:

• Research ethics committees in Africa are facing a number of challenges, including inadequate funding, staffing and training. One quarter of the research ethics committees report that no operating budget is in place. Half of the committees report that funding comes from fees for reviews, while the remaining committees report that funding comes from government or foreign agencies. Fees vary from US $5 for reviews submitted by students to US $585 for industry studies.
  
  
• A lack of expertise in how to consider the ethical aspects of proposed research was frequently found. This often led to a disproportionate focus on the scientific and financial aspects of the research being considered. Research ethics training is infrequent, while two committees report that its own members have never received training.
  
  
• Ethics review is increasingly seen as part of the professional research culture. Further, the longer a committee has been in existence, the more likely it is to have depth and training in ethics and secure funding for its work.
  
  
• The number of protocols reviewed each year varies widely. Three research ethics committees reviewed eight to 12 protocols per year, three reviewed 30-50, five reviewed 100-250, and one reviewed 600 per year.
  
  
• Most of the committees report completing their reviews in one to two months (ranging from two weeks to more than three weeks).
  
  
• Committee sizes ranged from nine to 31 members. Basic administrative capabilities were in place, but varied. While nearly all of the research ethics committees kept minutes of their meetings, two committees reported that no standard operating procedures existed.
  
  
• Two of the research ethics committees surveyed thought it was difficult to offer a truly independent assessment of proposed research knowing that greater funding for their own institutions was at stake.
  
  
• Reported challenges include the tendency of a few research ethics committees to "rubber stamp" approvals in order to secure international funding.

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 Bioethics Training 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 http://www.bioethicsinstitute.org.