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 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, deputy director for public health at the Berman
Institute of Bioethics and the Phoebe R. Berman Professor
of Bioethics and Public Health at the Bloomberg School.
Adnan A. Hyder, core faculty of the Berman Institute
of Bioethics and assistant professor at the Bloomberg
School, said, "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."
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 the following:
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 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 $5 for
reviews submitted by students to $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, and two committees reported 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 to 50, five reviewed 100 to 250, and one
reviewed 600 per year.
Most committees reported
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 the research
ethics committees kept minutes of their meetings, two
reported that no standard operating procedures existed.
Two of the research
committees 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," Kass said. "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.
The report is available at
www.plos.org/press/plme-04-01-kass.pdf.
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