E-drug: Drug testing in developing countries (cont)
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The Institutional Review Board (IRB) in the U.S. were set up to protect
human research subjects. The evolution of IRB in the US has been a
gradual process since 1966. The regulations concerning the functioning
of IRB have been gradually been updated. All research conducted in the
US must be approved by a Review Board which may be Institutional or
Non Institutional.
The review boards function is to ensure that the fundamental ethical
principles as outlined in the various reports and Commissions set up by
the US Government are followed by the research institutes. The Review
Boards look at respect for persons, beneficence ( do no harm), justice
and a good study design. Though the Review Boards have been in place
for several years, there are occasional incidences where they have
been
criticized for approving research proposals which according to some were
unethical.
The Review Boards work in a setting of a regulated environment with
several watchdogs such as the FDA ( Food and Drug Authority), and the
Department of Health and Human Services which has a basic policy for
protection of human subjects.
These standards must be compared with what exists in a developing
country.In a developing country, the institutional and legal framework
to approve research in human subjects do not exist. If they do, they are
not independent. Thus, a researcher may be a member of an " approving"
body. This leads to a fundamental issue of conflict between the
researcher and the need to get the approval as fast as possible.
The issue of respect for persons is a crucial matter. The mechanisms to
protect " respect of research subjects" such as the confidentiality, the
right give informed consent and the right to refuse coercion simply do
not exist in most developing countries. The mechanisms to protect human
subjects from " harm" do not exist in most developing countries.
The average per capital income in Sub Saharan African countries is less
then US$ 400 per annum. The regulatory mechanisms to protect human
research subjects do not exist. Corruption is "endemic" in most Sub
Saharan countries. Personal contacts with powerful people will get you
everywhere.
Is it really ethical to do research in this environment?
Let the IRB in the US have a look at the proposal and at the same time
let the developing countries develop their capacity to regulate.
If the requirement for US IRB approval is removed, we will soon have
the third world human subjects become the testing ground for
multinational
companies and " enthusiastic researchers" who will want to test their
drugs which will never be used in a developing country
Dr S K Sharif
Medical Specialist
Mombasa
Kenya
"Dr.S.K.Sharif" <sksharif@Africaonline.co.ke>
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